IN VITRO DIAGNOSTICS IVD MARKET ANALYSIS

In Vitro Diagnostics Ivd Market Size and Trends

In-vitro diagnostics market is estimated to be valued at USD 118.98 Bn in 2024 and is expected to reach USD 182.82 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 6.3% from 2024 to 2031.

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The market is expected to witness positive growth over the forecast period owing to rising geriatric population globally and increasing adoption of point-of-care testing. Demand for in-vitro diagnostic tests is increasing due to rising prevalence of chronic and infectious diseases. Additional factors such as technological advancements in IVF technologies, growing awareness regarding early disease diagnosis, growing demand for personalized medicine will further drive the market growth during this period.

Rising incidence of chronic disorders

The changing lifestyle and dietary patterns prevalent worldwide has led to increase in chronic medical ailments. Conditions like cardiovascular disease, diabetes, cancer are no longer perceived as diseases of affluence but have affected people across socioeconomic classes. Long-term exposure to environmental contaminants and rising levels of stress have further contributed to non-communicable diseases gaining epidemic proportions in many developed and developing regions. Unlike acute illnesses, these long-lasting health issues require constant clinical monitoring and therapy adjustments based on test results. Advanced diagnostic assays aid in prognostication and disease management by identifying biological markers, characterizing the extent or stage of the disease, detecting treatment effectiveness or resistance. These empower physicians to personalize treatment approaches.

Market Concentration and Competitive Landscape

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Increasing new product launches by key market players is  expected to drive the global in-vitro diagnostics market growth. For instance, in June 2022, Streck, a manufacturer of laboratory products, announced the commercialization of the Streck Viral Extraction Kit with partner Ceres Nanosciences, a life sciences company. Streck has developed a virus extraction kit using Nanotrap technology to reduce manual effort and simplify the workflow for isolating SARS-CoV-2 and Influenza A from clinical samples.

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Global in-vitro diagnostics market faces several challenges. Technology developments have increased diagnostic accuracy and speed, raising expectations amongst healthcare providers and patients. This has intensified the need for continual innovation. Budget constraints within healthcare systems hampers the adoption of new and advanced diagnostic devices. Regulations also present a challenge due to strict guidelines around product approval and quality standards.

Market Opportunities: Rising geriatric population

Growing geriatric population and increasing prevalence of chronic and infectious diseases boosts demand for diagnostic testing. Telehealth and home healthcare are opening new channels for diagnostic services. Further, point-of-care testing is gathering momentum due to its convenience and quick results. Partnerships along the healthcare continuum can help in vetting new technologies and expanding access.

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Product segment is sub-segmented into reagents & kits and instruments. Reagents & kits segment is anticipated to hold 67.8% of the market share in 2024. Advancements in medical care have led physicians to rely heavily on laboratory testing to better understand diseases and determine appropriate treatment plans. As diagnostic capabilities expand, more reagents and kits are needed to perform the wide range of tests available. Being consumable products that must be replenished regularly, reagents and kits witness high and recurring demand from hospitals, clinics, and other testing facilities. Their ability to work with various automated and non-automated analyzers also makes them a more universal option for laboratories compared to proprietary instruments. Manufacturers continue adding new reagents and assays to test menus to keep up with the evolving diagnostic needs. The demand for reagents and kits is also boosted by the trend of decentralization where diagnostic testing is being brought closer to patients through small laboratories, POC testing, and home use. This decentralized model improves access and boosts adoption of simple, cartridge-based reagents and kits that can be used outside traditional diagnostic settings.

Insights, By Test Type: Rising prevalence of infectious diseases drives the immunoassay segment growth

Test type segment is sub-segmented into clinical chemistry, immunoassay, hematology, molecular diagnostics, microbiology, coagulation & hemostasis, urinalysis, and others. Immunoassay segment contributes the highest share of the in-vitro diagnostics market and is projected to hold 34.1% of the market share in 2024. Immunoassays utilize the principle of antigen-antibody binding, and are highly sensitive and specific for detecting targets like proteins, antibodies, hormones, and others in patient samples. Their versatility has made immunoassays the primary technology used to diagnose HIV, hepatitis, influenza and other communicable illnesses. Rising prevalence of infectious diseases, especially in developing regions, is a key factor propelling the market growth. Factors like lack of adequate sanitation, vector proliferation, and limited vaccination drive up infections rates. Diagnosing these diseases early and tracking epidemics have become public health priorities, contributing significantly to immunoassays demand. Other promoting factors are new assays for emerging diseases and the ability of immunoassays to provide rapid results. Automated analyzers have also boosted efficiency and throughput. Continuous technology refinements will help immunoassays maintain their leading role in infectious disease diagnostics.

Insights, By Application: Growing prevalence of infectious diseases

Application segment is sub-segmented into infectious diseases, diabetes, oncology, cardiology, nephrology, autoimmune disorders, and others. Infectious diseases segment contributes the highest share of the in-vitro diagnostics market and is projected to hold 48.2% of the market share in 2024. The ability to quickly and accurately diagnose infectious diseases through various IVD tests is becoming increasingly important in clinical care and public health monitoring. As newer pathogens emerge and existing ones adapt and spread into new regions, the demand for advanced diagnostic capabilities is growing steadily. According to the data published by the World Health Organization in 2022, lack of diagnostic capacity early in the pandemic hampered disease surveillance and clinical management in many countries. However, test kit approvals and diagnostic infrastructure development has boosted global testing rates and supported strategic public health responses against the coronavirus. Other diseases like influenza, tuberculosis, malaria and antibiotic-resistant bacterial infections are also posing increased health burdens.

Regional Insights

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North America has established itself as the dominant region in the global in-vitro diagnostics market and is expected to hold 43.8% of the market share in 2024. The large presence of leading IVD companies such as Thermo Fisher Scientific, Abbott Laboratories, and Becton Dickinson has enabled the region to evolve considerably over the years in terms of innovation and product offerings. With some of the most stringent regulatory guidelines enforced by authorities such as the U.S. FDA, North American companies have set the benchmark for producing high-quality diagnostics products. Most new diagnostic technologies and platforms are commercialized first in this region, allowing companies to gain large market share before expanding globally. In addition, favorable reimbursement policies for diagnostic tests make the region highly lucrative.

The Asia Pacific region, on the other hand, is emerging as the fastest growing market. Several factors are contributing to this rapid growth like improving healthcare infrastructure, rising medical tourism, and growing investments by foreign players looking to tap the opportunities in developing economies. Country-level analyses indicate China and India will spearhead growth due to their huge patient populations and increasing healthcare expenditures. Both nations are working to reduce their dependence on imports and promote local manufacturing of IVD devices and reagents. Several global companies have established manufacturing facilities as well as research centers in these countries. Meanwhile, other Asian economies like South Korea, Japan, Singapore, Malaysia and Thailand offer attractive business environments and act as manufacturing and export hubs to cater to the demand across Asia and other regions.

Market Report Scope

In Vitro Diagnostics Ivd Industry News

• On March 06, 2024, CleanNA, a Netherlands-based manufacturer of magnetic bead-based nucleic acid extraction kits and systems, introduced its second CE-IVD-certified product. The Clean Quick Viral DNA/RNA (CE-IVD) kit extracts viral DNA and RNA from nasopharyngeal or oropharyngeal swabs that have been maintained in an inactivating viral transport medium.
• On February 12, 2024, Roche, a multinational healthcare company, introduced three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban, and rivaroxaban in countries that accept the CE mark. These anticoagulants were added to the World Health Organization's Model List of Essential Medicines in 2019 due to their potential advantages for patients.
• On January 04, 2024, HORIBA Medical, a manufacturer of in vitro diagnostic equipment, launched the new HELO 2.0 high throughput automated hematology platform, which is CE-IVDR approved and awaiting U.S. FDA certification. Following the success of HORIBA Medical's prior HELO, this next generation high-end hematology line was developed in collaboration with customers to further improve and meet all of the needs of high throughput fully automated hematology.
• In July 2022, DiaCarta Inc., a molecular diagnostics company, announced that the company had received CE-IVD Mark (CE Marking according to the Requirements of European Directive) for its newly developed QuantiVirus SARS-CoV-2 & Flu A/B test. The QuantiVirus SARS-CoV-2 & Flu A/B Detection Test is a real-time PCR test for the qualitative detection of SARS-CoV-2 and influenza virus nucleic acids in nasopharyngeal swabs or saliva from people with suspected COVID-19 and/or flu.
• In June 2022, Agilent Technologies Inc., an American analytical instrumentation development and manufacturing company, announced that previously CE-IVD marked instruments, kits and reagents had been approved as IVDR Class A under the new EU IVDR regulation on May 26, 2022. This introduction of Class A IVDR-compliant products ensures that EU laboratories that rely on Agilent IVDR instruments, kits and reagents in their diagnostic workflows can continue to use these products without interruption.

*Definition: In-Vitro Diagnostics Market involves products, instruments and reagents used to test specimens taken from the human body, such as blood, urine and tissue. These diagnostic tests are performed outside of a living body in controlled laboratory settings using instruments and reagents to examine various biomarkers that can help identify diseases and other medical conditions. Some common types of tests included in this market are immunoassays, clinical chemistry, molecular diagnostics, microbiology and hematology.

Market Segmentation

• Product  Insights (Revenue, USD BN, 2019 - 2031)
  • Reagents & Kits
  • Instruments
•  Test Type Insights (Revenue, USD BN, 2019 - 2031)
  • Clinical Chemistry
  • Immunoassay
  • Hematology
  • Molecular Diagnostics
  • Microbiology
  • Coagulation & Hemostasis
  • Urinalysis
  • Others
•  Application Insights (Revenue, USD BN, 2019 - 2031)
  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Nephrology
  • Autoimmune Disorders
  • Others
•  End User Insights (Revenue, USD BN, 2019 - 2031)
  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Academic & Research Institutes
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
    • Pradeep Tripathi
• Key Players Insights
  • Siemens Healthineers
  • Sysmex Corporation
  • Bio-Rad Laboratories
  • bioMérieux S.A.
  • Becton Dickinson and Company
  • Danaher Corporation
  • Abbott Laboratories
  • F. Hoffmann-la Roche Ltd
  • QIAGEN N.V.
  • Arkray Inc.
  • Nittobo Medical Co. Ltd.
  • Medical & Biological Laboratories Co. Ltd.
  • Miraca Holdings Inc.
  • Mizuho Medy Co. Ltd.
  • Thermo Fischer Scientific Inc
  • Diasorin
  • Agilent Technologies, Inc
  • Grifols SA