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Point of Care Diagnostics/Testing Market Research Report - Global Forecast till 2027

Point of Care Diagnostics/Testing Market: By Product (Glucose Monitoring, Cardiometabolic Monitoring, Infectious Disease Testing, Coagulation Monitoring, Pregnancy & Fertility Testing, Hematology Testing, Cancer/Tumor Marker Testing, Urinalysis Testing, Cholesterol, Drugs-of-Abuse Testing), By End User (Hospitals & Clinics, Diagnostic Centers, Homecare/Self Testing), By Mode of Purchase (OTC, Prescription-based), By Platform (Immunoassays, Molecular Diagnostics, Dipsticks), and Region (North America, Europe, Asia-Pacific, Rest of the W...

ID: MRFR/HC/9161-HCR | August 2021 | Region: Global | 120 pages

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Market Forecast


The global point of care diagnostics/testing market is expected to cross ~USD 36,740.3 million by 2027 at a CAGR of ~11.6% during the forecast period of 2021-2027.


Market Overview:


Point of care diagnostics/testing is a health analysis that is carried out near the patient and does not include any laboratory setting. Point of Care (POC) testing is also called near-patient testing, bedside testing, mobile testing, remote testing, and rapid diagnosis. The procedure is used to diagnose infectious diseases in sites with limited healthcare infrastructure. POC testing offers instant diagnostic results minimizing the number of patient visits, increasing diagnosis efficiency, and enabling timely treatment. In addition, it streamlines the testing process for the healthcare personnel and provides effective results. The POC testing devices are utilized to carry out diagnostic tests such as blood glucose level tests, levels of blood gases, analysis of electrolytes and enzymes, and tests for signs of infection. These devices run on different principles, including Lateral-Flow Immunochromatographic Assay (LFIA), molecular, and biochemical. Furthermore, portability, convenience, connectivity, speed, and result assurance areaugmenting the demand for POC testing products.


With an increasing number of chronic disorderssuch as diabetes across the globe and a limited number of healthcare facilities in the developing economies, the introduction of portable POC devices supporting government policies is augmenting the POC diagnostics/testing market. Moreover, the market players are offering digital and wireless POC solutions to increase the efficiency and accuracy of the diagnosis. The new era POCs are connected with smartphones and display the analysis and test results on the connected device. Additionally, this advancement has allowed the medical practitioners and the patients to manage the diagnosed data and maintain the records in an electrical format. These factors are driving the demand for POC diagnostic/testing products throughout the globe.


COVID-19 Analysis


The pandemic outbreak ceased the operations of all the sectors throughout the globe. The healthcare industry was hit hard during the initial phase of the lockdown. Medical stocks were piled up in large numbers, and the number of the produced goods rose as the supply chain within and across borders was highly affected due to the implementation of the safety guidelines. However, after the decline in the number of affected cases, the regulatory authorities allowed the limited mobility and manufacturing of the essential products. The relaxation in the guidelines accelerated the demand for healthcare products supporting the point of care diagnostics/testing market.


During the pandemic, the market players invested huge amounts in the development of rapid tests to diagnose COVID-19. According to WHO, in September 2020, the industry players partnered to develop 120 million economic antigen-based rapid diagnostic POC tests for developing countries. Bill & Melinda Gates Foundation (US), SD BioSensor Inc. (South Korea), and Abbott Laboratories (US) signed an agreement to offer the POC test products for a maximum price of USD 5. The Global Fund allotted USD 50 million to enable low- and middle-income countries (LMICs)to buy the diagnostic test product. Moreover, in September 2020 FDA authorized the POC antibody test for COVID-19 that will allow people to understand their health status and let them know whether the virus has infected them or not. Furthermore, the regulatory authorities updated their guidelines related to the SARS-CoV-2 pointof care and rapid testing. These supportive factors propelled the market growth and are expected to augment in the forecast period.


Market Dynamics


Drivers


  • Increasing demand for COVID-19 POC test kits


Increasing cases of coronavirus across the globe have augmented the demand for self-diagnosing kits and devices. Restricted mobility has accelerated the demand for POCs for diagnosing different variants of coronavirus. In addition, international healthcare authorities such as WHO)have shared guidelines related to the COVID-POCs to increase the self-diagnosis of the disease, further preventing the spread of the fatal virus. Moreover, a few market players are launching new products to gain a competitive edge over their competitors. For instance, in March 2020,Abbott Laboratories (US) launched a molecular pointofcare test to detect coronavirus within 5 minutes. The company delivered 50,000 tests every day. Moreover, the increasing population diagnosed with chronic diseases is driving the POC diagnostic/testing market.



