Point-of-Care (POC) Molecular Diagnostics are revolutionizing healthcare by enabling rapid, accurate, near-patient testing that is crucial for managing infectious diseases, cancer, genetic conditions, and more. Key advances such as PCR miniaturization, microfluidics, AI-enhanced NAAT, and CLIA-waived assays are making diagnostics faster, more accessible, and scalable across various settings, from hospitals to remote clinics.
The global point of care molecular diagnostics market size was valued at USD 8.74 billion in 2024 and is expected to be worth around USD 11.28 billion by 2034, growing at a compound annual growth rate (CAGR) of 2.58% over the forecast period from 2025 to 2034. The demand for quick and accurate diagnoses, particularly in emergency and outpatient settings, is prompting robust growth in the global point of care molecular diagnostics market. Other major factors driving that demand are the rising prevalence of infectious diseases and genetic disorders, together with ever-increased focus on personalized medicine. The technological advancements in PCR and NGS platforms are continuing to drive the market. More and more investments in portable, user-friendly devices are, nonetheless, driving growth. Cost of healthcare is increasingly being demanded, while decentralization of health service provision plays another major driving factor.
Molecular diagnostics are those diagnostics that detect nucleic acid from the patients' site of treatment, mostly outsides of centralized laboratory settings. Assays employing molecular techniques include PCR and next-generation sequencing, are used to quickly and accurately diagnose infections and genetic disorders. POC molecular diagnostics allow quicker decision-making, personalized treatment, and enhanced patient results through almost instant test results. Hence, the technology is even more relevant for use in emergency care, remote locations, and contexts in which timely diagnosis is vital for effective treatment.
Key Market Drivers & Government Initiatives in POC Molecular Diagnostics Market
Clinical Performance and Adoption Trends in Point-of-Care (POC) Molecular Diagnostics
Metric | Description |
COVID-19 Impact on POC MDx Adoption | Over 70% of urgent care centers adopted POC molecular COVID tests by 2021 |
Accuracy of Modern POC Molecular PCR Tests | Sensitivity: 94-99%, Specificity: 97-100% (e.g., flu, COVID-19, RSV) |
Lab Tech vs. Non-Lab Tech Usage | Over 50% of POC MDx systems are operated by non-laboratory-trained clinicians |
Cartridge-Based Platform Penetration | Approximately 68% of installed POC molecular systems are cartridge-based (closed system) |
Time Saved vs. Central Lab Diagnostics | 1-2 hours saved per test on average compared to traditional PCR testing |
Regulatory Approvals (U.S. CLIA-Waived) | Over 25 POC molecular devices have received CLIA-waived status as of 2024 |
Testing in Non-Traditional Settings | 40% of POC MDx usage now takes place in clinics, ambulances, pharmacies, and retail health |
Reimbursement Variability Across Countries | Up to a 45% difference in per-test reimbursement rates among the U.S., EU, and Asia |
Report Scope
Area of Focus | Details |
Market Size in 2025 | USD 8.97 Billion |
Expected Market Size in 2034 | USD 11.28 Billion |
Projected CAGR 2025 to 2034 | 2.58% |
Dominant Region | North America |
Region with the Quickest Growth | Asia-Pacific |
Key Segments | Technology, Application, Test Location, Product and Service, End-use, Region |
Key Companies | F. Hoffmann-La Roche AG, Abbott, QIAGEN, Bayer AG, Nova Biomedical, Danaher, Nipro Diagnostics, Bio-Rad Laboratories, Inc., Agilent Technologies, Inc., bioMérieux, OraSure Technologies, Abaxis |
PCR-based: The PCR segment dominated the market in 2024. The PCR (Polymerase Chain Reaction)-based technology is heavily used in point-of-care molecular diagnostics as it allows amplification of DNA or RNA to detect pathogen and genetic conditions. The PCR tests are extremely sensitive and specific and, thus, are highly recommended for diagnosis of infectious diseases, genetic mutations, and cancers. This technology provides quick results that are quite accurate even in low resource settings. It has hence become the most popular technology in decentralized healthcare environments.
Genetic Sequencing-based: The Genetic Sequencing-based segment is anticipated to register the highest CAGR over the forecast period. These technologies of next-generation sequencing are usually based on complete study of genetic material to describe the changes in mutations and their relevance in terms of the origin of a disorder, thus leading towards the establishment of a possible biomarker for cancer. It finds significant usage in the case of point-of-care diagnostics while bringing in personal medicine with an aid in discovering individualized variations associated with specific conditions and a specific reaction of therapy.
Hybridization-based: Technologies based on hybridization rely on the hybridization of complementary nucleic acid strands to detect specific sequences. It detects pathogens or genetic mutations, with fluorescence in situ hybridization and Southern blotting among them. Hybridization-based tests are specific and sensitive in diagnosing infections or genetic abnormalities. These tests, therefore, can be highly advantageous in point-of-care molecular diagnostics, particularly in a setting where quick and reliable results are demanded within a clinical or home environment.
Microarray-based: Microarray-based technology uses a microscopic grid to simultaneously detect thousands of genes or specific genetic markers by their expression. In point-of-care molecular diagnostics, microarrays allow multi-disease or multi-marker testing, which would help clinicians in making a quick and proper decision. It is mainly used in oncology, infectious disease testing, and genetic screening because of its high throughput without compromising the sensitivity and specificity required to provide a correct diagnosis.
Infectious Diseases: The infectious diseases segment has dominated the market in 2024. Technologies like PCR and genetic sequencing are used to detect a variety of pathogens, including viruses, bacteria, and fungi. The ability to quickly and accurately diagnose infectious diseases like COVID-19, HIV, and tuberculosis helps in timely treatment and containment, improving patient outcomes and minimizing the spread of infection, especially in resource-limited settings.
Oncology: The Oncology segment is estimated to emerge as the most lucrative segment. In oncology, point-of-care molecular diagnostics are a key tool in assessing cancer biomarkers, mutations, and genetic profiles linked with different types of cancers. Diagnostics at the point of care enable early detection, surveillance for disease progression, and individualized treatment plans tailored to a patient's genetic makeup. Rapid, detailed cancer testing at the point of care can greatly improve the accuracy and speed of diagnosis in cancer, potentially offering a greater chance for better treatment outcomes.
Hematology: Molecular diagnostics at the point of care for hematological diseases, such as anemia, leukemia, and hemophilia, helps identify genetic mutations, chromosomal abnormalities, or changes in the composition of blood cells. They are relatively quick to diagnose and can result in quicker clinical decisions and management of hematological conditions, especially critical in urgent care settings. This is the reason why molecular diagnostics in hematology is being rapidly expanded in relation to the growing need for an accurate and timely diagnosis of diseases of the blood.
Prenatal testing: Prenatal testing through point-of-care molecular diagnostics allows for early screening of genetic abnormalities, fetal infections, and chromosomal conditions such as Down syndrome. These tests are conducted using advanced techniques such as PCR and genetic sequencing, which provide accurate results with minimal discomfort to the mother. Through early intervention and personalized care, prenatal molecular diagnostics improve maternal and fetal health outcomes, making them an essential part of modern pregnancy management, especially in high-risk pregnancies.
Endocrinology: This is the determination of hormonal imbalance and endocrine disorders, such as diabetes, thyroid conditions, metabolic diseases, based on molecular information. Molecular analysis can help detect the genetic defect underlying these endocrine disorders so that appropriate diagnosis and management treatment can be advised. The faster diagnosis, better handling of the diseases, and an effective personalized form of therapy using molecular tests provided at the point of care is bound to advance the quality of care for patients presenting with endocrine-related conditions.
Decentralized Labs: The decentralized labs segment has dominated the market in 2024. POC molecular diagnostics are now increasing in decentralized labs based in remote, low-resource environments. Advanced infrastructures may not be available, yet they can continue to carry out important molecular tests on infections, genetic disorder, and cancers through portable devices that are not only easy to use but offer accurate results within shorter time spans. Decentralized labs are critical to the current global health services, particularly where there is underserved area and lack of basic facility.
Hospitals: These technologies allow clinicians to make immediate, well-informed decisions regarding the clinical care of patients, thus initiating appropriate treatment for better patient outcomes. Point-of-care diagnostics is used in hospitals for the quick diagnosis of several conditions, ranging from infectious diseases to genetic disorders. Its usage assists hospitals in managing a large number of patients who need immediate diagnosis, as well as integrating these technologies into the overall clinical operations of the hospital for greater efficiency and patient management.
Point of Care Molecular Diagnostics Market Revenue Share, By End-use, 2024 (%)
End-use | Revenue Share, 2024 (%) |
Decentralized Labs | 42.50% |
Hospitals | 20.40% |
Home-care | 18.70% |
Assisted Living Healthcare Facilities | 14.20% |
Others | 4.20% |
Home-care: Point-of-care molecular diagnostics is increasingly being utilized in home-care settings because there is a high demand for at-home testing and remote monitoring solutions. Devices that enable patients to diagnose diabetes, infections, or genetic disorders from their homes save them time and money as the results come immediately. These innovations are making the patients more aware of their health and thus helping them to catch problems at early stages and treat them; consequently, this reduces hospital visits as well as helps in proper management of chronic diseases.
