Point-of-Care Molecular Diagnostics Market Size, Share & Trends Analysis By Application (Infectious Diseases, Oncology, Prenatal Testing), By Technology, By Test Location, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Market Size & Trends

The global point-of-care molecular diagnostics market size was valued at USD 7.23 billion in 2022 and is anticipated to expand at a compound annual growth rate (CAGR) of 3.1% from 2023 to 2030. Rising demand for rapid tests along with a large number of new product launches for point-of-care tests is likely to drive the point-of-care molecular diagnostics market growth in coming years. Furthermore, continuous improvement in the quality of products offered on the shelf is one of the key factors for market growth.

The point-of-care molecular diagnostics market saw a significant growth due to the COVID-19 pandemic. Launch of rapid antigen tests and other assays providing accurate test results for COVID-19 diagnosis helped the key players achieve lucrative revenue growths during the pandemic. With government mandates regarding stringent testing protocols, there has been a continuous demand for POC MDx products across all regions. Inspite of negative impact on other business segments of the majority of the players, upsurge in demand of COVID-19 POC tests has been a massive revenue generation platform for the companies to compensate the losses from other segments.

Introduction of favorable regulatory initiatives aimed at promoting POC diagnosis over other forms is estimated to be a high impact-rendering driver of this market. For instance, the introduction of Clinical Laboratory Improvement Amendments (CLIA) in the U.S. is projected to boost usage rate during the forecast period.

The growing prevalence of cardiovascular diseases, diabetes, cancer, and infectious diseases is one of the key drivers of this market. As per WHO, cardiovascular diseases are estimated to cause approximately 23.3 million deaths by 2030. Factors such as increasing trend of smoking across the globe, unhealthy diet, rising incidence of obesity are responsible for the growing prevalence of cardiovascular diseases across the globe. Presence of unmet medical needs pertaining to cardiovascular diseases and rise in patient awareness about various advancements in disease testing have increased the uptake of POC MDx tests.

Point-of-care molecular diagnostics tests have accelerated diagnosis of cardiovascular diseases to improve patient care across diverse clinical settings including clinical research centers, homes, outpatient clinics, acute care, and healthcare settings in rural areas. In acute care settings such as operating rooms, intensive care unit, emergency rooms, or cardiac catheterization suite, physicians look for real-time feedback for optimization of patient care. In outpatient clinics, healthcare professionals seek solutions to replace reactive medicine with preventive measures that include wearables, apps, and mobile technologies as key components.

Application Insights

The infectious disease segment dominated the market and accounted for the largest revenue share of 29.8% in 2022. Continuous demand for molecular tests for COVID-19 detection was the major reason for the revenue growth. Respiratory infection molecular diagnostics has seen an exponential demand post the spread of SARS-CoV-2 infection. In addition, the increasing number of product launches in this segment is also driving the market. For instance, in April 2020, BD announced the launch of SARS-CoV-2 test on its BD MAX System. Increased rate of automation along with the ability to process higher number of samples is forecasted to drive the demand for molecular diagnostics reagents and consumables, accelerating the market growth. Detection of these pathogens using advanced molecular diagnostic techniques is useful in correlation of histopathological features and infectious organisms that cause gastrointestinal infections, thus, making the treatment easier. Products such as Savvygen GI Shigella, G-DiaShig, and SureTect Salmonella are some of the assays that are used in the detection of various infections.

Oncology segment is estimated to emerge as the most lucrative segment of all. Key players in the market are focusing on new product launches and collaborations to maintain their market position. For instance, in May 2022, Inex Innovate announced CE approval of their point-of-care OvaCis Rapid Test. This test helps determining whether the ovarian cysts are benign or malignant. This test provides results in 15 minutes and has brought test time down drastically. Large number of pipeline projects are likely to enter the market in coming years which is also predicted to support the growth of oncology segment. For instance, in March 2022, Capsulomics announced that they will be rolling out two PCR-based epigenetic tests for esophageal cancer.

Technology Insights

The PCR-based segment dominated the market and accounted for the largest revenue share of 65.8% in 2022, which is attributed to massive adoption of COVID-19 tests and other respiratory infectious diseases. The availability of several protocols in the RT-PCR and dPCR is expected to drive the segment growth in the coming years. Application of this amplification technology in the respiratory illness and HIV has substantially increased and companies operating in this market are embracing the trend of updating the platforms and cartridges based on the consumer requirements to provide ease of testing.

Genetic sequencing-based POC molecular diagnostics segment is anticipated to register fastest CAGR during the forecast period. The segment is predicted to grow at a CAGR of 6.6% by 2030. Exponential decrease in the cost of genome sequencing is expected to provide market potential avenues for growth by increasing its adoption rate for personalized genome mapping in order to provide fast and effective treatment. Rising competitive rivalry in the NGS market with respect to introduction of clinically applicable platforms and oncology CDx is expected to induce growth substantially.

