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In Vitro Diagnostics: Technologies and Global Markets

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    Report

  • 159 Pages
  • January 2025
  • Region: Global
  • BCC Research
  • ID: 5311440
The In Vitro Diagnostics Market was valued at USD 94.7 billion in 2024, and is expected to reach USD 141.9 billion by 2029, rising at a CAGR of 8.40%.

The immunochemistry segment was valued at $31.1 billion in 2023 and is estimated to grow at 5.5% CAGR during the forecast period. This segment’s market share of 35.5% in 2023 and its medium growth rate are attributed to factors such as the growth of the use of diagnosis procedures in clinics and the rise in demand for technologies to analyze blood samples for infections and disorders. The increase in virus or bacterial infection rates among different age groups has also increased the demand for immunochemistry procedures.

Report Scope

This report covers the in vitro diagnostic (IVD) technologies as well as in vitro diagnostic devices used in hospitals and point-of-care (POC) facilities to diagnose diseases. It also details the current and future market potential of in vitro diagnostic technology and includes an analysis of this market’s competitive environment. The report covers market drivers, restraints, opportunities, product approvals, regulatory scenario assessments and emerging technologies. It features market projections and estimates of the market shares of key players through 2029.

In this analysis, the in vitro diagnostics market is segmented based on technologies, applications, end users and region. Based on technologies, the market is segmented into the following categories: hematology, immunochemistry, molecular diagnostics, POC testing, clinical microbiology and tissue diagnostics. Based on applications, the in vitro diagnostics market is segmented into these categories: diabetes, nephrology, blood glucose evaluation and monitoring (BGEM), oncology, cardiology, infectious diseases and other applications. The market is segmented based on end users into diagnostic laboratories, hospitals and clinics, point-of-care centers, and other end users.

The global in vitro diagnostics market has been segmented by the following geographical regions: North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. The report features detailed analyses of major countries such as the U.S., Germany, the U.K., Italy, France, Spain, Japan, China, India, Australia and New Zealand (ANZ), Argentina, Brazil, South Africa, Mexico and the GCC countries. Market analysis data is provided for 2023, which serves as the base year, and estimates are given for 2024 and forecast values through 2029.

The report includes:

  • 41 data tables and 54 additional tables
  • Analysis of global market trends, with data from 2021-2023, estimates for 2024, and projections of compound annual growth rates (CAGRs) through 2029
  • Estimates of the size of the market for in vitro diagnostics (IVD) technologies, revenues, and market shares by technology, product, application, end user and region
  • Assessment of market dynamics such as drivers, restraints and opportunities
  • Discussion of how the rise in the number of respiratory infections, hospital acquired infections (HAIs), and sexually transmitted diseases are creating a constant need for IVD testing in hospitals and laboratories
  • Discussion of IVD for neglected infectious diseases, chemistry-based portable analysis and microfluidic platform-based POC tests
  • A discussion on ESG challenges and practices in the industry
  • Assessment of the competitive landscape, including the market shares of key companies, their product portfolios and financial overviews
  • Information on recent mergers, acquisitions, expansions, collaborations, investments, divestments and product launches
  • Profiles of the leading companies, including F. Hoffmann-La Roche Ltd., Abbott, Sysmex Corp., Danaher, BD, and Siemens Healthineers AG

