Global Point of Care (POC) Diagnostics/Testing Market Size (2024 – 2030)

As of 2023, the Global Point Of Care (POC) Diagnostics/Testing Market achieved a valuation of USD 47.87 Billion and is anticipated to ascend to USD 98.13 Billion by 2030. Projections indicate a compound annual growth rate (CAGR) of 10.8% during the forecast period spanning 2024-2030.

Industry Overview:

Point-of-care (POC) diagnostics/testing refers to medical devices utilized to promptly obtain results for the assessment (diagnosis & monitoring) of various illnesses, encompassing cancer, diabetes, cardiac diseases, among others. Factors propelling market expansion comprise the escalating prevalence of respiratory ailments (like COVID-19 and influenza) globally, burgeoning geriatric populace, sedentary lifestyles, and enhanced accessibility to point-of-care devices via online platforms. Point-of-care diagnostics/testing garners widespread acceptance among diverse patient demographics globally due to its rapid results facilitated by nano diagnostics, microfluids, and chips. Regulatory approvals for novel immunoassay techniques, augmented usage of home-based POC devices, and technological strides are poised to propel market growth throughout the forecast period.

Impact of COVID-19 Outbreak on Point of Care (POC) Diagnostics/Testing Market:

The COVID-19 pandemic has spurred global demand for diagnostic kits for swift disease detection. Market stakeholders prioritize augmenting test supply worldwide due to acute shortages of laboratory-based molecular assays in numerous countries. The imperative for expedited diagnostic outcomes has elevated the significance of point-of-care testing as a diagnostic modality. The surge in COVID-19 cases and governmental pressures to enhance patient management have heightened demand for rapid antigen testing kits amenable to point-of-care settings. The prevalence of COVID-19 directly correlates with increased demand for point-of-care diagnostics kits. Regulatory approvals for at-home POC test kits targeting COVID-19 have substantially contributed to market expansion, exemplified by the recent approval of Abbott's BinaxNOW rapid test for at-home utilization by the U.S. FDA.

Market Drivers:

The burgeoning geriatric population and heightened prevalence of infectious diseases globally drive Point of Care (POC) Diagnostics Market growth:

The elderly demographic is expanding rapidly, as per the World Health Organization projections, estimating a rise of approximately 1.5 billion individuals aged 65 and above by 2050. Geriatric health concerns encompass cancer, hypertension, diabetes, and glucose imbalances, accentuating the role of point-of-care diagnostics in managing these conditions. POC tests ameliorate infectious disease management, particularly in developing nations grappling with inadequate healthcare infrastructure and access to timely medical interventions. Escalating prevalence of infectious diseases and deficient healthcare infrastructure in emerging economies are anticipated to bolster POC testing adoption rates.

Growing Emphasis on Microfluidics Platforms, Technological Advancements, and Emerging Markets Drive Point of Care Diagnostics Market Growth:

Point-of-care diagnostics' efficacy has transformed patient care paradigms, paralleled by advancements in microfluidics technology. Noteworthy progress in microfabrication and microfluidics has facilitated the development of cost-effective, rapid, user-friendly, and portable POC devices. Emerging markets such as China, India, and Brazil offer lucrative growth prospects owing to high incidences of infectious and lifestyle-related ailments. Manufacturers prioritize partnerships and agreements with regional entities for product distribution and manufacturing to cater to escalating POC diagnostics demand in emerging markets.

Market Restraints:

Stringent Regulatory Frameworks May Impede Point of Care Diagnostics Test Kit Development and Market Growth:

Stringent regulatory policies pose challenges to the development of new POC diagnostics test kits, despite their enhanced accuracy and capabilities. Approval by regulatory bodies like the U.S. Food and Drug Administration (FDA) entails a protracted regulatory process, hindering product innovation. Adherence to rigorous regulatory standards impedes the development of novel diagnostic kits, deterring market growth potential.

