NEW YORK, March 24, 2016 /PRNewswire/ -- Although there is currently a market of less than 100 million dollars for molecular tests sold in a near-patient or POC format, that is likely to increase to over 1 billion dollars by 2020, according to Kalorama Information. The healthcare market research firm said that investment in this test category and the market available in sectors of testing where these tests compete suggests a much larger market. Kalorama made its finding in its latest study, The Market and Potential for Molecular Point of Care Diagnostics.
"There's a large umet need in the developed world for better testing solutions for upper respiratory infections and sexual health conditions," said Bruce Carlson, " and a large unmet need in the developing world for high-burden such as HIV and malaria, with efforts supported by fundraising. Together, that should add up to a sizeable market for manufacturers. The speed and portability of these devices make them well-positioned as a solution."
The major segments of molecular POC diagnostics or diseases and conditions provided market analysis in this 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. These infections represent one of the most common reasons for patients to seek outpatient care. At the height of the influenza or flu season, up to 6% of all U.S. outpatient visits can be for influenza-like illness (ILI). 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 molecular POC diagnostic platforms. The first CLIA-waived molecular tests were for influenza and are now available for adoption by the entirety of the U.S. physician office laboratory (POL) market and other outpatient testers. Decentralized hospital labs – labs or testing points used for triage, rapid response (STAT testing) or specialty departmental diagnostics – also represent an initial target market for rapid molecular tests for respiratory pathogens. Group A Streptococcus (strep A) and respiratory syncytial virus (RSV) represent the next two leading target markets for molecular POC diagnostics. Respiratory tract infections projected to develop into significant molecular POC diagnostics markets by 2020 include the following:
Kalorama notes that one of the first market success stories for molecular POC diagnostics was the Affirm VPIII introduced in 1993 for multiplex vaginitis testing and still offered by Becton, Dickinson & Co. (BD) today. The moderate-complexity platform provided results within an hour using non-amplification nucleic acid testing, and found significant placements at POLs and other outpatient labs. In addition to the causative pathogens of vaginitis (Trichomonas vaginalis, Candida and Gardnerella vaginalis), group B streptococcus (GBS) and STIs of Chlamydia (CT), gonorrhea (NG), herpes simplex virus (HSV) and human papillomavirus (HPV) have been frequently targeted for molecular POC assay development.
In addition, Kalorama thinks molecular 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 at average prices of $1.00 and roughly $0.35 respectively due to the above conditions as well as market consolidation. This report assumes that cost improvements will be made to molecular test options and preferential pricing will be available by vendors. This 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.
A few more demand areas of testing are worth noting. Gastrointestinal are projected to develop into significant molecular POC diagnostics markets by 2020, as are hospital-acquired infections (HAIs) – detection of infections acquired in healthcare settings, primarily C. difficile and methicillin-resistant S. aureus (MRSA), but also vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), and bacteria with beta-lactmase resistance; limited to decentralized testing performed outside of primary hospital labs.
Bloodstream Infections – identification of causative pathogens, primarily bacterial strains, resistance genes, and fungi; performed at decentralized testing points in a hospital in a rapid manner (without blood culture) is another likely growth area.
The Market and Potential for Molecular Point-of-Care Diagnostics has market sizing and opportunity forecasts for all of these areas. The report can be found at: http://www.kaloramainformation.com/redirect.asp?progid=88495&productid=9858007.
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
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SOURCE Kalorama Information