The global point-of-care molecular diagnostics market size is projected to reach USD 3.4 billion by 2028 from USD 2.0 billion in 2023, at a CAGR of 10.6% during the forecast period. The molecular diagnostics market is experiencing significant growth, primarily driven by several factors. These include the increasing incidence of infectious and chronic diseases, a growing emphasis on decentralized diagnostics, substantial research and development funding, and heightened awareness regarding early detection of infectious diseases. Additionally, the expanding applications of point-of-care diagnostic tests are contributing to market growth. However, there are certain challenges that may hinder the market’s progress. These challenges include the absence of a promising reimbursement scenario, technological advancements being slower in developing economies, and stringent regulatory hurdles related to point-of-care diagnostic test kits.

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The point-of-care molecular diagnostics market is categorized into different segments based on product & service, technology, application, end user, and region. Under the product & service segment, it is further divided into assays & kits, instruments & analyzers, and software & services. In 2022, the assays & kits segment held the largest market share. This significant share can be attributed to the widespread utilization of assays & kits in point-of-care molecular diagnostics, which is considerably higher in comparison to instruments or analyzers.

The point-of-care molecular diagnostics market is divided into various technology segments, including RT-PCR, INAAT, and other technologies. In 2022, the RT-PCR segment emerged as the dominant segment, capturing the largest share in the global market. The substantial market share can be attributed to the increasing utilization of RT-PCR applications in the fields of proteomics and genomics. Furthermore, the availability of portable and user-friendly devices has also contributed to the widespread adoption of RT-PCR technology in point-of-care molecular diagnostics.

Based on end-users, the point-of-care molecular diagnostics market is segmented into physicians’ offices, hospitals & ICUs, research institutes, and other end users. In 2022, The physicians’ offices segment held the largest market share in the point-of-care molecular diagnostics market. This segment’s significant revenue contribution can be attributed to its extensive utilization within physicians’ offices, where it enables rapid delivery of test results within 30 minutes. This quick turnaround time empowers physicians to make prompt treatment decisions without experiencing any delays.

The global market for point-of-care molecular diagnostics is divided into North America, Europe, Asia Pacific, and the Rest of the World. In 2022, North America emerged as the dominant region, capturing the largest market share in the point-of-care molecular diagnostics market. This can be attributed to several factors, including the presence of high healthcare expenditure levels in countries such as the US and Canada. Additionally, the region benefits from significant government support and funding initiatives, further contributing to its leading position among all the regions.

The major players operating in this market are Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), Quidel Corporation (US), QIAGEN N.V. (Netherlands), Co-Diagnostics, Inc. (US), Biocartis NV (Belgium), Meridian Bioscience, Inc. (US), Thermo Fisher Scientific, Inc. (US), Lucira Health, Inc. (US), Cue Health (US), OpGen, Inc. (US), Binx Health, Inc. (US), Molbio Diagnostics Pct. Ltd. (India), Genomadix (Canada), Visby Medical, Inc. (US), QuikPath PTE Ltd. (Singapore), MD-Bio (US), QuantuMDx Group Ltd. (UK), Aidian Oy (Finland), GeneSTAT Molecular Diagnostics, LLC (US), Labsystems Diagnostics Oy (Finland), Akonni Biosystems (US) and Curetis N.V. (Germany).

Recent Developments of Point of Care Molecular Diagnostics Industry:

In April 2023, QIAGEN N.V. (Netherlands) launched QIAstat-Dx in Japan with a respiratory panel for syndromic testing.

In June 2022, Biocartis NV (Belgium) launched the Rapid CE-marked IVD Idylla GeneFusion Panel for fast treatment decisions in lung cancer.

In May 2022, bioMérieux SA (France) received De Novo FDA Authorization for its BIOFIRE Joint Infection (JI) Panel.

In September 2021, F. Hoffmann-La Roche Ltd. (Switzerland) acquired TIB Molbiol (Germany) to expand its PCR test portfolio with a wide range of assays for infectious diseases.

The global point of care molecular diagnostics market is experiencing rapid growth, projected to expand from $2.0 billion in 2023 to $3.4 billion by 2028 at a compound annual growth rate of 10.6%. This surge is being driven by the rising incidence of infectious diseases, cancer, and other acute and chronic conditions worldwide. As healthcare providers increasingly focus on improving facilities and infrastructure, demand for fast, accurate diagnostic testing at the point of care is escalating.

However, uncertain reimbursement policies and a shortage of high-complexity testing facilities capable of performing point of care molecular diagnostics have posed obstacles to greater market penetration. Reimbursement remains a contentious issue, with Medicare revising payment mechanisms for certain in vitro diagnostic tests in recent years. Coverage policies can also limit testing for screening purposes in patients without an established condition.

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Despite these challenges, emerging markets in countries like India, South Korea, Brazil, and Mexico present immense growth opportunities. Relatively relaxed regulatory environments, healthcare infrastructure growth, expanding patient populations, and increasing healthcare spending are attractive to point of care diagnostics companies in these regions.

