In Vitro Diagnostics: Technologies and Global Markets

Table of Contents

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing This Study
Intended Readership
Scope of Report
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

Global Market Trends

Chapter 3 Market Landscape

COVID-19 Global Pandemic
Coronavirus Disease 2019 Testing Basics
Diagnostic Tests with Alternative Options
Molecular Diagnostic Tests
Increasing Access to Testing
Antigen Tests
Antibody (Serology) Tests
In Vitro Diagnostic Testing EUAs

• Diagnostic Tests
• Serology/Antibody Tests
• Tests for the Management of COVID-19 Patients

Market Overview and Segmentation
Key Findings
Factors Influencing the Global IVD Market

• Drivers
• Challenges

Regulatory Landscape

• IVD Regulations in North America
• IVD Regulations in Europe
• IVD Regulations in Asia-Pacific
• IVD Regulations in LAAM (Latin America, Africa and Middle East)

Chapter 4 Global Market for IVD by Product Segment

Immunochemistry
POC IVD
Molecular Diagnostic Testing
Hematology
Clinical Microbiology
Tissue Diagnostic Testing
Trends in IVD Segments
Competitive Structure

• Market Share Analysis

Chapter 5 Global Market for Immunochemistry Testing

Blood Gas, Electrolytes and Metabolites (BGEM)
Endocrine
Infectious Diseases
Cancer
Urinalysis
Diabetes
Cardiology
Blood Screening
Others
FDA Product Approvals in 2020

Chapter 6 Global Market for POC Testing

Glucose Testing
BGEM
Cardiac Marker Testing
Infectious Disease Testing
Pregnancy and Fertility Testing
Drug and Alcohol Abuse Testing
Hematology and Hemostasis Testing
Cholesterol Testing
Urine Chemistry Testing
Tumor Marker Testing
Other Types of POC Testing
FDA Product Approvals in 2020

Chapter 7 Global Market for Hematology Testing

Routine Hematology Tests
Hemostasis
FDA Product Approvals in 2020

Chapter 8 Global Market for Molecular Diagnostic Testing

Infectious Diseases
Blood Screening
Oncology
Genetic Testing
Others (Companion Diagnostics, Prenatal Genetic Tests and Rare Diseases)
FDA Product Approvals in 2020

Chapter 9 Global Market for Clinical Microbiology Testing

Blood Culture
General Culture (Urine/Saliva/Stool/Sputum/CSF and Other Body Fluids)
Identification and Antibiotic Susceptibility Testing
FDA Product Approvals in 2020

Chapter 10 Global Market for Tissue Diagnostic Testing

Cancer Diagnosis
Tissue Typing
Pathogen Detection

Chapter 11 Regional Analysis

Introduction
North America
Europe
Asia-Pacific
LAAM
International Health Expenditure and Trends

• North America
• Europe
• Western Europe
• Central and Eastern Europe
• Asia-Pacific
• Latin America, Africa and Middle East (LAAM)

Chapter 12 Market Trends

End Users

• Trends

Product Categories

• Trends

Technology Trends
Industry Developments
Opportunities

• IVD for Neglected Infectious Diseases
• Portable Devices Compatible with Simple Detection Platforms
• Chemistry-Based Portable Analyzers
• Improved Sample Preservation Technologies
• New Detection Technologies
• Alternative Technologies to PCR
• Key Biomarkers for Diseases of the Developing World
• Microfluidic Platform-based POC Tests for Remote Settings
• Combining Multiple Detection Technologies into a Single Instrument

Chapter 13 Mergers and Acquisitions

Chapter 14 Patent Review

Coronavirus COVID-19 Diagnostics

Chapter 15 Company Profiles

ABBOTT DIAGNOSTICS INC.
ALERE SAN DIEGO INC.
ASCENSIA DIABETES CARE
BECKMAN COULTER (PART OF DANAHER)
BECTON DICKINSON AND CO.
BIOMERIEUX
BIO-RAD
DANAHER CORP.
ELITECH GROUP
HOLOGIC INC.
INSTRUMENTATION LABORATORY
KEMENTEC A/S
ORTHO CLINICAL DIAGNOSTICS
ROCHE DIAGNOSTICS CORP.
QUIDEL CORP.
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SYSMEX
THERMO FISHER SCIENTIFIC INC.
TRANSASIA BIO-MEDICALS
WERFEN GROUP
Chapter 16 Appendix
List of IVD Market Participants
List of Acronyms

