In Vitro Diagnostic Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The In Vitro Diagnostic Market is segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Hematology, and Other Test Types), Product (Instruments, Reagents, and Other Products), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, and Other Applications), End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

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Market Snapshot

In Vitro Diagnostic Market Summary
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 4.9 %
In Vitro Diagnostic Market Major Players

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Market Overview

The in vitro diagnostics market was valued at approximately USD 76,281.75 million in 2021, and it is expected to witness a revenue of USD 1,01,542.35 million in 2027, with a CAGR of 4.90% over the forecast period (2022-2027).

The COVID-19 pandemic turned the spotlight on in vitro diagnostics since there is an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV2 virus infection among the global population. The outbreak of COVID-19 is expected to positively impact the market, as in vitro diagnostics involve the testing of various biological samples. This is expected to aid the diagnosis of infectious diseases, such as COVID-19. Testing remains a crucial step in controlling the COVID-19 pandemic. The article titled ' the impact of COVID-19 on the Invitro Disgnostic Industry' published in April 2021 mentioned that Invitro diganotics tests conducted on samples from the human body, have been indispendable tools in combating COVID-19. The industry is expcted to grow significantly post-COVID-19, due in part to increased use of pandemic-necessitated innovations such as remote collections and digital pathology. As the number of COVID-19 cases is increasing across the world, governments of various countries are exploring the possibility of allowing private laboratories to ramp up testing.

Also, the rapid launch of diagnostic kits for the diagnosis of COVID-19 by key players is driving the market during the pandemic. For instance, in May 2021 the Defense Research and Development Organization (DRDO) developed a COVID-19 antibody detection kit that offers result in just 75 minutes. Additionally, in February 2020, the US FDA issued a new policy to expedite the availability of diagnostics. A public health emergency was determined, justifying the authorization of emergency use of in vitro diagnostics (IVDs) for the diagnosis of COVID-19. Thus, the global COVID-19 pandemic is expected to have a positive impact on the growth of the studied market.

The growth of the global IVD market can be attributed to the high prevalence of chronic and infectious diseases. According to the Centers for Disease Control and Prevention (CDC), in 2021, around 18.2 million adults aged 20 and older had coronary artery disease (CAD) in the United States. Heart disease is the leading cause of death among people in the United States. The high incidence of chronic diseases increases the demand for huge diagnostic procedures, which, in turn, drives the market.

Additionally, the current market is also growing due to the use of advanced technologies in the IVD market. There has been a paradigm shift from traditional diagnostics to a new generation of diagnostics that work at the gene level. This was made possible by the inclusion of advanced technologies, such as genetic testing, molecular diagnostics, polymerase chain reaction (PCR), and next-generation sequencing (NGS) in the IVD platform. Also, the increasing product launches with advanced features are expected to drive the market. For instance, in January 2020, SphingoTec GmbH launched its IB10 sphingotest pencil, a CE-IVD-marked point-of-care test for Proenkephalin, the biomarker that allows real-time assessment of kidney function with a simple blood test.

Thus, given the aforementioned factors, the in vitro diagnostic market is anticipated to propel over the forecast period.

Scope of the Report

As per the scope of this report, in vitro diagnostics involves medical devices and consumables that are utilized to perform in vitro tests on various biological samples. They are used for the diagnosis of various medical conditions, such as diabetes and cancer. The In Vitro Diagnostic Market is segmented By Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Hematology, And Other Test Types), Product (Instruments, Reagents, And Other Products), Usability (Disposable IVD Devices And Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, And Other Applications), End User (Diagnostic Laboratories, Hospitals And Clinics, And Other End Users), And Geography (North America, Europe, Asia-Pacific, Middle-East And Africa, And South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Test Type
Clinical Chemistry
Molecular Diagnostics
Immuno Diagnostics
Hematology
Other Test Types
By Product
Instruments
Reagents
Other Products
By Usability
Disposable IVD Devices
Reusable IVD Devices
By Application
Infectious Disease
Diabetes
Cancer/Oncology
Cardiology
Autoimmune Disease
Nephrology
Other Applications
By End Users
Diagnostic Laboratories
Hospitals and Clinics
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Reagents are Expected to Hold the Largest Market Share in the Product Segment

In the product segment of the in vitro diagnostic market, the reagent segment is expected to witness the largest CAGR over the forecast period.

The COVID-19 pandemic is expected to significantly aid in the growth of the segment, owing to the high requirement of reagents to meet the increasing diagnostics demand globally for the diagnosis of the COVID-19 infection.

The reagent segment of the market includes chemical, biological, or immunological components, solutions, or preparations intended by the manufacturer to be used during the Vitro diagnosis process. Given the high cost of many diagnostic platforms, it is common for manufacturers to lease equipment instead of selling technology outright to end users. In these arrangements, the lease is tied to contracts to purchase associated reagents or assays for the equipment over the life of the contract.

Additionally, with the increasing burden of chronic diseases worldwide, the demand for in vitro diagnostics increases, which, in turn, surges the demand for reagents used in the various testing platforms. Also, the acquisitions by key market players are expected to contribute to the growth of the market. For instance, in March 2022 Medix Biochemica acquired myPOLS Biotech GmbH to exp Thus, owing to the aforementioned factors, the reagent segment is expected to grow tremendously over the forecast period.

In Vitro Diagnostic Market : Estimated Number of New Cases of Cancer, by Type, Both Sexes, United States, 2021

North America Dominates the Market and is Expected to Continue its Dominance in the Forecast Period

North America currently dominates the market for in vitro diagnostics, and it is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future, owing to the well-established healthcare industry and rising prevalence of chronic diseases in the region. The United States holds the majority of the market in the North American region, due to the rising healthcare expenditure, along with the rapid adoption of point-of-care testing.

According to the American Cancer Society, in 2020, about 1.8 million new cancer cases were diagnosed, and approximately 606,520 cancer deaths occurred in the United States. Moreover, people with chronic conditions are the most frequent users of healthcare facilities in the United States. They account for the majority of hospital admissions and prescription filling, and thus, they drive the growth of the market.

Moreover, in February 2020, the Food and Drug Administration issued its first Emergency Use Authorization to the Centers for Disease Control and Prevention (CDC), authorizing the use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from COVID-19 samples, in response to the COVID-19 pandemic. Hence, following this, many in vitro diagnostics received the Food and Drug Administration's Emergency Use Authorization, which is expected to impact the market growth in the region.

Additionally, the growing number of product launches in the region and the high concentration of key players in North America act as major factors in driving the market. For instance, in May 2020, Bio-Rad Laboratories Inc.’s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit was granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems.Thus, given the aforementioned factors, the in vitro diagnostic market is anticipated to grow significantly in North America over the forecast period.

In-Vitro Diagnostic Market Growth Rate by Region

Competitive Landscape

The In Vitro Diagnostic market is highly competitive and consists of several major players. In terms of market share, a few of the major players currently dominate the market. However, with technological advancements and product innovations, mid-size to smaller companies are increasing their market presence by introducing new products at lower prices. Companies like Thermo Fischer Scientific Inc., Abbott Laboratories, Siemens Healthcare GmbH, and F. Hoffmann-La Roche AG hold a substantial market share in the in vitro diagnostic market. 

Major Players

  1. Abbott Laboratories

  2. Siemens Healthcare GmbH

  3. F. Hoffmann-La Roche Ltd

  4. BioMérieux SA

  5. Thermo Fischer Scientific Inc

In Vitro Diagnostic Market Concentration

Recent Developments

  • In June 2022 Agilient Technologies launched Invitri-Diganostic compliant instruments, kits and Reagents for Use in compliance with the new European Union IVDR regulation. 
  • In August 2021, Roche received Food and Drug Administration (FDA) approval for VENTANA MMR RxDx Panel to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 High Prevalence of Chronic Diseases

      2. 4.2.2 Increasing Use of Point-of-care (POC) Diagnostics

      3. 4.2.3 Advanced Technologies in In Vitro Diagnostic Products

      4. 4.2.4 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics

    3. 4.3 Market Restraints

      1. 4.3.1 Stringent Regulations Regarding Product Approvals

      2. 4.3.2 Cumbersome Reimbursement Procedures

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Test Type

      1. 5.1.1 Clinical Chemistry

      2. 5.1.2 Molecular Diagnostics

      3. 5.1.3 Immuno Diagnostics

      4. 5.1.4 Hematology

      5. 5.1.5 Other Test Types

    2. 5.2 By Product

      1. 5.2.1 Instruments

      2. 5.2.2 Reagents

      3. 5.2.3 Other Products

    3. 5.3 By Usability

      1. 5.3.1 Disposable IVD Devices

      2. 5.3.2 Reusable IVD Devices

    4. 5.4 By Application

      1. 5.4.1 Infectious Disease

      2. 5.4.2 Diabetes

      3. 5.4.3 Cancer/Oncology

      4. 5.4.4 Cardiology

      5. 5.4.5 Autoimmune Disease

      6. 5.4.6 Nephrology

      7. 5.4.7 Other Applications

    5. 5.5 By End Users

      1. 5.5.1 Diagnostic Laboratories

      2. 5.5.2 Hospitals and Clinics

      3. 5.5.3 Other End Users

    6. 5.6 Geography

      1. 5.6.1 North America

        1. 5.6.1.1 United States

        2. 5.6.1.2 Canada

        3. 5.6.1.3 Mexico

      2. 5.6.2 Europe

        1. 5.6.2.1 Germany

        2. 5.6.2.2 United Kingdom

        3. 5.6.2.3 France

        4. 5.6.2.4 Italy

        5. 5.6.2.5 Spain

        6. 5.6.2.6 Rest of Europe

      3. 5.6.3 Asia-Pacific

        1. 5.6.3.1 China

        2. 5.6.3.2 Japan

        3. 5.6.3.3 India

        4. 5.6.3.4 Australia

        5. 5.6.3.5 South Korea

        6. 5.6.3.6 Rest of Asia-Pacific

      4. 5.6.4 Middle-East and Africa

        1. 5.6.4.1 GCC

        2. 5.6.4.2 South Africa

        3. 5.6.4.3 Rest of Middle-East and Africa

      5. 5.6.5 South America

        1. 5.6.5.1 Brazil

        2. 5.6.5.2 Argentina

        3. 5.6.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Biomerieux SA

      2. 6.1.2 Danaher Corporation

      3. 6.1.3 F. Hoffmann-La Roche Ltd

      4. 6.1.4 Becton, Dickinson and Company

      5. 6.1.5 Bio-Rad Laboratories Inc.

      6. 6.1.6 Abbott Laboratories

      7. 6.1.7 Arkray Inc.

      8. 6.1.8 Sysmex Corporation

      9. 6.1.9 Siemens Healthcare GmbH

      10. 6.1.10 Thermo Fischer Scientific Inc.

      11. 6.1.11 Qiagen NV

      12. 6.1.12 Grifols SA

      13. 6.1.13 AgilentTechnologies Inc.

      14. 6.1.14 Diasorin

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments
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Frequently Asked Questions

The Global In Vitro Diagnostic Market market is studied from 2019 - 2027.

The Global In Vitro Diagnostic Market is growing at a CAGR of 4.9% over the next 5 years.

The Global In Vitro Diagnostic Market is valued at 76281 Million USD in 2019.

The Global In Vitro Diagnostic Market is valued at 101542 Million USD in 2027.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Abbott Laboratories, Siemens Healthcare GmbH, F. Hoffmann-La Roche Ltd, BioMérieux SA, Thermo Fischer Scientific Inc are the major companies operating in Global In Vitro Diagnostic Market.

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