Therapeutics

The recombinant therapeutics business too has shown consistent growth during the past few years. During 2005-06, the therapeutics business registered 28 percent growth with the overall recombinant biotech market business standing at Rs 640 crore. Human insulin has been the single largest contributor to this figure. About 40 companies both Indian and multinationals are involved in one of the many activities such as R&D, importing, manufacturing and marketing of recombinant biotech products. At present 14 therapeutic drugs are available in India under about 50 brands.

In 2005-06, the human insulin business was estimated at Rs 330 crore. Novo Nordisk, a Bangalore based multinational company, continued to be the leader in the human insulin business with total estimated revenues of Rs 175 crore. The other major players in this segment include Eli Lilly, Aventis Pharma, Wockhardt, and Biocon.

The Erythropoietin (EPO) market for the year 2005-06 was estimated at about Rs 120 crore. Johnson & Johnson is the market leader in the EPO and is followed by Wockhardt, Emcure and LG Life Sciences etc. The streptokinase market was estimated at Rs 70 crore growing at a rate of 25 percent. Shantha Biotechnics and Bharat Biotech are the two home grown companies in this space.

Roche Scientific and Full Ford are the leading names in the interferon market estimated at Rs 35 crore. It is growing at rate of 30 percent. Zydus Cadila, Glenmark Labs, Nicholas Piramal, Shantha Biotechnics, and LG Life Sciences are the other major players in this segment. The market for Human Growth Hormone (HGH) and Follicle Stimulating Hormone (FSH) was estimated at Rs 20 crore and Rs 30 crore respectively. FSH market is growing at rate of 20 percent.

The market for G CSF for the year 2005-06 was estimated at Rs 35 crore and is growing at a rate of 25-30 percent. Emcure, Dr Reddy's Labs and Intas Pharma are the major players in this space.

Unlike the vaccines market, the therapeutics business is primarily dominated by global names. However, home grown players like Bharat Biotech, Biocon, Dr Reddy's Labs, Intas Pharma, Shantha Biotechnics, and Wockhardt have developed biotech drugs indigenously and launched their own products in areas such as streptokinase, human insulin, G CSF, erythropoietin, HGH and interferon alpha 2b. Indian companies are now investing more on R&D of these products in addition to the support these are getting from the government agencies. Biocon now sees oncology and diabetes as the two major areas for growth. Biocon has filed 266 patent applications globally and has been granted 37 patents, including eight in the US. Further, very recently, Biocon announced the availability of its monoclonal antibody, BioMAb EGFR. BioMAb EGFR, developed with the technology transferred to Biocon from Cuban Institute of Monoclonal Antibody (CIMAB), is used for the treatment of head and neck cancers.

Also companies such as Cadila, Emcure Biotech, Reliance Life Sciences, Serum Institute of India, Shashun Chemicals and Drugs, Virchow Biotech, and Zenotech are working on r-DNA drugs like recombinant insulin, interferon alpha 2a, 2b, and pegylated, interferon gamma 1b, G –CSF, G –CSF (pegylated), G –CSF (pegylated methionyl), GM-CSF, EPO, PEG- EPO, Growth Hormone, streptokinase, TNK-TPA, and monoclonal antibodies. About 16 companies both Indian and multinational have been involved in marketing of these products. A few companies like Sun Pharmaceuticals and Torrent Pharmaceuticals are into contract manufacturing of recombinant products for multinationals like Eli Lilly and Novo Nordisk respectively.

During 2005-06, while on one hand MNC companies like LG Life Sciences, Novo Nordisk and Eli Lilly got the GEAC approval to import and market recombinant biotech products, on the other hand some of the Indian companies received GEAC's nod to start production of rDNA drugs and also to scale up fermentors for R&D work.

Wockhardt received approval for manufacture and marketing of r-human interferon alpha (r-DNA Origin). Intas Pharmaceuticals started manufacturing of finished formulation of r-human Erythropoietin (r-h-EPO) after receiving approval from GEAC for the same. Bharat Biotech got the permission to manufacture and market r-human epidermal growth factor. Wockhardt and Dr Reddy's Labs have got approvals to scale up to 300 L fermenter for R&D work.

Novo Nordisk received approval for importing and marketing of human insulin Determir. LG Chemical got approval for import and marketing of 16 IU LG Eutropin (HGH). Wockhardt has received permission to import Erythropoietin (EPREX- with HAS, EPREX-without HAS and Neorecormon) for Test Analysis. Serum Institute of India received approval for import and marketing of r-human interferon beta 1 a from Industria Farmaceutica, Serono, SPA Italy. Eli Lilly Company (India got the permission for import and marketing of Humlog (Human Insulin Lispro –r-DNA). LG Life Sciences India will continue to import and market LG Espogen (r-Human Erythropoietin) and r-Interferon Injection) in India as it received permission do so for period of two more years. Going forward, the industry expects this market to one which will fetch them higher returns.

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