A potential disruptive threat looms in the form of alternative rapid testing technologies, particularly for infectious diseases like COVID-19. Antigen and serological tests can deliver results in 15 minutes at lower costs compared to molecular diagnostics. However, molecular methods offer higher accuracy and sensitivity, which could sustain demand amid the twin burdens of infectious disease and chronic illness surveillance.

Market leaders like Abbott, Roche, bioMerieux, Danaher, and QIAGEN continue driving innovation with expanded test menus, panel assays, and seamless integration with healthcare information systems. As the point of care diagnostics ecosystem evolves, these companies are poised to capitalize on rising demand for fast, informative testing that empowers clinicians to rapidly triage patients and initiate effective treatment pathways.

Abbott Laboratories (US) accounted for the largest share of the point-of-care molecular diagnostics market in 2022. The company’s leading position can be attributed to its strong sales and distribution network. The company invests a significant amount of its revenue in R&D. The company also adopts organic growth strategies such as product launches to increase its dominance in this market.

F. Hoffmann-La Roche Ltd. (Switzerland) held the second position in the point-of-care molecular diagnostics market in 2022. The company’s leading position is attributed to its wide product portfolio. Under its flagship brand- cobas- the company offers a wide variety instruments and reagents that are widely used by end users across the globe. The company also has a wide geographic presence, spanning North America, Europe, the Middle East and Africa, and Asia. This enables the company to cater to customers across the globe.

bioMérieux SA (France) accounted for the third-largest share of the point-of-care molecular diagnostics market. The company operates in more than 150 countries across the Americas, Europe, the Middle East and Africa, and the Asia Pacific and has 18 production sites and 20 R&D sites. It has 43 subsidiaries across the globe. The company has a strong product portfolio which has helped it to maintain and enhance its presence in the market.

Point of Care Molecular Diagnostics Market in terms of revenue was estimated to be worth $2.0 billion in 2023 and is poised to reach $3.4 billion by 2028, growing at a CAGR of 10.6% from 2023 to 2028 according to a new report by MarketsandMarkets™.

Point of Care Molecular Diagnostics Market by Product (Assays, Kits, Instruments, Software), Application (Respiratory Diseases, HAIs, Cancer, STDs, Hepatitis), Technology (RT-PCR, INAAT), End User (Clinics, Hospitals, ICUs) & Region — Global Forecast to 2028

The growth of this market is majorly driven by increasing prevalence of infectious diseases and cancer, rising focus on decentralized diagnostics, increasing R&D funding, increasing awareness on the early detection of infectious diseases, and the increasing use of POC diagnostic tests.

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Point of Care Molecular Diagnostics Industry Key Market Players:

The major players operating in this market are Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), Quidel Corporation (US), QIAGEN N.V. (Netherlands), Co-Diagnostics, Inc. (US), Biocartis NV (Belgium), Meridian Bioscience, Inc. (US), Thermo Fisher Scientific, Inc. (US), Lucira Health, Inc. (US), Cue Health (US), OpGen, Inc. (US), Binx Health, Inc. (US), Molbio Diagnostics Pct. Ltd. (India), Genomadix (Canada), Visby Medical, Inc. (US), QuikPath PTE Ltd. (Singapore), MD-Bio (US), QuantuMDx Group Ltd. (UK), Aidian Oy (Finland), GeneSTAT Molecular Diagnostics, LLC (US), Labsystems Diagnostics Oy (Finland), Akonni Biosystems (US) and Curetis N.V. (Germany).

The Assays & Kits segment is expected to account for the largest share of the Point of Care Molecular Diagnostics Market in 2022.

The products & services in the point-of-care molecular diagnostics market are categorized into assays & kits, instruments & analyzers, and software & services. Assays & kits specifically cater to various point-of-care settings such as hospital critical care units, physicians’ offices, outpatient clinics, home care settings, and long-term care settings, among others. The continuous demand and recurring purchases of assays & kits are anticipated to fuel the growth of the point-of-care molecular diagnostics market.

The Respiratory Diseases segment accounted for the largest share of the point-of-care molecular diagnostics market in 2022.

The molecular diagnostics market is categorized into various applications, including respiratory diseases, sexually transmitted diseases, hospital-acquired infections, cancer, hepatitis, gastrointestinal disorders, and other applications. The growth of this market segment is primarily driven by the escalating prevalence of infectious diseases and the growing demand for early diagnosis and detection of these diseases. These factors are particularly significant in emerging countries, where there is a heightened need to address the challenges posed by infectious diseases through timely and accurate molecular diagnostics.

North America dominates the global point of care molecular diagnostics market.

The point-of-care molecular diagnostics market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America emerged as the leading region, capturing the largest market share in the point-of-care molecular diagnostics market. The significant share of this region can be attributed to the highly advanced healthcare systems present in the United States and Canada. In recent years, there has been a notable increase in healthcare spending across North America. According to the Centers for Medicare & Medicaid Services, national health spending is projected to grow at an average annual rate of 5.4% from 2019 to 2028, reaching a staggering USD 6.2 trillion by 2028. This growing healthcare expenditure serves as a key driver for the biotechnology sector, including the point-of-care molecular diagnostics market.

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