체외진단(IVD) 시장 : 제품 유형, 검사 유형, 검체, 용도, 최종사용자별 - 세계 예측(2025-2030년)

The In-Vitro Diagnostics Market was valued at USD 79.99 billion in 2024 and is projected to grow to USD 85.16 billion in 2025, with a CAGR of 6.79%, reaching USD 118.68 billion by 2030.

The in-vitro diagnostics market is evolving at an unprecedented pace, driven by rapid innovations, technological advances, and a growing global demand for accurate and timely diagnostic solutions. Today's testing protocols and technological breakthroughs not only enhance clinical decision making but are also reshaping the industry's competitive framework. This report opens by offering a cohesive and detailed introduction to the market, highlighting both its current standing and future potential. The narrative focuses on how the integration of precision instruments, advanced reagents, comprehensive service tools, and robust software solutions is bolstering the quality of diagnostic processes worldwide. Furthermore, recent trends in personalized medicine, molecular biology, and digital integration are meticulously examined, providing a strong contextual foundation. Amid rising regulatory oversight and the global push towards quality and accessibility, the dynamic interplay between scientific discovery and technological innovation forms the core of this analysis. With a professional tone and clear insights tailored for decision-makers and industry experts, the overall framework distilled in this introduction sets the stage for a deep dive into the market's evolving strategies and transformative elements.

Exploring Transformative Shifts in the In-Vitro Diagnostics Landscape

The market has witnessed transformative shifts that have significantly altered the competitive landscape and investor sentiment. Rapid technological adoption has spurred a wave of digital transformation in diagnostics, pushing companies to incorporate digital interfaces, automation, and data analytics to streamline operations. These shifts have redefined the concept of diagnostic accuracy as ever-more sophisticated instruments and integrated software solutions become central to detecting complex health conditions swiftly and accurately. In parallel, regulatory reforms and increasing demands for high-quality medical testing drive companies to invest in advanced platforms that embody both precision and efficiency. Global digitalization, partnerships between technology providers and healthcare organizations, and a redefined emphasis on patient-centric outcomes have converged to create a fertile environment for innovation. Furthermore, evolving consumer expectations and digital health trends have inspired substantial investments in research and development, pushing legacy systems to rapidly upgrade into next-generation technologies. This potent combination of advanced analytics, automation, and a proactive regulatory landscape continues to reshape market dynamics, flattening traditional boundaries and promoting a paradigm that fuses technology with healthcare insight in real time.

Key Segmentation Insights Driving Market Dynamics

Deep segmentation insights offer a granular understanding of the in-vitro diagnostics market, revealing diverse and strategically important sub-categories. A detailed evaluation based on product type shows that the market is segmented into instruments, reagents and kits, services, and software, with instruments further divided into analyzers, automation systems, and sequencing instruments. Reagents and kits encapsulate unique domains such as enzymes and stains, while the services component covers critical operational functions such as calibration services, consultancy services, and maintenance services. Additionally, the segmentation based on software contrasts data management software with diagnostic software, underlining technology's central role. When the market is studied by test type, the breadth of available diagnostics emerges through clinical chemistry, hematology, immunoassays, microbiology, and molecular diagnostics. For instance, clinical chemistry is examined in the context of blood analysis, electrolyte panels, liver panels, thyroid function panels, and urine analysis, whereas testing types like immunoassays incorporate techniques including chemiluminescence, colorimetric methods, enzyme-linked immunosorbent assays, enzyme-linked immunospot assays, fluorescence, and radioimmunoassays. Additionally, the molecular diagnostics segment is dissected to highlight DNA sequencing together with next-generation sequencing, isothermal nucleic acid amplification technology, and polymerase chain reaction. Further segmentation by specimen-covering blood, serum and plasma, saliva, tissue samples, and urine-complements the detailed analysis. Insights into application reveal emphasis on monitoring autoimmune diseases, detecting cancer, cardia monitoring, managing diabetes, genetic testing, and screening for infectious diseases, while the end user dimension spans academic and research centers, diagnostic laboratories, hospitals, and point-of-care testing centers. Together these segmentation parameters underscore the market's complexity and the need for tailored strategies to address each niche effectively.

Based on Product Type, market is studied across Instruments, Reagents & Kits, Services, and Software. The Instruments is further studied across Analyzers, Automation Systems, and Sequencing Instrument. The Reagents & Kits is further studied across Enzymes and Stains. The Services is further studied across Calibration Services, Consultancy Services, and Maintenance Services. The Software is further studied across Data Management Software and Diagnostic Software.

