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Point-of-Care Diagnostics Market Forecasts to 2032 – Global Analysis By Product (Glucose Monitoring Kits, Infectious Disease Testing Kits, Pregnancy and Fertility Testing Kits and Other Products), Sample Type, Mode of Testing, Technology, Application, End

Publisher Stratistics Market Research Consulting
Published Nov 10, 2025
Length 200 Pages
SKU # SMR20542331

Description

According to Stratistics MRC, the Global Point-of-Care Diagnostics Market is accounted for $50.6 billion in 2025 and is expected to reach $75.0 billion by 2032 growing at a CAGR of 5.8% during the forecast period. Point-of-care diagnostics refers to medical testing conducted at or near the site of patient care, providing rapid results without the need for centralized laboratory facilities. These tests are designed for convenience, speed, and accessibility, enabling healthcare providers to make immediate clinical decisions. Common applications include glucose monitoring, infectious disease detection, pregnancy testing, and cardiac markers. POC diagnostics utilize portable devices and easy-to-use kits, often requiring minimal training. They are essential in emergency rooms, clinics, remote areas, and home settings. By reducing turnaround time and improving patient outcomes, point-of-care diagnostics play a vital role in modern, decentralized healthcare delivery.

Market Dynamics:

Driver:

Growing Demand for Rapid and Early Diagnosis

The increasing need for rapid and early diagnosis is a major driver of the point-of-care diagnostics market. These tests enable immediate clinical decisions, especially in emergency settings, rural areas, and home care. With rising cases of infectious and chronic diseases, healthcare providers rely on fast, accurate results to initiate timely treatment. Point-of-care solutions reduce turnaround time, improve patient outcomes, and support decentralized healthcare delivery. Their convenience and speed make them indispensable tools in modern medical practice across global health systems.

Restraint:

Regulatory and Compliance Challenges

Regulatory and compliance challenges pose a significant restraint to the point-of-care diagnostics market. Devices must meet stringent safety, accuracy, and quality standards across different regions, which can delay product approvals and market entry. Navigating complex regulatory frameworks requires substantial investment in testing, documentation, and certification. These hurdles are especially burdensome for startups and small manufacturers. Additionally, evolving regulations around data privacy and diagnostic accuracy further complicate compliance.

Opportunity:

Advancements in technology

Technological advancements offer a powerful opportunity for growth in the market. Innovations in biosensors, microfluidics, and portable analyzers are enhancing test speed, accuracy, and usability. Integration with digital platforms and mobile apps enables real-time data sharing and remote monitoring. These breakthroughs support personalized medicine, telehealth, and decentralized care models. As demand for user-friendly diagnostic tools rises, technology-driven solutions are transforming healthcare delivery. Continued R&D investment will unlock new applications and improve accessibility in both developed and emerging markets.

Threat:

Cost and Reimbursement Issues

Cost and reimbursement issues represent a key threat to the point-of-care diagnostics market. High upfront costs for devices and consumables can deter adoption, especially in low-resource settings. Inconsistent reimbursement policies across regions create uncertainty for providers and manufacturers. Without clear coverage, patients may face out-of-pocket expenses, limiting access to essential diagnostics. These financial barriers hinder market expansion and innovation. Addressing affordability and establishing supportive reimbursement frameworks are critical to ensuring widespread adoption.

Covid-19 Impact:

The COVID-19 pandemic significantly accelerated the adoption of point-of-care diagnostics. The urgent need for rapid testing and decentralized healthcare solutions highlighted the value of portable, easy-to-use diagnostic tools. POC tests played a crucial role in screening, monitoring, and managing outbreaks, especially in remote and high-risk areas. The crisis also spurred innovation in biosensors and mobile diagnostics, reshaping public health strategies. As healthcare systems adapt to post-pandemic realities, point-of-care diagnostics continue to support resilience, preparedness, and patient-centered care across global markets.

The biosensors segment is expected to be the largest during the forecast period

The biosensors segment is expected to account for the largest market share during the forecast period, due to its central role in enabling rapid, accurate point-of-care testing. Biosensors detect biological markers in real time, supporting applications in infectious disease detection, glucose monitoring, and cardiac diagnostics. Their integration into portable devices enhances usability and accessibility. As demand for fast, reliable diagnostics grows, biosensors remain at the forefront of innovation. Continued advancements in sensitivity, miniaturization, and connectivity will further solidify their dominance in the POC diagnostics landscape.

