Point-of-Care Diagnostics Market

Point-of-Care Diagnostics Market by Testing (Glucose, Lipids, HbA1c, HCV, HIV, Influenza, Urinalysis, Hematology, Cancer, Pregnancy, PT/INR), Platform (Lateral Flow, Immunoassay), Mode (Prescription, OTC), End-User - Global Forecast to 2022

Report Code: MD 2702 Oct, 2019, by marketsandmarkets.com

[226 Pages Report] The global Point-of-Care Diagnostics market is projected to reach USD 38.13 Billion by 2022 from USD 23.71 Billion in 2017, at a CAGR of 10.0% during the forecast period. Factors such as high prevalence of infectious diseases in developing countries, increasing incidence of target diseases, and rising preference for Home Healthcare across the globe are increasing the adoption of POC diagnostics products globally.

Market Dynamics

High prevalence of infectious diseases in developing countries

Point-of-care is a rapid diagnostic test used for the testing of various types of diseases, including infectious diseases. These tests are commonly used for the testing of HIV, syphilis, and tuberculosis. A rapid point-of-care HIV test enables physicians to provide results and HIV status of the patient during the same visit. It does not require a pre-test and post-test counseling of the patient as done during traditional laboratory analysis.

POC tests have a high potential to improve the management of infectious diseases, especially in developing countries where access to timely medical care is a challenge and healthcare infrastructure is antiquated and sparse. Due to the increasing prevalence of various types of infectious diseases in developing countries, there has been an increase in demand for POC infectious disease testing products. Mentioned below are some important statistics in this regard.

  • According to AVERT, in 2016, there were around 230,000 people living with HIV in the Middle East and North Africa (MENA). The MENA region is one of the only two regions across the globe in which HIV-related deaths continue to rise (Source: UNAIDS Data 2017).
  • In 2015, around 25.6 million people were suffering from HIV in the Sub-Saharan African region (Source: UNAIDS).
  • In 2016, the number of people infected by HIV in the Asia Pacific region was approximately 5.1 million (Source: UNAIDS Data 2017).
  • According to the WHO, India has the highest burden of tuberculosis, with an estimated incidence of 2.79 million cases in 2016.
  • In 2015, around 4.74 million new cases of tuberculosis were reported in Southeast Asia and 800,000 people died due to TB infection in this region (Source: WHO).
  • According to the National Influenza Policy 2017, each year around 10,000 deaths and 40,000 hospitalizations are caused due to influenza in South Africa.
  • China has a high burden of influenza infections. The annual influenza-associated excess mortality was 18.0 and 11.3 deaths per 100,000 population in Northern and Southern cities, respectively.
  • Malaria is a major health issue faced by people in India. According to the WHO, 1.2 million people in Southeast Asia are suffering from malaria, of which India alone contributes to around 76% of the total malaria cases.

Thus, the high prevalence of infectious diseases coupled with the inadequate healthcare infrastructural facilities in developing countries is expected to drive the adoption of POC testing in these countries.

Product recalls: Hampering user confidence

In the last two years, the POC diagnostics market has witnessed a growing number of product recalls majorly due to inaccurate readings and results provided by these devices.

  • In November 2017, Abbott Point of Care initiated the recall of its i-STAT 1 Analyzer (software). The company determined that i-STAT Total b-hCG cartridges may produce an increased number of quality check codes (QCC) 149 when used with the i-STAT 1 Analyzer software version JAMS 143/CLEW A34.
  • In March 2017, the One Step HCG urine pregnancy test (manufactured by AI DE Diagnostic Co. Ltd.) was recalled in Australia after it produced false negative results. With this recall, additional nine products were removed from the market with subject to regulatory action.
  • In July 2016, Alere Inc. (US) initiated the recall of its INRatio and INRatio2 PT/INR Monitoring System due to incorrect test results. The monitoring system includes INRatio or INRatio2 PT/INR Monitor and the INRatio Test Strips.
  • In May 2014, Alere Inc. (US) initiated a voluntary Class 1 recall of the Alere INRatio2 PT/INR Professional Test Strips in the US. The company has received nine serious adverse event reports, of which three were about bleeding and patient death.

These recalls not only affect consumer confidence but also the market position of leading players. Thus, the recall of these devices is expected to restrain the growth of the POC diagnostics market.

Growth opportunities in 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.

Globally, China has the highest number of diabetes patients, with around 109 million people (2015) suffering from diabetes in the country in 2015. Similarly, in emerging countries such as Brazil and India, the prevalence of diabetes, CVD, and HIV/AIDS is very high. In India, more than 2 million people die every year due to CVD, and this figure is projected to reach ~4.8 million by 2020 (Source: CCDC, India).

To meet the increasing demand for POC diagnostics in emerging markets, manufacturers are focusing on strategic acquisitions and agreements/partnerships with regional/domestic players for product distribution and manufacturing. Some of the developments in this regard have been mentioned below:

  • In January 2017, Chembio Diagnostics, Inc. (US) acquired RVR Diagnostics Sdn Bhd (RVR) (Malaysia) with the aim to expand its product offerings and presence in Southeast Asia.
  • In February 2016, Abbott Laboratories (US) entered into a strategic Technology License and Transfer agreement with Beijing Strong Biotechnologies, Inc. (BSBE) for clinical chemistry products. As per the agreement, BSBE will provide the license and technology for the clinical chemistry products manufactured in China to Abbott. This cooperation will help IVD companies in China in terms of technology transfer.
  • In March 2016, Chembio Diagnostics, Inc. (US) collaborated with Bio-Manguinhos/Fiocruz (Brazil) to develop a point-of-care diagnostic Zika test for the Brazilian market.
  • In August 2014, Enigma Diagnostics Ltd. (England) collaborated with China’s National Institute for Communicable Disease Control and Prevention—the China Center for Disease Control and Prevention (ICDC). Under this agreement, Enigma and ICDC aimed to develop a rapid and convenient molecular diagnostic technology for infectious disease pathogens using the company’s Mini Laboratory system.

The regulatory policies in the Asia Pacific region are more adaptive and business friendly due to the presence of less stringent regulations and data requirements as compared to the North American and European markets. Also, the increasing competition in mature markets will compel POC testing manufacturers to shift their focus on emerging markets across the APAC and LATAM.

Lack of alignment with definitive central lab methods

POC test results lack proper alignment with central lab methods due to a large number of 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 condition, and other factors such as fasting before functional tests or variation 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.

It has been observed that POC testing is often conducted in emergency situations to facilitate rapid clinical decision-making. In many cases, these tests are carried out by nurses or clinical team members and not by physicians. Such situations can lead to inappropriate order documentation and result documentation. These issues can potentially lead to erroneous diagnosis and affect the quality of care provided to patients. Considering such issues, several patients as well as doctors can decide not to opt for POC testing. This is one of the key challenges for the greater acceptance of POC testing.

This report broadly segments the rapid diagnostics market into product, platform, mode, end user, and region.

On the basis of product, the global market is segmented into products for glucose monitoring, infectious disease testing, coagulation testing, cardiometabolic testing, hematology testing, urinalysis testing, cholesterol testing, drugs of abuse testing, tumor/cancer marker testing, pregnancy and fertility testing, fecal occult testing, and others (multi-assay testing, liver testing, hepatitis A & B testing, and vitamin assay testing). The infectious disease testing products segment is expected to grow at the highest CAGR during the forecast period. The growing patient population base and increasing availability and awareness about infectious disease POC testing products are the major factors contributing to the segment’s growth.

Based on platforms, the Point-of-Care Diagnostics market is further segmented into lateral flow assays, immunoassays, POC molecular diagnostics, dipsticks, and microfluidics. The Molecular Diagnostics segment is expected to grow at the highest CAGR during the forecast period. The growth of this segment can be attributed to the growing advancements in technology, increasing initiatives of market players for developing POC molecular diagnostics products, and resource-limited settings.

On the basis of mode of prescription, the Point-of-Care Diagnostics market is categorized into two segments prescription-based testing and OTC testing. The prescription-based testing segment is expected to command the largest share of the global point-of-care diagnostics market in 2017. The growth of this segment can be attributed to the increasing incidence and prevalence of lifestyle diseases and the lack of awareness on OTC POCT devices in developing nations.

On the basis of end user, the market is further segmented into professional diagnostics centers, home care, research laboratories, and other end users. The home care settings segment is expected to grow at the highest CAGR during the forecast period. The high growth of this segment can be attributed to the increasing preference for home and remote monitoring and rising demand for rapid tests among home care users.

Point-of-Care Diagnostics market, by Region, 2022 (USD Billion)

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The report covers the Point-of-Care Diagnostics market across four major geographies, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America is expected to command the largest share of the Rapid Diagnostics Market in 2017, due to the growing prevalence of lifestyle diseases, increasing number of product approvals, and rising government initiatives in this region.

The major players of the market are Abbott (US), Roche (Switzerland), Siemens (Germany), Danaher (US), Becton, Dickinson, and Company (US), Johnson & Johnson (US), Instrumentation Laboratory (US), PTS Diagnostics (US), Quidel (US), Chembio (US), Sekisui Diagnostics (US), Nova (US), EKF Diagnostics (UK), AccuBioTech (China), and Trinity Biotech (US).

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Table of Contents

1 Introduction (Page No. - 18)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
    1.4 Markets Covered
           1.4.1 Years Considered for the Study
    1.5 Currency
    1.6 Limitations
    1.7 Stakeholders

2 Research Methodology (Page No. - 21)
    2.1 Research Data
           2.1.1 Secondary Data
                    2.1.1.1 Secondary Sources
           2.1.2 Primary Data
                    2.1.2.1 Primary Sources
                    2.1.2.2 Key Industry Insights
           2.1.3 Market Size Estimation Methodology
                    2.1.3.1 Bottom-Up Approach
                    2.1.3.2 Top-Down Approach
           2.1.4 Research Design
           2.1.5 Market Data Validation and Triangulation
           2.1.6 Assumptions for the Study

3 Executive Summary (Page No. - 31)
    3.1 Introduction

4 Premium Insights (Page No. - 35)
    4.1 POC Diagnostics: Market Overview
    4.2 POC Diagnostics Market, By Platform
    4.3 Geographic Analysis: POC Diagnostics Market, By End User and Region
    4.4 POC Diagnostics Market, By Product
    4.5 POC Diagnostics Market, By Prescription Mode
    4.6 Geographic Snapshot of the POC Diagnostics Market

5 Market Overview (Page No. - 40)
    5.1 Introduction
    5.2 Market Dynamics
           5.2.1 Drivers
                    5.2.1.1 High Prevalence of Infectious Diseases in Developing Countries
                    5.2.1.2 Increasing Incidence of Target Diseases
                    5.2.1.3 Rising Usage of Home-Based POC Devices
                    5.2.1.4 Growing Government Support
                    5.2.1.5 Technological Advancements and New Product Launches
                    5.2.1.6 Growing Number of Regulatory Approvals for Novel Immunoassay Techniques
                    5.2.1.7 Shortage of Skilled Laboratory Technicians
                    5.2.1.8 Rising Number of Clia-Waived POC Tests
           5.2.2 Restraints
                    5.2.2.1 Product Recalls: Hampering User Confidence
                    5.2.2.2 Pricing Pressure Owing to Reimbursement Cuts and Budget Constraints
                    5.2.2.3 Stringent and Time-Consuming Regulatory Policies are Significantly Increasing Gestation Period for Product Launches
           5.2.3 Opportunities
                    5.2.3.1 Growth Opportunities in Emerging Markets
                    5.2.3.2 Healthcare Decentralization —Converting Lab Tests to POC Tests
                    5.2.3.3 Increasing Number of Conferences and Events
                    5.2.3.4 POC Tests With Multiplexing Capabilities
           5.2.4 Challenges
                    5.2.4.1 Lack of Alignment With Definitive Central Lab Methods
                               5.2.4.1.1 Disadvantages of POC Testing Over Central Lab Methods
                    5.2.4.2 Inadequate Knowledge About the Use of POC Devices in Professional Settings
                    5.2.4.3 Reluctance Towards Changing Existing Diagnostic Practices
                    5.2.4.4 High Cost of Devices
           5.2.5 Emerging Applications of Point-of-Care Testing
                    5.2.5.1 Sepsis Biomarkers
                    5.2.5.2 Stroke Markers
                    5.2.5.3 Thyroid Testing
                    5.2.5.4 Dna Testing
                    5.2.5.5 Endocrine Testing

6 Point-of-Care Diagnostics Market, By Product (Page No. - 56)
    6.1 Introduction
    6.2 Glucose Monitoring Products
           6.2.1 Strips
           6.2.2 Meters
           6.2.3 Lancets & Lancing Devices
    6.3 Cardiometabolic Testing Products
           6.3.1 Cardiac Marker Testing Products
           6.3.2 Blood Gas/Electrolytes Testing Products
           6.3.3 HBA1C Testing Products
    6.4 Infectious Disease Testing Products
           6.4.1 Influenza Testing Products
           6.4.2 HIV Testing Products
           6.4.3 Hepatitis C Testing Products
           6.4.4 Sexually Transmitted Disease (STD) Testing Products
           6.4.5 Healthcare-Associated Infection (HAI) Testing Products
           6.4.6 Respiratory Infection Testing Products
           6.4.7 Tropical Disease Testing Products
           6.4.8 Other Infectious Disease Testing Products
    6.5 Coagulation Testing Products
           6.5.1 PT/INR Testing Products
           6.5.2 Activated Clotting Time (ACT/APTT) Testing Products
    6.6 Pregnancy and Fertility Testing Products
           6.6.1 Pregnancy Testing Products
           6.6.2 Fertility Testing Products
    6.7 Tumor/Cancer Marker Testing Products
    6.8 Urinalysis Testing Products
    6.9 Cholesterol Testing Products
    6.10 Hematology Testing Products
    6.11 Drugs-of-Abuse Testing Products
    6.12 Fecal Occult Testing Products
    6.13 Other POC Products

7 Point-of-Care Diagnostics Market, By Platform (Page No. - 94)
    7.1 Introduction
    7.2 Lateral Flow Assays (Immunochromatography Tests)
    7.3 Dipsticks
    7.4 Microfluidics
    7.5 Molecular Diagnostics
    7.6 Immunoassays

8 Point-of-Care Diagnostics Market, By Prescription Mode (Page No. - 102)
    8.1 Introduction
    8.2 Prescription-Based Testing
    8.3 OTC Testing

9 Point-of-Care Diagnostics Market, By End User (Page No. - 107)
    9.1 Introduction
    9.2 Professional Diagnostic Centers
           9.2.1 Clinical Laboratories, Outpatient Healthcare & Ambulatory Care Settings
           9.2.2 Hospitals/Critical Care Centers
    9.3 Home Care
    9.4 Research Laboratories
    9.5 Other End Users

10 Point-of-Care Diagnostics Market, By Region (Page No. - 116)
     10.1 Introduction
     10.2 North America
             10.2.1 US
             10.2.2 Canada
     10.3 Europe
             10.3.1 Germany
             10.3.2 France
             10.3.3 UK
             10.3.4 Rest of Europe (RoE)
     10.4 Asia Pacific
             10.4.1 Japan
             10.4.2 China
             10.4.3 India
             10.4.4 Rest of Asia Pacific
     10.5 Rest of the World (RoW)
             10.5.1 Latin America
             10.5.2 Middle East & Africa

11 Competitive Landscape (Page No. - 169)
     11.1 Overview
     11.2 Market Share Analysis, 2016
     11.3 Competitive Scenario and Trends
             11.3.1 Product Launches
             11.3.2 Agreements, Partnerships, and Collaborations
             11.3.3 Product Approvals
             11.3.4 Acquisitions

12 Company Profiles (Page No. - 173)
(Business Overview, Products Offered, Recent Developments, MnM View)*
     12.1 Abbott Laboratories
     12.2 Accubiotech
     12.3 Becton, Dickinson, and Company (BD)
     12.4 Chembio Diagnostics
     12.5 Danaher Corporation
     12.6 EKF Diagnostics
     12.7 Instrumentation Laboratory (A Werfen Company)
     12.8 Johnson & Johnson
     12.9 Nova Biomedical
     12.10 PTS Diagnostics (A Part of Sinocare Inc.)
     12.11 Quidel
     12.12 Roche Diagnostics (A Subsidiary of F. Hoffmann-La Roche Ltd.)
     12.13 Sekisui Diagnostics
     12.14 Siemens
     12.15 Trinity Biotech

*Business Overview, Products Offered, Recent Developments, MnM View Might Not Be Captured in Case of Unlisted Companies.

13 Appendix (Page No. - 217)
     13.1 Discussion Guide
     13.2 Knowledge Store: Marketsandmarkets’ Subscription Portal
     13.3 Introducing RT: Real-Time Market Intelligence
     13.4 Available Customizations
     13.5 Related Reports
     13.6 Author Details


List of Tables (129 Tables)

Table 1 Point-of-Care Diagnostics Market, By Product, 2015–2022 (USD Million)
Table 2 Market for Glucose Monitoring Products, By Type, 2015–2022 (USD Million)
Table 3 Glucose Monitoring Meters Market, By Region, 2015–2022 (Units)
Table 4 Market for Glucose Monitoring Products, By Region, 2015–2022 (USD Million)
Table 5 Market for Cardiometabolic Testing Products, By Type, 2015–2022 (USD Million)
Table 6 Market for Cardiometabolic Testing Products, By Region, 2015–2022 (USD Million)
Table 7 Cardiac Marker Testing Products Market, By Region, 2015–2022 (USD Million)
Table 8 Cardiac Marker Testing Products Market, By Region, 2015–2022 (Units)
Table 9 Blood Gas/Electrolytes Testing Products Market, By Region, 2015–2022 (USD Million)
Table 10 Blood Gas/Electrolytes Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 11 HBA1C Testing Products Market, By Region, 2015–2022 (USD Million)
Table 12 Point-of-Care Diagnostics Market for Infectious Disease Testing Products, By Type, 2015–2022 (USD Million)
Table 13 Market for Infectious Disease Testing Products, By Region, 2015–2022 (USD Million)
Table 14 Market for Influenza Testing Products, By Region, 2015–2022 (USD Million)
Table 15 Influenza Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 16 HIV Testing Products Market, By Region, 2015–2022 (USD Million)
Table 17 HIV Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 18 Hepatitis C Testing Products Market, By Region, 2015–2022 (USD Million)
Table 19 Hepatitis C Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 20 STD Testing Products Market, By Region, 2015–2022 (USD Million)
Table 21 Healthcare-Associated Infection Testing Products Market, By Region, 2015–2022 (USD Million)
Table 22 Respiratory Infection Testing Products Market, By Region, 2015–2022 (USD Million)
Table 23 Tropical Disease Testing Products Market, By Region, 2015–2022 (USD Million)
Table 24 Other Infectious Disease Testing Products Market, By Region, 2015–2022 (USD Million)
Table 25 Market for Coagulation Testing Products, By Type, 2015–2022 (USD Million)
Table 26 Point-of-Care Diagnostics Market for Coagulation Testing Products, By Region, 2015–2022 (USD Million)
Table 27 Coagulation Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 28 PT/INR Testing Products Market, By Region, 2015–2022 (USD Million)
Table 29 ACT/APTT Testing Products Market, By Region, 2015–2022 (USD Million)
Table 30 Market for Pregnancy and Fertility Testing Products, By Type, 2015–2022 (USD Million)
Table 31 Market for Pregnancy and Fertility Testing Products, By Region, 2015–2022 (USD Million)
Table 32 Pregnancy Testing Products Market, By Region, 2015–2022 (USD Million)
Table 33 Fertility Testing Products Market, By Region, 2015–2022 (USD Million)
Table 34 Market for Tumor/Cancer Marker Testing Products, By Region, 2015–2022 (USD Million)
Table 35 Market for Urinalysis Testing Products, By Region, 2015–2022 (USD Million)
Table 36 Urinalysis Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 37 Market for Cholesterol Testing Products, By Region, 2015–2022 (USD Million)
Table 38 Cholesterol Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 39 Market for Hematology Testing Products, By Region, 2015–2022 (USD Million)
Table 40 Hematology Testing Analyzers Market, By Region, 2015–2022 (Units)
Table 41 Market for Drugs-of-Abuse Testing Products, By Region, 2015–2022 (USD Million)
Table 42 Market for Fecal Occult Testing Products, By Region, 2015–2022 (USD Million)
Table 43 Market for Other POC Products, By Region, 2015–2022 (USD Million)
Table 44 POC Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 45 Lateral Flow Assays Market, By Region, 2015–2022 (USD Million)
Table 46 Dipsticks Market, By Region, 2015–2022 (USD Million)
Table 47 Microfluidics Market, By Region, 2015–2022 (USD Million)
Table 48 Molecular Diagnostics Market, By Region, 2015–2022 (USD Million)
Table 49 Immunoassays Market, By Region, 2015–2022 (USD Million)
Table 50 Point-of-Care Diagnostics Market, By Prescription Mode, 2015–2022 (USD Million)
Table 51 Prescription-Based Testing Market, By Region, 2015–2022 (USD Million)
Table 52 OTC Testing Products Market, By Region, 2015–2022 (USD Million)
Table 53 Point-of-Care Diagnostics Market, By End User, 2015–2022 (USD Million)
Table 54 Market for Professional Diagnostic Centers, By Type, 2015–2022 (USD Million)
Table 55 Market for Professional Diagnostic Centers, By Region, 2015–2022 (USD Million)
Table 56 Market for Clinical Laboratories, Outpatient Healthcare & Ambulatory Care Settings, By Region, 2015–2022 (USD Million)
Table 57 Market for Hospitals/Critical Care Centers, By Region, 2015–2022 (USD Million)
Table 58 Point-of-Care Market for Home Care, By Region, 2015–2022 (USD Million)
