Markets

Go to Market Strategies for Medical Device Start-ups and Entrepreneurs in India

Bhupesh Sood CEO, SEC Global Consulting

Tapan Kumar Patel Principal Consultant, SEC Global Consulting

Overview

India is the 4th largest market for medical devices in Asia. Medical device sector is projected to register a CAGR of 14.8% and is expected to reach $11.86 bn in 2021-22.

As stated by the new market research report on medical device outsourcing, the United States represents the largest market worldwide. Asia-Pacific is forecast to record the fastest CAGR of 14.9% over the analysis period- 2020. Less expensive production of devices coupled with adherence to stringent international quality standards marks the emergence of Asia as the most desirable production hub. Asian countries, specifically India and China, are emerging as attractive low-cost destinations for leading medical devices OEMs.

India’s medical devices industry is poised for significant growth in the next five years: The market size is 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, $2.1 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 . 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:

• Recognized Medical Devices as a sunrise sector under Make in India campaign, 2014

• The Medical Devices Rule of 2017

• Adopted risk-based classification based on GHT guidelines: Classes A, B, C, D

• Perpetual licences for manufacturers

• The Medical Devices Amendment Rules of 2020 bring all medical devices in India under regulation as drugs. The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale.

• The current market size of the medical devices industry in India is estimated to be $11 bn.

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 with extensive service networks. There are 750–800 domestic Medical Devices manufacturers in India. The manufacturing is developing in its scale and geography: there are six Medical devices manufacturing “clusters” in the country. Clusters have “Medical Device Parks” developing around them: states have committed to set-up dedicated industrial parks where efficient domestic manufacturing at lower costs. In 2019, Andhra Pradesh, Telangana, Tamil Nadu, and Kerala have got in principal approval from Government of India for new medical devices parks.

The Process from Ideation to Customer (i.e. Patient)