The diabetes segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the diabetes segment is predicted to witness the highest growth rate, due to global rise in diabetes prevalence and the need for continuous glucose monitoring. Point-of-care diagnostics offer convenient, real-time blood sugar testing, empowering patients to manage their condition effectively. Advances in biosensors and wearable devices are enhancing accuracy and ease of use. As healthcare systems prioritize chronic disease management, demand for accessible, personalized diabetes diagnostics continues to surge. This segment’s rapid growth reflects its critical role in preventive and long-term care.

Region with largest share:

During the forecast period, the Asia Pacific region is expected to hold the largest market share, due to rising healthcare demand, expanding middle-class populations, and government initiatives to improve medical access. Countries like China, India, and Japan are investing in decentralized healthcare infrastructure and affordable diagnostic solutions. The region’s strong manufacturing base and increasing adoption of mobile health technologies further support market expansion. Asia Pacific’s dynamic healthcare landscape positions it as a leader in point-of-care innovation and deployment.

Region with highest CAGR:

Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to advanced healthcare infrastructure, strong R&D investment, and high demand for rapid diagnostics. The region’s focus on personalized medicine, telehealth, and chronic disease management supports widespread adoption of POC technologies. Regulatory support and reimbursement frameworks also encourage innovation and market entry. With leading manufacturers and early adopters, North America continues to set the pace for technological advancement and market growth in point-of-care diagnostics.

Key players in the market

Some of the key players in Point-of-Care Diagnostics Market include Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Danaher Corporation, Becton, Dickinson and Company (BD), QuidelOrtho Corporation, Thermo Fisher Scientific, bioMérieux SA, Bio-Rad Laboratories, Hologic, Inc., LumiraDx Ltd., SD Biosensor, Nova Biomedical Corporation, Trinity Biotech plc, and Werfen.

Key Developments:

In June 2025, Abbott and MSD Pharmaceuticals (Merck & Co.) have forged a strategic distribution partnership in India for MSD’s oral anti-diabetic drugs Sitagliptin, its fixed-dose combination with metformin and the extended-release version marketed under the names Januvia, Janumet and Janumet XR.

In March 2025, Cadrenal Therapeutics and Abbott have entered collaboration for the “TECH-LVAD” trial to evaluate Tecarfarin in patients using the HeartMate 3 left ventricular assist device (LVAD).

Products Covered:
• Glucose Monitoring Kits
• Infectious Disease Testing Kits
• Pregnancy and Fertility Testing Kits
• Cardiometabolic Monitoring Kits
• Hematology Testing Kits
• Coagulation Testing Kits
• Urinalysis Testing Kits
• Drug-of-Abuse Testing Kits
• Cancer/Tumor Markers Testing Kits
• Other Products

Sample Types Covered:
• Blood
• Urine
• Saliva
• Nasal/Throat Swabs
• Other Sample Types

Modes of Testing Covered:
• Prescription-Based Testing
• Over-the-Counter (OTC) Testing

Technologies Covered:
• Lateral Flow Assays
• Dipsticks
• Microfluidics
• Molecular Diagnostics
• Immunoassays
• Biosensors
• Other Technologies

Applications Covered:
• Infectious Diseases
• Diabetes
• Cardiovascular Diseases
• Cancer
• Pregnancy and Fertility
• Respiratory Diseases
• Other Applications

End Users Covered:
• Hospitals and Critical Care Centers
• Clinics and Physician Offices
• Home Care Settings
• Ambulatory Care Settings
• Diagnostic Laboratories
• Research and Academic Institutes

Regions Covered:
• North AmericaUSCanadaMexico
• EuropeGermanyUKItalyFranceSpainRest of Europe
• Asia PacificJapan China India Australia New ZealandSouth KoreaRest of Asia Pacific
• South AmericaArgentinaBrazilChileRest of South America
• Middle East & Africa Saudi ArabiaUAEQatarSouth AfricaRest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

