India is a hub for the vaccine market. In 20032004 it grew at 18.64% and accounted for 47% of the total biopharma segment with sales of US$253 million. GlaxoSmithkline, Wyeth, and Aventis are major multinational players in the Indian vaccine market.
Several domestic players are competing in this market. Major vaccines produced include DPT, DT, BCG, Tetanus toxoid, oral polio, measles, mumps, rubella, hepatitis B, rabies (tissue culture-based), and an injectible typhoid vaccine.
Serum Institute of India (Pune) is the largest global exporter of vaccines and immunobiologicals from India. The company's flagship products are measles and DPT group vaccines, and it 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.
Shantha Biotechnology (Hyderabad) markets recombinant hepatitis B vaccine and streptokinase. According to V. Reddy, CEO, "India can position itself as an affordable base for producing vaccines for UNICEF and the developing countries and thereby fill the gap left by multinational companies that no longer find the market of pediatric vaccines profitable enough to operate in."
Bharat Biotech is producing Revac-B, recombinant vaccine for hepatitis B, using its HIMAX technology. This process eliminates ultracentrifugation 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 rotovirus vaccine.
Many Indian companies with multimillion dollar revenues in chemical, enzyme, or pharmaceutical areas have also invested heavily in the biotechnology subsidiaries. These include Biocon, Nicholas-Piramal India (Bombay), Panacea Biotech (New Delhi), Reliance, Ranbaxy and Reddy Laboratories.
Nicholas-Piramal has entered into exclusive licensing and co-marketing agreements with global giants like Biogen Idec, Gilead Sciences, and Genzyme.
Panacea Biotech is a leading manufacturer of vaccines. The company's oral polio vaccine received WHO-GMP certification, and its anthrax vaccine is in Phase I trials.
Panacea Biotech has entered joint ventures for vaccine manufacturing with Chiron Vaccines (Emeryville, CA) and thermostable vaccine production with Cambridge Biostability (Cambridge, U.K.). Panacea Biotech is also negotiating a collaboration with ApoLife (Detroit), for using ApoLife's yeast-based technology for the production of therapeutic humanized antibodies.
Wockhardt (Bombay) has an USFDA/EMEA-confirmed manufacturing facility for recombinant biotechnology, and the company is producing three products: Biovac-B (hep B) vaccine, Wepox (erythropoietin), and Wosulin (r-DNA human insulin).