Table 59 Market for Research Laboratories, By Region, 2015–2022 (USD Million)
Table 60 Market for Other End Users, By Region, 2015–2022 (USD Million)
Table 61 Point-of-Care Diagnostics Market, By Region, 2015–2022 (USD Million)
Table 62 North America: Market, By Country, 2015–2022 (USD Million)
Table 63 North America: Market, By Product, 2015–2022 (USD Million)
Table 64 North America: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 65 North America: Market, By Platform, 2015–2022 (USD Million)
Table 66 North America: Market, By End User, 2015–2022 (USD Million)
Table 67 US: Market, By Product, 2015–2022 (USD Million)
Table 68 US: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 69 US: Point-of-Care Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 70 US: Point-of-Care Diagnostics Market, By End User, 2015–2022 (USD Million)
Table 71 Canada: Market, By Product, 2015–2022 (USD Million)
Table 72 Canada: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 73 Canada: Point-of-Care Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 74 Canada: Market, By End User, 2015–2022 (USD Million)
Table 75 Europe: Market, By Country, 2015–2022 (USD Million)
Table 76 Europe: Market, By Product, 2015–2022 (USD Million)
Table 77 Europe: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 78 Europe: Market, By Platform, 2015–2022 (USD Million)
Table 79 Europe: Market, By End User, 2015–2022 (USD Million)
Table 80 Germany: Market, By Product, 2015–2022 (USD Million)
Table 81 Germany: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 82 Germany: Market, By Platform, 2015-2022 (USD Million)
Table 83 Germany: Market, By End User, 2015–2022 (USD Million)
Table 84 France: Market, By Product, 2015–2022 (USD Million)
Table 85 France: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 86 France: Market, By Platform, 2015–2022 (USD Million)
Table 87 France: Point-of-Care Diagnostics Market, By End User, 2015–2022 (USD Million)
Table 88 UK: Market, By Product, 2015–2022 (USD Million)
Table 89 UK: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 90 UK: Point-of-Care Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 91 UK: Market, By End User, 2015–2022 (USD Million)
Table 92 RoE: Market, By Product, 2015–2022 (USD Million)
Table 93 RoE: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 94 RoE: Market, By Platform, 2015–2022 (USD Million)
Table 95 RoE: Market, By End User, 2015–2022 (USD Million)
Table 96 APAC: Point-of-Care Diagnostics Market, By Country, 2015–2022 (USD Million)
Table 97 APAC: Market, By Product, 2015–2022 (USD Million)
Table 98 APAC: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 99 APAC: Market, By Platform, 2015–2022 (USD Million)
Table 100 APAC: Point-of-Care Diagnostics Market, By End User, 2015–2022 (USD Million)
Table 101 Japan: Market, By Product, 2015–2022 (USD Million)
Table 102 Japan: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 103 Japan: Market, By Platform, 2015–2022 (USD Million)
Table 104 Japan: Market, By End User, 2015–2022 (USD Million)
Table 105 China: Market, By Product, 2015–2022 (USD Million)
Table 106 China: Point-of-Care Diagnostics Market, By Prescription Mode, 2015–2022 (USD Million)
Table 107 China: Market, By Platform, 2015–2022 (USD Million)
Table 108 China: Market, By End User, 2015–2022 (USD Million)
Table 109 India: Market, By Product, 2015–2022 (USD Million)
Table 110 India: Market, By Prescription Mode, 2015-2022 (USD Million)
Table 111 India: Point-of-Care Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 112 India: Market, By End User, 2015–2022 (USD Million)
Table 113 RoAPAC: Market, By Product, 2015–2022 (USD Million)
Table 114 RoAPAC: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 115 RoAPAC: Market, By Platform, 2015–2022 (USD Million)
Table 116 RoAPAC: Market, By End User, 2015–2022 (USD Million)
Table 117 RoW: Market, By Country, 2015–2022 (USD Million)
Table 118 RoW: Point-of-Care Diagnostics Market, By Product, 2015–2022 (USD Million)
Table 119 RoW: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 120 RoW: Market, By Platform, 2015–2022 (USD Million)
Table 121 RoW: Market, By End User, 2015–2022 (USD Million)
Table 122 Latin America: Market, By Product, 2015–2022 (USD Million)
Table 123 Latin America: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 124 Latin America: Point-of-Care Diagnostics Market, By Platform, 2015–2022 (USD Million)
Table 125 Latin America: Market, By End User, 2015–2022 (USD Million)
Table 126 Middle East & Africa: Market, By Product, 2015–2022 (USD Million)
Table 127 Middle East & Africa: Market, By Prescription Mode, 2015–2022 (USD Million)
Table 128 Middle East & Africa: Market, By Platform, 2015-2022 (USD Million)
Table 129 Middle East & Africa: Market, By End User, 2015–2022 (USD Million)


List of Figures (36 Figures)

Figure 1 Research Methodology Steps
Figure 2 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 3 Data Triangulation
Figure 4 Global Point-of-Care Diagnostics Market, By Product, 2017 vs 2022
Figure 5 Global Market, By Prescription Mode, 2017 vs 2022
Figure 6 Global Market, By Platform, 2017 vs 2022
Figure 7 Global Market, By End User, 2017 vs 2022
Figure 8 Global Market, By Region, 2017 (USD Million)
Figure 9 High Prevalence of Infectious Diseases is Driving the Adoption of POC Devices Across the Globe
Figure 10 Lateral Flow Assays Segment Will Continue to Dominate the Market in 2022
Figure 11 Professional Diagnostic Centers Segment to Dominate the Global POC Diagnostics End-User Market in 2017
Figure 12 Glucose Monitoring Segment to Dominate the POC Diagnostics Products Market During the Forecast Period
Figure 13 Prescription-Based Testing Products to Dominate the POC Diagnostics Market During the Forecast Period
Figure 14 North America to Register the Highest CAGR During the Forecast Period
Figure 15 POC Diagnostics Market: Drivers, Restraints, Opportunities, and Challenges
Figure 16 Estimated Number of Diabetic Patients, By Region, 2015 vs 2040
Figure 17 The Infectious Disease Testing Products Segment is Projected to Grow at the Highest CAGR During the Forecast Period
Figure 18 Molecular Diagnostics Segment to Witness Highest Growth Rate During the Forecast Period
Figure 19 OTC Testing Segment to Witness Higher Growth During the Forecast Period
Figure 20 Home Care to Witness Highest Growth During the Forecast Period
Figure 21 Point-of-Care Diagnostics Market: Growth Forecast, By Region (2017–2022)
Figure 22 North America: Market Snapshot
Figure 23 Europe: Market Snapshot
Figure 24 APAC: Market Snapshot
Figure 25 Key Developments By Leading Market Players in the Market, 2015–2017
Figure 26 Point-of-Care Diagnostics Market Share, By Key Players, 2016
Figure 27 Abbott Laboratories: Company Snapshot
Figure 28 BD: Company Snapshot
Figure 29 Chembio Diagnostics: Company Snapshot
Figure 30 Danaher Corporation: Company Snapshot
Figure 31 EKF Diagnostics: Company Snapshot
Figure 32 Johnson & Johnson: Company Snapshot
Figure 33 Quidel: Company Snapshot
Figure 34 Roche Diagnostics: Company Snapshot
Figure 35 Siemens: Company Snapshot
Figure 36 Trinity Biotech: Company Snapshot

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The study involved four major activities to estimate the current size of the point-of-care diagnostic market. Exhaustive secondary research was done to collect information on the market and its different sub-segments. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. Thereafter, market breakdown and data triangulation procedures were used to estimate the size of the segments and sub-segments.

Secondary Research

This research study involved the extensive use of secondary sources, directories, and databases (such as D&B Hoovers, Bloomberg Businessweek, and Factiva), along with government databases, which were used to identify and collect information for this method-based, market-oriented, and commercial study of the point-of-care diagnostic market.

In-depth interviews were conducted with various primary respondents that mainly include key industry participants, medical practitioners, subject-matter experts (SMEs), C-level and D-level executives of key market players, and industry consultants to obtain and verify critical qualitative and quantitative information as well as to assess prospects of the point-of-care diagnostic market.

Primary Research

Extensive primary research was conducted after acquiring knowledge about the point-of-care diagnostic market scenario through secondary research. A significant number of primary interviews were conducted with both the demand (healthcare providers, research institutes, physicians, and healthcare professionals) and supply sides (developers, manufacturers, and distributors of point-of-care diagnostic products). The primaries interviewed for this study include experts from the point-of-care diagnostic and medical devices industry (such as CEOs, VPs, directors, sales heads, and marketing managers of tier 1, 2, and 3 companies engaged in offering point-of-care diagnostic solutions across the globe) and administrators & purchase managers of hospitals, diagnostic centers, and healthcare service providers.

Around 69% and 31% primary interviews were conducted with the supply and demand sides, respectively. A robust primary research methodology has been adopted to validate the contents of the report and to fill gaps. Telephonic and e-mail communications were adopted to conduct interviews (questionnaires were designed and sent to primary participants as per their convenience). The following is the breakdown of primary respondents:

Point-of-Care Diagnostics market, by Region, 2022 (USD Billion)

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

A detailed market estimation approach was followed to estimate and validate the size of the point-of-care diagnostic market and other dependent submarkets, as mentioned above. The key players in the point-of-care diagnostic market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. Research methodology includes the study of the annual and quarterly financial reports of the top market players as well as interviews with industry experts for key insights (both quantitative and qualitative trends) on the point-of-care diagnostic market. All percentage shares, splits, and breakdowns were determined by using secondary sources and verified through primary sources. All the possible parameters that affect the market segments covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. This data was consolidated and added to detailed inputs and analysis from MarketsandMarkets, and presented in this report. The research methodology used to estimate the market size includes the following:

  • The key players in the industry and markets have been identified through extensive secondary research.
  • The industry’s supply chain and market size, in terms of value, have been determined through primary and secondary research processes.
  • All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.

