In Vitro Diagnostics Market By Product Type (Reagents And Kits, Instruments, Services), By Application (Infectious Diseases, Oncology, Diabetes, Cardiology), By End-User (Hospital And Clinics, Diagnostic Laboratories, Research Institutes, Home Care Settings), And Region For 2024-2031
Report ID: 42365|No. of Pages: 202
In Vitro Diagnostics Market By Product Type (Reagents And Kits, Instruments, Services), By Application (Infectious Diseases, Oncology, Diabetes, Cardiology), By End-User (Hospital And Clinics, Diagnostic Laboratories, Research Institutes, Home Care Settings), And Region For 2024-2031
In Vitro Diagnostics Market Valuation – 2024-2031
A strong emphasis on early disease detection is a major driver in the in-vitro diagnostics (IVD) market, contributing to improved healthcare outcomes and reduced costs. Thus, the growing emphasis on early detection surged the growth of the market size, surpassing USD 108.97 Billion in 2023 to reach a valuation of USD 163.34 Billion by 2031.
The rising demand for personalized medicine, which tailors treatment to individual patient profiles, has also accelerated the adoption of IVD solutions. Thus, the shift toward personalized care enables the market to grow at a CAGR of 5.19% from 2024 to 2031.
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In Vitro Diagnostics Market: Definition/ Overview
In-vitro diagnostics (IVD) are essential medical devices that conduct diagnostic tests on biological samples, including blood, urine, and tissue, to identify and monitor various diseases and health conditions. These tests play a vital role in detecting infectious diseases, autoimmune disorders, and other medical conditions, and they are increasingly used to adjust and optimize drug therapies for individual patients. A significant trend in the IVD industry is the growth of molecular diagnostics, which focuses on analyzing genetic material, proteins, and other molecules to diagnose and manage diseases with high precision.
Advancements in molecular diagnostics, particularly within genomics and proteomics, have transformed IVD capabilities by enabling the detection of specific gene mutations and biomarkers linked to particular diseases. This progress allows for more accurate and tailored diagnoses, leading to the development of personalized treatment plans. Molecular diagnostics has profoundly impacted disease management in critical areas like oncology, infectious diseases, and genetic disorders, where precise identification of disease markers can guide individualized treatment approaches. The ongoing expansion of molecular diagnostics within the IVD field represents a leap forward in healthcare, supporting early diagnosis, informed decision-making, and improved patient outcomes.
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How do the Increasing Geriatric Population and Rising Chronic Diseases Surge the Growth of In Vitro Diagnostics Market?
The increasing aging population and growing chronic disorders cases surge the growth of in vitro diagnostics market. The WHO reported that between 2020 and 2023, the proportion of people aged 60+ years increased to 1.4 billion. According to the UN’s World Population Prospects 2022, by 2050, 1 in 6 people worldwide will be over 65 years old. This demographic requires more frequent diagnostic testing and disease monitoring. The CDC reported in 2022 that 6 in 10 American adults have at least one chronic disease. Diabetes affected approximately 537 million adults worldwide in 2021 according to the International Diabetes Federation. The American Heart Association stated that 48% of US adults had some form of cardiovascular disease in 2021. The FDA approved over 120 new IVD tests and devices between 2020-2022. The point-of-care testing market saw a 15% CAGR from 2020-2023. Molecular diagnostics segment grew by 30% during the pandemic period (2020-2021)
Over 2 billion COVID-19 tests were performed globally in 2021 according to WHO estimates. The global molecular diagnostics market reached USD 36.2 Billion in 2022. CDC reported that COVID-19 testing infrastructure improved laboratory capabilities for other infectious disease testing by 40%. The US healthcare spending reached USD 4.3 Trillion in 2021. The WHO reported global healthcare spending grew by 11% between 2020 and 2022. Medicare spending on diagnostic testing increased by 23% from 2020 to 2022.
How do the High Costs of Equipment and Maintenance Impede the Growth of In Vitro Diagnostics Market?
The high cost of equipment and maintenance hamper the growth of the in vitro diagnostics market. The average cost of a high-end molecular diagnostic system ranges from $100,000 to $500,000 as of 2022. Annual maintenance costs typically represent 10-15% of the initial equipment purchase price. According to a 2022 healthcare cost analysis, smaller laboratories spend approximately $150,000-$200,000 annually on IVD equipment maintenance. Also, the lack of skilled labor hinders market growth. The American Society for Clinical Laboratory Science reported a 7% vacancy rate for laboratory positions in 2022. According to the Bureau of Labor Statistics, there was a shortage of approximately 25,000 laboratory professionals in 2022. Training costs per laboratory technician averaged $40,000-$60,000 in 2021.
The stringent regulatory requirements and the reimbursement challenges in the industry act as a challenge for the market. FDA reported that the average time for IVD device approval increased to 9-12 months in 2022. Regulatory compliance costs increased by 25% between 2020 and 2022. Companies spent an average of $250,000-$500,000 per IVD device for regulatory submissions in 2022. Medicare reduced reimbursement rates for certain diagnostic tests by 15-20% in 2022. According to CMS data, laboratory test reimbursements decreased by an average of 10% between 2020-2022. Insurance claim denials for diagnostic tests increased by 23% in 2021 compared to 2020
Category-Wise Acumens
How the Precise and Efficient Diagnostic Test Surge the Growth of Reagents & Kits Segment?
The reagents & kits segment dominates the in vitro diagnostics (IVD) market owing to their vital role in performing accurate and efficient diagnostic tests. These products are essential for identifying and measuring biomarkers, pathogens, and other analytes across a range of biological samples, making them indispensable in diagnostics. A notable example of innovation within this segment occurred in February 2022, when Invitae Corporation introduced its CE-IVD-certified cancer testing kits, FusionPlex Dx and LiquidPlex Dx, in Europe. These advanced kits are tailored to enhance precision oncology, enabling more reliable cancer detection and management solutions, which respond to the increasing demand for effective diagnostic tools in the European healthcare market.
With continuous advancements and product launches, the Reagents & Kits segment reinforces its importance within the IVD field. Such innovations drive market growth and support the broader shift toward personalized medicine, which seeks to improve patient outcomes by providing tailored diagnostic and treatment options. By facilitating high-quality diagnostics, reagents and kits contribute significantly to expanding possibilities for individualized patient care, reinforcing their position as a cornerstone in the evolving IVD landscape.
How the Growing Prevalence of Infectious Disease Foster the Growth of Infectious Diseases Segment?
The infectious diseases segment holds a dominant in the in vitro diagnostics (IVD) market, driven by the increasing prevalence of infectious diseases such as HIV, tuberculosis, influenza, and hepatitis. The global demand for early and accurate diagnostics has grown significantly as healthcare systems prioritize rapid identification and treatment of these diseases to prevent widespread transmission. Moreover, the need for swift diagnostics and large-scale screening is amplified by government initiatives focused on controlling outbreaks and reducing disease impact. This focus has bolstered investment and innovation within the infectious disease diagnostics space.
With a particular emphasis on diseases like hepatitis, pneumonia, HIV-AIDS, and tuberculosis. As the incidence of these conditions rises globally, key industry players are accelerating efforts to develop innovative diagnostic systems designed to improve the speed, accuracy, and accessibility of testing. These advancements address the rising infectious disease burden and support effective response measures in urban and remote healthcare settings. As a result, the infectious diseases segment continues to play a pivotal role in the IVD landscape, addressing public health needs and reinforcing its dominance through ongoing technological progress and strategic initiatives.
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Country/Region-wise Acumens
How the Substantial Healthcare Expenditure and Robust Infrastructure Surge the Growth of In Vitro Diagnostic Market in North America?
North America substantially dominates the in vitro diagnostic market driven by the high healthcare expenditure & advanced healthcare infrastructure. According to the Centers for Medicare & Medicaid Services, U.S. healthcare spending reached USD 4.3 Trillion in 2021, representing 18.3% of GDP. According to the American Hospital Association, as of 2022, there were over 6,000 hospitals in the U.S. with sophisticated diagnostic laboratories. Canada’s healthcare spending exceeded USD 300 Billion in 2021, with significant investments in diagnostic infrastructure.
In addition, the rising prevalence of chronic diseases also contributes to the growth of in vitro diagnostics market. According to the CDC (2022), 6 in 10 Americans live with at least one chronic disease. According to the report of National Diabetes Statistics diabetes affected approximately 37.3 million Americans (11.3% of the population) in 2022. Cancer diagnoses in the U.S. were projected to reach 1.9 million new cases in 2023.
The growing elderly population requiring regular diagnostics propels the adoption of the in vitro diagnostics market in the region. The U.S. population aged 65 and older grew from 54.1 million in 2019 to nearly 57 million in 2021. By 2030, all baby boomers will be 65 or older, expanding the elderly population to 73 million. Medicare spending on clinical laboratory services reached USD 9.2 Billion in 2020.
How Does the High Population in the Region with Disease Burden Accelerate the Growth of the In Vitro Diagnostic Market in the Asia Pacific?
Asia Pacific is anticipated to witness the fastest growth in the in vitro diagnostic market during the forecast period owing to the large population base with a high disease burden. China and India together account for approximately 2.8 billion people (36% of the global population) as of 2022. In 2021, China reported 4.07 million new cancer cases with growing demand for early diagnostics. India recorded over 77 million diabetes cases in 2021, the second highest globally.
In addition, the rising healthcare expenditure & infrastructure development propel the growth of the market. China’s healthcare spending reached 7.12 trillion yuan (USD 1.1 Trillion) in 2021, rising 13.5% from 2020. Japan’s healthcare expenditure increased to 44.2 trillion yen (USD 333 Billion) in 2021. India allocated USD 10.6 Billion for healthcare infrastructure in the 2022-23 budget, with a significant focus on diagnostic capabilities
Also, the growing aging population & chronic disease management enhance the growth of market growth. According to the Statistics Bureau of Japan. Japan’s elderly population (65+ years) reached 29.1% of total population in 2021. South Korea’s elderly population is expected to reach 20.3% by 2025. China’s 60+ population exceeded 267 million in 2021 (National Bureau of Statistics), creating increased demand for diagnostic services.
Competitive Landscape
The In Vitro Diagnostics (IVD) Market is a highly competitive landscape dominated by a few major players and numerous smaller, specialized companies. Key factors driving competition include technological advancements, regulatory approvals, product innovation, and strategic partnerships.
The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the in vitro diagnostics market include:
- Abbott Laboratories
- Roche Diagnostics
- Siemens Healthineers AG
- Danaher Corporation
- Thermo Fisher Scientific, Inc.
- Johnson & Johnson
- Becton, Dickinson and Company
- Sysmex Corporation
- Merck KGaA
- bioMérieux
Latest Developments:
- In January 2023, Qiagen, a European business, announced the launch of EZ2 Connect MDx IVD, an automated sample platform for diagnostic laboratories.
- In September 2022, ADSTEC and its subsidiary ADS Biotec, a market player in automated instrument development, announced that their HANABI Cytogenetic Automation Instruments had received CE marking under the European Union In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC.
