India BioPharma market comprising primarily of
vaccines, therapeutic drugs, insulin, animal biologicals, statins and
diagnostics, continued to grab the largest share of the total biotech
industry revenue of
17,249.34 crore in 2010-11. The biopharma market
10,655 crore, with over 60 percent of market share in
2010-11. It accounted for
8,829 crore, taking 62 percent market share
Vaccines sector within biopharma segment witnessed a continued growth
of 12 percent during 2010-11. With the revenue of
2,441.6 crore in
2010-11, vaccines sector claimed the largest pie in the biopharma
segment. In 2009-10 the vaccines sector had sales of
2,180 crore. The
vaccine market will continue to drive the growth of the biopharma
segment, growing in the range of 10-13 percent in the next five years.
The factors that will drive this include, launch of new generation
vaccines from both multinational and local companies; education and
awareness about disease prevention; increase in disposable income and
participation by government.
During 2010, three Indian companies – Serum Institute of India, Cadila
Healthcare and Bharat Biotech – launched H1N1 swine flu vaccine. In
June, Ahmedabad-based Indian pharmaceutical major Cadila Healthcare was
the first to launch indigenous vaccine against H1N1 in India under the
VaxiFlu-S is an egg-based, inactivated vaccine, based on conventional
technology developed by Cadila’s researchers at its Vaccine Technology
Center (VTC) in Ahmedabad (India). VTC further plans to develop a wide
spectrum of vaccines against bacterial, viral and protozoal infections.
The Indian government has been importing H1N1 vaccine from global
pharma major Sanofi-Aventis.
In July 2010, Serum Institute of India (SII), one of India’s largest
vaccine manufacturers, launched its indigenously developed intra-nasal
H1N1 vaccine under the brand name, Nasovac. A live attenuated influenza
vaccine (LAIV) Nasovac, is a single-dose vaccine fitted at the top of
the syringe, and about 0.25 ml is administered in each nostril,
mimicking the path followed by the virus, to enter the body. The
product is priced at half the price of similar vaccines, marketed by
Indian and foreign companies. The price of a single dose of Nasovac
160. Initially, SII looked at the Indian market for the product.
However, it is looking at receiving the WHO pre-qualification, as it
intends to market the product in 100 countries.
In mid-October 2010, Bharat Biotech, another Indian leader, launched
India’s first indigenously developed cell culture H1N1 swine flu
vaccine under the brand name HNVAC. This claims to be the only flu
vaccine to be manufactured in cell culture in the developing world, a
highly sterile and controlled manufacturing process, instead of eggs.
Bill and Melinda Gates, during their visit to India in March 2011,
announced that they would pool in grants to fund late stage clinical
trials to Pune-based Serum Institute of India and Hyderabad-based,
Bharat Biotech International, for pneumonia and rotavirus vaccines.
Though the companies haven’t revealed the exact value of the grants,
reports say that the foundation is looking at granting around $30
million for late stage clinical trials of rotavirus vaccines.
The pricing pressure and competition in the market continue to downplay
the high growth (in terms of value) of vaccine market as against growth
in terms of volume.
India, known as vaccine manufacturing hub, witnessed a major setback
during last year. Shantha Biotechnics, the first Indian company to
launch an r-DNA vaccine in 1997, faced a significant drop in its
revenue, as it had to recall its five-in-one vaccine — Shan5 – from
across global markets following safety concerns. The WHO, which was
procuring Shan5 vaccine from Shantha Biotech under a long-time
contract, worth $340 million covering the period 2010-2012, advised
Shantha Biotech for this product batch recall.
In addition, Haffkine Bio-Pharmaceutical, a Mumbai-based public
enterprise engaged in the manufacture and supply of wide range of
biological and non-biological products comprising bacterial and viral
vaccines, witnessed significant drop in the revenue, because the
company, last year, was not able to get the global tender from
agencies, such as UNICEF.
However, Serum Institute of India, Panacea Biotec, Bharat Biotech and
multinationals such as GlaxoSmithKline, Pfizer (Wyeth), MSD
Pharmaceuticals, Sanofi Pasteur have done well by registering growth of
over 10 percent during 2010-11.
Driven by a rise in chronic diseases and investments in the healthcare
infrastructure, diagnostics and therapeutics business had a positive
impact on the diagnostic sector. The diagnostic market is estimated to
2,440 crore for 2010-11 registering growth of 22 percent over
last year’s market of
2,000 crore. The diagnostics market comprises
biochemical testing market, hematology, microbiology, immunology,
coagulation, urinalysis, critical care and molecular diagnostics. On a
broader level, this market comprises diagnostic instruments, reagents
and services – which is further split into organized and unorganized
sectors. The organized segment has reported strong growth to expand its
reach in rural and semi-urban areas. Just like vaccine market,
diagnostic market too is a highly competitive segment. The prices for
diagnostic kits/tests have dropped significantly in the last 10 years
with an increase in imports from China.
Major MNC companies in the diagnostic market include Roche, Siemens
(which has acquired Bayer Diagnostics), Johnson & Johnson and
Abbott while homegrown names in the top league include Tulip Group, J
Mitra & Co, Transasia Biomedicals, RFCL (Diagnova), Span
Diagnostics and Trivitron. This growth is driven from the gradual
acceptance of the concept of preventive and personalized medicine.
The rising prevalence of diseases, improving affordability of patients
and increasing penetration of health insurance have contributed
substantially to spur demand for diagnostic services in the country.
With the continuous increase in demand, the market is expected to post
around 22-25 percent growth in the coming years. This growth is
expected to drive high investments in the primary healthcare sector.
Of the many subsectors in diagnostics, molecular diagnostics is
emerging as one of the fastest growing segments of the diagnostics
market. The main reason for such a tremendous growth is the unique
ability of molecular diagnostic to treat a wide range of infectious and
genetic diseases. Realizing such a huge potential, various companies
are pouring investments in this segment. On the other hand, the
biochemical testing market is likely to account for the largest share
of the diagnostics market.
The total biologics market in India witnessed a growth of over 35
percent and stood at over
2,000 crore for year ending 2010 as
1,480 crore for the year ending 2009. For 2010, the human
insulin and analogues market stood at over
780 crore and
erythropoietin stood at
In insulin market, Novo Nordisk India is leading the market with close
to 60 percent of the market followed by Eli Lilly with about 26
percent. The other major players in the market include Aventis, Biocon,
Wockhardt and Shreya Lifesciences.
Today, there are 20 recombinant therapeutic products approved for
marketing in the Indian market. And, Indian companies have established
capabilities to manufacture about 15 of these recombinant therapeutic
products. Out of these, the products that have a large share in the
market include Human insulin Erythropoietin Hepatitis-B vaccine
(recombinant surface antigen-based), Human Growth Hormone, Granulocyte
Colony Stimulating Factor (GCS-F) and Streptokinase. Close to 50 brands
are being marketed in India by Biocon, Shantha Biotechnics, Bharat
Serums and Vaccines, Virchow Biotech, Zenotech, Reliance Life Sciences,
Bharat Biotech International, Wockhardt, Shreya Life Sciences, Intas
Biopharmceutcials and Shreya Life Sciences-manufacturing an average of
five brands in India and about 72 recombinant therapeutic products are
at different stages of clinical trials. From just six top Indian
companies with manufacturing capabilities in recombinant therapeutic
products in 2005, the number has more than doubled to about 15
companies in 2011.
Dr Reddy’s Laboratories that sells biologic products — Grafeel and
(generic Filgrastim) and Reditux, (generic Rituximab) has launched
Peg-grafeel in May 2011. Priced at
8,865, the product represents a
breakthrough in the pricing of this complex molecule. It is priced at
approximately 25 percent of the originator brand in India, and is
priced 95 percent lower than the US price for pegfilgrastim. This
breakthrough in pricing has been enabled by the company’s vertically
integrated global manufacturing network. Besides, it has another 11
biosimilars in various stages of development and commercialization.
India will see launch of many biosimilar products in the next two
years, as many biopharma companies have been working on these products
for the last few years and are now in different phases of clinical
trials. With the launch of these products the biopharma market will see
growth of over 25 percent by 2012.