In vitro Diagnostics (IVD) Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Hematology, and Others), By Setting (Laboratories and Point-of-care), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, and Others), By End-user (Clinical Laboratories, Hospitals, Physicians Offices, and Others), and Regional Forecasts, 2022-2029

The global in vitro diagnostics (IVD) market size was valued at USD 92.08 billion in 2021. The market is projected to grow from USD 71.43 billion in 2022 to USD 107.42 billion by 2029, exhibiting a CAGR of 6.0% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with in vitro diagnostics experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a higher growth of 25.2% in 2020 as compared to 2019.

In vitro Diagnostics (IVD) are medical devices used to perform diagnostic tests on biological samples such as blood, urine, and tissues. The IVD tests help detect and monitor infectious diseases, autoimmune diseases, and several medical conditions that are being used to analyze drug therapies. Furthermore, according to the British In-vitro Diagnostic Association, in vitro diagnostics tests influence approximately 70% of clinical decisions. However, less than 1% of the NHS's budget is spent developing innovative IVD product portfolios each year.

The rising demand for point-of-care IVD devices and the increasing adoption of these devices have been instrumental in driving the market growth. This is further augmented by increasing investment by key players in research & development to innovate products and explore new applications of IVD techniques.

• For instance, in February 2022, Thermo Fisher Scientific Inc. launched the Renvo Rapid PCR Test to detect in-air SARS-CoV-2 pathogens.

This test is performed on samples collected through AerosolSense Sampler. Such new launches are projected to contribute to the in vitro diagnostics market growth.

COVID-19 IMPACT

COVID-19 Pandemic Led to Significant Surge in Diagnostic Procedures Demand

The IVD market witnessed high growth in terms of revenues in 2020, owing to the mixed impact of COVID-19 on various segments. The COVID-19 pandemic has surged the demand for molecular diagnostics techniques as it is used to diagnose the SARS-CoV-2 virus. Additionally, there was increased demand for test kits and consumables for monitoring blood glucose levels, troponin levels, and many others among hospitalized patients suffering from COVID-19.

This would significantly increase the global demand for serology and molecular techniques based on point-of-care tests. Market players witnessed a considerable increase in molecular and point-of-care test sales, causing a substantial increase in their revenues.

However, some key players experienced declining revenue growth due to reducing routine testing performed in hospitals and laboratories worldwide. For instance, F. Hoffmann-La Roche Ltd, Abbott Laboratories, and bioMérieux SA witnessed a decline of -6.0%, -3.9%, and -7.0%, respectively, in the revenues generated from the immunodiagnostics segment in 2020 as compared to 2019.

Additionally, introducing new techniques for rapidly diagnosing COVID-19 has surged the demand for in vitro diagnostics products and services worldwide.

• For instance, in June 2021, Bio Rad Laboratories, Inc. launched the PREvalence ddPCR SARS-CoV-2 Wastewater Quantification Kit, which is a cost-effective tool for detecting SARS-CoV-2 in a community’s wastewater.


• In March 2021, Thermo Fisher Scientific launched ‘Applied Biosystems QuantStudio 5 Dx Real-Time PCR System’ to analyze a large number of samples in a short duration, resulting in an increase in efficiency of clinical laboratories & providing customizable output and used in molecular diagnostic testing.

In 2021, this market experienced significantly higher growth than the pre-pandemic level. In 2021, as lockdown restrictions uplifted in most countries, home-based tests & laboratory-based tests witnessed a high volume growth. This subsequently contributed to the significant increase in sales of point-of-care and molecular laboratory products.

• For instance, F. Hoffmann-La Roche Ltd experienced a surge in the revenue generated from the point-of-care segment by 139.4% in 2021 compared to 2020

LATEST TRENDS

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Increasing Adoption of Point-of-care Testing Devices to Fuel Demand for IVD Tests

Due to the increasing burden of diseases, medical device companies are continuously developing technologically advanced diagnostic devices. Furthermore, hospitals and laboratories have demonstrated a rising preference for point-of-care testing devices to get accurate real-time data. This factor is likely to increase the demand for point-of-care testing devices, ultimately increasing the demand for in vitro diagnostics devices.

Additionally, the significant rise in new advanced product launches contributes to the growth of the market.

• In March 2021, F. Hoffmann-La Roche Ltd launched Cobas pulse point-of-care blood glucose testing instrument. This new product is anticipated to be the successor of Accu-Chek Inform II's previous version.


• In March 2020, Abbott also launched a molecular test to detect COVID-19 on its ID NOW rapid point-of-care platform in the U.S., according to the EUA.

DRIVING FACTORS

Rising Incidence of Chronic Diseases to Augment Market Growth

The prevalence of several diseases, such as genetic, cardiovascular, and neurological diseases, is increasing significantly. According to the World Health Organization (WHO), Cardiovascular Diseases (CVDs) are the number 1 cause of death globally, causing 17.9 million deaths each year. This has led to a rise in awareness regarding early diagnosis among the population and an increase in routine diagnosis, which resulted in the market's overall growth. Moreover, the introduction of novel advanced IVD products also supports the rapid growth of the market.

Additionally, the aging population is more susceptible to several diseases, such as hypertension, diabetes, cardiovascular, liver, and kidney diseases, which are expected to increase significantly.

• According to the article published in Knoema, in 2021, globally, the population aged 65 years and above was 9.5%. This is projected to further propel the global market during the forecast period.

RESTRAINING FACTORS

High Cost of IVD Instruments to Restrict Growth in Emerging Countries

In vitro diagnostics products have witnessed significant advancements and developments in the past decade regarding new products being adopted and further design amendments. However, the high cost of IVD instruments and the high cost associated with the maintenance of the instruments hindered the market growth to a certain extent. Additionally, in-vitro diagnostics instruments require skilled professionals for operation. Thus, this increases the maintenance cost of the device, which ultimately hampers the overall growth of the market.

The cost of RT-PCR systems ranges from USD 15,000 to over USD 90,000. The above cost factors have been responsible for the relatively limited adoption of in vitro diagnostics products in several countries and regions.

SEGMENTATION

By Product Type Analysis

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Reagents & Consumables Segment to Dominate Backed by Advent of Advanced Products

Based on product type, the market is segmented into instruments and reagents & consumables.

The reagents & consumables segment held the dominant share of the global market in 2021 due to the surge in usage of self-testing kits, POC tests, and several other advanced products in in-vitro diagnosis. The increased number of research & development activities for diagnosing several chronic diseases is one of the major factors propelling the demand for reagents & consumables. Furthermore, increased emphasis on early diagnosis in developed and emerging countries leads to the rising number of patients undergoing routine tests, contributing to the higher growth of the segment.

The instruments segment is anticipated to expand at a comparatively sluggish CAGR during the forecast period. The introduction of advanced instruments offers an excellent avenue for segment growth. For instance, in March 2021, Sysmex Corporation launched two next-generation flagship models in the hematology business segment, the XR-Series Automated Hematology Analyzer and a compact 3-part WBC differential model, which is the XQ-Series Automated Hematology Analyzer.

By Technique Analysis

Incessant Technological Advancements in Molecular Diagnostics Devices to Fuel This Segment

On the basis of technique, the market is segmented into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others.

The molecular diagnostics segment held the dominating share in 2021 due to the increasing demand for molecular diagnosis in infectious diseases. As the COVID-19 pandemic hit worldwide, the SARS-CoV-2 virus that causes COVID-19 was diagnosed using Real-Time Quantitative Reverse Transcription PCR (qRT-PCR). Furthermore, in April 2021, Sysmex Corporation received approval from the Japanese medical regulatory authorities to manufacture and market the DetectAmp SARS-CoV-2 RT-PCR kit. It is a SARS coronavirus nucleic acid kit used to detect the RNA of the novel coronavirus (SARS-CoV-2).

Furthermore, the segment is projected to grow at a substantial CAGR during the forecast period. The growth is attributed to the rapid increase in acute and chronic diseases around the globe. According to the World Health Organization (WHO), in 2020, an estimated 10 million people will be affected by tuberculosis (TB) worldwide. Such factors are contributing to the high growth of the segment.

By Setting Analysis

Continuous Innovations in Point-of-Care Systems to Upsurge Demand of This Segment

On the basis of setting, the market is segmented into laboratories and point-of-care.

The laboratories segment held the dominating share in 2021. This is majorly due to the rising adoption of advanced instruments in this setting, along with rapid investments by public and private sectors in laboratory infrastructure in developing countries. Additionally, most complex and sensitive diagnostic tests are carried out in laboratories and require skilled lab staff, specialized equipment, and slightly more time to run.

The point-of-care segment is projected to grow at a substantial CAGR during the forecast period. Due to the increased burden of patient populations suffering from various diseases (diabetes, infectious disease, HIV), medical device giants are focusing on introducing innovative and accurate testing kits. Furthermore, companies' launch of COVID-19 POC diagnostics kits has elevated revenue growth. For example, in June 2021, Abbott received a CE mark for its Panbio rapid antigen self-test to detect the SARS-CoV-2 virus in adults and children with or without symptoms. Therefore, such novel product launches will significantly augment POC diagnostics business growth. Additionally, point-of-care testing does not require highly skilled laboratory personnel or equipment to be carried out. Therefore, it can be deployed in lots of different settings and at a significant scale.

By Application Analysis

Increasing Prevalence of Infectious Diseases to Boost Growth of This Segment

The market is segmented into infectious diseases, cardiology, oncology, gastroenterology, and other applications on the basis of application.

The infectious diseases segment held the dominating share in 2021 due to the increasing number of infectious diseases globally.

• According to the statistics from the UNAIDS, 37.7 million people globally will be living with HIV in 2020.

Furthermore, an increasing prevalence of several other infectious diseases, such as hepatitis, diphtheria, Respiratory Syncytial Virus (RSV), and many others, would contribute to the highest share of the segment.

The oncology application segment is expected to grow at a significant CAGR during the forecast period. The growth is attributed to the physician’s high preference for in vitro diagnostics products to diagnose cancer. Furthermore, the rising number of cancer patients globally is expected to grow in this segment.

• According to the American Cancer Society statistics, in 2021, an estimated 1.9 million new cancer cases were diagnosed in the U.S.

By End-user Analysis

Higher Test Volume at Clinical Laboratories to Lead to Dominance of the Segment

By end-user, the market is divided into clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2021 due to the higher number of diagnostics procedures in clinical laboratories. Additionally, the availability of advanced technology and equipment in clinical laboratories fuels the diagnosis test volume, which ultimately contributes to the segment's growth during the forecast period.

Furthermore, the physician's offices segment is expected to grow at a higher CAGR due to the rising shift of patients who prefer physician offices for point-of-care tests. Additionally, with increased adoption of rapid point-of-care tests for chronic and infectious diseases, such as diabetes and hepatitis, in physicians' offices is anticipated to drive the growth of the segment.

REGIONAL INSIGHTS

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On the basis of region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The market in North America was valued at USD 35.92 billion in 2021 and is anticipated to continue to dominate the global market during the forecast period. Some of the prominent factors contributing to the region’s highest share include the presence of major companies in the region, such as Abbott, Thermo Fisher Scientific Inc., Becton, Dickinson and Company, and Danaher Corporation, along with adequate and favorable government regulations, well-established diagnostic infrastructure, and adoption of technologically advanced diagnostic techniques.

Europe is anticipated to be the second-most dominant region in terms of in vitro diagnostics market share. The market in Europe holds a significant share due to rising healthcare expenditure, well-established infrastructure, and a large pool of patients suffering from infectious diseases and cancer.

The market in Asia Pacific is estimated to grow at the highest CAGR, especially in developing countries such as India, South Korea, Australia, and China. Improving approval & reimbursement policies and rising per capita healthcare expenditure in this region are projected to drive the market growth in Asia Pacific during 2022-2029. For instance, in April 2021, Seegene Inc. announced that it secured an export permit from South Korea’s Ministry of Food and Drug Safety to begin exporting its COVID-19 variant tests to countries worldwide. This permit will fortify the company's sales and market position globally.

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Latin America and the Middle East & Africa are anticipated to account for a limited market revenue share during the forecast period. However, improvement in healthcare expenditure and increasing adoption of point-of-care devices in Latin America and the Middle East & Africa are expected to lead to future growth prospects.

KEY INDUSTRY PLAYERS

F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation are Key Players in the Market

The global market is fragmented with major players, such as F. Hoffmann-La Roche Ltd, Abbott, Thermo Fisher Scientific Inc., and Sysmex Corporation, accounting for a significant share. Several key market players adopt organic and inorganic strategies, such as mergers and acquisitions, collaborations, new product developments, and launches, to reinforce their market position globally.

• For instance, in March 2021, F. Hoffmann-La Roche Ltd. signed a definitive merger agreement with GenMark Diagnostics Inc. This acquisition will help Roche access GenMark’s novel technology to test for a broad range of pathogens with one patient sample.


• In March 2021, F. Hoffmann-La Roche Ltd launched Cobas pure integrated solutions in countries accepting the CE mark. This new compact analyzer combines three technologies on a single platform helping to simplify operations in small to medium-sized labs.

Other market players with a significant presence in the global market include Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Seegene Inc., DiaSorin S.p.A., and Quest Diagnostics Incorporated. These companies are expected to focus on new products launched to increase their share in the market during the forecast period.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• Abbott Laboratories (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• Sysmex Corporation (Japan)


• Siemens Healthineers AG (Germany)


• BD (Becton, Dickinson, and Company) (U.S.)


• Seegene Inc. (Republic of Korea)


• DiaSorin S.p.A. (Italy)


• Quest Diagnostics Incorporated (U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• March 2021 - BD announced that the U.S. FDA granted Emergency Use Authorization (EUA) for a new, rapid antigen test to detect SARS-CoV-2, influenza A, and influenza B in a single test.


• February 2021 - BD and Scanwell Health announced a collaboration to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.


• May 2021 - Sysmex Corporation and ThinkCyte Inc., a Japan-based company, announced a joint development and investment agreement authorization. This is for the commercialization of cell analysis technology based on artificial intelligence.

REPORT COVERAGE

An Infographic Representation of In-vitro Diagnostics (IVD) Market

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The report provides a detailed market analysis. It focuses on key aspects such as an overview of the product, the prevalence of several diseases and disorders, key countries, and pricing analysis. Additionally, it includes an overview of reimbursement scenarios for diagnostic procedures, key industry developments, such as mergers, partnerships, & acquisitions, impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the in vitro diagnostics market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several key factors that have contributed to the market's growth in recent years. The report also covers regional analysis of different segments.

Report Scope & Segmentation