Background: Although the World Health Organization had recommended that every child be vaccinated for\r\nHepatitis B by the early 1980s, large multinational pharmaceutical companies held monopolies on the recombinant\r\nHepatitis B vaccine. At a price as high as USD$23 a dose, most Indians families could not afford vaccination.\r\nShantha Biotechnics, a pioneering Indian biotechnology company founded in 1993, saw an unmet need\r\ndomestically, and developed novel processes for manufacturing Hepatitis B vaccine to reduce prices to less than\r\n$1/dose. Further expansion enabled low-cost mass vaccination globally through organizations such as UNICEF. In\r\n2009, Shantha sold over 120 million doses of vaccines. The company was recently acquired by Sanofi-Aventis at a\r\nvaluation of USD$784 million.\r\nMethods: The case study and grounded research method was used to illustrate how the globalization of\r\nhealthcare R&D is enabling private sector companies such as Shantha to address access to essential medicines.\r\nSources including interviews, literature analysis, and on-site observations were combined to conduct a robust\r\nexamination of Shantha�s evolution as a major provider of vaccines for global health indications.\r\nResults: Shantha�s ability to become a significant global vaccine manufacturer and achieve international valuation\r\nand market success appears to have been made possible by focusing first on the local health needs of India. How\r\nShantha achieved this balance can be understood in terms of a framework of four guiding principles. First, Shantha\r\nidentified a therapeutic area (Hepatitis B) in which cost efficiencies could be achieved for reaching the poor.\r\nSecond, Shantha persistently sought investments and partnerships from non-traditional and international sources\r\nincluding the Foreign Ministry of Oman and Pfizer. Third, Shantha focused on innovation and quality - investing in\r\ninnovation from the outset yielded the crucial process innovation that allowed Shantha to make an affordable\r\nvaccine. Fourth, Shantha constructed its own cGMP facility, which established credibility for vaccine prequalification\r\nby the World Health Organization and generated interest from large pharmaceutical companies in its contract\r\nresearch services. These two sources of revenue allowed Shantha to continue to invest in health innovation\r\nrelevant to the developing world.\r\nConclusions: The Shantha case study underscores the important role the private sector can play in global health\r\nand access to medicines. Home-grown companies in the developing world are becoming a source of low-cost,\r\nlocally relevant healthcare R&D for therapeutics such as vaccines. Such companies may be compelled by market\r\nforces to focus on products relevant to diseases endemic in their country. Sanofi-Aventis� acquisition of Shantha\r\nreveals that even large pharmaceutical companies based in the developed world have recognized the importance\r\nof meeting the health needs of the developing world. Collectively, these processes suggest an ability to tap into\r\nprivate sector investments for global health innovation, and illustrate the globalization of healthcare R&D to the\r\ndeveloping world.
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