Vaccines are important preventive medicines for primary health care and are a critical component of a nation's health security. The global vaccine market is poised to surpass US$ 21 billion by 2010. India is among the major buyers and makers of vaccines, locally as well as globally, and has traditionally aimed at self-reliance in vaccine technologies and production.

Previously, vaccines were considered as commodity products, with low growth, low margin industry in developed countries and with no margin at all in developing ones. The prospects of profits were so anaemic that majority of firms had to leave the business. However, the market is currently at the centre of attraction for all leading pharmaceutical majors. Now, the vaccine market is registering growth rates much faster than the conventional pharma market. As many blockbuster vaccines are going to hit the market in near future, the growth is expected at a much faster pace.

Though market analysis has identified paediatric vaccines as the present highest share-holder, future holds promise for adult, therapeutic and influenza vaccine segments. Also, the cervical cancer vaccines will dominate the future sales. Moreover, vaccines for malaria and AIDS will also be made available in the market. However, it will take some time.HIV vaccine will not hit the market before 2016.

Presently, the domestic companies dominate this market covering around seven out of top 10 players. But with India’s Intellectual Property Rights (IPR) laws improving considerably and healthcare expenditure increasing, foreign companies have started to acknowledge India’s potential as a vaccine hub. Thus, the presence of multinationals in the country has increased dramatically in the last few years with companies like Wyeth, GlaxoSmithKline, Sanofi-Aventis and Eli Lilly launching a number of innovative products in India. Taking into consideration the factors like increasing public and private healthcare spending, birth of around 15 million babies each year and a large prevalence of both infectious and chronic diseases, the domestic demand for vaccines in India will continue to grow at a colossal rate, offering foreign players enough opportunities to expand their horizon in the country.

 Along with the improvements in the the domestic market, India is also also emerging as a centre for exports.

The volume of the business of Indian vaccine market is growing with the newer vaccines coming in and companies increasing their production capacities. As per the vision and mission statement contained in the draft National Biotechnology Development Strategy of the Government of India, biotechnology as a business segment has the potential of generating revenues to the tune of $5 billion and creating one million jobs by 2010 through products and services.

Challenges for marketing
The vaccines market in India is witnessing a lot of activity. But to market vaccines is not everybody‘s cup of coffee. There are numerous challenges.
■ There is falling realization for mass vaccines like Hepatitis B in the domestic market . This leaves the organization with minimal funds to plough back into research for newer vaccines.
■ Funding becomes a big problem when it comes to new enterprises. However, today there are quite a few VC funds in the country, which are open to invest in this sector. Even after receiving the initial funding, companies find it difficult to generate and utilize funds for expansion. Indian companies have performed exceptionally well in the domestic and the lesser regulated markets. However, funding downstream opportunities is important to rise up the value chain.
■ Vaccines require a complex infrastructure in place so that stockists and chemists in rural areas can store the products at the required temperature which generally ranges between 2-8°C. Vaccine R&D too requires high pay-offs making it a complicated field to enter. Also, vaccines can only be launched after a huge human trial which is expensive. Hence, vaccine research can be taken as “a spend more earn less project”.
■ Though the regulatory approval process has improved considerably, speeding up the process is the need of the hour. This can be possible only if the single window clearance system is implemented.

To take advantage of these opportunities, vaccine makers are partnering for drug discovery and co-development of newer vaccines.

Regulation of vaccines
It is known that WHO guidelines for clinical evaluation of vaccines are available to assist in evaluation of clinical trials as a part of the regulatory overview. The guidelines outline the data that should be obtained during the different stages of vaccine development to support a marketing approval. Additionally several specific issues should be considered as prerequisites for initiation of clinical trials of plant-derived vaccines. The problem to date is the production of a single dose delivery that is made under current GMP (cGMP) type manufacturing control.

In early 2008, four of India's biggest vaccine manufacturers - Pasteur Institute of India have had their licenses suspended by the Government of India after failing to meet GMP requirements.

The principle of the existing GMPs for drugs/biologics should be applied universally to all. However, considering the unique aspects of manufacturing vaccines in transgenic plants, additional requirements and modification of the existing regulations should be implemented. GMP should apply from the beginning to the final product.

All said and done, vaccines will be one of the fastest growing segments of the pharmaceutical market. Vaccine revenues will grow leaps and bounds between 2009 and 2023.Global vaccines market has undergone a sea change, as the importance of vaccines in both developed and developing nations are being underlined by epidemiological patterns and healthcare needs.

The key growth driver for vaccines is their cost-effectiveness in combating disease and also the new disease targets that could be mitigated through vaccination, including high profile targets such as cancer. The vaccines industry is responding with innovative products, making full use of technological advances in biotechnology. This market has great developmental potential, both therapeutically and commercially.

-The author is Team Lead, Drug Safety, TCS, Mumbai