Vaccines, the drugs that shaped the pharmaceutical industry of the 1970s and 1980s, were largely abandoned by most major drug companies in the mid 1990s. Big pharma’s exit from the vaccines business was based on a variety of factors, including 1) the rising costs of manufacturing biologics as compared with small molecule drugs, 2) diminishing market sizes in the developed world, 3) a lack of innovation in vaccine R&D, and 4) the increasing frequency of lawsuits brought against drug companies by persons who were allegedly harmed or injured by their use. By the early 2000s, there were only five major vaccine manufacturers in the world: Merck, GlaxoSmithKline, sanofi-aventis, Novartis, and Wyeth (now Pfizer). However, government-imposed limits on the liability of vaccine manufacturers; improvements in vaccine research and manufacturing capacity; the growth of emerging markets in Asia, South America, and elsewhere; and the advent of so-called therapeutic vaccines have rejuvenated the vaccine business. In 1992, the size of the global vaccine market was estimated to be $2.96 billion. This grew to almost $23 billion in 2008, and the size of the worldwide vaccine market is expected to exceed $30 billion by 2018.
While renewed interest in vaccines has spawned a multitude of start-up companies with novel and intriguing technology platforms, the industry is still dominated by the so-called “big five” vaccine manufacturing companies (mentioned above). One of these companies, GlaxoSmithKline (GSK), has long been recognized as a leading manufacturer of prophylactic childhood and adult vaccines. Since 2008, GSK has garnered regulatory approval and launched a number of new vaccines, including two highly touted, multivalent subunit vaccines. One, called Synflorix, is a vaccine designed to prevent pneumococcal disease. The second, called Cervarix, is an anti- human papilloma virus (HPV) and cervical cancer vaccine.