Point of Care Molecular Diagnostics Market

Market Overview:

The global point of care molecular diagnostics market size reached USD 4.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 8.7 Billion by 2033, exhibiting a growth rate (CAGR) of 8.78% during 2025-2033. North America dominates the market owing to its improved healthcare infrastructure, strong presence of key industry players, and high adoption of innovative diagnostic technologies. The increasing incidence of infectious diseases paired with rapid development in healthcare facilities is significantly driving the market growth.

Point-of-care (POC) molecular diagnostics refer to tests performed by physicians to diagnose and detect infectious diseases. It includes hematology, pregnancy, fertility, infectious diseases, urinalysis testing kits, and cardiometabolic and glucose monitoring devices. POC molecular diagnostics is widely used for identifying infectious agents, minimal residual disease, and gastrointestinal disorders, monitoring hemoglobin and fecal occult blood, and determining a patient's ability to metabolize a drug or drug class. These tests offer faster results, reduce complications associated with mistreatment, and improve infection control measures. As a result, POC molecular diagnostics finds extensive applications in hospitals, intensive care units (ICUs), research institutes, clinics, decentralized laboratories, and homecare facilities.

Point of Care Molecular Diagnostics Market Trends:

Rising Prevalence of Chronic and Infectious Diseases

The rising prevalence of diseases like cancer, diabetes, cardiovascular issues, and infectious outbreaks underscores the need for swift and precise diagnostic techniques. Point-of-care molecular diagnostics offer the benefit of prompt identification, allowing for timely medical action and efficient disease management. This is especially crucial for slowing disease progression, enhancing patient survival rates, and limiting the transmission of infectious diseases. In addition, the capability of point of care molecular diagnostics to track disease advancement and treatment efficacy enhances overall care management. With healthcare systems experiencing increased demand for diagnostic services from aging populations and changing health risks, point of care molecular diagnostics offer a scalable and effective solution. The ongoing necessity to tackle intricate health issues reinforces their acceptance, positioning disease prevalence as a key factor impelling the market growth.

Growing Geriatric Population

Elderly people are at greater risk for chronic illnesses, infectious diseases, and age-associated conditions, necessitating prompt and accurate diagnostics for effective treatment. As healthcare systems gear up to handle these increasing demands, the necessity for swift, precise, and readily available diagnostic tools is essential to facilitate early detection and intervention. The World Health Organization (WHO) emphasizes that by 2030, one in six people globally will be 60 years or older, and this figure is expected to reach 2.1 billion by 2050. Furthermore, the number of individuals aged 80 and over is predicted to grow three times, totaling 426 million by 2050. This demographic change is expected to exert significant strain on healthcare systems, highlighting the need for cutting-edge point-of-care molecular diagnostics to improve patient results, lessen hospital pressures, and facilitate effective, decentralized healthcare provision.

Emphasis on Decentralized Healthcare Delivery

With the growing healthcare needs, especially in rural, isolated, and resource-constrained areas, the need for diagnostic tools that can provide quick, accurate, and dependable results without relying on centralized lab facilities is becoming more vital. Point of care molecular diagnostics effectively tackle this issue by offering quick, on-site testing options that greatly minimize logistical obstacles like delays from sample transport, storage problems, and centralized processing delays. This decentralization guarantees that patients access earlier interventions and more precise treatment paths, leading to enhanced healthcare results and lower disease burdens. Additionally, as the focus on cost control and operational effectiveness grows, healthcare organizations are utilizing these technologies to improve patient management, boost workflow efficiency, and make the most of existing resources. Decentralized healthcare delivery remains a key growth factor for the point-of-care molecular diagnostics market by enhancing accessibility, speeding up turnaround times, and minimizing systemic inefficiencies.

Point of Care Molecular Diagnostics Market Growth Drivers:

Demand for Affordable and Accurate Diagnostic Solutions

As healthcare systems strive to ensure broad access to dependable testing, affordable molecular platforms are gaining significance. These solutions merge high precision with lower operational costs, enabling wider accessibility in clinics, pharmacies, and even home environments. Affordable diagnostic technologies simplify workflows and decrease turnaround times by removing intricate sample preparation and lessening the requirement for specialized training. This equilibrium between accuracy and cost-effectiveness facilitates the substitution of unreliable testing techniques, leading to enhanced patient results and superior disease management. As healthcare systems focus on value-based care, the need for cost-effective and precise diagnostics is a vital factor propelling the market growth. In 2024, 3EO Health launched its CLIA-waived point-of-care molecular diagnostics platform in the US, offering COVID-19 testing under $20 with no sample prep. The compact 3TR system enabled affordable, high-efficiency testing in clinics and homes, aiming to replace antigen tests with molecular accuracy.

