Point of Care Molecular Diagnostics Market by Product & Service (Assays, Kits, Analyzers, Software), Application (Respiratory Disease, Hospital Acquired Infection), Technology (RT-PCR, INAAT), End User (Physician Office, ICUS) - Global Forecast to 2023", The global point of care (POC) molecular diagnostics market is expected to reach USD 1440.2 Million by 2023 from USD 725.5 Million in 2018, at a CAGR of 14.7%.
Growth in the point-of-care (POC) molecular diagnostics market is mainly driven by factors such as the increasing worldwide prevalence of infectious diseases, rising focus on decentralized diagnostics, and the growing demand for CLIA-waived molecular POC tests.
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Product Analysis
Product matrix, which gives a detailed comparison of the product portfolios of each company
Company Information
Detailed analysis and profiling of additional market players (up to 5)
Geographic Analysis
Detailed analysis of POC molecular diagnostics market in European countries such as the UK, Germany, France, Italy, Spain, and others
Detailed analysis of POC molecular diagnostics market in Asia Pacific countries such as China, Japan, India, and others
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Growing demand for CLIA-waived respiratory test to drive the global point-of-care molecular diagnostics market close to USD 1.44 billion by 2023
Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, aimed to establish quality standards for all laboratory testing procedures to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer’s applications for test system waiver. In the past 2 years, the POC molecular diagnostics industry has witnessed a high number of CLIA-waived tests.
Some of the key CLIA waivers granted are as follows:
• In 2017, Alere Inc. (US) received a CLIA waiver from the FDA for the Alere i RSV Rapid Molecular Test used to detect RSV (respiratory syncytial virus) infections.
• In 2016, Roche Diagnostics Limited (Switzerland) was granted a CLIA waiver from the FDA for the cobas Influenza A/B & RSV test to be used on its cobas Liat System. This was the first CLIA-waived PCR test used to detect Influenza A/B & RSV within 20 minutes.
Increasing prevalence of diseases such as Influenza A/B,RSV, Hospital Acquired Infections (HAIs) likely to increase the demand for POC molecular tests