In Vitro Diagnostics (IVD) Market Size Could Reach USD 120.49 Billion by 2033

According to Report, the global in vitro diagnostics (IVD) market size is calculated at USD 77.96 billion in 2023 and it is increasing over USD 120.49 billion by 2033, growing at a CAGR of 4.45% from 2024 to 2033.

According to Report, the global in vitro diagnostics (IVD) market size is calculated at USD 77.96 billion in 2023 and it is increasing over USD 120.49 billion by 2033, growing at a CAGR of 4.45% from 2024 to 2033.

The in vitro diagnostics (IVD) market is driven by the rising incidence of chronic diseases, rise of personalized medicine, point-of-care testing (POCT) growth, and global expansion and market opportunities.

In Vitro Diagnostics (IVD) Market Size 2024 to 2033

Introduction to In Vitro Diagnostics (IVD)

At its core, IVD involves the analysis of specimens such as blood, urine, or tissue samples in a laboratory setting to diagnose diseases, monitor treatment progress, and assess overall health status. This branch of diagnostics has witnessed remarkable evolution over the years, fueled by advancements in technology and a deeper understanding of disease mechanisms.

Get Sample Copy of Report@

Key Pointers

  • North America maintained its leading position in the global market, holding the highest market share of 43% ($ 33.52 billion) in 2023.
  • Asia Pacific is forecasted to experience significant growth with a remarkable Compound Annual Growth Rate (CAGR) from 2024 to 2033.
  • Among products, the reagents segment accounted for the largest share of revenue, comprising 66% ($ 51.45 billion) in 2023.
  • The coagulation segment is projected to witness the highest CAGR in terms of technology from 2024 to 2033.
  • Hospitals emerged as the dominant end-use segment in terms of revenue share in 2023.
  • The oncology segment is expected to demonstrate the fastest CAGR among applications from 2024 to 2033.

Immediate Delivery Available, Get Full Access@

Types of In Vitro Diagnostic Tests

  • Clinical Chemistry Tests: These tests measure the levels of various chemicals and substances in the blood, urine, or other bodily fluids. They are used to assess organ function, detect abnormalities, and diagnose conditions such as diabetes, liver disease, and kidney disorders.
  • Immunoassays: Immunoassays detect the presence or quantity of specific substances, such as antibodies, antigens, hormones, or drugs, by utilizing the immune system’s natural response. They are widely used in diagnosing infectious diseases, autoimmune disorders, and monitoring therapeutic drug levels.
  • Molecular Diagnostics: Molecular diagnostic tests analyze genetic material (DNA or RNA) to detect genetic mutations, infectious agents (like viruses or bacteria), or identify specific genes associated with disease susceptibility. They play a crucial role in diagnosing genetic disorders, cancer, and infectious diseases with high precision.
  • Hematology Tests: Hematology tests evaluate the cellular components of blood, including red blood cells, white blood cells, and platelets. These tests are used to diagnose conditions such as anemia, leukemia, and blood clotting disorders, as well as to monitor responses to treatments like chemotherapy.

Importance of IVD in Healthcare

  • Early Disease Detection: IVD tests enable the early detection of diseases before symptoms manifest. Early diagnosis allows for prompt intervention and treatment, which can prevent the progression of diseases and improve patient outcomes.
  • Monitoring Treatment Efficacy: IVD tests are used to monitor the effectiveness of treatments, such as chemotherapy or antiretroviral therapy. By regularly monitoring biomarkers or disease markers in patient samples, healthcare providers can adjust treatment plans as needed to ensure optimal outcomes.
  • Precision Medicine: With the advent of personalized medicine, IVD plays a pivotal role in tailoring treatments to individual patients based on their genetic makeup, biomarker profiles, and other factors. This approach maximizes treatment efficacy while minimizing adverse effects.
  • Public Health Surveillance: IVD tests are essential for monitoring the spread of infectious diseases, such as influenza, HIV, and COVID-19. By detecting and tracking disease outbreaks, healthcare authorities can implement timely public health interventions to control the spread of pathogens and protect communities.
  • Screening Programs: IVD tests are used in population-based screening programs to identify individuals at risk for certain diseases, such as cancer or genetic disorders. Early detection through screening can lead to interventions that reduce morbidity and mortality associated with these conditions.
  • Diagnostic Accuracy: IVD tests provide accurate and reliable diagnostic information that guides clinical decision-making. By analyzing biological samples with precision and specificity, these tests help healthcare providers make informed decisions about patient care.

Recent Advances in IVD Technology

  • Next-Generation Sequencing (NGS): NGS technology allows for the rapid and cost-effective sequencing of entire genomes or specific gene regions. In the context of IVD, NGS is used for genetic testing, cancer diagnostics, and infectious disease detection. Its high throughput and accuracy have led to personalized treatment approaches and improved patient outcomes.
  • Digital Pathology: Digital pathology involves the digitization of histology slides, enabling pathologists to view, analyze, and share high-resolution images remotely. This technology enhances diagnostic accuracy, facilitates collaboration among healthcare professionals, and streamlines workflow efficiency in pathology laboratories.
  • Liquid Biopsies: Liquid biopsy techniques analyze circulating biomarkers, such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and exosomes, from blood or other bodily fluids. These non-invasive tests provide valuable information for cancer detection, monitoring treatment response, and detecting minimal residual disease.
  • Microfluidics: Microfluidic devices use small volumes of fluid to perform complex biochemical assays rapidly and efficiently. These miniaturized systems enable precise control over sample manipulation and analysis, making them ideal for point-of-care diagnostics, genetic testing, and drug screening applications.
  • Artificial Intelligence (AI) Integration: AI algorithms are increasingly being integrated into IVD platforms to enhance diagnostic accuracy, interpret complex data, and identify patterns that may be imperceptible to human observers. AI-driven diagnostics hold promise for improving efficiency, reducing errors, and facilitating personalized medicine.

Related Reports:

Product Insights

The reagents segment captured the majority share, representing 66% of total revenue in 2023. It is projected to sustain its dominance, exhibiting the swiftest compound annual growth rate (CAGR) from 2024 to 2033. This continuous expansion owes much to significant research and development efforts by key industry players, aimed at crafting innovative reagents and test kits. A case in point is BD’s milestone in February 2023, securing market approval for the BD Onclarity HPV Assay for use alongside the ThinPrep Pap Test in the U.S. The heightened emphasis on Research and Development (R&D), especially directed towards quicker cancer detection and precision medicine, empowers companies to carve profitable niches within the in vitro diagnostics (IVD) realm.

The ascent of precision medicine is expected to drive demand for these groundbreaking reagents and consumables. Meanwhile, the instruments segment clinched the second-largest share in 2023. Prospective growth in this sector is propelled by the mounting approvals for novel IVD instruments. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for VITEK REVEAL, a rapid Antimicrobial Susceptibility Testing (AST) system. Companies are aligning their instrument releases with the global upsurge in genetic testing demand.

Technology Insights

In 2023, the immunoassay segment emerged as the top revenue generator. The rising incidence of chronic and communicable diseases, alongside a growing emphasis on early detection, drove up demand for immunological methods, including various forms of Enzyme-Linked Immunosorbent Assays (ELISAs). Major industry players are focusing their efforts on Research and Development (R&D) endeavors aimed at developing new immunological diagnostic instruments and tests for in vitro diagnostics (IVD) applications. For instance, in October 2023, Sysmex Corporation and Fujirebio Holdings, Inc. partnered to enhance their R&D, production, clinical development, and marketing activities in the immunoassay field.

Simultaneously, the coagulation segment is expected to witness the fastest compound annual growth rate (CAGR) from 2024 to 2033. This growth is driven by the increasing prevalence of cardiovascular diseases, blood-related disorders, and autoimmune diseases. Innovations in instruments, such as the introduction of advanced handheld coagulation analyzers like the Xprecia Stride Coagulation Analyzer, are anticipated to enhance detection workflows. Key players in the provision of instruments and coagulation tests include Abbott, Siemens Healthcare GmbH, and Beckman Coulter, Inc.

End-use Insights

In 2023, the hospitals segment dominated the revenue share, mainly due to a rise in hospitalizations requiring prompt diagnostic assistance. Ongoing advancements in healthcare infrastructure, along with supportive initiatives from government entities, are anticipated to bolster existing hospital facilities, resulting in a surge in demand for hospital-based in vitro diagnostics (IVD) tests. Given that hospitals procure a significant volume of IVD devices and utilize them in substantial quantities, this demand is particularly significant.

In December 2023, the American Hospital Association appealed to the FDA, advocating against the imposition of device regulations on hospitals’ Laboratory Developed Tests (LDTs). Conversely, the homecare segment is poised for a high Compound Annual Growth Rate (CAGR) from 2024 to 2033, driven by the increasing elderly population and a growing demand for in vitro diagnostics (IVD) devices in home care settings. This trend is accompanied by a rising requirement for innovative molecular diagnostic and immunoassay platforms, facilitating patients in conducting self-tests.

Application Insights

In 2023, the infectious diseases segment emerged as the dominant force in the market, largely propelled by the outbreak of the COVID-19 pandemic in recent years. This surge in segment share was further fueled by major players introducing new testing products aimed at improving access to high-quality and innovative laboratory services for both patients and healthcare providers. For instance, in February 2023, BD achieved a significant milestone by obtaining Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic combination test designed to detect SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV). Such initiatives by key industry players are expected to play a crucial role in driving market growth.

In contrast, the oncology segment is projected to demonstrate the fastest compound annual growth rate (CAGR) from 2024 to 2033. The increasing prevalence of cancer, coupled with a high mortality rate, is fueling the demand for early-stage cancer biomarker tests. Moreover, the industry is anticipated to witness growth due to the rising approvals of novel tests, ongoing Research and Development (R&D) activities, and supportive initiatives from regulatory bodies. For example, in June 2023, the U.S. FDA announced a pilot program allowing manufacturers to submit validation and performance data for Laboratory Developed Tests (LDTs) for cancer. Additionally, in April 2023, Biocartis Group NV and APIS Assay Technologies Ltd. collaborated to develop and commercialize a breast cancer subtyping test on Idylla, a molecular diagnostics platform.

Regional Insights

In 2023, North America solidified its dominance in the market, capturing a significant share of 43%. Projections suggest that the region will maintain its leading position throughout the forecast period. Several factors contribute to the collective momentum of the market in North America, including the rising prevalence of chronic diseases, the presence of strong industry players, an increasing number of new test launches, and supportive government funding. For instance, in January 2023, BD and CerTest Biotec collaborated to secure Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a Polymerase Chain Reaction (PCR) test designed for Mpox virus detection in the U.S.

In contrast, Asia Pacific is positioned for substantial growth from 2024 to 2033. This anticipated expansion in the regional market can be attributed to several factors, such as stable economies, a rapidly growing middle-class population, supportive government policies, and rapid urbanization across the region. A notable collaboration in October 2023 involved Fapon and Halodoc partnering to enhance in vitro diagnostic product sales and services in Indonesia.

In Vitro Diagnostics (IVD) Market Key Companies

  • Abbott
  • bioMérieux SA
  • QuidelOrtho Corporation
  • Siemens Healthineers AG
  • Bio-Rad Laboratories, Inc.
  • Qiagen
  • Sysmex Corporation
  • Charles River Laboratories
  • Quest Diagnostics Incorporated
  • Agilent Technologies, Inc.
  • Danaher Corporation
  • BD
  • F. Hoffmann-La Roche Ltd.

In Vitro Diagnostics (IVD) Market Segmentations:

By Product

  • Instruments
  • Reagents
  • Services

By Technology

  • Immunoassay
    • Instruments
    • Reagents
    • Services
  • Hematology
    • Instruments
    • Reagents
    • Services
  • Clinical Chemistry
    • Instruments
    • Reagents
    • Services
  • Molecular Diagnostics
    • Instruments
    • Reagents
    • Services
  • Coagulation
    • Instruments
    • Reagents
    • Services
  • Microbiology
    • Instruments
    • Reagents
    • Services
  • Others
    • Instruments
    • Reagents
    • Services

By Application

  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Nephrology
  • Autoimmune Diseases
  • Drug Testing
  • Others

By Test Location

  • Point of Care
  • Home-care
  • Others

By End-use

  • Hospitals
  • Laboratory
  • Home-care
  • Others

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa (MEA)

Get a Full TOC of the Report:

Immediate Delivery Available, Get Full Access@

Ask here for more details OR USA: +1 650 460 3308 IND: +91 87933 22019 Europe: +44 2080772818