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Point of Care Molecular Diagnostics Market Size, Growth, Companies, Trends, and Regional Outlook by 2034

Point of Care Molecular Diagnostics Market

Point of Care Molecular Diagnostics Market Size

The global point of care molecular diagnostics market size was worth USD 8.74 billion in 2024 and is anticipated to expand to around USD 11.28 billion by 2034, registering a compound annual growth rate (CAGR) of 2.58from 2025 to 2034.

What is the Point-of-Care Molecular Diagnostics Market?

Point-of-care molecular diagnostics (POC MDx) refers to diagnostic technologies that detect genetic material—DNA or RNA—at or near the site of patient care. Unlike traditional laboratory-based testing that can take hours or even days, POC MDx delivers fast and accurate results within minutes to a few hours, often in decentralized settings such as emergency rooms, clinics, pharmacies, or even homes. These tests employ molecular biology techniques, including polymerase chain reaction (PCR), isothermal amplification, and CRISPR-based methods, allowing clinicians to rapidly diagnose infectious diseases, monitor chronic conditions, and guide therapy decisions with high sensitivity and specificity.

Why Is It Important?

The importance of point-of-care molecular diagnostics lies in their ability to improve patient outcomes through timely and accurate decision-making. In critical care scenarios—such as detecting sepsis, respiratory pathogens, sexually transmitted infections, or drug-resistant tuberculosis—early diagnosis can mean the difference between life and death. These systems reduce the burden on centralized labs, expedite care delivery, limit the spread of infectious diseases, and are especially vital in rural or resource-limited settings. Additionally, POC MDx is central to the global push toward personalized and precision medicine.

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Growth Factors Driving the Market

The growth of the point-of-care molecular diagnostics market is fueled by a combination of rapid technological advancements (e.g., miniaturization of PCR platforms, integration of AI in diagnostics), the growing demand for decentralized healthcare, rising prevalence of infectious diseases and antimicrobial resistance, increased government funding and public-private partnerships, the surge in self-monitoring and home-testing culture (boosted by COVID-19), regulatory push for rapid diagnostics, and rising awareness about early disease detection. Additionally, the demand for rapid diagnostics in developing countries and the global trend toward value-based healthcare are acting as catalysts for long-term market expansion.


Top Companies in the Point-of-Care Molecular Diagnostics Market

1. F. Hoffmann-La Roche AG

2. Abbott

3. QIAGEN

4. Bayer AG

5. Nova Biomedical


Leading Trends and Their Impact

1. Miniaturization and Integration of AI

AI-powered diagnostics enable automated interpretation of molecular results, reducing human error and empowering less-trained personnel to perform complex tests. Miniaturized, battery-operated systems enhance mobility and remote deployment.

2. Shift Toward Syndromic Testing

Syndromic panels detect multiple pathogens in a single test—crucial for respiratory infections where symptoms overlap. This trend improves diagnosis accuracy and accelerates treatment.

3. CRISPR-based Diagnostics

New CRISPR tools like SHERLOCK and DETECTR are disrupting the market by enabling ultra-fast, low-cost nucleic acid detection, especially for emerging infectious diseases.

4. Home-Based Molecular Testing

Fueled by the pandemic, consumer-friendly molecular platforms (e.g., Cue Health, Lucira) have become mainstream, encouraging self-testing and remote care models.

5. Regulatory Acceleration and Funding

Agencies like the FDA and EMA are streamlining emergency authorizations and fast-track approvals for POC MDx tools, while governments worldwide are increasing funding for decentralization of healthcare.


Successful Examples Around the World

1. United States: ID NOW by Abbott

Used across Walgreens and CVS pharmacies, ID NOW became a cornerstone of the U.S. COVID-19 response. It also supports flu and strep diagnostics in urgent care settings.

2. United Kingdom: Cobas Liat System in NHS

Deployed in National Health Service (NHS) hospitals for flu and RSV detection, reducing unnecessary antibiotic prescriptions and shortening isolation times.

3. India: Truenat by Molbio Diagnostics

A WHO-approved, battery-operated, real-time PCR platform used for tuberculosis and COVID-19 detection in rural and tribal regions. It exemplifies successful diagnostics in low-resource settings.

4. Sub-Saharan Africa: GeneXpert by Cepheid

Though not portable, GeneXpert is used as a POC solution in Africa for TB, HIV, and COVID-19. It integrates with solar-powered labs and mobile clinics.

5. Japan: Loopamp™ by Eiken Chemical

Utilizes Loop-mediated Isothermal Amplification (LAMP) for rapid molecular testing of infectious diseases like malaria and SARS-CoV-2.


Regional Analysis and Government Initiatives

North America

Europe

Asia-Pacific

Latin America

Middle East & Africa

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