India's biopharmaceutical industry, which was relatively modest only a decade ago, is expected to generate almost $2 billion
in sales in 2008, making it one of the largest biopharmaceutical segments in Asia.1 According to BioPlan Associates, Inc., and the Society for Industrial Microbiology's newly published joint study, Advances in Biopharmaceutical Technology in India, the Indian biopharmaceutical industry is growing 25 to 30% per year.1
Most biopharmaceutical organizations today have established their India and Asia strategies or they are rapidly recognizing
the importance of the historic changes occurring and the potential opportunities that are emerging there. This column is the
first in a monthly series on the growth and challenges facing this market. Future columns will cover biogenerics, the regulatory
situation, intellectual property (IP) protection, how clinical trials are driving this industry segment, bioinformatics, distribution
hurdles, government support for the industry, contract manufacturing, and other key topics.
THE HIGH-GROWTH CURVE
A few of the key findings in India's biopharma-ceuticals industry that are shaping international collaborative and investment
Growth in India is primarily export-driven. Export sales of Indian biopharmaceutical products are currently rising at an annual rate of 47%, while domestic sales of
Indian biopharmaceutical products have risen only 4–5% per annum for each of the past two years. The value of India's biopharmaceutical
exports is already double the value of its domestic biopharmaceutical sales.1
Vaccines are the largest and fastest-growing sector. Indian vaccine sales currently account for about 43% of the country's total biopharmaceutical sales, compared to 16% for
diagnostics and 13% for therapeutics. Most of the growth in Indian biopharmaceuticals is because of vaccines, sales of which
rose by about 42% from 2005 to 2007, compared to just 23% for therapeutics, and only 5% for diagnostics. India is one of the
world's leading suppliers of vaccines for measles and other childhood vaccinations.1
Industry growth is concentrated in a relatively small number of companies. About 30 Indian companies account for the great majority of the country's biopharmaceutical sales. This group is led by companies
in India such as Biocon (Bangalore), Serum Institute (Pune), and Panacea Biotec (New Delhi), which are all domestic players.
The list also includes Indian-based subsidiaries of Novo Nordisk (Bagsvaerd, Denmark), GlaxoSmithKline (Middlesex, UK), Eli
Lilly (Indianapolis, IN), and others.1,2
Indian companies manufacture an increasingly wide range of biopharmaceutical products. These include recombinant insulin, erythropoietin (EPO), G-CSF, recombinant hepatitis-B vaccine, streptokinase, interferon
alpha-2b, rituximab, and an anti-EGFR MAb product.1,2
Indian biopharmaceutical R&D is increasing rapidly. Since 2003, the R&D budgets of the top 10 Indian pharmaceutical companies have more than doubled. Much of this increase has
come in biopharmaceutical R&D, and the pipelines of Indian biotech companies are filling with novel large-molecule drugs for
diabetes, cardiovascular disease, oncology, and anti-inflammation applications, among others.1,2,3
The speed with which the Indian biopharmaceutical industry has developed in the past decade highlights the country's reserves
of well-educated, relatively inexpensive workforce. But it also shows the power of cultural change.
INDIA'S ATTITUDE ADJUSTMENT
A leader of the non-aligned movement after its independence, India was, in fact, a close trading partner of the Soviet Union
from the 1960s through the 1980s. But by the end of the Cold War it had begun to more closely align itself with Europe and
the US—economically as well as geopolitically. By 1991, the US had become India's largest trading partner. Spurred on in part
by this improving relationship and by the recognition of its own potential in the global marketplace, India in the 1990s began
to push its own industries to become global competitors.