MediPoint: Infectious Disease Point of Care Testing – Global Analysis and Market Forecasts

Point-of-care testing (POCT), as known as bedside/near-patient testing is one of the most rapidly growing areas in IVD. Systems that are categorized as POC include the following:

• Disposable systems or devices, which vary from reagent test strips for a single analyte to multi-analyte reagent strips

• Small analyzers, usually hand-held devices

• Desktop analyzers are larger and include systems designed for use in clinics or small laboratories.

The infectious disease POCT space represents one of the fastest growing markets within the POC space. Just under $700 million in annual global sales and growth rate of 7.7% during the forecast period; the US, India and Brazil, are expected to show the fastest growth.A number of factors, such as the increasing prevalence of infectious diseases in developing countries, the rising usage of home-based POC devices, the expansion of the test menu, and technological advancements in molecular testing and lab-on-chip technology are stimulating the demand for infectious disease POCT.The rate of infectious disease POCT adoption will be moderated by the requirement for regulatory compliance, the pressure to control cost, and the need to demonstrate the clear clinical-cost benefits of POCT over central laboratory testing.

Scope

Competitive assessment: Currently marketed infectious disease POC products and evolving competitive landscape

In-depth analysis of unmet needs and adoption trends of different infectious disease POC devices

Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Pipeline analysis: Emerging products and technologies.

Annualized total infectious disease POCT market revenue by segment and market outlooks by country from 2013–2022.

Other key topics covered include strategic competitive assessment, market characterization, identification of unmet needs, market dynamics, and implications of the emerging technologies on the market.

Key Highlights

What is the current and future infectious disease POCT market outlook in the developed and emerging markets? What trends are affecting the global market?

What is the competitive landscape and market share of major players in the infectious disease POCT space across different regions?

What are the key, high growth markets that IVD manufacturers should expand into? Which market segments are growing the fastest?

What are the unmet needs with the infectious disease POC tests currently on the market? How will emerging technologies such as molecular POC assays fulfil these unmet needs?

What are the key factors influencing a physician to use infectious disease POC tests? What is physician perception and market outlook of these devices?

What are the challenges and barriers that have hindered widespread adoption of infectious disease POC devices?

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Industry Overview

3.1Infectious Disease POCT Overview

3.2Reimbursement Trends

3.2.1US

3.2.2France

3.2.3Germany

3.2.4Italy

3.2.5Spain

3.2.6UK

3.2.7Japan

3.2.8China

3.2.9India

3.2.10Brazil

3.3Mergers, Acquisitions, and Key Partnerships

4Unmet Needs

4.1Multiplexing

4.2Sensitivity of Infectious Disease Immunoassays

4.3Analytical Performance

4.4Data Recording and Management

4.5Infectious Disease POCT to Curb Usage of Antibiotics

4.6Cost-Effectiveness Data

4.7Primary Care Physician Needs

5Competitive Assessment

5.1Company Share Analysis

5.1.1Global

5.2Alere

5.2.1Overview

5.2.2Marketed Products Assessment

5.2.3SWOT Analysis

5.3Beckman Coulter

5.3.1Overview

5.3.2Marketed Products Assessment

5.3.3SWOT Analysis

5.4BioMerieux

5.4.1Overview

5.4.2Marketed Products Assessment

5.4.3SWOT Analysis

5.5Cepheid

5.5.1Overview

5.5.2Marketed Products Assessment

5.5.3SWOT Analysis

5.6Chembio Diagnostics

5.6.1Overview

5.6.2Marketed Products Assessment

5.6.3SWOT Analysis

5.7Meridian Bioscience

5.7.1Overview

5.7.2Marketed Products Assessment

5.7.3SWOT Analysis

5.8OraSure Technologies

5.8.1Overview

5.8.2Marketed Products Assessment

5.8.3SWOT Analysis

5.9Quidel

5.9.1Overview

5.9.2Marketed Products Assessment

5.9.3SWOT Analysis

5.10Roche Diagnostics

5.10.1Overview

5.10.2Marketed Products Assessment

5.10.3SWOT Analysis

5.11Trinity Biotech

5.11.1Overview

5.11.2Marketed Products Assessment

5.11.3SWOT Analysis

5.12Other Companies

5.12.1North American Market Companies

5.12.2European Market Companies

5.12.3APAC and Other Markets Companies

6Pipeline Assessment

6.1Overview

6.2Early Development Pipeline

6.3Pre-clinical Stage Pipeline

6.4Clinical Stage Pipeline

6.5Products in the Approval Process

7Market Outlook

7.1Test Trends

7.1.1HIV POCT

7.1.2Influenza POCT

7.1.3HBV POCT

7.1.4HCV POCT

7.1.5C. difficile POCT

7.2Market Dynamics

7.2.1Driver: Fast Turnaround Time

7.2.2Driver: Emergence of Molecular Infectious Disease POCT

7.2.3Driver: Expansion POCT Menu

7.2.4Driver: CLIA-Waived Status for POCT

7.2.5Driver: Rising Prevalence of Diseases

7.2.6Barriers: Management of POCT

7.2.7Barriers: Competition with Laboratory Tests

7.2.8Barriers: Reimbursement

7.2.9Barriers: Regulatory Compliance

7.3Market Outlook By Market Segment

7.3.1Global Overview

7.3.2HIV POCT

7.3.3Influenza POCT

7.3.4HBV POCT

7.3.5HCV POCT

7.3.6C. difficile POCT

7.3.7Molecular POCT Analyzers

7.4Market Outlook By Geography

7.4.1Global Overview

7.4.2US

7.4.3France

7.4.4Germany

7.4.5Italy

7.4.6Spain

7.4.7UK

7.4.8Japan

7.4.9China

7.4.10India

7.4.11Brazil

8Appendix

8.1Bibliography

8.2Abbreviations

8.3Report Methodology

8.3.1Overview

8.3.2Coverage

8.3.3Secondary Research

8.3.4Forecasting Methodology

8.3.5Primary Research — Key Opinion Leader Interviews

8.3.6Primary Research – Physician and Industry Interviews

8.3.7Expert Panel Validation

8.4About the Team

8.4.1Analysts

8.4.2Tyler Fletcher, Global Head of Medical Devices

8.5About MediPoint

8.6About GlobalData

8.7Disclaimer

List of Tables

Table 1: Advantages and Disadvantages of POCT

Table 2: Medicare National Average of Clinical Laboratory Services Reimbursement for Infectious Disease Testing, 2014–2015

Table 3: Mergers, Acquisitions, and Key Partnerships, 2014–2016

Table 4: Company Profile – Alere

Table 5: Alere Infectious Disease POCT Portfolio Assessment, 2016

Table 6: SWOT Analysis – Alere

Table 7: Company Profile – Beckman Coulter

Table 8: Beckman Coulter Infectious Disease POCT Portfolio Assessment, 2016

Table 9: SWOT Analysis – Beckman Coulter

Table 10: Company Profile – BioMerieux

Table 11: BioMerieux’s Infectious Disease POCT Portfolio Assessment, 2016

Table 12: SWOT Analysis – BioMerieux

Table 13: Company Profile – Cepheid

Table 14: Cepheid’s Infectious Disease POCT Portfolio Assessment, 2016

Table 15: SWOT Analysis – Cepheid

Table 16: Company Profile – Chembio Diagnostics

Table 17: Chembio Diagnostics’ Infectious Disease POCT Portfolio Assessment, 2016

Table 18: SWOT Analysis – Chembio Diagnostics

Table 19: Company Profile – Meridian Bioscience

Table 20: Meridian Bioscience’s Infectious Disease POCT Portfolio Assessment, 2016

Table 21: SWOT Analysis – Meridian Bioscience

Table 22: Company Profile – OraSure Technologies

Table 23: OraSure Technologies’ Infectious Disease POCT Portfolio Assessment, 2016

Table 24: SWOT Analysis – OraSure Technologies

Table 25: Company Profile – Quidel

Table 26: Quidel’s Infectious Disease POCT Portfolio Assessment, 2016

Table 27: SWOT Analysis – Quidel

Table 28: Company Profile – Roche Diagnostics

Table 29: Roche Diagnostics’ Infectious Disease POCT Portfolio Assessment, 2016

Table 30: SWOT Analysis – Roche Diagnostics

Table 31: Company Profile – Trinity Biotech

Table 32: Trinity Biotech’s Infectious Disease POCT Portfolio Assessment, 2016

Table 33: SWOT Analysis – Trinity Biotech

Table 34: Other Infectious Disease POCT Companies in North America, 2016

Table 35: Other Infectious Disease POCT Companies in Europe, 2016

Table 36: Other Infectious Disease POCT Companies in APAC and Other Regions, 2016

Table 37: Key Infectious Disease POCT Products in Early Development, 2016

Table 38: Key Infectious Disease POCT Products in Pre-clinical Stage, 2016

Table 39: Key Infectious Disease POCT Products in the Clinical Stage, 2016

Table 40: Key Infectious Disease POCT Pipelines in Approval Process, 2016

Table 41: Global HIV POCT Volume Forecast (thousands) by Region, 2013–2022

Table 42: Global Influenza POCT Volume Forecast (Thousands) by Region, 2013–2022

Table 43: Global HBV POCT Volume Forecast (Thousands) by Region, 2013–2022

Table 44: Global HCV POCT Volume Forecast (Thousands) by Region, 2013–2022

Table 45: Global C. difficile POCT Volume Forecast (Thousands) by Region, 2013–2022

Table 46: Global Infectious Disease POCT Sales Forecast ($m) by Market Segment, 2013–2022

Table 47: HIV POCT Sales Forecast ($m), 2013–2022

Table 48: Influenza POCT Sales Forecast ($m), 2013–2022

Table 49: HBV POCT Sales Forecast ($m), 2013–2022

Table 50: HCV POCT Sales Forecast ($m), 2013–2022

Table 51: C. difficile POCT Sales Forecast ($m), 2013–2022

Table 52: Molecular POCT Analyzers Sales Forecast ($m), 2013–2022

Table 53: Global Infectious Disease POCT Sales Forecast ($m) by Country, 2013–2022

Table 54: US Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 55: France Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 56: Germany Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 57: Italy Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 58: Spain Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 59: UK Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 60: Japan Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 61: China Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 62: India Infectious Disease POCT Sales Forecast ($m), 2013–2022

Table 63: Brazil Infectious Disease POCT Sales Forecast ($m), 2013–2022

List of Figures

Figure 1: Global Infectious Disease POCT Market, by Company Share, 2015

Figure 2: Infectious Disease POCT Pipelines, by Stage of Development, 2016

Figure 3: Global HIV POCT Volume Forecast (Thousands) by Region, 2013–2022

Figure 4: Global Influenza POCT Volume Forecast (Thousands) by Region, 2013–2022

Figure 5: Global HBV POCT Volume Forecast (Thousands) by Region, 2013–2022

Figure 6: Global HCV POCT Volume Forecast (Thousands) by Region, 2013–2022

Figure 7: Global C. difficile POCT Volume Forecast (Thousands) by Region, 2013–2022

Figure 8: Global Infectious Disease POCT Sales Forecast ($m) by Market Segment, 2013–2022

Figure 9: Global Infectious Disease POCT Market Share Forecast ($m) by Segment, 2015 and 2022

Figure 10: HIV POCT Sales Forecast ($m), 2013–2022

Figure 11: Influenza POCT Sales Forecast ($m), 2013–2022

Figure 12: HBV POCT Sales Forecast ($m), 2013–2022

Figure 13: HCV POCT Sales Forecast ($m), 2013–2022

Figure 14: C. difficile POCT Sales Forecast ($m), 2013–2022

Figure 15: Molecular POCT Analyzers Sales Forecast ($m), 2013–2022

Figure 16: Global Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 17: Global Infectious Disease POCT Market Share Forecast ($m) by Country, 2015 and 2022

Figure 18: US Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 19: US Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 20: France Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 21: France Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 22: Germany Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 23: Germany Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 24: Italy Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 25: Italy Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 26: Spain Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 27: Spain Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 28: UK Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 29: UK Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 30: Japan Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 31: Japan Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 32: China Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 33: China Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 34: India Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 35: India Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 36: Brazil Infectious Disease POCT Sales Forecast ($m), 2013–2022

Figure 37: Brazil Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022

Figure 38: Infectious Disease POCT – Physician Survey Count by Country (N=121)

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