Global Point of Care Molecular Diagnostics Market Overview

Global Point of Care Molecular Diagnostics Market size was valued at USD 2 Billion in 2023 and is poised to grow from USD 2.21 Billion in 2024 to USD 4.95 Billion by 2032, growing at a CAGR of 9% in the forecast period (2024-2032).

The market for Global Point of Care (POC) Molecular Diagnostics is one rapid-rising bouree in the pharmaceutical world, courtesy to the advancement in technology, demand for personalized medicine, and faster yet accurate diagnosis. Point of Care molecular diagnosis refers to molecular biology techniques toward or close to the patient area for diagnosing diseases. Usually, they are about looking for distinct genetic materials or biomarkers of diseases like infections, cancers, inherited conditions, and other medical conditions. The Point of Care Molecular Diagnostics can render results in real-time, which makes it a perfect device for improving patients' outcomes.

Such kinds of trends are widening the arms for the great increase in this market space, with a shift from preference levels to much less invasive diagnostic methods. Traditionally, central laboratory-based analyses for molecular diagnostics involved high costs of equipment, hence delaying results from the test. However, Point of Care Molecular Diagnostics can deliver laboratory-quality testing at multiple clinical sites, including hospitals, clinics, and even home healthcare setups. It is significantly revolutionized due to the advent of smaller, portable, and very user-friendly devices that yield quick and precise results, often within the hour of testing.

A rising incidence of communicable diseases and chronic conditions that demand prompt diagnostic intervention accounts for one of the most significant reasons for driving this market growth. For example, in infectious disease testing, point-of-care (POC) molecular diagnosis can inform the health-care professionals about the presence of pathogens-such as bacteria, viruses, or fungi-regarding which therapy needs to be given without waiting for the lengthened laboratory process. The infectious disease issue during COVID-19 emphasized the relevance of such technology by making possible broad testing and monitoring while introducing Point of Care Molecular Diagnostics at an unmatched acceptance level.

Key Findings:

• In 2024, QIAGEN expanded its QIAstat-Dx platform into precision medicine through a partnership with AstraZeneca. The collaboration aims to develop and validate a genotyping assay using QIAstat-Dx, enabling specialty care providers to perform genotyping during routine clinical examinations.
• In 2024, Bayer AG has been leveraging CRISPR and next-generation sequencing (NGS) technologies to enhance diagnostic capabilities, particularly in oncology and infectious diseases. These efforts aim to improve the accuracy and speed of molecular diagnostics, aligning with the growing demand for rapid and precise testing solutions.

Market Drivers

Rising Rates of Cancer and Infectious Disorders

• Increasing incidence rates of cancer and infectious disorders are driving the global point-of-care (POC) molecular diagnostics market growth. With the steady increase in morbidity from such diseases, enhanced demand for accurate, rapid, and convenient tools becomes very strong at the point of patient home delivery in early detection and personalised treatment, which is all that Point of Care Molecular Diagnostics covers.
• Cancer detection is evolving due to the growing number of cases worldwide due to the aging population, changing lifestyles, and environmental exposomes. Early cancer detection significantly improves a patient's chances. POC molecular diagnosis seems to have the best promise, being high speed, thus allowing the patient's treatment to commence immediately after oncologic evaluation. Such diagnosis comprises haematological or biochemical mutational analysis, molecular markers, or biomarkers characteristic of most cancers, thus promising individualised treatment plans. Doing such tests on-site in the relevant clinical areas instead of waiting for laboratory results is changing cancer treatment and improving survival rates, along with the reduction for invasive procedures.
• Rising incidents of infectious diseases such as respiratory diseases, sexually transmitted diseases, and newly emerging diseases such as Covid-19 are driving up the demand for point-of-care Point of Care Molecular Diagnostics tests. Such tests identify the pathogens with high specificity and sensitivity within the real-time information that derives treatment decisions. It is important to rapidly diagnose an Infectious Disease, especially in remote deprived access areas, in order to avoid outbreaks and significantly decreasing the burden on health systems. As infectious diseases still pose a threat, the population even became more aware of the value of Point of Care Molecular Diagnostics-the faster, reliable, and accessible type.

Key Findings:

• In 2023, the U.S. Department of Health's Biomedical Advanced Research and Development Authority (BARDA) allocated $53.7 million to Aptitude Medical to advance the development of POC molecular diagnostic technologies. This funding aims to accelerate the availability of rapid diagnostic tools for infectious diseases, thereby enhancing early detection and treatment. Also, the National Institutes of Health (NIH) collaborated with diagnostics manufacturers to obtain authorization for multiplex tests capable of detecting multiple pathogens simultaneously.

Growing Emphasis on Decentralized Diagnoses and More Money for Research and Development

• The gaining popularity of decentralized diagnostics is moving the diagnostic tests closer to the patient's place. Most importantly, it is caused because of an increased demand for speedier, more efficient, and accessible health solutions. Testing can be done either at the bedside, clinic, hospital, or even home by Point of Care Molecular Diagnostics to initiate fast decisions on courses of treatment. For conditions like infection or cancer requiring rapid interventions by health care professionals, timely interventions are very important. Thus, decentralization minimizes waiting for lab results and reduces demand on the entire health care facility as well as provides immediate feedback, which can then contribute to modification of treatment.
• Increased investments into research and development are hastening the innovations in the field of Point of Care Molecular Diagnostics. With increase in public and private funding, research institutions and companies are able to achieve greater strides in developing more improved portable and user-friendly diagnostics. Over the years, R&D has focused on maximally improved accuracy and speed coupled with affordable molecular diagnostic tests for mass uptake. Thus, molecular diagnostics promise to cover a range of diseases from infectious diseases to complex conditions such as genetic disorders and cancers and provide valuable information at the POC. Investment in innovation also facilitates the miniaturization of diagnostic devices and their accessibility for use in remote locations or even in self-examining settings.

Key Findings:

• In September 2024, C2N Diagnostics received up to $7.025 million from the Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator initiative. This funding supports the development of a decentralized clinical mass spectrometry solution for Alzheimer's disease testing, highlighting the growing investment in decentralized diagnostic technologies.

Market Opportunities

Prospects for Expansion in Developing Nations

• The point-of-care (POC) molecular diagnostics market in developing nations has room to grow thanks to investments in healthcare infrastructure and rising healthcare awareness. These regions Africa, the Middle East, Latin America, and Asia-Pacific offer promise that might significantly quicken market growth. Lack of diagnostic facilities and restricted access to healthcare are two issues facing developing nations. Authorizing quick and precise testing at or close to the patient care site Even in environments with resources, Point of Care Molecular Diagnostics offer a solution by authorizing quick and precise testing at or close to the patient care site.
• Opportunities are being further nourished in these sectors by government financing programs and initiatives. Diagnostic solutions are frequently included in public health campaigns diseases like HIV, TB, and malaria to ensure effective treatment. Programs like the Global Fund to Fight AIDS, Tuberculosis, and Malaria, for instance, are increasingly using POC diagnostics in low-income countries.

Market Restraining Factors

Unfavourable Reimbursement Scenario

• The poor reimbursement landscape is severely constrain The Point-of-Care (POC) molecular diagnostics market's expansion. POC molecular diagnostic test reimbursement regulations are frequently intricate, disjointed, and differ greatly between jurisdictions and healthcare systems. Insurance companies frequently do not cover the expenses of these cutting-edge diagnostic technologies or government health programs, especially for novel or developing tests. The primary reasons for this include the lack of long-term data on the clinical benefits of several Point of Care Molecular Diagnostics.
• Healthcare providers may be dispirit from purchasing POC molecular diagnostic tool due to the unsure nature of payment, especially if they are unsure if they will receive just compensation for their services.
• Thus, the use of these technologies in clinical settings may be slowed down. High out-of-pocket expenses for diagnostic tests that are not covered by insurance may discourage patients from getting the testing they need in a timely manner, specially in areas where healthcare coverage is scarce or does not embrace new technologies.

Segmentation Analysis

The market scope is segmented because of by Product & Service, by Technology, by Application, by End User.

By Product & Service

Based on the Product of the market is segmented into Assays & kits, Instruments & Analyzers, Software & Services.

The major drivers for the Point of Care Molecular Diagnostics Market. They enable physicians to identify pathogens or genetic material within very short timeframes due to their high specificity and sensitivity. The rising incidences of infectious diseases and chronic illness such as cancer will fuel the increased need for such tests and kits. Such tests will allow rapid diagnosis and treatment, thereby improving patient care by yielding clinical results. This will also further open the market through multiplex assays that lead to diagnostics by the concurrent testing of many conditions. Thus, will also be assays and kits for personalized medicine, genetic testing, and management of infectious disease events. Another of the key drivers of the Point of Care Molecular Diagnostics Market would be the instruments and analyzers. Such devices are now available for many clinical settings, including hospitals, and in distant healthcare management sites, due to advances made in the portability and downsizing of such devices. Diagnostics is being revolutionized by the ability to perform high-precision tests right at the point of treatment rather than in a laboratory. Real-time data will enable the healthcare practitioner to make decisions far more informed and faster. Innovations in this market are driven by the increasing need for portable, user-friendly devices, critical to extending the application of molecular diagnostics.

