Biopharmaceuticals and one of its key aspects, research in monoclonal antibodies, might well turn out to be the next hot area for Indian drug companies, with a $30-billion market awaiting to be tapped globally over the next few years, industry experts say.
Biopharmaceuticals are medicines made by biological processes rather than by chemical synthesis. Many medicines developed using recombinant DNA techniques are termed biopharmaceuticals.
'Recombinant' is a term used to describe drugs that have been produced using the techniques of genetic engineering. The products are virtual replicas of compounds produced naturally by the body.
Bangalore-based Biocon Limited has recently developed Biomab-EGFR, a therapeutic antibody-based anti-cancer drug. The drug, the first of its kind to be indigenously developed in India, is prescribed for treating solid tumours of epithelial origin, such as those erupting in the head and neck.
The current global market size of biopharmaceuticals is estimated at $15 billion, and is expected to double by 2010. India is expected to be a strong centre for research in monoclonal antibodies.
Dr Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Limited said: “While therapeutic monoclonal antibodies have been introduced in the country, they are beyond the reach of a majority of cancer patients because of their prohibitive cost”.
Rajesh Jain, joint managing director of Panacea Biotec Ltd, a Delhi-based biopharmaceuticals company, said that the company is focussing heavily on the development of monoclonal antibodies and other biopharmaceuticals, primarily in the areas of diabetes, arthritis and organ transplants.
“Biopharmaceuticals and monoclonal antibodies hold out enormous potential for Indian drug companies. A couple of successful biopharmaceuticals would result in a market of a few billion dollars,” said Jain.
Mukesh Ambani controlled Reliance Life Sciences is also developing a range of biopharmaceutical products in the categories of blood plasma proteins, biogeneric recombinant proteins, novel recombinant proteins and humanised monoclonal antibodies. Besides, the company says that there are 15 biopharmaceuticals in various stages of development.
The country’s largest drug maker, Ranbaxy Laboratories Limited, last week signed an exclusive licensing agreement with Debiopharm Group (Debiopharm), a Swiss biopharmaceutical development company, to market its New Chemical Entity (NCE), Sanvar (vapreotide acetate). The injectible molecule will be used for the treatment of bleeding related to hypertension.
Sanjeev Dani, Regional Director, India and Middle East, Ranbaxy, said that the agreement with Debiopharm in the gastroenterology area would enable Ranbaxy to increase its focus in this segment.