Table of Contents

Chapter 1 Executive Summary
  • Market Outlook
  • Scope of Report
  • Market Summary
Chapter 2 Market and Technology Background
  • Introduction
  • In vitro Diagnostics Technology
  • Overview
  • Classification of In Vitro Diagnostic Elements
  • Importance of In Vitro Diagnostics Technologies and Quality Control
  • Difference Between In Vitro and In Vivo Diagnostics
  • Regulations in the IVD Industry
  • Regulation of IVD Products in Different Countries
Chapter 3 Market Dynamics
  • Overview
  • Market Drivers
  • Rise in Population of Older Adults: Dependence on Diagnosis Procedures
  • Integration of Artificial Intelligence in Vitro Diagnostics
  • Rising Prevalence of Chronic Diseases
  • Improving the Quality of Point-of-Care Testing (POCT)
  • Market Restraints
  • Challenges Associated with Technologies Product Packaging
  • Increases in Shipping Costs or Service Issues
  • Laboratory Assistant's Inability to Handle Laboratory Equipment and Consumables
  • Market Opportunities
  • Rise in Home Care Testing Devices
  • Demand for Point-of-Care (POC) Testing Units
  • Growing Demand for AI and the Internet of Things
Chapter 4 Emerging Technologies and Developments
  • Emerging Technologies in the IVD Market
  • Artificial Intelligence
  • Modified Old IVD Techniques
  • Liquid Biopsy
  • Automated In Vitro Diagnostic Devices
  • Emerging Developments in In Vitro Diagnostics
  • FDA Approval
  • Rise in Demand for Personalized Medicine
  • Lab Automation and Digital Health Platform
  • Portability Option in IVD Devices
  • Home Care Kits for Cancer Diagnosis
  • FDA Approved In Vitro Diagnostic Devices: AI Enabled
Chapter 5 Market Segmentation Analysis
  • Segmentation Breakdown
  • Market Analysis by Technology
  • Immunochemistry
  • POC Testing
  • Hematology
  • Molecular Diagnostics
  • Tissue Diagnostics
  • Clinical Microbiology
  • Market Analysis by Application
  • Diabetes
  • Nephrology
  • Blood Glucose Evaluation and Monitoring (BGEM)
  • Oncology
  • Cardiology
  • Infectious Diseases
  • Other Applications
  • Market Analysis by End User
  • Diagnostic Laboratory
  • Hospitals and Clinics
  • Point-of-Care (POC) Centers
  • Other End Users
  • Geographical Breakdown
  • Market Analysis by Region
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa
Chapter 6 Competitive Intelligence
  • Introduction
  • Global Analysis of Company Market Ranking
  • Glimpse of Leading In Vitro Diagnostics (IVD) Companies in China
  • Agreements, Collaborations and Partnerships
  • bioMérieux Agreements
  • Siemens Healthineers and Sysmex Enter into a Global Agreement
  • Roche Enters into Agreement with Path AI
  • Quidel Corp. Signs Agreement to Acquire Ortho Clinical Diagnostics
  • In Vitro Diagnostics Companies and Start-Ups in 2021-2023
  • Diagopreutic Private Limited
  • Diatherax
  • IPLEXMED
  • Magnify Bioscience Inc.
Chapter 7 Sustainability in the In Vitro Diagnostics Industry: An ESG Perspective
  • Importance of ESG in In Vitro Diagnostics Manufacturing Industry
  • ESG Practices in the In Vitro Diagnostics Industry
  • Environmental Performance
  • Social Performance
  • Governance Performance
  • Company Role in ESG Development
  • ESG Risk Ratings
  • BCC Research Viewpoint
Chapter 8 Appendix
  • Research Methodology
  • References
  • Company Profiles
  • ABBOTT
  • BD
  • BIOMERIEUX
  • BIO-RAD LABORATORIES INC.
  • BIO-TECHNE
  • BRUKER
  • DANAHER CORP.
  • EKF DIAGNOSTICS HOLDINGS PLC
  • F. HOFFMANN-LA ROCHE LTD.
  • HOLOGIC INC.
  • JSR CORP.
  • QUIDELORTHO CORP.
  • SIEMENS HEATHNIEERS AG
  • SYSMEX CORP.
  • THERMO FISHER SCIENTIFIC INC.
List of Tables
Summary Table: Global Market for In Vitro Diagnostics, by Technology, Through 2029
Table 1: Approved FDA In Vitro Diagnostics Devices, 2021-2024
Table 2: Differences Between In Vitro and In Vivo Diagnostics
Table 3: FDA Approval of Artificial Intelligence and Machine Learning-Enabled Medical Devices, 2024
Table 4: Global Market for In Vitro Diagnostics, by Technology, Through 2029
Table 5: Global Market for In Vitro Diagnostics in Immunochemistry, by Region, Through 2029
Table 6: Global Market for In Vitro Diagnostics in POC Testing, by Region, Through 2029
Table 7: Summary of Electrochemiluminescence POCT Devices with Their Analytic Performance
Table 8: Global Market for In Vitro Diagnostics in Hematology, by Region, Through 2029
Table 9: Global Market for In Vitro Diagnostics in Molecular Diagnostics, by Region, Through 2029
Table 10: Global Market for In Vitro Diagnostics in Tissue Diagnostics, by Region, Through 2029
Table 11: Global Market for In Vitro Diagnostics in Clinical Microbiology, by Region, Through 2029
Table 12: Global Market for In Vitro Diagnostics, by Application, Through 2029
Table 13: Global Market for Diabetes in In Vitro Diagnostics, by Region, Through 2029
Table 14: Global Market for Nephrology in In Vitro Diagnostics, by Region, Through 2029
Table 15: Global Market for BGEM in In Vitro Diagnostics, by Region, Through 2029
Table 16: Global Market for Oncology in In Vitro Diagnostics, by Region, Through 2029
Table 17: Global Market for Cardiology in In Vitro Diagnostics, by Region, Through 2029
Table 18: Global Market for Infectious Diseases in In Vitro Diagnostics, by Region, Through 2029
Table 19: Global Market for Other Applications in In Vitro Diagnostics, by Region, Through 2029
Table 20: Global Market for In Vitro Diagnostics, by End User, Through 2029
Table 21: Global Market for In Vitro Diagnostics for Diagnostic Laboratory, by Region, Through 2029
Table 22: Global Market for In Vitro Diagnostics for Hospitals and Clinics, by Region, Through 2029
Table 23: Global Market for In Vitro Diagnostics for Point-of-Care Centers, by Region, Through 2029
Table 24: Global Market for In Vitro Diagnostics for Other End Users, by Region, Through 2029
Table 25: Global Market for In Vitro Diagnostics, by Region, Through 2029
Table 26: North American Market for In Vitro Diagnostics, by Country, Through 2029
Table 27: European Market for In Vitro Diagnostics, by Country, Through 2029
Table 28: Asia-Pacific Market for In Vitro Diagnostics, by Country, Through 2029
Table 29: Latin American Market for In Vitro Diagnostics, by Sub-Region, Through 2029
Table 30: Total Imports of Medical Equipment into Brazil, 2021 and 2022
Table 31: Middle Eastern and African Market for In Vitro Diagnostics Technology, by Sub-Region, Through 2029
Table 32: bioMérieux Agreements
Table 33: ESG Practices: Environmental Performance
Table 34: ESG Practices: Social Performance
Table 35: ESG Practices: Governance Performance
Table 36: Creating an Attractive Workplace: Social Performance
Table 37: ESG Rankings for Leading In Vitro Diagnostics Companies, 2023 and 2024*
Table 38: Abbott: Company Snapshot
Table 39: Abbott: Financial Performance, FY 2022 and 2023
Table 40: Abbott: Product Portfolio
Table 41: Abbott: News/Key Developments, 2022-2024
Table 42: BD: Company Snapshot
Table 43: BD: Financial Performance, FY 2022 and 2023
Table 44: BD: Product Portfolio
Table 45: BD: News/Key Developments, 2022-2024
Table 46: BIOMÉRIEUX: Company Snapshot
Table 47: BIOMÉRIEUX: Financial Performance, FY 2022 and 2023
Table 48: BIOMÉRIEUX: Product Portfolio
Table 49: BIOMÉRIEUX: News/Key Developments, 2023 and 2024
Table 50: Bio-Rad Laboratories Inc.: Company Snapshot
Table 51: Bio-Rad Laboratories Inc.: Financial Performance, FY 2022 and 2023
Table 52: Bio-Rad Laboratories Inc.: Product Portfolio
