Infectious Disease In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents, Software), By Technology, By Application, By Test Location, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global infectious disease in vitro diagnostics market size was estimated to be USD 26.75 billion in 2023 and is projected to grow at a CAGR of 2.4% from 2024 to 2030. The growing geriatric population susceptible to infectious diseases, rising awareness about early testing, high demand for PoC testing owing to the pandemic, and rising prevalence of infectious diseases are key factors driving the market over the forecast period. The market witnessed a paradigm shift during the pandemic due to the launch of novel and innovative products for SARS-CoV-2 testing and amplified adoption of these products, resulting in the exponential growth of the industry in recent years.

The growing geriatric population across the globe and the presence of numerous untapped opportunities in developing countries are factors expected to propel the industry growth during the forecast period. According to the World Bank Group data, in 2022, there were about 779 million people aged 65 & above globally. In addition, the number of individuals aged 80 and above is projected to double by 2050. The rising prevalence of infectious diseases is a major factor driving steep revenue generation. Moreover, aged people have to be tested regularly to avoid severe infections, which creates growth opportunities for in vitro diagnostic tests in countries such as Russia, Japan, Germany, and the U.S., which have higher elderly people globally.

Furthermore, 40% of HIV cases are transmitted by people unaware of their positivity status. This demonstrates an unmet need for diagnostic tests for HIV. The acquisition and new product development are becoming a prominent strategy for growth and portfolio diversification. In April 2023, Cepheid, a subsidiary of Danaher, announced a plan to introduce novel tests for a range of infectious diseases, including respiratory diseases and tuberculosis in 2023. Furthermore, in December 2021, Advanced Conceptions, Inc. and Idaho Molecular, Inc.’s portfolio was acquired by Co-Diagnostics, Inc., allowing it to gain access to intellectual property rights, streamlining the commercialization of its integrated product line for infectious diseases. The multiplex assays targeting STI, respiratory and other infections accommodated in the PCR device of the company broadens the customer base.

The availability of at-home collection and self-testing kits reduces patient visits to clinics and promotes the discretion of patients. For instance, in November 2023, the U.S. FDA approved an at-home test for chlamydia and gonorrhea for early detection of these sexually transmitted infections. Moreover, in May 2021, BD received a CE marking for BD Onclarity HPV Assay, which is the first self-collection test for diagnosing HPV. Such instances are expected to fuel the market growth during the projected period.

Market Concentration & Characteristics

Market growth stage is low, and pace of the market growth is accelerating. The infectious disease in vitro diagnostics market is characterized by a high degree of innovation owing to the rapid technological advancements driven by increasing development of novel molecular diagnostics & immunoassays and point-of-care tests for infectious diseases. Moreover, market players are continuously involved the development of novel POC testing products to capture the market opportunities.

The market is also characterized by a high level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to gain access to new regions and technologies, need to consolidate in a rapidly growing market.

The infectious disease IVD market is also subject to increasing regulatory scrutiny. The regulatory framework for product approvals has always been one of the major restraining factors in the clinical diagnostic industry. The regulatory framework for the diagnostic sector is very stringent in countries where the market has a high potential to grow due to the availability of a large patient pool. Such discrete and uncertain regulatory scenario for in vitro diagnostics products creates confusion among manufacturers regarding commercialization.

There are a very limited number of direct substitute products and services for in vitro diagnostics. Using imaging tools to monitor infections to some extent can hamper the market growth. However, IVD tests for infectious diseases overcome the threat of substitutes due to their accuracy and cost-effectiveness.

End-user concentration is a significant factor in the market. Since there are a number of end-user such as hospitals, clinics, laboratories, patients, and others that are driving demand for IVD tests. Moreover, increasing demand for rapid and self-tests for multiple infectious diseases creates new market opportunities for market players in different end-use applications.

Product Insights

Reagents led the market and accounted for 67.21%% of the global revenue in 2023. This can be attributed to the high-volume usage of reagents and test kits for diagnosis of infectious diseases. Moreover, the COVID-19 testing programs to screen SARS-CoV-2 infection, are escalating the usage of reagents. For instance, as of May 2023, 449 tests and collection devices were approved for COVID-19 infection detection by the U.S. FDA. Out of the 449 products available in the market, around 116 products can be used as OTC or collected samples at-home tests.

Rapid innovation is becoming a key factor in the focus to achieve a competitive edge. For instance, in May 2023, the U.S. FDA approved 510(k) clearance for Hologic's Panther Fusion SARS-CoV-2, influenza A & B, and RSV assay. This assay is a molecular diagnostic test that discriminates between the four utmost common respiratory viruses, comprising the Respiratory Syncytial Virus (RSV), influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Consumer demands in the software segment are evolving continuously; the use of the software is not limited to laboratories. For instance, some consumers prefer cloud computing, while others opt for concierge services and need a team of professionals for software management. In January 2023, QIAGEN launched EZ2 Connect MDx platform to propel its capabilities of automation in sample processing.

