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In the past decade, the medical devices market in India has witnessed a remarkable surge, driven by growing demand for various medical devices, including consumables, dental products, diagnostic imaging equipment, prosthetics, orthopedics, patient aids, and more. To support and regulate this booming sector, the government has enacted several policies and reforms. These initiatives aim to foster the development of new technologies, ensure healthcare safety and quality, and meet the diverse needs of India’s health system.
However, despite these advancements, a significant gap remains between the demand for medical devices in India and their availability. To address this, the government has made notable changes to the Foreign Direct Investment (FDI) policy, encouraging the importation of medical devices to bridge the supply gap.
In this blog, we will explore the medical devices market in India and discuss how foreign medical device companies can successfully enter the Indian marketplace.
Market Volume of Medical Devices in India
India stands as the fourth-largest market for medical devices in Asia, behind Japan, China, and South Korea, and is among the top 20 global markets for medical devices. Let’s dive into the numbers that illustrate the size of India’s medical devices sector:
- In 2022, the medical devices market in India was valued at approximately Rs. 90,000 million (about US$11 billion). The market is projected to grow to US$50 billion by 2030, with a compound annual growth rate (CAGR) of 16.4%.
- The diagnostic equipment segment is expected to reach US$6 billion by 2027, with a CAGR of 16.4% from 2020 to 2030.
- India’s reliance on imported medical devices grew by 21% between November 2022 and October 2023, with imports totaling Rs. 61,262.84 crore (US$7.23 billion).
Key Drivers of Growth in the Medical Devices Market in India
Several factors contribute to the rapid growth of the medical devices market in India.
These include:
- Growing Population: With a population of over 1.4 billion, there is rising demand for medical devices to address chronic diseases, advanced diagnostics, and treatment options.
- Aging Demographics: By 2030, India’s elderly population is expected to reach 194 million, driving demand for medical devices that cater to mobility, diagnostics, and chronic disease management.
- Increase in Chronic Diseases: According to the International Diabetes Federation, India’s diabetes prevalence is predicted to reach 74% by 2025. Alongside this, the rise of other chronic conditions such as cancer and cardiovascular diseases further fuels the need for advanced diagnostic and therapeutic devices.
- Expansion of Health Insurance Coverage: Government initiatives like Ayushman Bharat, which provides health benefits to 500 million citizens, have significantly increased the need for medical devices in India.
- Rising Middle Class and Health Awareness: By 2026, 8% of Indians are expected to earn over USD 12,000 annually, and 73 million households will join the middle class within the next decade. This economic growth and awareness are driving healthcare spending and the adoption of health technologies.
- Growth of Private Healthcare: India’s private healthcare sector has seen rapid expansion, with 393 hospitals accredited by the National Accreditation Board for Hospitals & Healthcare Providers (NABH) by 2019, increasing demand for high-quality medical devices.
- Medical Tourism: India is becoming a major hub for medical tourism, attracting nearly 2 million international patients annually and generating US$6 billion in revenue, projected to reach US$13 billion by 2026. The medical devices market in India is a crucial enabler of this growth, supported by the government’s “Heal in India” initiative.
- Favorable Regulatory Environment: Regulatory reforms, such as the Medical Devices Rules, 2017, have streamlined access to the Indian market, supporting both domestic manufacturers and importers.
How Foreign Medical Device Companies Can Access the Indian Market
Foreign companies looking to enter the medical devices market in India should follow these steps:
1. Market Research: Conduct thorough research on market demand, pricing, competition, and regulatory requirements to identify export opportunities.
2. Regulatory Compliance: Familiarize yourself with India’s regulatory landscape, especially the Central Drugs Standard Control Organization (CDSCO), which governs medical device registration and approval.
3. Leverage Government Initiatives: Take advantage of tax benefits, regulatory harmonization efforts, and policies promoting high-quality medical devices in India.
4. Quality Assurance: Ensure compliance with the Bureau of Indian Standards (BIS), ISO, and IEC guidelines to build trust among Indian consumers.
5. Regulatory Support: Partner with regulatory consultants specializing in the medical devices market in India to navigate the approval process and ensure successful entry.
Future Outlook
With continued government support and technological advancements, the medical devices market in India is poised for robust growth. The government’s focus on regulatory ease, fostering innovation, and creating a favorable manufacturing environment will facilitate greater market access for foreign manufacturers, helping them capitalize on India’s rapidly expanding healthcare sector.
At Regulatory Solutions India (RSI), we specialize in regulatory consulting for medical devices, IVDs, cosmetics, and more. Let us help you navigate the medical devices market in India and achieve success. Send us an email here to discuss your specific needs and we’ll move forward from there.
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