Data Triangulation

After arriving at the overall market size of the point-of-care diagnostic industry from the market estimation approach explained above, the global market was split into several segments and sub-segments. To complete the overall market engineering process and arrive at the exact market value data, data triangulation and market breakdown methodology methods were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand- and supply-side analysis.

Report Objectives

  • To define, describe, and forecast the global point-of-care diagnostics market by product, prescription mode, end user, platform, and region
  • To provide detailed information regarding the major factors influencing the growth of the market (drivers, restraints, opportunities, and industry-specific challenges)
  • To strategically analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the total market
  • To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
  • To provide a five-year forecast for various segments of the market in terms of revenue with respect to the four main regions, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW)
  • To strategically profile the key players and comprehensively analyze their market shares and core competencies
  • To track and analyze competitive developments such as product launches; agreements, partnerships, collaborations, and joint ventures; and mergers and acquisitions in the global point-of-care diagnostics market

Scope of the Report

Report Metric

Details

Market Size Available for Years

2015–2022

Base Year Considered

2016

Forecast Period

2017–2022

Forecast Units

Value (USD)

Segments Covered

Products, Prescription Mode, Platform, End User, and Region

Geographies Covered

North America (US & Canada), Europe (Germany, France, UK, and RoE), APAC (Japan, China, India, and RoAPAC), and Rest of the world (LATAM and MEA).

Companies Covered

The major players in the market include Roche (Switzerland), Abbott (US), Siemens (Germany), Becton, Dickinson, and Company (US), Danaher Corporation (US), Johnson & Johnson (US), Instrumentation Laboratory (US), Nova (US), PTS Diagnostics (US), Sekisui Diagnostics (US), Quidel (US), EKF Diagnostics (UK), Chembio Diagnostics (US), Trinity Biotech (US), and AccuBioTech (China), among others.

This research report categorizes the market based on product, prescription mode, platform, end user, and region.

Global Point-of-care Diagnostics Market, by Product

  • Glucose Monitoring Products
    • Strips
    • Meters
    • Lancets & Lancing Devices
  • Cardiometabolic Testing Products
    • Cardiac Marker Testing Products
    • Blood Gas/Electrolytes Testing Products
    • HBA1C Testing Products
  • Infectious Disease Testing Products
  • Influenza Testing Products
    • HIV Testing Products
    • Hepatitis C Testing Products
    • Sexually Transmitted Disease (STD) Testing Products
    • Healthcare-Associated Infection (HAI) Testing Products
    • Respiratory Infection Testing Products
    • Tropical Disease Testing Products
    • Other Infectious Disease Testing Products
  • Coagulation Testing Products
    • PT/INR Testing Products
    • Activated Clotting Time (ACT/APTT) Testing Products
  • Pregnancy & Fertility Testing Products
    • Pregnancy Testing Products
    • Fertility Testing Products
  • Tumor/Cancer Marker Testing Products
  • Urinalysis Testing Products
  • Cholesterol Testing Products
  • Hematology Testing Products
  • Drugs-of-Abuse Testing Products
  • Fecal Occult Testing Products
  • Other POC Products

Global Point-of-care Diagnostics Market, by Platform

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

Global Point-of-care Diagnostics Market, by Mode 

  • Prescription-based Testing
  • OTC-based Testing

Global Point-of-care Diagnostics Market, by End User

  • Professional Diagnostic Centers
  • Research Laboratories
  • Home Care
  • Other End Users

Global Point-of-care Diagnostics Market, by Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • France
    • UK
    • Rest of Europe (RoE)
  • Asia Pacific
    • Japan
    • China
    • India
    • Rest of Asia Pacific (RoAPAC)
  • Rest of the World (RoW)
    • Latin America
    • Middle East & Africa

Aavailable customizations

With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the market report:

Product Analysis

  • Product matrix, which gives a detailed comparison of the product portfolios of the top five companies in the market

Company Information

  • Detailed analysis and profiling of additional market players (up to 5)
Report Code
MD 2702
Published ON
Oct, 2019
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