체외진단(IVD) 시장 규모, 점유율, 동향, 예측 : 검사 유형, 제품, 사용성, 용도, 최종사용자, 지역별(2025-2033년)

The global in vitro diagnostics market size was valued at USD 116.7 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 181.5 Billion by 2033, exhibiting a CAGR of 5.0% from 2025-2033. North America currently dominates the market, holding a market share of over 42.7% in 2024. The rising prevalence of infectious diseases, the continuous technological advancements, shifting consumer preferences towards personalized medicine, and increasing geriatric population are among the primary factors driving the in vitro diagnostics market share.

In vitro diagnostics (IVD) refers to medical tests and procedures that are performed outside the living organism, typically in a laboratory setting, using samples such as blood, urine, tissue, or other body fluids. These tests are designed to detect, diagnose, and monitor various medical conditions and diseases. Unlike in vivo diagnostics, which are conducted within the living body, in vitro diagnostics involve the examination of biological specimens in controlled laboratory conditions. IVD tests are an integral part of modern healthcare, providing crucial information to healthcare professionals for making informed decisions about patient care. These tests play a vital role in disease screening, early diagnosis, treatment selection, and monitoring treatment progress. They are used across various medical specialties, including clinical chemistry, microbiology, hematology, immunology, molecular diagnostics, and more.

The market is experiencing significant growth, driven by the increasing prevalence of chronic diseases and infectious conditions. With the rise in aging populations and lifestyle changes, chronic diseases such as diabetes, cardiovascular disorders, and cancer have become more prevalent. In vitro diagnostics provide healthcare professionals with essential insights into the early detection and effective management of these conditions, leading to improved patient outcomes and reduced healthcare costs. Moreover, advancements in technology and the integration of automation have revolutionized the IVD market. Automated systems, such as point-of-care testing devices and molecular diagnostics, have streamlined the diagnostic process, enabling faster and more accurate results. Additionally, the growing focus on personalized medicine and precision diagnostics has boosted the demand for specialized in vitro diagnostic tests. These tests help tailor treatment plans to individual patients' specific genetic and molecular characteristics, optimizing therapeutic outcomes and minimizing adverse reactions.

In Vitro Diagnostics Market Trends/Drivers:

Various technological advancements and automation

The rapid pace of technological innovation has revolutionized the In vitro diagnostics (IVD) market. Advanced technologies, such as molecular diagnostics, next-generation sequencing, and microfluidics, have enabled more accurate and sensitive testing methods. Automation has streamlined diagnostic processes, reducing human errors and increasing efficiency. Automated systems like point-of-care testing devices have facilitated faster results, enabling timely decision-making in patient care. These advancements not only enhance diagnostic accuracy but also contribute to cost savings and improved patient outcomes. Moreover, automation has extended the reach of diagnostic testing to remote or resource-limited areas, addressing healthcare disparities and improving patient access to essential diagnostic services. The integration of artificial intelligence and machine learning algorithms has further enhanced the analytical capabilities of diagnostic systems, allowing for more precise and personalized test interpretations. As technology continues to advance, the In vitro diagnostics market is expected to witness continued growth, with an ever-expanding range of diagnostic tests and applications.

The increasing prevalence of chronic diseases

The rising prevalence of chronic diseases, such as diabetes, cardiovascular disorders, and cancer, has been a key driver in the growth of the IVD market. With aging populations and lifestyle changes, chronic conditions have become more prevalent globally. In vitro diagnostics play a crucial role in the early detection, monitoring, and management of these diseases. Diagnostic tests assist healthcare professionals in making informed treatment decisions, leading to better disease management and improved quality of life for patients. Moreover, the prevalence of chronic diseases has prompted a paradigm shift towards preventive healthcare. Early detection and intervention are essential in preventing the progression of chronic conditions and reducing the burden on healthcare systems. In vitro diagnostics facilitate early screening and identification of risk factors, enabling timely preventive measures. This emphasis on preventive healthcare has spurred the adoption of IVD tests in routine health check-ups and wellness programs.

The growing emphasis on personalized medicine

The growing focus on personalized medicine has significantly impacted the IVD market. Personalized medicine aims to tailor medical treatment to individual patients based on their genetic makeup, lifestyle, and other factors. In vitro diagnostics, such as genetic testing and companion diagnostics, provide critical insights into patients' unique characteristics, enabling targeted therapies and avoiding unnecessary treatments or adverse reactions. Precision diagnostics, enabled by advanced technologies like Next-Generation Sequencing (NGS) and companion diagnostics, facilitate the identification of specific disease subtypes and molecular targets. As precision medicine gains prominence, the demand for specialized diagnostic tests continues to rise. Healthcare providers and pharmaceutical companies are increasingly investing in research and development to identify new biomarkers and create innovative diagnostic solutions to support precision medicine initiatives.

In Vitro Diagnostics Industry Segmentation:

Breakup by Test Type:

• Clinical Chemistry
• Molecular Diagnostics
• Immunodiagnostics
• Hematology
• Others

Molecular diagnostics represents the most popular test type

Molecular diagnostics offer high levels of accuracy and sensitivity in disease detection. They can identify even low concentrations of target molecules, enabling early diagnosis and precise monitoring of diseases. This level of sensitivity is particularly crucial in the detection of infectious diseases, genetic disorders, and certain types of cancer, where early intervention is vital for successful treatment. Moreover, molecular diagnostics play a key role in the advancement of personalized medicine. By analyzing an individual's genetic makeup or specific biomarkers, these tests can tailor treatment plans to each patient's unique characteristics. This approach optimizes therapeutic outcomes, minimizes adverse effects, and enhances overall patient care, contributing to the growing demand for personalized healthcare solutions.

Breakup by Product:

• Reagents and Kits
• Instruments

Reagents and kits represent the leading segment

Reagents and kits are fundamental components of diagnostic tests. They contain the necessary substances and chemicals required to perform specific assays and analyze patient samples. Diagnostic laboratories and healthcare facilities rely heavily on reagents and kits to conduct a wide range of tests, from routine screenings to complex molecular diagnostics. Moreover, Reagents and kits are designed to be user-friendly and standardized, ensuring consistent and reliable results across different laboratories and testing sites. They simplify the testing process, reducing the need for extensive manual preparation and minimizing the risk of errors. Standardization also facilitates inter-laboratory comparability, making it easier for healthcare providers to interpret and act upon test results.

Breakup by Usability:

• Disposable IVD Devices
• Reusable IVD Devices

Disposable IVD devices are designed for single-use and are discarded after a single patient interaction or testing procedure. They are pre-sterilized and come in a ready-to-use format, which eliminates the need for cleaning, disinfection, or reprocessing after each use. Healthcare providers find disposable IVD devices convenient and time-saving, as they eliminate the need for complex and time-consuming reprocessing procedures. This is especially advantageous in high-volume testing environments.

Reusable IVD devices, as the name suggests, can be used multiple times after appropriate cleaning, sterilization, and maintenance. They are made of durable materials that can withstand repeated use without compromising their performance. They also offer greater flexibility in terms of test customization and parameter adjustments, making them suitable for research and specialized testing needs.

Breakup by Application:

• Infectious Disease
• Diabetes
• Cancer/Oncology
• Cardiology
• Autoimmune Disease
• Nephrology
• Others

Infectious diseases currently dominate the market

Infectious diseases pose significant global health challenges, and outbreaks or pandemics can have severe consequences on public health and economies. The COVID-19 pandemic, for example, has highlighted the critical role of diagnostic testing in controlling the spread of infectious diseases. Besides, infectious diseases have a high incidence and prevalence rate, affecting millions of people worldwide. Common infectious diseases such as influenza, tuberculosis, hepatitis, and sexually transmitted infections continue to impact communities across the globe. Moreover, in vitro diagnostics offer a rapid and reliable way to identify infectious agents, allowing healthcare providers to initiate appropriate therapies, implement infection control measures, and prevent further transmission.

