November 2013

Driving Drug and Diagnostic R&D: The Influence of Biomarkers Beyond Oncology

Report Authors
Prachi Vora, M.P.H.
  • Pages:27
  • Tables:10
  • Figures:13
  • Citations:10
  • Drugs:22
  • Interviews:0


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.

Questions Answered in This Report:

  *   Biomarkers play a critical role in pharmaceutical development, and their role in trial design can reveal important information about drug efficacy. In what ways are biomarkers impacting the R&D path of pharmaceutical companies focusing on chronic diseases?

  *   Few biomarker-focused chronic disease therapies achieve blockbuster status, yet their influence in product development can be priceless if it is able to identify superior safety and efficacy results in the right types of patients. Which biomarker-influenced pipeline drugs are slated to reach the multi-billion-dollar mark upon launch? Which are anticipated to be game-changers within the therapeutic area?

  *   Nearly 60% of the more than 3,000 clinical trials utilizing biomarkers and predictive diagnostics are in therapy areas beyond oncology. Similarly, when taken together, non-cancer applications represent more than 50% of all biomarker-focused alliances in the past five years. Which companies are demonstrating a strong shift in innovative chronic condition drug development? Which diseases are of high interest to them?

  *   Focusing on the developments in Alzheimer’s disease, asthma, and type 2 diabetes, we explore how companies are capitalizing on the utility of biomarkers in R&D. The potential for breakthroughs in management of chronic diseases truly does appear within reach. What are Decision Resources analysts saying about specific biomarker strategies?


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.

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Mentioned in this report:

  • - Abbott
  • - Amgen
  • - AstraZeneca
  • - Baxter
  • - Bayer
  • - Bioberica
  • - Bristol-Myers Squibb
  • - Celgene
  • - Eli Lilly
  • - Encysive Pharmaceuticals
  • - Genentech
  • - Gen-Probe
  • - Genzyme
  • - GlaxoSmithKline
  • - Hoffmann-La Roche
  • - Hologic
  • - Human Genome Sciences
  • - InnaVirVax
  • - Janssen
  • - Johnson & Johnson
  • - Merck
  • - Merck Serono
  • - Novartis
  • - Novo Nordisk
  • - Noxxon Pharma
  • - Pfizer
  • - Prana Biotech
  • - Shire Human Genetic Therapies
  • - Takeda
  • - Theragen
Decision Resources Group brands include: