U.S. HIV Diagnostics and Monitoring Markets

The development and usage of innovative technologies such as viral load monitoring (VLM), genotyping, and phenotyping are spurring renewed growth in the HIV diagnostics and monitoring market by enabling better disease management. However, despite improved reimbursement rates, high costs and a marked preference to use homebrew techniques limit adoption by commercial laboratories, particularly since they have the ability to perform esoteric testing at lower costs. Low demand from these laboratories, which constitute a significant portion of end users, restrains the market from reaching anticipated levels of growth.

This Frost & Sullivan research is a detailed study of the HIV diagnostics and monitoring market in the United States, divided into the following segments: HIV diagnostics, CD4/CD8 cell monitoring, viral load monitoring, and genotyping/phenotyping. It discusses the challenges facing market participants and offers strategic recommendations to overcome them. This report examines drivers and restraints affecting individual segments, besides analyzing emerging opportunities that participants can capitalize on.

Increased Efforts in Automation and High Throughput Development Essential

Advancements in automation are crucial to securing future success in the newer areas of VLM, genotyping, and phenotyping. Automation and the usage of microarrays and biochips lead to higher throughputs and eventual economies of scale. Further, pursuing automation for research use only (RUO) technologies and platforms can often increase product acceptance after the Food and Drug Administration (FDA) grants approval.

Manufacturers must consider offering substantial discounts to secure business from resistant larger laboratories. Although this strategy may seem detrimental to profits, it will help establish lasting relationships and gain valuable accounts in the long run, especially as aggressive research and development activities eliminate snags in the new technologies. Says the analyst, "As costs gradually decrease and laboratories become more open to adoption, enterprising participants will find significant opportunities with these large accounts."

Identification of Growing Numbers of Infected Patients to Expand Market Base

Along with automation and higher throughputs, the concerted efforts of various public health organizations are expected to gradually identify a larger percentage of the infected but undiagnosed HIV patient population. OraSure's rapid screening test, OraQuick, recently approved by the FDA, is expected to play an integral role in achieving this goal. As a greater number of infected but untreated individuals come forward to seek long-term disease management, testing volumes are expected to swell. "With a larger patient base and genotyping and phenotyping testing integrated into management protocol, the HIV diagnostics and monitoring market is presented with new opportunities," notes the analyst.