Point-of-Care Diagnostics Market
Point-of-care Diagnostic Market Size, Share & Trends Analysis Report by Type (Glucose Monitoring Kits, Cardiometabolic Monitoring Kits, Infectious Disease Testing Kits, Pregnancy & Fertility Testing Kits, Tumor/Cancer Markers, Urinalysis Testing Kits, Cholesterol Testing Kits, Haematology Testing, and Others), by Prescription Mode (Over-The-Counter Testing, and Prescription-Based Diagnostics), by Technology (Lateral Flow Assays, Dipsticks, Microfluidics, Molecular Diagnostics, Immunoassays, and Biosensors), and by End-User (Hospitals and Clinics, Home Care, Ambulatory Care, Diagnostic Laboratories, and Pharmacies) Forecast Period (2025-2035)
Industry Overview
Point-of-care diagnostic market was valued at $44,240 million in 2024 and is projected to reach $85,737 million by 2035, growing at a CAGR of 6.2% from 2025 to 2035. The rise in chronic diseases, rapid emergency diagnosis, elderly population, technological advancements, infectious disease testing, home healthcare trends, and government support are driving these changes.
Market Dynamics
High Prevalence of Infectious Diseases
The rise in infectious diseases such as HIV, tuberculosis, hepatitis, and COVID-19 has fueled a surge in demand for rapid diagnostics, leading to market growth in portable, low-cost, and fast diagnostics. According to the World Health Organization (WHO), in March 2025, HIV continues to be a significant global health challenge, with approximately 42.3 million lives lost to date and ongoing transmission globally. Additionally, in 2023, across 39.9 million individuals were living with HIV, with 65% residing in the WHO African Region. In 2023, there were an estimated 630,000 HIV-related deaths and 1.3 million new infections. While there is no cure, effective prevention, diagnosis, and treatment have made HIV a manageable chronic condition, allowing individuals to lead healthy lives. Global strategies by the WHO, the Global Fund, and UNAIDS aim to end the epidemic by 2030, targeting 95% diagnosis, treatment, and viral suppression rates by 2025. As of 2023, 86% knew their status, 77% were on antiretroviral therapy, and 72% had suppressed viral loads.
Global Health Initiatives & Regulatory Support
Governments are boosting market growth by prioritizing access to essential diagnostics, especially in low- and middle-income countries, through prequalification and global health procurement frameworks. For instance, in April 2024, the World Health Organization (WHO) expands the prequalification scope of in vitro diagnostics, including monitoring blood glucose in capillary blood and HbA1c point-of-care assays, promoting safer and more accurate diagnostics. The World Health Assembly developed prequalification technical specifications for in vitro diagnostic medical devices for high-burden infectious diseases such as HIV, malaria, and hepatitis, with 113 IVDs currently prequalified. The demand for high-quality diagnostics is growing, particularly in the context of diabetes, a global public health issue with 420 million individuals living with it.
Market Segmentation
- Based on the type, the market is segmented into glucose monitoring kits, cardiometabolic monitoring kits, infectious disease testing kits, pregnancy & fertility testing kits, tumor/cancer markers, urinalysis testing kits, cholesterol testing kits, haematology testing, and others (coagulation testing kits, and fecal occult testing kits).
- Based on the prescription mode, the market is segmented into over-the-counter testing and prescription-based diagnostics.
- Based on the technology, the market is segmented into lateral flow assays, dipsticks, microfluidics, molecular diagnostics, immunoassays, and biosensors.
- Based on the end-user, the market is segmented into hospitals and clinics, home care, ambulatory care, diagnostic laboratories, and pharmacies.
Over-The-Counter (OTC) Testing: A Key Segment in Market Growth
Over-the-counter testing is a diagnostic method that provides immediate results, such as COVID-19 tests, without a doctor's prescription. Home OTC COVID-19 testing is FDA-approved for self-testing, with fast results, ease, early diagnosis, and public health monitoring. The tests are easy to perform, have quick results, and can be performed from home or other remote locations. It can additionally be used for other diseases, such as pregnancy and cholesterol testing. The FDA encourages voluntary reporting of test results. The market growth of OTC diagnostic tests is influenced by rising health awareness and demand for home-based care, consumerization, and FDA authorizations. For instance, in February 2025, Aptitude Medical Systems, Inc. received FDA authorization for the Metrix COVID/Flu Multiplex Molecular Test for Point-of-Care and Over-the-Counter Use. The test can detect and differentiate COVID, Flu A, and Flu B in 20 minutes, and can be used in home and CLIA-waived settings. The test is the second FDA-authorized molecular test on the platform, aiming to provide actionable lab-quality results for various health and wellness conditions.
Regional Outlook
The global point-of-care diagnostic market is further divided by geography, including North America (the US and Canada), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), and the Rest of the World (the Middle East & Africa, and Latin America).
Decentralization of Healthcare in Asia-Pacific
The decentralization of healthcare is boosting market growth, especially in rural and underserved areas, as POC tests facilitate quicker diagnosis and treatment. For instance, in May 2024, Cipla invested up to Rs. 26 crore ($3.1 million) in Achira Labs, a company specializing in developing and commercializing point-of-care medical test kits in India.
North America Region Dominates the Market with Major Share
North America holds a significant share, owing to the rise in chronic diseases such as cardiovascular, diabetes, and respiratory illnesses is driving the demand for portable diagnostic tools for early detection and management. According to the Centers for Disease Control and Prevention, in February 2024, the US, approximately 129 million individuals live with at least one major chronic disease, such as heart disease, cancer, diabetes, obesity, or hypertension, according to the US Department of Health and Human Services. Five out of the ten leading causes of death in the country are linked to preventable and treatable chronic conditions. As the prevalence of these diseases has been rising steadily over the past two decades, it is anticipated that this trend will persist, with 42% of Americans experiencing two or more chronic conditions and 12% coping with at least five. Chronic diseases significantly burden the US health care system, accounting for roughly 90% of the annual $4.1 trillion expenditure on health care and mental health conditions.
Market Players Outlook
The major companies operating in the global point-of-care diagnostic market include Abbott Laboratories, Danaher Corp., F. Hoffmann-La Roche Ltd., Siemens Healthcare Pvt. Ltd., and Thermo Fisher Scientific Inc., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Developments
- In January 2025, BioMérieux acquired SpinChip Diagnostics ASA, a Norwegian diagnostics company that develops a revolutionary immunoassay diagnostics platform. SpinChip aims to develop lab-quality tests for acute care settings, particularly Myocardial Infarction (MI), a leading cause of morbidity and mortality. The company initially focuses on established cardiac markers such as highly sensitive troponin I (hs-TnI), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and D-Dimer, and expands testing to other clinical areas important in acute care settings, and strengthens customer support, while focusing on compact hydraulic components.
- In January 2024, LumiraDx agreed to sell its point-of-care technology platform to Roche for $295 million, with an additional $55 million payment to fund the platform. The diagnostic testing system uses a portable instrument and microfluidic test strips.
- In July 2023, Fortis Life Sciences acquired Toronto-based International Point of Care, Inc., a leading manufacturer of diagnostic components, allowing Fortis to offer customizable solutions for immunodiagnostic and molecular diagnostic products.
The Report Covers
- Market value data analysis for 2024 and forecast to 2035.
- Annualized market revenues ($ million) for each market segment.
- Country-wise analysis of major geographical regions.
- Key companies operating in the global point-of-care diagnostic market. Based on the availability of data, information related to new products and relevant news is also available in the report.
- Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
- Analysis of market-entry and market expansion strategies.
- Competitive strategies by identifying ‘who-stands-where’ in the market.
1. Report Summary
• Current Industry Analysis and Growth Potential Outlook
• Global Point-of-care Diagnostic Market Sales Analysis – Type | Prescription Mode | Technology | End-User ($ Million)
• Point-of-care Diagnostic Market Sales Performance of Top Countries
1.1. Research Methodology
• Primary Research Approach
• Secondary Research Approach
1.2. Market Snapshot
2. Market Overview and Insights
2.1. Scope of the Study
2.2. Analyst Insight & Current Market Trends
2.2.1. Key Point-of-care Diagnostic Industry Trends
2.2.2. Market Recommendations
2.3. Porter's Five Forces Analysis for the Point-of-care Diagnostic Market
2.3.1. Competitive Rivalry
2.3.2. Threat of New Entrants
2.3.3. Bargaining Power of Suppliers
2.3.4. Bargaining Power of Buyers
2.3.5. Threat of Substitutes
3. Market Determinants
3.1. Market Drivers
3.1.1. Drivers For the Global Point-of-care Diagnostic Market: Impact Analysis
3.2. Market Pain Points and Challenges
3.2.1. Restraints For the Global Point-of-care Diagnostic Market: Impact Analysis
3.3. Market Opportunities
4. Competitive Landscape
4.1. Competitive Dashboard – Point-of-care Diagnostic Market Revenue and Share by Manufacturers
• Point-of-care Diagnostic Product Comparison Analysis
• Top Market Player Ranking Matrix
4.2. Key Company Analysis
4.2.1. Abbott Laboratories
4.2.1.1. Overview
4.2.1.2. Product Portfolio
4.2.1.3. Financial Analysis (Subject to Data Availability)
4.2.1.4. SWOT Analysis
4.2.1.5. Business Strategy
4.2.2. Danaher Corp.
4.2.2.1. Overview
4.2.2.2. Product Portfolio
4.2.2.3. Financial Analysis (Subject to Data Availability)
4.2.2.4. SWOT Analysis
4.2.2.5. Business Strategy
4.2.3. F. Hoffmann-La Roche Ltd
4.2.3.1. Overview
4.2.3.2. Product Portfolio
4.2.3.3. Financial Analysis (Subject to Data Availability)
4.2.3.4. SWOT Analysis
4.2.3.5. Business Strategy
4.2.4. Siemens Healthcare Pvt. Ltd.
4.2.4.1. Overview
4.2.4.2. Product Portfolio
4.2.4.3. Financial Analysis (Subject to Data Availability)
4.2.4.4. SWOT Analysis
4.2.4.5. Business Strategy
4.2.5. Thermo Fisher Scientific Inc.
4.2.5.1. Overview
4.2.5.2. Product Portfolio
4.2.5.3. Financial Analysis (Subject to Data Availability)
4.2.5.4. SWOT Analysis
4.2.5.5. Business Strategy
4.3. Top Winning Strategies by Market Players
4.3.1. Merger and Acquisition
4.3.2. Product Launch
4.3.3. Partnership And Collaboration
5. Global Point-of-care Diagnostic Market Sales Analysis by Type ($ Million)
5.1. Glucose Monitoring Kits
5.2. Cardiometabolic Monitoring Kits
5.3. Infectious Disease Testing Kits
5.4. Pregnancy & Fertility Testing Kits
5.5. Tumor/Cancer Markers
5.6. Urinalysis Testing Kits
5.7. Cholesterol Testing Kits
5.8. Hematology Testing
5.9. Others (Coagulation Testing Kits and Fecal Occult Testing Kits)
6. Global Point-of-care Diagnostic Market Sales Analysis by Prescription Mode ($ Million)
6.1. Over-The-Counter Testing
6.2. Prescription-Based Diagnostics
7. Global Point-of-care Diagnostic Market Sales Analysis by Technology ($ Million)
7.1. Lateral Flow Assays
7.2. Dipsticks
7.3. Microfluidics
7.4. Molecular Diagnostics
7.5. Immunoassays
7.6. Biosensors
8. Global Point-of-care Diagnostic Market Sales Analysis by End-User ($ Million)
8.1. Hospitals and Clinics
8.2. Home Care
8.3. Ambulatory Care
8.4. Diagnostic Laboratories
8.5. Pharmacies
9. Regional Analysis
9.1. North American Point-of-care Diagnostic Market Sales Analysis – Type | Prescription Mode | Technology | End-User | Country ($ Million)
• Macroeconomic Factors for North America
9.1.1. United States
9.1.2. Canada
9.2. European Point-of-care Diagnostic Market Sales Analysis – Type | Prescription Mode | Technology | End-User | Country ($ Million)
• Macroeconomic Factors for Europe
9.2.1. UK
9.2.2. Germany
9.2.3. Italy
9.2.4. Spain
9.2.5. France
9.2.6. Russia
9.2.7. Rest of Europe
9.3. Asia-Pacific Point-of-care Diagnostic Market Sales Analysis – Type | Prescription Mode | Technology | End-User | Country ($ Million)
• Macroeconomic Factors for Asia-Pacific
9.3.1. China
9.3.2. Japan
9.3.3. South Korea
9.3.4. India
9.3.5. Australia & New Zealand
9.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Others)
9.3.7. Rest of Asia-Pacific
9.4. Rest of the World Point-of-care Diagnostic Market Sales Analysis – Type | Prescription Mode | Technology | End-User | Country ($ Million)
• Macroeconomic Factors for the Rest of the World
9.4.1. Latin America
9.4.2. Middle East and Africa
10. Company Profiles
10.1. Abbott Laboratories
10.1.1. Quick Facts
10.1.2. Company Overview
10.1.3. Product Portfolio
10.1.4. Business Strategies
10.2. AccuBioTech Co., Ltd.
10.2.1. Quick Facts
10.2.2. Company Overview
10.2.3. Product Portfolio
10.2.4. Business Strategies
10.3. Alpha Laboratories Ltd
10.3.1. Quick Facts
10.3.2. Company Overview
10.3.3. Product Portfolio
10.3.4. Business Strategies
10.4. Becton, Dickinson and Co.
10.4.1. Quick Facts
10.4.2. Company Overview
10.4.3. Product Portfolio
10.4.4. Business Strategies
10.5. Biomeme, Inc.
10.5.1. Quick Facts
10.5.2. Company Overview
10.5.3. Product Portfolio
10.5.4. Business Strategies
10.6. bioMérieux SA
10.6.1. Quick Facts
10.6.2. Company Overview
10.6.3. Product Portfolio
10.6.4. Business Strategies
10.7. Bio-Rad Laboratories, Inc.
10.7.1. Quick Facts
10.7.2. Company Overview
10.7.3. Product Portfolio
10.7.4. Business Strategies
10.8. Chembio Diagnostics, Inc.
10.8.1. Quick Facts
10.8.2. Company Overview
10.8.3. Product Portfolio
10.8.4. Business Strategies
10.9. Danaher Corp.
10.9.1. Quick Facts
10.9.2. Company Overview
10.9.3. Product Portfolio
10.9.4. Business Strategies
10.10. EKF Diagnostics Holdings plc.
10.10.1. Quick Facts
10.10.2. Company Overview
10.10.3. Product Portfolio
10.10.4. Business Strategies
10.11. F. Hoffmann-La Roche Ltd
10.11.1. Quick Facts
10.11.2. Company Overview
10.11.3. Product Portfolio
10.11.4. Business Strategies
10.12. HORIBA Group
10.12.1. Quick Facts
10.12.2. Company Overview
10.12.3. Product Portfolio
10.12.4. Business Strategies
10.13. LumiraDx
10.13.1. Quick Facts
10.13.2. Company Overview
10.13.3. Product Portfolio
10.13.4. Business Strategies
10.14. Nan?mix, Inc.
10.14.1. Quick Facts
10.14.2. Company Overview
10.14.3. Product Portfolio
10.14.4. Business Strategies
10.15. Nova Biomedical
10.15.1. Quick Facts
10.15.2. Company Overview
10.15.3. Product Portfolio
10.15.4. Business Strategies
10.16. PixCell Medical Technologies Ltd.
10.16.1. Quick Facts
10.16.2. Company Overview
10.16.3. Product Portfolio
10.16.4. Business Strategies
10.17. PTS Diagnostics
10.17.1. Quick Facts
10.17.2. Company Overview
10.17.3. Product Portfolio
10.17.4. Business Strategies
10.18. QIAGEN GmbH
10.18.1. Quick Facts
10.18.2. Company Overview
10.18.3. Product Portfolio
10.18.4. Business Strategies
10.19. QuidelOrtho Corp.
10.19.1. Quick Facts
10.19.2. Company Overview
10.19.3. Product Portfolio
10.19.4. Business Strategies
10.20. Sekisui Diagnostics, LLC.
10.20.1. Quick Facts
10.20.2. Company Overview
10.20.3. Product Portfolio
10.20.4. Business Strategies
10.21. Siemens Healthcare Pvt. Ltd.
10.21.1. Quick Facts
10.21.2. Company Overview
10.21.3. Product Portfolio
10.21.4. Business Strategies
10.22. Spectral Medical Inc.
10.22.1. Quick Facts
10.22.2. Company Overview
10.22.3. Product Portfolio
10.22.4. Business Strategies
10.23. Sysmex Europe SE
10.23.1. Quick Facts
10.23.2. Company Overview
10.23.3. Product Portfolio
10.23.4. Business Strategies
10.24. Thermo Fisher Scientific Inc.
10.24.1. Quick Facts
10.24.2. Company Overview
10.24.3. Product Portfolio
10.24.4. Business Strategies
10.25. Trinity Biotech Plc.
10.25.1. Quick Facts
10.25.2. Company Overview
10.25.3. Product Portfolio
10.25.4. Business Strategies
10.26. Werfen
10.26.1. Quick Facts
10.26.2. Company Overview
10.26.3. Product Portfolio
10.26.4. Business Strategies
1. Global Point-of-care Diagnostic Market Research And Analysis By Type, 2024-2035 ($ Million)
2. Global Glucose Monitoring Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
3. Global Cardiometabolic Monitoring Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
4. Global Infectious Disease Testing Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
5. Global Pregnancy & Fertility Testing Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
6. Global Tumor/Cancer Markers Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
7. Global Urinalysis Testing Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
8. Global Cholesterol Testing Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
9. Global Hematology Testing Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
10. Global Other Type Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
11. Global Point-of-care Diagnostic Market Research And Analysis By Prescription Mode, 2024-2035 ($ Million)
12. Global Over-The-Counter Testing Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
13. Global Prescription-Based Diagnostics Market Research And Analysis By Region, 2024-2035 ($ Million)
14. Global Point-of-care Diagnostic Market Research And Analysis By Technology, 2024-2035 ($ Million)
15. Global Point-of-care Diagnostic For Lateral Flow Assays Market Research And Analysis By Region, 2024-2035 ($ Million)
16. Global Point-of-care Diagnostic For Dipsticks Market Research And Analysis By Region, 2024-2035 ($ Million)
17. Global Point-of-care Diagnostic For Microfluidics Market Research And Analysis By Region, 2024-2035 ($ Million)
18. Global Point-of-care Diagnostic For Molecular Diagnostics Market Research And Analysis By Region, 2024-2035 ($ Million)
19. Global Point-of-care Diagnostic For Immunoassays Market Research And Analysis By Region, 2024-2035 ($ Million)
20. Global Point-of-care Diagnostic Flow For Biosensors Market Research And Analysis By Region, 2024-2035 ($ Million)
21. Global Point-of-care Diagnostic Market Research And Analysis By End-User, 2024-2035 ($ Million)
22. Global Point-of-care Diagnostic For Hospitals and Clinics Market Research And Analysis By Region, 2024-2035 ($ Million)
23. Global Point-of-care Diagnostic For Home Care Market Research And Analysis By Region, 2024-2035 ($ Million)
24. Global Point-of-care Diagnostic For Ambulatory Care Market Research And Analysis By Region, 2024-2035 ($ Million)
25. Global Point-of-care Diagnostic For Diagnostic Laboratories Market Research And Analysis By Region, 2024-2035 ($ Million)
