The healthcare and medical device businesses in India have expanded dramatically over the previous decade. India produces a wide range of medical equipment, including consumables and surgical implants.
A large number of medical devices produced in India are disposables, such as catheters, perfusion sets, extension lines, cannulas, feeding tubes, needles, and syringes, as well as implants such as cardiac stents, drug-eluting stents, intraocular lenses, and orthopedic implants. The medical device market is highly capital-demanding and necessitates ongoing training of healthcare personnel to keep up with new technologies.
However, there is still a significant gap between the current demand and supply of medical equipment in India, as the country relies on medical device imports for 70-80% of its needs. Many medical device manufacturers are currently considering India’s huge, affordable medical equipment market to be a big growth opportunity.
Market Size Of Medical Device Sector
Large international corporations, as well as small and medium-sized businesses, make up India’s medical device sector.
The Indian medical device industry is predicted to be worth Rs. 90,000 crore (US$ 11 billion) in 2022, rising to US$ 50 billion by 2030 at a CAGR of 16.4%. India’s medical device market share in the global market is predicted to be 1.65%.
India is the fourth-largest Asian medical device market after Japan, China, and South Korea and one of the top twenty medical device markets worldwide.
Between 2020 and 2030, the diagnostic imaging market is expected to grow at a CAGR of 16.4%.
In FY22, India’s medical device exports were Rs. 19, 803 crore (US$2.40 billion). Medical equipment exports totaled Rs. 20,511 crore (US$ 2.49 billion) between April and December 2022 and are predicted to reach $10 billion by 2025.
To enhance medical device exports in the country, the Ministry of Health and Family Welfare (MOHFW) and Central Drugs Standard Control Organization (CDSCO) conducted the following initiatives:
- Re-examination and implementation of Schedule MIII (proposed guideline on good manufacturing practices and facility requirements)
- System for export labeling
- Clinical evaluation and clarity on adverse reporting
- The state licensing authority will extend the validity of free sales certificates from two to five years to allow exports.
- Create a list of businesses with export licenses for simple access to regulatory agencies around the world.
Investments in Developing the Medical Sector by the Government
Here are some noteworthy investments and developments in the medical device sector:
While speaking at the India MedTech Expo 2023 in August 2023, Union Health Minister Mr. Mansukh Mandaviya stated that India is on track to become a global hub for medical technology and products.
In August 2023, Manipal Academy of Higher Education (MAHE), Manipal, and Siemens Healthineers inked a Master Research Collaboration (MRA) to promote future collaboration between the two organizations in attaining shared outcomes for stakeholders.
According to an announcement made in August 2023, Omron Healthcare India Pvt. Ltd., a subsidiary of Japanese business Omron Healthcare Co. Ltd. that supplies home healthcare monitoring devices in India, plans to quadruple its income in 3 to 5 years.
In August 2023, Omron Healthcare India announced a partnership with supermodel, film producer, and fitness enthusiast Mr. Milind Soman to increase awareness about the necessity of home monitoring as part of a wellness regimen.
Medtronic stated in May 2023 that it would invest around Rs. 3,000 crore (more than US$ 350 million) to expand the Medtronic Engineering & Innovation Centre (MEIC) in Hyderabad. MEIC is Medtronic’s largest R&D center outside the United States.
Omron Healthcare, a Japanese manufacturer and distributor of personal healthcare goods, said in May 2023 that it will invest US$ 15.5 million (Rs. 128 crore) to establish a medical device manufacturing unit in Tamil Nadu.
In April 2023, Hindustan Syringes & Medical Devices Ltd achieved another milestone by supplying 1.75 billion syringes of the 13.3 billion COVID-19 vaccines delivered globally.
Siemens Healthineers, a medtech company focused on precision medicine, care delivery transformation, patient experience improvement, and healthcare digitalization, announced in March 2023 that it would invest Rs. 1,300 crore (US$ 157.2 million) in Bommasandra, Bengaluru, to establish a full-fledged campus.
Medtronic increased its footprint in India by investing around Rs. 3,000 crore (US$ 362.8 million) to expand the Medtronic Engineering & Innovation Centre in Hyderabad.
Transasia launched the first indigenously designed RT-PCR kit for monkeypox testing at the Andhra Pradesh Medtech Zone (AMTZ) in August 2022.
BeatO, a diabetic treatment company, raised $33 million in a Series B financing round led by Lightrock India. HealthQuad and current investors Orios Venture Partners, Blume Ventures, and Leo Capital all took part.
In August 2022, Wipro GE Healthcare announced a partnership with medical device manufacturer Boston Scientific to provide comprehensive, cutting-edge cardiac interventional care solutions in India.
FDI inflows into the medical and surgical appliances sector were $2.80 billion between April 2000 and March 2023.
The government has created a number of financial incentives to promote growth and innovation in the medical device industry. These incentives are intended to boost R&D, technology acquisition, and the building of manufacturing facilities.
Tax breaks, subsidies, and grants are among the financial strategies used to encourage investment and promote the growth of the medical device business.
Research and Development Support
Innovation is the lifeblood of the medical device industry. Recognizing the value of research and development (R&D), the government has put plans and initiatives in place to encourage medical device innovation.
Funding support, collaboration with research institutes, and the establishment of innovation centers are among the techniques used to foster a culture of continual improvement and technical advancement.
Quality Standards and Certification
Ensuring the quality and safety of medical equipment is critical to establishing confidence between healthcare providers and patients. To control the medical device business, the government has implemented severe quality requirements and certification systems.
This not only assures that domestically created equipment satisfies international standards but also makes it easier to export Indian medical gadgets to foreign markets.
Recognizing that collaboration is essential for global competitiveness, the Indian government has actively sought ties with international organizations and countries.
These agreements provide knowledge exchange, technology transfer, and access to global markets. Joint research and development initiatives with overseas peers help to improve the capabilities of the Indian medical device industry.
India’s regulatory landscape for medical devices has undergone major modifications to conform with international standards. The implementation of the Medical Devices Rules in 2017 marked a significant move towards a more complete and transparent regulatory system.
These regulations cover the full lifespan of medical devices, from production to post-market surveillance, assuring the safety and efficacy of products in the marketplace.
Wrapping It Up
The government’s experienced support for India’s medical device sector has established the groundwork for future growth and innovation. From regulatory efforts to financial incentives and international collaborations, the government’s complete strategy demonstrates a commitment to developing a self-sufficient and globally competitive medical device industry.
As the sector evolves, the government, industry stakeholders, and the workforce will work together to shape India’s future healthcare technology landscape.