Assisted Living Healthcare Facilities: Point-of-care molecular diagnostics in assisted living healthcare facilities helps monitor the health status of elderly residents better, particularly when relating to infection diagnosis, chronic conditions, and genetic disorders. Such facilities have, therefore arisen with a need for rapid, efficient diagnostic tools that could meet their diverse healthcare needs among their seniors. This would facilitate point-of-care molecular testing for earlier detection of the conditions, minimize hospitalization while enhancing the quality of care and providing timely intervention to support general well-being for elderly people staying in assisted living environments.
The point of care molecular diagnostics market is segmented into several key regions: North America, Europe, Asia-Pacific, and LAMEA (Latin America, Middle East, and Africa). Here’s an in-depth look at each region.
The North America point of care molecular diagnostics market size was estimated at USD 3.96 billion in 2024 and is expected to reach around USD 5.11 billion by 2034. The North America, mainly the United States and Canada, has the maximum hold. Advanced health infrastructure in the U.S. provides this market with good grounds, with strong adoption of novel technologies, coupled with personalized medicine. It is influenced by governmental drives, huge investment in researches, and immense demand for speed diagnosis in terms of rapid infectious diseases diagnosis and personalization in health. In fact, an article from The Commonwealth Fund reports in September 2024 how the United States ranks last among ten affluent nations while its people are paying almost double for their health care. Some critical issues in such rankings include health equity, access to care, and general outcomes. Experts believe that sweeping reforms can solve these issues through quality and accessible healthcare facilities for everyone as many suffer inequalities and unaffordable medical costs.
The Europe point of care molecular diagnostics market size was reached at USD 2.49 billion in 2024 and is expected to be worth around USD 3.21 billion by 2034. The regional market is inclusive of Europe; the main regional markets include Germany, United Kingdom, France, and Italy. Major drivers of growth for this regional market are an improved healthcare system; growing awareness concerning personalized medicine and government funding and support to make innovations in health care. Requirements for molecular diagnostic tests are emerging because of diseases concerning infectious, cancers, and gene testing. Europe's regulatory frameworks further support the growth opportunities of the point-of-care diagnostics market. As part of its plan to restore its position at the helm of European health, the June 2022 French Health Innovation Plan invests USD 7.6 billion through the France 2030 banner. The funding is targeted for research, maturation of technologies, and support to start-ups in three areas: biotherapies, digital health, and emerging diseases. In this way, it will trigger innovation and help France prepare better for future health crises by bettering its ecosystem of healthcare.
The Asia-Pacific point of care molecular diagnostics market size was accounted for USD 1.85 billion in 2024 and is expected to hit around USD 2.39 billion by 2034. Asia-Pacific is growing due to higher investments in health care, a large population base, and increasing incidences of chronic diseases. Improving health infrastructures in these countries, mainly in China and India, have marked this region as the main market for low-cost rapid diagnostics. Besides this, the necessity for decentralized testing solutions in the urban and rural areas is going up. An example of such a move from the Japanese government is nudging impact investing to contribute to health improvement globally while having a Return on Investment, which has a financial return, as well as measurable social return, in June 2023. SHIBUSAWA Ken, a chairman of the study group under Japan's government, said Japan follows a human security and health care approach in the South. This is supported by the G7 in terms of the private sector model as an investment opportunity for health care.
The LAMEA point of care molecular diagnostics market was valued at USD 0.44 billion in 2024 and is anticipated to reach around USD 0.56 billion by 2034. The LAMEA region, including Brazil, Mexico, South Africa, Saudi Arabia, and the UAE, is slowly adopting point-of-care molecular diagnostics. In the LAMEA region, healthcare access and infrastructure are not up to the mark; however, increased awareness of healthcare, government support, and an increased disease burden, such as infectious diseases, are driving the market. With increased investment in healthcare and a focus on improving medical diagnostics, the LAMEA region offers significant growth opportunities. For example, in December 2024, the healthcare sector in the UAE grew remarkably with a focus on performance improvement and quality of life. This meant allocating USD 1.56 billion as an effort to strengthen better health services and constitutes 8% of the federal budget in 2025. Relatedly, a community-based employee integrated insurance scheme has been brought by the government as a motivating scheme for people towards healthy living lifestyles and better easy access of medical services at community levels.
CEO Statements
Francis C. Manganaro , CEO of Nova Biomedical
Scott Verner, CEO of Nipro Diagnostics:
Alexandre Mérieux, CEO of bioMérieux:
Market Segmentation
By Technology
By Application
By Test Location
By Product and Service
By End-use
By Region