Introduction

Point-of-care (POC) molecular diagnostic testing enables physicians to improve the standard of care by combining quick diagnostic and treatment. Physicians can prescribe treatment without having to wait for the final results. Additionally, rising awareness regarding molecular mechanisms and rare disorders and advancements in DNA sequencing drive the point-of-care molecular diagnostics market.

The point-of-care molecular diagnostics market was valued at USD 1,823.2 million in 2019 and is expected to grow at a CAGR of 7.5% during the forecast period, 2020–2029.

Key Market Drivers

Advancements in Technological Tools & Development of Advanced Molecular Diagnostic Tests

Modern techniques such as the adoption of mutation-specific targeted screening can be employed with the use of specific analytical tools for diagnostic proposes; these tools are used for the identification of single-gene ailments. Advancements in technological tools enhance multi-gene examination, making it feasible for clinical testing.

On March 27, 2020, Abbott announced that the USFDA issued an Emergency Use Authorization (EUA) for the fastest available molecular point of care test to detect coronavirus (COVID-19), which delivers positive results in five minutes and negative results in 13 minutes. The test will run on the company’s ID NOW platform that offers a range of healthcare settings, such as physicians’ offices, urgent care clinics, and hospital emergency departments.

The healthcare industry is channelizing efforts to develop advanced molecular diagnostic tests, and market players are working to develop advanced molecular diagnostic tools for a competitive edge. On November 14, 2019, Linear Diagnostic received USD 2.6 million in investments, which the company plans to use for the development of its optical point-of-care diagnostic testing platform.

Point-of-Care Molecular Diagnostic Market: Segmentation

By Product Type

By product type, the test kit segment is anticipated to dominate the point-of-care molecular diagnostic market. The high capability and frequent use of test kits for the diagnosis of different types of diseases drive the segment’s growth.

• On March 21, 2020, the FDA approved the first COVID-19 test kit, which consists of a nasal swab that provides accurate results in 45 minutes
• On March 28, 2020, South Korea’s three test kits received FDA approval, which will be imported to the U.S. to test for the novel coronavirus

The segment is further segregated into bacterial, fungal, and viral tests. The bacterial test kits sub-segment is expected to grow at a CAGR of 7.79% due to the rising prevalence of foodborne illnesses and microbial contamination in water.

By Technology

Based on technology, the PCR technology segment is expected to hold the lion’s share during the forecast period. PCR technology is used in molecular biology research, genetics, biotechnology, and drug discovery, among others. It refers to a medical device that generates millions of copies of DNA. The rising prevalence of infectious diseases and acceptance of personalized medicines drive the segment. On November 1, 2012, the FDA approved the first MycoTool PCR Mycoplasma Detection Kit that can replace conventional and time-consuming mycoplasma detection assays in testing biologics and biopharmaceuticals.

By End-User

By end-user, the decentralized laboratories segment accounted for the largest revenue share in 2018. The efficiency of these labs in offering rapid and accurate molecular analysis augment the growth of the segment. The rising focus on patient-centric care and incidence of infectious diseases are increasing the acceptance of decentralized laboratories for quick and accurate testing.

Decentralized laboratories are prompting a transformation based on the format, wherein complex tests are performed in core labs, while decentralized testing is conducted in outpatient and other clinics as well as homes. They enhance the quality and access of care for the ever-growing geriatric population. Moreover, technological advancements have made it possible for even moderately trained staff to conduct tests.

Regional Insights

High Prevalence of Infectious Diseases in North America

The high prevalence of infectious diseases drives the need for point-of-care molecular diagnostics in North America.

• On February 7, 2018, the USFDA granted 510(K) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for Mesa Biotech Inc.’s POC AcculaFluA/Flu B test. It is the company’s first available test in the U.S. market.
• On October 25, 2018, Abbott received FDA clearance for its next-generation Influenza A and B 2 and Strep A2 molecular point-of-care assays. The influenza A & B 2 assay differentiates between Influenza A& B virus in 13 minutes or less, with early positive results in less than 5 minutes.

Governments are actively working to accelerate the process of approvals for POC molecular diagnostics, which further drives the regional market.

• On March 16, 2020, Becton, Dickinson and Company and BioGX Inc. submitted their EUA to the USFDA for new diagnostic tests. If approved, it would increase the potential capacity to screen for COVID-19 with an efficiency of 1,000 tests per day.

Development of Advanced Technologies for Rare Disease Diagnosis in Europe

Europe’s point-of-care molecular diagnostics market is projected to grow at a CAGR of 8.5% during the forecast period. Rapid development in new molecular diagnosis for rare diseases drives the regional point-of-care molecular diagnostics market.

• On March 28, 2019, the scientists at Lawson Research Institute (LRI) developed a new computational model or tool for the diagnosis of rare diseases. The LRI will be the first in the world to offer genetic testing. Additionally, the institute has partnered with Greenwood Genetics Laboratories in the U.S. and the University of Medical Centre Laboratories in Amsterdam.

Key Players

• Abaxis
• Roche
• Abbott
• Danaher
• BioMerieux
• Sysmex
• Bio-Rad Laboratories
• OraSure Technologies
• Bayer

Point-of-Care Molecular Diagnostic Market Segmentation

By Product Type

• Analyzers
• Test Kit
• Bacterial
• Fungal
• Viral

By Technology

• PCR
• Genetic sequencing
• Hybridization
• Micro-array

By End-user

• Decentralized laboratories
• Hospital
• Homecare
• Assisted living healthcare facilities

By Region

• North America
• Europe
• Asia-Pacific
• South America
• The Middle-East and Africa