Mumbai: Ahmedabad-based Cadila Healthcare Ltd (popularly known as Zydus Cadila) is looking to expand its vaccine business after becoming the first domestic firm to win approval for an H1N1 virus vaccine.
In addition, it is looking to become a high-volume producer in the much-in-demand rabies vaccine market at a time when other established vaccine makers face production and quality issues while entering the domestic and global markets.
Having invested in a high-capacity vaccine manufacturing plant at Moraiya in Gujarat, Zydus has also received approvals to participate in global vaccine supply contracts from the World Health Organization (WHO) for the anti-rabies vaccine. The company didn’t disclose the plant’s capacity or the amount it has invested in the facility.
Zydus is set to make more investments in the vaccine business in the next three-four years, a company executive said last week, adding that this would be mainly in the manufacturing, pre-clinical and clinical development of other vaccines that are in the pipeline.
“The company wanted to actively focus on the business, and there will be an overall investment of at least Rs500 crore in the next four years,” a Zydus spokesperson said.
India’s total vaccine market is currently estimated at around Rs3,000 crore, with Serum Institute of India Ltd, Bharat Biotech Ltd, Aventis Pharma Ltd, GlaxoSmithKline Pharmaceuticals Ltd, Panacea Biotech Ltd and Wyeth India Ltd among the key players.
There are no official estimates of the size of the market for the H1N1 vaccine as a majority of the supply is through government channels. Besides, the price realization varies among companies as it is based on negotiation with the government.
In India, at least 139,466 people have been tested for symptoms of so-called swine flu, with 23% testing positive for H1N1, according to clinical study data compiled by Zydus in its research on H1N1 vaccine. The fatality rate in swine flu infections is about 5%.
“The launch of VaxiFlu-S gives thrust to our objective of emerging as a strong player in the area of preventives,” chairman and managing director Pankaj Patel said last week in a media release on the launch of its H1N1 vaccine.
The rabies vaccine market in India is currently in the range of Rs200-300 crore, and is likely to increase, said Sujay Shetty, leader (pharma practices), at global consulting firm PricewaterhouseCoopers (India).
“Since the belief of ‘prevention better than cure’ is getting stronger in the world markets due to comparative cost benefit in preventive care, more companies which were not interested in pursuing the vaccine business earlier are coming back to it,” he said. The prospects for the flu vaccine market in India are also strong once market restrictions are removed, he said.
Elara Securities (India) Pvt. Ltd said in an April report that with WHO approval for generic Lyssavac N (the anti-rabies vaccine), Zydus is expected to start a new business in tender-based vaccine drugs.
“We believe that the company is actively pursuing a strategy for the vaccine business, which has become prominent following the acquisition of Italy-based Etna Biotech, the setting up of its own vaccine plant, and an agreement with WHO to develop the next generation biologicals for rabies vaccine,” the report said.
Indigenous research and development and domestic manufacturing will also give Zydus an upper hand in pricing when it participates in WHO tenders, the Elara report said.
WHO’s pre-qualification approval for Zydus’ rabies vaccine comes at a time of shortage following the withdrawal of leading brand Rabipur from the market by Aventis Pharma after its licensing agreement with the Novartis group expired.
Another rabies vaccine brand, Verorab, from Ranbaxy Laboratories Ltd, was also withdrawn after its licensor Sanofi-Aventis SA terminated the arrangement with the Indian firm late last year.