In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Application, By Technology (Immunochemistry, Molecular Diagnostics), By End-use, By Region, And Segment Forecasts, 2021 - 2027

Report Overview

The global in vitro diagnostics market size was valued at USD 83.4 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 4.5% from 2021 to 2027. The growth can be attributed to the increasing adoption of in vitro diagnostics (IVD) owing to a rise in testing due to the pandemic. The development of automated in vitro diagnostic systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnosis is expected to fuel market growth. The rising number of in vitro diagnostic products being launched by key players is also fueling the lucrative growth rate of the market.

Globally, the elderly population is growing at a faster rate than the younger. In many countries, the growth of the older population can be attributed to declining fertility and low birth rate. According to United Nations, it was estimated that, in 2017, there were around 962 million people aged above 60 years worldwide. In addition, the number of individuals aged 80 years and above is projected to increase by threefold from 137 million in 2017 to 425 million in 2050. With age, the immune system is affected, which increases susceptibility to acquiring various diseases. Hence, a large geriatric population requires better healthcare, especially for chronic diseases.

The COVID-19 outbreak, caused due to SARS-CoV-2, is affecting millions of people globally. The outbreak of the pandemic has impelled the diagnostics industry into action, with a race to develop novel and rapid diagnostics kits for the detection of coronavirus. A majority of the tests are approved under Emergency Use Authorization (EUA) by federal agencies. Major assays used for COVID-19 detection employ the RT-PCR technique. Although the conventional test takes 5 to 6 hours for result output, PoC assays have reduced the duration significantly.

The prevalence of various diseases such as cancer, autoimmune diseases, and inflammatory conditions is increasing worldwide and is expected to drive the demand for in vitro diagnostic testing. For instance, according to the American Cancer Society, in 2018, about 1.7 million new cancer cases were reported and around 609,640 individuals died due to cancer.

Product Insights

The reagents segment dominated the market for in vitro diagnostic and accounted for the largest revenue share of 65.3% in 2020. The growth of this segment can be attributed to the increasing demand for rapid, accurate, and sensitive devices. Furthermore, their wide usage in in-vitro diagnostic testing, increase in demand for self-testing and point-of-care products, and rise in the number of R&D initiatives pertaining to reagents are expected to aid market growth.

Equipment and machines that assist in automating the process of diagnosis and bringing reagents and samples together are referred to as analytical instruments. Commercial kits and robots are used in polymerase chain reaction (PCR) laboratories to help detect and quantify infectious microorganisms, blood antigens, and viral load. In addition, the increasing use of these systems to develop new tests that can detect infectious diseases is expected to fuel the growth of the market. For instance, in February 2020, Sherlock Biosciences collaborated with Cepheid to develop a new CRISPR-based molecular test that can be used on the GeneXpert platform.

The services segment includes program interfaces used for operating diagnostic instruments, conducting analysis, and interpreting results. In vitro diagnostic software is used in many devices, such as point-of-care analyzers, laboratory-based analyzers, handheld personal in vitro diagnostics, and others. In addition, increasing adoption of in vitro diagnostic systems with analyzer software at diagnostic centers is anticipated to fuel market growth.

Applications Insights

The infectious disease segment dominated the market and accounted for the largest revenue share of 41.8% in 2020, which is attributable to the increasing incidence of infectious diseases such as SARS-CoV-2, HIV, AIDS, tuberculosis, and pneumonia. Furthermore, an increase in the development of infectious disease detection assays by market players for in vitro diagnostics is expected to drive the segment. For instance, in December 2018, Siemens Healthineers received U.S. FDA premarket approval for its 12 new assays for viral hepatitis and other diseases. These assays are used on Atellica Solution that provides testing options for screening, diagnosis, and monitoring of hepatitis C.

Cancer, a chronic disease, is one of the major causes of death globally. The most common types of cancers are colorectal, prostate, breast, and lung. The increasing prevalence of cancer is expected to accelerate the demand for in vitro diagnostic tests. According to the National Cancer Institute, in 2018, it was estimated that 1,735,350 new cancer cases will be diagnosed, and among these 609,640 people will die from this disease in the U.S.

Alcohol abuse, smoking, unhealthy diet, decreased physical activity, and high blood pressure are expected to increase the risk for cardiovascular diseases. Furthermore, diabetes mellitus causes cardiac disorders, which leads to an increase in demand for in vitro diagnostics in cardiology. The introduction of PoC devices for quick and on-site diagnosis, especially in emergency cases, is expected to drive the market.

End-use Insights

The hospital segment dominated the market and accounted for the largest revenue share of 44.2% in 2020. This is owing to an increase in hospitalization as doctors require diagnostic interpretation for further treatment. Most often, diagnostic centers operate in collaboration with hospitals; hence, hospitals have their own diagnostic set up. Furthermore, the ongoing development of healthcare infrastructure is anticipated to enhance the existing hospital facilities. Thus, the demand for hospital-based in vitro diagnostic tests is increasing.

Home care refers to supportive care provided at home by licensed healthcare professionals, or self-care by patients. Self-care devices account for the majority share of the home care segment. It is more convenient and reduces hospital visits. The home care segment is expected to witness the fastest growth with a CAGR of 6.6% over the forecast period, due to the rising geriatric population and increasing demand for home care in vitro diagnostic devices.

Other end-users of in vitro diagnostics are other healthcare settings, laboratories, ambulatory care services, schools, and academic institutions, especially in emergency cases and research institutes. These healthcare institutions mostly perform POC tests for monitoring or detecting diseases. High adoption of these tests by the abovementioned organizations due to lower costs and quick results is expected to fuel the growth of the market.

Technology Insights

The immunoassay segment dominated the market and accounted for the largest revenue share of 29.8% in 2020. It is anticipated to grow at a lucrative rate in upcoming years owing to its use in the detection of infectious microbes, such as fungus, bacteria, and viruses, by detection of their toxins. The increasing prevalence of chronic diseases, such as HIV, and the introduction of instruments with higher accuracy can be attributed to the largest market share.

Clinical chemistry is the practical application of biochemistry and is used to analyze body fluids for diagnostic and therapeutic purposes. Serum, plasma, and urine are the most commonly tested samples in pathology. The increasing use of approved blood-gas analyzers to monitor respiratory conditions is expected to fuel the growth of the market for in vitro diagnostic. For instance, in March 2020, Siemens Healthineers AG received U.S. FDA approval for the Rapidpoint 500e blood gas analyzer that received the CE-IVD mark in August 2019.

The microbiology segment includes tests and assays for the identification of infectious microorganisms. An increase in initiatives by organizations to improve patient outcomes using cost-effective and rapid diagnostic techniques, to help fight antibiotic resistance, is expected to fuel market growth. For instance, in April 2019, The University of Antwerp, Wellcome Trust, and bioMérieux, together launched Value-Dx — an Innovative Medicines Initiative (IMI) project — that was initiated by six in vitro diagnostic companies to fight against antimicrobial resistance.

Regional Insights

North America accounted for the largest revenue share of 41.1% in the IVD market in 2020 and is expected to continue its dominance over the forecast period. This is attributable to the local presence of major market players. In addition, rising disease prevalence and increased consumer awareness are propelling the need for improved diagnostic devices.

In Asia Pacific, the market is expected to witness the fastest growth over the forecast period, with a CAGR of 6.2%. Asia Pacific consists of developing and developed economies. Increasing healthcare awareness and rising patients going for early diagnosis in the region along with high chronic disease prevalence is anticipated to fuel the market.

Key Companies & Market Share Insights

The IVD market is price-sensitive and, therefore, players enter into intensive competition in terms of manufacturing cost-effective and efficient products. Companies are engaging in acquisitions, partnerships, and mergers, in order to strengthen their manufacturing capacities, product portfolio, and provide competitive differentiation. In addition, companies are focusing on gaining market approvals for innovative products to diagnose different infectious diseases. For instance, in 2019, Abbott received the WHO’s prequalification approval for the m-PIMA HIV-1/2 VL, a PoC viral diagnostic test. This product received CE marked approval in December 2018.

The presence of prominent players in this market space significantly diminishes the opportunities for new entrants into the market as it is difficult to match the high capital requirements. Some of the prominent players in the in vitro diagnostics market include:

• Abbott

• Danaher

• bioMérieux SA

• Bio-Rad Laboratories, Inc.

• Becton, Dickinson and Company

• Siemens Healthineers AG

• QIAGEN

• Quidel Corporation

• F. Hoffmann-La Roche AG

• Sysmex Corporation

• Charles River Laboratories International, Inc.

• Quest Diagnostics

• Agilent Technologies

In Vitro Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global in-vitro diagnostic market report on the basis of product, technology, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2027)

  • Instruments

  • Reagents

  • Services

• Technology Outlook (Revenue, USD Million, 2016 - 2027)

  • 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

• Application Outlook (Revenue, USD Million, 2016 - 2027)

  • Infectious Disease

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Disease

  • Drug testing

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Hospitals

  • Laboratories

  • Home Care

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Argentina

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE