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India’s MedTech sector: A thriving industry set for global leadership

India’s MedTech and in-vitro diagnostics (IVD) industry is steadily growing due to increasing healthcare spending, awareness of preventive healthcare, and technological advancements. The sector has become an essential component of the healthcare industry, with a current market size of USD 11 billion and a 1.5-percent share in the global medical devices market. Over the last decade, the sector has witnessed fast growth with a compound annual growth rate (CAGR) of 10–12 percent. The IVD market in India is also proliferating, with an expected CAGR of nearly 7.1 percent during the forecast period and a market value projected to exceed the USD 1.8-billion mark by 2025. Creating an enabling environment for domestic IVD solutions, manufacturers need to invest in R&D, and enhance export competitiveness, as the IVD industry has a vast export growth potential.

The rapid development of extremely effective test solutions by the Indian IVD market to restrict the spread of Covid-19 in the nation demonstrates the diagnostic sector’s critical role in identifying and controlling the spread of healthcare emergencies, such as pandemics. However, the industry needs help with difficulties like contradictory rules, slow adoption of cutting-edge technology, reliance on imports, and restricted access to finance for start-ups.

Until 2017, the sector remained largely unregulated, when the Central Drugs Standard Control Organization framed the Medical Devices Rules. India is the fourth largest Asian medical devices market after Japan, China, and South Korea. It is among the top 20 medical devices markets globally. The government has initiated the production-linked incentive (PLI) scheme to promote domestic manufacturing of medical devices and support for setting up medical device parks. Additionally, the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme, launched by the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD), verifies the quality, safety, and efficacy of medical devices.

Policymakers need to lessen reliance on imports and support home manufacturing and innovation to help handle the sector’s difficulties. Medical devices businesses can help India become a hub for the manufacturing, work together on the Make in India and Innovate in India initiatives, and concentrate on creating low- to medium-tech items for underserved local markets.

The National Medical Devices (NMD) Policy, 2023, has been approved by the Union Cabinet to accelerate the growth of the medical devices sector in India. The policy aims to achieve access, affordability, quality, patient-centered care, preventive health, security, research, innovation, and a skilled workforce. Key features of the policy include regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments, human resources development, and brand positioning. The policy is expected to strengthen the medical devices industry and place India on an accelerated growth path with a patient-centric approach. The goal is to become a global leader in the manufacturing and innovation of medical devices by achieving a 10–12 percent share in the expanding global market over the next 25 years. The policy is expected to help the medical devices sector grow from USD 11 billion to USD 50 billion by 2030.

The development of novel medical equipment, diagnostic procedures, and the adoption of digital technology are anticipated to drive the MedTech and IVD sectors in India. Growth is anticipated to be fuelled by government programs, including the NDHM, Atal Innovation Mission, and Biotechnology Industry Research Assistance Council. Medical equipment and diagnostic test exports are also anticipated to increase, with the industry aiming to become a prominent player in the global market under the PLI scheme. Within the next 25 years, the Indian medical devices industry has the potential to dominate production and innovation worldwide; by 2030, it may have grown by 28 percent annually and reached USD 50 billion. Overall, India’s MedTech and IVD industries are poised for significant growth, driven by innovation, digitalization, and export opportunities, with the potential to become a global leader in the next 25 years.

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