In-vitro Diagnostics (IVD) Market Size, Share & Industry 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, 2024-2032

The global in-vitro diagnostics (IVD) market size was USD 74.92 billion in 2023 and is expected to grow from USD 73.99 billion in 2024 to USD 117.60 billion by 2032, exhibiting a CAGR of 6.0% during the forecast period (2024-2032). North America dominated the IVD market with a market share of 37.21% in 2023.

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 market growth. This growth is further augmented by key players' increasing investment in research and development to innovate products and explore new applications of IVD techniques.

• For instance, in May 2022, Cipla Inc. launched an advanced real-time RT-PCR kit to detect the SARS-CoV-2 pathogens among the patients in 45 minutes.

Thus, increasing focus on launching advanced test kits is likely to support the market's growth globally. The COVID-19 pandemic positively impacted the market due to the increased use of molecular diagnostic tests among patients and healthcare providers to monitor hospitalized patients' blood glucose and troponin levels. This and the growing demand for point-of-care COVID-19 tests among patients supported the market growth during the pandemic.

In-vitro Diagnostics (IVD) Market Trends

Rising Penetration of Point-of-Care Testing Devices

The increasing prevalence of acute and chronic disorders is leading medical device companies to launch technologically advanced diagnostic devices. 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 the Sonosite PX ultrasound system in India. This launch was intended to optimize clinician ergonomics and improve efficiency.


• In January 2023, Cipla Inc. launched a point-of-care testing device for various non-communicable diseases and other medical conditions among patients.


• 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 the Cobas pulse point-of-care blood glucose testing instrument. This new product is anticipated to replace Accu-Chek Inform IIs.

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In-vitro Diagnostics Market Growth Factors

Surging Burden of Chronic Diseases is Presenting a Large Patient Pool Requiring IVD Tests

The rising prevalence of several diseases, such as genetic, cardiovascular, and neurological ailments, is 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) caused 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. In addition, the rising geriatric population with increased susceptibility to diseases, including hypertension, liver and kidney disease, and cardiovascular disorders, among others, is likely to support the growth of the market.

• For instance, according to a news article by Visual Capitalist in May 2023, 771 million people globally were 65 and older in 2022, which will rise to 1.3 billion by 2050. The number of people aged 80 years or older is growing even faster, which is projected to propel the global market's growth during the forecast period.

Increasing Funding and Government Support to Develop and Use IVD devices Contribute to Market Growth

Government organizations, associations, and agencies encourage the use of IVD by launching awareness initiatives and driving 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 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 impact patient lives positively.

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

RESTRAINING FACTORS

High Cost of Instruments to Restrict Market Growth in Emerging Countries

Numerous advantages are associated with these in-vitro diagnostics products. However, the high cost associated with these instruments and their maintenance is likely to hinder their adoption. Additionally, in-vitro diagnostics instruments can be used only by skilled professionals, which increases the maintenance cost of the devices, ultimately hampering 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.

In-vitro Diagnostics (IVD) Market Segmentation Analysis

By Product Type Analysis

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 2023 due to a 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, the 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.

• For instance, in February 2021, Thermo Fisher Scientific launched CE-IVD marked and applied Biosystems TaqPath COVID-19 HT kit to provide high-throughput solutions in the market.

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 the 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.

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By Technique Analysis

Technological Advancements in Molecular Diagnostics Devices to Fuel their Demand      

The market is segmented by technique into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others.

The molecular diagnostics segment held the dominating share in 2023 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). Increasing research and development activities among market players are leading to the introduction of innovative instruments based on novel techniques in the market.  

• For instance, in April 2023, ELITech Group launched a new high throughput sample-to-result instrument for molecular diagnostics to expand its product portfolio globally.

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 worldwide. 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

Increasing Adoption of Homecare Diagnostics to Increase Growth of Point-Of-Care Segment

On the basis of setting, the market is segmented into laboratories and point-of-care. The laboratories segment held a dominating share in 2023. 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 instance, in January 2023, Cipla Inc. launched a new point-of-care product, Cippoint, a diagnostic device for various conditions, including diabetes, infectious diseases, and thyroid.

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

The market is segmented by application into infectious diseases, cardiology, oncology, gastroenterology, and others. The infectious disease segment held the largest share in 2023 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, the rising geriatric population, which has increased susceptibility to infectious diseases, including hepatitis diphtheria, among others, and the rising number of outbreaks, is likely to support the segmental growth in the market.

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 American Cancer Society statistics, an estimated 1.9 million new cancer cases were recorded in the U.S. in 2021. 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

The market is divided by end-user into clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2023 due to the increasing number of clinical laboratories, further supporting the growing number of diagnostic procedures among patients in the market. 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.

• For instance, according to 2023 data published by the American Clinical Laboratory Association, there are approximately 322,488 clinical laboratories in the U.S.

Furthermore, the physician's offices segment is expected to register a higher CAGR during the forecast period due to patients' rising preference 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 27.88 billion in 2023 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.

This, along with the increasing number of point-of-care device launches, is likely to support the growing adoption of these instruments in the market.

• In June 2023, Sysmex Corporation launched its first point-of-care testing system to assess the effectiveness of antimicrobials using urine samples among patients in Europe.

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 Companies in the In-vitro Diagnostics Market

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 January 2024, F. Hoffmann-La Roche Ltd. Acquired LumiraDx’s point-of-care diagnostics platform for USD 295.0 million. This acquisition will help Roche access LumiraDx’s novel technology to increase the penetration of point-of-care diagnostics products in the market.

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:

• F. Hoffmann-La Roche Ltd. (Switzerland)


• Abbott (U.S.)


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


• Sysmex Corporation (Japan)


• Siemens Healthineers AG (Germany)


• BD (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:

• December 2023: Thermo Fisher Scientific Inc. launched Thermo Scientific KingFisher Apex Dx and Applied Biosystems MagMAX Dx Viral/Pathogen NA Isolation Kit to isolate and purify viral and bacterial pathogens in samples efficiently.


• October 2023: Sysmex Corporation collaborated with Fujirebio Holdings, Inc., to launch advanced products in the field of immunoassay among patients.


• August 2023: Qiagen received U.S. FDA approval for its therascreen PDGFRA RGQ PCR kit to meet the growing demand for diagnosing infectious diseases among patients.


• October 2022: Qiagen received CE approval for its in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Devices Regulation (IVDR) to expand its product portfolio.


• February 2022: BD acquired Cytogonos from Vitro S.A. to expand its portfolio of flow cytometry solutions for blood cancer diagnosis among patients.

REPORT COVERAGE

The 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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Report Scope & Segmentation