The global In vitro diagnostics market is projected to reach USD 157,632.5 million by 2030 from USD 109,065.5 million in 2025, at a CAGR of 7.6% during the forecast period. This is due to the increasing global burden of chronic diseases such as diabetes, cardiovascular conditions, cancer, and infectious diseases (e.g., HIV, tuberculosis). Demand for faster results, decentralized testing, and home-based diagnostics are pushing growth in point-of-care (POC) testing devices, innovations such as high-throughput systems, lab-on-a-chip, next-generation sequencing (NGS), and POC diagnostics, and government and private sector investments in healthcare infrastructure, especially in developing economies, are improving access to diagnostic services.
Scope of the Report
Years Considered for the Study
2024-2030
Base Year
2024
Forecast Period
2024-2030
Units Considered
Value (USD million)
Segments
Product & Service, Technology, Specimen, Site of Testing, Application, End User, and Region
Regions covered
North America, Europe, APAC, LATAM, MEA
The reagents & kits segment is expected to grow at the highest CAGR during the forecast period.
Based on the product, the in vitro diagnostics market is divided into reagents & kits, instruments, and data management software & services. In 2024, the reagents & kits segment grew at the highest CAGR in vitro diagnostics market. This is due to the growing number of tests across hospitals, labs, and home settings, the expansion of rapid and self-testing kits, especially for glucose, pregnancy, and infectious disease detection, the expansion of clinical laboratories, diagnostic chains, and POC testing environments increases reagent usage. Continuous product launches and regulatory approvals-such as CE-IVD marking and FDA clearances-are expanding the portfolio and accessibility of specialized test kits across various clinical applications.
The infectious diseases segment of the in vitro diagnostics market, by application, is expected to hold the largest market share during the forecast period.
Based on application, the in vitro diagnostics market is segmented into infectious diseases, oncology, endocrinology, cardiology, blood screening, genetic testing, autoimmune diseases, allergy diagnostic, drug monitoring & testing, bone & mineral disorders, coagulation testing, blood group typing, and other applications. The infectious disease segment accounts for the largest market share of the in vitro diagnostics market due to the continued prevalence of diseases such as HIV, hepatitis, and tuberculosis, and emerging threats such as Malaria and Mpox, the need for fast, accessible testing-especially in remote or resource-limited settings-has boosted the adoption of portable and easy-to-use IVD kits for infectious diseases, and technologies such as RT-PCR (Reverse transcription polymerase chain reaction) and syndromic panel testing enable accurate, high-throughput diagnosis of multiple pathogens, driving growth in hospital and lab settings.
Asia Pacific is expected to hold the highest CAGR in the in vitro diagnostics market during the forecast period.
The global in vitro diagnostics market is segmented into six major regions, namely, North America, Europe, Asia Pacific, Latin America, Middle East & Africa, and GCC Countries. Asia Pacific is estimated to grow at the highest CAGR during the forecast period. The IVD market in the Asia Pacific region is growing rapidly due to the increasing prevalence of communicable and non-communicable diseases, especially in highly populated countries such as China and India. These countries are seeing a rise in conditions such as diabetes, cancer, cardiovascular diseases, tuberculosis, and hepatitis. Concurrently, the aging population is driving the IVD market in the Asia Pacific region, especially in Japan, South Korea, and China. For instance, within China, 216.76 million people are aged 65 and above, or 15.4% of the population, a 2023 report by China's Ministry of Civil Affairs and the China National Committee on Aging stated. This trend is resulting in a growing demand for chronic disease monitoring and regular diagnostics. In an effort to increase local production and decrease the reliance on imports, regional governments are promoting the manufacture of diagnostic reagents, kits, and equipment locally, thus also fuelling the growth of the market.
A breakdown of the primary participants referred to for this report is provided below:
By Company Type: Tier 1- 42%, Tier 2- 30%, and Tier 3- 28%
By Designation: C-level- 46%, Director level- 23%, and Others- 31%
By Region: North America- 23%, Europe- 45%, Asia Pacific- 28%, Latin America- 3%, Middle East & Africa- 0.5%, and GCC Countries- 0.5 %
Note 1: Companies are classified into tiers based on their total revenue. As of 2023, Tier 1 = >USD 10.0 billion, Tier 2 = USD 1.0 billion to USD 10.0 billion, and Tier 3 = <USD 1.0 billion.
Note 2: C-level primaries include CEOs, CFOs, COOs, and VPs.
Note 3: Others include sales managers, marketing managers, business development managers, product managers, distributors, and suppliers.
The major players operating in the in vitro diagnostics market include Danaher (US), F. Hoffmann-La Roche Ltd (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (US), Illumina, Inc. (US), Hologic, Inc. (US), Bio-Rad Laboratories, Inc. (US), bioMerieux (France), Sysmex Corporation (Japan), Revvity (US), Becton, Dickinson and Company (US), Agilent Technologies, Inc. (US), Qiagen (Germany), DiaSorin S.p.A. (Italy), Grifols, S.A. (Spain), Werfen (Spain), and QuidelOrtho Corporation, (US) among others.
Research Coverage
This report studies the in vitro diagnostics market based on product & service, technology, specimen, site of testing, application, end user, and region. The report also studies factors (such as drivers, restraints, opportunities, and challenges) affecting market growth and provides details of the competitive landscape for market leaders. Furthermore, the report analyzes micro markets with respect to their individual growth trends and forecasts the revenue of the market segments with respect to six major regions (and the respective countries in these regions).
Reasons to Buy the Report
The report will enable established firms as well as entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them to gain a larger market share. Firms purchasing the report could use one or a combination of the below-mentioned strategies to strengthen their market presence.
This report provides insights on the following points:
Analysis of key drivers (Increasing geriatric population and subsequent rise in chronic diseases, growing awareness of early disease diagnosis in emerging economies, emergence of rapid PoC technologies and rising adoption of automated analyzers, growing preference for personalized medicines), restraints (Unfavorable reimbursement scenario, stringent regulatory requirements, High cost of diagnostic equipment), opportunities (introduction of disease-specific biomarkers and tests, increasing significance of companion diagnostics, growth opportunities in developing countries, Improvements in immunoassay diagnostic technologies, digitalization trend), challenges (operational barriers, data privacy, and cybersecurity risks)
Market Penetration: Complete knowledge of the spectrum of products presented by the major companies in the in vitro diagnostics market
Product Development/Innovation: Comprehensive understanding of the forthcoming trends, research and development initiatives, and product launches within the in vitro diagnostics market
Market Development: Complete knowledge about profitable developing regions
Market Diversification: Exhaustive knowledge of new goods, expanding geographies, and current changes in the in vitro diagnostics industry helps to diversify the market
Competitive Assessment: Comprehensive evaluation of market segmentation, development plans, income analysis, and goods of the top market participants
TABLE OF CONTENTS
1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.3 STUDY SCOPE
1.3.1 MARKETS COVERED AND REGIONAL SCOPE
1.3.2 INCLUSIONS AND EXCLUSIONS
1.3.3 YEARS CONSIDERED
1.4 CURRENCY CONSIDERED
1.5 STAKEHOLDERS
1.6 SUMMARY OF CHANGES
2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.1.1 SECONDARY RESEARCH
2.1.1.1 Key data from secondary sources
2.1.2 PRIMARY DATA
2.1.2.1 Primary sources
2.1.2.2 Key data from primary sources
2.1.2.3 Key industry insights
2.2 MARKET SIZE ESTIMATION
2.2.1 BOTTOM-UP APPROACH
2.2.1.1 Approach 1: Company revenue estimation approach
2.2.1.2 Approach 2: Presentations of companies and primary interviews
2.2.1.3 Growth forecast
2.2.2 TOP-DOWN APPROACH
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION
2.4 MARKET SHARE ANALYSIS
2.5 RESEARCH ASSUMPTIONS
2.5.1 PARAMETRIC ASSUMPTIONS
2.5.2 GROWTH RATE ASSUMPTIONS
2.6 RESEARCH LIMITATIONS
2.7 RISK ASSESSMENT
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 IN VITRO DIAGNOSTICS MARKET OVERVIEW
4.2 NORTH AMERICA: IN VITRO DIAGNOSTICS MARKET, BY PRODUCT & SERVICE AND COUNTRY, 2024
4.3 IN VITRO DIAGNOSTICS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES
4.4 IN VITRO DIAGNOSTICS MARKET: GEOGRAPHIC MIX
4.5 IN VITRO DIAGNOSTICS MARKET: EMERGING ECONOMIES VS. DEVELOPED MARKETS
5 MARKET OVERVIEW
5.1 INTRODUCTION
5.2 MARKET DYNAMICS
5.2.1 DRIVERS
5.2.1.1 Increasing geriatric population and subsequent rise in chronic diseases
5.2.1.2 Growing awareness of early disease diagnosis in emerging economies
5.2.1.3 Emergence of rapid PoC technologies and rising adoption of automated analyzers
5.2.1.4 Growing preference for personalized medicines
5.2.2 RESTRAINTS
5.2.2.1 Unfavorable reimbursement scenario
5.2.2.2 Stringent regulatory requirements
5.2.2.3 High cost of diagnostic equipment
5.2.3 OPPORTUNITIES
5.2.3.1 Introduction of disease-specific biomarkers and tests
5.2.3.2 Increasing significance of companion diagnostics
5.2.3.3 Growth opportunities in developing countries
5.2.3.4 Improvements in immunoassay diagnostic technologies
5.2.3.5 Digitalization trend
5.2.4 CHALLENGES
5.2.4.1 Operational barriers
5.2.4.2 Data privacy and cybersecurity risks
5.3 TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS
5.4 PRICING ANALYSIS
5.4.1 AVERAGE SELLING PRICE TREND, BY KEY PLAYER
5.4.2 AVERAGE SELLING PRICE TREND, BY REGION
5.4.3 AVERAGE SELLING PRICE TREND, BY PRODUCT
5.5 VALUE CHAIN ANALYSIS
5.5.1 RESEARCH & DEVELOPMENT
5.5.2 RAW MATERIAL SUPPLIERS
5.5.3 MANUFACTURING
5.5.4 DISTRIBUTION, MARKETING, AND SALES
5.5.5 RETAILERS
5.5.6 POST-SALES SERVICES
5.6 SUPPLY CHAIN ANALYSIS
5.6.1 PROMINENT COMPANIES
5.6.2 SMALL & MEDIUM-SIZED ENTERPRISES
5.6.3 END USERS
5.7 ECOSYSTEM ANALYSIS
5.8 INVESTMENT AND FUNDING SCENARIO
5.9 TECHNOLOGY ANALYSIS
5.9.1 KEY TECHNOLOGIES
5.9.2 COMPLEMENTARY TECHNOLOGIES
5.9.2.1 Immunohistochemistry
5.10 PATENT ANALYSIS
5.11 TRADE ANALYSIS
5.11.1 IMPORT DATA FOR HS CODE 382200
5.11.2 EXPORT DATA FOR HS CODE 382200
5.12 KEY CONFERENCES AND EVENTS, 2025-2026
5.13 CASE STUDY ANALYSIS
5.13.1 CASE STUDY 1: LOCALIZED STRATEGY TO TAP MARKET POTENTIAL IN EUROPE
5.13.2 CASE STUDY 2: ENHANCED COMPANY FOOTPRINT IN COMPETITIVE INDIAN MARKET
5.13.3 CASE STUDY 3: CUSTOMER-CENTRIC DIFFERENTIATION FOR PRODUCT OPTIMIZATION AND PREMIUM PRICING
5.14 REGULATORY LANDSCAPE
5.14.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
5.15 REGULATORY FRAMEWORK
5.15.1 NORTH AMERICA
5.15.1.1 US
5.15.1.2 Canada
5.15.2 EUROPE
5.15.3 ASIA PACIFIC
5.15.3.1 Japan
5.15.3.2 China
5.15.3.3 India
5.15.3.4 South Korea
5.15.3.5 Indonesia
5.15.3.6 Russia
5.15.4 MIDDLE EAST & AFRICA
5.15.4.1 Saudi Arabia
5.15.4.2 Africa
5.15.5 LATIN AMERICA
5.15.5.1 Mexico
5.15.5.2 Brazil
5.16 PORTER'S FIVE FORCES ANALYSIS
5.16.1 BARGAINING POWER OF SUPPLIERS
5.16.2 BARGAINING POWER OF BUYERS
5.16.3 THREAT OF NEW ENTRANTS
5.16.4 THREAT OF SUBSTITUTES
5.16.5 INTENSITY OF COMPETITIVE RIVALRY
5.17 KEY STAKEHOLDERS AND BUYING CRITERIA
5.17.1 KEY STAKEHOLDERS IN BUYING PROCESS
5.17.2 BUYING CRITERIA
5.18 RECENT POLICY CHANGES IN US MARKET AND THEIR POTENTIAL IMPACT ON APPROVAL PROCESS
5.19 INFLUENCE OF TARIFFS ON SUPPLY CHAIN RESILIENCE OF MEDTECH COMPANIES
5.20 GROWTH OF DECENTRALIZED TESTING VS. ADOPTION OF COST-EFFECTIVE CENTRALIZED TESTING
5.21 IMPACT OF AI/GENERATIVE AI ON IN VITRO DIAGNOSTICS MARKET
5.21.1 INTRODUCTION
5.21.2 MARKET POTENTIAL OF AI IN IVD DEVICES
5.21.3 AI USE CASES
5.21.4 KEY COMPANIES IMPLEMENTING AI
5.21.5 FUTURE OF GENERATIVE AI IN IN VITRO DIAGNOSTICS MARKET
6 IN VITRO DIAGNOSTICS MARKET, BY PRODUCT & SERVICE
6.1 INTRODUCTION
6.2 REAGENTS & KITS
6.2.1 RISE IN TEST VOLUMES ACROSS CLINICAL LABS, HOSPITALS, AND POINT-OF-CARE SETTINGS TO AID GROWTH
6.3 INSTRUMENTS
6.3.1 GROWING TREND OF AUTOMATION TO DRIVE MARKET
6.4 DATA MANAGEMENT SOFTWARE & SERVICES
6.4.1 INCREASING SHIFT TOWARD CLOUD-BASED PLATFORMS AND REMOTE DATA ACCESS TO STIMULATE GROWTH
7 IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY
7.1 INTRODUCTION
7.2 IMMUNOASSAYS
7.2.1 ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISA)
7.2.1.1 Increasing use of immunoassays in cancer, infectious disease testing, and therapeutic drug monitoring to aid growth
7.2.2 CHEMILUMINESCENCE IMMUNOASSAYS
7.2.2.1 Need for minimal human intervention to support growth
7.2.3 IMMUNOFLUORESCENCE ASSAYS
7.2.3.1 Growing introduction of innovative diagnostic platforms to drive market
7.2.4 RAPID TESTS
7.2.4.1 Need for rapid diagnostic tests to expedite growth
7.2.5 ENZYME-LINKED IMMUNOSPOT ASSAYS (ELISPOT)
7.2.5.1 Need for early detection and monitoring of immune-related disorders to amplify growth
7.2.6 WESTERN BLOTTING
7.2.6.1 Increasing focus on biomarker discovery and personalized treatment to advance growth
7.2.7 OTHER IMMUNOASSAY TECHNOLOGIES
7.3 CLINICAL CHEMISTRY
7.3.1 BASIC METABOLIC PANELS
7.3.1.1 Increasing incidence of diabetes, kidney disorders, and hypertension to promote growth
7.3.2 LIVER PANELS
7.3.2.1 Rising prevalence of cirrhosis and viral hepatitis to foster growth
7.3.3 RENAL PROFILES
7.3.3.1 Growing awareness for preventive health check-ups to boost market
7.3.4 LIPID PROFILES
7.3.4.1 Rising prevalence of obesity to accelerate growth
7.3.5 THYROID FUNCTION PROFILES
7.3.5.1 High incidence of thyroid-related disorders to support growth
7.3.6 ELECTROLYTE PANELS
7.3.6.1 Growing shift toward home care and remote patient monitoring to fuel market
7.3.7 SPECIALTY CHEMICAL TESTS
7.3.7.1 Rising demand for specialized tests to contribute to growth
7.4 MOLECULAR DIAGNOSTICS
7.4.1 POLYMERASE CHAIN REACTION
7.4.1.1 High accuracy and speed in detecting pathogens to aid growth