Indian Medical Devices Industry:

India is becoming an increasingly important market for medical device outsourcing. Over the last decade, the industry has experienced enormous Growth Opportunities, and current development trends promise even more potential in the next years. The Indian Medical Devices Industry has been influenced by a number of joint ventures, agreements, and loan licencing procedures.

Indian Medical Devices Industry is Asia’s fourth largest market and one of the top twenty in the world. According to a forecast by the Indian Brand Equity Foundation (IBEF), India’s medical device market will expand at a 35.4 percent compound annual growth rate (CAGR), with a market value of $11 billion in 2020 and $50 billion by 2025. Imports, on the other hand, currently supply the majority of the medical device market in the country, accounting for 80% of total sales.

The government has amended the medical equipment legislation to significantly increase the scope of the regulation. Medical devices are now categorised as pharmaceuticals under the Drugs and Cosmetics Act, hence new legislative law for medical devices is being considered.

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Indian Medical Devices Industry is Booming:

Promoting health-related innovation the current market size of India’s medical devices business is expected to be $11 billion, making it a promising sector of the Indian economy. Large multinationals and small and medium companies (SMEs) coexist in Indian medical devices industry, which is expanding at an unprecedented rate.

Indian Medical Devices Industry is poised for significant growth, with the market size expected to reach $50 billion by 2025 at a CAGR of 15% over the last three years. The automatic method allows 100 percent FDI in both brownfield and Greenfield projects. Strong FDI inflows demonstrate international investors’ confidence in the Indian market.

  • Since April 2000, $2.2 billion in FDI has been received; of this, $600 million has been received in the last five years. Key investors include Singapore, the United States, Europe, and Japan.
  • The most FDI has gone into equipment and instruments, consumables, and implants.

For further details, please refer FDI Policy

By 2025, India’s medical equipment exports are estimated to exceed $10 billion. Over the last five years, the Indian government has taken many initiatives to support the creation of a vibrant medical device manufacturing ecosystem in the country.

• Medical Devices Rules (MDR) 2017: The Medical Devices Rules (MDR) 2017 govern clinical research, manufacturing, importation, sale, and distribution of medical devices. The gadgets are divided into four categories in accordance with international standards.

• Medical Device Parks Promotion Scheme: The Indian government has approved the establishment of four medical device parks to offer shared infrastructure, build a healthy ecosystem for medical device manufacture, and lower manufacturing costs.

• By 2025, the market is estimated to be worth $ 50 billion.

• India is Asia’s fourth largest market for medical equipment, and one of the world’s top 20 markets for medical products.

• India is the world’s second largest PPE Kits manufacturer, with a daily manufacturing capacity of 10 lakh+ PPE coveralls.

Production Linked Incentive (PLI) Scheme:

Medical devices have been recognised as a priority sector for the flagship ‘Make in India’ programme, and the Indian government is dedicated to developing the manufacturing environment. The Production Linked Incentive Scheme (PLI) Promoting Domestic Manufacturing of Medical Devices and the Production Linked Incentive Scheme for Pharmaceuticals (PLI 2.0) were introduced to help India achieve its goal of becoming a worldwide medical device manufacturing powerhouse.

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Advantages:

Despite the current challenges in comparison to the global market, India’s advantages in areas such as lower labour costs, a high level of technical expertise, and government funding for R&D investment to accelerate new product development have made India one of the most popular outsourcing manufacturing destinations.

The segment is only expected to grow in the coming years, as more multinational companies look to customise their products to meet country-specific requirements. Medical devices, equipment, consumables, and diagnostic goods are expected to be recognised as distinct under the recently introduced ‘The Drugs and Cosmetics Amendment Bill, 2013′. The separation of medical devices from medications will result in a significant reduction in the time it takes for medical devices to be approved or licenced. This will enable local firms to expand rapidly and compete globally.

Scenario of Indian Medical Devices Industry:

Indian medical devices industry has the potential to grow at a 37 percent CAGR to $50 billion by 2025.

Medical equipment are divided into five categories:

• Needles and syringes, among other consumables and disposables

• Diagnostic imaging includes MRI, X-rays, and ultrasounds, among other procedures.

• Dentures, braces, and other dental products.

• Orthopaedics and Prosthetics include knee implants and artificial joints

• Hearing aids and pacemakers are examples of patient aids.

Around 65 percent of Indian manufacturers are domestic operators in the consumables sector, catering mostly to domestic consumption with negligible exports. With vast service networks, large multinational corporations dominate the high-tech end of the Medical Devices industry in India.

In India, there are 750–800 medical device makers, with an average investment of $2.3–2.7 million and a sales of $6.2–6.9 million.

Around clusters, “Medical Device Parks” are emerging: states have pledged to establish specialised industrial parks where efficient domestic manufacture at cheaper prices can take place. The state governments of Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh have been given “in principle” approval to build Medical Device Parks and create a strong medical device manufacturing ecosystem in the country.

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Market Size:

India is one of the top 20 medical equipment markets in the world. From Rs. 75,611 crore (US$ 10.36 billion) in 2020 to US$ 50 billion in 2025, the market is predicted to grow at a 37 percent CAGR. Large multinationals as well as small and midsized businesses make up Indian medical devices industry.

To increase the industry, the Government of India (GOI) has started a number of efforts to strengthen the medical devices sector, with a focus on research and development (R&D) and 100 percent FDI for medical devices. Between April 2000 and December 2021, FDI into the medical and surgical appliances sector totaled US$ 2.35 billion.

Diagnostic imaging is expected to grow at a CAGR of 13.5 percent between 2020 and 2025. In the July–September 2021 quarter, India’s wearable market expanded by 93.8 percent year on year, shipping 23.8 million devices. With a 26 percent market share in the third quarter, Noise maintained its dominance for the sixth consecutive quarter, followed by Boat (23.1 percent), Fire-Boltt (15.3 percent), Realme (7.3 percent), and Amazfit (4.8 percent).

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Future Growth Opportunities:

The medical device industry is expected to grow to $400 billion in revenue this year. Indian medical device industry is predicted to grow at an unparalleled rate over the next decade. The industry is expected to be worth $50 billion by 2025. This is due to the country’s rising middle class, as well as a growth in the number of hospitals and, as a result, a greater need for sophisticated medical gadgets and improved healthcare.

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Drivers of Growth:

  • India’s population is expected to reach 1.45 billion by 2028, making it the world’s most populated country.
  • Life expectancy in India is anticipated to rise to 70 years by 2025, up from the current 67.5 years.
  • Disease Burden Shift: In India, non-communicable diseases (NCDs) account for half of the disease burden and 60% of all deaths.
  • Preferences Change: Increasing health knowledge, a shift in attitudes toward preventative healthcare, and an increase in the occurrence of lifestyle disorders
  • Growing Middle Class: Over the next ten years, 73 million Indian households will enter the middle class, increasing their purchasing power, including in the area of medical devices.
  • Increasing Disposable Income: By 2026, 8% of Indians will earn over $12,000 per year.
  • Health Insurance: About 20% of Indians are covered by health insurance. With increased affluence and urbanisation, this number is anticipated to rise.
  • Medical Tourism is on the rise in India, because to the relatively low cost of medical care. It contributes more than $2 billion to India’s healthcare market. Medical tourism has increased demand for healthcare and medical devices.
  • Infrastructure Development: India is planning four medical device parks.
  • Policy Support and Incentives: 100% FDI authorised in Greenfield and brownfield projects, lower entry hurdles than other industries, and a varied and vibrant start-up ecosystem.

Industry Changes:

Big Data: Medical devices provide enormous amounts of vital, timely data that can have a big clinical impact. Predictive analytics models based on ‘Big Data’ can assist physicians get helpful insights while also improving the quality of care and patient outcomes.

Wearable Devices: Due to their ease of use, wearables such as glucose monitors, exercise trackers, and wearables for mental health are becoming increasingly popular among Indian customers.

Surgical Robotics: Robotics is one of the most fascinating and rapidly increasing areas of healthcare, with potential innovations ranging from robot companions to exoskeletons. In healthcare, robot companions can help alleviate loneliness, cure mental health difficulties, and even assist children with chronic illnesses.

Startups: India has around 250 active medical technology startups. Between 2011 and 2020, Indian health-tech and digital health startups raised over $2 billion, including 500+ investments into 340+ companies. Over the last decade, there have been more than 70 successful exits.

Home Healthcare has the potential to save up to 65 percent of unnecessary hospital visits in India while also lowering hospital expenditures by 20%. By 2027, it is predicted to increase at a CAGR of 19.2%, reaching $ 21.3 billion.

Telemedicine

Telemedicine is expected to reach $5.5 billion by 2025, rising at a CAGR of 31 percent between 2020 and 2025. eSanjeevani, a MoHFW-conceived technical intervention, has enabled virtual doctor consultations and connected thousands of people living in remote parts of the country with doctors in major cities while sitting in the comfort of their own homes.

Every day, over 1,10,000 patients are served. Telemedicine trials have shown that virtual consultations cost roughly 30% less than identical in-person visits, with remote consultations replacing half of in-person consultations in India by 2025 if the country pursues an aggressive approach.

The Government of India will release Telemedicine Practice Guidelines in March 2020 to assist medical practitioners in pursuing a sound course of action to provide effective and safe medical care based on current information, available resources, and patient needs in order to ensure patient and provider safety.

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