Global Point of Care (POC) Diagnostics/Testing Market Size (2023 – 2030)

In 2022, the Global Point Of Care (POC) Diagnostics/Testing Market was valued at USD 43.2 Billion and is projected to reach a market size of USD 98.13 Billion by 2030. Over the forecast period of 2023-2030, the market is projected to grow at a CAGR of 10.8%.

Industry Overview:

The point-of-care (POC) diagnostics/testing are medical devices used to get an instant result in the investigation (diagnosis & monitoring) of various diseases, including cancer, diabetes, cardiac diseases, and others. Factors such as the increasing prevalence of respiratory diseases (such as COVID-19 and influenza) around the world, increase in the geriatric population, sedentary lifestyles, and improved access to point-of-care devices through online platforms,  are driving the growth of the point-of-care diagnostics market. Point-of-care diagnostics/testing is gaining wide acceptance by different patients worldwide, as the results can be achieved in less time, owing to the use of nano diagnostics, micro fluids, and chips. The growing number of regulatory approvals for novel immunoassay techniques, the rising usage of home-based POC devices, and technological advancements are anticipated to fuel the market growth, over the forecast period.

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

The COVID-19 pandemic has accelerated the global demand for diagnostic kits to rapidly detect the disease. Market players are focusing on increasing the supply of tests worldwide as many countries are facing a severe shortage of laboratory-based molecular assays. The need for speedy diagnostic test results has made point-of-care testing an important diagnostic tool. The rapid growth in the cases of COVID-19 and pressure on governments to improve patient management have boosted the demand for rapid antigen testing kits that can be used in point-of-care settings. COVID-19 rapid kits are to detect COVID-19. Thus, an increase in the prevalence of COVID-19 has surged the demand for point-of-care diagnostics kits. The increase in approvals of at-home POC test kits for detecting COVID-19 has significantly contributed to the growth of the market. Abbott's BinaxNOW rapid test was recently approved by U.S. FDA for at-home use.

MARKET DRIVERS:

The growing geriatric population and high prevalence of infectious diseases across the globe are driving the growth of the market:

The elderly population is rapidly increasing. According to the World Health Organization, the number of people aged 65 and up is estimated to increase by around 1.5 billion by 2050. Cancer, high blood pressure, diabetes, and blood sugar levels are some of the health issues that the geriatric population faces. The growing geriatric population is likely to drive the growth of the point of care diagnostics market in the coming years. POC tests improve the management of infectious diseases, especially in developing economies where access to timely medical care is a challenge with poor healthcare infrastructure. The rising prevalence of infectious diseases and inadequate healthcare infrastructural facilities in developing nations is anticipated to drive the adoption of POC testing.

Growing focus on microfluidics platforms, technological advancements, and emerging markets are some factors likely to fuel the growth of the Point of Care Diagnostics Market:

The efficiency of point of care diagnostics has revolutionized patient care. With advancements in the field of microfluidics, point of care technologies has also improved. Methods in microfabrication and microfluidics have evolved in the last few years that allow POC devices to be fabricated at low cost, generate rapid results, are easy to use, and are portable. Emerging markets such as China, India, and Brazil are likely to offer significant growth opportunities for players operating in the point of care diagnostics market. This is attributable to the high prevalence of infectious and lifestyle diseases in emerging countries. Manufacturers are focusing on acquiring or entering into agreements and partnerships with regional players for product distribution and manufacturing to meet the increasing demand for POC diagnostics in emerging markets.

MARKET RESTRAINTS:

The stringent regulatory framework can hamper the development of new point of care diagnostics test kits and thus, negatively affect the market growth:

The stringent regulatory policies have affected the development of new point of care diagnostics test kits, despite their improved accuracy and capabilities. The diagnostic test is approved by the Food and Drug Administration (FDA) in the U.S., for which it must go through a lengthy regulatory process. Businesses developing new products need to get strict laws passed. The stringent regulatory authorities’ enforcement of regulations on a certain point of care diagnostics testing kits threatens the development of novel diagnostic kits.

Pricing pressure owing to reimbursement cuts and budget constraints can hamper the Point of Care (POC) Diagnostics Market growth:

The pricing pressure caused by reimbursement and insufficient budgets impacts the growth of the global point of care diagnostics market. According to the US government healthcare reform bill (2013), manufacturers must pay a heavy 2.3% annual excise tax on medical devices. In France, the cost of patient care is rolled out into one prospective payment under the Diagnosis Related Group (DRG) system, which makes reimbursement a negligible factor. Expenditure on general-use medical devices is stagnating owing to a decrease in the number of healthcare products eligible for reimbursement. Manufacturers thus find it challenging to support prices and prevent margin erosion as competition intensifies.

POINT OF CARE POC) DIAGNOSTICS/TESTING MARKET REPORT COVERAGE:

This research report on the global Pont of Care (POC) Diagnostics/Testing Market has been segmented and sub-segmented based on product, mode of prescription, platform, end-user, and region.

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

• 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

Based on the Product, the Point of Care (POC) Diagnostics/Testing Market is bifurcated into Blood Glucose Monitoring Testing, Cardiac-Metabolism Monitoring Testing, Infectious Disease Testing, Coagulation Monitoring, Coagulation Monitoring, Tumor/Cancer Markers Testing, Cholesterol Testing, Urinalysis Testing, Hematology Testing, Drugs of Abuse Testing, Fecal Occult Testing, and Other POC Testing. The Blood Glucose Monitoring Testing segment holds the largest share in the market. The demand from diabetic patients to monitor their glucose levels regularly has prompted the adoption of point of care diagnostics among diabetic patients. The growing prevalence of diabetes around the world is anticipated to drive the segment growth. Blood glucose monitoring devices offer better glucose control and enable accurate treatment decisions. POC glucose monitoring kits are for analyzing results which are less invasive as compared to lab tests. These kits can also be easily used by diabetes patients to monitor their glucose levels and prevent complications.

