In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents, Services), By Test Location (PoC, Homecare), By End-use (Hospitals, Laboratory), By Application, By Technology, And Segment Forecasts, 2023 - 2030

Report Overview

The global in vitro diagnostic market size was valued at USD 132.95 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of -2.8 % from 2023 to 2030. The growth can be attributed to the increasing adoption of IVD owing to the rise in testing due to the pandemic. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel the market growth. The rising number of IVD (in vitro diagnostics ) products being launched by key players is also fueling the growth of the market. IVD products with molecular diagnostic capabilities deliver effective and accurate results.

In May 2021, an ultrasensitive molecular test was developed by the University of California. This test is based on a chip technology that can detect the presence of influenza A and SARS-CoV-2 antigens. The test is under further study for conversion into a Point-of-Care (POC) test. There has been a shift in the industry dynamics, with an increasing number of players focusing on launching tests for home-based testing. Moreover, in 2021, the FDA also prioritized home-based molecular diagnostic tests. In March 2021, BATM Advanced Communications Ltd. announced the launch of its molecular diagnostics self-test kit for the detection of COVID-19. Moreover, these tests enable the early detection of diseases, maintaining a low threat of substitutes. However, the high prices of these tests are expected to encourage patients to shift to external substitutes. Moreover, for the detection of newer infections, such as SARS-CoV-2, the rate of internal substitution is high, which boosts competitive rivalry. The penetration of IVD products from established players is low in regions, such as APAC; this region is highly dominated by local players selling instruments at lower costs. Technological advancements in terms of portability, accuracy, and cost-effectiveness are projected to be among the major drivers of this market.

The rise in the geriatric population and growth in knowledge regarding early testing has led to a surge in the number of regular check-ups, as a majority of deaths due to infections and chronic conditions occur in the population aged over 75 years. As per the Office for Budget Responsibility, U.K., healthcare costs have risen exponentially, which can create economic pressure on rapidly aging nations. However, this expenditure is anticipated to translate positively for the IVD industry, driving the market growth.

Product Insights

The reagents products segment led the global market in 2022 and accounted for the largest revenue share of more than 65.00%. The region is expected to retain its dominance growing at the second-fastest CAGR during the forecast period owing to the extensive R&D initiatives being undertaken by major market players for the development of novel reagents. The launch of kits that enable faster detection of cancer is allowing companies to focus on niche profitable areas in the IVD business. For instance, in February 2022, LiquidPlex Dx and FusionPlex Dx cancer testing kits were launched by Invitae to allow efficient management of cancer patients with therapy with timely provision of the required information.

The growth in precision medicine is projected to enhance the overall demand for such novel reagents and consumables. Players are aligning their instrument launches in line with the increasing genetic test requirement globally. For instance, in March 2022, Ion Torrent Genexus Dx Integrated Sequencer was introduced in the market by Thermo Fisher Scientific for research as well as diagnostic purposes. The company has further announced the development of a line of assays for hemato-oncology and genomic profiling using the system, which is anticipated to enhance the adoption of the system.

Technology Insights

The molecular diagnostics application segment held the highest market share of 40.92% in 2022 owing to the launch of novel products and continuous evolution in technology. Although PCR usually needs complex equipment, research efforts in this segment have given rise to innovations, such as plasmofluidic chips, which are the size of a postage stamp. As per ACS Nano Journal in May 2021, plasmofluidic chips are effective and ultrafast; they can perform a PCR test in 8 minutes, and thus, are expected to accelerate diagnosis in current as well as future pandemics. The immunoassay segment witnessed multiple launches in 2021.

This can be attributed to the continued impact of the COVID-19 pandemic on the market and the enhanced need of consumers in the market. For instance, flu and COVID-19 have similar symptoms, which made differentiation difficult. This unmet need was fulfilled by the launch of novel products that could detect Flu as well as SARS-CoV-2. Companies, such as Roche, have made SARS-CoV-2 & Flu A/B Rapid Antigen Test available in the market to fulfill the demand. The microbiology segment includes tests and assays for the identification of infectious microorganisms.