200 Pages
1 Executive Summary
2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions
3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 Technology Analysis
3.8 Application Analysis
3.9 End User Analysis
3.10 Emerging Markets
3.11 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global Point-of-Care Diagnostics Market, By Product
5.1 Introduction
5.2 Glucose Monitoring Kits
5.3 Infectious Disease Testing Kits
5.4 Pregnancy and Fertility Testing Kits
5.5 Cardiometabolic Monitoring Kits
5.6 Hematology Testing Kits
5.7 Coagulation Testing Kits
5.8 Urinalysis Testing Kits
5.9 Drug-of-Abuse Testing Kits
5.10 Cancer/Tumor Markers Testing Kits
5.11 Other Products
6 Global Point-of-Care Diagnostics Market, By Sample Type
6.1 Introduction
6.2 Blood
6.3 Urine
6.4 Saliva
6.5 Nasal/Throat Swabs
6.6 Other Sample Types
7 Global Point-of-Care Diagnostics Market, By Mode of Testing
7.1 Introduction
7.2 Prescription-Based Testing
7.3 Over-the-Counter (OTC) Testing
8 Global Point-of-Care Diagnostics Market, By Technology
8.1 Introduction
8.2 Lateral Flow Assays
8.3 Dipsticks
8.4 Microfluidics
8.5 Molecular Diagnostics
8.6 Immunoassays
8.7 Biosensors
8.8 Other Technologies
9 Global Point-of-Care Diagnostics Market, By Application
9.1 Introduction
9.2 Infectious Diseases
9.3 Diabetes
9.4 Cardiovascular Diseases
9.5 Cancer
9.6 Pregnancy and Fertility
9.7 Respiratory Diseases
9.8 Other Applications
10 Global Point-of-Care Diagnostics Market, By End User
10.1 Introduction
10.2 Hospitals and Critical Care Centers
10.3 Clinics and Physician Offices
10.4 Home Care Settings
10.5 Ambulatory Care Settings
10.6 Diagnostic Laboratories
10.7 Research and Academic Institutes
11 Global Point-of-Care Diagnostics Market, By Geography
11.1 Introduction
11.2 North America
11.2.1 US
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 Italy
11.3.4 France
11.3.5 Spain
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.2 China
11.4.3 India
11.4.4 Australia
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.1 Argentina
11.5.2 Brazil
11.5.3 Chile
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.2 UAE
11.6.3 Qatar
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.4 Expansions
12.5 Other Key Strategies
13 Company Profiling
13.1 Abbott Laboratories
13.2 F. Hoffmann-La Roche Ltd.
13.3 Siemens Healthineers
13.4 Danaher Corporation
13.5 Becton, Dickinson and Company (BD)
13.6 QuidelOrtho Corporation
13.7 Thermo Fisher Scientific
13.8 bioMérieux SA
13.9 Bio-Rad Laboratories
13.10 Hologic, Inc.
13.11 LumiraDx Ltd.
13.12 SD Biosensor
13.13 Nova Biomedical Corporation
13.14 Trinity Biotech plc
13.15 Werfen
List of Tables
Table 1 Global Point-of-Care Diagnostics Market Outlook, By Region (2024-2032) ($MN)
Table 2 Global Point-of-Care Diagnostics Market Outlook, By Product (2024-2032) ($MN)
Table 3 Global Point-of-Care Diagnostics Market Outlook, By Glucose Monitoring Kits (2024-2032) ($MN)
Table 4 Global Point-of-Care Diagnostics Market Outlook, By Infectious Disease Testing Kits (2024-2032) ($MN)
Table 5 Global Point-of-Care Diagnostics Market Outlook, By Pregnancy and Fertility Testing Kits (2024-2032) ($MN)
Table 6 Global Point-of-Care Diagnostics Market Outlook, By Cardiometabolic Monitoring Kits (2024-2032) ($MN)
Table 7 Global Point-of-Care Diagnostics Market Outlook, By Hematology Testing Kits (2024-2032) ($MN)
Table 8 Global Point-of-Care Diagnostics Market Outlook, By Coagulation Testing Kits (2024-2032) ($MN)
Table 9 Global Point-of-Care Diagnostics Market Outlook, By Urinalysis Testing Kits (2024-2032) ($MN)
