Global In Vitro Diagnostics Market to Reach $138.4 Billion, Globally by 2032: Allied Market Research 

The global in vitro diagnostics market is expanding rapidly due to a surge in the number of diagnostic laboratories, rise in awareness regarding personalized medicine and early disease diagnosis, and growing prevalence of infectious and chronic diseases. 


Wilmington, Delaware, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Allied Market Research published a report, titled, "In Vitro Diagnostics Market by Product and Services (Reagents and Kits, Instruments, Software, and Services), Technique, (Immunodiagnostics, Hematology, Molecular Diagnostics, Tissue Diagnostics, Clinical Chemistry, Others), Application, (Infectious Diseases, Cancer, Cardiac Diseases, Immune System Disorders, Nephrological Diseases, Gastrointestinal Diseases, and Others), and End User (Standalone Laboratories, Hospitals, Academic and Medical Schools, Point Of Care, and Others): Global Opportunity Analysis and Industry Forecast, 2023-2032".  

As per the report, the global market for in vitro diagnosis is expected to generate $138.4 billion by 2032. The market generated $92.5 billion in 2022 and is anticipated to witness a notable CAGR of 4.1% during the forecast period of 2023 to 2032. 

In Vitro Diagnostic (IVD) refers to a medical procedure wherein the examination, diagnosis, and monitoring of a sample extracted from the human body such as blood, urine, or tissue takes place in a laboratory setting. The term "in vitro" is rooted in the Greek language, translating to "in glass." IVD encompasses a wide spectrum of medical tests, ranging from clinical chemistry and immunoassays to molecular diagnostics, microbiology, and genetic testing. This field plays a crucial role in healthcare decision-making by enabling the early detection of diseases, monitoring treatment effectiveness, and enhancing patient outcomes. 

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Factors influencing the growth of the market: 

The global in vitro diagnostics market is expanding rapidly due to a surge in the number of diagnostic laboratories, rise in awareness regarding personalized medicine and early disease diagnosis, and growing prevalence of infectious and chronic diseases. However, strict regulatory norms are estimated to restrain market growth to some extent. Nevertheless, advanced technologies in in-vitro diagnostics will offer remunerative growth opportunities in the upcoming years.  

Report Coverage & Details:   

Report Coverage  Details  
Forecast Period  2023–2032  
Base Year  2022 
Market Size in 2022  $92.5 Billion  
Market Size in 2032  $138.4 Billion  
CAGR  4.1 % 
No. of Pages in Report  391 
Segments covered  Product and Services, Technique, Application, End User, and Region  
Drivers  Increase in prevalence of chronic and infectious diseases  
Surge in awareness about early disease diagnosis and personalized medicine  
Rise in the number of diagnostic laboratories  
Opportunities  Technological advancements in IVD  
Restraints  Stringent regulatory policies 

Recent Developments in the In Vitro Diagnostics Market 

  • In August 2023, Agilent Technologies Inc., announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR). 
  • In May 2023, Freenome announced that it has acquired Oncimmune Ltd, a UK-based global immunodiagnostics developer with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures. 
  • In January 2022, Exact Sciences Corporation announced that it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). 
  • In September 2021, Illumina, Inc. and Merck announced a partnership to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD). 
  • In March 2021, Natera, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Device Designations (BDDs) covering new intended uses of the Signatera molecular residual disease (MRD) test. 

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An examination of the economic downturn and its impact on the In Vitro Diagnostic (IVD) market in 2023: 

  • In times of economic downturn, both individuals and governments tend to streamline their budgets, resulting in a decrease in healthcare expenditure. Consequently, this has impacted the accessibility and affordability of in vitro diagnostics products for patients, potentially resulting in a diminished demand for such products. Moreover, the financial instability associated with a recession may prompt individuals to postpone or forego non-essential medical appointments, including routine check-ups. 
  • Nevertheless, the surge in research and development efforts dedicated to in vitro diagnostics, coupled with a growing prevalence of chronic diseases, is showing a modest positive influence amid the worldwide economic downturn. 

The reagents and kits segment to grab the lion’s share during the forecast period 

On the basis of product and services, the reagents and kits segment grabbed the highest share in 2022, contributing to around three-fifths of the global in vitro diagnostics market and is expected to grab the largest market share by 2032. The fundamental role of reagents and kits in diagnostic testing, adaptability to various applications, and continuous demand drives the growth of the segment. The instruments segment, on the other hand, would display the fastest CAGR of 4.7% throughout the forecast timeframe. The growth is attributed to the surge in demand for efficient and accurate diagnostic testing in the healthcare sector and advanced technologies in instruments are the factors contributing to the growth of the segment. 

The immunodiagnostics segment to retain its dominance by 2032 

On the basis of technique, the immunodiagnostics segment gained the highest market share in 2022, contributing to more than one-fourth of the global in-vitro diagnostics market and is projected to continue its supremacy during the forecast period. The growth is attributed to rise in occurrence of infectious and chronic diseases across the world, which has propelled the need for diagnostic tests, specifically immunodiagnostics as it offers robust specificity and sensitivity, assuring reliable and accurate results. The molecular diagnostics segment, on the other hand, would cite the fastest CAGR of 5.3% during the forecast period, due to its vital role in genomics, cancer management, infectious disease detection, and its application in several healthcare settings.  

The infectious diseases segment to lead the trail throughout the forecast timeframe 

By application, the infectious diseases segment garnered the highest share of around half of the global in-vitro diagnostics market in 2022 and is projected to rule the roost throughout the forecast period. The surge in occurrence of infectious diseases and the constant risk of evolving infectious diseases, and the routine testing for disorders like norovirus, RSV, COVID-19, and hepatitis. The cancer segment, on the other hand, would display the fastest growth with 5.5% CAGR by 2032, owing to an increase in the number of individuals suffering from cancer and demand for early detection and accurate cancer diagnosis.  

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North America to witness the fastest growth throughout the forecast timeframe 

The regional analysis in the report states that North America grabbed the largest market share in 2022, accounting for around two-fifths of the global in vitro diagnostics market and is expected to lead the trail throughout the forecast timeframe. The market is driven by surge in occurrence of chronic diseases and advanced healthcare infrastructure drive the expansion of the market across the region. On the other hand, the Asia-Pacific region is projected to showcase the fastest growth with 5.1% throughout the forecast timeframe. The growth is attributed to a rise in healthcare expenditure, an increase in R&D activities, growing prevalence of chronic diseases, and elevated geriatric population with a surge in the requirement for diagnostic procedures. 

Key Market Players: 

  • Neogenomics Laboratories 
  • Invitae Corporation 
  • Thermo Fisher Scientific, Inc. 
  • InterVenn Biosciences 
  • Guardant Health 
  • F. Hoffmann-La Roche Ltd. 
  • Illumina, Inc. 
  • Exact Sciences Corporation 
  • Agilent Technologies, Inc. 
  • Natera, Inc. 
  • Freenome Holdings, Inc. 

The report offers a thorough analysis of prominent players in the global in vitro diagnostics market. These frontrunners have employed various strategies, including launching new products, making acquisitions, forming partnerships, obtaining product approvals, and expanding their operations, all with the goal of augmenting their market share and upholding dominant positions across diverse regions. The report is instrumental in spotlighting the business performance, operating segments, product portfolios, and strategic maneuvers of these market players, providing a comprehensive overview of the competitive landscape. 

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