In vitro Diagnostics Market Size, Share, Growth & 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, Physician’s Offices, and Others), and Regional Forecasts, 2023-2030

The in vitro diagnostics [IVD] market size was valued at USD 94.67 billion in 2022 and is expected to grow from USD 97.12 billion in 2023 to USD 157.02 billion by 2030, exhibiting a CAGR of 7.1% during 2023-2030. North America dominated the global market with a share of 38.88% in 2022.

In Vitro Diagnostics (IVD) are medical devices that perform diagnostic tests on biological samples such as blood, urine, and tissues. These tests help detect and monitor infectious diseases, autoimmune diseases, and several medical conditions and are also used to analyze drug therapy modifications from time to time. Furthermore, according to the British In-Vitro Diagnostic Association, these tests influence approximately 70% of clinical decisions.

The rising demand for and adoption of IVD devices have driven the market growth. This growth 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 the AerosolSense Sampler. Such new launches are projected to contribute to the in vitro diagnostics market growth.

COVID-19 IMPACT

Increased Use of Molecular Diagnostics during COVID-19 Pandemic Positively Impacted Market Growth

IVD consists of many tests and techniques to diagnose various disorders. The COVID-19 pandemic had a positive and negative impact on different segments; however, the increased use of molecular diagnostics overcame the negative effect of other segments, leading to a positive impact on the market during the pandemic. Molecular diagnostics techniques were used to diagnose the SARS-CoV-2 virus. Additionally, there was increased demand for test kits and consumables for monitoring blood glucose and troponin levels among hospitalized patients suffering from COVID-19.

This significantly increased the global demand for serology and molecular techniques based on point-of-care tests. Market players witnessed a considerable growth in molecular and point-of-care test sales, causing a substantial rise in their revenues. For instance, Abbott witnessed a revenue growth of around 225% in its molecular diagnostics segment in 2020 as compared to 2019.

However, some key players saw their revenue margins decline due to a notable decrease in 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 their immunodiagnostics segment in 2020 as compared to 2019.

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

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


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

In 2021, the global in vitro diagnostics market experienced significantly higher growth than the pre-pandemic level. As lockdown restrictions were lifted in most countries during this year, the number of home-based and laboratory tests grew. This subsequently caused a significant increase in the sales of point-of-care and molecular diagnostics products. For instance, F. Hoffmann-La Roche Ltd experienced a 139.4% growth in the revenue generated from its point-of-care segment in 2021 as compared to 2020.

LATEST TRENDS

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Increasing Adoption of Point-of-Care Testing Devices in Primary Care to Fuel Demand for In-vitro Diagnostic Tests

Due to the growing burden of diseases, medical device companies are rigorously developing technologically advanced diagnostic devices. Hospitals and laboratories have also demonstrated a rising preference for point-of-care testing devices to get accurate real-time data. Point-of-Care (PoC) testing is performed near the patient, usually needs only a small volume of blood, and provides faster test results during clinical decision-making, enabling doctors to make early treatment decisions without waiting for results from a central laboratory. This factor will likely increase the demand for point-of-care testing devices, ultimately boosting the demand for in vitro diagnostics devices.

Additionally, a significant rise in new and advanced product launches will contribute to the market's growth.

• In January 2023, FUJIFILM Sonosite, Inc. announced the launch of Sonosite PX ultrasound system in India. This launch was intended to optimize clinician ergonomics and improve efficiency.


• In July 2022, BioGX announced the launch of CE-marked Point-of-Care (POC) three gene multiplex COVID-19 test on its pixl platform.


• 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 IIs.

IN VITRO DIAGNOSTICS MARKET GROWTH FACTORS

Rising Burden of Chronic Diseases to Augment Market Growth

The rising prevalence of several diseases, such as genetic, cardiovascular, and neurological ailments are putting a significant burden on healthcare. The efficient use of IVD in the early diagnosis of such diseases allows doctors to work on appropriate treatments effectively.

• For instance, according to a September 2022 factsheet by the WHO, Non-Communicable Diseases (NCDs) were responsible for 41 million deaths, equivalent to 74% of all deaths globally.


• Similarly, according to the same source, cardiovascular diseases are the leading cause of death globally, causing 17.9 million deaths every year. This is followed by cancers at 9.3 million, chronic respiratory diseases at 4.1 million, and diabetes at 2.0 million; this includes kidney disease-related deaths due to diabetes. These four ailments account for over 80% of all premature NCD deaths.

This rising disease burden can be easily managed with proper awareness of early diagnosis and efficient use of IVD at both patient and physician levels. Moreover, the aging population is more susceptible to several diseases, such as hypertension, diabetes, cardiovascular, and liver, & kidney diseases, leading to increased use of homecare IVD devices.

