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by EOS Intelligence EOS Intelligence No Comments

Indian Pharma Needs to Reinforce Supply Chain Capabilities

COVID-19 has emphasized the importance of strong healthcare and pharmaceutical ecosystem for India. Constant demand for drugs and the expectation to deliver them in time put a lot of pressure on pharma supply chains, highlighting several challenges and shortcomings. At the same time, the Indian pharma sector seems to have benefited from the situation as well, as the pandemic unlocked new avenues of growth. To seize new opportunities, the Indian pharma sector should now focus on increasing manufacturing capacity, invest in R&D capabilities, develop world-class infrastructure, and strengthen its supply chain network.

Challenging times for the Indian pharma sector

With coronavirus wreaking havoc, the Indian pharmaceutical sector was shaken and the pandemic inflicted several challenges on the industry.

The key challenge faced by pharmaceutical companies has been the shortage of key raw materials for manufacturing drugs. India imports 60% of APIs (Active Pharmaceutical Ingredients) and DIs (Drug Intermediates) and nearly 70% of this demand is met by Chinese companies (as of July 2020). This reliance to import cheaper raw materials from countries such as China is a result of lack of tax incentives, high cost of utilities, and low import duties in India.

India’s dependence on China has affected the supply of essential APIs. The recent pandemic has magnified this problem, and in order to meet the increasing demand, Indian pharma manufacturers need to strengthen their supply chain strategies by working with multiple API suppliers, both domestic as well as international.

Another concern has been the increased raw materials and logistics cost. Between January and June 2020, the production costs at the Chinese suppliers increased due to the implementation of safety and hygiene measures thus increasing the overall cost of APIs and other materials imported by India by an average of 25%. Logistics prices also went up during the same period, with the cost of shipping a container from China to India increasing to an average of US$ 1,250 up from US$ 750. Additionally, air freight charges also went up from US$ 2/kg to US$ 5-6/kg.

Furthermore, restrictions on movement of products and other goods also posed a problem for pharma supply chain. Even though the sector was exempted from these restrictions, delays in the delivery of drugs were registered. These delays have been largely contributed to by the complexity of various processes and their elements (from raw material procurement to procuring casing and other packaging material – all of which come from different locations to the final assembly point, and their delivery can be exposed to delays at each stage). While logistics companies tried to make product deliveries on time, they were restrained by limited workforce and movement restrictions (that required clearance at every step).

Moreover, due to panic buying, scarcity of OTC and generic drugs was also observed.

Government’s push to make India self-reliant

The government has undertaken steps to strengthen the pharma sector and announced several schemes and policies to boost domestic pharma manufacturing.

To reduce import dependence in APIs and boost domestic manufacturing, the government approved a US$ 971.6 million (INR 69.4 billion) Production Linked Incentive (PLI) Scheme in March 2020 to promote domestic manufacturing of APIs and KSMs (Key Starting Materials)/DIs. Under the scheme, financial incentives ranging from 5% to 20% of incremental sales will be given to selected manufacturers of 41 critical bulk drugs (of the identified 53 APIs for which the country is heavily dependent on imports). This includes aid for fermentation-based products from FY2023–2024 to FY2028–2029 and for chemical-synthesis-based products from FY2022–2023 to FY2027–2028. It is expected that the scheme will result in incremental sales of US$ 649.6 million (INR 464 billion) and generate a large number of employment opportunities.

Moreover, in November 2020, a new PLI Scheme (referred to as PLI 2.0) for the promotion of domestic manufacturing of pharmaceutical products was announced, wherein US$ 210 million (INR 150 billion) were allotted for pharma goods manufacturers based on their Global Manufacturing Revenue (GMR). Financial incentives ranging from 3% to 10% of incremental sales will be given to manufacturers (classified under Group A – having GMR of pharmaceutical goods of at least US$ 700 million (INR 50 billion), Group B – having GMR between US$ 70 million (INR 5 billion) and US$ 700 million (INR 50 billion), and Group C – having GMR less than US$ 70 million (INR 5 billion). The objective of the scheme is to promote production of high-value products, increase the value addition in exports, and improve the availability of a wider range of affordable medicines for local consumers. The initiative is likely to create 100,000 (20,000 direct and 80,000 indirect) jobs while generating total incremental sales of US$ 41,160 million (INR 2,940 billion) and total incremental exports of US$ 27,440 million (INR 1,960 billion) during six years from FY2022-2023 to FY2027-2028.

Another scheme named Promotion of Bulk Drug Parks was announced by the government in March 2020 to attain self-reliance. Under the plan, funds worth US$ 420 million (INR 30 billion) were allotted for setting up three bulk drug parks between 2020 and 2025. This initiative aims at reducing the manufacturing cost as well as the dependency on importing bulk drugs from other countries. Financial assistance will be given to selected bulk drug parks to the extent of 70% of the project cost of common infrastructure facilities (for north-eastern regions and states in the mountainous areas, the assistance will be 90%). The aid per bulk Drug Park will be limited to US$ 140 million (INR 10 billion).

Furthermore, to end reliance on China, Indian pharma companies are also taking steps to strengthen their operations and manufacturing capabilities with regard to pharmaceutical ingredients. For instance, Cipla Ltd. (Mumbai-based pharmaceutical company) launched the “API re-imagination” program in 2020 to expand its manufacturing capacity by using the government incentive schemes.

The announcement of the above schemes is a show of intent by the government towards building a self-sufficient pharma sector in India. It will be interesting to see how much pharma players stand to gain from these potentially game-changing initiatives. However, only time will tell if these policies are good enough for the industry stakeholders or will these schemes not be plentiful enough to truly help the manufacturers.

Indian Pharma Needs to Reinforce Supply Chain Capabilities by EOS Intelligence

Investment in API and intermediaries’ sub-sectors on the rise

Since the outbreak of COVID-19, Indian pharmaceutical companies (that deal particularly with manufacturing of APIs, vaccine-related products, and bulk pharma chemicals) have been attracting huge investment from private equity firms. This is happening mainly because of two reasons. Firstly, the occurrence of the second wave of COVID-19 in India has increased the demand for medicines (including demand for self-care, nutritional, and preventive pharma products to boost immunity), and secondly, pharma companies across North America and Europe are shifting their manufacturing sites from China to India (to reduce dependency on a single source). Indian companies received an investment worth US$ 1.5 billion from private equity firms during the FY2020-2021 (since the coronavirus outbreak) and the investment is expected to reach US$ 3-4 billion in the FY2021-2022.

Some of the major deals that happened in this space included Carlyle Group (US-based private equity firm) buying 20% stake in Piramal Pharma (Mumbai-based pharma company) for US$ 490 million in June 2020 and 74% stake in SeQuent Scientific (India-based pharmaceutical company) for US$ 210 million in May 2020. Further, KKR & Co. (US-based global investment company) purchased a 54% controlling stake in J.B. Chemicals & Pharmaceuticals Ltd. (Mumbai-based pharmaceutical company) for nearly US$ 410 million in July 2020. Another example is Advent International (US-based private equity firm) acquiring stakes in RA Chem Pharma (Hyderabad-based pharmaceutical company) for US$ 128 million in July 2020.

From a capital perspective, COVID-19 acted as an investment accelerant that will keep the market open for opportunistic deals for many years to come. In the current scenario, investment firms are re-evaluating the pharma landscape and looking to invest in innovative ideas and products that help them grow. It is highly likely that in the coming months, if the right opportunity strikes, the investment firms will not deter from going ahead with novel deal structures. This could include arrangements such as both parties sharing equal risk and rewards, a for-profit partnership wherein the investor specifically focuses on enhancing the digital-marketing capabilities of the pharma company (rather than sticking to just acquiring a certain share or merge with an existing company) and being open to taking more risk, if needed.

Partnerships expected to increase

The pandemic has led pharma companies to rethink their operational and business strategies. For long-term sustainability, players are analyzing their market position and partnering with other industry stakeholders for better market penetration and value creation for their customers.

In November 2020, Indian Immunologicals Ltd. (Hyderabad-based vaccine company) announced that the company would invest US$ 10.5 million (INR 0.75 billion) in a new viral antigen manufacturing plant based in Telangana that would cater to the need for vaccines for diseases such as dengue, zika, varicella, and COVID-19 (in April 2021, the company announced a research collaboration agreement with the Griffith University, Australia to develop a vaccine for the coronavirus).

Furthermore, Jubilant Life Sciences Ltd. (Noida-based pharma company) entered into a non-exclusive licensing agreement with Gilead Sciences (US-based biopharmaceutical company) granting it the right to register, manufacture, and sell Remdesivir (Gilead Sciences’ drug currently used as a potential therapy for Covid-19) in India (along with other 126 countries).

In February 2021, to scale up the biopharma ecosystem, the state government of Telangana partnered with Cytiva (earlier GE Healthcare Life Sciences) to open a new Fast Trak lab in Hyderabad. This facility will enable the biopharma companies in the region to improve and increase production efficiency, reduce operational costs, and make products available in the market quicker.

Future ripe for new opportunities

The pandemic has opened a stream of opportunities for India’s pharma sector which are expected to drive the growth of the sector in the long term.

China’s supply disruption and increased raw material costs have forced global pharma companies to reduce dependence on China. As an alternative, the companies either set up new API manufacturing plants (which is time-consuming) or turn to existing European or US drug manufacturers to help them meet their requirements. However, both options are capitally draining and there is a need for finding a cost-efficient solution. This presents a huge opportunity for the Indian API sector which is also a key earnings growth driver for pharma manufacturers.