List of Tables

Summary Table : Global Market for In Vitro Diagnostics (IVD), by Region, Through 2025
Table 1 : Total Cumulative Cases of COVID-19, by WHO Region/Country, as of 2/10/2021
Table 2 : Different Types of Coronavirus Tests, 2020
Table 3 : Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 as of 2/1/2021
Table 4 : Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2, as of 2/1/2021
Table 5 : Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2, as of 2/1/2021
Table 6 : Individual EUAs for Serology Tests for SARS-CoV-2, as of 2/1/2021
Table 7 : Individual EUAs for IVDs for the Management of COVID-19 Patients, as of 2/1/2021
Table 8 : Types of Diagnostic Tests and How They are Regulated
Table 9 : Changes in IVD Regulations in Asia-Pacific, 2020
Table 10 : Global Market for IVD, by Segment, Through 2025
Table 11 : Global Company Market Shares of IVD, 2020
Table 12 : Global Market for Immunochemistry Testing, by Application, Through 2025
Table 13 : Global Market for Immunochemistry Testing, by Region, Through 2025
Table 14 : FDA Immunology Products Approved in 2020
Table 15 : Global Market for POC Testing, by Application, Through 2025
Table 16 : Global Market for POC Testing, by Region, Through 2025
Table 17 : FDA POC Products Approved in 2020
Table 18 : Global Market for Hematology Testing, by Application, Through 2025
Table 19 : Global Market for Hematology Testing, by Region, Through 2025
Table 20 : FDA Hematology Products Approved in 2020
Table 21 : FDA Immunohematology Products Approved in 2020
Table 22 : Global Market for Molecular Diagnostic Testing, by Application, Through 2025
Table 23 : Global Market for Molecular Diagnostic Testing, by Region, Through 2025
Table 24 : FDA-Approved Nucleic Acid-Based Human Genetic Tests, as of 2/1/2021
Table 25 : FDA-Approved Nucleic Acid Based Microbial Tests, as of 2/1/2021
Table 26 : List of Cleared or Approved Companion Diagnostic Devices,2/4/2021
Table 27 : Global Market for Clinical Microbiology Testing, by Application, Through 2025
Table 28 : Global Market for Clinical Microbiology Testing, by Region, Through 2025
Table 29 : FDA Bacteriology Products Approved in 2020
Table 30 : FDA Virology Products Approved in 2020
Table 31 : Global Market for Tissue Diagnostic Testing, by Application, Through 2025
Table 32 : Global Market for Tissue Diagnostic Testing, by Region, Through 2025
Table 33 : Global COVID-19 Prevalence, by WHO Region/Country, 2/10/2021
Table 34 : Global Market for IVD, by Region, Through 2025
Table 35 : Global Market Shares of IVD, by Region, 2019-2025
Table 36 : North American Market for IVD, by Segment, Through 2025
Table 37 : North American Market for Immunochemistry Testing, by Segment, Through 2025
Table 38 : North American Market for POC Testing, by Segment, Through 2025
Table 39 : North American Market for Hematology Testing, by Segment, Through 2025
Table 40 : North American Market for Molecular Diagnostic Testing, by Segment, Through 2025
Table 41 : North American Market for Microbiology Diagnostic Testing, by Segment, Through 2025
Table 42 : North American Market for Tissue Diagnostic Testing, by Segment, Through 2025
Table 43 : European Market for IVD, by Segment, Through 2025
Table 44 : European Market for Immunochemistry Testing, by Segment, Through 2025
Table 45 : European Market for POC Testing, by Segment, Through 2025
Table 46 : European Market for Hematology Testing, by Segment, Through 2025
Table 47 : European Market for Molecular Diagnostic Testing, by Segment, Through 2025
Table 48 : European Market for Microbiology Testing, by Segment, Through 2025
Table 49 : European Market for Tissue Diagnostic Testing, by Segment, Through 2025
Table 50 : Asia-Pacific Market Shares of IVD, by Country, 2020
Table 51 : Asia-Pacific Market for IVD, by Segment, Through 2025
Table 52 : Asia-Pacific Market for Immunochemistry Testing, by Segment, Through 2025
Table 53 : Asia-Pacific Market for POC Testing, by Segment, Through 2025
Table 54 : Asia-Pacific Market for Hematology Testing, by Segment, Through 2025
Table 55 : Asia-Pacific Market for Molecular Diagnostic Testing, by Segment, Through 2025
Table 56 : Asia-Pacific Market for Clinical Microbiology Testing, by Segment, Through 2025
Table 57 : Asia-Pacific Market for Tissue Diagnostic Testing, by Segment, Through 2025
Table 58 : LAAM Market for IVD, by Segment, Through 2025
Table 59 : LAAM Market for Immunochemistry Testing, by Segment, Through 2025
Table 60 : LAAM Market for POC Testing, by Segment, Through 2025
Table 61 : LAAM Market for Hematology Testing, by Segment, Through 2025
Table 62 : LAAM Market for Molecular Diagnostic Testing, by Segment, Through 2025
Table 63 : LAAM Market for Clinical Microbiology Testing, by Segment, Through 2025
Table 64 : LAAM Market for Tissue Diagnostic Testing, by Segment, Through 2025
Table 65 : U.S. FDA Approvals of High-Complexity IVD Products, 2019-2020
Table 66 : Diagnostics Manufacturer Mergers and Acquisitions, 2004-2020
Table 67 : U.S. COVID-19-Related Patents, 2020