Pricing Pressures Stemming from Reimbursement Cuts and Budget Constraints May Dampen Point of Care (POC) Diagnostics Market Growth:

Pricing pressures, driven by reimbursement cuts and constrained budgets, exert adverse effects on the global point of care diagnostics market. Legislative measures such as the U.S. government's healthcare reform bill of 2013 levy a substantial 2.3% annual excise tax on medical devices, exacerbating pricing challenges. Healthcare systems like France's Diagnosis Related Group (DRG) system consolidate patient care costs into a single prospective payment, minimizing reimbursement considerations. Concomitant with a dwindling number of healthcare products eligible for reimbursement, expenditure on general-use medical devices stagnates, intensifying price competition and margin erosion for manufacturers.

Point of Care (POC) Diagnostics/Testing Market – By Product Categories

• Blood Glucose Monitoring Testing
  • Strips
  • Meters
  • Lancets & Lancing Devices
• Cardiac-Metabolism Monitoring Testing
  • Cardiac Marker
  • HbA1c Testing
  • Blood Gas/Electrolytes Testing
• Infectious Disease Testing
  • Influenza Testing
  • HIV Testing
  • Hepatitis C Testing
  • Healthcare-Associated Infection (HAI) Testing
  • Respiratory Infection Testing
  • Sexually Transmitted Disease (STD) Testing
  • Tropical Disease Testing
  • Other Infectious Disease Testing
• Coagulation Monitoring
  • Prothrombin Time (PT/INR) Testing
  • Activated Clotting Time (ACT/aPTT) Testing
• Pregnancy and Fertility Testing Products
  • Pregnancy Testing
  • Fertility Testing
• Tumor/Cancer Markers Testing
• Cholesterol Testing
• Urinalysis Testing
• Hematology Testing
• Drugs of Abuse Testing
• Fecal Occult Testing
• Other POC Testing

The Point of Care (POC) Diagnostics/Testing Market is categorized by its diverse product offerings. These include Blood Glucose Monitoring Testing, Cardiac-Metabolism Monitoring Testing, Infectious Disease Testing, Coagulation Monitoring, Pregnancy and Fertility Testing, Tumor/Cancer Markers Testing, Cholesterol Testing, Urinalysis Testing, Hematology Testing, Drugs of Abuse Testing, Fecal Occult Testing, and Other POC Testing. Among these, Blood Glucose Monitoring Testing commands the largest market share. The surge in demand for point of care diagnostics among diabetic patients, driven by the necessity to monitor glucose levels regularly, propels the growth of this segment. Moreover, the rising global prevalence of diabetes further fuels this expansion. These monitoring devices offer enhanced glucose control and facilitate precise treatment decisions. Additionally, they provide less invasive analysis compared to lab tests, enabling diabetes patients to conveniently monitor their glucose levels and prevent complications.

Point of Care (POC) Diagnostics/Testing Market – By Prescription Modes

• Prescription-based Testing
• Over-the-counter (OTC) Testing

The Point of Care (POC) Diagnostics/Testing Market is segmented based on Prescription Modes into Prescription-based Testing and Over-the-counter (OTC) Testing. Prescription-based testing, predominantly utilized in healthcare facilities and prescribed by healthcare professionals, is experiencing rapid growth. Conversely, Over-the-counter (OTC) testing is projected to witness the fastest expansion during the forecast period. This growth is attributed to factors such as cost reduction, enhanced quality, convenience to patients and clinicians, and the increasing adoption of novel technologies like nanotechnology, electrical impedance, microfluidics, reflectance, and time-resolved fluorescence, which enable device miniaturization and the proliferation of point-of-care (POC) testing.

Point of Care (POC) Diagnostics/Testing Market – By Testing Platforms

• Lateral Flow Assays
• Microfluidics
• Dipsticks
• Immunoassays
• Molecular Diagnostics

The Point of Care (POC) Diagnostics/Testing Market's platform classification includes Lateral Flow Assays, Microfluidics, Dipsticks, Immunoassays, and Molecular Diagnostics. Lateral Flow Assays dominate this market due to their clinical utility and cost-effectiveness. Furthermore, technological advancements continually enhance the performance of lateral flow assays, meeting the evolving demands of POC testing. These assays are simple devices used to detect the presence or absence of target analytes in samples. The market for lateral flow assays in POC diagnostics has witnessed significant growth, especially in home care settings. Manufacturers are focusing on developing innovative lateral flow assay-based POC devices. Additionally, Molecular Diagnostics is gaining rapid traction, further propelling this segment's growth.

Point of Care (POC) Diagnostics/Testing Market - By End Users

• Clinical Laboratories
• Ambulatory Care Facilities and Physician Offices
• Pharmacies, Retail Clinics, & E-commerce Platforms
• Hospitals
• Home Care & Self Testing
• Other End Users

The Point of Care (POC) Diagnostics/Testing Market's end-user segmentation includes Clinical Laboratories, Ambulatory Care Facilities and Physician Offices, Pharmacies, Retail Clinics, & E-commerce Platforms, Hospitals, Home Care & Self Testing, and Other End Users. Hospitals hold a significant share in the market due to the escalating prevalence of chronic diseases. Meanwhile, Home Care & Self Testing commands a substantial portion of the global POC diagnostics market, driven by the increasing preference for at-home healthcare, growing emphasis on continuous and remote monitoring, and the rising demand for rapid tests at home.

Point of Care (POC) Diagnostics/Testing Market - By Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Geographically, the North American Point of Care (POC) Diagnostics/Testing Market dominates, poised for substantial growth during the forecast period. This dominance is attributed to factors such as the growing geriatric population, rising chronic diseases, and favorable government initiatives aimed at enhancing healthcare infrastructure. The European market is also expected to witness significant growth due to the high prevalence of chronic diseases, integration of automated techniques in healthcare, and the introduction of new products. Additionally, the Asia Pacific market, particularly in countries like China, Japan, and India, is experiencing rapid growth owing to increasing demand for efficient diagnostics, rising chronic disease prevalence, and growing disposable income. The Latin American, Middle Eastern, and African markets are forecasted to register high growth, supported by government efforts to increase disease awareness, rising healthcare expenditures, and the expansion of hospitals and clinical diagnostic laboratories.

Key Players in the Market:

Leading companies in the Point of Care (POC) Diagnostics/Testing Market include:

1. Abbott Laboratories (US)
2. Thermo Fisher Scientific (US)
3. Siemens Healthineers AG (Germany)
4. Nova Biomedical (US)
5. Quidel Corporation (US)
6. F. Hoffman-La Roche Ltd. (Switzerland)
7. Danaher Corporation (US)
8. Becton, Dickinson and Company (US)
9. Chembio Diagnostics (US)
10. EKF Diagnostics (UK)
11. Trinity Biotech plc (Ireland)
12. Instrumentation Laboratory (a Werfen Company) (US)
13. PTS Diagnostics (US)
14. Sekisui Diagnostics (US)
15. bioMérieux S.A. (France)

Abbott Laboratories leads the market owing to continuous R&D investments, strong brand presence, broad customer base, and geographical reach. Abbott focuses on developing novel products and enhancing existing ones. Additionally, it expands its domestic and emerging markets through acquisitions and collaborations.

Recent Developments in the Global Point of Care (POC) Diagnostics/Testing Market:

• Product Launch: In January 2022, Roche introduced the Cobas Pulse System in CE Mark-accepting countries, offering a connected point-of-care solution for professional blood glucose management.
• Investment: In April 2021, FIND invested USD 21 million in Biomeme, Bioneer, Qlife, and SD Biosensor to foster the development, manufacturing, and launch of affordable point-of-care molecular diagnostic platforms for detecting multiple pathogens, including COVID-19.
• Acquisition: In June 2021, bioMérieux signed a co-exclusive distribution agreement with Specific Diagnostics for the SPECIFIC REVEAL Rapid AST system in Europe.
• Product Approval: In October 2021, Thermo Fisher Scientific received FDA Emergency Use Authorization for conducting COVID-19 tests using the new saliva sample collection method with the SpectrumDNA SDNA-1000 collection device.
• Investment: In November 2021, the US Department of Health and Human Services allocated USD 650 million from the American Rescue Plan to increase rapid molecular point-of-care diagnostic tests for SARS-CoV-2.
• Collaboration: In January 2020, Roche Diagnostics expanded its collaboration with Inotrem S.A. for the development of a rapid blood test for septic shock, aimed at creating a companion diagnostic test to measure sTREM-1 levels in the bloodstream.
• Product Launch: In March 2020, Nova Biomedical launched the Stat EMS Basic blood testing system for emergency and ambulance care in CE-regulated countries.