India is among the leading global producers of cost-effective generic medicines. Now there is a need to diversify the product offerings by focusing on complex generics and biosimilars. With the guidance of the United States Food & Drug Administration (USFDA) in identifying the most appropriate methodology for developing complex generic drugs, Indian pharma companies such as Dr. Reddy’s, Zydus, Glenmark, Aurobindo, Torrent, Lupin, Cipla, Sun, and Cadila are working on their product pipeline of complex generics. Currently, the space has limited competition and offers higher margins (in comparison to generic drugs) thus presenting a lucrative opportunity for Indian players to explore and grow.

Similarly, biosimilars (referred to as similar biologics in India) is another area where Indian companies have not been faring too well in international markets mainly due to the non-alignment of Indian regulatory guidelines with the guidelines in other markets (mainly in Europe and USA). The government had already revised the guidelines of similar biologics (done in 2016, which provided an efficient regulatory pathway for manufacturing processes assuring safety and efficacy with quality as per cGMP (Current Good Manufacturing Practice regulations enforced by the FDA)) and introduced industry-institute initiatives (such as ‘National Bio-Pharma Mission’, launched in 2017 to accelerate biopharmaceutical development, including biosimilars, among others) to improve the situation. But now with the intensified need for improved healthcare system and more effective medicines, COVID has presented Indian companies with an opportunity to shape their biosimilar landscape.

India holds a strong position as a key destination for outsourcing research activities. While it has been a preferred location for global pharma companies to set R&D plants for a number of years now, becoming an outsourcing hub for pharma research is another growth area that is yet to be explored to its full potential.

EOS Perspective

Currently, the Indian pharma industry is at an interesting crossroad wherein the industry responded to the unprecedented situation with agility and persistence. The pandemic presented several opportunities and challenges for the industry and unsurprisingly, had a positive impact on the sector. The pandemic acted as a catalyst for change and investment for the pharma sector, which also responded to the challenges by adjusting to the new normal that furthered new opportunities.

In the past few months, COVID-19 has led the government to reassess the country’s pharmaceutical manufacturing capabilities and led them to take steps to make India self-sufficient. As an immediate measure, the country has been reviewing its business policies (for the ease of doing business and to attract more investment) and pharma companies recalibrating their business models, and some success has been achieved. The government should also be mindful that, in the long run, success will only be achieved when industry stakeholders are presented with a business environment (in the form of incentives, tax-subsidies, low rate of interest on bank loans, utilities such as electricity and water at discounted rates, and transparent business policies, etc.) that is conducive for growth.

Moving forward, the Indian pharma companies need to be adaptive and flexible. While the sector has been resilient to the effects of the coronavirus pandemic, companies need to focus on risk management as well. Moreover, with continuous capital flowing into the sector, there is an opportunity for firms to not just broaden their scope of innovation but also to invest in critical therapeutic areas.

To emerge as a winner post pandemic, the Indian pharma industry needs to focus on its strengths and propel full steam in the direction of opportunities presented by COVID-19.

*All currency conversions as on 20th May, 2021, 1 INR = 0.014 US$

by EOS Intelligence EOS Intelligence No Comments

Ethiopia’s Half-Hearted Push to Telecom Privatization Finds Limited Success

Ethiopia’s telecom sector has been considered as the last frontier for telecom players, since the country is one of just a few to still have a state-run telecom industry. However, this is due to change, as the Ethiopian government has finally opened up the sector to private investment. Privatization of the telecom sector has been on the prime minister Abiy Ahmed’s agenda since he first took office in 2018, however, it was initially a slow process, mostly due to bureaucracy, ongoing military conflicts, and COVID-19 outburst. Apart from that, the privatization terms have not been very attractive for private players, making the whole process complicated.

With a population of about 116 million and only about 45 million telecom subscribers, Ethiopia has been one of the most eyed markets by telecom players globally. The telecom sector has immense potential as Ethiopia has one of the lowest mobile penetration rates in Africa.

To put this in perspective, Ethiopia has a mobile connection rate of only 38.5%, while Sub-Saharan Africa has a mobile connection rate of 77%. Moreover, 20% of Ethiopian users have access to the Internet and only about 6% currently use social media, which is much lower than that in other African countries. That being said, about 69% of the country’s population is below the age of 29, making it a strong potential market for the use of mobile Internet and social media in the future.

This makes the market extremely attractive for international players, who have for long been kept at bay by the Ethiopian government. Thus, when the government expressed plans to open up the sector, several leading telecom players such as MTN, Orange, Etisalat, Axian, Saudi Telecom Company, Telkom, Vodafone, and Safaricom showed interest in penetrating this untapped and underserved market.

Currently, state-owned Ethio Telecom, is the only player in the market. Lack of competition has resulted in subpar service levels, poor network infrastructure, and limited service offerings. For instance, mobile money services, which are extremely popular and common across Africa have only been introduced in Ethiopia in May 2021.

Moreover, as per UN International Telecommunication Union’s 2017 ICT Development Index (IDI), Ethiopia’s telecom service ranked 170 out of 176 countries. To correct this, in June 2019, the government introduced a legislation to allow privatization and infuse some competition and foreign investment into the sector. The privatization process is expected to rack up the country’s foreign exchange reserves, in addition to facilitating payment of state debt. It also aims to improve the overall telecom service levels and help create employment in the sector.

As a part of its privatization drive, the government has proposed offering two new telecom licenses to international players as well as partially privatizing Ethio Telecom by selling a 40% stake in the company. The sale of the two new licenses will be managed by the International Finance Corporation, which is the private sector arm of the World Bank.

Ethiopia’s Half-Hearted Push to Telecom Privatization Finds Limited Success by EOS Intelligence

While this garnered interest from several international telecom players, with 12 bidders offering ‘expression of interest’ in May 2020, the process has not been very smooth, owing to bureaucracy, ongoing military conflicts in the north of the country, and the proposal of an uneven playing field for international players versus Ethio Telecom. This last challenge appears to be a major obstacle to a smooth privatization process.

As per the government’s initial rulings, the new international players were not to be allowed to provide financial mobile services to their customers, while this service was only to be reserved for Ethio Telecom. Mobile money is a big part of the telecom industry, especially in Africa, where it is extremely popular and profitable as banking infrastructure is weak. This made the deal much less attractive for foreign bidders as mobile money constitutes a huge revenue stream for telecom players in African markets.

However, post the bidding process in May 2021, the government has tweaked the ruling to allow foreign players to offer mobile money services in Africa after completing a minimum of one year of operations in the country. However, since this ruling came in after the bidding process was completed, the government missed out on several bids as well as witnessed lower bids, since companies were under the impression that they will not be allowed to offer mobile money services. As per government estimates, they lost about US$500 million on telecom licenses because of initial ban on mobile money.

Another deterrent to the entire process has been the government’s refusal to allow foreign telecom tower companies to enter the Ethiopian market. The licensed telecom companies would either have to lease the towers from Ethio Telecom or build them themselves, but they would not be allowed to get third party telecom infrastructure players to build new infrastructure for them, as is the norm in other African countries. This greatly handicaps the telecom players who will have to completely depend on the state player to provide infrastructure, who in turn may charge high interconnection charges that may further create an uneven playing field.

These two regulations are expected to insulate Ethio Telecom from facing fierce competition from the potential new players, and in turn may result in incumbency and poor service levels to continue. Moreover, even with regards to Ethio Telecom, the government only plans to sell 40% stake to a private player (while 5% will be sold to public), thereby still maintaining the controlling stake. With minority stake, private players may not be able to work according to their will and make transformative changes to the company. It is considered a way to just get fresh capital infused into the company without the government losing real control of it.

In addition to these limitations, the overall process of privatization has faced delays and complications. The bidding process has been delayed several times over the past year owing to regulatory complexities, the COVID crisis, and ongoing military conflict in the northern region. The process, which was supposed to be completed in 2020 was completed in May 2021, with the final bidding process taking place in April 2021 and the government awarding the bids in May 2021.

During the bidding process, the government received only two technical bids out of the initial 12 companies that had shown interest. These were from MTN and a consortium called ‘Global Partnership for Ethiopia’ comprising Vodafone, Safaricom, and Vodacom. While the Vodafone consortium partnered with CDC Group, a UK-based sovereign wealth fund, and Japanese conglomerate, Sumitomo Corporation, for financing, MTN group teamed up with Silk Road Fund, China’s state-owned investment fund to finance their expansion plans into Ethiopia. The other companies that had initially shown interest backed out of the process. These include Etisalat, Axian, Orange, Saudi Telecom Company, Telkom SA, Liquid Telecom, Snail Mobile, Kandu Global Communications, and Electromecha International Projects.

In late May 2021, the government awarded one of the licenses to the ‘Global Partnership for Ethiopia’ (Vodafone, Safaricom, and Vodacom) consortium for a bid of US$850 million. While it had two licenses to give out, it chose not to award the other license to MTN, who had made a bid of US$600 million. As per government officials, the latter bid was much lower than the expected price, which was anticipated to be close to a billion by the government.

Moreover, the government seems to have withheld one of the licenses as currently the interest in the deal has been low, considering that it only received two bids for two licenses. Given that they have somewhat altered and relaxed the guidelines on mobile money (from not being allowed to be allowed after minimum one year of operations), there may be some renewed interest from other players in the market. That being said, the restriction on construction of telecom infrastructure is expected to stay as is.

