In-Vitro Diagnostics Market

Report Overview

The global in-vitro diagnostics market was pegged at US$ 83.5 billion in 2021 and is expected to witness a CAGR of 2.4% during the forecast period.

Market Fundamentals 

According to the World Health Organization, ‘In-Vitro diagnostic tests are a subset of medical device. These tests are used for in-vitro examination of specimens derived from the human body to provide information on screening, diagnosis, or for treatment monitoring purposes’. Samples are analyzed by measuring the concentration of analytes or by detecting the absence or presence of a particular marker in the sample. Clinicians also use in-vitro diagnostic tests to prevent future diseases.

In-vitro diagnostics can also be used in precision medicine for identifying patients that are likely to benefit from specific treatments. These can include next-generation sequencing (NGS) tests, in which an individual’s DNA is analyzed to detect genomic variations or alterations. In-vitro diagnostic tests can be performed by experienced healthcare professionals or recently, even by consumers at home.

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Market Dynamics

The global in-vitro diagnostics market is mainly driven by increasing incidences of chronic infectious diseases which in turn have led to a surge in the number of in-vitro diagnostics tests. Rising awareness regarding disease diagnostics among patients and increasing the adoption of point-of care in-vitro diagnostics by patients are also playing a pivotal role in contributing to market growth globally. However, unfavorable reimbursement scenario is one of the major factors hindering the market growth.

Market Ecosystem

The global in-vitro diagnostics market has been analyzed from five perspectives: Products & Services, Technology, Application, End-User, and Region. 

In-Vitro Diagnostics Market by Products & Services 

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Based on products & services, the market has been segmented into instruments, kits & reagents, and services. Instruments segment is further bifurcated into fully automated instruments, semi-automated instruments, and others. Kits & reagents segment is anticipated to witness the highest CAGR during the forecast period. The growth of this segment can be majorly attributed to the increasing use of IVD tests in the diagnosis of diseases. IVD manufactures have developed several diagnostic kits that can be used for coronavirus diagnostic testing in laboratories and a few of these have also received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.

In-Vitro Diagnostics Market by Technology

Based on technology, the market is segmented into immunoassay, molecular diagnostics, hematology, urinalysis, microbiology, and others. Molecular diagnostic segment is further bifurcated into polymerase chain reaction (PCR), DNA sequencing & next-generation sequencing (NGS), microarrays, isothermal nucleic acid amplification technology, hybridization, and other molecular diagnostics technologies. Molecular diagnostics segment is anticipated to witness the highest CAGR during the forecast period owing to rising demand for early diagnosis of diseases such as cancer, genetic disorders, among others. 

In-Vitro Diagnostics Market by Application

Based on application, the market has been segmented into infectious diseases, oncology, cardiology, nephrology, diabetes, gastrointestinal diseases and others. Infectious disease segment held the largest market share owing to the increasing incidence of infectious diseases such as AIDs, pneumonia, HIV, among others, and the launch of new products by IVD manufactures. For instance, in Sep 2020, Roche launched Elecsys, Anti-SARS-CoV-2 S antibody test. The test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus.

In-Vitro Diagnostics Market by End User

Based on end-user, the market has been segmented into hospitals, clinical laboratories, academics/research institutes, point-of-care testing, and other end users. Point-of-care testing segment is expected to witness the highest CAGR during the forecast period. The growth of the segment can be attributed to the increasing volume of point-of-care testing in response to surging demand for faster on-site screening during the COVID-19 pandemic.

In-Vitro Diagnostics Market by Region

Based on the region, the global in-vitro diagnostics market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America dominated the in-vitro diagnostics market (2020). The large share of North America in the global market can be attributed to the rising geriatric population, rising prevalence of chronic diseases, and the presence of prominent IVD manufacturers in the region. Moreover, as COVID-19 has spread, the demand for molecular testing has increased in countries such as the U.S. as molecular testing is considered the gold standard for the diagnosis of infectious diseases. Between March and October 2020, the demand for molecular diagnostic rose 20-fold.

Competitive Landscape

Some of the prominent players operating in the global in-vitro diagnostics market includes:-

• F. Hoffmann-La Roche Ltd
• Thermo Fisher Scientific Inc
• Abbott
• Siemens Healthcare Private Limited
• Bio-Rad Laboratories, Inc
• Danaher
• BD
• Johnson & Johnson Services, Inc
• Agilent Technologies, Inc
• Sysmex Corporation, among others

Strategic Developments

• In November 2019, Lexent Bio, Inc., a precision oncology company entered in partnership with Illumina, Inc. for developing in-vitro diagnostic kit for Lexent's portfolio of NGS-based cancer diagnostics
• In January 2020, Sysmex Corporation invested in Astrego Diagnostics AB, a company developing in-vitro diagnostic products related to drug susceptibility

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