The Indian medical devices market, estimated at INR 90,000 crore (USD 11 billion) in 2022, is set to surge to USD 50 billion by 2030, boasting a Compound Annual Growth Rate (CAGR) of 16.4%. Despite its modest global share of approximately 1.65%, India ranks among the top 20 markets globally and is the fourth largest in Asia. While maintaining a significant import dependency, the sector shows promising export growth, totalling USD 2.49 billion from April to December 2022. Optimism abounds for India's self-sufficiency in medical device manufacturing by 2025-26, supported by government initiatives and burgeoning domestic and international investments. Recent trends indicate a rise in predictive analytics leveraging 'Big Data,' increasing adoption of wearable devices, advancements in robotic surgeries, and a thriving health-tech start-up ecosystem. Telemedicine platforms like eSanjeevani bridge healthcare gaps, while home healthcare services are expected to grow substantially. Educational institutions are addressing the demand for skilled professionals, and the sector is witnessing financial expansion through IPOs. These developments underscore the dynamic growth and potential of India's medical device industry.
Market Overview
India's medical devices market, valued at USD 11 billion in 2022, stands as the fourth largest in Asia and among the top 20 globally, yet its potential for growth is significant. Projected to reach USD 50 billion by 2030, the sector sees accelerated expansion, especially among small to mid-sized companies, fuelled by government support and 100% FDI. With a steady 15% CAGR over the last three years, India's manufacturing prowess in critical healthcare items during the COVID-19 pandemic underscores its importance. The sector is diversified across five segments, with start-ups playing a vital role in innovation. India's establishment of dedicated Medical Device Parks reflects its commitment to fostering efficient domestic manufacturing.
Growth Drivers
- Government Incentives: The Indian government has introduced the Production Linked Incentive (PLI) scheme for Medical Devices, with 26 projects approved and an investment of INR 1,206 crore (USD 147 million). Additionally, the new Drugs, Medical Devices, and Cosmetics Bill 2022 aim to ensure high standards and legal protections for medical products. The PLI scheme for Pharmaceuticals, worth INR 18,420 crore (USD 2.24 billion), aims to enhance manufacturing capabilities and increase medicine availability.
- Medical Parks: The "Promotion of Medical Device Parks" program, initiated in August 2022 with a budget of INR 400 crore (USD 48.97 million), aims to reduce manufacturing costs by providing essential infrastructure. Notable projects include a significant medical device park in Noida with an investment of INR 5,250 crore (USD 705.38 million) and employment opportunities for 20,000 individuals.
- Foreign Direct Investment (FDI): Allowing 100% FDI in the medical devices sector under the automatic route has attracted significant investments, totalling USD 600 million between 2015-2020. Notable inflows from countries like Singapore, the US, Europe, and Japan highlight global confidence in India's medical devices market.
- Commercialization Initiatives: The collaboration between the Indian Council of Medical Research (ICMR) and Indian Institutes of Technology (IITs) aims to establish Centres of Excellence (CoEs) to foster the development and commercialization of indigenous medical devices. This initiative incentivizes local manufacturing and supports technologies nearing commercialization.
Why Invest in India?
The Indian medical devices sector receives strong government support, allowing 100% Foreign Direct Investment (FDI) and benefiting from policies promoting domestic manufacturing and innovation. Initiatives like the establishment of an export promotion council underscore India's commitment to enhancing global competitiveness. With the sector poised to reach USD 50 billion by 2030, driven by initiatives like the PLI scheme and medical park development, demand is set to surge. Export opportunities abound, driven by import reliance and bilateral trade targets, particularly with Russia. Significant investments, including FDI inflows of USD 3.22 billion and a substantial budget allocation of USD 11.3 billion for healthcare, reflect the industry's potential for growth and innovation.
Government Support and Policies
Several key developments have shaped the landscape of the medical devices sector in India. The introduction of the Medical Device (Amendment) Rules 2020 by the Central Drugs Standard Control Organisation (CDSCO) brought about significant regulatory changes, including the establishment of new registration procedures and exemptions for certain categories of medical devices. Additionally, the formation of the National Medical Devices Promotion Council in January 2020 aimed to boost domestic production and attract investments in high-end medical devices. In line with the 'Make in India' initiative, the Public Procurement Order was revised in March 2021 to include 19 medical devices, fostering local manufacturing and reducing import costs. The introduction of Health and Wellness ATMs in Uttar Pradesh in July 2021 signifies efforts to enhance primary healthcare infrastructure across the state. Furthermore, the approval of the National Medical Devices Policy 2023 in April 2023 sets the stage for structured growth, targeting accessibility, affordability, quality, and innovation in the sector. These developments collectively signal a concerted effort to propel the Indian medical devices industry toward a projected valuation of USD 50 billion by 2030.
Regulatory Framework
The regulatory framework for medical device manufacturing in India is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. Governed by the Medical Devices Rules of 2017, this framework entails guidelines for registration, licensing, classification, and quality standards. The Bureau of Indian Standards (BIS) sets mandatory quality standards, while the Indian Pharmacopoeia Commission (IPC) establishes standards for drug and device identity, purity, and strength. Compliance with ISO 13485 for quality management systems is mandatory. Regulatory approvals from CDSCO, including manufacturing licenses and product registrations, are requisite. Post-market surveillance ensures ongoing monitoring of device safety and performance, with manufacturers mandated to report adverse events. The framework evolves through amendments and updates to address emerging concerns and align with global standards.
Manufacturing Clusters
Various states across India are actively developing specialized zones and parks dedicated to the manufacturing and innovation of medical devices. Andhra Pradesh's MedTech Zone (AMTZ) in Visakhapatnam leads the way as India's first medical technology manufacturing park, providing advanced infrastructure and regulatory support. Telangana, Kerala, Gujarat, Karnataka, Tamil Nadu, Maharashtra, Haryana, Uttar Pradesh, Punjab, and Rajasthan are also establishing MedTech parks and clusters to attract investments, promote domestic production, and foster innovation in the medical device industry. These initiatives aim to create conducive ecosystems for collaboration between industry, academia, and government, driving research, manufacturing excellence, and economic growth in the sector.
Conclusion
In conclusion, India's medical device manufacturing industry is poised for significant growth, with the market expected to reach USD 50 billion by 2030 from USD 11 billion in 2022. The establishment of dedicated manufacturing clusters like AMTZ and initiatives such as the National Medical Devices Promotion Council underscore the government's commitment to indigenous production and investment attraction. Collaborations between government, industry, and research institutions drive regulatory advancements and infrastructure development. Despite challenges, the industry's resilience during the pandemic highlights its potential. Moving forward, innovation, R&D, and regulatory agility will be pivotal for the industry's continued success and contribution to healthcare and the economy.
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