India Medical Devices

The Indian medical device market is rapidly growing, fueled by a rising population, increasing health concerns, and proactive government initiatives. Projected to expand from $12 billion in 2023-24 to $50 billion by 2030, the market presents substantial opportunities for U.S. MedTech companies. However, navigating India’s complex regulatory landscape, especially its “Make in India” initiative, requires a strategic and adaptable approach.

India’s global market share of medical devices is expected to rise from 1.65% to 10-12% over the next 25 years. Key growth drivers include a rising middle class, increasing disposable incomes, an aging population, and the growing prevalence of chronic diseases. This growth will also be supported by expanding healthcare infrastructure and heightened health awareness, leading to greater demand for and supply of advanced medical technologies. High-potential segments driving the market include diagnostic imaging, cardiovascular devices, orthopedic implants, medical consumables, and in-vitro diagnostics.

Opportunities for U.S. Companies

U.S. MedTech firms are well-positioned to meet India’s growing demand for cutting-edge medical technologies. By leveraging their expertise in advanced technologies, U.S. firms can introduce next-generation medical devices to meet growing demand. Collaborating with Indian companies through strategic partnerships can provide access to local distribution networks and regulatory insights, easing market entry. With the increasing adoption of digital health technologies in India, U.S. companies can also tap into the rising demand for telemedicine, remote monitoring, and other digital health solutions. Despite efforts to ramp up domestic production, India remains reliant on imports for nearly 70% of its medical devices. This dependency creates significant opportunities for U.S. exports. In fact, U.S. medical device exports to India rose by 66.3% in FY24, reaching $1.45 billion—up from approximately $872 million in FY20.

Policy Landscape and Regulatory Challenges

India’s policy environment is undergoing transformation to boost domestic manufacturing and reduce import reliance. Initiatives such as “Make in India” and the Production Linked Incentive (PLI) scheme incentivize local production and favor Indian products in government procurement. The National Medical Devices Policy 2023 further promotes growth through regulatory reforms, infrastructure development, and skill enhancement, while the Central Drugs Standard Control Organization oversees regulations, aligning them with global standards.

India currently allocates under 1.5% of GDP to public health spending—among the lowest globally—but is working to increase this to 2.5% by 2025 to improve access, especially for underprivileged populations, and fund infrastructure projects. This growth is further driven by Government of India’s incentive programs such as Pradhan Mantri Ayushman Bharat (Prime Minister’s Live Long India) Health Infrastructure Mission and expanded budgets for health missions.

Challenges for U.S. MedTech Firms

Despite the opportunities, U.S. companies face several hurdles in the Indian market. Intellectual property protection remains a concern, as does the proliferation of substandard and counterfeit products, which threaten both brand integrity and patient safety. The “Make in India” initiative introduces local content requirements, which complicate access to government contracts for foreign companies. These factors make it more difficult for U.S. firms to navigate the market and legally protect their products. Regulatory complexity, price sensitivity, and competition from domestic manufacturers also pose barriers. Additionally, import duties and health taxes impact pricing strategies, making U.S. products less competitive in cost-sensitive segments.

Way Forward

India’s medical device sector presents a compelling growth story for U.S. companies—driven by increasing healthcare demand, demographic shifts, and supportive government investment. To succeed, companies should focus on thorough market research, flexible entry strategies, and strong partnerships with local distributors and manufacturers while ensuring regulatory compliance and delivering high-quality, cost-effective products.  U.S. medical device companies are in the market and are able to overcome these challenges.

For more information, market research, details about the Indian Healthcare industry, or establishing a local presence in India, please contact your nearest local  U.S. Commercial Service office in the U.S. or Healthcare team at the U.S. Commercial Service in India.