By Technology

Based on the Disease Type of the market is segmented into RT-PCR, INAAT, Other technologies.

Each of these core technologies, RT-PCR (Reverse Transcription Polymerase Chain Reaction), the recently developed INAAT (Isothermal Nucleic Acid Amplification Technology), and many more, has its own specialty that makes them attractive features for boosting market growth towards making diagnostic test procedures more accurate, speedy, and within reach.

RT-PCR (Reverse Transcription Polymerase Chain Reaction) is actually one of the greatest most popularly known and critically based poct molecular diagnostic technology, particularly with its whole combined usage for genetic material-detection for its greatest accuracy and sensitivity in infectious agents, which has become the gold standard for diagnosing infectious diseases, such as COVID-19, and genetic disorders. Moreover, RT-PCR can even quickly amplify and detect nucleic acids in very small quantities, valuable to clinical environments. Although traditionally larger equipment and lab-based procedures, advances in miniaturization and small portable RT-PCR devices have changed this trend toward point-of-care applications. Moreover, the rapid acceptance of RT-PCR promotes significantly driving an increasing marketplace towards effective management of averages in infectious disease outbreaks as patients are enabled into a speedy data-driven decision-making realm of healthcare.

Use of isothermal nucleic acid amplification technology for molecular diagnostics in POC applications is a new startup in the field because this technology amplifies nucleic acids at constant temperature and does not require complex thermal cycling as in RT-PCR. This makes INAAT even more portable, faster, and user-friendly for decentralized or remote health care settings. Under the INAAT family, procedures such as LAMP (Loop-Mediated Isothermal Amplification) produce results rapidly and precisely, as proven in resource-limited settings. These progressively change the game on how INAAT technologies will develop further in their utility app spector.

Regional Snapshots

The dominance of North America, the revenue share accounted for it in the Global Market was about 45.1%. Implementation of the existing healthcare infrastructure and recent technological developments in the region has made POC molecular diagnostic technologies rapidly adopted. The major driver of this development is the need for quicker and more accurate diagnoses-the vast majority in infectious diseases, such as COVID-19. The real-time data from POC molecular tests allows prompt patient management and treatment decisions, which are favorable. Advances towards miniaturization, AI integration, and networking further create Point of Care Molecular Diagnostics more effective and accessible, and hence a relevant part of North American healthcare systems. The fastest growth rate in the region is expected in the Asia Pacific over the projected period. The region exhibits an increased demand for Point of Care Molecular Diagnostics, driven by the large and varied healthcare system-infrastructures that include urban and rural areas and necessitating quick and easy diagnoses. Innovations in POC molecular testing improve healthcare access by allowing easy delivery of uncentralized lab results on time. A rise in infectious diseases such as COVID-19 across Asia-Pacific countries is another driving force for expansion and cuts clearly on time needing accurate diagnostics.

List of Companies Profiled

• Hoffmann-La Roche AG
• Abbott
• QIAGEN
• Bayer AG
• Nova Biomedical
• Danaher
• Nipro Diagnostics
• Bio-Rad Laboratories, Inc.
• Agilent Technologies, Inc.
• bioMérieux
• OraSure Technologies
• Abaxis

Key Industry Developments

• In May 2023, Mobilo Diagnostics has announced the release of Truenat H3N2/H1N1, the first PoC Real-Time Polymerase Chain Reaction (PCR) test that aids in the confirmed diagnosis of influenza infections.
• In July 2022, The Rapid CE-marked IVD Idylla GeneFusion Panel was introduced by Biocartis NV (Belgium) to facilitate prompt treatment decisions for lung cancer.
• In June 2022, The FDA De Novo Authorized bioMérieux SA (France) for their BIOFIRE Joint Infection (JI) Panel.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Point of Care Molecular Diagnostics Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Global Point Of Care Molecular Diagnostics Market Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Point Of Care Molecular Diagnostics market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Point Of Care Molecular Diagnostics. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Point Of Care Molecular Diagnostics companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Point Of Care Molecular Diagnostics Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Point Of Care Molecular Diagnostics Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S.
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K.
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Reasons to Purchase

• To gain insightful analyses of the Point Of Care Molecular Diagnostics market and have comprehensive understanding of the global market and its commercial landscape.
• Assess the production processes, major issues, and solutions to mitigate the development risk.
• To understand the most affecting driving and restraining forces in the market and its impact in the global market.
• Learn about the Point Of Care Molecular Diagnostics market strategies that are being adopted by leading respective organizations.
• To understand the future outlook and prospects for the Point Of Care Molecular Diagnostics market. Besides the standard structure reports, we also provide custom research according to specific requirements.

Research Scope of Point Of Care Molecular Diagnostics Market

• Historic year: 2019-2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Billion