In the meanwhile, Orange, instead of bidding for the new licenses, has shown interest in purchasing the 40% stake in Ethio Telecom, which will give the company access to mobile money services right away. However, no formal statement or bid has been made by either of the parties yet. If the deal goes through, it will give Orange a definite advantage over its international competitors, who would have to wait for minimum one year to launch mobile money services in the market. In May 2021, Ethio Telecom launched its first mobile money service, called Telebirr, and managed to get 1 million subscribers for the service within a two-week span. This brings forth the potential mobile money holds in a market such as Ethiopia.

EOS Perspective

While several international telecom companies had initially shown interest in entering the coveted Ethiopian market, most of them have fizzled out over the course of the previous year, with the government only receiving two bids. Moreover, the bid amounts have been much lower than what the government initially anticipated and the government chose to accept only one bid and reject the other. Thus the privatization process can be deemed as only being partially successful. Furthermore, the opportunity cost of restricting mobile money services has been about US$500 million for the government, which is more than 50% of the amount they have received from the one successful auction.

This has occurred because the government has been focusing on sheltering Ethio Telecom from stiff competition by adding the restrictions on mobile money and telecom infrastructure. While this may help Ethio Telecom in the short run, it is detrimental for the overall sector and the privatization efforts.

Restrictions on using third-party infrastructure partners, may also result in a slowdown in rolling out of additional infrastructure, which is much needed especially in rural regions of Ethiopia. Other issues such as ongoing political instability in the northern region have further cast doubt in the minds of investors and foreign players regarding the government’s stability and in turn has impacted the number of bids and bid value.

It is expected that the government will restart the bidding process for the remaining one license soon. However, the success of it depends on the government’s flexibility towards mobile money services. While it has already eased its stance a little, there is still a lot of ambiguity regarding the exact timelines and conditions for the approval. The government must shed clarity on this before re-initiating the bidding process. MTN has also mentioned that it may bid again if mobile money services are included in the bid.

However, with Vodafone-Safaricom-Vodacom consortium already winning one bid and expecting to start services in Ethiopia as early as next year, the company definitely has an edge over its other competitors. Considering that the first bid took more than a year and faced several bureaucratic delays, it is safe to say that the second bid will not happen any time soon, especially since this time it is expected that the government will give a serious thought to the inclusions/exclusions of the deal and the value that mobile money brings to the table for both the government and the bidding company.

by EOS Intelligence EOS Intelligence No Comments

Global Economy Bound to Suffer from Coronavirus Fever

Global economy has slowed down in response to coronavirus. Factories in China and many parts of Europe have been forced to halt production temporarily as some of the largest manufacturing hubs in the world battle with the virus. While the heaviest impact of the virus has been (so far) observed in China, global economy too is impacted as most industries’ global supply chains are highly dependent on China for small components and cheaper production rates.

China is considered to be the manufacturing and exporting hub of the world. Lower labor costs and advanced production capabilities make manufacturing in China attractive to international businesses. World Bank estimated China’s GDP in 2018 to be US$13.6 trillion, making it the second largest economy after the USA (US$20.58 trillion). Since 1952, China’s economy has grown 450 fold as compared with the growth rate of the USA economy. International trade and investment have been the primary reason for the economic growth of the country. This shows China’s strong position in the world and indicates that any disturbances in the country’s businesses could have a global effect.

On New Years’ Eve 2019, an outbreak of a virus known as coronavirus (COVID-19) was reported in Wuhan, China to the WHO. Coronavirus is known to cause respiratory illness that ranges from cough and cold to critical infections. As the virus spreads fast and has a relatively high mortality rate, the Chinese government responded by quarantining Wuhan city and its nearby areas on January 23, 2020. However, this did not contain the situation. In January 2020, WHO designated coronavirus a “public health emergency of international concern” (PHEIC), indicating that measures need to be taken to contain the outbreak. On March 11, 2020, WHO called coronavirus a pandemic with the outbreak spreading across about 164 countries, infecting more than 190,000 people and claiming 7,800+ lives (as of March 18, 2020).

Coronavirus threatening businesses in China and beyond

Businesses globally (and especially in China) are feeling the impact of coronavirus. Workers are stuck in their homes due to the outbreak. Factories and work places remain dormant or are running slower than usual. Also, the effects of coronavirus are spreading across the globe. Initially, all factory shutdowns happened in China, however, the ripple effects of the outbreak can now be seen in other parts of the world as well, especially Italy.

Automotive industry

Global automobile manufacturers, such as General Motors, Volkswagen, Toyota, Daimler, Renault, Honda, Hyundai, and Ford Motors, who have invested heavily in China (for instance, Ford Motor joined ventured with China’s state-owned Chongqing Changan Automobile Company, Ltd., one of China’s biggest auto manufacturers) have shut down their factories and production units in the country. According to a London-based global information provider IHS Markit, Chinese auto industry is likely to lose approximately 1.7 million units of production till March 2020, since Wuhan and the rest of Hubei province, where the outbreak originated, account for 9% of total Chinese auto production. While the factories are reopening slowly (at least outside the Wuhan city) and production is expected to ramp up again, it all depends on how well the outbreak is contained. If the situation drags on for few months, the auto manufacturers might face significant losses which in turn may result in limited supply and price hikes.

American, European, and Japanese automobile manufacturers, among others, are heavily dependent on components supplied from China. Low production of car parts and components in China are resulting in supply shortages for the automakers globally. UN estimates that China shipped close to US$35 billion worth of auto parts in 2018. Also, according to the US Commerce Department’s International Trade Administration, about US$20 billion of Chinese parts were exported to the USA alone in 2018. A large percentage of parts are used in assembly lines that are used to build cars while remaining are supplied to retail stores. Supply chain is crucial in a connected global economy.

Coronavirus outbreak poses a risk to the global automotive supply chain.

South Korea’s Hyundai held off operations at its Ulsan complex in Korea due to lack of parts that were supposed to be imported from China. The plant manufactures 1.4 million vehicles annually and the shutdown has cost approximately US$500 million within just five days of shutting down. However, Hyundai is not the only such case. Nissan’s plant in Kyushu, Japan adjusted its production due to shortage of Chinese parts. French automaker Renault also suspended its production at a plant in Busan, South Korea due to similar reasons. Fiat Chrysler predicts the company’s European plant could be at risk of shutting down due to lack of supply of Chinese parts.

However, very recently, automobile factories in China have started reopening as the virus is slowly getting contained in the region. While Volkswagen has slowly started producing in all its locations in China, Nissan has managed to restart three of its five plants in the country.

That being said, auto factories are facing shutdowns across the world as coronavirus becomes a pandemic. Ford Chrysler has temporarily shut down four of its plants in Italy as the country becomes the second largest affected nation after China.

Automobile supply chains are highly integrated and complex, and require significant investments as well as a long term commitment from automobile manufacturers. A sudden shift in suppliers is not easy. The virus is spreading uncontrollably across Europe now and if France and Germany are forced to follow Italy’s footsteps of shutting down factories to contain its spread, this will spell doom for the auto sector as the two countries are home to some of the biggest automobile manufacturers in the world.

Technology industry

China is the largest manufacturer of phones, television sets, and computers. Much of the consumer technologies from smartphones to LED televisions are manufactured in China. One of the important sectors in the technology industry is smartphones.

The outbreak of coronavirus is bad news for the technology sector, especially at the verge of the 5G technology roll-out. Consumers were eagerly waiting for smartphone launches supporting 5G but with the outbreak, the demand for smartphones has seen a decline. According to the China Academy of Information and Communications Technology, overall smartphone shipments in China fell 37% year over year in January 2020.

Foxconn, which is a China-based manufacturing partner of Apple, has iPhone assembling plants in Zhengzhou and Shenzhen. These plants, which make up a large part for the Apple’s global iPhone assembly line, are currently facing a shortage of workers that will ultimately affect the production levels of iPhone in these factories. According to Reuters, only 10% of workers resumed work after the Lunar New Year holiday in China. As per TrendForce, a Taiwanese technology forecasting firm, Apple’s iPhone production is expected to drop by 10% in the first quarter of 2020.

Moreover, Apple closed down all its retail stores and corporate offices in the first week of February 2020 in China in response to the outbreak. On March 13, 2020, it reopened all of its stores in China as the outbreak seems to be under control. However, while Apple seems to recover from the outbreak in China, it is equally affected by store shutdowns in other parts of the world (especially Europe). On March 11, Apple announced that all stores in Italy will be closed until further notice. Italy has been hit by the virus hard after China. The Italian government imposed a nationwide lockdown on the first week of March 2020.

On the other hand other multinational smartphone giants such as LG, Sony Mobile, Oppo, Motorola, Nokia, and many others have delayed their smartphone launches in the first quarter of 2020 due to the outbreak.

The coronavirus outbreak is more likely to be a disaster for smartphone manufacturers relying on China.

Other sectors such as LCD panels for TVs, laptops, and computer monitors are mostly manufactured in China. According to IHS Markit, there are five LCD factories located in the city of Wuhan and the capacity at these factories is likely to be affected due to the quarantine placed by the Chinese government. This is likely to force Chinese manufacturers to raise prices to deal with the shortage.

According to Upload VR, an American virtual reality-focused technology and media company, Facebook has stopped taking new orders for the standalone VR headset and also said the coronavirus will impact production of its Oculus Quest headset.

Shipping industry

In addition to these sectors, the new coronavirus has also hit shipping industry hard. All shipping segments from container lines to oil tanks have been affected by trade restrictions and factory shutdowns in China and other countries. Shipyards have been deserted and vessels are idle awaiting services since the outbreak.

