In Vitro Diagnostics Market is Expected to Grow USD 181.5 Billion by 2033 | At CAGR 5.0%

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 In Vitro Diagnostics 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 size was valued at USD 116.7 Billion in 2024 and is projected to reach USD 181.5 Billion by 2033, exhibiting a compound annual growth rate (CAGR) of 5.0% during the forecast period from 2025 to 2033. North America dominates with over 42.7% market share in 2024. The market growth is primarily driven by the rising prevalence of infectious diseases, continuous technological advancements, increasing geriatric population, and shifting consumer preferences toward personalized medicine.

Study Assumption Years

● Base Year: 2024
● Historical Year/Period: 2019-2024
● Forecast Year/Period: 2025-2033

In Vitro Diagnostics Market Key Takeaways

● Current Market Size: USD 116.7 Billion (2024)
● CAGR: 5.0% (2025-2033)
● Forecast Period: 2025-2033

● North America holds the largest share of over 42.7% in 2024.

● Molecular diagnostics segment holds the biggest share at 23.1%, offering high accuracy and sensitivity.

● Reagents and kits dominate product segments with approximately 67.2% market share in 2024.

● Infectious diseases lead application segments with about 37.6% share in 2024.

● Point-of-care testing centers are the fastest growing end-user segment.

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Market Growth Factors

Increasing Geriatric Population:

The global population over 60 years is expected to nearly double from 12% in 2015 to 22% by 2050, with around 80% residing in low- and middle-income countries. This demographic surge contributes to higher incidences of cancer, diabetes, cardiovascular, and neurodegenerative diseases such as Alzheimer's. These chronic conditions necessitate frequent diagnostic testing for early detection and management, intensifying demand for in vitro diagnostics products. Extensive health checks covering molecular diagnostics, immunoassays, and clinical chemistry tests are increasingly vital for geriatric patients, positively influencing market growth.

Technological Advancements:

The market growth is bolstered by innovations like next-generation sequencing, molecular diagnostics, microfluidics, and diagnostic automation. These technologies enable stronger, more sensitive, and accurate testing. Recent approvals such as ARUP Laboratories' AAV5 DetectCDx and Siemens Healthineers' Atellica Solution illustrate this trend. Regulatory approvals and product launches, including Toray APOA2-iTQ for pancreatic cancer diagnosis and Abbott's traumatic brain injury blood test, demonstrate rapid technological progress enhancing diagnostic capabilities and efficiency.

Rising Prevalence of Chronic Diseases and Personalized
Medicine:

The increasing incidence of chronic illnesses such as diabetes (537 million globally as of latest data), cardiovascular disorders, and cancer drives demand for in vitro diagnostics. Early disease detection, monitoring, and treatment personalization benefit from advanced diagnostics. The Personalized Medicine Coalition reports that 33% of new FDA drug approvals in 2023 were personalized medicines. Companion diagnostics and genetic testing facilitate tailored therapies, reducing adverse reactions and improving outcomes, thus propelling market expansion. WHO's Essential Diagnostics List and collaborations like Africa CDC-AUDA NEPAD enhance diagnostic access, further supporting growth.

Market Segmentation

Analysis by Test Type:

● Clinical Chemistry

● Molecular Diagnostics: Largest share at 23.1%, noted for high accuracy and sensitivity in disease detection including infections, genetic disorders, and cancers.

● Immunodiagnostics
● Hematology
● Others

Analysis by Product:

● Reagents and Kits: Holding roughly 67.2% market share in 2024, these form the Consumables basis for diagnostic tests, enabling consistent, user-friendly, and standardized testing.

● Instruments

Analysis by Usability:

● Disposable IVD Devices: Single-use, pre-sterilized, convenient, saving time by eliminating cleaning and reprocessing.

● Reusable IVD Devices: Designed for multiple uses, composed of durable materials allowing customization and repeated usage after cleaning and sterilization.

Analysis by Application:

● Infectious Disease: Leading application with ~37.6% share in 2024, vital for prompt identification and control of widespread infections like tuberculosis, influenza, hepatitis.

● Diabetes
● Cancer/Oncology
● Cardiology
● Autoimmune Disease
● Nephrology
● Others

Analysis by End User:

● Hospitals: Provide diagnostic services to inpatients and outpatients, equipped with multiple IVD technologies.

● Laboratories
● Clinical Laboratories: Specialized high-volume testing not available in all hospital labs.

● Point-of-care Testing Centers: Fastest growing segment, delivering tests near patients in emergency rooms and remote settings.

● Academic Institutes
● Patients
● Others

Regional Insights

North America dominates the in vitro diagnostics market with over 42.7% share in 2024, driven by a sophisticated healthcare infrastructure, advanced clinical labs, and strong R&D investments. The region benefits from technological advancements and rising chronic disease prevalence with chronic conditions being the leading cause of disability and death annually in the US. The availability of modern diagnostic tools, such as the FDA-authorized SARS-CoV-2 Droplet Digital PCR test kit by Bio-Rad, further supports market leadership.

Recent Developments & News

● October 2024: India's IVD regulatory body CDSCO has removed clinical trial waivers for IVDs to align with global standards, aiming to enhance patient safety.

● August 2024: Sysmex India ended its distribution partner agreement and continues direct client support for haematology and clinical chemistry diagnostics.

● November 2023: Newland EMEA launched a new IVD product line showcased at MEDICA trade show in Dusseldorf.

● January 2024: ELITechGroup announced the GI Bacterial PLUS ELITe MGB® Kit for diagnosing gastrointestinal bacterial infections, with expansion plans for additional kits.

● April 2024: Revvity's EUROIMMUN and ALPCO-GeneProof collaborated to increase GeneProof PCR kits availability across the EU.

Key Players

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

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