Breakup by End User:

• Hospitals Laboratories
• Clinical Laboratories
• Point-of-care Testing Centers
• Academic Institutes
• Patients
• Others

Hospital laboratories are an essential part of healthcare facilities, providing diagnostic testing services to inpatients and outpatients. These laboratories are equipped with a wide range of IVD instruments and reagents to perform various tests, including clinical chemistry, hematology, microbiology, and immunology. Hospitals rely on timely and accurate diagnostic results from their in-house laboratories to aid in patient diagnosis, treatment, and disease management.

Clinical laboratories, also known as independent or reference laboratories, are separate entities that offer diagnostic testing services to healthcare providers, hospitals, clinics, and other healthcare settings. They often handle high-volume and specialized tests that may not be available in all hospital laboratories. Clinical laboratories serve as centralized testing facilities, supporting multiple healthcare facilities with their comprehensive testing capabilities.

Point-of-care testing (POCT) centers represent a rapidly growing segment in the IVD market. These centers provide diagnostic tests at or near the location where patient care is delivered. POCT devices offer rapid results, allowing for immediate treatment decisions and interventions. Point-of-care testing centers are especially valuable in emergency rooms, ambulances, nursing homes, and remote or resource-limited settings where quick diagnosis is critical.

Academic institutes, including research universities and medical schools, contribute to the IVD market through research, development, and education. They play a pivotal role in advancing diagnostic technologies, discovering new biomarkers, and evaluating the effectiveness of diagnostic tests. Academic institutes often collaborate with diagnostic companies to conduct clinical trials and validate the performance of novel diagnostic assays.

Patients are becoming increasingly involved in their healthcare decisions, including diagnostic testing. The IVD market caters to the direct-to-consumer testing trend, where patients can access certain diagnostic tests without a healthcare provider's prescription. These tests allow individuals to monitor their health status, identify risk factors, and take proactive steps towards better health management.

Breakup by Region:

• North America
• United States
• Canada
• Asia-Pacific
• China
• Japan
• India
• South Korea
• Australia
• Indonesia
• Others
• Europe
• Germany
• France
• United Kingdom
• Italy
• Spain
• Russia
• Others
• Latin America
• Brazil
• Mexico
• Others
• Middle East and Africa

North America accounts for the majority of market share

The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (United States, Canada); Asia-Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others); Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others); Latin America (Brazil, Mexico, Others); and the Middle East and Africa. According to the report, North America was the largest market for in vitro diagnostics.

North America boasts a well-developed and advanced healthcare infrastructure, including modern hospitals, clinical laboratories, and research institutions. The region's robust healthcare system supports a high volume of diagnostic testing, driving the demand for IVD products and services. Besides, North America is at the forefront of technological innovations in the IVD industry. The region is home to many leading diagnostic companies and research institutions that invest heavily in research and development, leading to the creation of cutting-edge diagnostic technologies and products. Moreover, the region has stringent regulatory standards for diagnostic products, ensuring safety and efficacy. Companies operating in the region must comply with rigorous quality control measures, which helps build trust in the reliability of IVD products.

Competitive Landscape:

The competitive landscape of the In vitro diagnostics (IVD) market is characterized by a diverse and highly competitive environment, with numerous companies vying for market share. They are developing advanced technologies, novel biomarkers, and point-of-care testing devices to meet the evolving needs of the healthcare industry. They are engaging in mergers and acquisitions (M&As) to expand their product portfolios, gain access to new markets, and enhance their technological capabilities. They are also expanding their market presence by establishing distribution networks in new regions or countries. Moreover, companies are embracing digitalization and investing in digital diagnostic solutions. This includes the development of digital pathology, remote monitoring, and telehealth solutions to enhance diagnostic efficiency and accessibility.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Abbott Laboratories
• Agilent Technologies Inc.
• Biomerieux SA
• Bio-Rad Laboratories Inc.
• F. Hoffmann-La Roche Ltd
• Fujifilm Holdings Corporation
• Illumina Inc.
• Qiagen N.V
• Quest Diagnostics
• Shimadzu Corporation
• Siemens Healthcare GmbH
• Sysmex Corporation

Key Questions Answered in This Report

• 1.What is the IVD market?
• 2.What is the global outlook on the in vitro diagnostics industry?
• 3.What is the market size of in vitro diagnostics?
• 4.What are the key factors driving the in vitro diagnostics market?
• 5.Which region accounts for the largest in vitro diagnostics market share?
• 6.Which are the leading companies in the global in vitro diagnostics market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global In Vitro Diagnostics Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Test Type

• 6.1 Clinical Chemistry
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Molecular Diagnostics
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Immunodiagnostics
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast
• 6.4 Hematology
  • 6.4.1 Market Trends
  • 6.4.2 Market Forecast
• 6.5 Others
  • 6.5.1 Market Trends
  • 6.5.2 Market Forecast

7 Market Breakup by Product

• 7.1 Reagents and Kits
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Instruments
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast

8 Market Breakup by Usability

• 8.1 Disposable IVD Devices
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Reusable IVD Devices
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast

9 Market Breakup by Application

• 9.1 Infectious Disease
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Diabetes
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Cancer/Oncology
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Cardiology
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast
• 9.5 Autoimmune Disease
  • 9.5.1 Market Trends
  • 9.5.2 Market Forecast
• 9.6 Nephrology
  • 9.6.1 Market Trends
  • 9.6.2 Market Forecast
• 9.7 Others
  • 9.7.1 Market Trends
  • 9.7.2 Market Forecast

10 Market Breakup by End User

• 10.1 Hospitals Laboratories
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Clinical Laboratories
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Point-of-care Testing Centers
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast
• 10.4 Academic Institutes
  • 10.4.1 Market Trends
  • 10.4.2 Market Forecast
• 10.5 Patients
  • 10.5.1 Market Trends
  • 10.5.2 Market Forecast
• 10.6 Others
  • 10.6.1 Market Trends
  • 10.6.2 Market Forecast

11 Market Breakup by Region

• 11.1 North America
  • 11.1.1 United States
    • 11.1.1.1 Market Trends
    • 11.1.1.2 Market Forecast
  • 11.1.2 Canada
    • 11.1.2.1 Market Trends
    • 11.1.2.2 Market Forecast
• 11.2 Asia-Pacific
  • 11.2.1 China
    • 11.2.1.1 Market Trends
    • 11.2.1.2 Market Forecast
  • 11.2.2 Japan
    • 11.2.2.1 Market Trends
    • 11.2.2.2 Market Forecast
  • 11.2.3 India
    • 11.2.3.1 Market Trends
    • 11.2.3.2 Market Forecast
  • 11.2.4 South Korea
    • 11.2.4.1 Market Trends
    • 11.2.4.2 Market Forecast
  • 11.2.5 Australia
    • 11.2.5.1 Market Trends
    • 11.2.5.2 Market Forecast
  • 11.2.6 Indonesia
    • 11.2.6.1 Market Trends
    • 11.2.6.2 Market Forecast
  • 11.2.7 Others
    • 11.2.7.1 Market Trends
    • 11.2.7.2 Market Forecast
• 11.3 Europe
  • 11.3.1 Germany
    • 11.3.1.1 Market Trends
    • 11.3.1.2 Market Forecast
  • 11.3.2 France
    • 11.3.2.1 Market Trends
    • 11.3.2.2 Market Forecast
  • 11.3.3 United Kingdom
    • 11.3.3.1 Market Trends
    • 11.3.3.2 Market Forecast
  • 11.3.4 Italy
    • 11.3.4.1 Market Trends
    • 11.3.4.2 Market Forecast
  • 11.3.5 Spain
    • 11.3.5.1 Market Trends
    • 11.3.5.2 Market Forecast
  • 11.3.6 Russia
    • 11.3.6.1 Market Trends
    • 11.3.6.2 Market Forecast
  • 11.3.7 Others
    • 11.3.7.1 Market Trends
    • 11.3.7.2 Market Forecast
• 11.4 Latin America
  • 11.4.1 Brazil
    • 11.4.1.1 Market Trends
    • 11.4.1.2 Market Forecast
  • 11.4.2 Mexico
    • 11.4.2.1 Market Trends
    • 11.4.2.2 Market Forecast
  • 11.4.3 Others
    • 11.4.3.1 Market Trends
    • 11.4.3.2 Market Forecast
• 11.5 Middle East and Africa
  • 11.5.1 Market Trends
  • 11.5.2 Market Breakup by Country
  • 11.5.3 Market Forecast