Table 53: Bio-Rad Laboratories Inc.: News/Key Developments, 2021-2024
Table 54: Bio-Techne: Company Snapshot
Table 55: Bio-Techne: Financial Performance, FY 2022 and 2023
Table 56: Bio-Techne: Product Portfolio
Table 57: Bio-Techne: News/Key Developments, 2022 and 2023
Table 58: Bruker: Company Snapshot
Table 59: Bruker: Financial Performance, FY 2022 and 2023
Table 60: Bruker: Product Portfolio
Table 61: Bruker: News/Key Developments, 2021-2024
Table 62: Danaher Corp.: Company Snapshot
Table 63: Danaher Corp.: Financial Performance, FY 2022 and 2023
Table 64: Danaher Corp.: Product Portfolio
Table 65: Danaher Corp.: News/Key Developments, 2021-2023
Table 66: EKF Diagnostics Holdings plc.: Company Snapshot
Table 67: EKF Diagnostics Holdings plc.: Financial Performance, FY 2022 and 2023
Table 68: EKF Diagnostics Holdings plc.: Product Portfolio
Table 69: EKF Diagnostics Holdings plc.: News/Key Developments, 2022-2024
Table 70: F. Hoffmann-La Roche Ltd.: Company Snapshot
Table 71: F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2022 and 2023
Table 72: F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 73: F. Hoffmann-La Roche Ltd.: News/Key Developments, 2022-2024
Table 74: Hologic Inc.: Company Snapshot
Table 75: Hologic Inc.: Financial Performance, FY 2022 and 2023
Table 76: Hologic Inc.: Product Portfolio
Table 77: Hologic Inc.: News/Key Developments, 2022-2024
Table 78: JSR Corp.: Company Snapshot
Table 79: JSR Corp.: Financial Performance, FY 2022 and 2023
Table 80: JSR Corp.: Product Portfolio
Table 81: JSR Corp.: News/Key Developments, 2024
Table 82: QuidelOrtho Corp.: Company Snapshot
Table 83: QuidelOrtho Corp.: Financial Performance, FY 2022 and 2023
Table 84: QuidelOrtho Corp.: Product Portfolio
Table 85: QuidelOrtho Corp.: News/Key Developments, 2021-2024
Table 86: Siemens Healthineers AG: Company Snapshot
Table 87: Siemens Healthineers AG: Financial Performance, FY 2022 and 2023
Table 88: Siemens Healthineers AG: Product Portfolio
Table 89: Siemens Healthineers AG: News/Key Developments, 2021-2024
Table 90: Sysmex Corp.: Company Snapshot
Table 91: Sysmex Corp.: Financial Performance, FY 2022 and 2023
Table 92: Sysmex Corp.: Product Portfolio
Table 93: Sysmex Corp.: News/Key Developments, 2022 and 2023
Table 94: Thermo Fisher Scientific Inc.: Company Snapshot
Table 95: Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
Table 96: Thermo Fisher Scientific Inc.: Product Portfolio
Table 97: Thermo Fisher Scientific Inc.: News/Key Developments, 2022 and 2023
List of Figures
Summary Figure: Global Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 1: Snapshot of Market Dynamics
Figure 2: Older Adults Using Technology to Manage Chronic Health Issues in the U.S., by Age Group, 2024
Figure 3: Percentage of People Aged 50+ Using Digital Services in the U.S., 2024
Figure 4: Breakdown of Global Elderly Population (Aged 65+ Years), by Select Countries, 2022
Figure 5: Emerging AI Applications in In Vitro Diagnostics
Figure 6: Global Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 7: Global Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 8: Snapshot of IVD Tests in Oncology
Figure 9: Global Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 10: Global Market Shares of In Vitro Diagnostics, by Region, 2023
Figure 11: North American Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 12: North American Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 13: North American Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 14: North American Market Shares of In Vitro Diagnostics, by Country, 2023
