The global in vitro diagnostics (IVD) market size was estimated at around USD 77.96 billion in 2023 and it is projected to hit around USD 120.49 billion by 2033, growing at a CAGR of 4.45% from 2024 to 2033.
Key Pointers
- In 2023, North America held the greatest market share of 43% worldwide.
- From 2024 to 2033, Asia Pacific is expected to develop at an impressive CAGR.
- In terms of product, the reagents section had the highest revenue share in 2023—that is, 66%.
- According to technology, the coagulation market is predicted to grow at the fastest rate possible between 2024 and 2033.
- In 2023, the hospitals segment held a dominant revenue share based on end-use.
- According to application, the oncology market is expected to grow at the quickest rate between 2024 and 2033.
In Vitro Diagnostics (IVD) Market Overview
The market for in vitro diagnostics (IVD) is crucial to the healthcare industry because it offers the diagnostic data needed for illness detection, tracking, and treatment selection. IVD is a fast developing area of the healthcare sector that includes a wide variety of tests and non-invasive diagnostic methods.
In Vitro Diagnostics (IVD) Market Growth
The market for in vitro diagnostics (IVD) is rising due to a number of variables that work together to increase the market’s significance in the healthcare industry. One main factor is the rising incidence of chronic illnesses worldwide, which makes effective diagnostic instruments necessary for early identification and surveillance. Furthermore, as older people frequently need routine health evaluations, the aging population adds to the rising demand for diagnostic tests. Technological developments that expand the accuracy and range of diagnostic capabilities, including the combination of next-generation sequencing and molecular diagnostics, are driving the industry. The rise of personalized medicine, tailoring treatments based on genetic profiles, has spurred demand for IVD tests that provide more nuanced insights into individual health conditions.
In Vitro Diagnostics (IVD) Market Dynamics
In Vitro Diagnostics (IVD) Market Drivers
- Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases worldwide, such as cardiovascular disorders, diabetes, and cancer, is a primary driver for the IVD market. Diagnostic tests play a crucial role in early detection, disease monitoring, and effective management of these conditions.
- Rise of Personalized Medicine: The growing trend toward personalized medicine, where treatment plans are tailored to individual genetic profiles, boosts the demand for IVD tests that provide detailed insights into patients’ unique characteristics. This contributes to more precise and effective healthcare interventions.
In Vitro Diagnostics (IVD) Market Restraints
- High Development Costs: The research, development, and validation processes for new diagnostic tests involve substantial financial investments. High development costs can limit the ability of smaller companies to bring innovative IVD products to market, contributing to a concentration of innovation among larger players.
- Limited Accessibility in Developing Regions: In some developing regions, access to advanced IVD technologies may be limited due to infrastructure constraints, economic factors, or a lack of awareness. This limitation in accessibility can impede the widespread adoption of IVD solutions, particularly in areas with resource constraints.
In Vitro Diagnostics (IVD) Market Opportunities
- Expansion of Point-of-Care Testing (POCT): The increasing demand for rapid and decentralized diagnostic solutions creates opportunities for the expansion of Point-of-Care Testing (POCT). POCT allows for quick and convenient testing at or near the patient, meeting the need for immediate results in various healthcare settings.
- Companion Diagnostics Development: The rise of companion diagnostics, which are tests designed to identify the most effective treatment for a specific patient, presents opportunities for collaboration between IVD manufacturers and pharmaceutical companies. This can lead to the development of more targeted therapies.
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Product Insights
In 2023, the reagents segment accounted for 66% of total revenue, securing the leading share. It is anticipated to continue to rule, growing at the quickest rate between 2024 and 2033. The industry’s leading companies have been conducting substantial research and development to create novel reagents and test kits, which has resulted in this continuous expansion. The success that BD had in February 2023 in obtaining market approval for the BD Onclarity HPV Assay to be used in conjunction with the ThinPrep Pap Test in the United States serves as an example. In vitro diagnostics (IVD) companies are finding lucrative niches in the market thanks to increased attention on R&D activities, particularly those focused on precision medicine and speedier cancer detection.
The need for these cutting-edge consumables and reagents is expected to increase with the popularity of precision medicine. In 2023, the instruments segment managed to capture the second-largest share. Growth in this market is anticipated due to an increase in the approval of innovative IVD devices. For instance, bioMérieux SA filed a 510(k) application for the fast Antimicrobial Susceptibility Testing (AST) system VITEK REVEAL to the U.S. Food and Drug Administration (FDA) in April 2023. Businesses are timeing the release of new instruments to coincide with the global upsurge in demand for genetic testing.
Technology Insights
The immunoassay market emerged as the top revenue-generating sector in 2023. The increased prevalence of infectious and chronic illnesses, along with the increasing focus on early detection, drove higher demand for immunological techniques. This comprises many types of assays called Enzyme-Linked Immunosorbent Assays (ELISAs). Notably, leading industry participants are focusing their efforts on Research and Development (R&D) projects aimed at developing novel immunological diagnostic tools and assays for use in in vitro diagnostics (IVD). For example, Sysmex Corporation and Fujirebio Holdings, Inc. partnered in October 2023 to support each other’s R&D, production, clinical research, and marketing efforts related to immunoassay.
Meanwhile, from 2024 to 2033, the coagulation category is anticipated to grow at the fastest rate. The rising incidence of autoimmune diseases, blood-related illnesses, and cardiovascular diseases is blamed for this increase. Instrument improvements, such as the release of new handheld coagulation analyzers like the Xprecia Stride Coagulation Analyzer, are expected to improve the overall detection procedure. Important suppliers of coagulation testing and instruments include Beckman Coulter, Inc., Siemens Healthcare GmbH, and Abbott.
End-use Insights
The growth in hospitalizations requiring quick diagnostic assistance was the main factor driving the hospitals segment’s dominance of the revenue share in 2023. In vitro diagnostics (IVD) tests performed in hospitals are predicted to become more in demand as a result of the ongoing expansion of the healthcare infrastructure and supportive government efforts. It is especially noteworthy because hospitals purchase and use a large number of IVD devices.
The American Hospital Association wrote to the FDA in December 2023 to express their opposition to the hospital’s Laboratory Developed Tests (LDTs) being subject to device limitations. Conversely, the homecare industry is expected to rise at a rapid rate between 2024 and 2033 due to the aging population and the rising need for in vitro diagnostics (IVD) equipment in home care environments. Alongside this, there is an increasing demand for cutting-edge immunoassay and molecular diagnostic platforms that enable patients to perform self-tests.
Application Insights
After a major uptick in recent years due to the COVID-19 pandemic, the infectious illnesses category became the leading force in the market in 2023. The introduction of new testing products by major players, which aimed to improve patient and healthcare provider access to innovative and high-quality laboratory services, contributed to this spike in segment share. A prime example is what BD accomplished in February 2023 when it received the FDA’s Emergency Use Authorization (EUA) for a novel molecular diagnostic combo test that is intended to identify SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV). Key industry companies’ initiatives of this kind have the potential to be extremely important in propelling market expansion.
On the other hand, it is projected that the oncology segment will grow at the quickest rate between 2024 and 2033. Early-stage cancer biomarker tests are becoming more and more popular due to the rising incidence of cancer and its high death rate. In addition, the sector is anticipated to rise as a result of the increasing number of new tests that are approved, continuous research and development (R&D) projects, and supportive regulatory body initiatives. For example, the U.S. FDA announced in June 2023 a pilot program that allows manufacturers to submit performance and validation data for Laboratory Developed Tests (LDTs) for cancer. Furthermore, in April 2023, APIS Assay Technologies Ltd. and Biocartis Group NV joined forces to develop and market a breast cancer subtyping test using the molecular diagnostics platform Idylla.
Regional Insights
North America consolidated its leadership in the industry in 2023, taking home a sizeable 43% of the market. Predictions suggest that the area will continue to hold the top spot for the duration of the prediction. The market in North America is driven by a variety of factors, including the rising incidence of chronic illnesses, the existence of strong industry competitors, the increasing number of new test launches, and government financing that is supportive of the sector. The January 2023 partnership between BD and CerTest Biotec serves as an example. Through this partnership, the FDA granted an Emergency Use Authorization (EUA) for a Polymerase Chain Reaction (PCR) test intended to identify the Mpox virus in the United States.
Asia Pacific, on the other hand, is expected to increase significantly between 2024 and 2033. Many variables, such as the existence of stabilized economies, a fast growing middle class, encouraging government policies, and rising urbanization throughout the region, are responsible for this predicted rise in the regional market. In October 2023, Fapon and Halodoc made a significant partnership to increase the sales and services of in vitro diagnostic products in Indonesia.
Read More: https://www.heathcareinsights.com/digital-health-market/
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)
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