Medical Devices
Indian entrepreneurs on the move
Alongside the rise in digital health tools has been a surge in companies focused on medical devices. According to Invest India, the country’s national investment promotion and facilitation agency, the medical devices market in India is estimated at US$11 billion, and is forecasted to reach US$50 billion by the end of the decade. Growing at two and a half times the rate of the global average, India’s medical devices market is the fastest amongst all emerging markets.
Helping spur on this growth is the Indian government’s assistance in establishing industrial parks dedicated to the creation of medical device manufacturing clusters. Recognizing the costly nature of investing in scientific facilities, state governments across the country are establishing industrial parks to be leased to manufacturers with the aim of decreasing the cost of products. Such parks are in the works or are already established in Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh, as well as in powerhouses like Gujarat and Maharashtra.
With all the progress the country is making, there still remains significant growth potential. As of 2021, roughly 70% of medical devices in India were imported, offering manufacturers a significant opportunity to fill the gap through indigenous manufacture and sales. One area that has proven to be particularly promising is point-of-care diagnostics (POC). This method of testing is ideal for resource limited settings, as unlike conventional clinical diagnostic procedures that require pricey and sizeable instruments often used at a hospital or in a laboratory, POC devices are portable and can be used on-site.
Bhaskar Malladi, head of strategy of in vitro diagnostics manufacturer Agappe Diagnostics, points to the evolution of POC testing as prices begin to drop: “POC testing used to be expensive, but with the rapid evolution of the technology, it has become more affordable and competitive in the marketplace. For example, diagnostics for sickle cell anemia previously required extremely high cost, high performance liquid chromatography (HPLC) testing, which requires expert staff and centralized lab testing. Today, POC technology allows for testing at approximately US$1,000 less, at only US$2 to US$3 per test, while providing the same quality of results.”
Looking at the benefits of POC testing, particularly in countries like India, Mohal Sarabhai, CEO of Asence Pharma Private, decided to enter the molecular diagnostics space. As Asence traditionally focuses more on providing finished dosage forms and APIs to international markets, the company’s move in 2017 to enter a joint venture with the US-based company Co-Diagnostics Inc. to form CoSara Diagnostics was a strategic decision that proved to be very timely.
“At first, we were mainly focused on India-specific diseases like tuberculosis, but when Covid-19 hit, we were able to turn our affordable, molecular diagnostics technology into Covid-19 PCR tests and thereby became one of the first companies in India to offer these tests,” recalled Sarabhai.
His company’s mission is to make these tests available beyond urban hubs where PCR machines are typically concentrated by distributing the devices at collection centers in class two or class three towns in India. Looking forward, Asence is working closely with its US partners to bring what they hope will be one of the most affordable POC devices to market. According to Sarabhai, the device, which has been submitted to the US-FDA for approval, will be saliva-based to provide the accuracy of a PCR machine on a POC device.
“You could invest billions of dollars in capex intensive models to build hospitals and tertiary healthcare centers, but it would be a drop in the ocean given the size of the population and lack of education. Our approach is to take simple, affordable, and scalable consumer healthcare products that can be distributed to the masses.”
Sahil Dharia, CEO & Founder, Soothe Healthcare
A lag in regulations
The largest challenge currently impacting the health of India’s medical device sector is not funding or interest but rather a lag in its regulatory framework. Prior to 2020, the market was barely regulated, as medical devices did not fall within the portfolio of products over which medical regulators had oversight. Although Covid-19 brought to the government’s attention the quantity of substandard products in circulation, such as ineffective PPE kits that were delivering people false results, India still lacks a uniform regulatory approach to the market.
“The regulatory landscape is unfavorable for companies like Premier that produce medical devices that adhere to high quality standards,” remarked Nilesh Mehta, CEO of Premier Medical Corporation, one of the top three global diagnostics providers and manufacturer of over 200 million tests per year.
Given the costs associated with competing against lower quality manufacturers and trying to navigate an incredibly fragmented distribution network, Mehta acknowledged that his company tends to avoid India’s consumer market. “Premier Medical has the efficiency of scale by being among the largest manufacturers of point-of-care tests, meaning we have our manufacturing costs basically as low as possible. Yet there are Indian companies that claim to manufacture the same product much cheaper,” he said. “How are they able to do so? They create products that are far inferior or even defective.”
As the Indian government collaborates with industry stakeholders to define regulations in the coming years, hopefully a more level playing field from a quality perspective will encourage players to take advantage of the sector’s potential.
Image courtesy of Adobe Stock