Convergence of Biomarkers and Diagnostics, The

Summary

In recent years, there have been concerted efforts to enhance the precision of disease diagnosis and monitoring as the hetrogeneity of conditions becomes increasingly understood. Targeting broad patient populations in a 'one-pill-fits-all' approach has begun to attract criticism, with the average efficacy of such drugs being estimated at 50% or less. In the current climate, biomarkers have emerged as key tools in the realisation of personalised medicine by characterizing specific diseases and treatment responses at the DNA, RNA, protein, or metabolite level.

Key Findings...

• The biomarker market was worth $5.5bn in 2007 and is forecast to grow at a CAGR of 17.6% to $12.4b in 2012. Rapid growth in the cardiovascular segment will result in this area becoming the leading category by sales volume in 2012.
• Cancer has more biomarker patent claims than any other indication based on analysis from patent documents in the World Intellectual Property Organization (WIPO) database.
• A large number of cardiovascular-based biomarkers are under investigation for inclusion in multimarker panels, including those indicative of inflammation, plaque instability and rupture, thrombosis and ischemia.
• Genotyping tests (primarily for viral infections) are currently worth an estimated $104mn. Business Insights forecast that this will grow to $686m in 2012 to become the fastest growing segment in the biomarker market, with an CAGR of 45.8%.
• Specialist companies use a variety of strategies and technologies to discover and validate new diagnostic biomarkers, with many bioinformatics companies now supporting biomarker discovery.

Key Questions answered include

• What types of molecules can serve as diagnostic biomarkers?
• Which in-vitro biomarker detection platforms are currently available?
• Where has progress been most evident in cancer, CNS, Alzheimer's and cardiovascular disease profiling?
• What are the latest developments in the search for new diagnostic biomarkers?
• Why are multimarker assays being developed?
• What is the outlook for the biomarker-based diagnostics market?

Key issues examined by this report

• Rise of omic technologies. There is growing interest in the application of high-throughput omic technologies to biomarker discovery. Recent advances have provided a large inventory of candidate DNA, RNA, and protein biomarkers with potential for risk assessment, screening, diagnosis, prognosis, and selection.
• Advances in diagnostics. Transcriptomic, proteomic and metabolomic profiling represents a revolutionary approach to molecular diagnostics. It is anticipated that proteomic profiling will result in better tests to diagnose HBV infection.
• Biomarker-based targeting. With increasing numbers of drugs failing when aimed at broad populations, biomarkers are being used to differentiate between patient groups. This will help pharma companies revive the fortunes of poor performing products and develop new targeted drugs.
• Multiple biomarkers. There is an growing consensus that multiple biomarkers convey the multi-dimensional nature of a disease state more accurately, with panels of biomarkers expected to become the norm in the future. Researchers are also increasingly turning to biomedical imaging as a tool to track disease progress and improve patient outcomes.

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