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

• Prescription-based Testing

• Over-the-counter (OTC) Testing

Based on the Mode of Prescription, the Point of Care (POC) Diagnostics/Testing Market is bifurcated into prescription-based Testing and Over-the-counter (OTC) Testing. The Prescription-based point-of-care testing segment is growing rapidly as it is most frequently used in healthcare facilities and prescribed by healthcare professionals. The Over-the-counter (OTC) testing segment is anticipated to witness the fastest growth during the projected period owing to the cost reduction, quality improvement, convenience to patients and clinicians, and growing use of novel technologies such as nanotechnology, electrical impedance, microfluidics, reflectance, and time-resolved fluorescence, which allows the miniaturization of devices and the proliferation of point-of-care (POC) testing.

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

• Lateral Flow Assays

• Microfluidics

• Dipsticks

• Immunoassays

• Molecular Diagnostics

Based on the Platform, the Point of Care (POC) Diagnostics/Testing Market is bifurcated into Lateral Flow Assays, Microfluidics, Dipsticks, Immunoassays, and Molecular Diagnostics. The Lateral Flow Assay segment dominates the global POC diagnostics market owing to its clinical utility and affordability. Moreover, this technology continuously evolving as POC testing demands higher performance. Lateral flow assays (LFA) are simple devices used for detecting the presence or absence of target analytes in samples. The Point of Care diagnostics market for Lateral flow assays has grown significantly In the past few years, owing to the increasing adoption of Lateral flow assays testing products in-home care settings. Companies are focusing on the development of innovative Lateral flow assay-based Point of Care devices. Molecular Diagnostics is rapidly gaining traction which is driving the segment.

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

• Clinical Laboratories

• Ambulatory Care Facilities and Physician Offices

• Pharmacies, retail clinics, & E-comm. Platforms

• Hospitals

• Home Care & Self Testing

• Other End Users

Based on End-User, the Point of Care (POC) Diagnostics/Testing Market is bifurcated into Clinical Laboratories, Ambulatory Care Facilities and Physician Offices, Pharmacies, retail clinics, & E-comm. Platforms, Hospitals, Home Care & Self Testing, and Other End Users. The Hospital segment accounts for a significant share in the Point of Care (POC) Diagnostics/Testing Market owing to the rising prevalence of chronic diseases. Home care/self-testing holds a major share of the global point of care diagnostics market, owing to the growing inclination for at-home healthcare, rising focus on continuous and remote monitoring, and growing need for rapid tests in home.

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

• North America

• Europe

• Asia-Pacific

• Rest of the World

Geographically, the North American Point of Care (POC) Diagnostics/Testing Market dominates the global market and is anticipated to grow significantly during the forecast period. This is attributed to

growing geriatric population, rising chronic diseases, and favorable government legislation and initiatives aimed at improving the healthcare infrastructure.

The European Point of Care (POC) Diagnostics/Testing Market is anticipated to grow significantly during the forecast period owing to the high prevalence of chronic diseases, integration of automated techniques in healthcare, and rise in new product launches in the region.

The Point of Care (POC) Diagnostics/Testing Market in the Asia Pacific has registered the highest growth rate and is anticipated to grow rapidly in developing countries particularly China, Japan, and India. This growth is attributed to the increasing demand for efficient and effective diagnostics, the growing prevalence of chronic diseases, and rising disposable income.

The Point of Care (POC) Diagnostics/Testing Market in Latin America, the Middle East, and Africa is anticipated to register high growth during the forecast period. Latin American point of care diagnostic market is likely to register high growth during the forecast period owing to supportive government efforts in increasing awareness about the early detection of diseases, increasing healthcare expenditures, and increasing the number of hospitals and clinical diagnostic laboratories.

Major Key Players in the Market:

Companies like

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 is the leading market player in point-of-care diagnostics owing to continuous investments in R&D, a strong focus on strengthening its brand presence, broad customer base, and strong geographical foothold. Abbott is also engaged in the development of novel products and improving its existing product line and processes. Furthermore, the POC diagnostics business is witnessing expansion in domestic and emerging markets through acquisitions and collaborations with other players.

Notable happenings in the Global Point of Care (POC) Diagnostics/Testing Market in the recent past:

• Product Launch - In January 2022, Roche announced the launch of its Cobas Pulse System in countries accepting the CE Mark. Cobas Pulse System is a connected point-of-care solution for professional blood glucose management.

• Investment - In April 2021, FIND, the global alliance for diagnostics, invested USD 21 million in Biomeme, Bioneer, Qlife, and SD Biosensor, to promote the development, manufacturing, and launch of affordable point-of-care molecular diagnostic platforms to detect multiple pathogens that cause diseases 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 was granted Emergency Use Authorization (EUA) by the FDA to conduct 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 invested 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 updated its collaboration with Inotrem S.A. for the development of a rapid blood test for septic shock. The collaboration is targeted toward developing a companion diagnostic test to measure sTREM-1 levels in the bloodstream.

• Product Launch - In March 2020, Nova Biomedical announced the launch of the Stat EMS Basic blood testing system to be used in emergency and ambulance care in CE-regulated countries.