26. Global Point-of-care Diagnostic For Pharmacies Market Research And Analysis By Region, 2024-2035 ($ Million)
27. Global Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
28. North American Point-of-care Diagnostic Market Research And Analysis By Country, 2024-2035 ($ Million)
29. North American Point-of-care Diagnostic Market Research And Analysis By Type, 2024-2035 ($ Million)
30. North American Point-of-care Diagnostic Market Research And Analysis By Prescription Mode, 2024-2035 ($ Million)
31. North American Point-of-care Diagnostic Market Research And Analysis By Technology, 2024-2035 ($ Million)
32. North American Point-of-care Diagnostic Market Research And Analysis By End-User, 2024-2035 ($ Million)
33. European Point-of-care Diagnostic Market Research And Analysis By Country, 2024-2035 ($ Million)
34. European Point-of-care Diagnostic Market Research And Analysis By Type, 2024-2035 ($ Million)
35. European Point-of-care Diagnostic Market Research And Analysis By Prescription Mode, 2024-2035 ($ Million)
36. European Point-of-care Diagnostic Market Research And Analysis By Technology, 2024-2035 ($ Million)
37. European Point-of-care Diagnostic Market Research And Analysis By End-User, 2024-2035 ($ Million)
38. Asia-Pacific Point-of-care Diagnostic Market Research And Analysis By Country, 2024-2035 ($ Million)
39. Asia-Pacific Point-of-care Diagnostic Market Research And Analysis By Type, 2024-2035 ($ Million)
40. Asia-Pacific Point-of-care Diagnostic Market Research And Analysis By Prescription Mode, 2024-2035 ($ Million)
41. Asia-Pacific Point-of-care Diagnostic Market Research And Analysis By Technology, 2024-2035 ($ Million)
42. Asia-Pacific Point-of-care Diagnostic Market Research And Analysis By End-User, 2024-2035 ($ Million)
43. Rest Of The World Point-of-care Diagnostic Market Research And Analysis By Region, 2024-2035 ($ Million)
44. Rest Of The World Point-of-care Diagnostic Market Research And Analysis By Type, 2024-2035 ($ Million)
45. Rest Of The World Point-of-care Diagnostic Market Research And Analysis By Prescription Mode, 2024-2035 ($ Million)
46. Rest Of The World Point-of-care Diagnostic Market Research And Analysis By Technology, 2024-2035 ($ Million)
47. Rest Of The World Point-of-care Diagnostic Market Research And Analysis By End-User, 2024-2035 ($ Million)
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FAQS
The size of the Point-of-Care Diagnostics market in 2024 is estimated to be around $44,240 million.
North America holds the largest share in the Point-of-Care Diagnostics market.
Leading players in the Point-of-Care Diagnostics market include Abbott Laboratories, Danaher Corp., F. Hoffmann-La Roche Ltd., Siemens Healthcare Pvt. Ltd., and Thermo Fisher Scientific Inc., among others.
Point-of-Care Diagnostics market is expected to grow at a CAGR of 6.2% from 2025 to 2035.
The Point-of-Care Diagnostics market is driven by rising demand for rapid, accurate testing amid growing chronic diseases and infectious outbreaks.
