Europe IVD Market by Offering (Kits, Software), Technology (Immunoassay, Molecular Diagnostics [PCR, NGS, Microarray], Rapid Tests, Biochemistry), Application (Infectious Diseases, Oncology), Diagnostic Approach (Lab, PoC) - Forecast to 2030

The Europe IVD Market is expected to reach $39.77 billion by 2030 at a CAGR of 3.7% from 2024 to 2030. In vitro diagnostics (IVD) are tests performed on biological samples such as blood, saliva, and other tissues taken from the human body to detect a wide range of diseases. IVD tests are used to screen biological samples to monitor individuals’ health and prevent or diagnose diseases. These consist of various tests based on techniques such as enzyme-linked immunosorbent assay (ELISA), radioimmunoassay, polymerase chain reaction (PCR), isothermal nucleic acid amplification, and next-generation sequencing. These tests can be performed in laboratories, homes, and healthcare facilities.

The growth of the Europe IVD market is attributed to the rising prevalence of chronic diseases coupled with the increasing geriatric population, the rising prevalence of infectious diseases, the growing demand for point-of-care (PoC) and rapid diagnostics, rising awareness regarding early disease diagnosis, rising healthcare expenditures, and increasing funding for research activities.

However, stringent technical requirements and regulatory processes for high/moderate-complexity tests and the variance in test results observed in rapid IVD tests restrain the growth of the IVD market. The increasing inclination toward personalized medicine and advancements in genomics and proteomics are expected to create growth opportunities for the players operating in this market. However, the evolving regulatory landscape is a major challenge for market growth.

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Rising Prevalence of Chronic Diseases Coupled with the Increasing Geriatric Population is Driving the Growth of this Market

The prevalence of chronic diseases and conditions such as cancer, diabetes, arthritis, and heart disease is on the rise in European countries. According to Eurostat, 35.2% of Europeans reported suffering from chronic illnesses in 2021. The growth in the geriatric population and social behaviors such as tobacco and alcohol consumption, physical inactivity, and unhealthy diets are major factors driving a steady increase in the number of people suffering from chronic diseases. According to the International Diabetes Federation, the prevalence of diabetes in Europe will increase by 13% by 2045.

Chronic diseases are often associated with the elderly population due to the declining bodily functions and immunity among this population segment. Aging is associated with progressive deterioration in the structure and functioning of organs. The elderly population is more prone to various chronic diseases. According to the European Commission, in 2022, more than one-fifth (21.1%) of the European population was aged 65 and over. This remarkable growth in the elderly population is driven by declining fertility rates and improvements in longevity.

The growth in the elderly population and associated chronic disease is increasing the demand for IVD testing.

Rising Awareness Regarding Early Disease Diagnosis is Driving the Market

Early diagnosis of infectious diseases leads to better treatment and future care. It helps healthcare professionals and patients make important medical decisions regarding care and support. There is a growing awareness about early disease diagnosis due to its advantages. Diagnosing a disease in its early stages can help patients save significantly on treatment costs. For instance, according to the WHO, studies conducted in some high-income countries have revealed that the treatment of cancer patients diagnosed early leads to cost savings by two to four times. Additionally, early diagnosis can be lifesaving for patients with critical diseases such as cancer.

Laboratory examination is one of the most effective and popularly practiced testing techniques for disease diagnosis. Immunoassays, biochemical characterization, polymerase chain reaction, isothermal nucleic acid amplification, and next-generation sequencing are performed to identify a comprehensive range of chronic and infectious diseases. Organizations are undertaking initiatives to promote early diagnosis and prevent/eradicate mortalities associated with infectious diseases.

Key Findings of the Market Study:

In 2024, the Kits & Reagents Segment is Expected to Dominate this Market

Based on offering, the Europe IVD market is segmented into reagents and kits, systems, and software & services. In 2024, the kits & reagents segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the frequent use of reagents and kits in the detection of various chronic diseases, the commercial availability of a diverse range of reagents and consumables for the diagnosis of various diseases, the increase in the volume of testing for infectious diseases such as COVID-19 and influenza, and the growing awareness about self-testing among the general population.

In 2024, the Molecular Diagnostics Segment is Expected to Account for the Largest Share of the Market

Based on technology, the Europe IVD market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, point-of-care (POC) diagnostics, whole blood glucose monitoring, microbiology, hematology, coagulation/hemostasis, urinalysis, and other technologies. In 2024, the molecular diagnostics segment is expected to account for the largest share of the market. The segment’s large share is mainly attributed to the technological innovations and the advantages of molecular diagnostics tests, such as cost-effectiveness, rapid results, and high sensitivity and specificity over laboratory tests.

Additionally, the growing prevalence of infectious diseases is also increasing the demand for molecular diagnostics. In Europe, several factors driving the growth in the genomic sector increase the adoption of molecular diagnostic products. For instance, the establishment of national programs or pan-European programs, such as the “1+ Million Genomes” initiative, which involves 23 countries across Europe and aims to improve the uptake of genomics by healthcare systems and in personalized healthcare.

The Cardiology Segment Is Projected to Register the Highest CAGR During the Forecast Period

Based on application, the Europe in vitro diagnostics (IVD) market is segmented into infectious diseases, oncology, diabetes, cardiology, nephrology, autoimmune disorders, and other applications. The cardiology segment is expected to register the highest CAGR during the forecast period. Cardiovascular diseases (CVD) remain the leading cause of death globally. According to the American Heart Association, in 2020 highest mortality rates due to cardiovascular diseases were reported in Eastern Europe and Central Asia. Thus, the high prevalence of cardiovascular diseases is increasing the demand for IVD testing in the region. IVD testing is used for the biomarker measurement. The early-stage biomarkers of CVD can potentially save many lives and help alleviate the global burden of CVD.

