Molecular Point-of-Care: Continued Growth But Stubborn Competition, Says Report

ROCKVILLE, Md., Jan. 26, 2018 /PRNewswire/ -- The molecular point-of-care market, consisting of systems with molecular capability used in decentralized test environments, was estimated at $165 million in 2017 and is expected to continue with double-digit growth levels to 2023, according to IVD market researcher Kalorama Information.  The firm said that though molecular point-of-care remains a significant trend in in vitro diagnostics, across many categories of testing, indications suggest a longer period for brisk revenues than in some public reports and even in the firm's own projections from early 2016.  Yet in terms of revenue growth, molecular systems in decentralized settings will see some of the fastest revenue growth compared to other IVD market categories.  This conclusion was made in Kalorama Information's report, The Market and Potential for Molecular Point of Care Diagnostic Tests. 

The most successful area of molecular point-of-care, the firm found, was in the respiratory testing areas such as flu where systems have concentrated in approvals.   Key companies in the market include Cepheid, Roche, Abbott/Alere and bioMerieux, according to the report.   Influenza and respiratory is the key area of molecular diagnostics, and is expected to continue to dominate, making up nearly 40% of the market now and the same percentage expected in 2023.   Yet the firm said that  Immunoassay POCs have not shown visible decline in revenue growth and there are innovations in this competitive area.  Even in the mainstay of molecular POC testing, influenza testing, immunoassays have not experienced a decline from the presence of molecular testing. Market growth estimates at 25.3% are down from the potentials in our report (78% growth) published early 2016.  More models, additional menu expansions and robust replacements of systems were expected. 

"Projections are for fast growth but down somewhat from our last study when replacement of existing testing technology seemed to be brisker, new systems were being developed at breakneck pace and investment was intense," said Bruce Carlson, Publisher of Kalorama Information.  "Pricing and stubborn competition from traditional tests has been an obstacle, but molecular POC systems will outpace growth of most IVD products, and will continue to find users especially in infectious disease." 

The firm said some product development announcements from two years ago have not materialized, and some companies have not updated their product development pipeline in significant ways since our last study. 

The advantages of molecular diagnostics at clinical points of care include the general advantages or unique clinical benefits of POCTs compared to lab-based tests. Molecular diagnostic tests confer higher analyte specificity (by targeting nucleic acid sequences specific to the pathogen) and sensitivity than that offered by more common rapid diagnostic tests, preventing both false positives and false negatives, respectively. A notable advantage of this attribute is the ability to better detect specific strains of certain pathogens ? for example, the H1N1 2009 flu strain ? than can simple antigen tests. Turnaround time to results are improving in molecular POC diagnostics, reaching amounts of time comparable or better than RDTs; speedy delivery of results are more actionable, and when coupled with the more advanced diagnostic capabilities of molecular tests, doctors are able to make faster, more effective decisions at the point-of-care, potentially reducing the number of office visits by patients.

Molecular point-of-care solutions have come to offer multiplexing capabilities, in which an assay is able to detect multiple pathogenic targets for an infectious condition, in a single run. The most common multiplex assays are those for respiratory infections, which target multiple flu viruses and strains as well as respiratory syncytial virus, among others; test panels are available to detect multiple possible causes of gastrointestinal infection, sepsis, or even multiple tropical disease agents like Ebola, Dengue, Chikungunya, malaria, and so on. Assays can also be designed to target specific genes that are commonly associated with noninfectious diseases such as cancer or Alzheimer's disease, or can determine a patient's sensitivity or resistance to pharmaceutical treatments.

Due mostly to their technological novelty and high costs, on the other hand, there are some disadvantages to molecular POC diagnostics. They are nearly always more expensive to perform, and because of their relative complexity to RDTs or other solutions, including fewer instrument-free options, this may always be the case. Without recognized or empirically demonstrated improvement in the cost-benefit ratio, the incentive to adopt molecular diagnostic methods is slow to build. Likewise, the target market for molecular POC diagnostics is already saturated with low-cost rapid immunoassay tests; users of these waived, low-complexity RDTs have little concern with brand identity and are less likely to switch to a new product without proper support in reimbursable rates.

Kalorama Information's report contains detailed breakouts of the market by segment, as well as analysis of the major products and competitors.  The report can be found at: https://www.kaloramainformation.com/Potential-Molecular-Point-Care-11403174/.

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