Test Location Insights

The OTC segment dominated the market and accounted for the largest revenue share of 52.1% in 2022. OTC diagnostic products offer flexibility and comparatively lower cost for testing and ease of availability as compared to POC diagnostics, thereby accounting for larger revenue share. Furthermore, increasing threats of outbreak of infectious diseases and demand from forensic sciences also boosts the demand for OTC diagnostic products.

Point of care test location segment is estimated to register fastest growth during the forecast period. PoC is gaining popularity in molecular diagnostics space. PoC includes tests that provide rapid results and are portable. Molecular tests that identify genetic material of an infectious agent are one of the fastest growing PoC test types. Since many tests are fast, portable, and inexpensive, they are being adopted in as well as away from hospital settings. Companies such as Alere, Roche Diagnostics, and Cepheid have already marked their presence in this space. Growing interest in developing molecular diagnostic platforms that can be used in PoC settings is driving various companies to design assays & molecular diagnostic systems for near-patient testing.

End-use Insights

The decentralized labs segment dominated the market and accounted for the largest revenue share of 42.6% in 2022. 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. Moreover, with the advances in personalized medicine, usage rate of the point-of-care technology is expected to increase substantially. However, availability of centralized testing and established penetration of centralized testing coupled with the lack of well-defined reimbursement in POC diagnostics is expected to sidetrack potential users to a certain extent.

The home care segment is expected to grow at a fastest CAGR compared to others. Rise in lifestyle related diseases like diabetes, obesity, high blood pressure coupled with adoption of home health care facilities is expected to drive growth in home care segment. With POC diagnostics it possible to identify and monitor lifestyle related diseases in primary stage for early stage treatment and prevention of further fatal effects. Such factors are likely to support the segment growth over the study period.

Regional Insights

North America dominated the point-of-care molecular diagnostics market and accounted for the largest revenue share of 45.70% in 2022 and is anticipated to grow at a significant rate over the forecast period. Growing geriatric population base and the presence of higher healthcare expenditure levels are some key factors attributing to its largest share. Furthermore, increasing government support and funding for COVID-19-related products is expected to form a foundation for market within the region. In October 2021, the Department of Health and Human Services and the Department of Defense awarded more than USD 562 million to a dozen U.S. companies for supporting the manufacturing of COVID-19 tests and associated supplies.

Asia Pacific is expected to register fastest CAGR over the forecast period. Increasing approvals for molecular diagnostic kits that can detect SARS-0oV-2 is expected to accelerate market growth. Furthermore, aging population coupled with increasing demand for rapid and efficient testing is also likely to have positive impact on the market growth.

Key Companies & Market Share Insights

Key players are focusing on new product development and seeking regulatory approvals at a rapid pace. For instance, in March 2021, F. Hoffmann-La Roche Ltd launched a new blood glucose meter Accu-Chek Instant system, which helped the company expand into personalized diabetes management business. Additionally, in September 2019, Radiometer showcased its novel range of POC solutions at the Institute of Biomedical Science Congress, 2019 at the International Convention Centre in the U.K. The company represented its ABL90 FLEX PLUS blood gas analyzer, PICO Blood Samplers, AQT90 FLEX immunoassay analyzer with sepsis biomarkers, and ACQURE Data Management POC IT Solution. This initiative is likely to raise awareness about the company’s products in the market. Some of the prominent players in the global non-opioid pain treatment market include:

• Abbott

• Bayer AG

• F. Hoffmann-La Roche AG

• Nova Biomedical

• QIAGEN

• Nipro Diagnostics

• Danaher

• Bio-Rad Laboratories, Inc.

• bioMérieux

• Agilent Technologies, Inc.

• Abaxis

• OraSure Technologies

Point-of-Care Molecular Diagnostics Report Scope

Global Point-of-Care Molecular Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the point-of-care molecular diagnostics market on the basis of application, technology, test location, end-use, and region

• Point-of-Care Molecular Diagnostics Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • PCR-based

  • Genetic Sequencing-based

  • Hybridization-based

  • Microarray-based

• Point-of-Care Molecular Diagnostics Application Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Diseases

    • HIV POC

    • Clostridium difficile POC

    • HBV POC

    • Pneumonia or Streptococcus associated infections

    • Respiratory syncytial virus (RSV) POC

    • HPV POC

    • Influenza/Flu POC

    • HCV POC

    • MRSA POC

    • TB and drug-resistant TB POC

    • HSV POC

    • Other Infectious Diseases

  • Oncology

  • Hematology

  • Prenatal Testing

  • Endocrinology

  • Other Applications

• Point-of-Care Molecular Diagnostics Test Location Outlook (Revenue, USD Million, 2018 - 2030)

  • OTC

  • POC

• Point-of-Care Molecular Diagnostics End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Decentralized Labs

  • Hospitals

  • Home-care

  • Assisted Living Healthcare Facilities

  • Others

• Point-of-Care Molecular Diagnostics Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait