India is the 4th largest market for medical devices in Asia, among the top 20 markets globally.The current market size of the medical devices industry in India is estimated at $11 bn, represents a sunrise sector of the Indian economy.
The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale. The medical device sector has been growing steadily at a CAGR of 15% over the last 3 years.
The medical devices industry in India is poised for significant growth with the market size expected to reach $50 bn by 2025.
100% FDI is allowed under the automatic route for both brownfield and greenfield setups. Strong FDI inflows reflect the confidence of global players in the Indian market.
Since April 2000, ~$2.2 bn in FDI of this, $600 mn was received in the last 5 years. Singapore, United States, Europe, and Japan are key investors. Equipment & Instruments, Consumables and Implants have attracted most FDI.India’s expected export of medical devices will reach ~ $10 bn by 2025.
The Government of India has taken several steps to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India over the past 5 years:
Medical Devices Rules, (MDR) 2017: The Medical Devices Rules (MDR), 2017 regulates Clinical Investigation, Manufacture, Import, Sale, and Distribution of Medical Devices. The devices are classified into 4 classes, harmonized with international guidelines.
Production Linked Incentive Schemes: To boost domestic manufacturing, Government has launched Production Linked Incentive Schemes (PLI 1.0 & PLI 2.0) for medical devices for 4 key target segments & in- vitro diagnostics.
Scheme for Promotion of Medical Devices Parks: Government of India has approved to establish 4 medical devices parks to provide common infrastructure facilities, create a robust ecosystem for medical device manufacturing, and reduce the manufacturing cost.
The medical devices market in India has the potential to increase at a 37% CAGR and reach $50 bn by 2025.
Around 65% of the manufacturers in India are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market in India with extensive service networks.
There are 750–800 domestic Medical Devices manufacturers in India, with an average investment of $2.3–2.7 mn and an average turnover of $6.2-6.9 mn.