The scope of this study is global. The research analyzes each market and its applications, regulatory environment, technologies involved, market projections and market shares. The emerging markets discussed include countries such as India, China, Korea, Taiwan, Africa, Australia, Brazil and Russia, among others. The report also examines IVD market drivers, as well as restraints and challenges affecting its growth. Furthermore, the report also highlights the emerging products and technologies and associated start-ups that are likely to accelerate the growth of the IVD industry through their best practices in the research and development of IVDs. Excluded from this study is diagnostic testing such as imaging, veterinary diagnostics and their associated products.
This study will provide information on these areas:
- Structure and current market size of the IVD market as outlined with forecasts through 2025.
- Impact of chronic diseases, growing and aging populations.
- Current technology and product suppliers and key innovations.
- A look at the IVD industry and trends affecting the market.
- Markets by each segment (immunochemistry, molecular diagnostics, POC tests, clinical microbiology, hematology and tissue diagnostics).
- A global overview showing market data for North America, Europe, Asia-Pacific and Latin America, Africa and the Middle East (LAAM).
- Emerging opportunities and potential investment opportunity areas for IVD.
- Technology patent trends relating to IVD.
- Profiles for more than 20 companies in the industry with significant contributions and market shares.
The report Includes:
- 47 data tables and 21 additional tables
- An overview of the global market for in vitro diagnostics (IVD) within the industry
- Analysis of global market trends, with data from 2019-2020, and projections of compound annual growth rates (CAGRs) through 2025
- Assessment of market dynamics such as drivers, restraints, opportunities, and identification of growth-inhibiting areas that affect the global market
- Evaluation of market size and forecast, and technological advancements within the industry; and market share analysis of the global IVD market by application, segment and region
- A look at how the rise in the number of diseases like respiratory infections, hospital-acquired infections (HAI), and sexually transmitted diseases are creating a constant need for IVD testing in hospitals and laboratories
- Coverage of technologies such as IVD for neglected infectious diseases, chemistry-based portable analysis and discussion on advantages of microfluidic platform based POC tests
- Detailed description on COVID-9 pandemic, including symptoms, and progression; information on coronavirus disease 2019 testing basics and impact analysis of COVID-19 on the IVD market
- Comprehensive company profiles of major market players, including Abbott Diagnostics Inc., Beckman Coulter, Becton, Dickinson and Co., Bio-Rad Laboratories, Roche Diagnostics, Siemens Healthcare and Thermo Fisher Scientific Inc.
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
- Custom Research
- Related 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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Executive Summary
In-vitro diagnostics (IVD), of the utmost importance in the global healthcare industry, are the highest revenue segment of the medical device market, valued in the multi-billion-dollar range. IVD includes analyzers, reagents, disposable and reusable products, and accessory software products used by both clinical and research laboratories around the world. IVDs range from simple self-use tests to state-of-the-art genomic tests performed in laboratories and can be used in the diagnosis of infectious and chronic diseases, as well as for preventive care and drug therapy monitoring.
IVDs are of significant value to the general public, as they are deemed not only as indispensable tools of medical diagnoses but also as decision-making aids for disease prevention and timely treatment to enhance well-being and keep healthcare costs under check. In addition, IVDs are also one of the vital aids that address the needs of governments, payers and patients by delivering optimal, individualized and affordable treatments.
These factors and rapid technological developments should drive the growth of the IVD market in the next five years. The market is also expected to be driven by the aging demographics of the developed world, the rising demand and improving healthcare infrastructure in the developing world and, most importantly, the shift from curative to preventive healthcare for both infectious and chronic diseases such as diabetes. Further, two emerging segments of IVDs companion diagnostics and next-generation sequencing techniques - are expected to contribute to the market growth of IVDs through the decade.
Global Market Trends
The most significant market trend during 2020 was the origin and global spread of COVID-19, the disease caused by the novel coronavirus. Originating in late 2019 in China, the virus quickly became a global pandemic. Global health organizations and diagnostic manufacturers quickly developed and approved tests for the virus. This effort overwhelmed all other trends in 2020. One effect of this activity was a complete halt of merger and acquisition activity among major diagnostic manufacturers in 2020.
Because of its large population and its position as a medical technology innovation hub, North America is the global leader in terms of IVD utilization. It remains the largest market. The emerging markets of India, China, Russia and Brazil are poised to grow at double-digit growth rates due to rising incomes, growing healthcare budgets and heightened health awareness among the population.
Companies Mentioned
- Abbott Diagnostics Inc.
- Alere San Diego Inc.
- Ascensia Diabetes Care
- Beckman Coulter (Part Of Danaher)
- Becton Dickinson And Co.
- Bio-Rad
- Biomerieux
- Danaher Corp.
- Elitech Group
- Hologic Inc.
- Instrumentation Laboratory
- Kementec A/S
- Ortho Clinical Diagnostics
- Quidel Corp.
- Roche Diagnostics Corp.
- Siemens Healthcare Diagnostics Inc.
- Sysmex
- Thermo Fisher Scientific Inc.
- Transasia Bio-Medicals
- Werfen Group
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 302 |
| Published | April 2021 |
| Forecast Period | 2020 - 2025 |
| Estimated Market Value ( USD | $ 74.1 Billion |
| Forecasted Market Value ( USD | $ 102.4 Billion |
| Compound Annual Growth Rate | 6.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 20 |
