Point of Care Diagnostics Market Trends & Forecast 2025–2033

According to Renub Research Latest Report point-of-care (POC) diagnostics market is projected to grow from US$ 50.08 billion in 2024 to US$ 105.22 billion by 2033, registering a CAGR of 8.60% during 2025–2033. Factors propelling this growth include the increasing need for faster and more convenient diagnostic solutions, a rise in infectious and chronic diseases, and technological innovations such as miniaturization and artificial intelligence (AI) integration.

POC diagnostics allow medical tests to be conducted near the patient, offering rapid results without the need to send samples to centralized labs. This capability is transforming healthcare delivery, enabling timely diagnosis, improved patient care, and better clinical decision-making across hospitals, clinics, and home-care settings.

What Are Point-of-Care Diagnostics?

Point-of-Care Diagnostics (POC) refers to medical testing performed at or near a patient’s location, providing immediate results. Unlike traditional lab-based diagnostics, POC tests reduce the time between sample collection, analysis, and treatment decisions, enabling healthcare providers to act promptly.

POC diagnostics are used in multiple healthcare settings, including primary care clinics, hospitals, emergency rooms, and homes. Common applications include:

Cholesterol and blood sugar monitoring

Infectious disease detection (COVID-19, HIV, influenza)

Pregnancy and fertility tests

Cardiac markers and blood gas analysis

The immediacy and accessibility of POC diagnostics improve patient outcomes, particularly in rural or resource-limited areas where traditional laboratory facilities may be unavailable.

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Key Growth Drivers

Technological Advancements

POC diagnostics are benefitting from technological progress, including miniaturized devices, lab-on-a-chip solutions, biosensors, and AI integration. These innovations improve sensitivity, accuracy, and versatility, making POC devices more practical and widely applicable.

Collaborations between companies, such as Molbio Diagnostics and SigTuple in 2023, aim to develop next-generation AI-powered portable devices capable of performing a wide range of routine and diagnostic tests. This trend accelerates the adoption of POC diagnostics globally.

Rising Importance of Personalized Medicine

The global focus on personalized medicine is driving demand for POC diagnostics. By providing rapid and accurate testing, POC devices enable tailored treatment strategies based on individual patient profiles.

For instance, the National Cancer Institute (NCI) has launched precision medicine programs for cancer, highlighting the increasing need for quick, patient-specific diagnostic solutions. POC devices support this approach by enabling fast monitoring of treatment efficacy and disease progression.

Increasing Incidence of Chronic Diseases

Chronic diseases are a major factor propelling POC diagnostics growth. According to the World Health Organization (WHO), 41 million people die from non-communicable diseases each year, representing 74% of global deaths. Conditions like diabetes, cardiovascular diseases, and respiratory disorders are rising globally.

POC diagnostics are critical in early detection, monitoring, and management of chronic diseases, particularly in regions with limited access to conventional laboratories. The ease-of-use and immediacy of these tests allow healthcare providers to deliver timely interventions, improving disease outcomes and patient quality of life.

Market Challenges

Accuracy and Adoption Limitations

Despite their advantages, POC diagnostics face challenges. Some devices may produce less accurate results than centralized laboratory tests. This can limit adoption, especially in clinical settings where accuracy is critical.

Additionally, the high cost of devices and the lack of connectivity in developing regions can hinder implementation. Manual record-keeping can lead to errors, delays, and duplicate testing, raising overall healthcare costs.

Regulatory and Quality Assurance Constraints

Maintaining regulatory and quality assurance standards is challenging in low-resource settings. Limited access to skilled personnel, infrastructure, and monitoring systems can compromise device accuracy and reliability.

Ensuring continuous calibration, safety compliance, and staff training in such environments is difficult, which may slow POC adoption despite its potential to improve healthcare delivery.

Product Segmentation

Glucose Monitoring Kits

Glucose monitoring kits dominate the POC market due to the global prevalence of diabetes. These kits allow patients to track blood sugar levels in real-time, facilitating timely medication adjustments and lifestyle changes.

With rising diabetes incidence, glucose monitoring kits remain essential tools for patients, caregivers, and healthcare providers, driving strong demand.

Infectious Disease Kits

POC infectious disease kits are crucial for detecting illnesses like COVID-19, HIV, and influenza. Rapid testing facilitates early intervention, reduces the spread of infection, and improves patient outcomes, particularly during outbreaks.

Pregnancy & Fertility Testing Kits

Pregnancy and fertility kits are widely used for home-based diagnostics, providing quick, convenient, and private results. These kits are part of a growing trend toward self-monitoring and preventive care.

Other Products

Other POC products include hematology kits, cardiometabolic monitoring kits, urinalysis kits, cholesterol test strips, and drugs-of-abuse kits, catering to diverse diagnostic needs.

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Technology Segmentation

Lateral Flow – Simple, rapid, and widely adopted for decentralized testing

Agitation – Enhanced detection in portable devices

Flow Through – Efficient for multiple analytes

Solid Phase – High accuracy for specific biomarkers

Biosensor-Based – Integrates advanced sensing technology

Others – Emerging technologies improving versatility

Lateral flow technology is expected to lead the market due to its low cost, ease of use, and wide applicability in home, clinical, and resource-limited settings.

Point of Prescription

Prescription-Based Devices – Used in clinical and professional settings

Over-the-Counter (OTC) Devices – Enable home testing and self-monitoring, driving market growth through convenience and accessibility

OTC devices empower consumers to take control of their health, increasing proactive disease monitoring and preventive care adoption.

End-User Segmentation

Professional Diagnostic Centers – Offer comprehensive testing with skilled personnel

Research Laboratories – Focus on advanced diagnostic research

Home Care – Expanding due to accessibility and convenience

Others – Includes mobile health services and telemedicine applications

Professional diagnostic centers remain a key market segment due to their wide-ranging testing capabilities and expertise.

Regional Market Insights

United States

The U.S. POC diagnostics market is expanding rapidly due to rising demand for on-site testing, chronic disease management, and technological innovations. Home-testing and OTC devices further support growth.

Example: The ADEXUSDx hCG Test was FDA-approved in 2022 for early pregnancy detection, demonstrating how regulatory approvals drive adoption.

Germany

Germany’s POC diagnostics market benefits from an aging population, advanced healthcare infrastructure, and early disease detection emphasis. OTC testing kits and home diagnostics also contribute to growth, despite challenges related to reimbursement, data integration, and regulatory compliance.

India

India is experiencing fast growth in POC diagnostics due to a large population, rising chronic disease prevalence, and limited access to conventional labs in rural areas. Initiatives such as Cipla’s Cippoint (2023), offering multi-parameter diagnostics, highlight the market’s expansion potential.

Saudi Arabia

Saudi Arabia’s market is expanding as medical technology improves and Vision 2030 initiatives promote preventive healthcare. POC devices help address chronic disease management and reduce hospital visits. Growth is supported by home testing, mobile health solutions, and government programs, though regulatory and accuracy challenges remain.

Competitive Landscape

Key players in the global POC diagnostics market include:

Sysmex

Abbott Laboratories (US)

Becton Dickinson and Company (US)

Danaher Corporation (US)

Quidel Diagnostics (US)

F. Hoffmann-La Roche Ltd

Thermo Fisher Scientific Inc.

Bio-Rad Laboratories Inc.

These companies focus on innovative product development, collaborations, and technological advancements, ensuring rapid adoption of cutting-edge POC diagnostics solutions globally.

Market Outlook 2025–2033

The global POC diagnostics market is set to grow strongly due to:

Increasing chronic and infectious disease prevalence

Growing demand for rapid, on-site, and home-based testing solutions

Advancements in miniaturization, AI integration, and biosensors

Rising awareness of personalized medicine and preventive care

Challenges such as accuracy concerns, regulatory compliance, and high device costs persist but are expected to be mitigated by technology innovations, quality assurance measures, and policy support.

By 2033, POC diagnostics will play a vital role in healthcare delivery, improving patient outcomes, reducing hospital dependence, and supporting self-monitoring initiatives, making diagnostics faster, more accessible, and more reliable worldwide.

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