Taking a global shot

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research in indiaWhile there is no doubt that biotechnology is unlocking a new vista for tackling various complex problems of world food security, human diseases, etc, it is the rapid progress being seen by India in order to emerge as a significant player in the global biotech arena that is drawing global attention. Early this month, it caught the attention of French biotech billionaire Alain Merieux —whose father Marcel Merieux was a former laboratory aide to Louis Pasteur—when his vaccine behemoth Merieux Alliance (2005 turnover: 1.128 billion Euros) acquired a majority stake in Hyderabad-based bio-pharmaceuti cals company Shantha Biotechnics. The Indian company specialises in the development and production of vaccines, therapeutic proteins and monoclonal antibodies.

In association with Shantha Biotechnics, the European company, which has a strong presence in preventive medicine, aims to develop a global strategy for managing the infectious diseases segment. Specifically, it will have access to the Indian company’s indigenous proprietary R&D and a branded product base in recombinants.

And Shantha Biotechnics is not an exception. Other players like Serum Institute of India, Panacea Biotec, Indian Immunologicals, Aventis Pharma and GlaxoSmith Kline, are fast making a strong global presence. Says Varaprasad Reddy, MD, Shantha Biotechnics: “Indian majors have created a sensation in the global vaccine market. For the first time in the vaccine segment, we are working on a human papilloma virus (HPV), which is being developed indigenously. We have got strains from the US-based National Institute of Health (NIH).” Then, Serum Institute was the first to have developed a vaccine for MMR (measles, mumps and rubella). It supplies vaccines to over 137 countries across the world and has been partnering with Chiron for development of a meningitis vaccine. It also has a tie-up with Gates Foundation and PATH for accessing testing technology at an international level for developing a pneumococcal vaccine. In the case of aersol measles vaccine for improved vaccine delivery system, Serum Institute is working with Indian Council of Medical Research (ICMR) and World Health Organisation (WHO).

Says Krishna Ella, CMD, Bharat Biotech, “We have started giving competition to global majors and there is momentum in research as well.’’

The company has tied up with the UK-based Acambis for a single dose of encephalitis.

There is also an agreement with the Nasdaq-listed Novavax to develop pandemic influenza vaccine for India and other ASEAN markets.

Given the prevailing trend, vaccines are perhaps the most important area for the Indian biotech industry. This is one area where we have a competitive advantage and should leverage it effectively, says Utkarsh Palnitkar, head—healthcare practice, Ernst & Young India. According to industry estimates, the Indian vaccines market was worth Rs 1,800 crore in 2005-06, and the human vaccines segment is the fastest growing segment in this sector. The major share of the revenue is generated through exports, accounting for almost 53%.

“With increasing consolidation of manufacturing and marketing capabilities by Indian firms, India is all set to grab the market opportunity in the global recombinant therapeutics market,” he says.

Until a few years back, the Indian vaccines market was suffering from cut throat competition and price erosions, thereby leading to reduced market shares and increasing market fragmentation.

However due to active initiation on the part of the government, and organisations like the WHO and UNICEF, Indian players have gradually shifted focus towards the global markets. These global organisations have engaged prominent players such as Serum Institute of India, Panacea Biotec and Shantha Biotechnics as pre-qualified vaccine manufacturers and procure vaccines from them at highly competitive prices, says Palnitkar.

The Bill and Melinda Gates Foundation provides financial assistance and support for development of vaccines like Malaria, HPV, Hepatitis B and Pneumococcus. They are also keen to see development of vaccines against diseases like TB and HIV. In fact, ICMR in India is already supporting development of 2 types of vaccines for HIV/AIDS- one undergoing clinical trials in Chennai and another one at NARI, Pune.

In India, new generation vaccines at various stages of development include Anthrax, HPV, HIV, Typhoid, Japanese Encephalitis, Malaria, Cholera, Rotavirus, HIB meningitis, and improved versions of TB vaccine. These are being developed in close cooperation with leading research institutes like the National Institute of Cholera & Enteric Diseases, Kolkata, National Institute of Immunology, All India Institute of Medical Sciences, New Delhi, Central Drug Research Institute, Lucknow, Institute of Microbial Technology, Chandigarh, among others.

Analysts point out that the vaccine industry in the country is dependent on biogenerics as a means of sustaining the growth momentum. There are about 14 recombinant therapeutics that have obtained market approval in India. Of these products, seven are indigenously manufactured here. Prominent products in this segment include the recombinant human insulin, recombinant human erythropoietin, granulocyte colony stimulating factor, interferon-alpha and interferon-beta, human growth hormone, human follicle stimulating hormone, recombinant streptokinase, and others.

All the seven products, indigenously manufactured in India, are generic versions of branded biopharmaceuticals. Until a few years back, this segment was largely dominated by multinational players and predominant business models were importing and marketing the products rather than indigenous manufacturing. However, recent years have witnessed rising dominance of domestic players such as Wockhardt, Shantha Biotechnics, Biocon Indian and others.

Even otherwise, the bio-generics industry faces various challenges such as the tactics used by innovator companies by introducing reformulated versions, modified drug delivery systems or IP consolidation of the manufacturing processes.

However with rising healthcare costs, a spiralling population of aged persons particularly in developed countries, authorities worldwide have been forced to consider the cost-effective generic versions of branded biopharmaceuticals.

A Frost and Sullivan report says that the global vaccines market has been traditionally strong in North America and Europe, with the latter taking a major share in manufacturing activities. On the other hand, North America is the largest market in terms of revenues. It accounts for 47.5% of the global vaccines market, followed by Europe and rest of the world. Pediatric vaccines account for two-third of the global vaccine sales.

Going forward, the global vaccines market is forecast to grow at 10.5% CAGR from 2005 to 2012. And, emerging economies like India, China and Brazil are poised to lead the growth beyond 2008, with reforms in their healthcare infrastructure. Then, there is cost and regulatory pressures which are restraining vaccine manufacturers in the US and Europe from expanding capacity. Naturally, it’s advantage India.

source - Financial Express