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Medical Devices : India Market and Context


( abstracted from report prepared by “Sathguru” for “Assocham India )


Innovation Adoption for Expanded Clinical Possibilities & Making-in-India



Medical device sector represents 9% of the overall Indian healthcare industry5. Indian medical device market is the 4th largest in Asia and under top 20 in the world. It was valued at $4.2 Billion in 2014 and is growing at a CAGR of 16% over the period of five years6. There are several contributing growth factors such as high volume demand, epidemiological transition, growing GDP; and government efforts such as Make-in-India, 100% FDI, medical parks and shared infrastructure facilities buoyed by modest private sector investment.


The industry is at the cusp of a major transitionary phase. The highly import dependent industry (more than 70% by value) has gained significant attention for the potential it holds to contribute to ‘Making in India’. Contrastingly, there are about 800 medical device manufacturers in India, but hardly 10% generate a turnover in excess of Rs.600 Million, creating a wide stratification in indigenous manufacturing landscape. Most indigenous manufacturers have historically focused on consumables and disposables.


The current shift reflects Indian companies moving up the value chain steadily. They are building competitiveness through indigenous innovation, absorption of acquiring synergistic and sophisticated technologies from global sources and strategic partnerships. On the other end, MNC’s are now seeking to grow beyond the high end of the market and establish presence in the low value segment. They are exploring possibilities such as setting up their own facility (3M in Pune, Becton Dickinson in Haryana), acquiring local manufacturers (Philips Medical System’s acquisition of Alpha X-Ray Technologies), developing cost efficient solutions relevant to the Indian context (GE’s low cost warmer) and even introducing products from Chinese acquisitions in India (Orthopedic devices – Stryker and Medtronic).


However, the segment still struggles with fundamental problems such as an inverted duty structure that often favors importers over manufacturers and slow regulatory reform. Public health procurement channels for innovative devices have also been underdeveloped and call for attention.


Despite the above challenges, devices represent the segment where greater change is expected in the next five to ten years. We discuss below pervasive innovation trends observed across segments of devices and glimpses from the evolving the Indian landscape.


Pervasive Innovation Trends across Device Categories


1. Drug Device Combinations – The Convergent Opportunity Drug device combinations offer attractive growth opportunity for both drug and device companies. Device innovation is emerging as preferred lifecycle management strategy and source of competitive advantage for several drugs. There has been an unmet need for novel drug delivery mechanisms to improve medication adherence, drug absorption including less frequent dosing, extended-release formulations, easy administration and targeted delivery and device innovation has helped address some of these priorities. Self-injecting insulin pens are a pertinent example of drug companies leveraging device innovation. The recent Epipen pricing controversy in the US also highlights how proprietary devices have been used tactically for competitive advantage by drug companies even in the case of highly established drugs. At the other end, integration of drugs for various objectives has allowed device companies also to provide more clinically attractive solutions and seek growth opportunities. One of the older examples would be the case of drug eluting stents that now dominate markets globally. We have outlined below some of the popular areas of innovation for drug device combinations:


A. Vascular: drug-eluting stents, coated vascular prostheses


High incidence of cardiac ailments, coronary artery disease in particular, has paved way for minimally invasive solutions offered by drug-eluting stents. They combine the polymer and drug to achieve coronary revascularization and at the same time deliver anti-proliferative drug at the target.


B. Drug delivery: transdermal patches, inhalers, drug pumps


In India, drug pumps, insulin in particular, has seen an unprecedented demand, owing to 65 million diabetic patients. Insulin pumps have been in use for a considerable time, but the new pumps are being designed to be smarter, smaller and programmable, to detect insulin level and systemically release it. While insulin pumps are wearable, implantable pumps for direct CNS delivery are also being developed.


Simultaneously, innovations in nanotechnology has enabled targeted drug delivery reducing off-target toxicity and dosage quantity. Antibody-based delivery and similar technologies in particular will make delivery of large molecule drugs easy and convenient.


C. Orthopedic: Bone implants/cements


The new generation of bone implants are not only bio absorbable but also contain pellets of antibiotic drugs to be delivered at the site of the morbidity. Recent FDA approvals and clearer regulations have escalated the development of combination products and consecutively research has transpired beyond USA. Combination products has seen convergence of pharma and devices industries to co-develop products. This also presents an opportunity for CDMO’s in India to grow and offer novel solutions to address this unmet need.


Large pharma players have been actively involved in technology development like Sun Pharma’s Levulan Kerastick for treating actinic keratosis or Dr. Reddy’s Zembrace SymTouch pen to treat acute migraines.


India’s strong pharma industry offers ripe collaboration opportunities for device companies to co-create value and seek growth opportunities.

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