Advancements in Portable Diagnostic Technologies

Small and easy-to-use devices are facilitating dependable testing beyond conventional lab environments, broadening access to essential diagnostic services in urban and rural regions. These advancements deliver quick, precise outcomes, aiding prompt clinical choices and minimizing the wait times linked to centralized testing centers. Improved portability enables healthcare professionals to perform testing in various settings, ranging from community health facilities to distant clinics, thus expanding healthcare access and enhancing disease management results. The simplicity of deployment, paired with low infrastructure needs, enables portable diagnostics to be highly versatile for extensive usage. Enhancing efficiency, scalability, and accessibility, innovations in portable molecular diagnostics bolster the market’s contribution to advancing global healthcare delivery and guaranteeing fair access to vital testing. In 2024, India’s Truenat, a point-of-care molecular diagnostics platform by Molbio, was recognized at the 77th World Health Assembly for its role in combating TB. The portable, battery-operated PCR device delivers rapid, high-accuracy results in under an hour and is widely deployed across India.

Integration with Digital Health and Data Analytics

The combination of point-of-care molecular diagnostics with digital health platforms and sophisticated data analytics is contributing to the market growth. Contemporary connectivity capabilities, such as cloud data storage, mobile health apps, and electronic health record (EHR) integration, enable the smooth transfer, access, and monitoring of diagnostic results throughout healthcare networks. This interoperability enhances clinical decision-making by enabling healthcare providers to obtain real-time data, monitor disease progression, and more efficiently coordinate personalized treatment plans. Additionally, analytics-driven insights support population health management by identifying disease trends, predicting potential outbreaks, and improving the allocation of healthcare resources. Furthermore, integrating diagnostic technologies with telemedicine services and remote monitoring systems allows patients in rural and underserved regions to access prompt, precise, and ongoing care. This cohesive ecosystem promotes enhanced precision and operational effectiveness, alongside increased patient involvement and adherence, supporting the adoption of point-of-care molecular diagnostics globally.

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global point of care molecular diagnostics market report, along with forecasts at the global, regional and country level from 2025-2033. Our report has categorized the market based on product and service, technology, application and end user.

Breakup by Product and Service:

• Assays and Kits
• Instruments and Analyzers
• Software and Services

Breakup by Technology:

• Polymerase Chain Reaction (PCR)
• Hybridization
• DNA sequencing
• Microarray
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Others

Breakup by Application:

• Infectious Diseases
• Oncology
• Hematology
• Prenatal Testing
• Endocrinology
• Others

Breakup by End User:

• Physicians’ Offices
• Hospitals and ICUs
• Research Institutes
• Others

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

Competitive Landscape:

The report has also provided a comprehensive analysis of the competitive landscape in the global point of care molecular diagnostics market. Detailed profiles of all major companies have also been provided. Some of the companies covered include:

• Abbott Laboratories
• Becton, Dickinson and Company
• binx health, inc.
• Cepheid (Danaher Corporation)
• Co-Diagnostics Inc.
• F. Hoffmann-La Roche Ltd
• Meridian Bioscience
• Molbio Diagnostics Limited
• QuantuMDx Group Limited
• Thermo Fisher Scientific Inc.
• Visby Medical Inc.

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

Point of Care Molecular Diagnostics Market Recent Developments:

• June 2025: LEX Diagnostics submitted dual applications to the FDA for 510(k) clearance and CLIA waiver for its LEX VELO system, an ultra-fast PCR-based point-of-care diagnostic platform. The system delivers results for respiratory pathogens like Influenza A/B and COVID-19 in under 10 minutes. It aims to bring lab-quality molecular testing to decentralized clinical settings.
• April 2025: Diagnostics for the Real World (DRW) announced the upcoming launch of a retooled rapid, multiplexed point-of-care molecular diagnostics platform along with six new test panels. Originally spun out of the University of Cambridge, DRW is enhancing its platform for faster and more accurate detection of infectious diseases. The update reflects its renewed focus on qPCR-based testing in global healthcare settings.
• January 2025: Roche received FDA 510(k) clearance and CLIA waiver for its cobas® liat point-of-care molecular diagnostic tests for STIs including chlamydia, gonorrhea, and Mycoplasma genitalium. These rapid PCR-based tests deliver results in 20 minutes, enabling same-visit diagnosis and treatment in decentralized settings.
• July 2024: Roche announced the acquisition of LumiraDx’s Point of Care technology for expanding access to diagnostic tests in primary care.
• July 2024: Co-Diagnostics, Inc. announced that it will be hosting and presenting at the Association for Diagnostics & Laboratory Medicine (ADLM) annual meeting and expo in August 2024. It planned to exhibit the role of its new point-of-care and at-home Co-Dx PCR platform in limiting the global diagnostics gap for a diverse range of potential indications, including tuberculosis.

Report Scope: