Summary

The global in-vitro diagnostics market was valued at approximately USD 68,410 million in 2020, and it is expected to witness a revenue of USD 91,250 million in 2026, with a CAGR of 4.90% over the forecast period.

The COVID-19 pandemic turned the spotlight on in-vitro diagnostics, since there is an increasing demand for the 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 studied, as in-vitro diagnostics involves 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. As the number of COVID-19 cases is increasing across the world, governments of various countries are exploring the possibilities 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 studied market during the pandemic. For instance, in March 2020, Qiagen launched QIAstat-Dx test kit for detection of SARS-CoV-2 coronavirus in Europe, and in April 2020, Altona Diagnostics launched CE-IVD marked RealStar SARS-CoV-2 RT-PCR Kit 1.0, an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of lineage B-beta coronavirus (lineage B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. 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 World Heart Federation 2018, coronary heart disease is the leading cause of death worldwide. An estimated 3.8 million men and 3.4 million women die each year from coronary heart disease. Besides, 80% of the deaths occur in low- and middle-income countries. The high incidence of chronic diseases increases the demand for huge diagnostic procedures, which, in turn, drives the studied 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 studied market. For instance, in January 2020, SphingoTec GmbH launched its IB10 sphingotest penKid, 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.

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 is expected to witness the largest CAGR over the forecast period.

The reagent segment of the market studied includes chemical, biological, or immunological components, solutions, or preparations intended by the manufacturer to be used during the in-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.

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

Additionally, with the increasing burden of chronic diseases worldwide, the demand for in vitro diagnostics rises, which, in turn, surges the demand for reagents used in the various testing platforms. Also, the growing product launches in the market are expected to drive the market. For instance, in November 2019, Vidan Diagnostics launched β-Hydroxybutyrate 21FS Reagent for Beckman Coulter AU clinical chemistry systems. Thus, in view of the aforementioned factors, the reagent segment is expected to grow tremendously over the forecast period.

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 diagnostic, 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 expected to be diagnosed, and approximately 606,520 cancer deaths may occur 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 prescriptions filling, and thus, they drive the growth of the studied market.

Moreover, in February 2020, the FDA 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 FDA's EUA, which is expected to impact the market growth in the region.

Additionally, the growing number of product launches in the region and 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 has been granted Emergency Use Authorization (EUA) by the US 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.

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 lesser 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. Additionally, the key players are involved in strategic alliances, such as acquisitions, collaborations, and partnerships, with companies that complement their product portfolio. For instance, in May 2020, Becton Dickinson and Company completed the acquisition of NAT Diagnostics to expand its point-of-care testing for infectious disease portfolio.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 High Prevalence of Chronic Diseases
4.2.2 Increasing Use of Point-of-care (POC) Diagnostics
4.2.3 Advanced Technologies in In-vitro Diagnostic Products
4.2.4 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics
4.3 Market Restraints
4.3.1 Stringent Regulations Regarding Product Approvals
4.3.2 Cumbersome Reimbursement Procedures
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 Test Type
5.1.1 Clinical Chemistry
5.1.2 Molecular Diagnostics
5.1.3 Immuno Diagnostics
5.1.4 Hematology
5.1.5 Other Test Types
5.2 Product
5.2.1 Instruments
5.2.2 Reagents
5.2.3 Other Products
5.3 Usability
5.3.1 Disposable IVD Devices
5.3.2 Reusable IVD Devices
5.4 Application
5.4.1 Infectious Disease
5.4.2 Diabetes
5.4.3 Cancer/Oncology
5.4.4 Cardiology
5.4.5 Autoimmune Disease
5.4.6 Nephrology
5.4.7 Other Applications
5.5 End Users
5.5.1 Diagnostic Laboratories
5.5.2 Hospitals and Clinics
5.5.3 Other End Users
5.6 Geography
5.6.1 North America
5.6.1.1 United States
5.6.1.2 Canada
5.6.1.3 Mexico
5.6.2 Europe
5.6.2.1 Germany
5.6.2.2 United Kingdom
5.6.2.3 France
5.6.2.4 Italy
5.6.2.5 Spain
5.6.2.6 Rest of Europe
5.6.3 Asia-Pacific
5.6.3.1 China
5.6.3.2 Japan
5.6.3.3 India
5.6.3.4 Australia
5.6.3.5 South Korea
5.6.3.6 Rest of Asia-Pacific
5.6.4 Middle-East and Africa
5.6.4.1 GCC
5.6.4.2 South Africa
5.6.4.3 Rest of Middle-East and Africa
5.6.5 South America
5.6.5.1 Brazil
5.6.5.2 Argentina
5.6.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Biomerieux SA
6.1.2 Danaher Corporation
6.1.3 F. Hoffmann-La Roche Ltd
6.1.4 Becton, Dickinson and Company
6.1.5 Bio-Rad Laboratories Inc.
6.1.6 Abbott Laboratories
6.1.7 Arkray Inc.
6.1.8 Sysmex Corporation
6.1.9 Siemens Healthcare GmbH
6.1.10 Thermo Fischer Scientific Inc.
6.1.11 Qiagen NV
6.1.12 Grifols SA
6.1.13 Luminex Corporation
6.1.14 AgilentTechnologies Inc.
6.1.15 Diasorin

7 MARKET OPPORTUNITIES AND FUTURE TRENDS