Global Vaccines

Medical diagnostic and vaccine companies, along with the rest of the pharmaceutical industry, are undergoing a period of disruptive innovation. This disruption is occurring due to shifting paradigms in seven major areas: increasing burden of chronic disease; control of the practice of healthcare by policy-makers and payers; focus of payers on pharmacoeconomic performance and outcomes; blurring of boundaries between medical disciplines; significant growth in emerging economies; increasing government interest in preventive medicine; and regulatory skepticism of innovation.iThe old paradigm of diagnosing and classifying diseases becomes meaningless in light of new understanding of the mechanisms of dysfunction in the human body. Cardiovascular disease and celiac disease are prime examples of how one disease may have multiple causes, and one initiating factor may cause multiple diseases.ii These changes require development of a new business model in order to survive.iii,iv The current model, where virtually the entire business of a company is lost every 10-12 years when a blockbuster drug goes off patent, no longer meets the needs of the market.v

It is in this climate that pharmaceutical giants are looking to collaborate much more closely with key stakeholders and improve their value propositions. PriceWaterhouseCoopers proposes two potential business models for this collaboration: Fully Diversified (one parent company with a network of collaborative entities), and Federated (a network of separate entities).3 These collaborative models will enable companies to develop services beyond just pharmaceutical agents, including companion diagnostics for pharmaceutical agents, finding niche or orphan markets for unmet needs in diagnostics and vaccines, pharmacogenomics, nutrigenomics, and technology innovation on new and current platforms to provide a competitive edge.1Global market size is expected to reach $6.35 billion by the year 2015. The US market is the largest, accounting for 42.75% in 2008. Growth in pharmacogenomics however, is expected to dwarf that of other sectors with annual growth predicted at a rate of 184 %, and an expectation to be over $60 billion by 2016.vi ,vii

One of the primary drivers for companion diagnostics is the upsurge in the practice of personalized medicine and nutrition. In less than a decade after completion of the Human Genome project, the fields of personalized medicine and nutrition are developing with an emphasis on identification and application of biomarkers in disease diagnosis.viii The identification of these biomarkers is a discipline requiring the use of cutting-edge microarray technologies and PCR technologies such as nucleic acid testing.ix Theranostics, clinical pharmacogenomics, and nutrigenomics are new and evolving disciplines where diagnostics are being used in conjunction with pharmaceutical treatments and nutrition recommendations. Companion diagnostics, still in its relative infancy, is expected