세계의 체외진단(IVD) 시장 예측 : 제품별, 검체별, 기술별, 용도별, 최종 사용자별, 지역별 분석(-2030년)

According to Stratistics MRC, the Global In Vitro Diagnostics (IVD) Market is accounted for $104.1 billion in 2024 and is expected to reach $148.5 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In Vitro Diagnostics (IVD) refers to medical tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are conducted outside the body, in a controlled laboratory environment, to provide crucial information for diagnosis, treatment monitoring, and disease prevention, playing a vital role in modern healthcare and personalized medicine.

According to a report by the National Center for Biotechnology Information (NCBI), IVD testing is valuable in clinical practice, with 88% of patients using it for initial diagnosis, 77% for treatment monitoring, and 72% for follow-up. This highlights the indispensable role of IVDs in patient management and healthcare outcomes.

Market Dynamics:

Driver:

Increasing prevalence of chronic diseases

The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is a significant driver for the In Vitro Diagnostics (IVD) market. These conditions require regular monitoring and early diagnosis, which IVD tests facilitate. As the global population ages and lifestyle-related health issues increase, the demand for accurate and efficient diagnostic tools continues to grow, thereby driving market expansion.

Restraint:

High cost of diagnostic platforms

The high cost of advanced diagnostic platforms poses a significant restraint to the IVD market. These platforms often require substantial investment in terms of initial setup, maintenance, and skilled personnel. Smaller healthcare facilities and developing regions may find it challenging to afford these technologies, limiting their adoption and slowing market growth. Additionally, the cost factor can deter frequent upgrades and integration of new technologies.

Opportunity:

Growth in emerging markets

Emerging markets present substantial growth opportunities for the IVD market. Regions such as Asia-Pacific, Latin America, and parts of Africa are experiencing rapid economic development, improved healthcare infrastructure, and increased healthcare spending. These factors, combined with a growing awareness of early disease detection and preventive healthcare, create a fertile ground for the expansion of IVD products and services. Companies investing in these regions can tap into a large, underserved patient population.

Threat:

Stringent regulatory framework

The stringent regulatory framework governing the approval and commercialization of IVD products is a significant threat to market growth. Regulatory bodies like the FDA and EMA impose rigorous standards to ensure the safety and efficacy of diagnostic tests. While these regulations protect patient safety, they also lead to lengthy approval processes and increased costs for manufacturers. Non-compliance can result in product recalls, legal issues, and loss of market credibility.

Covid-19 Impact:

The COVID-19 pandemic significantly boosted the IVD market, with a sharp rise in demand for diagnostic tests such as PCR, NGS, and serology-based rapid tests. The pandemic accelerated the adoption of point-of-care testing and remote diagnostics, highlighting the importance of rapid and accurate diagnostic solutions. This surge in demand led to increased investments in IVD technologies and infrastructure, setting a precedent for future growth.

The reagents & kits segment is expected to be the largest during the forecast period

The reagents and kits segment is anticipated to dominate the IVD market due to their essential role in diagnostic testing. Reagents are critical components used in various IVD tests to detect and measure specific analytes in patient samples. The continuous need for these consumables in routine diagnostic procedures, coupled with advancements in reagent formulations and the introduction of new test kits, drives the segment's growth.

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

The immunoassays segment is projected to experience the highest CAGR due to its widespread application in detecting infectious diseases, cancer biomarkers, and hormone levels. Immunoassays offer high sensitivity and specificity, making them indispensable in clinical diagnostics. Technological advancements, such as the development of automated immunoassay systems and multiplex assays, further enhance their efficiency and adoption, contributing to rapid market growth.

Region with largest share:

North America is positioned to dominate the IVD market due to its advanced healthcare infrastructure, high healthcare expenditure, and the presence of major IVD companies. The region's focus on early disease detection, personalized medicine, and the adoption of advanced diagnostic technologies drives market growth. Additionally, supportive government policies and a high prevalence of chronic diseases contribute to North America's leading market share.

Region with highest CAGR:

The Asia Pacific region anticipates rapid growth in the IVD market, driven by increasing healthcare investments, improving healthcare infrastructure, and a growing awareness of preventive healthcare. The rising prevalence of chronic and infectious diseases, coupled with economic development and expanding middle-class populations, fuels the demand for advanced diagnostic solutions. Government initiatives to enhance healthcare access and affordability further support the region's high CAGR.

Key players in the market

Some of the key players in In Vitro Diagnostics (IVD) market include Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation (Beckman Coulter), Thermo Fisher Scientific, Becton, Dickinson and Company (BD), bioMerieux SA, Sysmex Corporation, Johnson & Johnson (Ortho Clinical Diagnostics), Bio-Rad Laboratories, Qiagen N.V., Hologic, Inc., Grifols, Illumina, Inc., and Agilent Technologies.

Key Developments:

In December 2023, Thermo Fisher Scientific Inc., the world leader in serving science, announced the launch of the Thermo Scientific(TM) KingFisher(TM) Apex(TM) Dx, an automated nucleic acid purification instrument, and Applied Biosystems(TM) MagMAX(TM) Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.

In November 2023, Roche announced the launch of the LightCycler(R) PRO System based on the proven gold standard technology of the LightCycler(R) Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in vitro diagnostics. The LightCycler PRO System further complements Roche's molecular PCR testing portfolio, which includes solutions for a variety of healthcare professionals - from those performing research, to those testing patients for cancer, infectious diseases, and other public health challenges.

In June 2023, Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Products Covered:

• Instruments
• Reagents & Kits
• Software

Specimens Covered:

• Blood
• Urine
• Stool
• Saliva
• Tissue Biopsies
• Other Specimens

Technologies Covered:

• Immunoassays
• Molecular Diagnostics
• Clinical Chemistry
• Hematology
• Microbiology
• Coagulation & Hemostasis
• Other Technologies

Applications Covered:

• Infectious Diseases
• Oncology
• Endocrinology
• Cardiology
• Blood Screening
• Genetic Testing
• Autoimmune Diseases
• Allergy Diagnostics
• Drug Monitoring & Testing
• Coagulation Testing
• Other Applications

End Users Covered:

• Hospitals & Clinics
• Diagnostic Laboratories
• Point-of-Care Testing Sites
• Homecare Settings
• Research Institutions

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 2022, 2023, 2024, 2026, and 2030
• 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 (IVD) Market, By Product

• 5.1 Introduction
• 5.2 Instruments
  • 5.2.1 Analyzers
  • 5.2.2 Point-of-care (POC) devices
  • 5.2.3 Microscopes
  • 5.2.4 Other Instruments
• 5.3 Reagents & Kits
  • 5.3.1 Molecular Diagnostics Kits
  • 5.3.2 Clinical Chemistry Assays
  • 5.3.3 Hematology Assays
  • 5.3.4 Microbiology Assays
  • 5.3.5 Other Reagents & Kits
• 5.4 Software
  • 5.4.1 Data Analysis Software
  • 5.4.2 Laboratory Information Management Systems (LIMS)
  • 5.4.3 Remote Diagnostics Software

6 Global In Vitro Diagnostics (IVD) Market, By Specimen

• 6.1 Introduction
• 6.2 Blood
• 6.3 Urine
• 6.4 Stool
• 6.5 Saliva
• 6.6 Tissue Biopsies
• 6.7 Other Specimens

7 Global In Vitro Diagnostics (IVD) Market, By Technology

• 7.1 Introduction
• 7.2 Immunoassays
  • 7.2.1 Enzyme-Linked Immunosorbent Assay (ELISA)
  • 7.2.2 Chemiluminescence Immunoassays (CLIA)
  • 7.2.3 Radioimmunoassay (RIA)
• 7.3 Molecular Diagnostics
  • 7.3.1 Polymerase Chain Reaction (PCR)
  • 7.3.2 Isothermal Nucleic Acid Amplification Technology (INAAT)
  • 7.3.3 Microarrays
  • 7.3.4 Next-Generation Sequencing (NGS)
• 7.4 Clinical Chemistry
• 7.5 Hematology
• 7.6 Microbiology
• 7.7 Coagulation & Hemostasis
• 7.8 Other Technologies

8 Global In Vitro Diagnostics (IVD) Market, By Application

• 8.1 Introduction
• 8.2 Infectious Diseases
  • 8.2.1 HIV/AIDS Testing
  • 8.2.2 Hepatitis Testing
  • 8.2.3 Bacterial & Viral Infections
• 8.3 Oncology
  • 8.3.1 Cancer Screening & Diagnosis
  • 8.3.2 Monitoring Treatment Response
• 8.4 Endocrinology
  • 8.4.1 Diabetes Testing
  • 8.4.2 Thyroid Function Testing
• 8.5 Cardiology
  • 8.5.1 Cardiac Markers Testing
  • 8.5.2 Cholesterol Testing
• 8.6 Blood Screening
  • 8.6.1 Newborn Screening
  • 8.6.2 Prenatal Testing
• 8.7 Genetic Testing
  • 8.7.1 Carrier Screening
  • 8.7.2 Pharmacogenomics
• 8.8 Autoimmune Diseases
  • 8.8.1 Rheumatoid Arthritis Testing
  • 8.8.2 Celiac Disease Testing
• 8.9 Allergy Diagnostics
  • 8.9.1 Food Allergy Testing
  • 8.9.2 Drug Allergy Testing
• 8.10 Drug Monitoring & Testing
  • 8.10.1 Therapeutic Drug monitoring
  • 8.10.2 Anti-doping Testing
• 8.11 Coagulation Testing
  • 8.11.1 Blood Group Typing
  • 8.11.2 Bone & Mineral Disorders
• 8.12 Other Applications

9 Global In Vitro Diagnostics (IVD) Market, By End User

• 9.1 Introduction
• 9.2 Hospitals & Clinics
• 9.3 Diagnostic Laboratories
• 9.4 Point-of-Care Testing Sites
• 9.5 Homecare Settings
• 9.6 Research Institutions

10 Global In Vitro Diagnostics (IVD) Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Roche Diagnostics
• 12.2 Siemens Healthineers
• 12.3 Abbott Laboratories
• 12.4 Danaher Corporation (Beckman Coulter)
• 12.5 Thermo Fisher Scientific
• 12.6 Becton, Dickinson and Company (BD)
• 12.7 bioMerieux SA
• 12.8 Sysmex Corporation
• 12.9 Johnson & Johnson (Ortho Clinical Diagnostics)
• 12.10 Bio-Rad Laboratories
• 12.11 Qiagen N.V.
• 12.12 Hologic, Inc.
• 12.13 Grifols
• 12.14 Illumina, Inc.
• 12.15 Agilent Technologies