Report Scope
| REPORT ATTRIBUTES | DETAILS |
|---|---|
| Study Period | 2020-2031 |
| Growth Rate | CAGR of ~5.19% from 2024 to 2031 |
| Base Year for Valuation | 2023 |
| Historical Period | 2020-2022 |
| Forecast Period | 2024-2031 |
| Quantitative Units | Value in USD Billion |
| Report Coverage | Historical and Forecast Revenue Forecast, Historical and Forecast Volume, Growth Factors, Trends, Competitive Landscape, Key Players, Segmentation Analysis |
| Segments Covered |
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| Regions Covered |
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| Key Players |
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| Customization | Report customization along with purchase available upon request |
In Vitro Diagnostics Market, By Category
Product Type:
- Reagents & Kits
- Instruments
- Services
Application:
- Infectious Diseases
- Oncology
- Diabetes
- Cardiology
End-User:
- Hospital & Clinics
- Diagnostic Laboratories
- Research Institutes
- Home care settings
Region:
- North America
- Europe
- Asia-Pacific
- South America
- Middle East & Africa
Research Methodology of Verified Market Research
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Reasons to Purchase this Report
• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
• Provision of market value (USD Billion) data for each segment and sub-segment
• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions and acquisitions in the past five years of companies profiled
• Extensive company profiles comprising of company overview, company insights, product benchmarking and SWOT analysis for the major market players
• The current as well as future market outlook of the industry with respect to recent developments (which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
• Includes an in-depth analysis of the market of various perspectives through Porter’s five forces analysis
• Provides insight into the market through Value Chain
• Market dynamics scenario, along with growth opportunities of the market in the years to come
• 6-month post sales analyst support
Customization of the Report
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Frequently Asked Questions
1 INTRODUCTION OF GLOBAL IN VITRO DIAGNOSTICS MARKET
1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions
2 EXECUTIVE SUMMARY
3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH
3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources
4 GLOBAL IN VITRO DIAGNOSTICS MARKET OUTLOOK
4.1 Overview
4.2 Market Dynamics
4.2.1 Drivers
4.2.2 Restraints
4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis
5 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY PRODUCT TYPE
5.1 Overview
5.2 Reagents & Kits
5.3 Instruments
5.4 Services
6 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY APPLICATION
6.1 Overview
6.2 Infectious Diseases
6.3 Oncology
6.4 Diabetes
6.5 Cardiology
7 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY END-USER
7.1 Overview
7.2 Hospital & Clinics
7.3 Diagnostic Laboratories
7.4 Research Institutes
7.5 Home care settings
8 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY GEOGRAPHY
8.1 Overview
8.2 North America
8.2.1 U.S.
8.2.2 Canada
8.2.3 Mexico
8.3 Europe
8.3.1 Germany
8.3.2 U.K.
8.3.3 France
8.3.4 Rest of Europe
8.4 Asia Pacific
8.4.1 China
8.4.2 Japan
8.4.3 India
8.4.4 Rest of Asia Pacific
8.5 Rest of the World
8.5.1 Latin America
8.5.2 Middle East and Africa
9 GLOBAL IN VITRO DIAGNOSTICS MARKET COMPETITIVE LANDSCAPE
9.1 Overview
9.2 Company Market Ranking
9.3 Key Development Strategies
10 COMPANY PROFILES
10.1 Abbott Laboratories
10.1.1 Overview
10.1.2 Financial Performance
10.1.3 Product Outlook
10.1.4 Key Developments
10.2 Roche Diagnostics
10.2.1 Overview
10.2.2 Financial Performance
10.2.3 Product Outlook
10.2.4 Key Developments
10.3 Siemens Healthineers AG
10.3.1 Overview
10.3.2 Financial Performance
10.3.3 Product Outlook
10.3.4 Key Developments
10.4 Danaher Corporation
10.4.1 Overview
10.4.2 Financial Performance
10.4.3 Product Outlook
10.4.4 Key Developments
10.5 Thermo Fisher Scientific, Inc.
10.5.1 Overview
10.5.2 Financial Performance
10.5.3 Product Outlook
10.5.4 Key Developments
10.6 Johnson & Johnson
10.6.1 Overview
10.6.2 Financial Performance
10.6.3 Product Outlook
10.6.4 Key Developments
10.7 Becton, Dickinson and Company
10.7.1 Overview
10.7.2 Financial Performance
10.7.3 Product Outlook
10.7.4 Key Developments
10.8 Sysmex Corporation
10.8.1 Overview
10.8.2 Financial Performance
10.8.3 Product Outlook
10.8.4 Key Developments
10.9 Merck KGaA
10.9.1 Overview
10.9.2 Financial Performance
10.9.3 Product Outlook
10.9.4 Key Developments
10.10 bioMérieux
10.10.1 Overview
10.10.2 Financial Performance
10.10.3 Product Outlook
10.10.4 Key Developments
11 KEY DEVELOPMENTS
11.1 Product Launches/Developments
11.2 Mergers and Acquisitions
11.3 Business Expansions
11.4 Partnerships and Collaborations
12 Appendix
12.1 Related Research
Report Research Methodology
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This additionally supports the market researchers in segmenting different segments of the market for analysing them individually.
We appoint data triangulation strategies to explore different areas of the market. This way, we ensure that all our clients get reliable insights associated with the market. Different elements of research methodology appointed by our experts include:
Exploratory data mining
Market is filled with data. All the data is collected in raw format that undergoes a strict filtering system to ensure that only the required data is left behind. The leftover data is properly validated and its authenticity (of source) is checked before using it further. We also collect and mix the data from our previous market research reports.
All the previous reports are stored in our large in-house data repository. Also, the experts gather reliable information from the paid databases.
For understanding the entire market landscape, we need to get details about the past and ongoing trends also. To achieve this, we collect data from different members of the market (distributors and suppliers) along with government websites.
Last piece of the ‘market research’ puzzle is done by going through the data collected from questionnaires, journals and surveys. VMR analysts also give emphasis to different industry dynamics such as market drivers, restraints and monetary trends. As a result, the final set of collected data is a combination of different forms of raw statistics. All of this data is carved into usable information by putting it through authentication procedures and by using best in-class cross-validation techniques.
Data Collection Matrix
| Perspective | Primary Research | Secondary Research |
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| Supplier side |
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Econometrics and data visualization model
Our analysts offer market evaluations and forecasts using the industry-first simulation models. They utilize the BI-enabled dashboard to deliver real-time market statistics. With the help of embedded analytics, the clients can get details associated with brand analysis. They can also use the online reporting software to understand the different key performance indicators.
All the research models are customized to the prerequisites shared by the global clients.
The collected data includes market dynamics, technology landscape, application development and pricing trends. All of this is fed to the research model which then churns out the relevant data for market study.
Our market research experts offer both short-term (econometric models) and long-term analysis (technology market model) of the market in the same report. This way, the clients can achieve all their goals along with jumping on the emerging opportunities. Technological advancements, new product launches and money flow of the market is compared in different cases to showcase their impacts over the forecasted period.
Analysts use correlation, regression and time series analysis to deliver reliable business insights. Our experienced team of professionals diffuse the technology landscape, regulatory frameworks, economic outlook and business principles to share the details of external factors on the market under investigation.
Different demographics are analyzed individually to give appropriate details about the market. After this, all the region-wise data is joined together to serve the clients with glo-cal perspective. We ensure that all the data is accurate and all the actionable recommendations can be achieved in record time. We work with our clients in every step of the work, from exploring the market to implementing business plans. We largely focus on the following parameters for forecasting about the market under lens:
- Market drivers and restraints, along with their current and expected impact
- Raw material scenario and supply v/s price trends
- Regulatory scenario and expected developments
- Current capacity and expected capacity additions up to 2027
We assign different weights to the above parameters. This way, we are empowered to quantify their impact on the market’s momentum. Further, it helps us in delivering the evidence related to market growth rates.
Primary validation
The last step of the report making revolves around forecasting of the market. Exhaustive interviews of the industry experts and decision makers of the esteemed organizations are taken to validate the findings of our experts.
The assumptions that are made to obtain the statistics and data elements are cross-checked by interviewing managers over F2F discussions as well as over phone calls.
Different members of the market’s value chain such as suppliers, distributors, vendors and end consumers are also approached to deliver an unbiased market picture. All the interviews are conducted across the globe. There is no language barrier due to our experienced and multi-lingual team of professionals. Interviews have the capability to offer critical insights about the market. Current business scenarios and future market expectations escalate the quality of our five-star rated market research reports. Our highly trained team use the primary research with Key Industry Participants (KIPs) for validating the market forecasts:
- Established market players
- Raw data suppliers
- Network participants such as distributors
- End consumers
The aims of doing primary research are:
- Verifying the collected data in terms of accuracy and reliability.
- To understand the ongoing market trends and to foresee the future market growth patterns.
Industry Analysis Matrix
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