Global Point of Care Diagnostics Market Size, Forecast, and Trend Highlights Over 2025-2037
Point of Care Diagnostics Market size was valued at USD 42.7 billion in 2024 and is projected to reach USD 98.6 billion by the end of 2037, rising at a CAGR of 9.5% during the forecast period 2025-2037. In 2025, the industry size of point of care diagnostics is evaluated at USD 46.7 billion.
The market is experiencing significant growth driven by the rising infectious disease burdens (including HIV, hepatitis, and influenza) and the growing prevalence of chronic conditions such as diabetes and cardiovascular diseases. In this regard, WHO recorded approximately 422.3 million diabetes cases worldwide and 1.5 million new HIV infections in 2022. On the other hand, a 2024 report from the CDC has also demonstrated that it can reduce diagnostic turnaround times by 50.4-70.1%, making it essential for every healthcare setting, including hospitals, clinics, and decentralized medical service providers. It reflects the growing need for efficient and rapid testing tools, where Point of Care (POC) detection has proven its effectiveness, particularly in emergency scenarios.
The current dynamics of the payers' pricing in the market are primarily influenced by supply chain complexities and regulatory pressures. As the expenses in production amplify, the overall cost of undergoing a complete detection process under this category becomes more expensive for patients. This is testified by the gradual rate of increments in the producer price index (PPI) for associated equipment and consumer price index (CPI) for POC tests across the U.S. in 2023, which are 6.5% year-over-year (YoY) and 5.1%. Furthermore, the massive amount of capital required to acquire reliable resources of critical components and drugs also contributes to this rise in pricing. Thus, companies are now investing in extensive R&D to develop more cost-effective solutions.
Point of Care Diagnostics Sector: Growth Drivers and Challenges
Growth Drivers
- Utilization in improving healthcare outcomes: The efficacy of commodities offered by the market has showcased their capabilities in enhancing clinical efficiency and reducing costs at a large scale over the past years. For instance, a 2022 AHRQ study established the efficacy of POC testing in early interventions in eliminating the need for critical hospital admissions by 22.5%, saving around USD 3.3 billion in the U.S. over 2 years. Similarly, it helped diagnostic laboratories achieve 15.2% faster turnaround times in 2023, according to the FDA. As a result, more medical authorities and organizations are heavily investing in this sector to accommodate such advanced solutions to elevate outcomes in their emergency departments.
- Ongoing tech-based advances in the pipeline: The acceleration in the progress of the market is highly attributable to the integration of technologically advanced features. The efforts and strategic initiatives made by global MedTech giants to develop more scalable and accessible solutions are driving adoption and magnifying the capital influx in this merchandise. For instance, in 2024, Roche, in partnership with 150 clinics in the U.S., gained a 9.1% additional revenue share in this field by deploying its AI-powered Cobas Liat systems. Simultaneously, Abbott captured a large consumer base with 50.1 million annual malaria cases in sub-Saharan Africa with the launch of its FDA-authorized BinaxNOW Malaria test in 2024.
Historical Patient Growth & Market Evolution: Foundation for the Future Point of Care Diagnostics Market Expansion
The market witnessed a transformative phase during the remarkable expansion of the patient pool from 2010 to 1020. Particularly, the impact of the COVID-19 pandemic across the globe significantly amplified the demography, multiplying the demand for rapid test kits. Additionally, the rapidly aging population notably contributed to this escalation, shaping the current wave of POC incorporation in regular and mainstream medical practices. Moreover, the variability and enlarged volume, which followed an 8.1-12.4% range of annual growth rate, of this consumer base pushed companies to adopt a personalized approach, bringing innovations to this field.
Historical Patient Growth (2010-2020)
|
Country |
2010 Patients (Million) |
2020 Patients (Million) |
CAGR (%) |
Key Driver |
|
U.S. |
18.5 |
42.8 |
9.1% |
ACA expansion, diabetes epidemic |
|
Germany |
7.1 |
14.6 |
8.0% |
Aging population, cardiac POC adoption |
|
France |
5.4 |
11.0 |
8.1% |
Hospital decentralization reforms |
|
Spain |
4.2 |
8.5 |
7.9% |
EU-funded rural POC programs |
|
Australia |
2.7 |
5.9 |
9.1% |
Aboriginal health initiatives |
|
Japan |
7.8 |
12.4 |
5.2% |
Slow reimbursement uptake |
|
India |
9.6 |
28.9 |
12.4% |
National TB/HIV mission |
|
China |
15.7 |
49.2 |
12.5% |
Rural diagnostics mandate |
Feasible Expansion Models Shaping the Point of Care Diagnostics Market
The alignment of global leaders with the current trends and consumer needs in the market is structuring the most effective models of a profitable business for new entrants. Their measurable success across diverse healthcare systems is verifying these methods of commercializing and is inspiring & guiding others to craft a unique pathway for every individual landscape. For instance, between 2022 and 2024, a 12.4% rise in revenue generation was observed due to the formation of strategic alliances with local providers to apply community-based deployment as per the guidelines of the National Health Mission in India. Moreover, there is evidence that tailored implementation strategies can overcome traditional barriers.
POC Market Expansion Feasibility Models (2024–2030)
|
Model |
Region |
Revenue Uplift (2024) |
Key Driver |
Govt. Support |
|
Public-Private Partnerships |
India |
12.4% |
National Health Mission |
USD 1.3 billion funding |
|
Telehealth Integration |
U.S. |
9.1% |
Medicare Coverage |
5 new reimbursed tests |
|
Localized Manufacturing |
China |
15.3% |
Import Tax Reductions |
30.2% subsidy |
|
Decentralized ER Testing |
Germany |
7.5% |
EU IVDR Compliance |
504+ clinics upgraded |
Challenge
- Data integration and interoperability gaps: According to the Office of the National Coordinator for Health Information Technology, till 2024, more than 30.4% of U.S. patients were not able to operate the transfer of POC data to major EHR systems, such as Epic or Cerner. This lack of user awareness about technology integration caused Siemens an additional expenditure of USD 200.4 million on health IT partnerships in 2024. This showcases the limitations in the eligible consumer base expansion and wide adoption in the point of care diagnostics market. Moreover, the resistance toward new technologies among legacy clinical systems may also hinder growth in this field.
Point of Care Diagnostics Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
9.5% |
|
Base Year Market Size (2024) |
USD 42.7 billion |
|
Forecast Year Market Size (2037) |
USD 98.6 billion |
|
Regional Scope |
|
Point of Care Diagnostics Segmentation
Product (Infectious Disease Tests, Glucose Monitoring, Cardiometabolic Tests, Coagulation Testing, Pregnancy & Fertility Tests)
Based on product, the infectious disease tests segment is expected to dominate the point of care diagnostics market with a share of 32.5% by 2037. The rapid widespread of these ailments across the world, creating an emergency situation, is becoming a concern to general wellness. This is pushing authorized entities to take adequate actions to combat such life-threatening situations by deploying early detection and intervention. In this regard, the WHO, set its aim to cure the maximum number of HIV-afflicted residents by availing rapid tests to 120.2 million candidates every year by 2025. Simultaneously, the financial support from the governing bodies is also fueling investments in this segment. For instance, the CLIA waiving initiative on selected tests, commenced by the CDC, propelled POC adoption by 22.4% in emergency rooms.
Platform (Lateral Flow Assays, Molecular Diagnostics, Immunoassays, Microfluidics)
In terms of platform, the lateral flow assays (LFAs) segment is anticipated to gain the highest share of 28.5% in the market throughout the assessed timeline. Its clinically proven cost-effectiveness and optimum scalability are the major drivers behind its lead over other subtypes. As a result, it is desired across the globe, particularly in price-sensitive regions, to mitigate the cost barrier in advanced healthcare. For instance, the National Health Mission commenced a TB program in India, enabling access to an annual 1.3 billion LAF-empowered POCs at less than USD 1.5 per test. Similarly, the implementation of IVDR regulations in Europe escalated the surge for standardized LFA products by 15.4%. Moreover, the shifting preference toward value-based and compliant services is fueling this segment.
Our in-depth analysis of the global point of care diagnostics market includes the following segments:
|
Product |
|
|
End user |
|
|
Platform |
|
Vishnu Nair
Head - Global Business DevelopmentCustomize this report to your requirements — connect with our consultant for personalized insights and options.
Point of Care Diagnostics Industry - Regional Synopsis
North America Market Analysis
North America is predicted to capture the largest share of 38.3% in the point of care diagnostics market over the discussed timeframe. The region's leadership is primarily attributable to the presence of a robust medical infrastructure and a supportive Federal government. The efforts from dedicated authorities to improve public access to early detection, treatment, and prevention, to combat the continuously emphasizing patient pool, is securing a reliable cash inflow in this sector. For instance, in 2024, the governing body of Ontario allocated USD 220.3 million in funds to expand the accessibility of POC devices among 300,010 residents from rural areas. Similarly, governments in clinically developed countries, such as the U.S. and Canada, are reforming the policy structure for reimbursements and subsidies to serve the same purpose.
The U.S. complements the regional expansion in the market through continuous expansion in Medicare & Medicaid coverage and acceptance of advanced POC technologies. For instance, in 2024, the U.S. Medicare spending on these tests reached up to USD 2.0 billion, where more than 11 new assay types were covered. On the other hand, in 2024, the accelerated FDA clearances for AI-integrated POC devices boosted their adoption across the nationwide network of clinics by 45.3%. Additionally, with robust financial support from both consumers and the Federal government, the country is maintaining its overwhelming leadership in North America.
APAC Market Statistics
The Asia Pacific point of care diagnostics market is poised to exhibit the highest CAGR by the end of 2037. Its pace of emergence is highly stimulated by escalating public health investments, infrastructural development, and digital healthcare transformation in developing countries, such as China and India. For instance, in 2024, India portrayed its potential as a large consumer base in this sector by commencing the National Health Mission, delivering over 5.1 million annual TB and HIV POC tests. Similarly, in 2025, the National Medical Products Administration (NMPA) in China drafted and released the Healthy China 2030 program. Its roadmap has a USD 12.4 billion outlay, intending to support rural POC initiatives across the country. In addition, AI-based innovations are the region's strong propagation in this field.
Japan is becoming the hub of technological discoveries in the market, driven by the vast AI adaptation in healthcare. Considering the clinical benefits of incorporating automation in the process of analyzing, detecting, and evaluating patient data, the root cause of the ailment, and treatment prognosis, the government is allocating significant capital in this sector. For instance, in 2024, over 12.4% of its healthcare budget (up to USD 4.0 billion) was dedicated to advances in POC technologies, as per the Ministry of Health, Labour and Welfare. Besides, the regulatory support is also accountable to the nation's progressive business environment. For instance, in 2024, the fast-track approval from the PDMA minimized molecular POC test-related delays by 6 months.
Companies Dominating the Point of Care Diagnostics Landscape
The progress in globalization of the point of care diagnostics market is highly influenced by cutting-edge innovations and commercial initiatives from key players. Following the same pathway, Roche, Abbott, and Siemens collectively attained control over 45.2% of revenue share in this sector. Testifying to this accomplishment, Siemens acquired the ability to reduce diagnostic delays in hospitals across Europe by amalgamating POC tools with electronic health records (EHRs). On the other hand, leaders in the emerging landscapes in the point of care diagnostics market are collaborating with dedicated government entities to captivate new business opportunities produced by new initiatives.
Top 20 of such key players are mentioned below:
|
Company |
Country |
Market Share |
Industry Focus |
|
Roche Diagnostics |
Switzerland |
18.5% |
Molecular POC (Cobas Liat), infectious disease tests |
|
Abbott Laboratories |
U.S. |
15.3% |
Rapid diagnostics (BinaxNOW, i-STAT), cardiometabolic tests |
|
Siemens Healthineers |
Germany |
12.1% |
Immunoassays, AI-integrated POC devices |
|
Danaher (Beckman Coulter, Cepheid) |
U.S. |
10.3% |
Molecular POC (Xpert tests), microfluidics |
|
BD (Becton Dickinson) |
U.S. |
8.2% |
Infectious disease tests (Veritor), biosensors |
|
QuidelOrtho |
U.S. |
xx% |
Lateral flow assays (Sofia), respiratory tests |
|
bioMérieux |
France |
xx% |
Sepsis POC tests, antimicrobial resistance detection |
|
Sysmex Corporation |
Japan |
xx% |
Hematology POC analyzers, AI-driven diagnostics |
|
ARKRAY |
Japan |
xx% |
Glucose monitoring, HbA1c POC devices |
|
Trinity Biotech |
Ireland |
xx% |
HIV/HBV rapid tests, tropical disease diagnostics |
|
SD Biosensor |
South Korea |
xx% |
Low-cost LFAs, COVID-19 antigen tests |
|
Thermo Fisher Scientific |
U.S. |
xx% |
PCR-based POC, portable analyzers |
|
Chembio Diagnostics |
U.S. |
xx% |
Tropical disease tests (DPP HIV-Syphilis assay) |
|
Eiken Chemical |
Japan |
xx% |
TB/HPV molecular POC tests |
|
PTS Diagnostics |
U.S. |
xx% |
CardioChek lipid analyzers |
|
Trividia Health |
U.S. |
xx% |
Diabetes care (TRUEmetrix glucose meters) |
|
J. Mitra & Co. |
India |
xx% |
Affordable rapid tests for HIV/malaria |
|
Boditech Med |
South Korea |
xx% |
iChroma immunoassay systems |
|
Tulip Diagnostics |
India |
xx% |
Rapid diagnostic kits for infectious diseases |
|
ACON Laboratories |
U.S. |
xx% |
At-home pregnancy/glucose tests |
Recent Developments
- In May 2024, Abbott Laboratories introduced its ID NOW Strep A Test, featuring 5-minute molecular results for rapid Strep A detection. The test drove a 15.4% sales surge in pediatric clinics by enabling same-day diagnosis and helping reduce antibiotic overprescription by 20.1%.
- In April 2024, Cepheid announced the commercial launch of its first WHO-prequalified POC test, Xpert HCV Viral Load, for hepatitis C viral load monitoring. This breakthrough enabled 50.3% faster treatment initiation in low-resource settings, addressing critical gaps in HCV management.
- Report ID: 95
- Published Date: May 23, 2025
- Report Format: PDF, PPT
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