Global Point-of-Care Infectious Disease Diagnostics/Testing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

The global point-of-care (POC) infectious disease diagnostics/testing market is experiencing significant growth driven by the increasing need for quick, accurate, and affordable diagnostics across various diseases. This market is categorized by different types of infectious diseases, such as HIV, Clostridium difficile, HBV, pneumonia, RSV, HPV, influenza, HCV, MRSA, tuberculosis (TB), and drug-resistant TB, along with other infectious diseases. The demand for POC testing is especially high for diseases like HIV and TB, as early diagnosis plays a critical role in improving treatment outcomes and preventing further transmission. The rise in infections, especially in developing regions with limited access to advanced laboratory testing, further bolsters the need for these portable diagnostic solutions.

The technology segment of this market includes lateral flow, agglutination assays, flow-through, and solid-phase methods. Lateral flow devices hold a significant share in the market due to their simplicity, affordability, and rapid results. These devices are widely used in HIV and influenza diagnostics, where timely testing is crucial for effective treatment. Agglutination assays and flow-through systems are also gaining traction for their accuracy and ability to handle a wide range of infectious diseases. Each technology type is selected based on the specific needs of the diagnostic application, such as speed, sensitivity, and cost-effectiveness.

From an application standpoint, the market is segmented into various therapeutic areas, including HIV, tropical diseases, liver diseases, inflammatory diseases, respiratory diseases, hospital-associated infections (HAIs), sexual health disorders, and others. Respiratory diseases, including influenza and pneumonia, are among the leading contributors to market growth due to the frequent outbreaks of seasonal flu and other respiratory infections. Tropical diseases, such as malaria and dengue, are also pushing the demand for POC testing in regions where these infections are endemic. The ability to diagnose liver diseases, inflammatory diseases, and HAIs quickly in clinical settings is driving the adoption of POC solutions in hospitals and clinics.

The end-use segment highlights the key sectors where these diagnostic tests are applied, such as hospitals, clinics, home healthcare, assisted living facilities, and laboratories. Hospitals and clinics remain the largest end-users due to their high patient volumes and the need for immediate diagnostic results. However, there is a growing trend towards home-based testing, especially for diseases like HIV, where patients prefer privacy and convenience. Assisted living healthcare facilities and laboratories also represent significant end-users of POC infectious disease tests, as these environments require rapid diagnosis to manage infections effectively and prevent outbreaks. The expanding application of POC testing in various settings further indicates the increasing preference for decentralized, accessible healthcare solutions.

Global Point-of-Care Infectious Disease Diagnostics/Testing Segment Analysis

In this report, the Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by Disease, Technology, Application, End Use and Geography.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market, Segmentation by Disease

The Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by Disease into HIV POC, Clostridium difficile POC, HBV POC, Pneumonia or Streptococcus associated infections, Respiratory syncytial virus (RSV) POC, HPV POC, Influenza/Flu POC, HCV POC, MRSA POC, TB and drug-resistant TB POC, HSV POC and Other infectious disease POC.

The global point-of-care infectious disease diagnostics/testing market encompasses a diverse array of diseases, each with its unique challenges and opportunities. HIV point-of-care testing remains a critical focus, given the global burden of HIV/AIDS and the importance of early detection for timely intervention and prevention of transmission. The emergence of drug-resistant strains of tuberculosis (TB) highlights the need for rapid and accurate TB testing at the point of care, enabling prompt initiation of appropriate treatment and containment measures.

Clostridium difficile infection poses significant healthcare-associated challenges, with point-of-care testing offering rapid diagnosis to guide infection control measures and optimize antibiotic stewardship. Hepatitis B virus (HBV) and hepatitis C virus (HCV) point-of-care testing play crucial roles in screening, diagnosis, and monitoring of these viral infections, especially in resource-limited settings where laboratory infrastructure may be lacking.

Respiratory infections, including pneumonia and streptococcus-associated infections, represent a substantial burden on healthcare systems globally. Point-of-care testing for respiratory syncytial virus (RSV) and influenza/flu enables rapid diagnosis and appropriate management, particularly during seasonal outbreaks and pandemics. Point-of-care testing for methicillin-resistant Staphylococcus aureus (MRSA) and herpes simplex virus (HSV) offers timely identification of these pathogens, guiding infection control measures and improving patient outcomes.

In addition to these targeted diseases, the market for point-of-care infectious disease testing encompasses a broader range of pathogens, including human papillomavirus (HPV) and other emerging infectious diseases. The continued evolution of diagnostic technologies, coupled with expanding access to point-of-care testing in diverse clinical settings, holds promise for enhancing disease surveillance, improving patient care, and mitigating the spread of infectious diseases on a global scale.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market, Segmentation by Technology

The Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by Technology into Lateral Flow, Agglutination Assays, Flow-Through, and Solid Phase.

The global point-of-care infectious disease diagnostics/testing market is segmented by technology into several categories, each offering unique advantages for diagnosing infections quickly and accurately. Lateral flow tests, one of the most widely used technologies, are known for their ease of use and rapid results. These tests work by detecting specific antigens or antibodies in a patient's sample, providing results within minutes. Lateral flow devices are commonly used for detecting infections like COVID-19, malaria, and influenza, offering a cost-effective solution for diagnostics in both clinical and remote settings.

Agglutination assays, another key segment, involve the clumping or agglutination of antigens in the presence of antibodies. This technology is often used for detecting bacterial and viral infections, as well as for blood typing. It is highly reliable and offers rapid results, which makes it ideal for point-of-care settings where quick diagnostic decisions are necessary. These assays can be easily adapted for a variety of infectious diseases and have proven particularly useful in developing regions due to their simplicity and low cost.

Flow-through and solid phase technologies further enhance the point-of-care diagnostics landscape by offering high sensitivity and specificity for detecting infections. Flow-through assays work similarly to lateral flow tests but involve a sample being passed through a membrane with immobilized reagents, typically used for more complex infectious diseases. Solid-phase testing, on the other hand, involves immobilizing antigens or antibodies on a solid surface, and these tests are often used in clinical laboratories for detailed analysis. Both these technologies contribute to the expansion of the point-of-care infectious disease diagnostics market by addressing a wide range of diagnostic needs in different healthcare environments.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market, Segmentation by Application

The Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by Application into HIV, Tropical Disease, Liver Disease, Inflammatory Disease, Respiratory Disease, Hospital Associated Infections (HAIs), Sexual Health Disorders, and Others.

The global point-of-care infectious disease diagnostics/testing market has been segmented based on application, which includes various disease categories that require quick and accurate diagnosis at the point of care. HIV testing remains one of the prominent applications in this market, as rapid detection is essential for early diagnosis and management of the disease. Point-of-care testing for HIV is widely used in both developed and developing regions due to its ability to provide results quickly, enabling timely interventions to reduce transmission and improve patient outcomes.

Tropical diseases, which are prevalent in regions with hot climates and poor healthcare infrastructure, also account for a significant portion of the market. Point-of-care testing for tropical diseases like malaria, dengue, and Zika virus is increasingly in demand as these tests can provide rapid and reliable results, which are crucial for prompt treatment. Similarly, liver diseases, such as hepatitis B and C, are major contributors to the market, with point-of-care diagnostic tools offering faster results than traditional laboratory methods, enabling better patient management and monitoring.

Respiratory diseases, including pneumonia and tuberculosis, are key applications for point-of-care diagnostics, especially in areas with high rates of respiratory infections. Hospital-associated infections (HAIs) also play a crucial role in this market segment, as rapid testing can help prevent the spread of infections within healthcare settings. Inflammatory diseases and sexual health disorders are other important segments, where early diagnosis through point-of-care tests facilitates better treatment and reduces the spread of infectious diseases. The "Others" category includes a variety of other infectious diseases, for which point-of-care diagnostics are increasingly being developed.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market, Segmentation by End Use

The Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by End Use into Hospitals, Clinics, Home, Assisted Living Healthcare Facilities, Laboratories and Others.

The global point-of-care infectious disease diagnostics/testing market is characterized by diverse end uses, each playing a crucial role in the accessibility and delivery of diagnostic services. Hospitals, as the frontline of healthcare delivery, represent a significant end-use segment for point-of-care testing. Rapid diagnostic capabilities in hospitals enable timely identification of infectious diseases, facilitating prompt treatment decisions and infection control measures, thus contributing to better patient outcomes and reduced healthcare-associated infections.

Clinics serve as primary points of contact for patients seeking healthcare services, making them pivotal in the delivery of point-of-care infectious disease testing. Point-of-care diagnostics in clinics offer convenience, efficiency, and rapid results, enhancing patient satisfaction and enabling healthcare providers to make informed decisions regarding patient management and disease surveillance. Clinics in remote or resource-limited areas benefit greatly from portable and easy-to-use point-of-care testing devices, improving access to timely diagnosis and treatment.

The home setting is increasingly recognized as a valuable domain for point-of-care infectious disease testing, empowering individuals to monitor their health status conveniently and proactively. Home-based testing kits for infectious diseases enable early detection, self-management, and timely intervention, particularly for chronic conditions and contagious illnesses. Moreover, the COVID-19 pandemic has accelerated the adoption of home testing solutions, driving innovation and market growth in this segment.

Assisted living healthcare facilities cater to the unique needs of elderly or disabled individuals, where point-of-care infectious disease testing plays a vital role in infection prevention and control. These facilities rely on rapid and reliable diagnostic tools to monitor residents' health status, detect outbreaks, and implement appropriate infection control measures promptly. Point-of-care testing in assisted living facilities enhances resident safety, quality of care, and overall operational efficiency, highlighting its importance in geriatric healthcare management.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market, Segmentation by Geography

In this report, the Global Point-of-Care Infectious Disease Diagnostics/Testing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Point-of-Care Infectious Disease Diagnostics/Testing Market Share (%), by Geographical Region, 2024

The global point-of-care infectious disease diagnostics/testing market is poised for significant growth across various regions from 2020 to 2030. In North America, robust healthcare infrastructure, technological advancements, and increasing investments in infectious disease management drive market expansion. The region witnesses high adoption rates of point-of-care testing due to the need for rapid diagnosis, particularly during outbreaks such as COVID-19. Favorable regulatory policies and reimbursement frameworks further bolster market growth, with the United States leading in terms of market share and innovation.

In Europe, stringent regulatory standards, coupled with growing awareness about infectious disease control, fuel the demand for point-of-care diagnostics. Countries like Germany, France, and the United Kingdom are key contributors to market growth, driven by investments in research and development, as well as initiatives to strengthen healthcare systems' pandemic preparedness. Collaborations between academic institutions, healthcare providers, and industry players stimulate innovation and market penetration across the region.

The Asia Pacific region presents vast opportunities for market expansion, supported by rapid economic development, increasing healthcare expenditure, and rising awareness about the importance of early disease detection. Countries like China, India, and Japan are witnessing a surge in demand for point-of-care testing solutions, driven by the need to address infectious disease outbreaks and improve healthcare access in remote and underserved areas. Furthermore, partnerships between multinational corporations and local manufacturers contribute to technology transfer and market growth in the region.

In the Middle East and Africa (MEA) and Latin America, the adoption of point-of-care infectious disease diagnostics/testing is gaining traction, albeit at a slower pace compared to other regions. Factors such as limited healthcare infrastructure, resource constraints, and socioeconomic challenges pose barriers to market growth. Increasing investments in healthcare infrastructure, government initiatives to combat infectious diseases, and the growing role of public-private partnerships are expected to drive market expansion in these regions over the forecast period. Overall, the global point-of-care infectious disease diagnostics/testing market is set to witness significant growth across diverse geographical regions, driven by technological advancements, rising disease burden, and efforts to improve healthcare access and outcomes.

This report provides an in depth analysis of various factors that impact the dynamics of Global Point-of-Care Infectious Disease Diagnostics/Testing Market. These factors include; Market Drivers, Restraints and Opportunities.

Drivers, Restraints and Opportunity

Drivers:

• Technological Advancements
• Increasing Awareness and Healthcare Expenditure

• Rapid Spread of Pandemics and Epidemics-The rapid spread of pandemics and epidemics significantly influences the global point-of-care infectious disease diagnostics/testing market. Infectious disease outbreaks, such as the COVID-19 pandemic, Ebola, and Zika, underscore the critical need for decentralized testing capabilities. Point-of-care diagnostics play a pivotal role in facilitating early detection, containment, and mitigation efforts during public health crises. By providing rapid and accessible testing at the point of need, these diagnostic tools empower healthcare providers to quickly identify infected individuals, implement appropriate infection control measures, and curb disease transmission.

  The urgency of pandemic response highlights the importance of point-of-care testing in complementing traditional laboratory-based diagnostic methods. Unlike centralized testing facilities, point-of-care tests offer immediate results, enabling timely decision-making and intervention in emergency situations. This capability is especially crucial in containing outbreaks and preventing further spread of infectious diseases within communities, healthcare facilities, and high-risk settings. As a result, there is a growing demand for portable, user-friendly point-of-care diagnostic devices capable of delivering accurate results within minutes to hours.

  The dynamic nature of pandemics and epidemics necessitates continuous innovation and adaptation in point-of-care testing technologies. Market players are investing in research and development to enhance the sensitivity, specificity, and multiplexing capabilities of diagnostic platforms. Advances in molecular diagnostics, immunoassays, and biosensors are driving the development of next-generation point-of-care tests capable of detecting a wide range of pathogens with high accuracy and throughput. These innovations enable healthcare providers to rapidly screen for infectious agents, monitor disease trends, and tailor public health interventions accordingly.

