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India’s vaccine manufacturing set to soar to $800m: Prof Steven Myint

May 16
23:19 2011

Prof. Steven H. Myint

NEW YORK: India has emerged as a key vaccine manufacturer in recent times. It already produces 60 percent of the global health vaccines. The country had revenue of $665 million in this space which was expected to reach $800 million soon, said Prof. Steven H. Myint, chairman of Chennai-based Green Signal Bio Pharma Private Limited.

The Indian vaccine market is forecast to grow at 23 percent from 2009-10 through 2011-12 registering revenues around $2 Billion. Vaccines have emerged as one of the growth drivers of the global pharmaceutical industry, he said on a recent visit to New York.

The distinguished scientist said that scare of the avian influenza, bioterrorism organisms and new emerging infections like SARS and the introduction of cancer and rotavirus vaccines have led to phenomenal growth in the vaccine market in the last few years.

Exports have a major share in the Indian vaccine market, with 70 percent vaccines being exported. Of the total domestic market, the private sector’s share stood at $120 million or at 40 percent.

Top vaccine manufacturers have a reasonably diverse product portfolio which has led to reduced competition in the Indian market. The Indian market includes foreign majors like GSK, Sanofi, Eli Lily, and Merck to name some.

But the scene is essentially dominated by Indian players such as Green Signal Bio Pharma based in Chennai who have gained significant expertise in manufacturing practices for macromolecules with quality but at low cost and have capitalized on the rising global demand for affordable vaccines, he said.

The global vaccine market grew at a healthy 28 percent during 2005-08 and reached a size of approximately $20 billion. Growth from the sales of vaccines has surpassed the growth in many traditional pharma areas of vaccine manufacturers such as GSK, Merck, Wyeth and Sanofi Aventis.

Globally, the US recorded the largest share in the vaccine market at around 43 percent and Europe is the second largest vaccine market and source of production.

However, it is estimated that in the future more opportunities for manufacture and sales of vaccines will emerge from developing nations such as India and China, he said.
Prof. Myint, an eminent senior board level physician with experience in public health, academia and biopharmaceutical industries is a well – known strategist, planner and organizational leader supported by outstanding research and analytical skills. He took over as chairman of Green Signal Pharma Private Limited from its founder-president N. Sundar Paripoornan in Jan 2011.

As head of Green Signal Bio Pharma which is one of the top vaccine manufacturers in India and one of only two producing BCG and BCG oncology vaccines, Prof. Myint is all set to take the company to next level to make it a global vaccine manufacturing company producing other vaccines as well for overseas markets especially in global health.

The company, in pharma field for the last six years, has now diversified into manufacturing vaccine. With the objective to go global, GSBPL has many on-going joint venture projects with many government and private manufacturers of the World. Besides manufacturing it is undertaking R&D both in house and with Partners in UK, Singapore and US.

Manufacturing and quality control is done to GMP requirements and is on par with all international Standards.

In India, GSBPL has judicial developmental partnerships, new products in pipeline, economical pricing and successful marketing strategies for vaccine field, he said.
Unveiling his plans, Prof. Myint said the company would go in for manufacturing R & D in-house to improve vaccines including introducing circumvention of the ‘cold chain’. It would also partner with companies across the globe to help develop new vaccines. Using his network with established pharmaceutical companies outside India, he has lined up partners and associates for tie-up for these future expansion projects.

“India is growing faster than China in the area of biopharmaceuticals and we will introduce new vaccines with the help of new technology. Our company had lined up partners and would be ready to go into action in Singapore and another one within India to help us with technology to diversifying into newer areas,” he said.

According to Prof. Myint developing newer vaccines is an expensive process and hence the company needed partnerships with research grants and aids. We will be doing a lot of manufacturing R and D in India in house. “We are also developing plans with the Nigerian Government and with a major university in Nigeria where PhD students are involved in tuberculosis research projects for making biomarkers for TB vaccines,” he said.

“The company will work closely with bodies such as the Bill and Melinda Gates Foundation to get grants to do research, Green Signal Bio Pharma has spent the last four years developing BCG vaccines on its own and the credit should go to the outgoing chairman Sundar Paripoornan and his team who have made a successful effort to get those vaccines out,” he added.

“What I do not want to do is to take another four years to develop our next vaccine but would work in collaboration with partner companies. Within 18 months we will have that next vaccine being produced for the market. We could be a hub for the whole world not only Asia because of our strategic location in India,” he said.

The company plans to work in partnership with the Gates Foundation in the TB vaccine project. Green Signal Bio Pharma has offered to give free vaccines for the coming years to Bill and Melinda Gates Foundation for use in poorer countries, he said.

With a number of blockbuster vaccines in pipeline, the market is expected to explode in future with vaccines expected to grow faster than any other therapy area at around 13 percent during 2009-12, registering highest growth rate among all the therapy areas, he said.

Successful development and launch of a vaccine is a highly cash intensive work. Anything between $500 million to $1 billion may be incurred in successfully launching a vaccine in the market, and failure in any of the clinical trial phases would leave the company with substantial loss. This risk is mitigated to a large extent by assured support from Government and NGOs in the form of immunization financing.

Vaccine developers have to contend with the lack of infrastructure and facilities for conducting large-scale clinical trials in developing countries. In phase III trials, the developer should not only manufacture the vaccine in relatively small amounts needed for the trials, but should also be prepared to manufacture the vaccine for wider use as soon as possible in case the vaccine is found effective.

However, developers face considerable risks by investing large amounts in manufacturing capacity before the trials conclude, since the vaccine may yet be proven ineffective, Prof. Myint said.

India Post News Service

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