Global In–Vitro Diagnostics (IVDs) Medical Device Supply, Demand and Key Producers, 2026-2032
Description
The global In–Vitro Diagnostics (IVDs) Medical Device market size is expected to reach $ 117400 million by 2032, rising at a market growth of 4.0% CAGR during the forecast period (2026-2032).
In Vitro Diagnostic (IVD) tests are a subset of medical devices. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. A medical device is an in vitro diagnostic medical device (IVD) if it is a reagents, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.
The global healthcare spending contributes to ca. 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The IVD market plays a significant role in the HC industry, influencing over 60% of laboratorial decision-making. However, it only accounts for ca. 2% of total HC spending, signifying an enormous potential for cost-effective tests.
The primary driver of growth in the IVD market is the aging of the global population. In addition, prevalence of chronic diseases is anticipated to propel this growth. More, growing demand for point-of-care devices and rapid diagnostic testing and increasing willingness to pay for preventive care testing.
COVID-19 pandemic is expected to continue to positively impact the market in 2020, 2021 and 2022, Due to the relaxation of global epidemic supervision, the reduction of COVID-19 testing in the post-epidemic era will reduce the total market size.
The In Vitro Diagnostics (IVD) market is driven by several key factors, including the rising prevalence of chronic and infectious diseases, advancements in diagnostic technologies, and increasing demand for personalized medicine. Innovations such as next-generation sequencing (NGS), point-of-care testing, and AI-driven diagnostics are transforming the industry by enabling faster, more accurate, and cost-effective testing. Additionally, the growing emphasis on preventive healthcare and the expansion of healthcare access in emerging markets are further fueling market growth. Regulatory support for precision diagnostics and increased investment in R&D also play a significant role in driving the adoption of IVD products globally.
Despite these drivers, the market faces several challenges. Stringent regulatory requirements and the high cost of R&D and clinical validation pose significant barriers for both established players and new entrants. Market saturation in developed regions and price sensitivity in emerging markets make it difficult to balance innovation with affordability. Furthermore, the integration of new diagnostic tools with existing laboratory infrastructure and IT systems can be complex and costly. Lastly, competition from established players and the need for significant capital investment to scale production and distribution add to the challenges for companies operating in this space.
This report studies the global In–Vitro Diagnostics (IVDs) Medical Device demand, key companies, and key regions.
This report is a detailed and comprehensive analysis of the world market for In–Vitro Diagnostics (IVDs) Medical Device, and provides market size (US$ million) and Year-over-Year (YoY) growth, considering 2025 as the base year. This report explores demand trends and competition, as well as details the characteristics of In–Vitro Diagnostics (IVDs) Medical Device that contribute to its increasing demand across many markets.
Highlights and key features of the study
Global In–Vitro Diagnostics (IVDs) Medical Device total market, 2021-2032, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by region & country, CAGR, 2021-2032, (USD Million)
U.S. VS China: In–Vitro Diagnostics (IVDs) Medical Device total market, key domestic companies, and share, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device revenue by player, revenue and market share 2021-2026, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by Type, CAGR, 2021-2032, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by Application, CAGR, 2021-2032, (USD Million)
This report profiles major players in the global In–Vitro Diagnostics (IVDs) Medical Device market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Roche, Abbott, Danaher, Siemens Healthineers, Thermo Fisher Scientific, Sysmex, BioMerieux, Ortho Clinical Diagnostics, Becton Dickinson, Bio-Rad Laboratories, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the world In–Vitro Diagnostics (IVDs) Medical Device market
Detailed Segmentation:
Each section contains quantitative market data including market by value (US$ Millions), by player, by regions, by Type, and by Application. Data is given for the years 2021-2032 by year with 2025 as the base year, 2026 as the estimate year, and 2027-2032 as the forecast year.
Global In–Vitro Diagnostics (IVDs) Medical Device Market, By Region:
United States
China
Europe
Japan
South Korea
ASEAN
India
Rest of World
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Type:
Consumables
Instruments
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Technology:
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Application:
Hospital
Laboratory
Household
Companies Profiled:
Roche
Abbott
Danaher
Siemens Healthineers
Thermo Fisher Scientific
Sysmex
BioMerieux
Ortho Clinical Diagnostics
Becton Dickinson
Bio-Rad Laboratories
Hologic
LifeScan
Qiagen
Wuhan Easy Diagnosis
Wondfo
KHB
Hotgen
Mindray
Sinocare
Getein Biotech
Key Questions Answered
1. How big is the global In–Vitro Diagnostics (IVDs) Medical Device market?
2. What is the demand of the global In–Vitro Diagnostics (IVDs) Medical Device market?
3. What is the year over year growth of the global In–Vitro Diagnostics (IVDs) Medical Device market?
4. What is the total value of the global In–Vitro Diagnostics (IVDs) Medical Device market?
5. Who are the Major Players in the global In–Vitro Diagnostics (IVDs) Medical Device market?
6. What are the growth factors driving the market demand?
In Vitro Diagnostic (IVD) tests are a subset of medical devices. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. A medical device is an in vitro diagnostic medical device (IVD) if it is a reagents, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.
The global healthcare spending contributes to ca. 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The IVD market plays a significant role in the HC industry, influencing over 60% of laboratorial decision-making. However, it only accounts for ca. 2% of total HC spending, signifying an enormous potential for cost-effective tests.
The primary driver of growth in the IVD market is the aging of the global population. In addition, prevalence of chronic diseases is anticipated to propel this growth. More, growing demand for point-of-care devices and rapid diagnostic testing and increasing willingness to pay for preventive care testing.
COVID-19 pandemic is expected to continue to positively impact the market in 2020, 2021 and 2022, Due to the relaxation of global epidemic supervision, the reduction of COVID-19 testing in the post-epidemic era will reduce the total market size.
The In Vitro Diagnostics (IVD) market is driven by several key factors, including the rising prevalence of chronic and infectious diseases, advancements in diagnostic technologies, and increasing demand for personalized medicine. Innovations such as next-generation sequencing (NGS), point-of-care testing, and AI-driven diagnostics are transforming the industry by enabling faster, more accurate, and cost-effective testing. Additionally, the growing emphasis on preventive healthcare and the expansion of healthcare access in emerging markets are further fueling market growth. Regulatory support for precision diagnostics and increased investment in R&D also play a significant role in driving the adoption of IVD products globally.
Despite these drivers, the market faces several challenges. Stringent regulatory requirements and the high cost of R&D and clinical validation pose significant barriers for both established players and new entrants. Market saturation in developed regions and price sensitivity in emerging markets make it difficult to balance innovation with affordability. Furthermore, the integration of new diagnostic tools with existing laboratory infrastructure and IT systems can be complex and costly. Lastly, competition from established players and the need for significant capital investment to scale production and distribution add to the challenges for companies operating in this space.
This report studies the global In–Vitro Diagnostics (IVDs) Medical Device demand, key companies, and key regions.
This report is a detailed and comprehensive analysis of the world market for In–Vitro Diagnostics (IVDs) Medical Device, and provides market size (US$ million) and Year-over-Year (YoY) growth, considering 2025 as the base year. This report explores demand trends and competition, as well as details the characteristics of In–Vitro Diagnostics (IVDs) Medical Device that contribute to its increasing demand across many markets.
Highlights and key features of the study
Global In–Vitro Diagnostics (IVDs) Medical Device total market, 2021-2032, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by region & country, CAGR, 2021-2032, (USD Million)
U.S. VS China: In–Vitro Diagnostics (IVDs) Medical Device total market, key domestic companies, and share, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device revenue by player, revenue and market share 2021-2026, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by Type, CAGR, 2021-2032, (USD Million)
Global In–Vitro Diagnostics (IVDs) Medical Device total market by Application, CAGR, 2021-2032, (USD Million)
This report profiles major players in the global In–Vitro Diagnostics (IVDs) Medical Device market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Roche, Abbott, Danaher, Siemens Healthineers, Thermo Fisher Scientific, Sysmex, BioMerieux, Ortho Clinical Diagnostics, Becton Dickinson, Bio-Rad Laboratories, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the world In–Vitro Diagnostics (IVDs) Medical Device market
Detailed Segmentation:
Each section contains quantitative market data including market by value (US$ Millions), by player, by regions, by Type, and by Application. Data is given for the years 2021-2032 by year with 2025 as the base year, 2026 as the estimate year, and 2027-2032 as the forecast year.
Global In–Vitro Diagnostics (IVDs) Medical Device Market, By Region:
United States
China
Europe
Japan
South Korea
ASEAN
India
Rest of World
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Type:
Consumables
Instruments
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Technology:
Global In–Vitro Diagnostics (IVDs) Medical Device Market, Segmentation by Application:
Hospital
Laboratory
Household
Companies Profiled:
Roche
Abbott
Danaher
Siemens Healthineers
Thermo Fisher Scientific
Sysmex
BioMerieux
Ortho Clinical Diagnostics
Becton Dickinson
Bio-Rad Laboratories
Hologic
LifeScan
Qiagen
Wuhan Easy Diagnosis
Wondfo
KHB
Hotgen
Mindray
Sinocare
Getein Biotech
Key Questions Answered
1. How big is the global In–Vitro Diagnostics (IVDs) Medical Device market?
2. What is the demand of the global In–Vitro Diagnostics (IVDs) Medical Device market?
3. What is the year over year growth of the global In–Vitro Diagnostics (IVDs) Medical Device market?
4. What is the total value of the global In–Vitro Diagnostics (IVDs) Medical Device market?
5. Who are the Major Players in the global In–Vitro Diagnostics (IVDs) Medical Device market?
6. What are the growth factors driving the market demand?
Table of Contents
149 Pages
- 1 Supply Summary
- 2 Demand Summary
- 3 World In–Vitro Diagnostics (IVDs) Medical Device Companies Competitive Analysis
- 4 United States VS China VS Rest of World (by Headquarter Location)
- 5 Market Analysis by Type
- 6 Market Analysis by Technology
- 7 Market Analysis by Application
- 8 Company Profiles
- 9 Industry Chain Analysis
- 10 Research Findings and Conclusion
- 11 Appendix
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