  In conclusion, the rapid spread of pandemics and epidemics serves as a catalyst for the growth and evolution of the global point-of-care infectious disease diagnostics/testing market. As the world grapples with emerging infectious threats, the demand for decentralized testing solutions will continue to escalate. By leveraging technological advancements and strategic partnerships, stakeholders in the healthcare ecosystem can strengthen pandemic preparedness, improve outbreak response capabilities, and ultimately safeguard public health on a global scale.

Restraints:

• Limited Sensitivity and Specificity
• Infrastructure and Resource Constraints

• Reimbursement Issues-Reimbursement issues present a significant challenge for the global point-of-care infectious disease diagnostics/testing market. In many healthcare systems, reimbursement policies for these tests vary widely, creating uncertainty for manufacturers and healthcare providers alike. The lack of standardized reimbursement mechanisms can hinder the widespread adoption of point-of-care tests, particularly in settings where financial resources are limited.Reimbursement may not always cover the full cost of testing, leading to concerns about the financial viability of implementing these technologies, especially in resource-constrained environments.

  The complexity of reimbursement procedures and the administrative burden associated with claims processing can deter healthcare providers from offering point-of-care testing services. In some cases, reimbursement rates may not adequately reflect the value of rapid diagnostics in terms of improved patient outcomes, reduced transmission of infectious diseases, and healthcare cost savings. This discrepancy between reimbursement rates and the perceived value of point-of-care testing may impede investment in these technologies and limit their availability to patients who could benefit from them.

  Another challenge related to reimbursement is the lack of clear guidelines or criteria for coverage of specific point-of-care tests. Different payers may have disparate policies regarding which tests are eligible for reimbursement and under what circumstances, leading to inconsistencies in access and coverage across different patient populations and geographic regions. The evolving nature of infectious diseases and diagnostic technologies may outpace the development of reimbursement policies, creating further uncertainty for stakeholders in the market.

  Addressing reimbursement issues requires collaboration among policymakers, payers, healthcare providers, and manufacturers to develop transparent and sustainable reimbursement frameworks that incentivize the adoption of point-of-care infectious disease diagnostics. This may involve conducting health economic studies to demonstrate the value of these tests in terms of improved patient outcomes, reduced healthcare costs, and public health benefits. Efforts to streamline reimbursement processes, standardize coding and billing practices, and improve communication and education about reimbursement policies can help alleviate barriers to market growth and facilitate broader access to point-of-care testing solutions.

Opportunities:

• Limited Sensitivity and Specificity
• Infrastructure and Resource Constraints

• Reimbursement Issues-Reimbursement issues present significant challenges for the global point-of-care infectious disease diagnostics/testing market. In many healthcare systems, the reimbursement policies and coverage for point-of-care tests vary widely, creating uncertainty for manufacturers and healthcare providers alike. Limited or inconsistent reimbursement can deter investment in point-of-care technologies and hinder their widespread adoption, particularly in regions where financial resources are constrained. Without adequate reimbursement, the affordability and accessibility of these tests may be compromised, limiting their utility in underserved communities and resource-limited settings.

  The lack of standardized reimbursement mechanisms for point-of-care testing can impede market penetration and slow down the pace of innovation. Manufacturers may hesitate to develop new products or expand existing offerings without clear pathways for reimbursement approval and coverage. This uncertainty may also deter healthcare providers from integrating point-of-care tests into routine clinical practice, despite their potential benefits in improving patient outcomes and reducing healthcare costs through timely diagnosis and treatment.

  Reimbursement issues also pose challenges for demonstrating the cost-effectiveness of point-of-care testing compared to traditional laboratory-based methods. While point-of-care tests may offer advantages such as rapid results, decentralized testing, and reduced patient wait times, their higher upfront costs and lack of reimbursement parity with laboratory tests can create barriers to adoption. Without robust economic evidence supporting their value proposition, point-of-care tests may struggle to gain acceptance from payers, clinicians, and healthcare administrators, limiting their market growth and scalability.

  Addressing reimbursement issues requires collaboration between industry stakeholders, regulatory agencies, and healthcare payers to develop transparent and equitable reimbursement policies that incentivize investment in point-of-care technologies. Strategic partnerships and advocacy efforts can help raise awareness about the clinical and economic benefits of point-of-care testing, driving policy changes and reimbursement reforms to promote greater access and utilization of these essential diagnostic tools in the fight against infectious diseases.

Key players in Global Point-of-Care Infectious Disease Diagnostics/Testing Market include:

• Abbott
• Bio-Rad Laboratories, Inc
• Quest Diagnostics Inc
• Thermo Fisher Scientific, Inc
• Hoffmann-La Roche Ltd
• Danaher
• Siemens Healthineers
• Sight Diagnostics Ltd
• bioMrieux SA
• Cardinal Health

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis