Point of Care Diagnostics Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global point of care diagnostics market growth forecasted to transform from USD 49.7 billion in 2023 to USD 77.8 billion by 2028, driven by a CAGR of 9.4%. The growth of this market is attributed to the increasing prevalence of infectious diseases, cardiovascular diseases, and metabolic disorders such as diabetes. Additional factors include technological advancements in rapid tests, approvals of CLIA-waived PoC tests, the growing trend toward healthcare decentralization, and the increasing emphasis by manufacturers on developing affordable and user-friendly home-based rapid tests for various conditions. However, the stringent regulatory approval process for new PoC devices and increasing pricing pressure on PoC device manufacturers are expected to negatively impact the growth of the point-of-care diagnostics market.

Point of Care Diagnostics Market – Global Forecast and Growth Insights to 2028

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Point of Care Diagnostics Market – Global Forecast and Key Opportunities to 2028

e- Estimated; p- Projected

Point of care Diagnostics Market Dynamics to 2028

Driver: Increasing prevalence of infectious diseases globally

POC tests can primarily improve the management of infectious diseases, especially in emerging markets and resource limited settings. According to UNAIDS, approximately 39 million people were suffering from HIV-AIDS globally as of 2022, and an estimated 1.3 million individuals acquired HIV.

In 2022, Tuberculosis ranked as the second leading cause of death globally among single infectious agents following COVID-19. Globally, the newly diagnosed tuberculosis cases reached 7.5 million in 2022 (Source: WHO Global Tuberculosis Report 2023). Point-of-care tests with high sensitivity and specificity enable the rapid diagnosis of infectious diseases, initiating prompt treatment further enhancing patient outcome. The global rise in prevalence of infectious diseases such as malaria, tuberculosis, HIV are likely to boost the demand for point-of-care diagnostics

Restraint: Pricing pressure on PoC Manufacturers

Intense competition in the POC testing market can lead to pricing pressure, Moreover, decrease in reimbursement rates for POC tests from government payers, private insurers, or healthcare reimbursement programs are driving down profit margins for manufacturer significantly impacting the growth of point of care diagnostics market. Healthcare facilities, especially those in areas with limited resources or financial constraints, may have constrained budgets for investing in point-of-care testing equipment and materials, limiting the adoption of point of care testing.

Opportunity: High growth potential of emerging markets

Emerging markets such as China, India, Brazil, and Mexico are expected to offer significant growth opportunities for players operating in the POC diagnostics market. This is primarily due to the high and growing prevalence of infectious and lifestyle diseases in these countries. To meet the increasing demand for POC diagnostics in emerging markets, manufacturers focus on acquiring or entering into agreements and partnerships with regional/domestic players for product distribution and manufacturing. Regulatory policies in the Asia Pacific region are flexible and have less stringent regulations than established markets in North America and Europe. The saturation of mature markets will further compel manufacturers and leading POC testing companies to shift their focus to emerging markets

Challenge: Inadequate standardization with centralized lab methods

POC test results lack alignment with central lab methods due to many pre- and post-analytical errors. Pre-analytical errors for POC testing include unsuitable indications for the performance of the test, inappropriate sampling times and techniques, lack of information about patient conditions, and other factors such as fasting before functional tests or variations in posture/position during similar tests. On the other hand, post-analytical errors include inadequate technical validation, false assignment of results, and errors in data storage.

POC testing is often conducted in emergencies to facilitate clinical decision-making. In several cases, these tests are conducted by nurses or clinical team members, not physicians. These issues can potentially lead to erroneous diagnoses and affect the quality of patient care. Considering such issues, patients & doctors can decide not to opt for POC testing. This is one of the critical challenges to the higher acceptance of POC testing.

Point of Care Diagnostics Market Map & Ecosystem Overview

The Glucose Monitoring Product segment to hold significant share of the global point of care diagnostics industry, by product type, in 2022

Based on the product, point of care diagnostics market is segmented into glucose monitoring products, cardiometabolic monitoring products, COVID-19 testing products, infectious disease testing products, coagulation monitoring products, pregnancy & fertility testing products, hematology testing products, cancer marker testing products, fecal occult testing products, urinalysis testing products, drug-of-abuse testing products, thyroid-stimulating hormone (TSH) testing products, cholesterol testing products, and other products. In 2022, the glucose monitoring testing products segment accounted for the second largest share of the market. The significant rise in the diabetes cases globally, widespread adoption of glucose monitoring kits, and greater awareness of the diabetes care are expected to propel the growth of the segment

By platform, the lateral flow assay segment held the largest share of point of care diagnostics industry

Based on platform, the point of care diagnostics market is segmented into lateral flow assays, immunoassays, microfluidics, dipsticks, and molecular diagnostics. The lateral flow assays segment accounted for the largest share of the market in 2022. Lateral flow assay is more affordable compared to traditional laboratory testing methods, moreover the ease of conducting lateral flow assay makes this technology well suited for healthcare settings with limited resources, enabling rapid testing for various conditions.

