Point-of-Care Molecular Diagnostics Market Size, Share & Trends Analysis Report By Test Location (OTC, PoC), By Application (Infectious Diseases, Oncology), By End Use, By Technology, And Segment Forecasts, 2019 - 2024

Industry Insights

The global point-of-care molecular diagnostics market size was valued at USD 1.72 billion in 2018 and is anticipated to expand at a CAGR of 14.4% over the forecast period. Increased need for accurate and faster testing methods and results for the molecular tests is expected to propel the market growth. These modern techniques are enabling a remarkable makeover in the field of molecular diagnosis. Other factor driving the market includes high quality of test results in very short time.

POC Molecular testing enables physicians to improve the standard of care by combining quick diagnosis with treatment decision in the first visit by the patient instead of hours and days to have the test results. This would help prescribe a treatment in the first instance without having to wait for final results. In addition, improving knowledge in the understanding of molecular mechanisms in the common as well as rare disorders and the advancement of DNA sequencing and analysis are some other factors that are expected to enhance POC molecular diagnostics capabilities.

For instance, the use of mutation-specific targeted analysis using comparatively more portable sequence analysis platforms for the diagnosis of ‘single gene’ ailments and extremely parallel next-gen sequencing enables simultaneous multi-gene examination, which can be used to sequence exomes for direct clinical testing. These are the type of developments that can improve the current way of molecular diagnosis into a more robust and rapid technology. Over the last decade, healthcare industry has focused its attention and development effort in the enhancement of two key aspects of molecular diagnostics such as moving towards prevention and early detection rather than finding a cure, enhancing portable testing capabilities.

As a consequence, to this concentrated effort in the direction, it has been observed that a sizeable revenue flow is progressively being directed towards areas focused on diagnostic capabilities and PoC testing enhancement. During the course of the next decade, a significant number of product commercialization and new product development cycles are expected to take place that will reinforce the molecular diagnostics expected high rate of growth. The ongoing R&D, future product commercialization, POC MDx application and usage, market adoption, penetration rates, and revenue flow for these products are expected to contribute in the development and growth of the market.

Application Insights

PoC testing in molecular diagnostics has numerous applications including near patient testing in infectious disease management, oncology, hematology, prenatal testing, and endocrinology. Most significant developments on an application basis have taken place in the fields of infectious diseases and oncology PoC molecular tests.

Infectious diseases segment accounted for the largest revenue share in 2018. Some of the factors contributing to the revenue share of infectious diseases for rapid molecular diagnostic tests are, they provide and facilitate suitable antimicrobial treatment, faster disease management, improved distribution of healthcare laboratory assets and reduce mortality and costs.

Technology Insights

Based on technology, the PoC molecular diagnostics market has been categorized into PCR-based, genetic sequencing-based, hybridization-based, and microarray-based tests and devices. PCR-based tests accounted for the largest revenue share in 2018. Commercialization of PoC tests that provide rapid real time PCR analysis with a high level of accuracy for infectious diseases, such as H1N1 and influenza, will drive the market. NGS-based molecular testing near the patient is anticipated to witness considerable growth over the forecast period due to a number of developments in the market.

Innovative changes of the platforms that enable genetic sequencing and analysis of DNA data at the point of care with high accuracy and provide rapid diagnosis are attributive towards anticipated progress of this segment. Rapid DNA analysis is expected to register considerable growth in the coming years owing to the continued innovation and R&D by major players in this market.

Test Location Insights

Based on test location, the market is bifurcated into PoC and Over-the-Counter (OTC) tests. OTC tests have higher levels flexibility and portability than POC tests when it comes to usage at homes and assisted living facilities. Majority of the OTC users constitute non-skilled personnel and, in most cases, the patients themselves. In addition, a number of these testing devices are CLIA waived, which encourages the users to use these tests in non-laboratory settings. Owing to their ease of usage, easy availability, and greater adoption rate, OTC tests are expected to generate higher revenue over the forecast period.

End Use Insights

Based on end use, the market is divided into decentralized laboratories, hospitals, homecare, assisted living healthcare facilities, and others. Decentralized laboratories accounted for the largest revenue share in 2018.

Ability of these tests to provide rapid and accurate molecular analysis while having a significantly smaller physical footprint as compared to the central laboratory-based counterparts is a major factor that supports the segment’s larger revenue share.

Regional Insights

Ongoing efforts by major market participants to strengthen their market position is an important factor contributing to the major share. Furthermore, a number of clinical studies investigating the efficiency and accuracy of novel molecular tests are also expected to contribute towards the market growth over the forecast period. Growing demand for rapid diagnosis and development of newer molecular diagnostic tests for DNA analysis have poised the European region as a major market space. However, Asia Pacific is expected to witness the fastest growth over the forecast period due to the lack of sophisticated central laboratory testing services, a larger population base in need for clinical testing, and potential cost-effective implementation of PoC molecular tests.

Point-of-Care Molecular Diagnostics Market Share Insights

Key market participants operating in the market are Abbott Laboratories, Bayer Healthcare; F. Hoffmann-La Roche AG; Becton, Dickinson and Company; BioMerieux; Bio-Rad Laboratories, Inc.; Cepheid, Inc.; Danaher Corporation; and Johnson and Johnson. Owing to ongoing developments and commercialization of novel miniaturized molecular diagnostic tests by relatively smaller market entities, the market is also witnessing a phase of consolidation, amalgamation, and acquisitions wherein, larger market participants are trying to strengthen their market positions.

Report Scope

Segments Covered in the Report

This report forecasts revenue and volume growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2013 to 2024. For the purpose of this study, Grand View Research has segmented the global point-of-care molecular diagnostics market report on the basis application, technology, test location, end use, and region:

• Application Outlook (Revenue, USD Million, 2013 - 2024)

  • Infectious Diseases

  • Oncology

  • Hematology

  • Prenatal Testing

  • Endocrinology

  • Other Applications

• Technology Outlook (Revenue, USD Million, 2013 - 2024)

  • PCR-based

  • Genetic Sequencing-based

  • Hybridization-based

  • Microarray-based

• Test Location Outlook (Revenue, USD Million, 2013 - 2024)

  • Over-the-Counter (OTC)

  • PoC

• End Use Outlook (Revenue, USD Million, 2013 - 2024)

  • Decentralized Labs

  • Hospitals

  • Homecare

  • Assisted Living Healthcare Facilities

  • Other Uses

• Regional Outlook (Revenue, USD Million, 2013 - 2024)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • MEA

    • South Africa