If we talk about biotechnology, then, today, India is one of the most exciting emerging markets in the world. There are several factors that create the impetus for India to develop exceptional capabilities in the realm of biotechnology. A large reservoir of scientists, centres of academic excellence in life sciences, a virile pharmaceutical industry and fast developing clinical capabilities collectively point to a booming biotechnology sector in the future.
Indian biotechnology market, valued at INR 112.6 billion (US$ 2.86 billion) in 2007-08, is projected to hit a compound annual growth rate (CAGR) of 30 per cent in the near future. By 2012-13, the sector is expected to be worth INR 224.13 billion (US$ 5.7 billion). Presently, exports dominate the Indian biotechnology market, especially from segments like bioservices and bioinformatics. Biopharma remains India's biggest biotech sector accounting for nearly 70 per cent of the total revenues in 2007-08. The bioagriculture sector, driven by the sales of BT cotton, is the industry's fastest growing sector. Strong research and development (R&D) capability and a large patient pool for clinical trials are expected to make the bioservices sector amongst the most potential sectors in the Indian biotechnology market.
HOT SPOTS OF BIO ACTIVITY
Indian biotech industry is predominantly spread over six major regions in India - Bangalore, Hyderabad, Chennai, Pune-Mumbai, Delhi and Ahmedabad-Vadodara. Out of these, Bangalore, Hyderabad, Pune-Mumbai and Ahmedabad-Vadodara have been natural biotechnology strongholds. India's silicon hub Bangalore dominates not only in information technology (IT), but also in biotechnology, accounting for about 60 per cent of the country's bio export pie. In the case of investments, Bangalore accounted for 12 of the 24 biotech firms set up in 2008. Top five biotech firms, Serum, Biocon, Shantha, Wockhardt and Panacea, account for a third of the total biotech market share. Revenue from biotech research activities reached $500 million, wherein bioinformatics alone generated $200 million. Biotech firms from Bangalore maintained 35 per cent growth rate with upfront investment of $250 million in 2008.
R&D & INFRASTRUCTURE
Many international biotech firms are laying out plans for direct investments in India. The World Bank has been funding the India biotech sector. Also, Indian companies have been able to attract investors. Despite these positive indications, there however appears to be a lack of adequate funding for early-stage biotech ventures. According to industry experts, seed capital to fund start-ups will be a critical factor influencing the growth of India's biotech sector and Government initiatives to spur seed capital hold the key to the much needed investments.
BIOPHARMA
Indian biopharma is export-driven with 61 per cent of revenues coming from exports. India supplies more than 60 per cent of the world's requirements of basic vaccines. India is one of the largest producers of traditional vaccines in the world, particularly paediatric vaccines.
Cutting-edge research is being carried out by Indian companies in close collaboration with leading research institutions and companies throughout the globe. Some of the examples include:
●Bharath Biotech has partnered with US-based Novavax to develop an Avian Influenza Vaccine, and also tied up with Acambis to develop a vaccine for Japanese Encephalitis
●Chiron has partnered with Serum Institute for a Meningitis Vaccine
●Serum Institute is also collaborating with the Gates Foundation and the Programme for Appropriate Technology in Health (PATH) for accessing testing technology for a pneumococcal vaccine
●Indian Immunologicals has been working closely with the Indian Institute of Science (IISc) to develop a DNA vaccine for rabies
●Shantha Biotech works with the National Institute of Health (NIH) for a rotavirus vaccine
A large number of Monoclonal Antibodies (mAbs) have already been introduced in India by innovator companies. The mAbs market is becoming a fast-growing segment in India, especially in oncology and auto-immune diseases such as Rheumatoid Arthritis.
Due to the technological complexity, mAbs development is at a budding stage in India. Biocon has partnered with an innovator for an anti-EFGR (Epidermal Growth Factor Receptor) mAb. It is indicated for the treatment of head and neck cancer, non-small cell lung cancer, brain tumours, colorectal cancer and pancreatic cancer.
In April 2007, Dr. Reddy's Laboratories launched Reditux, the generic version of Rituximab, at a price 50 per cent lower than the innovator drug's price. Reditux has the distinction of being the first generic mAb to be launched in the world.
Serum Institute of India has entered into an agreement with Akorn of USA for definitive development and exclusive distribution rights for a rabies mAb.
BIOSERVICES
In India, bioservices include clinical research and contract research organisations (CROs) and custom manufacturing. Presently, there are more than 70 companies involved in activities such as data management, clinical trials, site management, bioequivalence and toxicology studies and knowledge process outsourcing for the biopharma industry. Biocon's subsidiary, Syngene, has collected the highest revenues at US $ 38 million in the bioservices sector during 2006-07.
As clinical trials get larger and more complicated and R&D expenditure escalates, global R&D outsourcing creates a huge opportunity for Indian players. India offers a US $1 billion opportunity in clinical research alone. Abundant manpower, speedy trials and high quality of service, make India a preferred destination for global clinical services outsourcing.
Leading global CROs in India include Quintiles, ICON, PRA, Parexel, Chiltern and ClinPharm, while major Indian players are Lambda Therapeutics, Clininvent and iGATE Clinical Research International.
India has also attracted various outsourcing deals in the area of biomanufacturing. They are:
BIOAGRICULTURE
Bioagriculture is the third largest contributor to Indian biotech industry during 2006-07 with a turnover of US $225 million. This growing segment accounts for almost 11 per cent of the biotech market pie. However, its growth rate of almost 55 per cent is the highest among all the biotech segments.
About 15 biotech products are under development by both the public and private sector in the country. These crops offer pest and disease resistance and delayed ripening. R&D work is also being carried out in the areas of mustard hybrids, nutritionally enhanced potatoes and vitamin A-rich golden rice.
BIOINFORMATICS
India's bioinformatics sector is at a blossoming stage. However, dynamic activity in the segment indicates exponential growth in the near future. The international client base for Indian bioinformatics companies include the National Institute of Health (NIH), University of Mexico, National Institute for Cellular Biology, Dublin, National Research Council, Sequencing Centre at Halifax and David Eisenberg's research lab at DOE Institute for Genomics and Proteomics, UCLA. The emerging DNA chips market is valued at about US $1 million and has witnessed a growth of 50 per cent.
EMERGING AREAS
Stem cell research continues to pick up momentum in India and significant investments have been made in this field. The Centre for Cellular and Molecular Biology (CCMB) has collaborations with Deccan Medical College (DMC) for liver stem cell research and the Japan-based Nichi-in Centre for regenerative medicine for human trials using stem cells in end-stage liver failure patients.
The conjunction of nanotechnology and biotechnology has paved way for rapid advances in the medical field. Dabur Pharma recently developed a nanotech-based chemotherapy agent called Nanoxel. This nanoscale drug delivery system is the country's first indigenously developed chemotherapy agent, and is also the first developed outside USA.
India is estimated to be home to more than 400 biotech companies by 2010. The overall size of the Indian market is expected to touch US $5 billion by the end of this decade and US $25 billion by 2015.
There are almost 17 recombinant products, which have been approved for marketing in India as of today. It is expected that this number will move up to approximately 100 biotech products. The industry has tremendous employment potential and about 50,000 scientists would be working in Indian biotechnology labs by 2010.
Triggered by the surge in both R&D and production, the future of the biotechnology looks bright.
(The author is with Noida-based Accure Labs Pvt. Ltd)