Pankaj Patel, chairman and managing director of Zydus Cadila said, "We expect to launch the pentavalent vaccine in 2015. Currently clinical trials are on, and afterwards, the data would be submitted to DCGI for approval. The launch would depend on how soon the approvals are received."
He added that the company is also close to launching a vaccine for the human papilloma virus (HPV) which causes cervical cancer in women. "The HPV vaccine is likely to be launched around the same time. The pentavalent vaccine, however, could come first," he said.
Zydus has invested close to Rs 200 crore on research and development (R&D) to develop these vaccines including an anti-malarial one. Around Rs 200 crore has been invested to set up a bio-tech facility at Moraiya near Ahmedabad, where these vaccines would be manufactured.
The pentavalent vaccine provides protection against five potentially life threatening diseases, Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib (Haemophilus influenza type b).
Of these, diptheria, pertussis and tetanus were already a part of the national routine immunisation programme. Haemophilus influenza type B (Hib), which causes severe pneumonia, meningitis and other life-threatening conditions in children less than five years of age has been added to the programme.
In October 2013, the National Technical Advisory Group on Immunisation (NTAGI) has recommended a scale-up of the pentavalent vaccine across the country, which eventually means a significantly large potential market for the vaccine.
In 2008 the NTAGI had recommended to add the vaccine to the universal immunisation programme, and has been introduced in eight states so far in a phased manner since 2011. In the states of Kerala and Tamil Nadu in December 2011 and Puducherry, Goa, Haryana, Gujarat, Karnataka and Jammu & Kashmir in 2012-13.
Market size for pentavalent vaccine is expected to be around $130-140 million (around Rs 800 crore) in India, while the demand for anti-malaria vaccine is estimated to be over $200 million (Rs 1200 crore) by 2020.
Meanwhile, the market size for the HPV vaccine in India could be between $170 million to $480 million (Rs 1059 crore -2990 crore) by 2020.
MSD Pharmaceuticals, the Indian arm of Merck & Co, and the GlaxoSmithKline market two HPV vaccines under the brand name of Gardasil and Cervarix respectively.
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