In 2024, the Laboratory Testing Segment is Expected to Dominate this Market

Based on diagnostic approach, the Europe IVD market is segmented into laboratory testing, OTC/self-testing, and point-of-care testing. In 2024, the laboratory testing segment is expected to account for the largest share of the market. The laboratory testing approach for IVD has many advantages over other approaches. It has higher accuracy and reliability when compared to point-of-care testing. The laboratory equipment and analyzers have a high sensitivity and specificity. Unlike point-of-care testing, laboratory testing can be performed on all IVD tests. Such factors support the large market share of the segment.

The Hospitals & Clinics Segment Is Projected to Register the Highest CAGR During the Forecast Period

Based on end user, the Europe in vitro diagnostics (IVD) market is segmented into diagnostic laboratories, hospitals & clinics, home healthcare, and other end users, which includes nursing homes, academic & research institutes, ambulatory care centers, and transfusion laboratories. The hospitals & clinics segment is expected to register the highest CAGR during the forecast period. The highest CAGR of this segment is attributed to the increasing number of hospitalizations due to various diseases requiring molecular diagnosis and the proliferation of hospitals and clinics in the region, leading to growth in the utilization of molecular diagnostic products.

France: Fastest Growing Market

France is expected to register the highest CAGR during the forecast period. The highest CAGR of this regional market is attributed to the increasing prevalence of infectious diseases, growth in the geriatric population, rising prevalence of cancer, and government initiatives to improve healthcare infrastructure in France. For instance, in June 2021, the Government of France launched the Health Innovation Plan to improve the healthcare system of France with a total budget of USD 6.2 billion (EUR 7.5 billion). Of this, USD 0.8 billion (EUR 1 billion) is allocated to R&D infrastructures, cross-cutting research support, attracting high-level scientists, clusters, and translational research. The fund of USD 1.2 billion (EUR 1.5 billion) was allocated for national projects and an Important Project of Common European Interest (IPCEI) to accelerate the development of healthcare innovations. Additionally, USD 1.9 billion (EUR 2.4 billion) for improving medical technologies, biotherapies, emerging infectious diseases, digital health, and CBRN (Chemical, Biological, Radiological, Nuclear) sectors.

Key Players

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over the years . The key players operating in the Europe IVD market are Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), bioMérieux SA (France), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Illumina, Inc. (U.S.), QIAGEN N.V. (Netherlands), Shenzhen Mindray Bio-Medical Electronics Co., Ltd (China), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (U.S.), QuidelOrtho Corporation (U.S.), Agilent Technologies Inc. (U.S.), and DiaSorin S.p.A. (Italy).

Scope of the Report:

Europe In Vitro Diagnostics Market, by Offering

• Kits & Reagents
• Instruments
• Software & Services

Europe In Vitro Diagnostics Market, by Technology

• Molecular Diagnostics 
  • Polymerase Chain Reaction (PCR)
  • Hybridization
  • Isothermal Nucleic Acid Amplification Technology
  • DNA Sequencing & Next-generation Sequencing
  • Microarrays
  • Mass Spectrometry
  • Other Molecular Diagnostic Technologies
    (Note: Other Molecular Diagnostic Technologies majorly include electrophoresis, Ligase Chain Reaction (LCR), Northern Blot, and Southern Blot)
• Point of Care (PoC) Diagnostics 
  • Lateral Flow Assays/Rapid Tests
  • POC Molecular Diagnostics
  • Other PoC Products
    (Note: Other PoC products include coagulation tests and blood glucose monitoring systems)
• Immunoassay/Immunochemistry 
  • Enzyme-linked Immunosorbent Assays (ELISA)
  • Radioimmunoassays
  • Western Blotting
  • Enzyme-Linked Immunospot Assays
  • Immunohistochemistry (IHC) 
• Biochemistry/Clinical Chemistry 
  • Metabolic Panel
  • Electrolyte Panel
  • Liver Panel
  • Lipid Profile
  • Renal Profile
  • Thyroid Function Panel 
• Whole Blood Glucose Monitoring
• Microbiology
• Hematology
• Coagulation/Hemostasis
• Urinalysis
• Other IVD Technologies
  (Note: Other IVD technologies comprise anatomical pathology, histochemistry, and loop-mediated amplification)

Europe In Vitro Diagnostics Market, by Application

• Infectious Diseases 
  • COVID-19 Testing
  • Sexually Transmitted Diseases (STD) Testing
  • Healthcare-associated Infections (HAIs)
  • Hepatitis
  • HIV
  • Tropical Diseases
  • Respiratory Infections (Excluding Influenza)
  • Influenza
  • Other Infectious Diseases
    (Note: Other infectious diseases include congenital infections, meningitis, norovirus (stomach flu), hand, foot, and mouth disease (HFMD), and pertussis)
• Oncology
• Diabetes
• Cardiology
• Nephrology
• Autoimmune Disorders
• Other Applications
  (Note: Other applications comprise drugs of abuse tests, coagulation tests, neonatal testing, genetic testing, and neurological disorders testing.)

Europe In Vitro Diagnostics Market, by Diagnostic Approach

• Lab Testing 
• OTC/Self-testing
• Point of Care Testing

Europe In Vitro Diagnostics Market, by End User

• Diagnostic Laboratories
• Hospitals & Clinics
• Home Healthcare
• Other End Users
  (Note: Other end users comprise nursing homes, academic & research institutes, ambulatory care centers, and transfusion laboratories)

Europe In Vitro Diagnostics Market Assessment, by Country/Region

• Germany
• U.K.
• France
• Italy
• Spain
• Switzerland
• Netherlands
• Denmark
• Rest of Europe

Key questions answered in the report: