Combination Drug/Diagnostic Products: Pathways to R&D and Commercial Success

Abstract

This new report from CHI' s Insight Pharma Reports assesses the commercial opportunities and provides the information and guidance that companies need to steer clear of the pitfalls in combination drug/diagnostic R&D. Specifically, it provides:

• A quantitative survey, rendered in easy-to-scan charts, of the industry' s views, plans, and current actions with regard to combination drug/diagnostic products
• A review of drug/diagnostic combinations in current use such as Monogram Bioscience' s Trofile Assay, which was co-developed with Pfizer' s Celsentri (for HIV) as a means to identify responders to the drug
• A review of existing safety and status biomarkers that are being used as diagnostics, such as a simple genotyping test to guide warfarin dosing, or molecular markers for identifying responders to Gleevec and Nexavar
• Patenting activity around combination drug/diagnostic products in cancer, neurodegenerative disease, respiratory disease, and viral infection
• The current state and outlook for reimbursement of diagnostics, including a case study of Genomic Health' s Oncotype DX gene expression test for predicting the benefits of chemotherapy in newly diagnosed breast cancer patients
• A model of the potential expansion of a therapeutic market generated by incremental improvements in biomarker test sensitivity
• Implications of FDA' s IVDMIA and ASR draft guidances

As innovative technology drives down the cost of biomarker discovery, and knowledge accumulates about the multigenic, multi-target nature of complex diseases such as cancer, the demand will surge for diagnostics that can detect the molecular variation underlying disease, and facilitate the prescription of the right drug. Participants in CHI' s survey (individuals involved with the planning and development of combination drug/diagnostic products) revealed fattening pipelines and the firm conviction that the drug and the diagnostic must be developed concurrently and "arrive together". Respondents overwhelmingly held the view that reimbursement and clear regulatory pathways will be the most significant determinants of the future viability of drug/diagnostic pairs.

The trends are aligning to favor the development and commercialization of drug/diagnostic pairs:

• Growth in the molecular diagnostic market in terms of unit volume, sales, and venture capital investment
• Lower costs to discover biomarkers
• Easing regulations governing Medicare reimbursement of molecular tests
• Compelling market precedents that patient stratification through combination drug and diagnostic is commercially rewarding

Combination Drug/Diagnostic Products: Pathways to R&D and Commercial Success is a rigorous evaluation of the therapeutic and commercial potential of combinations that are either co-developed, already in use for approved drugs, or in development to approve the focus and efficacy of existing drugs.