세계의 체외진단 시장 예측(-2032년) : 제품 유형, 기술, 샘플 유형, 검사장소, 용도, 최종사용자, 지역별 세계 분석

According to Stratistics MRC, the Global In-Vitro Diagnostics Market is accounted for $116.53 billion in 2025 and is expected to reach $194.59 billion by 2032 growing at a CAGR of 7.6% during the forecast period. In-Vitro Diagnostics (IVD) involves analyzing biological specimens, including blood, urine, and tissue, to identify diseases, disorders, or infections. Conducted externally, either in laboratories or through point-of-care testing systems, these diagnostics utilize methods such as molecular assays, immunological techniques, and biochemical testing. IVD is essential in modern healthcare, offering early detection, disease monitoring, and treatment optimization. It also contributes significantly to precision medicine, ensuring tailored healthcare solutions and improved patient management outcomes.

According to CDC, chronic diseases such as cancer & diabetes and chronic kidney & respiratory diseases, such as asthma, are responsible for 7 in 10 deaths in the U.S. each year.

Market Dynamics:

Driver:

Rising prevalence of chronic and infectious diseases

The global surge in chronic illnesses such as diabetes, cardiovascular disorders, and cancer is intensifying the need for accurate diagnostic testing. Simultaneously, recurring outbreaks of infectious diseases are prompting investments in rapid and scalable testing platforms. Technological advancements in molecular diagnostics, next-generation sequencing (NGS), and liquid biopsy are transforming early detection and disease monitoring. Aging populations across developed and emerging regions are further amplifying demand for routine diagnostics. Healthcare systems are increasingly integrating personalized testing protocols to guide treatment decisions. This convergence of demographic shifts and technological innovation is propelling the IVD market forward.

Restraint:

Limited reimbursement policies

Many healthcare payers remain cautious about covering newer technologies, especially those involving high-cost molecular platforms. The lack of harmonized global reimbursement standards creates uncertainty for manufacturers entering new markets. Smaller diagnostic firms face challenges navigating complex billing codes and payer negotiations. This financial ambiguity slows innovation and limits access to cutting-edge diagnostics in underserved regions. Without policy reform, reimbursement bottlenecks may continue to constrain market expansion.

Opportunity:

Rising demand for home-based diagnostics

Consumers are increasingly seeking portable, user-friendly kits for chronic disease monitoring and infectious disease screening. Innovations in microfluidics, smartphone-integrated biosensors, and cloud-based analytics are enabling real-time results outside clinical settings. Regulatory bodies are supporting this trend by fast-tracking approvals for telehealth-compatible diagnostics. Emerging markets are witnessing rapid adoption of home-based testing, especially in rural and remote areas. This evolution is opening new pathways for personalized care and preventive health management.

Threat:

Data privacy and cybersecurity concerns

Cloud-based diagnostic systems and AI-driven analytics require robust encryption and compliance with global data protection laws. Breaches in health data can erode patient trust and expose companies to legal liabilities. The integration of IoT-enabled devices into diagnostic workflows adds complexity to cybersecurity protocols. Regulatory scrutiny is increasing, with mandates for transparent data handling and breach reporting. Without proactive investment in cybersecurity infrastructure, digital diagnostics may face reputational and operational risks.

Covid-19 Impact

The pandemic dramatically reshaped the IVD landscape, accelerating demand for rapid testing and remote diagnostics. Lockdowns disrupted supply chains, but also catalyzed innovation in point-of-care and molecular platforms. Emergency use authorizations enabled swift deployment of new assays, while telehealth integration expanded diagnostic reach. Hospitals prioritized automation and digital workflows to manage testing volumes efficiently. Post-pandemic strategies now emphasize resilience, with manufacturers investing in decentralized production and AI-powered diagnostics.

The instruments segment is expected to be the largest during the forecast period

The instruments segment is expected to account for the largest market share during the forecast period, due to its critical role in laboratory automation and high-throughput testing. Advanced analyzers, PCR systems, and immunoassay platforms are central to clinical workflows across hospitals and diagnostic labs. Continuous innovation in robotics, multiplexing, and connectivity is enhancing operational efficiency and diagnostic accuracy. Demand is rising for integrated systems that support multiple test types and remote monitoring capabilities. Manufacturers are focusing on modular designs and cloud-enabled instruments to meet evolving lab needs. As precision diagnostics gain traction, instruments remain the backbone of scalable testing infrastructure.

The infectious diseases segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the infectious diseases segment is predicted to witness the highest growth rate, driven by global efforts to combat emerging pathogens. Rapid diagnostic kits, molecular assays, and syndromic panels are being deployed for early detection and outbreak control. Technological breakthroughs in CRISPR-based diagnostics and portable nucleic acid testing are reshaping field diagnostics. Governments and NGOs are investing in scalable platforms for pandemic preparedness and antimicrobial resistance monitoring. The rise of travel-related infections and zoonotic diseases is further boosting demand for agile testing solutions. This segment is evolving rapidly, with innovation focused on speed, sensitivity, and accessibility.

Region with largest share:

During the forecast period, the Asia Pacific region is expected to hold the largest market share supported by expanding healthcare infrastructure and rising disease burden. Countries like China, India, and Japan are investing in diagnostic modernization and local manufacturing capabilities. Government-led initiatives are improving access to testing in rural and underserved regions. The region is witnessing strong uptake of automated analyzers and AI-powered diagnostic platforms. Strategic collaborations between global players and regional firms are accelerating technology transfer and market penetration.

