The medical drug (proteins including antibodies, nucleic acids, DNA, RNA or antisense oligonucleotides) produced using biotechnology is called biopharmaceutical. The biopharmaceuticals are complex macromolecules created through the genetic manipulation of living organism using gene cloning, recombinant DNA or cell fusion technology. In the past decade biopharmaceuticals have captured the market and provided some of the biggest breakthrough in medicines. The biotechnology has created a positive wave around the world and has influenced all aspects of life. The biotech sector is set to create the greatest revolution in business world providing unprecedented opportunity and wealth. India is going to play the lead role in this sector with human resource already in place and investment. Now it has a strong position in the Asian Pacific region and India constitutes around two per cent of global biotechnology market.
The India’s interest in the biopharmaceutical market dates back to 1925 when Haffkine Institute began production of vaccines in Mumbai and later with Pasture Institute of India. During the period India was primarily dependent on foreign companies to meet the country’s growing demand for basic medication due to its rapidly growing population and frequent epidemics. In 1960’s many companies were established for the production of vaccines and subsequently later the focus on biopharmaceutical products shifted to enzyme market and companies such as Biocon became the first Indian company to manufacture and export enzymes to US and Europe.
In the present scenario, most of the major Indian biopharmaceuticals companies are involved in the production of recombinant DNA and monoclonal antibodies (mAbs). The biopharmaceutical products now manufactured by the Indian companies cover a wide range of products like hormones such as Insulin, Erythropoietin, Streptokinase and Interferon, Growth Hormones, Granulocyte Stimulating Factor, Follicle Stimulating Factor, Blood Factor VIII, Tissue Plasmogen Activator and Vaccines. The Biopharmaceutical Industry in India is now close to 200 biotechnology companies. These are a mixture of Indian companies and multinational companies with their subsidiaries or joint ventures. The top 10 companies accounts for over 50 percent of the revenue. The change in the patent regime and the government undertaking various initiatives, it is expected to touch the $5 billion mark by 2010. The world has woken up to the fact that India is a country that cannot be ignored while plotting the landscape of the biotechnology industry of the future. By the year 2020 the market is forecast to be worth over$200 billion driven by a shift in usage from conventional drugs to biopharma products.
The Indian biotechnology market can be divided into Biopharmaceuticals, BioServices, BioAgriculture, BioIndustrial, Bioinformatics. The Indian biotechnology Industry segment break-up as on 2006 (Fig-1). The Biopharmaceuticals constitutes the largest segment of the industry both in terms of domestic and export revenues. The percentage wise break up of the Indian Biopharmaceutical market as on 2006 (Fig-2). The market share of key biotech services (Fig-3).
The biotech industry in India is growing at the rate of 30-40 percent per annum. The Indian biopharmaceutical industry has posted a turnover of Rs. 12,137crore in 2008-2009 compared with the previous year for an amount 10,274 in 2007-08. The net sales of leading Biotech companies for the quart ended in june 2008 (Fig-4). In India the vaccine sales has accounted for 47% of the country total bio pharmaceutical product in comparison with diagnostics and therapeutics. India is the world leading suppliers for measles vaccine and other childhood vaccination. The biotech industry is looking at various business models to sustain the growth in a globally challenging environment. The expected investment in biopharmaceutical products within next five (Fig-5).
The Indian pharmaceutical industry is receiving increased global attention owing to low cost, high-quality production and regulatory compliance. The industry provides better manufacturing services as it has good infrastructure for producing biopharmaceuticals in line with the global standards. India has large and growing US FDA approved plant with low cost of research and world class testing facilities. The cost for the research scientist in India is only about one fifth of that of the west. The research services touched US $ 500 million and research in bio informatics was US $ 250 million. The new biotech policy initiated by the central government, the biotech sector is targeting to generate a revenue of US $1billion- US $ 16 billion by 2015.
The Indian companies numbering over 30, accounts for the great majority of the country’s bio pharmaceutical sales. The industry is fast emerging as a favoured destination for many companies especially in the US and European Union. India is counted among the top 12 global biotech hots spots and is also the third largest in Asian Pacific (in terms of number of biotech companies). The Indian industry is now looking for overseas collaboration and alliances to leverage these advantages. Two US – based biotech companies, Impac and Indus Expression floated by non resident Indians have planned an investment of US $ 104 million to set up unit in India at the SSEZ proposed by Andhra Pradesh. Bicon Ltd has announced the collaboration with the US- based generic drugs major Mylan Inc to develop high value generic biologic compound for global markets. The Panacea Biotech Ltd has bagged a three year contract worth over US $119.2 million from UNICEF to provide pentavalent vaccine.
Many leading international biotech giants are ready to invest in India. The worlds leading biotech Company, the $3.3 billion Genentech is open to have alliances with Indian companies. The Genenech alone accounts for half of worlds installed capacity in biopharma sector.
The tax incentives, establishment of DBT by Ministry of Science and Technology, number of patent and drug master files filed with USFDA in recent years, agreement with WTO TRIPS has given a boost to the fast growing biopharmaceutical industry. The new patent law, tax regime, skilled labour force, its evident seriousness in building a biotech industry and amendment of schedule Y of drugs and cosmetics act rule 1945 has paved the way for the western investment.
The biopharmaceutical product development is characterised by high uncertainty of product outcome and a heavy reliance on R&D. As large pharmaceutical companies are becoming increasingly unable to conduct complete in-house drug development, and as a result there is number of strategic alliances between pharmaceutical companies, biotech’s and academic centres. The past few decades the time and cost of development have soared. Today it takes about 15 years and cost up to $800 million to convert a promising new compound in to a drug on the market. The biotechnology drug candidates account for around 32% of all pipeline research programmes. The biopharmaceutical industry are focusing on outsourcing in their critical resources and competencies on developing new drugs through R&D offering higher productivity, higher quality, time to market, generating more profit and achieving higher customer satisfaction.
The advancement of the biotech growth in India was primarily due to establishment of National Biotechnology Board by the DST in 1981-1982 which later developed into a full-fledged department named Department of Biotechnology. The DBT has been a factor in the economic revitalization. In 1990 DBT started funding for research in vaccine and other biotech based drug development (Fig-6). The Department has now started providing grants and loans to Indian companies to cover international patent and other R&D costs. The department has initiated to set up biotech parks with special economic zone privileges. The union government has also been supporting the upstart firm with speed funds through the New Millennium India Technology leadership Initiative (NMITLI) in special drug development research in the field of biotechnology.
The research in biotechnology in the last two decades have evolved in new techniques and advancement, which led to the complexity to the research done in biotechnology, drug discovery and biomedical research. The major techniques involved are of computational in nature, taking their particular disciplines in silico. This technique is termed as biomedical computing to find the drug target. The biological target is a macromolecule, which is crucial for the biological activity, or process, which is to be inhibited.
The bioinformatics play a major role in scanning the current genomic data basis for an optimal target. The three-dimensional structures of target macromolecule can be determined by NMR or X-Ray crystallography or by molecular modelling techniques. Once the target macromolecule is determined and if a lead compound is isolated, the structure of target compound complex can be determined by same techniques. The target compound structures can be examined using computational chemistry techniques and the possible modification of the compound can be determined.
Another area of biotech research is protein engineering were an attempt rationally engineer protein molecules to modify existing activities and to design novel proteins de-novo. The recent research in biotech is focusing on de-nova protein engineering with more quantitative approaches and to design and solve the inverse folding problem and predict protein sequence. The magnetic separation and DNA micro arrays technology is a recent innovation for drug discovery. The wide selection of DNA micro arrays offers a high throughput method for simultaneously evaluating large numbers of genes and monitoring physiological responses to drug candidates.
- The author is Assistant Professor, National College of Pharmacy, Manassery, Calicut, Kerala State