The vaccine business is booming, spurred by worldwide efforts to contain the global influenza pandemic and to halt the spread of AIDS and other infectious diseases. National health agencies ordered millions of H1N1 flu vaccine doses last year, prompting manufacturers to ramp up production along with R&D. Since 2000, the global vaccine market has almost tripled, reaching an estimated $20 billion. Yet delays in producing the huge quantities of requested flu vaccine has raised questions about continued reliance on decades-old production methods and delivery technologies.
A Robust Pipeline
The good news is that a record 120 vaccines are available to meet the health needs of people all over the world, and a significant number of vaccine candidates are moving through the R&D pipeline. Over 80 new products are in late-stage clinical testing, including some 30 that target untreated diseases, according to last fall's "State of the World's Vaccines and Immunization" report published by the World Health Organization (WHO) and UNICEF. The surge in vaccine development over the past decade has produced new vaccines for meningococcal meningitis, rotavirus diarrheal disease, pneumococcal disease and cervical cancer caused by human papillomavirus (HPV). Public–private partnerships (many funded by the Bill & Melinda Gates Foundation) are developing vaccines to counter diseases such as malaria, tuberculosis, and dengue fever, which kill millions in Third World nations.
While much of the growth in vaccine sales reflects purchases of newer, more costly products in western countries, the market expansion also supports higher immunization rates around the world. According to the WHO report, a record 106 million children were administered the traditional roster of childhood vaccines in 2008. There's also been progress on the HIV/AIDS vaccine front, despite a let-down following initial reports last year of benefits from an AIDS vaccine tested in Thailand. And the search for cancer vaccines is still going strong, supported by FDA draft guidance on how to conduct clinical trials to test new therapies designed to simulate an immune response against tumors.
Meanwhile, this burgeoning vaccine business is attracting more Big Pharma investment. Johnson & Johnson recently linked up with Crucell NV of Holland to develop vaccines, Pfizer's acquisition of Wyeth makes it a lead player in the global vaccines business, and Abbott Laboratories aims to get in the game by purchasing Solvay's drug and vaccine business. Sanofi-Aventis is looking to double its vaccine business over five years, according to CEO Chris Viehbacher; Glaxo is investing $40 million in Nabi BioPharmaceuticals' anti-smoking vaccine; and Merck recently hired Julie Gerberding, former director of the US Centers for Disease Control and Prevention (CDC), to reinvigorate its vaccines division.