Unfavorable safety and efficacy ratings, lengthy trials with disappointing outcomes, pressure from regulators and payers, and an overall slump in innovative drug development all indicate that business-as-usual practices of the pharmaceutical industry must change. Biopharmaceutical companies are increasingly equipping themselves with aggressive biomarker strategies to meet the challenges of continuing to innovate and stand out in a competitive landscape; many on this path are specifically pursuing chronic conditions that affect large populations. While most of the biomarker-drug success stories are in oncology, biomarkers have also created value in other therapeutic areas this report showcases how biomarkers will continue to be the cornerstone of personalized medicine, which promises to facilitate the ability to guide the fate of a drug and change the future of medicine.
Biomarker-involved drugs in development: Examples of select pipeline drugs in the context of how specific biomarkers aided their development. Also includes forecasts for select drugs.
Clinical trials analysis: There are more than 3,000 open studies with known status that have incorporated biomarkers in their design. Includes insights on those trials focusing on non-cancer indications.
Key chronic diseases highlights: Using examples of three high-burden chronic conditions—Alzheimer’s disease, asthma, and type 2 diabetes—we highlight how biomarkers and diagnostics will bring about specific and significant changes in pharmaceutical R&D in those indications.