How the MedTech industry will pan out over the next couple of years

In recent years, the in vitro diagnostics (IVD) market has experienced significant double-digit growth, with India emerging as a promising destination for establishing manufacturing facilities due to its abundant resources.

The MedTech/IVD industry has undergone a notable transformation driven by regulatory reforms aimed at fostering innovation, ensuring patient safety, and facilitating market access. These changes have laid the foundation for a dynamic 2024 in the MedTech sector. One pivotal development is the implementation of the National Medical Devices Policy, 2023, strategically designed to diminish import reliance and enhance domestic production. Aligned with the Atmanirbhar Bharat and Make in India initiatives, this policy seeks to position India as a global manufacturing hub, targeting a 10-12 percent share in the global medical devices market over the next 25 years. It focuses on manufacturing advanced medical devices and outlines missions for improving access, affordability, quality, patient-centered care, health promotion, security, research, innovation, and skilled manpower.

Another transformative initiative is the National Policy on Research and Development (R&D) and Innovation in the Pharma-MedTech Sector, introduced alongside the Scheme for Promotion of Research and Innovation in the Pharma-MedTech Sector (PRIP). These measures are poised to further bolster India’s capabilities in research, development, and innovation within the pharmaceutical and medical technology domains, driving growth and competitiveness in the sector.

PRIP is dedicated to establishing Centers of Excellence, enhancing research infrastructure, and addressing healthcare challenges through interdisciplinary collaborations, with a particular focus on precision medicine, new entities, medical devices, and antimicrobial resistance. The scheme aims to bolster the regulatory framework, promote innovation, and cultivate a supportive ecosystem, with the ambition of achieving a market value of ₹4.02 lakh crore (USD 50 billion) by 2030. This vision entails transforming India’s MedTech industry through research and development, domestic manufacturing, accessible healthcare, skill enhancement, and job creation.

These regulatory advancements have spurred a surge in investments and partnerships within India’s med-tech sector. Startups focusing on innovative yet low-risk devices are attracting venture capital, while established players are broadening their product portfolios to comply with evolving regulations. The influx of funding is expected to drive further research and development, leading to the development of cutting-edge medical technologies tailored to India’s unique healthcare needs. Moreover, there is a growing demand for expertise in regulatory compliance, prompting companies to invest in robust quality management systems and regulatory affairs teams to navigate the changing regulatory landscape effectively.

Emerging issues and areas of concern
While the MedTech industry is poised for sustained growth, fuelled by innovation, expanded market penetration, and an increased emphasis on product quality. Nevertheless, challenges persist, particularly for companies dealing with high-risk devices navigating heightened regulatory scrutiny. Striking a balance between promoting innovation and ensuring patient safety emerges as a pivotal challenge for both regulators and industry stakeholders.

A major concern is the skills gap in specialized manufacturing and R&D roles, coupled with the high cost of innovation in a price-sensitive market. Strengthening the intellectual property regime is crucial to safeguard indigenous innovations and attract further investment in the sector.

Several key developments are expected to shape India’s MedTech and IVD industry in the coming years. The resurgence of domestic manufacturing, supported by schemes like PLI and other incentives, is expected to significantly boost India’s capacity to produce medical devices locally. There will be a notable emphasis on R&D, with government support likely driving substantial advancements in medical device innovation. Furthermore, India’s MedTech sector is poised for growth in the global export market, leveraging its cost-effective manufacturing and skilled labor force to increase its share in international markets. Additionally, the integration of AI, machine learning, and big data analytics is set to revolutionize medical technology, further enhancing efficiency and outcomes.

The regulatory changes implemented in India’s med-tech landscape have opened up new opportunities and challenges. This period marks a significant juncture that will shape the future trajectory of MedTech/IVD industry in India.