As the pharmaceutical industry turns to ever more sophisticated specialty treatments for highly defined, often very small patient populations, competition intensifies and payer tensions grow. The return on innovative launches has not kept pace with rising clinical development costs.
The pharmaceutical industry is in both the best and worst of times. The industry is in a golden age of pipeline productivity – but as the focus turns to ever more sophisticated specialty treatments for highly defined, often very small patient populations, competition intensifies and payer tensions grow. The countries driving most of the industry’s return on innovation see budgetary challenge, rebate and discount growth and increased risk.
Profitability has reduced, and the return on innovative launches has not kept pace with rising clinical development costs. Portfolios see faster, and more extensive, value erosion post loss of exclusivity as biologics experience low-cost competition. Technology has hugely improved the availability of data to understand patients and conditions better, to demonstrate the value of new medicines and to guide pharma decision making. But often, companies struggle to make the best use possible of this data.
The pharmaceutical industry is in a revolutionary period of innovation. Advances in understanding the genomics of disease, and in the personalisation of treatment, have been augmented by the introduction of regenerative medicine platforms, where gene and cell therapies offer curative approaches to serious, often life limiting, disease. If these technologies fulfil their promise, they will revolutionise the pharmaceutical market far more fundamentally than the advent of biologic therapies in cancer and autoimmune disease in the 1990s and early 2000s. Disease areas will be transformed, and healthcare systems will need to re-design their approaches to provision of, and payment for treatments. The pharmaceutical companies making the right choices on the right assets have extraordinary commercial opportunities.
This white paper presents the case for revolutionizing research and development, and outlines new approaches to make clinical trials more cost effective and focused from start to finish.