Diagnosis is done by plating patient samples and selecting pure cultures from the same. Antibiotic susceptibility testing is considered one of the fastest-growing applications in microbiology testing. A rise in the prevalence of pathogenic diseases is expected to fuel the growth of the microbiology segment. The FDA clearance of advanced devices, such as Colibri (approved in January 2022), is projected to propel the development of clinical microbiology analyzers by facilitating AI-based automated workflow.

End-use Insights

Based on end-uses, the global market has been further sub-segmented into hospitals, laboratories, home care, and others. The laboratory end-use segment led the global market in 2022 and accounted for the highest revenue share of more than 41.00%. An increase in awareness about personalized medicine, a rise in demand for affordable services, and technological advancements are some of the key factors expected to boost the growth of the laboratory segment. This is one of the major revenue-generating segments in the market owing to the large volume of testing conducted in the laboratories.

Furthermore, the higher accuracy of laboratory-based tests makes them more reliable as compared to PoC and home tests, giving these tests a competitive edge over the other two segments. The hospitals segment held a significant market share of 36.44% in 2022, owing to a rise in the rate of hospitalizations that require support from faster diagnostics. Moreover, the ongoing development of healthcare infrastructure is anticipated to enhance the existing hospital facilities. Thus, the demand for hospital-based IVD tests is increasing. Most of the IVD devices are purchased by hospitals and are used in significant volumes. In 2022, there are over 6,093 hospitals in the U.S. that require constant aid from IVD for critical decision-making, as IVD tests provide faster and more accurate results.

Test Location Insights

The point-of-care test location segment held the largest revenue share of more than 20.75% in 2022. The demand for point-of-care tests and devices is rising owing to the increased demand for rapid identification of diseases in close proximity to patients to facilitate faster decision-making. This trend is pushing the manufacturers to launch small, transportable, fast, and easy-to-use instruments, making use of these instruments easier in non-laboratory settings. For instance, in July 2021, QuantuMDx announced the launch Q-POC system, which offers rapid PoC molecular diagnostics advantageous for settings, such as ICUs, clinics, and birthing centers.

The U.K. government granted funding of USD 20.12 million to the company to develop the system. Homecare testing location trend has witnessed a surge in recent years and is expected to grow at a CAGR of 5.2%. These tests have been an important source to mitigate the spread of the SARS-CoV-2 pandemic. Significant actions have been taken by governments globally to ensure access to affordable and efficient homecare tests. For instance, in January 2022, Biden Administration announced the distribution of one billion COVID-19 tests to enhance testing rates. The government has further mandated the insurance providers to cover the costs of eight tests with no out-of-pocket costs.

Application Insights

The infectious disease application segment held the highest market share of 63.66% in 2022. IVDs enable the detection of microorganisms that cause infectious diseases. The most common life-threatening infections are HIV/AIDS, tuberculosis, hepatitis, and pneumonia. Furthermore, key market players are entering into a collaboration to improve access to high-quality, innovative laboratory services for patients & healthcare providers. For instance, in January 2020, Quest Diagnostics collaborated with Memorial Hermann Health System to provide improved, cost-efficient, high-quality, and innovative diagnostic services for 21 hospital laboratories in the Huston region. Such initiatives by market players to strengthen their presence are expected to drive the market.

The spread of COVID-19 has caused a sudden spike in uptake of IVD in this segment, leading to a higher market share. Diabetes is one of the leading causes of death globally. According to the International Diabetes Federation (IDF), in 2021, there were 537 million people across the globe suffering from diabetes, and the number is expected to increase to 643 million by 2030. Among the total number of people diagnosed with diabetes, about 49.7% remain undiagnosed. Cancer, a chronic disease, is one of the major causes of death globally. In February 2022, Cancer Moonshot was initiated by the U.S. government to enhance the screening rate for cancer for identifying the missed cases due to the COVID-19 pandemic. In the next 25 years, the government aims to reduce the cancer death rate by 50% with early diagnosis and treatment, thereby propelling the demand for cancer IVD tests.

Regional Insights

Based on geographies, the global market has been further sub-segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market in 2022 and accounted for the largest share of more than 41.00% of the overall revenue. The region is estimated to retain its leading market position throughout the forecast period. The market in this region is collectively driven by the factors, such as the rising incidence of chronic diseases, rapidly growing geriatric population, high healthcare expenditure, and supportive government funding.

The increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to further drive the market growth in North America. Asia Pacific also accounted for a significant revenue share of 23.7% in 2022 and is expected to be the fastest-growing regional market during the forecast period. In vitro diagnostics tests are used for the diagnosis of infectious diseases, cardiological disorders, and cancer amongst others. The regional market of Asia Pacific is expected to be driven by a number of factors, some of which include the presence of stabilizing economies, rapidly growing middle-class population, supportive government policies, and rapid urbanization across the region.

Key Companies & Market Share Insights

Market players undertake this strategy to strengthen their product portfolios and offer diverse technologically advanced & innovative products to their customers. In January 2021, Abbott received FDA approval for its rapid handheld Traumatic Brain Injury (TBI) blood test. The first-of-its-kind test is used for assessing mild TBIs and concussions in patients. Moreover, in March 2020, Abbott launched the RealTime SARS-CoV-2 assay, a PCR-based test, for the diagnosis of COVID-19, and BioMedomics launched a point-of-care COVID-19 test that can detect antibodies in blood within 15 minutes. Some of the key players in the global in vitro diagnostics market include:

• Abbott

• bioMérieux SA

• Quidel Corp.

• Siemens Healthineers

• Bio-Rad Laboratories, Inc.

• Qiagen

• Sysmex Corp.

• Charles River Laboratories

• Quest Diagnostics

• Agilent Technologies, Inc.

• Danaher Corporation

• Becton Dickinson and Company

• F. Hoffmann-La Roche Ltd.

Recent Developments

• In April 2023, bioMérieux and Oxford Nanopore entered into a collaboration to jointly improve patient care and boost in vitro diagnostic (IVD) research.

• In April 2023, QIAGEN launched the QCI Interpret to support IVD regulations (IVDR) in Europe.

• In March 2023, Abbott announced that its Alinity i laboratory instrument, used for traumatic brain injuries (TBIs) diagnosis and concussion assessment with two biomarkers, is ready for commercial launch after recent FDA approval.

• In April 2022, QuidelOrtho Corporation and the Alliance collaborated to drive research and development in biotherapies and diagnosis.

• In February 2022, bioMérieux launched the first-of-a-kind free mobile application, MYACUTECASETM for the correct interpretation of IVD tests.

• In October 2021, Bio-Rad Laboratories launched the CFX Opus 384 Dx Real-Time PCR and CFX Opus 96 Dx systems to enhance IVD assay development & diagnostic testing and deliver accurate quantification.

In Vitro Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global in vitro diagnostics market report based on product, technology, application, end-use, test location, and region:

• Product Outlook (Number of Instruments Installed in Thousands, Number of Reagents Sold in Millions; Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Reagents

  • Services

• Technology Outlook (Number of Instruments Installed in Thousands, Number of Reagents Sold in Millions; Revenue, USD Million, 2018 - 2030)

  •  Immunoassay

    • Instruments

    • Reagents

    • Services

  • Hematology

    • Instruments

    • Reagents

    • Services

  • Clinical Chemistry

    • Instruments

    • Reagents

    • Services

  • Molecular Diagnostics

    • Instruments

    • Reagents

    • Services

  • Coagulation

    • Instruments

    • Reagents

    • Services

  • Microbiology

    • Instruments

    • Reagents

    • Services

  • Others

    • Instruments

    • Reagents

    • Services

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Disease

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Disease

  • Drug Testing

  • Others

• End-use Outlook (Number of Instruments Installed in Thousands, Number of Reagents Sold in Millions; Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Laboratories

  • Home Care

  • Others

• Test Location Outlook (Revenue, USD Million, 2018 - 2030)

  • Point of Care

  • Home Care

  • Others

• Regional Outlook (Number of Instruments Installed in Thousands, Number of Reagents Sold in Millions; Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Spain

    • France

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • UAE

    • Saudi Arabia