Based on Test Type, market is studied across Clinical Chemistry, Hematology, Immunoassays, Microbiology, and Molecular Diagnostics. The Clinical Chemistry is further studied across Blood Analysis, Electrolyte Panel, Liver Panel, Thyroid Function Panel, and Urine Analysis. The Immunoassays is further studied across Chemiluminescence Immunoassays, Colorimetric Immunoassays, Enzyme-Linked Immunosorbent Assay, Enzyme-Linked Immunospot Assays, Fluorescence Immunoassays, and Radioimmunoassay. The Molecular Diagnostics is further studied across DNA Sequencing & Next-Generation Sequencing, Isothermal Nucleic Acid Amplification Technology, and Polymerase Chain Reaction.

Based on Specimen, market is studied across Blood, Serum & Plasma, Saliva, Tissue Samples, and Urine.

Based on Application, market is studied across Autoimmune Diseases, Cancer Detection, Cardiac Monitoring, Diabetes Management, Genetic Testing, and Infectious Disease Testing.

Based on End User, market is studied across Academic & Research Centers, Diagnostic Laboratories, Hospitals, and Point-Of-Care Testing Centers.

Regional Trends Influencing Global Diagnostics Markets

Regional dynamics continue to shape the in-vitro diagnostics industry profoundly, with various parts of the world contributing uniquely to market trends. Market drivers in the Americas reflect a mature yet innovative framework that combines robust healthcare infrastructure with a forward-thinking approach to adopting new technologies, underscoring its position as a leader in early diagnostic innovation. Meanwhile, insights from Europe, Middle East and Africa illustrate a balanced confluence of regulatory authority, investment in research, and rising public health initiatives that are steadily broadening diagnostic capabilities across diverse demographic groups. The Asia-Pacific region demonstrates remarkable growth potential fueled by rapid industrialization, increased healthcare spending, and an expanding pool of patients seeking high-quality diagnostic solutions. Economic development, urbanization, and government-driven healthcare initiatives in this region further accelerate technological adoption and innovation. The interplay of these regional trends not only diversifies the competitive landscape but also presents unique opportunities and challenges that vary by geography. Thus, understanding the regional distinctions in infrastructure, regulatory requirements, and consumer behavior is pivotal to developing a strategic market approach that leverages local insights while aligning with global market trends.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Market Leaders Enhancing Innovation and Driving Progress

The industry's competitive landscape is largely defined by a roster of influential companies that continue to drive innovation and push boundaries within the in-vitro diagnostics space. Leaders such as 10x Genomics, Inc. and Abbott Laboratories have set benchmarks in technological advancements and market penetration. Adaptive Biotechnologies Corp and Agilent Technologies Inc. are noted for their substantial contributions to next-generation diagnostic platforms. Other prominent players include Arkray Inc. and Becton, Dickinson and Company, both of which have continuously reinforced their reputations through robust research and development. Bio-Rad Laboratories Inc. and Biomerieux SA exemplify excellence in product quality and service reliability. Moreover, industry giants like Danaher Corporation, DiaSorin S.p.A., and EKF GmbH have significantly expanded innovative offerings through strategic investments and mergers. F. Hoffmann-La Roche Ltd. and Grifols SA have capitalized on emerging trends, while Hologic, Inc. and Illumina, Inc. have consistently invested in advanced sequencing technologies. Companies such as Menarini Diagnostics and Mindray Medical International Limited further highlight market dynamism through their expansive product portfolios, and trailblazers like Myriad Genetics, Inc. and Ortho-Clinical Diagnostics, Inc. have set industry standards in specialized testing. Qiagen GmbH, Randox Laboratories, Siemens AG, Sysmex Corporation, and Thermo Fisher Scientific, Inc. are also making substantial inroads by driving research innovations and service enhancements. The collective influence of these key corporate players not only spurs significant market advancement but also shapes the emerging paradigms and standards for tomorrow's diagnostics.

The report delves into recent significant developments in the In-Vitro Diagnostics Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., Abbott Laboratories, Adaptive Biotechnologies Corp, Agilent Technologies Inc., Arkray Inc., Becton, Dickinson and Company, Bio-Rad Laboratories Inc., Biomerieux SA, Danaher Corporation, DiaSorin S.p.A., EKF GmbH, F. Hoffmann-La Roche Ltd., Grifols SA, Hologic, Inc., Illumina, Inc., Menarini Diagnostics, Mindray Medical International Limited, Myriad Genetics, Inc., Ortho-Clinical Diagnostics, Inc., Qiagen GmbH, Randox Laboratories, Siemens AG, Sysmex Corporation, and Thermo Fisher Scientific, Inc.. Actionable Strategies for Maintaining Industry Leadership

For industry leaders, a forward-looking strategy is paramount to harnessing the rapid transformation in the in-vitro diagnostics market. Companies should prioritize investment in digital technologies and automation to streamline operations and boost diagnostic accuracy. Embracing emerging trends such as artificial intelligence, machine learning, and big data analytics can further enhance testing protocols and result interpretations. It is vital to continuously innovate product portfolios by focusing on tailored solutions across diverse segmentation categories including instruments, reagents and kits, services, and diagnostic software. Additionally, an integrated approach that combines investment in research and development with strategic partnerships is necessary to overcome market challenges and capture new opportunities. Leaders must ensure regulatory compliance while concurrently championing innovations that meet the evolving expectations of both clinical practitioners and end users. Consideration of regional dynamics is also critical; adapting strategies to cater to the unique needs of mature markets in the Americas, the balanced sectors in Europe, Middle East and Africa, and the rapidly growing regions in Asia-Pacific will provide a competitive advantage. Diversification of offerings, coupled with robust market intelligence driven by detailed segmentation, enables firms to navigate uncertainties while setting the pace for the future of diagnostic excellence.

Synthesizing Insights and Concluding Market Perspectives

In conclusion, the in-vitro diagnostics market is characterized by dynamic shifts that have fundamentally altered its competitive landscape and operational frameworks. The detailed analysis presented here underscores how technological innovation, regulatory evolution, and regional realignments contribute to the current market momentum. The segmentation insights reveal a vast spectrum of products and services that require tailored strategies to meet the nuanced needs of various diagnostic pathways and end user profiles. As companies continue to invest in next-generation platforms and harness the power of digital transformation, the interplay between technological precision and operational efficiency emerges as a central theme. The synthesis of regional trends offers critical insights into localized market behaviors, while the comprehensive review of industry leaders highlights the competitive forces driving innovation. Ultimately, strategic foresight combined with agile execution will be the cornerstone of future success in this increasingly competitive environment, ensuring that the industry remains not only reactive to change but also proactive in shaping the trajectory of diagnostic advancements.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Increasing prevalence of chronic diseases that necessitate early detection and consistent monitoring
    • 5.1.1.2. Growing focus on personalized treatment coupled with increased adoption of companion diagnostics
    • 5.1.1.3. Expanding government initiatives and supportive regulatory policies aimed at improving healthcare access
  • 5.1.2. Restraints
    • 5.1.2.1. Lack of comprehensive reimbursement policies for certain diagnostic tests
  • 5.1.3. Opportunities
    • 5.1.3.1. Advancements in point-of-care testing technologies that offer rapid and reliable diagnostic results
    • 5.1.3.2. Integration of digital health solutions and data analytics in diagnostic equipment for enhanced accuracy
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent regulations and approval processes associated with in vitro diagnostics
• 5.2. Market Segmentation Analysis
  • 5.2.1. Specimen: Growing use of blood and, serum & plasma for early cancer detection
  • 5.2.2. Application: Rising prevalence of diabetes across the globe boosts demand for in vitro diagnostics solutions
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. In-Vitro Diagnostics Market, by Product Type

• 6.1. Introduction
• 6.2. Instruments
  • 6.2.1. Analyzers
  • 6.2.2. Automation Systems
  • 6.2.3. Sequencing Instrument
• 6.3. Reagents & Kits
  • 6.3.1. Enzymes
  • 6.3.2. Stains
• 6.4. Services
  • 6.4.1. Calibration Services
  • 6.4.2. Consultancy Services
  • 6.4.3. Maintenance Services
• 6.5. Software
  • 6.5.1. Data Management Software
  • 6.5.2. Diagnostic Software

7. In-Vitro Diagnostics Market, by Test Type

• 7.1. Introduction
• 7.2. Clinical Chemistry
  • 7.2.1. Blood Analysis
  • 7.2.2. Electrolyte Panel
  • 7.2.3. Liver Panel
  • 7.2.4. Thyroid Function Panel
  • 7.2.5. Urine Analysis
• 7.3. Hematology
• 7.4. Immunoassays
  • 7.4.1. Chemiluminescence Immunoassays
  • 7.4.2. Colorimetric Immunoassays
  • 7.4.3. Enzyme-Linked Immunosorbent Assay
  • 7.4.4. Enzyme-Linked Immunospot Assays
  • 7.4.5. Fluorescence Immunoassays
  • 7.4.6. Radioimmunoassay
• 7.5. Microbiology
• 7.6. Molecular Diagnostics
  • 7.6.1. DNA Sequencing & Next-Generation Sequencing
  • 7.6.2. Isothermal Nucleic Acid Amplification Technology
  • 7.6.3. Polymerase Chain Reaction

8. In-Vitro Diagnostics Market, by Specimen

• 8.1. Introduction
• 8.2. Blood, Serum & Plasma
• 8.3. Saliva
• 8.4. Tissue Samples
• 8.5. Urine

9. In-Vitro Diagnostics Market, by Application

• 9.1. Introduction
• 9.2. Autoimmune Diseases
• 9.3. Cancer Detection
• 9.4. Cardiac Monitoring
• 9.5. Diabetes Management
• 9.6. Genetic Testing
• 9.7. Infectious Disease Testing

10. In-Vitro Diagnostics Market, by End User

• 10.1. Introduction
• 10.2. Academic & Research Centers
• 10.3. Diagnostic Laboratories
• 10.4. Hospitals
• 10.5. Point-Of-Care Testing Centers

11. Americas In-Vitro Diagnostics Market

• 11.1. Introduction
• 11.2. Argentina
• 11.3. Brazil
• 11.4. Canada
• 11.5. Mexico
• 11.6. United States

12. Asia-Pacific In-Vitro Diagnostics Market

• 12.1. Introduction
• 12.2. Australia
• 12.3. China
• 12.4. India
• 12.5. Indonesia
• 12.6. Japan
• 12.7. Malaysia
• 12.8. Philippines
• 12.9. Singapore
• 12.10. South Korea
• 12.11. Taiwan
• 12.12. Thailand
• 12.13. Vietnam

13. Europe, Middle East & Africa In-Vitro Diagnostics Market

• 13.1. Introduction
• 13.2. Denmark
• 13.3. Egypt
• 13.4. Finland
• 13.5. France
• 13.6. Germany
• 13.7. Israel
• 13.8. Italy
• 13.9. Netherlands
• 13.10. Nigeria
• 13.11. Norway
• 13.12. Poland
• 13.13. Qatar
• 13.14. Russia
• 13.15. Saudi Arabia
• 13.16. South Africa
• 13.17. Spain
• 13.18. Sweden
• 13.19. Switzerland
• 13.20. Turkey
• 13.21. United Arab Emirates
• 13.22. United Kingdom

14. Competitive Landscape

• 14.1. Market Share Analysis, 2024
• 14.2. FPNV Positioning Matrix, 2024
• 14.3. Competitive Scenario Analysis
  • 14.3.1. CeRAI at IIT Madras and Roche join forces to integrate advanced analytics and ethical AI for transformative patient-centric in-vitro diagnostics and sustainable digital health innovation
  • 14.3.2. Akoya Biosciences and Argonaut Manufacturing expand their strategic collaboration to scale high-quality IVD companion diagnostics for precision medicine initiatives
  • 14.3.3. Biocare Medical's Advanced Antigen Retrieval Chamber (ARC), Revolutionizing Immunohistochemistry
  • 14.3.4. GenWorks Health launches IVD tests for dengue & malaria
  • 14.3.5. Oxford Nanopore and bioMerieux to Enter Into a Strategic Partnership Agreement to Develop Innovative Infectious Disease Diagnostics
• 14.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. 10x Genomics, Inc.
• 2. Abbott Laboratories
• 3. Adaptive Biotechnologies Corp
• 4. Agilent Technologies Inc.
• 5. Arkray Inc.
• 6. Becton, Dickinson and Company
• 7. Bio-Rad Laboratories Inc.
• 8. Biomerieux SA
• 9. Danaher Corporation
• 10. DiaSorin S.p.A.
• 11. EKF GmbH
• 12. F. Hoffmann-La Roche Ltd.
• 13. Grifols SA
• 14. Hologic, Inc.
• 15. Illumina, Inc.
• 16. Menarini Diagnostics
• 17. Mindray Medical International Limited
• 18. Myriad Genetics, Inc.
• 19. Ortho-Clinical Diagnostics, Inc.
• 20. Qiagen GmbH
• 21. Randox Laboratories
• 22. Siemens AG
• 23. Sysmex Corporation
• 24. Thermo Fisher Scientific, Inc.