12 SWOT Analysis

• 12.1 Overview
• 12.2 Strengths
• 12.3 Weaknesses
• 12.4 Opportunities
• 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

• 14.1 Overview
• 14.2 Bargaining Power of Buyers
• 14.3 Bargaining Power of Suppliers
• 14.4 Degree of Competition
• 14.5 Threat of New Entrants
• 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

• 16.1 Market Structure
• 16.2 Key Players
• 16.3 Profiles of Key Players
  • 16.3.1 Abbott Laboratories
    • 16.3.1.1 Company Overview
    • 16.3.1.2 Product Portfolio
    • 16.3.1.3 Financials
    • 16.3.1.4 SWOT Analysis
  • 16.3.2 Agilent Technologies Inc.
    • 16.3.2.1 Company Overview
    • 16.3.2.2 Product Portfolio
    • 16.3.2.3 Financials
    • 16.3.2.4 SWOT Analysis
  • 16.3.3 Biomerieux SA
    • 16.3.3.1 Company Overview
    • 16.3.3.2 Product Portfolio
    • 16.3.3.3 Financials
    • 16.3.3.4 SWOT Analysis
  • 16.3.4 Bio-Rad Laboratories Inc.
    • 16.3.4.1 Company Overview
    • 16.3.4.2 Product Portfolio
    • 16.3.4.3 Financials
    • 16.3.4.4 SWOT Analysis
  • 16.3.5 F. Hoffmann-La Roche Ltd
    • 16.3.5.1 Company Overview
    • 16.3.5.2 Product Portfolio
    • 16.3.5.3 SWOT Analysis
  • 16.3.6 Fujifilm Holdings Corporation
    • 16.3.6.1 Company Overview
    • 16.3.6.2 Product Portfolio
    • 16.3.6.3 Financials
    • 16.3.6.4 SWOT Analysis
  • 16.3.7 Illumina Inc.
    • 16.3.7.1 Company Overview
    • 16.3.7.2 Product Portfolio
    • 16.3.7.3 Financials
    • 16.3.7.4 SWOT Analysis
  • 16.3.8 Qiagen NV
    • 16.3.8.1 Company Overview
    • 16.3.8.2 Product Portfolio
    • 16.3.8.3 Financials
    • 16.3.8.4 SWOT Analysis
  • 16.3.9 Quest Diagnostics
    • 16.3.9.1 Company Overview
    • 16.3.9.2 Product Portfolio
    • 16.3.9.3 Financials
    • 16.3.9.4 SWOT Analysis
  • 16.3.10 Shimadzu Corporation
    • 16.3.10.1 Company Overview
    • 16.3.10.2 Product Portfolio
    • 16.3.10.3 Financials
    • 16.3.10.4 SWOT Analysis
  • 16.3.11 Siemens Healthcare GmbH
    • 16.3.11.1 Company Overview
    • 16.3.11.2 Product Portfolio
  • 16.3.12 Sysmex Corporation
    • 16.3.12.1 Company Overview
    • 16.3.12.2 Product Portfolio
    • 16.3.12.3 Financials
    • 16.3.12.4 SWOT Analysis