Imagine if you could simply vaccinate your children?in the childhood itself?against some of the most dreaded forms of cancer such as those of the lung, prostate, colon or cervical region, before they were old enough and the diseases ravaged their bodies. Or, addictions to alcohol, nicotine, heroin, cocaine or other drugs could simply be done away with by giving them ?shots??again, in the childhood itself?that could make their brains switch off to the ?ecstasy? of these drugs, thereby keeping addictions at bay.

It?s not plain wishful thinking as cancer vaccines and addiction drugs are presently undergoing trials and are all set to storm the market in the next couple of years. Armed with a robust product pipeline, Indian vaccine makers are quite excited about the opportunity on the horizon. Their confidence emerges from various market forecasts doing the rounds.

A quick sampler: global vaccine market is growing at the rate of 16.52% and is projected to reach $21.05 billion by 2010, from $11.42 billion in 2006. Cancer vaccines will become a major player in the vaccine market, rising from its current level of $135 million to more than $8 billion by 2012. The market for adult vaccines (oncology, influenza and Hepatitis B) will rise from $4 billion to $7.5 billion by 2012.

Addiction vaccines too are poised to post a growth of over 100% after their launch from next year onwards.

Globally, 174 vaccines are in the pipeline, most of which are in phase I or phase II clinical trials. Ninety companies are sponsoring these vaccines, two-thirds of which are in the US, 30% in Europe, and the remainder in other countries such as Israel, Cuba, and Australia. Anti-infective vaccines make up about half of the vaccines in development, and the remainder are therapeutic vaccines for diseases such as cancer and diabetes.

For the likes of Biocon, Bharat Biotech, Ranbaxy, Panacea Biotec, Serum Institute of India and Wockhardt, the appetite for growth is no longer restricted to developing paediatric vaccines for the global markets, or the Rs 1,800 crore domestic vaccines market. Backed by their innovative research and development (R&D), Indian players are taking on the might of global vaccine makers such as Sanofi-Aventis, GlaxoSmithKline (GSK) Plc, Merck & Co Inc, Novartis and Wyeth. And if broad contours emerging from the changing landscape are an indication, Indian vaccines makers are set to significantly expand their product pipelines and develop new technologies for manufacture of vaccines for AIDS, dengue, malaria, cancer, allergy, rheumatoid arthritis, hypertension, among others.

New generation vaccines at various stages of development include anthrax, human papilloma virus (HPV), HIV, typhoid, Japanese encephalitis, malaria, cholera, rotavirus, HIB meningitis, and improved versions of TB vaccine, and others.

Says Habil Khorakiwala, chairman, Wockhardt, ?The market for vaccines?for Indian companies?is growing at a fast pace. Nowadays, there is greater understanding of the mechanism of disease and how the immune systems can be harnessed to target it. Naturally, the emphasis is on the development of new vaccines, not only to prevent infectious diseases, but also to treat various types of cancers.?

Even otherwise, growth in the market for vaccines is driven by a multitude of factors including:

* Improved vaccines with higher immunity rates and fewer side effects

* Focus on therapeutic vaccines

* Increasing demand for vaccines against infectious diseases Closer home, the vaccine industry struggling with market saturation, price erosions leading to shrinking profit margins in the recent years, has witnessed a spurt with emergence of new vaccines like HIV, rotavirus, malaria, tuberculosis and human papilloma virus. This has been fuelled with consistent and dedicated interests from the Indian government and erstwhile organisations like WHO, GAVI (Global Alliance for Vaccines & Immunisation), UNICEF, Indo-US Vaccine Action Programme and others. These organisations have recognised Indian players like the Serum Institute of India, Panacea Biotec and Shantha Biotechnics as pre-qualified vaccine manufacturers and procure vaccines from them at competitive prices. Besides, Bharat Biotech, Biological E and Cadila Pharmaceuticals are doing research in developing new vaccines in collaboration with national and international organisations, informs Utkarsh Palnitkar, head of life sciences practice, Ernst & Young (India). The research table for Indian vaccine makers is also brimming with combination vaccines. From mere monovalent vaccines, the transition is now towards multivalent to an extent of even 7-in-1 combos. The likes of Serum Institute of India, Panacea Biotec, Indian Immunologicals, Biological E, Biocon, Bharat Biotech, and Shantha Biotechnics have created a momentum for combo doses and created a sensation in the global vaccine market.

The reasons for this are not hard to decipher. The cost of manufacturing is relatively cheap and various stages for clinical trials are also reduced. Further, the growth is buoyed by UN agencies which are demanding combos due to increasing health consciousness.

That?s not all. With increasing manufacturing cost, global companies are looking at sourcing from emerging markets such as India and China. Analysts inform that China is still in the process of getting its plants approved by the USFDA as opposed to India which has already caught the opportunity. Indian vaccine makers have the edge to perform and be in the centre stage due to cost arbitrage factor both for manufacturing as well as clinical trial testing, say analysts. Besides, the global vaccine market, in its bid to reduce costs and time to market, is likely to drive the global drug discovery CRO market. Here again, its advantage India.

A report by Frost & Sullivan says that paediatric vaccines account for almost two-thirds of the global vaccine sales. Emerging economies like India, China and Brazil are likely to lead growth beyond 2008, with reforms in healthcare infrastructure underway. Increased market consolidation, demand for combination vaccines, increased competition from regional vaccine companies for DNA vaccines, vaccines against AIDS and cancer are the future R&D focus, adds the report.

Krishna Ella, CMD, Bharat Biotech says, ?Indian vaccine makers have started giving competition to global majors and there is momentum in research as well. However, there has to be governmental support for manufacturing as well as marketing and vaccine usage has to be brought under the agenda of the Union health ministry.? Bharat Biotech has tied up with the UK-based Acambis for a single dose of encephalitis. It is also in an agreement with the US-listed Novavax, to pursue the rapid development of pandemic influenza vaccine for India and other Asean markets; and ICGEB has signed with the company for malarial vaccine for which clinical trials are on.

?In the recombinant vaccines segment, the next few years will witness emergence of multivalent vaccines with improved patient compliance and newer vaccines to meet the unmet medical needs of the people. Pricing dynamics will play a critical role and so will the active participation and support from the government,?? says Ella.

For Indian vaccine makers, the pressures are to counter ageing of the product basket and ensure a good viable pipeline of products. Domestic companies have started investing in drug development in collaborations with various institutes. Some new generation vaccines are being developed in cooperation with research institutes like the National Institute of Cholera & Enteric Diseases, Kolkata; National Institute of Immunology, Jawaharlal Nehru University and All India Institute of Medical Sciences all in New Delhi; Central Drug Research Institute, Lucknow, Institute of Microbial Technology, Chandigarh, Indian Institute of Science Bangalore, Centre for DNA Fingerprinting & Diagnostics, Hyderabad, National AIDS Research Institute and National Institute of Virology, both at Pune.

Along with pipeline generation, putting in place efficient global supply chains to boost effectiveness in distribution is the key for companies to go global. There is still an untapped potential for adult vaccines and travellers? vaccines for the Indian players to capture a big pie in the global vaccine market. Says D Balasubramanian, director, LV Prasad Eye Institute, for all the 21-odd vaccines available in the country, there is a huge demand from the UN agencies for combination vaccines which can be tailored for developing markets.

The Indian vaccines market currently stands at an interesting threshold, where the next few years shall witness emergence of new competitive therapies, and improved product portfolios that could change the dynamics of the existing market.