Region with highest CAGR:

Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, underpinned by its leadership in diagnostic innovation and digital health integration. The U.S. and Canada are pioneering developments in genomics, liquid biopsy, and AI-enhanced diagnostics. Regulatory agencies are streamlining pathways for novel test approvals, encouraging faster market entry. Hospitals are adopting cloud-based lab management systems and predictive analytics to optimize testing workflows. The region benefits from strong reimbursement support and high consumer awareness of preventive diagnostics.

Key players in the market

Some of the key players profiled in the In-Vitro Diagnostics Market include Roche, Illumina, Abbott Laboratories, Agilent Technologies, Siemens Healthineers, DiaSorin, Thermo Fisher Scientific, Hologic, Danaher Corporation, QuidelOrtho, bioMerieux, Becton Dickinson (BD), Sysmex Corporation, QIAGEN, and Bio-Rad Laboratories.

Key Developments:

In February 2025, Shedd Aquarium and Abbott are announcing one of Shedd's largest corporate gifts in recent history - a $10 million pledge from Abbott and Abbott's philanthropic foundation, Abbott Fund. The investment cements the longstanding partnership between Shedd, Abbott, and Abbott Fund to enrich the cultural, educational and environmental fabric of Chicago and spark passion for protecting the ocean environment.

In May 2025, Roche announced a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche's recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery. It will also aim to establish the SBX technology as a routine offering for fast, scalable sequencing for Broad Clinical Lab's research community.

Product Types Covered:

• Instruments
• Reagents & Consumables
• Software & Services

Technologies Covered:

• Immunodiagnostics
• Molecular Diagnostics Capsule
• Clinical Chemistry
• Hematology
• Microbiology

Sample Types Covered:

• Blood
• Tissue
• Urine
• Saliva

Test Locations Covered:

• Laboratory-based Testing
• Point-of-Care Testing (POCT)
• Home-based Testing

Applications Covered:

• Infectious Diseases
• Genetic Disorders
• Oncology
• Drug Testing
• Cardiology
• Nephrology
• Autoimmune Disorders
• Diabetes
• Other Applications

End Users Covered:

• Hospitals
• Homecare Settings
• Clinical Laboratories
• Physician Offices
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 Technology Analysis
• 3.8 Application Analysis
• 3.9 End User Analysis
• 3.10 Emerging Markets
• 3.11 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global In-vitro Diagnostics Market, By Product Type

• 5.1 Introduction
• 5.2 Instruments
• 5.3 Reagents & Consumables
• 5.4 Software & Services

6 Global In-vitro Diagnostics Market, By Technology

• 6.1 Introduction
• 6.2 Immunodiagnostics
  • 6.2.1 ELISA
  • 6.2.2 CLIA
  • 6.2.3 Rapid Tests
  • 6.2.4 Fluorescence Immunoassay
• 6.3 Molecular Diagnostics
  • 6.3.1 PCR / RT-PCR
  • 6.3.2 Isothermal Amplification (INAAT)
  • 6.3.3 Microarrays
  • 6.3.4 Sequencing
• 6.4 Clinical Chemistry
  • 6.4.1 Enzymatic Assays
  • 6.4.2 Electrolyte Analysis
• 6.5 Hematology
  • 6.5.1 CBC Analyzers
  • 6.5.2 Coagulation Testing
• 6.6 Microbiology
  • 6.6.1 Culture-based Diagnostics
  • 6.6.2 Antimicrobial Susceptibility Testing

7 Global In-vitro Diagnostics Market, By Sample Type

• 7.1 Introduction
• 7.2 Blood
• 7.3 Tissue
• 7.4 Urine
• 7.5 Saliva

8 Global In-vitro Diagnostics Market, By Test Location

• 8.1 Introduction
• 8.2 Laboratory-based Testing
• 8.3 Point-of-Care Testing (POCT)
• 8.4 Home-based Testing

9 Global In-vitro Diagnostics Market, By Application

• 9.1 Introduction
• 9.2 Infectious Diseases
• 9.3 Genetic Disorders
• 9.4 Oncology
• 9.5 Drug Testing
• 9.6 Cardiology
• 9.7 Nephrology
• 9.8 Autoimmune Disorders
• 9.9 Diabetes
• 9.10 Other Applications

10 Global In-vitro Diagnostics Market, By End User

• 10.1 Introduction
• 10.2 Hospitals
• 10.3 Homecare Settings
• 10.4 Clinical Laboratories
• 10.5 Physician Offices
• 10.6 Other End Users

11 Global In-vitro Diagnostics Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 Roche
• 13.2 Illumina
• 13.3 Abbott Laboratories
• 13.4 Agilent Technologies
• 13.5 Siemens Healthineers
• 13.6 DiaSorin
• 13.7 Thermo Fisher Scientific
• 13.8 Hologic
• 13.9 Danaher Corporation
• 13.10 QuidelOrtho
• 13.11 bioMerieux
• 13.12 Becton Dickinson (BD)
• 13.13 Sysmex Corporation
• 13.14 QIAGEN
• 13.15 Bio-Rad Laboratories