List of Figures

Summary Figure : Global Market for In Vitro Diagnostics (IVD), by Region, 2019-2025
Figure 1 : Global Market for IVD, by Segment, 2019-2025
Figure 2 : Global Market Shares of IVD, by Segment, 2020
Figure 3 : Global Market Shares of Immunochemistry Testing, by Application, 2020
Figure 4 : Global Market for Immunochemistry Testing, by Region, 2019-2025
Figure 5 : Global Market for POC Testing, by Application, 2019-2025
Figure 6 : Global Market for POC Testing, by Region, 2019-2025
Figure 7 : Global Market for Hematology Testing, by Application, 2019-2025
Figure 8 : Global Market Shares of Hematology Testing, by Technique, 2020
Figure 9 : Global Market Shares of Hematology Testing, by System, 2020
Figure 10 : Global Market for Hematology Testing, by Region, 2019-2025
Figure 11 : Global Market for Molecular Diagnostic Testing, by Application, 2019-2025
Figure 12 : Global Market Shares of Molecular Diagnostic Testing, by Application, 2020
Figure 13 : Global Market Shares of Molecular Diagnostic Testing, by Infectious Disease, 2020
Figure 14 : Global Market for Molecular Diagnostic Testing, by Region, 2019-2025
Figure 15 : Global Market for Clinical Microbiology Testing, by Application, 2019-2025
Figure 16 : Global Market Shares of Clinical Microbiology Testing, by Application, 2020
Figure 17 : Global Market for Clinical Microbiology Testing, by Region, 2019-2025
Figure 18 : Global Market for Tissue Diagnostic Testing, by Application, 2019-2025
Figure 19 : Global Market Shares of Tissue Diagnostic Testing, by Application, 2020
Figure 20 : Global Market for Tissue Diagnostic Testing, by Region, 2019-2025
Figure 21 : European Market Shares of IVD, by Country, 2020
Figure 22 : Western European Market Shares of IVD, by Country, 2020
Figure 23 : Central and Eastern European Market Shares of IVD, by Country, 2020
Figure 24 : Latin American Market Shares of IVD, by Country, 2020
Figure 25 : Middle East and African Market Shares of IVD, by Region, 2020
Figure 26 : Global Market Shares of IVD, by End User, 2020
Figure 27 : Global Market Shares of IVD, by Product Type, 2020

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