  • Risingnumber of chronic disease cases across the globe

  • Growing demand for AI integrated POCs for real-time diagnostics


Market Restraints


  • Stringent regulatory policies


The healthcare regulation varies regionally, which is one of the major challenges faced by device manufacturers to deploy their devices in compliance with the regional authorities. The multi-layered regulations established by the international governing authorities such as FDA and CLIA are restraining the market growth of the POC manufacturers and creating a regulatory barrier in the promotion and sales of their products. In addition, the healthcare device manufacturers have to submit the performance data of their products stating the pros and cons of the product on the tested individuals. These authorities verify the accessibility and challenges of the POCrelated to the product administration. These actors are hindering the market growth of the POC diagnostics/testing market across the globe.



  • Technology Analysis


Point of care testing is gaining importance due to the efficient and accurate diagnostic results. The POC testing products are integrated with new technologies such as biosensors and artificial intelligence that offer real-time remote monitoring. The introduction of biosensors in the POC testing devices increases the potential of rapid medical diagnosis. The biosensors are available specifically as chip-based biosensors and paper-based biosensors with the ability to detect antibodies, antigens, or nucleic acids using samples such as blood, saliva, and sputum. Moreover, the integration of artificial intelligence technology in POC testing devices aims to decrease the testing time and increase the accuracy of the tests.

Additionally, the deployment of AI technology will store the test results for further reference. The device aims to analyze the results and suggest the preventivemeasures that the patients should adopt to maintain their physical and mental health. These technologies are driving the point of care diagnostics/testing market and are projected to propagate rapidly in the forecast timeline.


Segment Overview


By Product



  • Glucose Monitoring: It is a type of device in which glucose concentrationin the blood is measuredusing a lancet, meter, or any other device.

  • Cardiometabolic Monitoring: It is a type of monitoring device in which risk related to cardiovascular functions such as blood pressure, blood gas,blood fat, LDL (low-density lipoprotein) levels, etc., is monitored.

  • Infectious Disease Testing: It is a type of device which detects disorders caused by organisms such as viruses, bacteria, and fungi.

  • Coagulation Monitoring: It is a type of device in which blood clotting ability is tested. It will provide significant analysis to the doctors about the proper deployment of the clotting factor in the bleeding area.

  • Pregnancy & Fertility Testing: It is a type of device that tests the ability to conceive naturally and the presence of any kind of sexually transmitted diseases in both men and women.

  • Hematology Testing:These devices carry out blood tests to evaluate complete blood count, protein levels, infection, inflammation, blood-clotting disorders, anemia, and leukemia.

  • Cancer/Tumor Marker Testing:It is a device in which tumor markers in the blood, tissue, urine, and other body fluids are monitored. The device tracks the protein and other substances that are formed in response to the tumor cells.

  • Urinalysis Testing: This device diagnoses urinary tract infections, detects kidney disorders, diabetes levels, liver problems, and other metabolic functions.

  • Cholesterol: It is a type of device that measures high-density and low-density proteins and certain fats in the blood.

  • Drugs-of-Abuse Testing: It is a type of device that measures illegal substances for non-medical reasons in urine, saliva, blood, hair, and sweat.


By End User


  • Hospitals & Clinics Hospitals & Clinics are the organizations that offer medical and surgical treatment to the wounded.

  • Diagnostic Centers It is a place where diagnostic services are offered to the general public and medical practitioners.

  • Homecare/Self Testing It is healthcare support offered by the professional caregiver for health services to patients in their homes.


By Mode of Purchase


  • OTC Testing Products It is a type of test that does not require a prescription and isindependent of healthcare settings.

  • Prescription-based testing products It is a type of test that is carried out based on the prescription by the doctor.


By Platform


  • Immunoassays It is a platformused to measure particular proteins and supplementary substances through their antigen and antibody properties.

  • Molecular Diagnostics It is a platform used to identify disease using molecules such as DNA, RNA, tissue, fluid, and proteins.

  • Dipsticks It is a chemical integrated sensitive strip of paper used to detect glucose, protein, and other components in urine.


Regional Analysis

North America


Increasing demand for remote diagnostics is driving the North American point of care diagnostics/testing market
North America held the largest point of care diagnostics/testing market share in 2020, owing to the increasing number of market players across the region, acquisition of the market players by the healthcare giants, and supportive government policies. The healthcare product providers are involved in the merger and acquisition of the existing market players to expand their product availability across the region. For instance, in January 2021, Heska Corporation (US) acquired Lacuna Diagnostics (US), a company that provides digital cytology point of care and telemedicine service. This acquisition enables the company to expand its product pipeline. Moreover, the market players are adopting business strategies such as the launch of new products, R&D activities, and collaborative product development for business growth.

Asia-Pacific


  • Advancement in healthcare infrastructure is fueling the Asia-Pacific point of care diagnostics/testing market

  • The Asia-Pacific point of care diagnostics/testing market is projected to be the fastest-growing regional market due to limited availability of the healthcare staff, diversified manufacturing facilities, changing demographics, and shifting consumer healthcare expectations. Moreover, other factors supporting the point of care diagnostics/testing market include reassuring government guidelines, significant funding by industry players, and innovation of technically advanced products.


Competitive Landscape


  • Siemens (Germany) is one of the prominent players in the point of care testing market. The company offers a wide range of products to detect medical conditions such as acute respiratory distress, acute kidney injury, sepsis/septic shock, and acute respiratory failure. Under the blood gas systems, the company offers products such as EPOC blood analysis system with the NXS host, Rapidlab 1200 systems, rapidpoint 500e blood gas system, and blood gas syringes and capillaries. In addition, under the diabetes testing equipment, the company provides a DCA vantage analyzer, DCA HbA1c reagent kit, and DCA microalbumin/creatinine urine test kit. Moreover, the CLINITEK analyzer and urine chemistry analyzer are the urinalysis testing products offered by the company.

  • The industry players are consistently evolving with the changing healthcare needs. These market competitors are adopting various business strategies to augment their market growth. The companies are capitalizing on the new technologies and are advancing their R&D facilities to develop new products, further driving the point of care diagnostics/testing market. Additionally, the industry players are involved in contractual agreements, acquisitions and mergers, product innovations, increasing investments, and partnering with other regional or local players to expand their global footprint.


List of Key Companies Covered in this Report:


  • Abbott Laboratories (US)

  • Siemens Healthineers GmbH (Germany)

  • Chembio Diagnostics, Inc.(US)

  • Hoffmann-La Roche Ltd (Switzerland)

  • Johnson & Johnson Services, Inc. (US)

  • Becton, Dickinson and Company (US)

  • Danaher Corporation (US)

  • PTS Diagnostics (US)

  • Nova Biomedical (US)

  • QuidelCorporation (US)

  • Sekisui Diagnostics (US)

  • Trinity Biotech (Ireland)

  • , Ltd.(China)

  • Instrumentation Laboratory Company (Werfen) (US)

  • EKF Diagnostics Holdings plc (UK)


Recent Developments


  • In June 2021,DCN Dx(US) acquired the pointofcare diagnostics development company PortaScience Inc. (US). This acquisition will expand the point of care product portfolio of the company.

  • In April 2021,the Indian Institute of Technology Kharagpur (India), an Indian engineering institute,launched a nucleic acid-based pointof care diagnostic devicefor COVID-19 diagnosis.

  • In April 2021,LumiraDx (US), a next-generation point of care diagnostics testing company,announced its merger with CA Healthcare Acquisition (CAHC) (US)in a deal worth USD 5 billion.

  • In March 2021, MatMaCorp (US) launched MYRTA, a handheld real-time POCPCR device for molecular diagnostics.

  • In March 2020, Abbott(US) launched the fastest available molecular pointofcare test to detect the coronavirus in less than 5 minutes.


Report Overview


  • The study covers the existing short-term and long-term market effects andhelps decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter’s Five Forces, value chain, and impact of COVID on the market.


Scope of the Report & Segmentation

By Product



  • Glucose Monitoring

    • Strips

    • Meters

    • Lancets



  • Cardiometabolic Monitoring

    • Cardiac Marker Testing Products

    • Blood Gas/Electrolyte Testing Products

    • HbA1c Testing Products



  • Infectious Disease Testing

    • HIV Testing  

    • Respiratory Infection Testing

    • Hepatitis Testing

    • Sexually Transmitted Disease Testing

    • Others



  • Coagulation Monitoring

    • PT/INR Testing

    • ACT/APTT Testing



  • Pregnancy & Fertility Testing

  • Hematology Testing

  • Cancer/Tumor Marker Testing

  • Urinalysis Testing

  • Cholesterol

  • Drugs-of-Abuse Testing

  • Others


By End User


  • Hospitals & Clinics

  • Diagnostic Centers

  • Homecare/Self Testing

  • Others


By Mode of Purchase


  • OTC Testing Products

  • Prescription-based testing products


By Platform


  • Immunoassays

  • Molecular Diagnostics

  • Dipsticks

  • Others



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