Test Location Insights

Central laboratories segment dominated in 2023 with a share of 50.81%. Laboratory-based tests ensure higher accuracy when compared to point-of-care tests, which makes them reliable. In addition, the availability of tests that allow for sample collection at home and sending it to the laboratories for testing makes testing highly convenient for the patients. Most of the key market players offer laboratory-based molecular diagnostic solutions across the globe, and these players are continuously involved in developing novel molecular diagnostic tests. For instance, in April 2023, EliTech announced its plan to launch EliVerse, a high-throughput molecular diagnostics instrument, in the European market in 2024.

The high demand for faster turnaround time has escalated the demand for point-of-care tests. COVID-19 has strengthened segment growth and created an intensified demand for these products. The rapid turnaround time and low complexity are giving products of this segment a competitive edge. Increasing demand for patient-centric healthcare services, and growing adoption of technologically advanced testing products at point of care facilities such as clinics, retail pharmacies, others are further projected to drive the market expansion over the forecast period. For instance, in February 2023, Huwel Lifesciences designed a portable RT-PCR machine to test types of viruses.

Technology Insights

Molecular diagnostics technology accounted for the largest market revenue share of 35.76% in 2023. This can be attributed to the high market penetration of MDx technologies such as PCR, NGS, and others and its high testing accuracy. Moreover, key players are engaged in launching novel instruments for molecular diagnostics and expanding their product portfolios. For instance, in April 2023, ELITechGroup revealed plans for its upcoming innovation: introducing a high throughput sample-to-result molecular diagnostics equipment.

The demand for immunoassay technology is expected to increase over the forecast period. Companies are focusing on the development and commercialization of immunoassays for infectious diseases due to increased demand for rapid tests. For instance, in October 2023, F. Hoffmann-La Roche Ltd filed a biologics license application (BLA) for Elecsys HTLV I/II assay to detect antibodies to HTLV-I and HTLV-II in human serum and plasma. Increasing use of immunoassays to detect different infectious diseases is expected to increase in the coming years.

Application Insights

The COVID-19 application accounted for largest market revenue share of 26.27% in 2023. The high share of the segment can be attributed to the increased adoption of SARS-CoV-2 testing to limit the spread of the infection and government initiatives to enhance public testing. Moreover, the introduction of rapid combination tests for multiple infections is supporting the segment growth over the forecast period. For instance, in February 2023, BD gained Emergency Use Authorization from the U.S. DFA for a new combination test for SARS-CoV-2, Influenza A + B, and RSV.

HIV is projected to witness highest growth rate over the forecast period. Increasing introduction of novel tests, high prevalence of HIV, and rising initiatives by market players to improve access to cost-effective HIV tests are anticipated to drive the segment growth. For instance, in February 2023, Thermo Fisher Scientific Inc. partnered with MyLab to procure RT-PCR kits for various infectious diseases, such as tuberculosis & HIV. Moreover, self-testing kits for HIV are attracting more customers. In June 2020, OraSure Technologies, Inc. announced a partnership with Walgreens to donate 10,000 HIV tests.

Regional Insights

North America infectious disease in vitro diagnostics market accounted for 38.49% share of the global market in 2023. The region is expected to expand further at a lucrative growth rate over the forecast period. The presence of a favorable & flexible regulatory framework, the presence of major industry players offering novel IVD products, and the focus on increasing disease surveillance by conducting more tests are major drivers for the North America region.  For instance, in March 2023, BD received 510(k) clearance from U.S. FDA for the BD Vaginal Panel on the BD COR System to detect infectious causes of vaginitis.

U.S. Infectious Disease In Vitro Diagnostics Market Trends

The infectious disease in vitro diagnostics market in the U.S. is expected to grow over the forecast period. The COVID-19 outbreak dramatically changed the infectious disease diagnostics market landscape as companies were engaged in developing tests with quicker turnaround time and efficacy. Post the pandemic, other infectious disease segments such as respiratory, flu, and STIs are garnering higher share.

Europe Infectious Disease In Vitro Diagnostics Market Trends

Europe infectious disease in vitro diagnostics market was identified as a lucrative region in this industry. New IVD regulations are estimated to present a more robust and sustainable framework for compliance of IVD devices. IVD infectious disease tests are launched at various conferences, symposiums, and other events to provide early visibility.

The infectious disease in vitro diagnostics market in UK is expected to grow over the forecast period due to presence of several key companies in the diagnostic industry, and high awareness initiatives undertaken by government and nonprofit organizations

The France infectious disease in vitro diagnostics market is expected to grow over the forecast period. Technological advancements, high disease prevalence & diagnosis rate, and product reach are factors expected to drive the market over the coming years.

The infectious disease in vitro diagnostics market in Germany is expected to grow over the forecast period due to strong presence of several companies in Germany, such as Roche Diagnostics, QIAGEN, bioMérieux, Siemens Healthineers, and Agilent Technologies, involved in the development of IVD infectious disease panels & reagents, stringent regulations, and government support.

Asia Pacific Infectious Disease In Vitro Diagnostics Market Trends

Asia Pacific infectious disease in vitro diagnostics market is anticipated to witness significant growth in the infectious disease IVD market. This growth owes to the high prevalence of infectious diseases, growing healthcare access in emerging economies, such as India and China, is boosting the region’s growth. The rising geriatric population in nations such as Japan is also acting as a driver for the adoption of IVD tests. The rapid economic development in the region and presence of emerging market players are expected to increase the adoption of novel tests for infectious diseases diagnostic in the regions.

The infectious disease in vitro diagnostics market in China is expected to grow over the forecast period. Increased need for early diagnosis, high focus on developing instruments with novel technologies, and rising number of collaborations between key companies & private laboratories.

The Japan infectious disease in vitro diagnostics market is expected to grow over the forecast period owing to various initiatives undertaken by government, favorable reimbursement scenarios, and major key players operating in the U.S. expanding in Asia Pacific countries such as Japan.

Latin America Infectious Disease In Vitro Diagnostics Market Trends

Latin America infectious disease in vitro diagnostics market is primarily driven by government focus on improving regulatory reforms & reimbursement scenarios, increasing patient awareness, and rising investment and funding for developing products with faster turnaround time.

The infectious disease in vitro diagnostics market in Brazil is expected to grow over the forecast period due to the rising prevalence of chronic diseases in the country due to the moderate standards of living, further increasing the need for advanced diagnostic and treatment options.

Middle East & Africa Infectious Disease In Vitro Diagnostics Market Trends

The Middle East & Africa infectious disease in vitro diagnostics market was identified as a lucrative region in this industry. The increasing prevalence of chronic diseases created a significant need for enhanced diagnostic tools and therapeutic alternatives in the country.

The infectious disease in vitro diagnostics market in Saudi Arabia is expected to grow over the forecast period owing to the rapid launch of new products in the region, increasing number of government initiatives, and rising prevalence of infectious diseases.

Key Infectious Disease In Vitro Diagnostics Company Insights

Some of the key players operating in the market include F. Hoffmann-La Roche Ltd.; Abbott, Quest Diagnostics Incorporated; and Danaher. Established players are undertaking strategies such as acquiring small portfolios of emerging companies, collaborating with bigger laboratories, and launching novel diagnostic products in order to stay competitive and maintain their market share.

Llusern Scientific, ELITech Group, and Huwel Lifesciences are some of the emerging market participants in the infectious disease in vitro diagnostics market. These companies plan to launch accurate and cutting-edge diagnostic solutions to help healthcare professionals to improve patient outcomes and enhance the quality of life by providing better diagnostic results.

Recent Developments

• In March 2024, SEKISUI Diagnostics, a global leader in medical diagnostics manufacturing, obtained EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test. It is approved for use in both professional and home testing settings.

• In October 2023, Tangen Biosciences and SD Biosensor received Emergency Use Authorizations (EUAs) from the U.S. FDA for point-of-care SARS-CoV-2 tests.

• In August 2023, BD received U.S. FDA 510(k) clearance for its Respiratory Viral Panel for BD MAX System to identify and distinguish SARS-CoV-2, influenza A, influenza B, and RSV in two hours.

• In April 2023, EliTech announced its plan to launch ELITe InGenius in 2024. EliVerse is a novel high-throughput molecular diagnostics instrument for more than 50 CE-IVD parameters.

Infectious Disease In Vitro Diagnostics Market Report Scope

Global Infectious Disease In Vitro Diagnostics Market Report Segmentation

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

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • Instruments

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB And Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others Infectious Disease

  • Reagents

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB And Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others Infectious Disease

  • Software Services

    • MRSA

    • Streptococcus

    • Clostridium Difficile

    • VRE

    • CRE

    • Respiratory Virus

    • Candida

    • TB And Drug-resistant TB

    • Gastro-intestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HPV

    • HIV

    • Hepatitis C

    • Hepatitis B

    • COVID-19

    • Others Infectious Disease

• Technology Outlook (Revenue, USD Billion, 2018 - 2030)

  • Immunoassay

  • Molecular Diagnostics

    • Polymerase Chain Reaction (PCR)

    • In Situ Hybridization

    • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Chips And Microarrays

    • Sequencing & NGS

    • Transcription Mediated Amplification

    • Others

  • Microbiology

  • Others

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

  • MRSA

  • Streptococcus

  • Clostridium Difficile

  • VRE

  • CRE

  • Respiratory Virus

  • Candida

  • TB And Drug-resistant TB

  • Gastro-intestinal Panel Testing

  • Chlamydia

  • Gonorrhea

  • HPV

  • HIV

  • Hepatitis C

  • Hepatitis B

  • COVID-19

  • Others Infectious Disease

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

  • Point of Care

  • Central Laboratories

  • Others

• Regional Outlook (Revenue, USD Billion; 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia

    • Kuwait