Abstract
To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.
Highlights
Human life expectancy has increased due to the implementation of hygiene, sanitation and vaccination
The risk profile for the average vaccine in development from 1998 to 2009 only partially behaved as predicted (Figure 1) the timeline has lengthened by 0,71 years, yet the cumulative success rate is lower at an estimated transition probability of 0,07 (Table 2)
The remaining disease areas are not represented by a sufficient quantity of vaccine projects to attain statistically significant comparisons
Summary
Human life expectancy has increased due to the implementation of hygiene, sanitation and vaccination. Developing a human vaccine from the preclinical phase to registration requires an increasing average investment of approximately US$ 200 to 900 million [5]. This process is known as the value chain; the consecutive development stages a vaccine or medical compound progresses through to accumulate value and become established as a safe, effective and qualitative product. Merely 22% of the initiatives were forecasted in 1996 to successfully reach the market after 10 years of development [11,12] This imbalance is to a large extent caused by rising cost of research and development (R&D), biological and technical challenges associated with targeting more complex diseases, competition with better standards of care, larger scale of clinical studies to prove safety and efficacy and last but not least an increasingly stringent regulatory environment [13,14]. From the perspective of the patient, and in financial terms: the subsequent attrition rate is substantial and should be improved
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