By End User, home care settings and self testing of the point of care diagnostics industry to grow at a significant rate from 2023-2028

Based on end user, home care setting and self-testing segment is expected to grow at a significant rate owing to growing awareness about home care, increasing availability of user-friendly and advanced POC diagnostic products, including blood glucose, cholesterol, and pregnancy. Additionally, the COVID 19 pandemic has accelerated the adoption of home care self-testing products, particularly for diagnostic testing and monitoring of infectious diseases. Along with this the rising partnerships, and collaborations among various players to develop novel rapid testing products for home use are likely to contribute towards the rapid growth of the segment

Point of Care Diagnostics Market by Region – Forecast to 2028

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North America to account for the largest share of point of care diagnostics industry during the forecast period.

North America is the expected to be the largest regional market for point of care diagnostics during the forecast period. The presence of a well-established healthcare system, rapid adoption of advanced point of care testing products, increase in the availability of medical reimbursement, favourable government support for the novel product development, and higher user awareness about the presence of point of care testing products are anticipated to support the market growth in the region

As of 2022, Prominent players in the point of care diagnostics market include Abbott Laboratories (US), F. Hoffman-La Roche Ltd. (Switzerland), BD (US), Danaher Corporation (US), Siemens Healthineers (Germany), QuidelOrtho Corporation (US), Chembio Diagnostics, Inc. (US), EKF Diagnostics Holdings plc (UK), among others

Point of Care Diagnostics Market Report Scope and Insights

Point of Care Diagnostics Market Segmentation and Analysis

By Product

• COVID-19 test products
• Glucose Monitoring Products
  • Strips
  • Meters
  • Lancets & Lancing Devices
• Cardiometabolic Monitoring Products
  • Point-of-care and rapid diagnostics Products
  • Blood Gas/Electrolyte Testing Products
  • HbA1c Testing Products
• Infectious Disease Testing Products
  • Influenza Testing Products
  • HIV Testing Products
  • Hepatitis C Testing Products
  • Influenza Testing Products
    • Sexually Transmitted Disease Testing Products
      • Syphilis Testing Products
      • Human Papillomavirus (HPV) Testing Products
      • Chlamydia Trachomatis Testing Products
      • Herpes simplex virus (HSV) Testing Products
    • Healthcare-associated Infection Testing Products
    • Respiratory Infection Testing Products
    • Tuberculosis (TB) Testing Products
    • Clostridium Difficile Infection (CDI) Testing Products
    • Tropical Disease Testing Products
    • Other Infectious Disease Testing Products
• Coagulation Monitoring Products
  • PT/INR Testing
  • ACT/APTT
• Pregnancy & Fertility Testing Products
  • Pregnancy Testing Products
  • Fertility Testing Products
• Tumor/Cancer Marker Testing Products
• Urinalysis Testing Products
• Cholesterol Testing Products
• Hematology Testing Products
• Thyroid Stimulating Hormone (TSH) Testing Products
• Drugs-of-abuse Testing Products
• Fecal Occult Testing Products
• Other POC Products

Note* Other PoC products include multi-assay testing, disease-resistant bacteria testing, vitamin assay testing

By Platform

• Lateral Flow Assays
• Dipsticks
• Microfluidics
• Molecular Diagnostics
  • Polymerase Chain Reaction (PCR)
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Other Molecular Diagnostic Technologies
• Immunoassays

By Mode of Purchase

• Prescription-based Products
• OTC Products

By Sample

• Blood Sample
• Urine Sample
• Nasal and Oropharyngeal Swabs Sample
• Other Samples

Note*Other samples include saliva, sputum, stool, and urethral/genital swabs.

By End User

• Clinical Laboratories
• Ambulatory Care Facilities and Physician Offices
• Pharmacies, retail clinics, & E-comm. Platforms
• Hospitals, Critical Care Centers, Urgent care centers
• Home Care & Self Testing
• Other End Users

Note*Other end users includes rehabilitation centers, sports centers, nursing homes, research institutes, and blood banks.

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • RoAPAC
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East & Africa
  • GCC Countries
  • Rest of Middle East & Africa

Point of Care Diagnostics Market Recent Developments and Insights

• In May 2023, bioMérieux received the US FDA CLIA-waiver for the BIOFIRE SPOTFIRE Respiratory (R) Panel Mini,a second multiplex PCR-based test cleared for use on the BIOFIRE SPOTFIRE System
• In August 2023, BD received the US FDA approval for its BD Respiratory Viral Panel (RVP) for BD MAX System, a single molecular diagnostic combination test that identifies & distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in ~ 2 hours.
• In December 2023, Thermo Fisher Scientific Inc. and Project HOPE, a leading global health and humanitarian organization, partnered to expand the accessibility of HIV testing services offered by Thermo Fisher among HIV Positive Youth in Sub-Saharan Africa.

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