With cost effective vaccines, the vaccine manufacturers in India are all set to play a significant role in the global vaccine industry, which is expected to grow more than US $20 billion by 2010.
According to industry sources, the Indian vaccines market was worth Rs 1800 crore in 2005-06 with the human vaccines segment growing fastest than any other segments in this sector. Prominent players in the segment include Serum Institute of India Ltd, Panacea Biotec, Shantha Biotechnics, GlaxoSmithKline, Sanofi Pasteur, Indian Immunologicals, Bharat Biotech International Ltd and Biological E Ltd. The volume of business is growing with the introduction of newer vaccines and in tandem with it the companies are increasing their production capacities.
With the advantages like relatively lower manufacturing, clinical trial and research and development costs, ability to produce and develop high quality vaccines, large pool of scientists and skilled manpower, India is rapidly turning into a favorite hub for vaccine development and manufacturing. According to industry experts, there is also high potential for the Indian players to provide contract research services in areas like basic research, molecular cloning and gene expression, development of cell lines for vaccines, fermentation and purification process, clinical trials and manufacturing.
As per the available data, Indian companies supply more than 60 per cent of the world's basic vaccine requirements. Vaccine research in India is mainly being carried out by scientists in the academic or research institutes and research and development (R&D) units of the biopharmaceutical and biotech companies. Some of the key vaccine programmes, which are of national significance, are being carried out at academic institutes with financial support from government agencies like DBT, DST, ICMR and CSIR.
Indian vaccine manufacturers are heavily investing in the R&D and many of them have collaborated with overseas players to develop new vaccines. Bharat Biotech has tied up with International Centre for Genetic Engineering and Biotech for a malaria vaccine, besides partnerships with Centre for Disease Control, Atlanta, National Institutes of Health, Washington D.C, Institute of Genomics and Integrative Biology, New Delhi and National Institute of Virology, Pune.
When it comes to Shantha Biotechnology, the company has collaborated with ICMR and National Institute of Health for developing a HIV vaccine. Meanwhile, Serum Institute is developing an aerosol measles vaccine. It is also developing a quadravalent vaccine (combination of Hep B, diphtheria, Pertussis and tetanus). However, pipeline products of most of the companies are similar, which may lead to destructive price war among the Indian firms.
The Pune-based Serum Institute of India is the largest global exporter of vaccines and immunobiologicals from India. The company's flagship products are measles and DPT group vaccines. The company is now working on a quadravalent vaccine that will reduce the number of injections for infants to just one. It has established a marketing alliance with Serono in Switzerland.
The Hyderabad-based Shantha Biotechnology markets recombinant hepatitis B vaccine and streptokinase. The company has so far exported hepatitis-B vaccines to various countries through UNICEF and PAHO and also directly to more than 20 countries. During the last financial year, the company recorded an export sale of Rs 95 crores, an 86 per cent of its turnover in the year. The company has various vaccines in different stages of development. The company is expected to launch haemophilus influenza (Hib) based pentavalent vaccine containing diphtheria (D), tetanus (T), pertussis (P), hepatitis B (HB) and Hib, tetravalent DPT and Hib and Hib monovalent vaccines. Other vaccines in development are rotavirus, cholera, typhoid, measles, mumps, rubella combination (MMR) and varicella.
Bharat Biotech with its revac-B, a recombinant vaccine for hepatitis B using its HIMAX technology, is active in the vaccines business. The technology used eliminates ultra centrifugation and the use of toxic metals, while increasing the recovery of antigenic proteins. Revac-B thus became the world's first recombinant hepatitis B vaccine to be manufactured without the use of cesium chloride. The company also markets streptokinase and is developing a rotavirus vaccine.
Panacea Biotech, yet another important player in this segment, has received WHO-GMP certification for oral polio vaccine. The company's anthrax vaccine is in phase I trials. Panacea Biotech has entered into joint ventures with Chiron Vaccines (Emeryville, CA) and Cambridge Biostability (Cambridge, U.K.) for vaccine manufacturing and thermostable vaccine production, respectively. The company is also negotiating collaboration with ApoLife (Detroit) for using ApoLife's yeast-based technology for the production of therapeutic humanised antibodies.
Many Indian companies with multimillion dollar revenues in chemical, enzyme and pharmaceutical fields have also invested heavily in the biotechnology subsidiaries. These include, Biocon, Piramal Healthcare, and Dr Reddy's Laboratories. Among these companies, Piramal Healthcare has entered into exclusive licensing and co-marketing agreements with global giants like Biogen Idec, Gilead Sciences and Genzyme.