According to a February 2020 survey conducted by Shanghai International Shipping Institute, a Beijing based think-tank, capacity utilization at major Chinese ports has been 20%-50% lower than normal and one-third of the storage facilities were more than 90% full since goods are not moving out. Terminal operations have also been slow since the outbreak in China. The outbreak is costing container shipping lines US$350 million per week, as per Sea-Intelligence, a Danish maritime data specialist.

According to Sea-Intelligence, by February 2020, 21 sailings between China and America and 10 sailings in the Asia-Europe trade loop had been cancelled since the outbreak. In terms of containers, these cancellations encompass 198,500 containers for the China-America route and 151,500 boxes for the Asia-Europe route.

Moreover, shutting down of factories in China has resulted in a manufacturing slowdown, which in turn is expected to impact the Asian shipping markets. European and American trade is also getting affected as the virus spreads to those continents. US retailers depend heavily on imports from China but the outbreak has caused the shipping volumes to diminish over the first quarter.

The USA is already in the middle of a trade war with China that has put a dent in the imports from China. National Retail Federation (world’s largest retail trade association) and Hackett Associates (US based consultancy and research firm) projects imported container volumes at US seaports is likely to be down by 9.5% in March 2020 from 2019. The outbreak is heavily impacting the supply chains globally and if factory shutdowns continue the impact is more likely to be grave.


Read our other Perspectives on US-China tensions: Sino-US Trade War to Cause Ripple Effect of Implications in Auto Industry and Decoding the USA-China 5G War


Other businesses

In addition to the auto, technology, and shipping industries, other sectors are also feeling the heat from the outbreak. Under Armour, an American sports clothing and accessories manufacturer, estimated that its revenues are likely to decline by US$50-60 million in 2020 owing to the outbreak.

Disney’s theme parks in California, Shanghai, Tokyo, and Hong Kong have been shut down due to the outbreak and this is expected to reduce its operating income by more than US$175 million by second quarter 2020.

Further, IMAX, a Canadian film company, has postponed the release of five films in January 2020, due to the outbreak.

Several fast food chains have been temporarily shut down across China and Italy, however, most of them have opened or are in the process of reopening in China as the outbreak is slowly coming under control there. While the global fast food and retail players have limited exposure in China, they are suffering huge losses in Europe, especially Italy. The restaurant sector is severely impacted there, where all restaurants, fast food chains, and bars have been shut down temporarily till April 3 in an attempt to contain the outbreak.

Another significantly affected industry is the American semiconductor industry as it is heavily connected to the Chinese market. Intel’s (a US-based semiconductor company) Chinese customers account for approximately US$20 billion in revenue in 2019. Another American multinational semiconductor and telecommunications equipment company, Qualcomm draws approximately 47% of its revenue from China sales annually. The outbreak is making its way through various industries and global manufacturers could now see how much they have become dependent on China. Although the virus seems to be getting under control as days pass, the businesses are not yet fully operational. Losses could ramp up if the virus is not contained soon.

Global Economy Bound to Suffer from Coronavirus Fever by EOS Intelligence

 

Housebound consumers dealing with coronavirus

Since the virus outbreak, people across many countries are increasingly housebound. Road traffic in China, Italy, Iran, and other severely affected countries has been minimized and public places have been isolated. People are scared to go out and mostly remain at home. This has led local businesses such as shopping malls, restaurants, cinemas, and department stores to witness a considerable slowdown, while in some countries being forced to shut down.

TV viewing and mobile internet consumption on various apps have increased after the outbreak. According to QuestMobile, a research and consultancy firm, daily time spent with mobile internet rose from 6.1 hours in early January 2020 to 6.8 hours during Lunar New Year (February 2020).

While retail outlets and other businesses are slower, people have turned to ordering products online. JD.com, a Chinese online retailer, reported that its online grocery sales grew 215% (year on year) to 15,000 tons between late January and early February 2020. Further, DingTalk, a communication platform developed by Alibaba in 2014, was recorded as the most downloaded app in China in early February 2020.

EOS Perspective

International businesses depend heavily on Chinese factories to make their products, from auto parts to computer and smartphone accessories. The country has emerged as an important part in the global supply chain, manufacturing components required by companies globally. The coronavirus outbreak has shaken the Chinese economy and global supply chains, which in turn has hurt the global economy, the extent of which is to be seen in the months to come. Oxford Economics, a global forecasting and analysis firm, projected China’s economic growth to slip down to 5.6% in 2020 from 6.1% in 2019, which might in turn reduce the global economic growth by 0.2% to an annual rate of 2.3%.

A similar kind of outbreak was seen in China in late 2002 and 2003, with SARS (Severe Acute Respiratory Syndrome) virus. China was just coming out of recession in 2003 and joined the World Trade Organization, attaining entrance to global markets with its low cost labor and production of cheaper goods. The Chinese market was at its infancy at that time. As per 2004 estimates by economists Jong-Wha Lee and Warwick J. McKibbin, SARS had cost the global economy a total of about US$40 billion. After SARS, China suffered several months of economic retrenchment.

The impact of coronavirus on Chinese as well as global economy seems to be much higher than the impact of SARS, since COVID-19 has spread globally, while China has also grown to be the hub for manufacturing parts for almost every industry since the SARS outbreak. In 2003, China accounted for only 4% of the global GDP, whereas in 2020, its share in the global GDP is close to 17%.

Currently, the key challenge for businesses would be to deal with and recover from the outbreak. On the one hand, they need to protect their workers safety and abide by their respective governments’ regulations, and on other hand they need to safeguard their operations under a strained supply chain and shrunken demand.

In the current landscape, many businesses in China have reopened operations but the outbreak is rapidly spreading to other parts of the world (especially Europe and the USA), where it is impacting several business as well as everyday lives. The best thing for manufacturing companies in this scenario is to re-evaluate their inventory levels vs revised demand levels (which may differ from industry to industry), and consider a short-term re-strategizing of their global supply chains to ensure that raw materials/components or their alternates are available and accessible – bearing in mind their existing production capability with less workers and customer needs during this pandemic period.

With the rapid spread of the virus, it seems that the outbreak is likely to cause considerable damage to the global economy (both in terms of production levels as well as psychological reaction on stock markets), at least in the short term, i.e. next 6 months. However, many experts believe that the situation should soon start coming under control at a global level. For instance, some experts at Goldman Sachs, one of the world’s largest financial services companies, believe that while this pandemic will bring the lowest growth rate of the global GDP in the last 30 years (expected at 2% in 2020), it does not pose any systematic risks to the world’s financial system (as was the case during the 2008 economic crisis).

Having said that, it is difficult to estimate what real impact the coronavirus will have on the global economy yet, and if opinions such as Goldman Sachs’ are just a way to downplay the situation to keep the investors calm. It is more likely to depend on how long the virus continues to spread and linger and how effectively do governments around the world are able to contain it.

by EOS Intelligence EOS Intelligence No Comments

Indian Medical Device Rules: Prospects among Ordeals for Manufacturers

India’s recent notification on regulating medical devices is another step on the government’s behalf to raise healthcare standards in the country. These regulations have implications for all stakeholders in the medical device industry, including medical device manufacturers and importers. The actual impact of these regulations will only be felt in next four to five years, once the regulatory regime comes into effect. However, based on some of the specific regulatory requirements, it is not difficult to ascertain what lies ahead for manufacturers and importers.

In 2019, Indian medical device industry was worth US$9 billion and is expected to reach US$14 billion by 2025. India imports nearly 70% of its medical devices, particularly high-end medical equipment including cancer diagnostics, medical imaging, ultrasonic scans, and PCR technologies, among others, the demand for which is met by multinational companies. The key medical devices that India imports include electronics and equipment – 53%, consumables – 14%, surgical instruments – 10%, IVD reagents – 9%, implants – 7%, and disposables – 7%. Domestic medical device market comprises mainly of small and medium medical device manufacturers with a large portion with turnover of less than US$ 1.3 million.

New Medical Device Rules – Prospects among Ordeals for Manufacturers

For many years, Indian medical device industry has dealt with a lot of challenges owing to lack of regulations. However, with the new medical device regulatory system, the scenario is expected to improve and reduce concerns among the device manufacturers around the lack of standardization and best practices. We discussed the new regulations of medical devices and their impact on various stakeholders in the healthcare sector in our article Indian Medical Device Rules: a Step towards a Better Future in February 2020.

Impact of new regulations on device manufacturers

Once the new regulations come into play, all manufacturers will have to maintain quality standards to avoid any punitive action by the regulator, as compromise on quality could result in suspension or cancellation of their license disabling them for doing business in the Indian market.

In order to assure quality, manufacturers will have to focus on quality management best practices to meet the quality objectives. This would mean creation of quality manual, documentation and execution of the quality-related procedures, and maintenance of quality-related records. Establishment of a quality assurance unit and installation of IT system to support quality-related processes will be the two key steps towards achieving quality objectives.

However, all this will not be easy to achieve from a financial viewpoint for manufacturers, considering majority of players are small and medium-sized. As an indicator, the average cost per year of having a five member quality assurance team in place can be anything between US$ 27,000 to US$ 34,000, which would account for about 2% of the annual turnover for a medical device company reporting US$ 1.3 million in sales (65% of the Indian medical device companies earn less than that). This would be a significantly high expense and, if incurred, is likely to be passed on to consumers.

The amount of expenditure on IT-related infrastructure for implementation on QA would depend primarily on two things. Firstly – the kind of medical device being manufactured (while some medical devices work on the principle of embedded software others do not require software-related quality checks, such as syringes, masks, head covers, etc.). Secondly – the extent to which a manufacturer wants to invest in IT (based on global standards, it would come to around 15-20% of annual IT budget).