• For instance, according to a news article by the United Nations in January 2023, 761 million people worldwide were aged 65 years and older in 2021, which will rise to 1.6 billion by 2050. The number of people aged 80 years or older is growing even faster. This is projected to propel the global market growth during the forecast period.

Increasing Funding and Government Support for Development and Innovation of Devices Anticipated to Contribute to Market Growth

Government organizations, associations, and agencies encourage the use of IVD by launching awareness initiatives, driving the market growth. To clarify the priority of diseases based on burden and prevalence, WHO released a model list of Essential In Vitro Diagnostics for primary healthcare and medical facilities with clinical laboratories. Both the categories are further sub-sectioned for general IVDs and specific diseases.

Moreover, increasing research and government funding are supporting the development of innovative products that further propel the market growth.

• For instance, in June 2022, the European Commission invested approximately USD 203 million (€ 190.9 million) in a project named “AGLYC Project”. This project aimed to develop a first-class blood-based biomarker for early detection of ischemia before the irreversible injury of the heart. CVD is the leading cause of mortality and morbidity across the world, and implementing the AGLYC biomarker is expected to positively impact patient lives.

Similar initiatives and the introduction of new products are expected to drive the market growth in the coming years.

RESTRAINING FACTORS

High Cost of Instruments to Restrict Market Growth in Emerging Countries

In-vitro diagnostics products have witnessed significant advancements and developments in the past decade with respect to further design improvements. However, the high costs associated with these instruments and their maintenance hindered the market growth to a certain extent. Additionally, in vitro diagnostics instruments can be used only by skilled professionals. This also increases the maintenance cost of the devices, 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. These cost factors have been responsible for the limited adoption of in-vitro diagnostics products in several countries.

SEGMENTATION

By Product Type Analysis

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Reagents & Consumables to be Widely Adopted due to the Advent of Advanced Products

Based on product type, the market is segmented into instruments and reagents & consumables. The reagents & consumables segment held the dominant in vitro diagnostics market share in 2022 due to surge in the 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 chronic diseases is one of the major factors propelling the demand for reagents & consumables. Furthermore, growing emphasis on early diagnosis in developed and emerging countries is increasing the number of patients undergoing routine tests, contributing to the strong growth of the segment.

The instruments segment is anticipated to record a comparatively sluggish CAGR during the forecast period. The introduction of advanced instruments offers an excellent avenue for the segment’s growth. For instance, in September 2022, Sysmex Corporation announced the launch of UD-1500 Fully Automated Urine Particle Analyzer for urine sediment testing. The product inherits the high functionality and usability of the UF-5000 Fully Automated Urine Particle Analyzer.

By Technique Analysis

Technological Advancements in Molecular Diagnostics Devices to Fuel their Demand

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 2022 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 this infection was diagnosed using Real-Time Quantitative Reverse Transcription PCR (qRT-PCR). Continuous research on the method to make it more innovative is still going on, leading to the development of advanced products.

• For instance, according to research published in ScienceDaily in July 2022, the Columbia University School of Engineering and Applied Science researchers developed an RT-PCR platform that gave results in 23 minutes that matched the time-consuming laboratory-based tests. This test was claimed to be faster than other PCR tests in the market. It could be adapted to test for a broad range of infectious diseases including flu, strep, and other viruses that require a fast diagnosis.

Moreover, the segment is projected to record a substantial CAGR during the forecast period. The growth is attributed to the rapid increase in chronic diseases around the globe. According to the World Health Organization (WHO), in 2021, an estimated 10.6 million people across the world were affected by tuberculosis (TB). Such factors are contributing to the segment’s growth.

By Setting Analysis

Rising Adoption of Advanced Point-of-Care Diagnostics Instruments to Boost the Segment’s Growth

On the basis of setting, the market is segmented into laboratories and point-of-care. The laboratories segment held a dominating share in 2022. This is due to the rising adoption of advanced instruments in this setting and rapid investments by public and private sectors in laboratory infrastructure in developing countries. Additionally, most of the complex and sensitive diagnostic tests are carried out in laboratories, requiring skilled lab staff, specialized equipment, and more time to run.

The point-of-care segment is projected to record a substantial CAGR during the forecast period. Due to the increased burden of various diseases, medical device manufacturing giants are focusing on introducing innovative and accurate testing kits. Furthermore, companies' launch of COVID-19 POC diagnostics kits has accelerated their 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 the growth of POC diagnostics. Additionally, point-of-care testing does not require highly skilled laboratory personnel or equipment. Therefore, it can be deployed in many different settings and at a large scale.

By Application Analysis

In vitro Diagnostics Devices to Find Robust Usage in Treatment of Infectious Diseases

In terms of application, the market is segmented into infectious diseases, cardiology, oncology, gastroenterology, and others. The infectious disease segment held the largest share in 2022 due to the rising prevalence of these ailments globally.

• For instance, according to the European Centre for Disease Prevention and Control, tuberculosis remains one of the world’s deadliest infectious diseases, second only to COVID-19, and drug-resistant TB strains are still a major concern.

Moreover, an increasing prevalence of several other infectious diseases, such as hepatitis, diphtheria, Respiratory Syncytial Virus (RSV), and many others, will contribute to the segment’s growth.

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

• According to the American Cancer Society statistics, in 2021, an estimated 1.9 million new cancer cases were recorded in the U.S. Additionally, a report by the UICC revealed that 30% of cancers could be screened using IVDs.

By End-user Analysis

Higher Test Volume to Boost Adoption of IVDs at Clinical Laboratories

By end-user, the market is divided into clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2022 due to the higher number of diagnostics procedures being carried out at these medical centers. Additionally, the availability of advanced technologies and equipment in these laboratories increases the diagnosis test volume, which will ultimately contribute to the segment's growth during the forecast period.

Furthermore, the physician's offices segment is expected to register a higher CAGR during the forecast period due to the rising preference of patients for physician’s offices for point-of-care tests. Additionally, the increased adoption of rapid point-of-care tests for diagnosing 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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The market in North America was valued at USD 36.77 billion in 2022 and may continue to dominate the global market during the forecast period. Some of the prominent factors contributing to the region’s rapid growth include the presence of major companies, such as Abbott, Thermo Fisher Scientific Inc., Becton, Dickinson and Company, and Danaher Corporation, along with favorable government regulations, well-established diagnostic infrastructure, and adoption of technologically advanced diagnostic techniques.

• For instance, in January 2022, Sight Diagnostics received Health Canada’s approval for its Sight OLO analyzers for point-of-care settings. Through its distribution partner Inter Medico, Sight will bring the first and only 5-part differential CBC testing to emergency departments, hospitals, and other decentralized settings across Canada.

Europe is anticipated to be the second-most dominant region in terms of market share. This is due to factors, such as rising healthcare expenditure, well-established infrastructure, and a large pool of patients suffering from infectious diseases and cancer.

• In December 2021, F. Hoffmann-La Roche Ltd announced the launch of infectious disease tests on the cobas 5800 System in nations that accept the CE mark. The test includes cobas HBV, cobas HIV-1, cobas HCV, cobas HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit. These launches aimed to expand the Roche Molecular portfolio by providing standardized performance and efficiencies across low, medium, and high-volume molecular laboratory tests.

The Asia Pacific market is estimated to record the highest CAGR over the forecast period, 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 2023-2030.

• For instance, in April 2021, South Korea’s Seegene Inc. announced that it had secured an export permit from the country’s Ministry of Food and Drug Safety to export its COVID-19 variant tests to countries across the world. This permit was expected to fortify the company's sales and market position globally.

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

KEY INDUSTRY PLAYERS

Companies Focus on Inorganic Growth Strategies to Strengthen their Market Position

The market is fragmented as many market players, such as Sysmex Corporation, Shimadzu Corporation, and Quidel Corporation, are expanding their diagnostics portfolio to increase the market share. Also, F. Hoffmann-La Roche Ltd, Abbott, and Thermo Fisher Scientific Inc. account for a significant share. Several key market players are adopting organic and inorganic growth strategies, such as mergers & acquisitions, collaborations, and new product developments & 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.

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

LIST OF KEY COMPANIES PROFILED IN IVD Market:

• 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:

• January 2023 – QIAGEN announced the CE-IVD marking and commercial launch of its molecular diagnostic platform EZ2 Connect MDx for automated sample processing in diagnostic laboratories.


• December 2022 – BrightInsight Inc. announced a partnership with bioMérieux to develop and bring to market a clinical digital solution for diagnostics, offering clinical decision support for disease areas across its diagnostic tests.


• September 2022 – BD announced the launch of the BD MAX system in India. The system utilizes a rapid molecular diagnostic technique to detect MDR-TB and other infectious diseases, enabling clinicians to test TB at a faster rate.


• March 2022 – Medix Biochemica, an IVD raw material manufacturing company, announced the acquisition of myPOLS Biotec GmbH. The acquisition aimed to broaden Medix Biochemica’s molecular diagnostic portfolio and strengthen its local presence in Western Europe.


• May 2021 - Sysmex Corporation and ThinkCyte Inc., a Japanese company, announced that they had signed a joint development and investment agreement. This deal aimed to commercialize the cell analysis technology based on Artificial Intelligence (AI).

REPORT COVERAGE

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

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

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