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HIV Diagnostics: Key Disease Management Role Spells Opportunity
Decision Resources, Inc, Sep 2005, Pages: 19
HIV stands out as a highly lucrative and expanding market for diagnostics because of the close integration of diagnostics in day-to-day disease diagnosis, management, and drug selection. The greatest changes and improvements in HIV diagnostics will be in the area of monitoring disease progression in individual patients. Such tests will help physicians optimally manage the disease and minimize drug failures and will ultimately have the potential to be incorporated into treatment algorithms.
In this report, we review HIV diagnostics in use and in development, the main players involved in the development of novel HIV diagnostics, and the impact these tests will have on HIV drug development in the United States.
Business Implications
- The HIV diagnostics market is attractive because diagnostics play an integral role in disease management. Diagnostics are widely used in initial diagnosis as well as in determining therapeutic options and monitoring disease progression in patients. Room remains for development of novel diagnostics that can aid in better disease management (i.e., help minimize drug failures and ensure effectiveness of a therapeutic).
- The markets for HIV screening tests and disease staging tests have matured to offer several rapid and reliable tests—but opportunity still awaits novel combination screening/confirmatory tests that can improve diagnosis rates.
- Although several tests serve as markers for disease progression, novel diagnostics that can monitor disease progression in individual patients and measure clinically meaningful markers will be widely adopted by physicians to optimally manage the disease and minimize drug failures.
- Development of novel diagnostics can help drug developers identify the most promising agent (a targeted product that will not be cross-resistant to other classes of ARV drugs and will achieve clinically meaningful efficacy end points) and also help select the right target population for clinical trials.
- Novel diagnostics such as replication capacity (RC) tests have the potential to accelerate the drug development process by providing
valuable insight into an agent's activity. FDA acceptance of a marker identified by new diagnostics as an efficacy end point will speed drug development—decisions can be reached earlier about the therapeutic potential of the agent.
- The development and commercialization of a rapid, relatively inexpensive tropism assay will help bring to market a widely awaited new class of therapeutics: the chemokine receptor antagonists, which are being touted as the next breakthrough in HIV therapeutics. Without an associated diagnostic, these agents will not be able to reach their full market potential.
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