Spending on IT infrastructure should be considered as a long-term investment, considering this would be required not only to ensure compliance on quality assurance but also to be done if the company wants to compete in export markets. In any case, the manufacturer would spend less than 1% of its annual revenue on IT for achieving quality objectives.

The government also wants all the device manufacturers to be compliant with Good Manufacturing Practices (GMP), laid down under the Drugs and Cosmetics Act of 1940, and currently introduced as a self-audit or self-assessment activity.

Getting a GMP certification (that confirms a firm uses quality assurance approach to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization) for a single device is likely to cost less than US$ 135 for the manufacturer. Considering a manufacturer produces a range of devices, most of the small device manufacturing units do not follow the voluntary practice of attaining a GMP certificate citing certification costs (for the entire range of devices manufactured) and renewal fees (for each device after a certain number of years) to be adding to their overall expenses, but not significant enough to be passed on to customers. However, on the positive side, if companies were to get GMP certification, it would make their products compliant as per international standards making them more competent in the export market.

Road ahead for importers

Imports constitute a sizeable part of the medical device market in India. It is easier for importers now to place their products in the Indian market considering that there is a streamlined regulatory standard in place highlighting regulatory approval procedures to be followed in India, as against only the FDA (US Food and Drug Administration) or CE (Conformity Europé) approved products that were allowed to enter the market earlier. This will limit the importers’ cost required for approvals to market in India, rather than requiring marketing approval from international agencies.

Registration fees, license fees, and all duties levied for importing devices in India have been explained paving a clearer pathway for importers to operate in the market. Additionally, a list of forms specific for import purposes, required to apply for medical device approval has also been revealed.

All these practices and clarifications from the regulatory bodies have made it more convenient for manufacturers to import products. Clarity on import-related regulations is expected to make it easier for the importers to bring products to India thereby creating more challenges for the domestic players; however, it is too early to say how the market will evolve and which product segments will witness intensified competition in the next four to five years.

EOS Perspective

From the healthcare industry’s standpoint, governments’ step to ensure that medical devices available in the market meet quality standards in the future is positive and welcomed as it brings assurance of superior quality products for the people using them.

It is the small and medium sized enterprises that make up the low priced, high volume market segment of the medical device industry in India, that will need to make major operational changes and keep a close watch on the cost of compliance on quality aspect. The added cost aspect, if encountered, for developing high-quality products is most likely to hit them the hardest (especially the micro units and small-scale manufacturers) leaving them with no option but to pass on the increased cost onto the consumers. Larger players (5% manufacturers) are likely to remain practically unaffected. Nevertheless, it will be interesting to watch how these regulations shape the operations of device manufacturing companies functioning in India.

by EOS Intelligence EOS Intelligence No Comments

Indian Medical Device Rules: a Step towards a Better Future

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Healthcare sector in India is witnessing a churn as a result of the government’s attempt to make healthcare more affordable and to promote domestic healthcare industry. Recent medical devices-related notification is also part of the government’s vision for a better managed healthcare market, though it has ignited a debate about the future of medical device industry. There is hope as well as an apprehension among the stakeholders, as they wait for the notification to become fully effective in next three years.

The Notification

In the second week of February 2020, India’s Ministry of Health & Family Welfare announced that all medical devices sold in the country would be treated as drugs from April 1, 2020 onward and would be regulated under the Drugs and Cosmetics Act of 1940. To understand the context of this announcement, we will have to turn the clock back by about three years.

In 2017, Indian government announced Medical Device Rules-2017 (MDR-17) – a set of rules, which included:

  • Classification of medical devices into four classes (A, B, C, and D), based on the associated risks, i.e. low, low moderate, moderate high, and high risk devices
  • Procedures, including the required documents, for registration and regulatory approval of devices
  • Details regarding manufacturing, quality audit, import/export, and labelling-related requirements

There was no risk-based classification of medical devices prior to 2017 and it was also difficult to introduce new products, as the approval procedures were undefined. In case of imports, only the products approved by Conformité Européene (CE) and the US Food and Drug Administration were allowed. MDR-17 were expected to unlock the potential of Indian medical device market by introducing a well-defined regulatory regime, while assuring quality products to consumers.

Under the rules, a medical device had to be notified as ‘drug’ under the Drugs and Cosmetics Act to be regulated by Central Drugs Standard Control Organization (CDSCO):

  • Initially, 15 categories of medical devices (syringes, stents, catheters, orthopedic implants, valves, etc.) were notified as drugs
  • In 2019, the government notified (effective April 2020) another eight categories – MRI equipment, PET, bone marrow separators, dialysis machines, CT scan and defibrillators, etc., thereby placing a total of 23 categories of medical devices under drugs

The February 2020 notification, called Medical Devices (Amendment) Rules, 2020, has made the entire range of medical devices available in India (about 5,000 different types) under the ambit of drugs, as opposed to 23 categories before the announcement. The compliance requirements are to be enforced in a phased manner, with 30 months given to low and low moderate risk devices and 42 months for moderate high risk and high risk devices.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence

The Concerns

The February notification has drawn reactions, most of them positive, regarding the future from those associated with the industry. There are some concerns as well, such as:

  • What if the device rules accord unrestrained power to drug inspectors due to medical devices being regulated under the Drugs and Cosmetics Act?
  • Would the cost of quality compliance be substantial for device manufacturers?
  • Would the government resort to price control of medical devices, as it does in case of drugs?

Though the concerns are valid, they are unlikely to cause immediate disruption, as there would be at least 30 months (time given for enforcement of compliance for class A and B devices) after the notification date for the rules to start impacting the industry. An increased cost of compliance is a possibility, however, it would be found across the industry and should not impact only specific companies or a specific product segment.

At present, for price control purpose, four medical devices – cardiac stents, drug-eluting stents, condoms, and intrauterine devices – are in the national list of essential medicines that can be further expanded. However, the expansion cannot be directly linked with the medical device rules, which were primarily framed to ensure a better operating environment for industry players. For instance, from the initial list of 15 categories (i.e. about 350 devices) under MDR-17, only cardiac stents and knee implants were brought under price control (condoms and intrauterine devices were already under the price control regime when MDR-17 were introduced).

Impact on stakeholders

Indian medical device industry is expected to evolve under medical device rules (including the February 2020 notification). Even if the impact of the rules is speculative at present, it is interesting to take a look at their potential effect on key stakeholders in the coming years. While the patients appear to be the greatest beneficiaries due to improvement in quality of treatment, wholesalers and retailers of medical devices may have to prepare for a more demanding operating environment.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence


Read more on the implications for all stakeholders in the medical device industry in India in our article: Indian Medical Device Rules: Prospects among Ordeals for Manufacturers


EOS Perspective

Decision to notify all medical devices as drugs for regulatory purpose was a result of a long consultative process, which involved various stakeholders and experts, including Drugs Technical Advisory Board (DTAB). The industry was expecting such an announcement, as the government had previously shown its intent to do so. Hence, the February 2020 notification was only part of the process that was initiated in 2017 with the introduction of medical device rules. The notification is a show of intent by the government of India towards building a better regulated industry offering more quality products, thereby raising the standards of healthcare in the country. The phased implementation of rules is likely to provide enough time for the industry to adapt according to new regulatory requirement.

Any comment on the future of Indian medical device industry on account of probable price control measures would be purely speculative, as it is difficult to predict the outcome of such steps at present. The case in point is of stents, which were brought under price control regime in 2017. There were fears that the move might kill the sector; however, the stent-related procedures have not witnessed decline despite the multinational companies taking their high end products off the shelf, indicating that the domestic manufacturers have been able to cater to demand.

While the end-users can view the medical device rules as a means to provide better care to them, the device manufacturers can also look for positives, especially when the rules are seen along with the government’s other efforts, such as Make in India initiative, to boost domestic manufacturing. Device classification and the associated regulatory requirements have removed ambiguity for the manufacturers of medical devices in India. This clarity might also fast track investments in the sector, as the potential investors now know what to expect while operating in India. Under Make In India, up to 100% foreign direct investment is permitted in medical devices through automatic route.

by EOS Intelligence EOS Intelligence No Comments

Media Players Push the Envelope to Sway in on Streaming Arena

The emergence of online entertainment has led to consumers transitioning from a fixed time-based entertainment on TV to on-demand watching across a wide array of devices. Continuously shifting viewing preferences will further expand digital mode of entertainment thus intensifying the competition between online streaming services and other entertainment providers. This will likely set the tone of how traditional entertainment players refurbish their business objectives and modify their operational models to acquire and retain consumers in the times ahead.

Online video streaming soars, both in subscribers and revenue

In early 2000’s if one wished to watch a movie at home, it meant day(s) of wait before the DVD arrived at the doorstep via mail. However, in 2007, when Netflix launched its online video streaming service, it started a new wave in the entertainment world – the ability to enjoy your favorite movie at the click of a button without having to wait for it to be delivered. This marriage of content and digital technology gave consumers an exciting experience of viewing content in a new way. Since then, video streaming has come a long way and now is a multi-billion dollar industry. In 2018, the video streaming industry was valued at US$ 36.64 billion and is expected to grow at a CAGR of 19.6% between 2019 and 2025, reaching a value of US$ 124.57 billion by 2025.

A surge in the number of devices supporting digital media, increasing internet speed, and the ease to access content (be it information, entertainment, or social) anytime, anywhere is driving the growth of online content.

As the demand for digital on-demand content is growing, consumers are spending more on subscription video on demand (SVOD) such as Netflix and Amazon Prime, making it the most commonly used video service in the over-the-top (OTT) content (content delivered via internet) market – in 2018, of the total global OTT revenue of US$ 67.8 billion, SVOD generated nearly 53% of the revenue standing at US$ 36 billion. SVOD revenue is estimated to reach US$ 87 billion by 2024.

According to global information provider, IHS Markit, the number of global subscribers to online video services such as Netflix and Amazon Prime increased by 27% in 2018 and reached 613.3 million subscribers, an increase of 131.2 million in comparison to 2017. The top three online streaming players account for 45% of this share – Netflix with 155 million subscribers (148 million paid users, with another 7 million using trial accounts), Amazon Prime with 100 million subscribers, and Hulu with 28 million subscribers (26.8 million paid users, with an additional 1.3 million using promotional accounts), totaling to 283 million subscribers.

Media Players Push the Envelope to Sway in on Streaming Arena by EOS Intelligence

Cable TV bearing the brunt

Online video subscriptions (613.3 million) surpassed cable subscriptions (that stood at 556 million, a 2% decrease from 567 million in 2017) for the first time in 2018. However, the online subscription video platforms generated nearly three times less revenue than cable TV, mainly due to low subscription rates. These affordable rates coupled with the flexibility to watch any program at any convenient time has resulted in a drop in the viewership of the television network.

Cable and satellite providers, to some extent, are taking a beating from online streaming as consumers are abandoning traditional cable for streaming services. In the USA, consumers spend US$ 23.3 billion annually on home entertainment, of this 75% (US$ 17.5 billion) is spent on digital entertainment, which depicts the fact that people are spending more on online subscriptions than on the cable TV. This implies that consumers prefer viewing content online than on cable TV, which is further reinforced by the low subscription rates for online services. As a consequence, in 2018, two of the largest direct broadcast satellite service providers in the USA, AT&T-owned DirecTV and Dish Network Corporation’s DishTV, reported losing 1.24 million and 1.13 million subscribers, respectively.

Consumers prefer viewing content online than on cable TV, which is further reinforced by the low subscription rates for online services.

While both players lost a huge number of viewers of the cable television services, during the same year, they were also the largest aggregators through their streaming cable services, namely, DirectTV Now (owned by AT&T) and Sling TV (owned by Dish), which added 436,000 and 205,000 new subscribers each. This shift denotes a change in the way people consume content, choosing a plan that is cable-like but shifting to streaming services at low price point making budgetary cuts while still enjoying favorite programs.

For providers that offer both pay-tv and online subscription as part of their service portfolio, staying afloat in this competitive arena is easier since consumers can shift from one package to another (according to changes in their financial capabilities) and the company does not end up losing customers.

However, for traditional cable companies, the situation is more difficult than expected. In 2018, the top six cable companies in the USA (Comcast, Charter, Cox, Altice, Mediacom, and Cable One) lost a combined 910,000 TV subscribers in comparison to 660,000 subscribers lost in 2017 (38% more in a year). Large cable telecommunications companies such as Comcast and Charter are still in a better position to deal with the situation owing to various business verticals and strong financial records. It is the small players operating in limited territories who are in a muddle – they need to look for alternative ways (other than offering cable TV services, subscribers for which are drastically reducing) to keep their businesses afloat.

Other than losing customers, they are also challenged by the increasing negotiations with programmers (for distributing content via cable) who now have the alternative to broadcast their content via online partners, eliminating the need of cable middleman.

However, unlike in the USA, where the online streaming market is pretty much advanced, in other less developed parts of the world, the development of online streaming platforms is still in its infancy. In the immediate future, it is expected that the streaming services will not be able to cause major impact on traditional video platforms in these geographies, as the adoption of video streaming will be restricted mainly by slow internet connectivity, unlike in the USA, where 5G services are on the brink of being launched.

Constantly evolving entertainment landscape, not without challenges

Online streaming is disrupting the traditional mode of video entertainment challenging the domination of TV as the main entertainment hub. Ascent of digital media players such as Netflix, Amazon, or YouTube, is posing major challenges for other players such as content production studios, cable companies, and media networks thus compelling them to develop new business models and adapt to compete with online streaming players.

To catch up with the changing dynamics of the industry, players from all verticals (including media houses, internet providers, telecom companies, distributors, etc.) in the entertainment industry are revising their business choices and strategically launching new product and services.

Media companies are reformulating their business models by including exclusive streaming services into their overall product and service portfolio. For instance, Disney, US-based mass media and entertainment company, is planning to launch its suite of direct-to-consumer (DTC) services in 2019 starting with Disney+ (to be launched in the USA in November, 2019, followed by launch in Asia and Europe in 2020 and 2021, respectively) focusing on delivering original productions, with all content available for offline viewing. It is estimated that Disney+ is likely to attract up to 90 million subscribers by 2024, nearly more than two times of what Netflix accomplished in five years.

In another example, Comcast-owned mass media house, NBCUniversal, announced the launch of its ad-supported streaming service in April 2020. The service will be free if viewers watch TV through a paid provider with NBCU access (including Comcast and Sky) but one can opt for subscription service to eliminate ads. To start with, the service will focus on licensed content with some original programming.

Recently acquired Time Warner, now named WarnerMedia (acquired by AT&T), also plans to launch its streaming service by the end of 2019 with three tiers of options – an entry-level package focused on movies, premium service with original programming and blockbuster movies, and third option that offers content from the first two packages plus an extensive library of WarnerMedia and licensed content.

With more and more players venturing into the streaming territory and offering new and fresh content, the competition is only going to get harder for Netflix and the likes of it. Players who lack in offering content volume-wise, even though successful in launching their streaming services, will find it difficult to survive, in the medium term, especially when offering premium subscriptions.

Players who lack in offering content volume-wise, even though successful in launching their streaming services, will find it difficult to survive, especially when offering premium subscriptions.

Other than media companies, pure-play cable operators are also feeling the heat of the ever-changing entertainment landscape. As the majority of viewers receiving at-home-video services through means other than traditional cable subscription increases, cable TV players are left with no choice but to look for alternative ways to engage with the market. Increasing demand for broadband services is a saving grace for cable operators in this situation. For example, cable provider, Comcast, is becoming more broadband-centric than cable-centric and shifting its focus to high-speed internet services since customers have started dumping high-priced TV services for cheaper streaming services. The company, in March 2019, launched a streaming platform, Xfinity Flex, targeted at broadband internet services customers (who do not use the company’s cable services). The service offers customers set-top streaming box that includes Netflix, Prime Video, HBO, and other apps, and voice control to manage all of the connected devices in their homes.

However, for cable operators, the situation will only worsen in the future. High-speed internet access market, currently dominated by cable operators, will soon be challenged by the rollout of 5G wireless technology by telecom companies such as Verizon, AT&T, T-Mobile, and Sprint, among others. The implementation of 5G services will be a whole new ballgame, highly likely to transform the online viewing experience, and it will be interesting to see how exactly this space will be changed.

New entrants challenging the players

If the TV content and service providers were already not in deep waters due to the rise of online streaming, entry of retail and media players into the entertainment sector has not made the situation any better. Though these entrants are most likely going to be a direct competition for the video streaming players rather than the traditional ones, it cannot be denied that this may be a potential threat to the entire entertainment industry.

In May 2019, retail chain, Walmart, that bought Vudu, content delivery and media technology company in 2010, launched a video service offering more than 8,000 movies and TV shows for viewers to watch for free (with ads), as well as a library of more than 150,000 movies and TV titles that people can purchase or rent. The company dropped its initial plans to launch Vudu as a streaming service (competing with Netflix) citing huge investment requirement and lack of experience in producing original content as the reasons. However, the idea was not off the table for too long, as the company announced a list of original content programs including reviving an old movie to be delivered in 11-minute installments, a travel show, an entertainment series, and a crime thriller. Vudu is currently focused on developing content that costs much less than other top video streaming service providers spend on original content, which costs them billions of dollars; the future vision takes the path of reaching the front of the pack slowly and steadily.

In another example from 2018, Snapchat, a multimedia messaging app, launched Snap Originals, offering premium content (with episodes lasting for about five minutes) created exclusively for Snapchat’s users to be viewed on their mobiles. The content includes a range of genres including drama, comedy, documentary, etc., and is developed in partnership with film and television writers and producers.

EOS Perspective

The amount of money viewers spent globally on entertainment reached US$ 55.7 million in 2018, an increase of approximately 16% in comparison to 2017 (US$ 48.1 million). Between 2014 and 2018, consumers’ entertainment spending increased nearly 1.5 times driven by increased expenditure on digital entertainment (including electronic sell-through, video-on-demand, and paid subscriptions). The digital entertainment spending in 2018 was US$ 42.6 million in comparison to US$ 15.7 million in 2014, an increase of 171%, exhibiting a giant move towards digital viewing.

There has been a plethora of cases where TV players have either launched new ideas and concepts or joined hands with other players (in the same realm or similar playfield) to have a foothold in the otherwise challenging entertainment industry. With more and more options congesting the already tight, but diverse streaming video topography, it is most likely going to present increasing competition for traditional television. This, topped with dropping numbers of television viewers globally, only adds to the inevitable nostalgic observation that television may become obsolete, if not dead, in the next five to six decades.

Developing content and building own platforms for streaming videos does not come cheap – players will have to invest billions of dollars in developing content whilst losing revenue by not selling distribution rights to third-party networks and distributors. This stands true for content creators such as Disney and WarnerMedia, who are likely to gradually withdraw their content from online streaming platforms to be broadcasted on their own networks. For instance, Disney will bear an estimated loss of US$ 300 million in annual revenues it currently gets from Netflix for pay-tv rights to its theatrical releases. Thus, it is clear that shifting to a newer streaming business model will not only be costlier but also riskier since it would be difficult to ascertain beforehand how well the content will be accepted by the viewers. Nonetheless, in the current scenario, where there is always demand for more content, players hardly have any other alternative to explore.

The outlook for video entertainment, in the short to medium term, looks promising with coalition among various operators’ in reshaping the video media scene. It can be expected that potential partnerships, particularly among content creators and service (internet and mobile network) providers, if done right, could be a tough nut to crack for pure-play online streaming operators.

Potential partnerships, particularly among content creators and service (internet and mobile network) providers, if done right, could be a tough nut to crack for pure-play online streaming operators.

Nevertheless, given the low-price point and round the clock content availability, it can be anticipated that online streaming business will continue to see significant growth in the years to come. For other players, it is important to understand that while their direct audience is shifting, it is not vanishing – just that viewers are watching the content via different modes. Thus, in the long haul, it will be necessary for players to offer a combination of traditional TV packages along with online streaming plans and become a one-stop-shop for content to retain old customers and signing up new subscribers. However, for the businesses, the challenge lies in knowing what offerings to create and whom to partner with, all while retaining customers and generating revenue in the constantly evolving entertainment topography.

Looking at the current scenario, it is apparent that digital platform players will further continue to disrupt (and redefine) the TV and video market in the future. To survive, industry-wide alliances in the form of joint production, partnerships, and mergers are an obvious choice to make. However, in their desperate attempt to stay ahead, it can be expected that companies will try to come up with innovative solutions, something that is neither exactly a cable TV offering nor a video that can be streamed online, but an experience that enthralls the viewers and keeps them hooked to the device of their choice.

by EOS Intelligence EOS Intelligence No Comments

Commentary: India’s Automobile Sector Breakdown Causing Economic Distress

Over the past few months, a lot has been said about the shrinking automobile sales in the Indian market. Touted as one of the key drivers of India’s economic growth, the automobile industry is facing the worst slowdown in two decades as production and sales numbers continue to drop month after month sending the sector in a slump. While the government has made efforts to improve the situation, it will take more than just policies and measures to flip the status quo and bring the industry back on the growth path.

Indian automotive industry witnessed a period of growth during the first term of Modi government – we wrote about it in our article Commentary: Indian Automotive Sector – Reeling under the Budget in February 2018. However, over the past year, the auto sector is in shambles and far from recovery. The sector that contributes 49% of the manufacturing GDP in the country (and more than 7% to the country’s total GDP) has shown decline in growth in the past 18 months as the numbers continue to fall each month. The slowdown is so severe that it has affected all aspects of the business leading to piled up inventory, stalled production lines, decelerating dealership sales, delayed business investments, and job loss.

Quintessential factors that triggered the slowdown

There are various reasons that have plagued the auto industry in the recent months. One of the key factors is the inability of NBFCs (Non-Bank Financial Companies) to lend money. NBFCs, which largely depend on public funds (mainly in the form of bank borrowings, debentures, and commercial paper), have been facing liquidity crunch in the recent past as both public sector and private sector banks have discontinued lending money. This had a double effect on the auto sales – firstly low liquidity has restricted NBFCs ability to finance vehicles, thus having an adverse impact on sales, and secondly, the limited availability of funds bulleted the cost of financing vehicles thereby making them relatively more expensive, further worsening the sales scenario.

In October 2018, the Supreme Court of India announced that no BS-IV cars shall be sold in India with effect from April 1, 2020 (all automobiles should be equipped with BS-VI compliant engines, with an aim to help in reducing pollution in terms of fumes and particulate matter). Owing to this, consumers have delayed their plans to purchase vehicles expecting automobile companies to offer huge discounts in the early months of 2020. And to clear out their existing stock of BS-IV vehicles, it is highly likely that the companies will offer massive concessions before the deadline hits. Delay in purchase of vehicles on consumers’ end has contributed to the overall low sales.

Additional factors that add to the downfall include changes in auto insurance policy (implemented in September 2018) under which buyers have to purchase a three-year and five-year insurance cover for car and two-wheeler, respectively (as against annual renewals), inclusion of additional safety features (including airbags, seat-belt reminders, and audio alarm systems) in all vehicles manufactured after July 1, 2019 adding to the manufacturing cost for the OEMs, and stiff competition from growing organized pre-owned vehicle market which has doubled in size in less than a decade (the share of the organized channel of the pre-owned car market has increased to 18% in 2019 from 10% in 2010). Customers have been passive on buying new vehicles as the total cost of ownership goes up due to an increase in fuel prices, higher interest rates, competition from used cars segment, and a hike in vehicle insurance costs.

Government initiatives to help the auto sector recover

To boost demand for automobiles and offer some respite to the businesses operating in the space, the government announced a number of measures and policies. These include lifting the ban on purchase of vehicles by government departments (the ban was introduced in October 2014), which is hoped to result in loosening of stocked-up inventory and getting sales for automakers, component manufacturers, and dealers. Government also announced additional 15% depreciation on new vehicles for commercial fleet service providers acquired till March 2020 with the aim to clear the high inventory build-up at dealerships.

Other than lifting the ban and price reductions, the government also announced that all BS-IV engine-equipped vehicles purchased until March 2020 will remain operational for the entire period of registration. This will have a two-fold effect – firstly, automakers will be able to push out their stock without having to upgrade existing models and make them BS-VI-complaint (since no more BS-IV-complaint vehicles will be registered post March 2020 and manufacturers will have to upgrade to BS-VI from BS-IV emission standard on the old stocks) thus clearing old inventory, and secondly, consumers can expect much higher discounts. This is expected to provide enough movement within the auto sector, both in terms of sales and revenue generation.

Government has also taken steps to stabilize the NBFC crisis where a separate budget of US$ 14 billion (INR 100,000 crore) has been announced to refinance selected NBFCs. While it is clear that these limited funds will not last long, currently, any step taken to recover from the situation is welcomed.

Though considered temporary, the relief measures offered by the government have gained traction in the industry and players believe that these provisions will have a positive impact on the buyers’ sentiment, even if for a short period of time.

Implications of the auto industry crisis

The slowdown is expected to have a negative impact across all aspects of auto business, especially in the short term. Drop in sales has led manufacturers to decrease production (and even stop production for a certain period of time), cut down overall costs, and reduce headcounts thus weighing down the overall automotive sector.

The months leading to reduced sales did not only impact the production capacities but also resulted in the loss of more than 350,000 jobs. In the coming months, many more risk losing their jobs owing to plant shutdowns, dealership closures, and small component manufacturers going bankrupt.

The cost of vehicle ownership has also increased. Automobiles attracts the highest GST slab of 28%, and this, coupled with the varying road and registration charges imposed by state governments, makes the upfront cost of the vehicle exorbitant for a large segment of consumers (especially the working middle class for whom a two-wheeler or a small segment car is a basic necessity rather than a nice-to-have convenience) making it almost impossible for them to but it.

Given that the automobile sector works in conjunction with other industries, the current slump in auto sales will pull down ancillary industries including parts and components, engines, battery, brakes and suspension, and tire, among others. Considering the fact that the sector contributes nearly half to the country’s manufacturing GDP, if the issue at hand is not addressed immediately, it will further add to the ongoing economic crisis within the country worsening the situation altogether.

EOS Perspective

Policies announced by the Modi government to revive the tumbling automobile sector only seem to mitigate the negative sentiments circling about the future of the industry. However, at this stage, what the industry really needs is a stimulus package in the form of tax incentives or liquidity boost to immediately change things on the ground level.

There is an urgent need of a remedial course of action on the government’s part to stop the vehicle sales from dropping further. As an immediate relief to boost sales and invigorate the auto sector, the government should implement a GST cut on vehicles. This would kick-start vehicle demand almost instantaneously that would work in favor of the automobile industry – manufacturers (to resume halt production), dealers (to clear inventory), and parts makers (to resume small parts and component manufacturing), help resuscitate lost jobs, and contribute, to a small extent, to strengthen country’s slow economic growth.

However, with the government turning a blind eye to industry needs (lowering the GST slab), there is only so much the business owners can do. Under this current scenario, unless the government takes some drastic measures that ensure validation in backing automakers, auto ancillary businesses, and dealers, the sector is unlikely to recover soon. Provisional policies and short-term measures can offer momentary relief but not the survival kick the auto industry is in dire need of.

by EOS Intelligence EOS Intelligence No Comments

EU New Medical Device Regulations: Cause of Ache for Medical Device Players

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Circling around patient care and improving overall healthcare services, the European Parliament has set new requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. However, medical device manufacturers have realized that they are bound to face many challenges in order to make their products market-ready, not to forget the gigantic task of implementing new protocols in a timely manner, which will not be easy.

Need for a comprehensive updated medical device regulatory system

EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were made official in May 2017, with transition period of three years (fully applicable from May 26, 2020) for the former and five years (fully applicable from May 26, 2022) for the latter. These regulations will replace EU’s previous directives: Medical Device Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Directive (IVDD).

The need for new regulations of medical devices in EU arose from the growing demand for technologically advanced medical products which necessitated more stringent monitoring of these devices to ensure a high level of efficacy and safety among patients.

Unlike earlier version of the regulations where the main focus revolved around the pre-approval stage of medical device manufacturing, the new regulatory guidelines promote an overall product-life cycle approach, focusing on both device safety and performance.

Enhanced supervision, easy documentation of devices, more stringent clinical evidence requirement, and increased supervision on part of authorities providing medical device certifications are some of the key changes in MDR as compared to the EU’s previous directives.

Bumpy road ahead for medical device manufacturers

Reclassifying existing product line-up

Based on the risk factor, changes have been made to the way medical devices are classified. Under MDR, the number of classification rules has expanded from 18 to 22 intensifying the task of product re-classifications by the manufacturer.

For instance, products using software for monitoring purposes being implanted in the body has been reclassified to higher-risk class (from Class I to Class III) which would now require conformity assessment by a notified body (NB – an organization that assess the conformity of medical devices before they are placed on the market), unlike earlier, when Class I products did not require assessment via a NB. This is going to burden players with increased operational costs; thus, it is imperative that the manufacturers familiarize themselves with the classification changes and study the impact on their product portfolio.

New products are also being added to the list of medical devices that earlier were not part of the medical device regulatory framework. For instance, products manufactured utilizing human tissues or cells and devices incorporating nanomaterial, under new regulations, will be considered medical devices. Manufacturers of such products have work cut out for them – from conducting clinical investigations, preparing technical documentation and evaluation processes, to product certification. Though such products could only form a very small percentage of the company’s product range, the task to make them available in the market is great, especially under current circumstances.

Manufacturers who do not comply with the new regulations will no longer be able to market their products in Europe. Thus, a robust strategy in terms of resource allocation, time management, and budget is an absolute must for manufacturers to make this transition possible.

EU MDR Cause of Ache for Medical Device Players - EOS Intelligence

Distress over notified bodies

Strict parameters are also being applied on NBs. Since all devices will require new certification from a NB, only designated NBs will be able to certify a device. The designation process is a complex procedure as it involves audits and corrective actions (once a NB expresses interest). However, while the medical device manufacturers have been in the process of switching to newer protocols since mid-2017, the first designated NB (BSI United Kingdom, the national standards body of the UK) was announced in January, 2019, almost 18 months after the regulations were announced and 14 months into the formally started designation process.

Such time-consuming process raises concern among medical device companies about the ability to complete the necessary conformity assessments within the allotted time. The huge task of recertifying medical devices with only a handful of designated NBs is a cause of worry for companies, as it could potentially result in significant backlogs as the last date approaches. However, there is only so much companies can do – even though they are proactive to comply with the new regulations much ahead of the deadline, poor process planning and lack of supporting bodies (notified bodies in this case) results in a long halt for these players.

The companies are heavily dependent on NBs for auditing and product certification, and the insufficient number of designated bodies adds to the risk of many devices being non-compliant according to new regulations. As of May 2019, less than 40 NBs have filed application for designation procedure (out of 58 designated NBs under the directives); only two have actually received a designated status – BSI UK and Germany based TÜV SÜD Product Service GmbH Zertifizierstellen (certification received in May 2019). With very little time at hand to reassess and rectify issues (if any), this could jeopardize the product availability in the market, resulting in not only risking the patients’ life (due to non-availability) but also in huge financial losses for the players.

Detailed clinical evaluation of medical devices

Owing to reclassification of product categories, many devices will require changes to their existing clinical evaluation reports, another challenge for medical device manufacturers. Manufacturers that have not previously been required to perform clinical testing will have to do so now. For instance, mechanical heart valve sizers will be moved up from Class I to Class III, and unlike in MDD where clinical evaluation was based on literature analysis, new evaluation of valve sizers will require clinical investigation. This will require a huge deal of additional time, money, and expertise, further burdening the device manufacturers.

Medical devices already in the market that remain untouched by the reclassification criteria will still require reassessment of clinical data. If the data do not meet the new requirements, devices will need to undergo additional testing to be recertified, increasing the expense for manufacturers.

MDR also calls for inclusion of risk management within the clinical evaluation expecting clinical risks to be addressed in clinical investigations and evaluation studies – adding another task to the long list of activities to be accomplished before MDR fully rolls out.


Explore our other Perspectives on medical devices markets


Comprehensive demonstration of equivalence data

Unlike MDD, where device manufacturers were able to use clinical data of an equivalent device for their own product registration, under MDR, equivalence is going to be less accepted, particularly for higher risk devices.

There are two ways out – manufacturers can either conduct their own trials not having to deal with the equivalence commotion or they can demonstrate that they have access to the equivalent device (with respect to technical and clinical properties) data. The latter is highly unlikely to happen considering equivalent device would typically belong to a competitor unwilling to grant such access. Thus, with stern requirements for comparative evaluations, more effort, planning, money, and resources will be needed for device manufacturers to demonstrate product safety and performance.

As new medical devices are developed, multiple small incremental improvements (minor changes in design, addition or subtraction of small hardware parts such as bolts or screws) happen over time. Once the device is already in the market, it is practically impossible to conduct a re-trial to gain approval for such small changes. An expected solution to this would be a provision to accept such minor changes through pre-clinical evidence or prior trial results. However, with equivalence testing being reduced drastically under MDR, unless a solution for such cases is offered, manufacturers will have to conduct re-trial and re-document everything, which would result in significantly increased cost. Another issue that could arise from such situations is the reduction in R&D activities inclined towards product improvement.

Trouble galore for SME’s

While making amendments and prioritizing to comply with new regulations seems to be the top most priority for medical and diagnostic device manufacturers, it seems SMEs will be dramatically more impacted than large players – in Europe, a small-sized company employs less than 50 people and has a turnover of less than or equal to €10 million while a medium-sized company employs less than 250 people and has a turnover of less than or equal to €50 million. Owing to the increase in cost, time, and resources associated with the process, the new regulations may put smaller companies under pressure, possibly resulting in altering (such as merging with or being acquired by larger companies) the European medical device market structure, currently dominated by SMEs – there are nearly 27,000 medical technology companies in EU, 95% of which are SMEs.

SMEs also need to be more vigilant when it comes to being associated with a designated NB as not all currently functioning NBs are expected to get a designated status. With their already dwindling numbers married with an increased demand for their services, once the new regulations roll out, it is quite possible that small manufacturers are orphaned since NBs could be partial towards larger players and prioritize them over other small and medium players.

Smaller players will not only have to hire additional personnel for dealing with regulatory issues but also employ clinical trials specialists (for documenting insights to be presented and approved by the NB) for launching products in the market which means higher costs. Adjusting budgets to keep costs under control would hamper other critical business operations, e.g. reduce R&D activities or cut the number of products being launched in the market.

As a step to overcome these issues, players with limited financial resources should strategically study their product portfolio to determine which products are worth investing in for MDR compliance. For doing this, they should lay out a detailed plan for each product and decide whether to remediate, transition, or divest.

It is also advised that SMEs should devise a clear step-by-step approach plan to ensure compliance. As an alternative to hiring transition specialists, they could engage employees from various functions within the organization to take responsibility for specific processes thus keeping costs in check.

EOS Perspective

The changes and revisions required to be carried out under MDR are company-wide and require significant investment to plan and execute. This will lead to players devising a business strategy based on assessing risk associated with product portfolio (whether some products need to be pulled out from the market and what effect it would have on future revenue) or looking for acquisition partners. Based on these decisions, the medical device market topography in EU is expected to see some major changes in the coming years – small companies looking for partners to get acquired or for new partnership with a service provider (specializing in regulations compliance). This will also result in organizational restructuring, revamping design processes, and systems implementation.

Companies have to make crucial decisions around the product portfolio. For some of the already existing products, if reclassified, the cost of compliance could be much higher than actual market returns. In such cases, manufacturers may be compelled to pull away such products from the market resulting in high healthcare costs and ultimately burdening the patients, who (theoretically) form the center point of the MDR. Though this is unlikely to happen at a large scale, since there are always alternative products available, it cannot be denied that this may be a major loophole in MDR requiring immediate attention.

Since SMEs drive the EU medical device market, as an immediate consequence, MDR is not likely to have any positive effect on these players other than distorting their business operations. However, it can only be anticipated that, with time, MDR may adapt and amend to offer some relaxation in provisions especially for small and medium-sized players. Nonetheless, MDR also brings an opportunity for such players to audit their current offerings and come out with an enhanced product portfolio, which could be an opportunity to be capitalized on in the distant future.

Modifications being made in the functioning of NBs are also likely to have an impact on the device manufacturers. For high risk devices, manufacturers may expect deeper scrutiny of design records and data files leading to providing more credentials, in case any query arises. This, along with long wait time for product review (due to reduction in the number of designated NBs) and limited availability of resources (again on account of NBs), could lead to unknown delays for obtaining product re-certification. Thus, companies need to chalk out their market strategies very effectively and be prepared to address any concern that rises during product reviews.

The aim of implementing new regulations is to bring a transparent and robust regulatory framework for medical devices. However, there is no assurance that the new regulations are completely accurate and will apply seamlessly to live case scenarios. Therefore, once implemented, there is a possibility that MDR may see revisions in the initial months of coming into action.

These changes, though certainly positive from a healthcare point of view, are enormous. Transitioning to meet the new standards within the stipulated time frame is challenging for manufacturers. Not adapting to the changes is not a choice for manufacturers as non-compliance could result in losing license to operate in the EU market. And for players fearing stringent scrutiny in the future, operating in the European healthcare market will not be easy once the new regulations come into force.

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