MARKET SIZE AND THE KEY OPPORTUNITY SEGMENTS
The Indian biotechnology sector is one of the fastest growing knowledge-based sectors in India and is expected to play a key role in shaping India's rapidly developing economy. With numerous comparative advantages in terms of research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player.
The Indian biotech industry grew threefold in just five years to report revenues of US$ 3 billion in 2009-10, a rise of 17 per cent over the previous year, according to the eighth annual survey conducted by the Association of Biotechnology-Led Enterprises (ABLE) and a monthly journal, BioSpectrum, based on inputs from over 150 biotech companies.
The biopharma sector contributed nearly three-fifth to the industry's revenues at US$ 1.9 billion, a rise of 12 per cent, followed by bioservices at US$ 573 million and bioagri at US$ 420.4 million. The remaining revenue came from the bioindustrials US$ 122.5 million and bioinformatics US$ 50.2 million segments.
Biopharma and bioservices sectors contributed 63 per cent and 33 per cent, respectively, to the total biotech exports. The bioagriculture, bioindustrials and bioinformatics sectors remained focussed on domestic operations, bringing in nearly 90 per cent of their revenues from India.
While the industry, spanning bio-pharma and agri-biotech, accounted for US$ 3 billion, the equipment and ancillary segment contributed around US$ 1 billion.
Moreover, as per Kiran Mazumdar-Shaw who is also the Chairman and Managing Director of Biocon, which has topped the list of biotech companies in India in the ABLE survey, India is looking forward to achieve US$ 5 billion in revenue this fiscal (2010-11).
India is also gaining importance as a clinical trial destination. According to a joint study by an industry body and Ernst and Young (E&Y) released in August 2009, the industry-sponsored Phase II, Phase III clinical trial sites in India have grown by 116 per cent during June 2008 and August 2009, with the country moving from rank 18 to 12 across the 60 most active countries.
India participates in 7 per cent of the global Phase III trials and 3.2 per cent in the Phase II trials with industry-sponsored trials having grown by 39 per cent compound annual growth rate (CAGR) during 2004-08.
Major investments
Investments, along with outsourcing activities and exports, are key drivers for growth in the biotech sector.
According to data released by the Department of Industrial Policy and Promotion (DIPP), the drugs and pharmaceuticals sector has attracted foreign direct investment (FDI) worth US$ 1.82 billion between April 2000 and September 2010.
Some of the major investments in the sector are as follows:
- Swiss Pharma company Lonza AG, plans to invest around US$ 55.33 million through its Indian subsidiary in a phased manner in Genome Valley project, Hyderabad, said Stefan Borgas, CEO, Lonza.
- Biotechnology major Biocon plans to invest around US$ 64 million - US$ 107 million over the next three years to set up plants that would supply generic biotechnology drugs to Europe and the United States, said Murali Krishnan K N, President-Group Finance, Biocon.
- The Defence Research and Development Organisation (DRDO), which caters primarily to the armed forces, plans to spend US$ 63.5 million to upgrade and custom-make its existing line of biotech products for civilian use.
TIE UPS
Bangalore-based Biocon Ltd signed a marketing deal with the drug-maker Pfizer to globally commercialise four of its insulin biosimilar products. Pfizer will upfront pay US$ 200 million for the exclusive world rights.
The Department of Biotechnology, Government of India and the Indian Council of Agricultural Research (ICAR) have entered into a MoU with Biotechnology and Biological Science Research Council (BBSRC), UK and Deptt. for International Development (DFID). The initiative is expected to forge productive global partnerships between scientists in the UK, India and other developing countries to leverage high quality biological and biotechnological research for sustainable crop production in South Asia and Sub-Saharan Africa.
An agreement on Russia-India Biotech Network (RIBN) was signed to serve as a dedicated platform to help facilitate collaboration between Russian and Indian biotech companies on September 14, 2010.
Hyderabad-based contract research firm, GVK Biosciences has also partnered with ResearchPoint Global, the US-based clinical organisation. Together, the two companies which are full-service contract research organisations (CROs) will offer access to medical writing, clinical data management and biostatistics, as well as quicker patient recruitment.
Biocon Limited has signed a MoU with Malaysia's Biotechnology Corporation (BiotechCorp) to explore collaboration and potential investment in Malaysia's biotechnology industry.
Moreover, Syngene International, the custom research subsidiary of Biocon Ltd, has entered into a discovery and development collaboration with Endo Pharmaceuticals of the United States to develop biological therapeutic molecules against cancer.
GOVERNMENT INITIATIVES
In recognition of the need of training and education for generating interdisciplinary human resource relevant to biotechnology, the Government of India and UNESCO, have taken a joint decision to establish the Regional Centre for research, training and education in biotechnology under the auspices of UNESCO. The UNESCO Regional Centre for Biotechnology is scheduled to come up in Faridabad, Haryana by the end of 2010.
Further, the Department of Biotechnology (DBT), Government of India, has also decided to set up a unique Health Biotech Science Cluster (HBSC) at Faridabad.
Moreover, the government will fast forward the process of setting up a National Biotechnology Regulatory Authority, to stimulate public and private investment in biotechnology. A draft bill to set up the Biotechnology Regulatory Authority of India (BRAI) to modulate the research, import, manufacture and use of organisms and biotechnology products is ready, said Mr Prithviraj Chavan, Union Minister of Earth Sciences, on November 10, 2010.
Besides the central government initiatives, individual states are also doing their bit to promote the biotechnology industry. Karnataka takes the lead and the state's revised biotech policy offers many fiscal incentives and concession to prospective investors in the industry.
According to the Mr B S Yeddurappa, Chief Minister of Karnataka, a bio-venture fund with a seed capital of US$ 10 million will be set up to incubate start-ups by young entrepreneurs.
Moreover, the state government is setting up 10 biotech finishing schools in association with the industry and academia to create a steady talent pool. Sector specific biotech parks are expected to be set up at Mysore, Mangalore, Dharwad and Bidar in north Karnataka. Similarly, a bio-cluster will be set up in the Bangalore Biotech Park on a public-private partnership mode.
The Government proposes to set up a US$ 640.68 million venture capital fund for giving a fillip to drug discovery and strengthening the pharma infrastructure in the country, stated Mr. Ashok Kumar, Secretary, Department of Pharmaceuticals.
The National Agri Food Biotechnology Institute (NABI), a project of the Department of Biotechnology (DBT), Ministry of Science and Technology, is likely to be ready in the next three years. The autonomous institute, along with a bio-processing unit, would become India's first institute in the field of agri-biotechnology, for which the centre has earmarked US$ 86.36 million to be injected in next five years.
Looking ahead
India is already being globally recognised as a manufacturer of economical, high-quality bulk drugs and formulations. With a huge base of talented, skilled and cost-competitive manpower, and a well-developed scientific infrastructure, India has great potential to become a leading global player in biotechnology.
According to Kiran Mazumdar Shaw, CEO of biotechnology company, Biocon, and Chairman of the Karnataka Vision Group on Biotechnology, the next goalpost that the domestic biotechnology sector has set for itself, is to reach a turnover of US$ 10 billion by 2015.
Bangalore-based Biocon Ltd signed a marketing deal with the drug-maker Pfizer to globally commercialise four of its insulin biosimilar products. Pfizer will upfront pay US$ 200 million for the exclusive world rights.
The Department of Biotechnology, Government of India and the Indian Council of Agricultural Research (ICAR) have entered into a MoU with Biotechnology and Biological Science Research Council (BBSRC), UK and Deptt. for International Development (DFID). The initiative is expected to forge productive global partnerships between scientists in the UK, India and other developing countries to leverage high quality biological and biotechnological research for sustainable crop production in South Asia and Sub-Saharan Africa.
An agreement on Russia-India Biotech Network (RIBN) was signed to serve as a dedicated platform to help facilitate collaboration between Russian and Indian biotech companies on September 14, 2010.
Hyderabad-based contract research firm, GVK Biosciences has also partnered with ResearchPoint Global, the US-based clinical organisation. Together, the two companies which are full-service contract research organisations (CROs) will offer access to medical writing, clinical data management and biostatistics, as well as quicker patient recruitment.
Biocon Limited has signed a MoU with Malaysia's Biotechnology Corporation (BiotechCorp) to explore collaboration and potential investment in Malaysia's biotechnology industry.
Moreover, Syngene International, the custom research subsidiary of Biocon Ltd, has entered into a discovery and development collaboration with Endo Pharmaceuticals of the United States to develop biological therapeutic molecules against cancer.
GOVERNMENT INITIATIVES
In recognition of the need of training and education for generating interdisciplinary human resource relevant to biotechnology, the Government of India and UNESCO, have taken a joint decision to establish the Regional Centre for research, training and education in biotechnology under the auspices of UNESCO. The UNESCO Regional Centre for Biotechnology is scheduled to come up in Faridabad, Haryana by the end of 2010.
Further, the Department of Biotechnology (DBT), Government of India, has also decided to set up a unique Health Biotech Science Cluster (HBSC) at Faridabad.
Moreover, the government will fast forward the process of setting up a National Biotechnology Regulatory Authority, to stimulate public and private investment in biotechnology. A draft bill to set up the Biotechnology Regulatory Authority of India (BRAI) to modulate the research, import, manufacture and use of organisms and biotechnology products is ready, said Mr Prithviraj Chavan, Union Minister of Earth Sciences, on November 10, 2010.
Besides the central government initiatives, individual states are also doing their bit to promote the biotechnology industry. Karnataka takes the lead and the state's revised biotech policy offers many fiscal incentives and concession to prospective investors in the industry.
According to the Mr B S Yeddurappa, Chief Minister of Karnataka, a bio-venture fund with a seed capital of US$ 10 million will be set up to incubate start-ups by young entrepreneurs.
Moreover, the state government is setting up 10 biotech finishing schools in association with the industry and academia to create a steady talent pool. Sector specific biotech parks are expected to be set up at Mysore, Mangalore, Dharwad and Bidar in north Karnataka. Similarly, a bio-cluster will be set up in the Bangalore Biotech Park on a public-private partnership mode.
The Government proposes to set up a US$ 640.68 million venture capital fund for giving a fillip to drug discovery and strengthening the pharma infrastructure in the country, stated Mr. Ashok Kumar, Secretary, Department of Pharmaceuticals.
The National Agri Food Biotechnology Institute (NABI), a project of the Department of Biotechnology (DBT), Ministry of Science and Technology, is likely to be ready in the next three years. The autonomous institute, along with a bio-processing unit, would become India's first institute in the field of agri-biotechnology, for which the centre has earmarked US$ 86.36 million to be injected in next five years.
Looking ahead
India is already being globally recognised as a manufacturer of economical, high-quality bulk drugs and formulations. With a huge base of talented, skilled and cost-competitive manpower, and a well-developed scientific infrastructure, India has great potential to become a leading global player in biotechnology.
According to Kiran Mazumdar Shaw, CEO of biotechnology company, Biocon, and Chairman of the Karnataka Vision Group on Biotechnology, the next goalpost that the domestic biotechnology sector has set for itself, is to reach a turnover of US$ 10 billion by 2015.
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