Near-Patient Molecular Diagnostics Forecasted to USD 1 Billion

“There’s a large unmet need in the developed world for better testing solutions for upper respiratory infections and sexual health conditions,” said Kalorama editor Bruce Carlson, “and a large unmet need in the developing world for high-burden such as HIV and malaria, with efforts supported by fundraising.”

The major segments analyzed in the report include respiratory tract infections; women’s health and sexual health; high-burden diseases; gastrointestinal (GI), hospital-acquired (HAIs) and bloodstream infections (BSIs); and non-infectious disease testing for pharmacogenetics (PGx), hereditary genetics and cancer. Upper respiratory infections represent a large potential market and one of the most common reasons for patients to seek outpatient care. Complications from respiratory infections in young children and the elderly can also lead to emergency or inpatient care.

Rapid flu testing is a leading application for POC platforms. The first CLIA-waived molecular tests were for influenza and are now available for adoption by the entirety of the US physician office laboratory (POL) and other outpatient testers. Decentralized hospital labs also represent an initial target market. Group A Streptococcus (strep A) and respiratory syncytial virus (RSV) represent the next two leading target markets. Respiratory tract infections projected to develop into significant molecular POC diagnostics markets by 2020 are also included in the report.

In addition to well-developed tests for vaginitis, Group B Streptococcus (GBS) and STIs of Chlamydia (CT), gonorrhea (NG), herpes simplex virus (HSV) and human papillomavirus (HPV) have also been frequently targeted for molecular POC assay development.

POC products for human immunodeficiency virus (HIV), tuberculosis (TB), hepatitis, malaria and other tropical or neglected infectious diseases are expected to find significant markets in the developing world. Sales of infectious disease tests to the developing world are highly dependent upon concessional pricing by vendors; co-financing by international organizations and recipient national governments; and bulk procurement on the regional and national levels. Rapid immunoassay tests for HIV and malaria, for instance, are now sold low prices due to the above conditions as well as market consolidation. This report assumes that cost improvements will be made to molecular options and preferential pricing will be available by vendors.

Kalorama’s report also mentions expected healthcare developments in the developing world relevant to POC testing, such as the decentralization of TB testing and expansion of the global population receiving antiretroviral therapy. Other demand areas of testing projected to develop significantly by 2020 include gastrointestinal, hospital-acquired, and bloodstream infections.

The report provides market sizing and opportunity forecasts for all of these areas.

Related Links:
Kalorama Information
Report: The Market and Potential for Molecular Point-of-Care Diagnostics