Figure 15: European Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 16: European Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 17: European Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 18: European Market Shares of In Vitro Diagnostics, by Sub-Region , 2023
Figure 19: Asia-Pacific Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 20: Asia-Pacific Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 21: Asia-Pacific Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 22: Asia-Pacific Market Shares of In Vitro Diagnostics, by Country, 2023
Figure 23: Latin American Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 24: Latin American Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 25: Latin American Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 26: Latin American Market Shares of In Vitro Diagnostics, by Sub-Region, 2023
Figure 27: Middle Eastern and African Market Shares of In Vitro Diagnostics, by Technology, 2023
Figure 28: Middle Eastern and African Market Shares of In Vitro Diagnostics, by Application, 2023
Figure 29: Middle Eastern and African Market Shares of In Vitro Diagnostics, by End User, 2023
Figure 30: Middle Eastern and African Market Shares of In Vitro Diagnostics, by Sub-Region, 2023
Figure 31: Rankings of Leading Companies in Global In Vitro Diagnostics Market, 2023
Figure 32: Snapshot: Key ESG Trends in the In Vitro Diagnostics Industry
Figure 33: Abbott: Revenue Shares, by Business Unit, FY 2023
Figure 34: Abbott: Revenue Shares, by Country/Region, FY 2023
Figure 35: BD: Revenue Shares, by Business Unit, FY 2023
Figure 36: BD: Revenue Shares, by Country/Region, FY 2023
Figure 37: BIOMÉRIEUX: Revenue Shares, by Business Unit, FY 2023
Figure 38: BIOMÉRIEUX: Revenue Shares, by Country/Region, FY 2023
Figure 39: Bio-Rad Laboratories Inc.: Revenue Shares, by Business Unit, FY 2023
Figure 40: Bio-Rad Laboratories Inc.: Revenue Shares, by Country/Region, FY 2023
Figure 41: Bio-Techne: Revenue Shares, by Business Unit, FY 2023
Figure 42: Bio-Techne: Revenue Shares, by Country/Region, FY 2023
Figure 43: Bruker: Revenue Shares, by Business Unit, FY 2023
Figure 44: Bruker: Revenue Shares, by Country/Region, FY 2023
Figure 45: Danaher Corp.: Revenue Shares, by Business Unit, FY 2023
Figure 46: Danaher Corp.: Revenue Shares, by Country/Region, FY 2023
Figure 47: EKF Diagnostics Holdings plc.: Revenue Shares, by Business Unit, FY 2023
Figure 48: EKF Diagnostics Holdings plc.: Revenue Shares, by Country/Region, FY 2023
Figure 49: F. Hoffmann-La Roche Ltd.: Revenue Shares, by Business Unit, FY 2023
Figure 50: F. Hoffmann-La Roche Ltd.: Revenue Shares, by Country/Region, FY 2023
Figure 51: Hologic Inc.: Revenue Shares, by Business Unit, FY 2023
Figure 52: Hologic Inc.: Revenue Shares, by Country/Region, FY 2023
Figure 53: JSR Corp.: Revenue Shares, by Business Unit, FY 2023
Figure 54: JSR Corp.: Revenue Shares, by Country/Region, FY 2023
Figure 55: QuidelOrtho Corp.: Revenue Shares, by Business Unit, FY 2023
Figure 56: QuidelOrtho Corp.: Revenue Shares, by Country/Region, FY 2023
Figure 57: Siemens Healthineers AG: Revenue Shares, by Business Unit, FY 2023
Figure 58: Siemens Healthineers AG: Revenue Shares, by Country/Region, FY 2023
Figure 59: Sysmex Corp.: Revenue Shares, by Business Unit, FY 2023
Figure 60: Sysmex Corp.: Revenue Shares, by Country/Region, FY 2023
Figure 61: Thermo Fisher Scientific Inc.: Revenue Shares, by Business Unit, FY 2023
Figure 62: Thermo Fisher Scientific Inc.: Revenue Shares, by Country/Region, FY 2023

Companies Mentioned

  • Abbott
  • BD
  • Biomerieux
  • Bio-Rad Laboratories Inc.
  • Bio-Techne
  • Bruker
  • Danaher Corp.
  • EKF Diagnostics Holdings PLC
  • F. Hoffmann-La Roche Ltd.
  • Hologic Inc.
  • JSR Corp.
  • Quidelortho Corp.
  • Siemens Heathnieers AG
  • Sysmex Corp.
  • Thermo Fisher Scientific Inc.

Table Information