IMARC Group, a leading market research company, has recently released a report titled " In Vitro Diagnostics Market Size, Share, Trends and Forecast by Product, Material, Distribution Channel, Pricing, End-User, and Region, 2025-2033."The study provides a detailed analysis of the industry, including the footwear market size, share, trends, and growth forecast. The report also includes competitor and regional analysis and highlights the latest advancements in the market.

In Vitro Diagnostics Market Overview

The global in vitro diagnostics market was valued at USD 116.7 Billion in 2024 and is projected to reach USD 181.5 Billion by 2033, growing at a CAGR of 5.0% during the forecast period 2025-2033. The market is primarily driven by rising infectious disease prevalence, continuous technological advancements, growing emphasis on personalized medicine, and an increasing geriatric population. North America dominates with over 42.7% market share in 2024.

Study Assumption Years

  • Base Year: 2024
  • Historical Years: 2019-2024
  • Forecast Period: 2025-2033

In Vitro Diagnostics Market Key Takeaways

  • Current Market Size: USD 116.7 Billion in 2024
  • CAGR: 5.0%
  • Forecast Period: 2025-2033
  • North America holds the largest share with over 42.7% in 2024 due to advanced healthcare infrastructure.
  • Molecular diagnostics is the leading test type segment with a 23.1% share, valued for its high sensitivity and accuracy.
  • Reagents and kits dominate the product segment with approximately 67.2% market share in 2024.
  • Infectious diseases lead the application segment with about 37.6% market share in 2024.
  • The U.S. market holds 94.01% of total share within North America driven by technological advances and chronic disease prevalence.

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Market Growth Factors

The global in vitro diagnostics (IVD) market growth is strongly supported by the increasing geriatric population worldwide. The population over the age of 60 is expected to nearly double from 12% in 2015 to 22% in 2050, with approximately 80% residing in low- and middle-income countries. This demographic shift leads to a higher prevalence of age-associated morbidities, such as cancer, diabetes, cardiovascular diseases, and neurodegenerative disorders like Alzheimer's disease. These conditions require frequent diagnostic testing for early detection and management, thereby increasing demand for diverse IVD products ranging from molecular diagnostics to clinical chemistry tests.

Technological advancements are a significant driver in the IVD market. Developments in next-generation sequencing, molecular diagnostics, and microfluidics have enhanced test sensitivity and accuracy, enabling early and precise disease detection. Automation of diagnostic processes is reducing human error and increasing efficiency. Recent regulatory approvals of novel diagnostic tools such as ARUP Laboratories' AAV5 DetectCDx, Siemens Healthineers' Atellica Solution, and Abbott’s TBI blood test demonstrate ongoing innovation that supports market growth.

The rising incidence of chronic diseases also propels market expansion. According to the International Diabetes Federation, 537 million people aged 20-79 have diabetes globally, expected to rise to 643 million by 2030 and 783 million by 2045. Chronic conditions necessitate early detection and continuous monitoring. IVD tests facilitate these healthcare needs by enabling timely screening and informed treatment decisions. For example, Abbott Laboratories’ Panbio COVID-19 rapid antigen test allowed quick infection screening, while Roche's Cobas pulse system enhances blood glucose management. Additionally, the growing adoption of personalized medicine, evidenced by over one-third of new FDA drug approvals in 2023 being personalized therapies, fuels demand for targeted IVD tests such as companion diagnostics and genetic testing.

Market Segmentation

Analysis by Test Type:

  • Clinical Chemistry
  • Molecular Diagnostics: Accounts for 23.1% market share; offers highly sensitive, accurate disease detection essential for infectious diseases, genetic disorders, and cancers.
  • Immunodiagnostics
  • Hematology
  • Others

Analysis by Product:

  • Reagents and Kits: Hold about 67.2% of market share; consist of chemicals and consumables essential for conducting diagnostic analyses, ensuring consistent and reliable results across labs.
  • Instruments

Analysis by Usability:

  • Disposable IVD Devices: Designed for single use, pre-sterilized, eliminating the need for cleaning and reducing risk and time.
  • Reusable IVD Devices: Can be reused multiple times after cleaning and sterilization; offer customization in test performance.

Analysis by Application:

  • Infectious Disease: Leading segment with approximately 37.6% share in 2024; enables prompt identification and early therapy initiation.
  • Diabetes
  • Cancer/Oncology
  • Cardiology
  • Autoimmune Disease
  • Nephrology
  • Others

Analysis by End User:

  • Hospitals: Provide diagnostic services for inpatients and outpatients using multiple IVD tests.
  • Laboratories
  • Clinical Laboratories: Standalone entities offering specialized, high-volume diagnostic testing.
  • Point-of-care Testing Centers: Fastest growing segment; perform diagnostics near patient care points for timely results.
  • Academic Institutes
  • Patients
  • Others

Regional Insights

North America dominates the in vitro diagnostics market with over 42.7% share in 2024. This leadership is attributed to highly developed healthcare infrastructure, including advanced clinical laboratories, hospitals, and research centers. Moreover, continuous technological advancements and substantial investments in research and development further drive market growth. The U.S. market shapes North America’s dominance with 94.01% share, fueled by rising chronic disease burden, aging population, personalized medicine demand, and regulatory support fostering innovation.

Recent Developments & News

  • October 2024: India’s Central Drugs Standard Control Organisation (CDSCO) eliminated clinical trial waivers for IVDs to enhance product safety and align with global standards.
  • August 2024: Sysmex India ended its distribution partnership but continues client support with over 250 professionals serving hospitals, labs, and medical institutions.
  • November 2023: Newland EMEA launched a new IVD product line showcased at MEDICA tradeshow, Dusseldorf.
  • January 2024: ELITechGroup introduced GI Bacterial PLUS ELITe MGB® Kit targeting key bacterial gastrointestinal pathogens, with plans for additional kits.
  • April 2024: Revvity's EUROIMMUN and ALPCO-GeneProof formed a strategic partnership to expand GeneProof PCR kits availability across the EU.

Key Players

  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • Beckman Coulter, Inc.
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  • Bio-Rad Laboratories, Inc.
  • Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Qiagen N.V
  • Shimadzu Corporation
  • Siemens Healthineers AG
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.

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