In January, Takeda said it was planning to go whole-hog in India operations, while lining up the company’s growth strategies for different markets. The firm was looking at, preferably, an Indian vaccine maker as partner for establishing full-scale operations. For this purpose, Japan’s largest pharma company held discussions with several established players in vaccine manufacturing to explore M&A or other deal structures, reports said.

Soon after a month, headlines said that Cipla was holding talks with Serum Institute of India (SII), Asia’s largest vaccine producer by volume, for a possible merger. A well-known name in the generic world, Cipla plunged into the vaccines space in November last year, by signing a pact with SII to market pediatric vaccines in Europe.

Apparently, the vaccine manufacturing industry in India is gaining steam and the players in the field register high on the radars of those companies interested in the vaccine business.

Globally, the vaccine market grew over three-fold in the past decade, according to Kalorama Information. Figures from the market research agency show that vaccine sales, world over, jumped to $25.5 billion from $7.4 billion in 2005.

The speedy growth in vaccine sales is driven, primarily, by two major trends: increasing demand for new, high-value vaccines in the western markets; and widening use of vaccines as part of their immunization drive in the developing world. Vaccine uptake in the developing nations is very high and sales of vaccines are now double the rate in comparison with other pharma products, according to World Health Organization (WHO) figures.

Chasing Blockbusters
Even as the call for affordable versions of advanced vaccines is getting louder across the world, the urgency for developing new low-priced vaccines, especially against the backdrop of the Ebola outbreak in western Africa, is stronger than ever.
Traditionally known for their skills to develop low-cost technologies for producing pharmaceutical products, Indian companies seems to have made their imprint in complex biologicals, as well.

Already, with several vaccines in the global markets, Indian firms are, presently, among the major source points for vaccines to WHO. They supply a range of vaccines such as the ones for diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps, rubella, meningitis A, influenza and polio, mostly, to the developing world.

Reportedly, select vaccine companies are in the works to bring out affordable versions of certain top-selling vaccines. SII, for instance, is preparing to launch a vaccine for human papilloma virus in late 2018. If developed successfully, Serum’s tetravalent HPV vaccine could offer an alternative to the blockbuster Gardasil. Merck’s $1.8 billion Gardasil was the second largest-selling vaccine in 2013. Apart from cervical cancer, Gardasil got extended approval for use in boys against oral and anal cancers caused by HPV. Last year, FDA gave its nod to a new variant of Gardasil that covers nine different strains of the virus. 

Now that WHO recommended universal use of HPV vaccines, SII is considering to offer its version at one-third of the procurement cost of the UN agency.

Challenges Ahead
Besides HPV, Serum is planning to supply a five-strain vaccine against rotavirus at half of the price agreed by Merck for its RotaTeq to UNICEF, reports said quoting a top official from the company. Its rotavirus vaccine is expected to hit markets by 2018.
SII is also having a pneumococcal vaccine in its pipeline, which is scheduled to be introduced by the year 2019. Again, the offer-price of the vaccine would be much lower than Glaxo’s Synflorix. It is worth recalling that Serum had entered into a pact with Merck to develop a pneumococcal conjugate vaccine to emerging and developing markets in 2011.

The company, located in Pune in the western Indian state of Maharashtra, is working on specialized vaccine formulations including a powdered measles vaccine that requires no refrigeration. Such a vaccine would remain stable for a longer period irrespective of weather conditions.

India’s vaccine industry, with prominent players including Bharat Biotech, Shantha Biotechnics (now part of Sanofi), Biological Evans, Panacea Biotec as well as  SII, has distinguished itself with low-cost manufacturing as its forte. Cost-competitiveness is expected to lend these players an edge over others in the rapidly expanding vaccine marketplace, particularly where cost is a major criterion.

In the meantime, huge operational costs and lack of expertise limit the entry of fresh players. Maybe, this explains why there are not very many vaccine makers around. The most challenging thing vaccine companies face, however, is the task of establishing efficacy to win approval for their generic equivalents in tightly regulated markets. Even tougher, perhaps, is the job to get the new versions prescribed as substitutes of proprietary products.