Table 10 Global Point-of-Care Diagnostics Market Outlook, By Drug-of-Abuse Testing Kits (2024-2032) ($MN)
Table 11 Global Point-of-Care Diagnostics Market Outlook, By Cancer/Tumor Markers Testing Kits (2024-2032) ($MN)
Table 12 Global Point-of-Care Diagnostics Market Outlook, By Other Products (2024-2032) ($MN)
Table 13 Global Point-of-Care Diagnostics Market Outlook, By Sample Type (2024-2032) ($MN)
Table 14 Global Point-of-Care Diagnostics Market Outlook, By Blood (2024-2032) ($MN)
Table 15 Global Point-of-Care Diagnostics Market Outlook, By Urine (2024-2032) ($MN)
Table 16 Global Point-of-Care Diagnostics Market Outlook, By Saliva (2024-2032) ($MN)
Table 17 Global Point-of-Care Diagnostics Market Outlook, By Nasal/Throat Swabs (2024-2032) ($MN)
Table 18 Global Point-of-Care Diagnostics Market Outlook, By Other Sample Types (2024-2032) ($MN)
Table 19 Global Point-of-Care Diagnostics Market Outlook, By Mode of Testing (2024-2032) ($MN)
Table 20 Global Point-of-Care Diagnostics Market Outlook, By Prescription-Based Testing (2024-2032) ($MN)
Table 21 Global Point-of-Care Diagnostics Market Outlook, By Over-the-Counter (OTC) Testing (2024-2032) ($MN)
Table 22 Global Point-of-Care Diagnostics Market Outlook, By Technology (2024-2032) ($MN)
Table 23 Global Point-of-Care Diagnostics Market Outlook, By Lateral Flow Assays (2024-2032) ($MN)
Table 24 Global Point-of-Care Diagnostics Market Outlook, By Dipsticks (2024-2032) ($MN)
Table 25 Global Point-of-Care Diagnostics Market Outlook, By Microfluidics (2024-2032) ($MN)
Table 26 Global Point-of-Care Diagnostics Market Outlook, By Molecular Diagnostics (2024-2032) ($MN)
Table 27 Global Point-of-Care Diagnostics Market Outlook, By Immunoassays (2024-2032) ($MN)
Table 28 Global Point-of-Care Diagnostics Market Outlook, By Biosensors (2024-2032) ($MN)
Table 29 Global Point-of-Care Diagnostics Market Outlook, By Other Technologies (2024-2032) ($MN)
Table 30 Global Point-of-Care Diagnostics Market Outlook, By Application (2024-2032) ($MN)
Table 31 Global Point-of-Care Diagnostics Market Outlook, By Infectious Diseases (2024-2032) ($MN)
Table 32 Global Point-of-Care Diagnostics Market Outlook, By Diabetes (2024-2032) ($MN)
Table 33 Global Point-of-Care Diagnostics Market Outlook, By Cardiovascular Diseases (2024-2032) ($MN)
Table 34 Global Point-of-Care Diagnostics Market Outlook, By Cancer (2024-2032) ($MN)
Table 35 Global Point-of-Care Diagnostics Market Outlook, By Pregnancy and Fertility (2024-2032) ($MN)
Table 36 Global Point-of-Care Diagnostics Market Outlook, By Respiratory Diseases (2024-2032) ($MN)
Table 37 Global Point-of-Care Diagnostics Market Outlook, By Other Applications (2024-2032) ($MN)
Table 38 Global Point-of-Care Diagnostics Market Outlook, By End User (2024-2032) ($MN)
Table 39 Global Point-of-Care Diagnostics Market Outlook, By Hospitals and Critical Care Centers (2024-2032) ($MN)
Table 40 Global Point-of-Care Diagnostics Market Outlook, By Clinics and Physician Offices (2024-2032) ($MN)
Table 41 Global Point-of-Care Diagnostics Market Outlook, By Home Care Settings (2024-2032) ($MN)
Table 42 Global Point-of-Care Diagnostics Market Outlook, By Ambulatory Care Settings (2024-2032) ($MN)
Table 43 Global Point-of-Care Diagnostics Market Outlook, By Diagnostic Laboratories (2024-2032) ($MN)
Table 44 Global Point-of-Care Diagnostics Market Outlook, By Research and Academic Institutes (2024-2032) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

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