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
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
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
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.