Europe in-vitro Diagnostics Market is Set to Reach Valuation of USD 36.93 Billion By 2032, at a CAGR of 4.5%, Says Astute Analytica

The European IVD market is driven by innovation, with investment in areas like next-generation sequencing and AI. COVID-19 had a major impact, while a patient-centric shift with home-based kits and wearables is growing. Germany leads, with the “Big Five” nations dominating the market.

New Delhi, April 04, 2024 (GLOBE NEWSWIRE) — According to Astute Analytica, the Europe in-vitro diagnostics market is projected to reach US$ 36.93 billion by 2032, up from US$ 24.85 billion in 2023, at a CAGR of 4.5% during the forecast period 2024–2032.

The remarkable influence of In Vitro Diagnostics (IVD) is seen in the 30-year increase in life expectancy for European citizens. This trend, however, comes with a challenge – healthcare costs now consume over 10% of Europe’s GDP. An aging population with rising rates of chronic conditions will put pressure on budgets and healthcare systems. Fortunately, the development of advanced point-of-care testing kits, known for their ease of use and efficiency, is expected to increase the adoption of IVD products in Europe. One example is the launch of Q-POC by QuantuMDx Group Ltd., offering highly accurate and fast SARS-CoV-2 results within just 30 minutes. Furthermore, growing initiatives to raise awareness of chronic diseases are encouraging the use of IVD tests for timely diagnosis and intervention.

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Thermo Fisher Scientific and Becton, Dickinson and Company stand out as major players in the in-vitro diagnostics market. Thermo Fisher Scientific reported substantial IVD revenue in 2021 and 2022, while Becton, Dickinson and Company have demonstrated significant growth in IVD revenue from 2011 to 2022.

IVD tests are transformative, offering a deeper understanding of the connections between individuals, their illnesses, and potential treatments. Initiatives like those undertaken by MedTech Europe and its Market Research Committee, including market trackers, product classification, and the European IVD Market Statistics Report, further enhance market knowledge. The European IVD sector encompasses a diverse range of instruments utilizing immunodiagnostics, tissue diagnostics, hematology, and molecular diagnostics to aid in the diagnosis of infectious diseases, cancer, heart disorders, and kidney-related conditions.

Key Findings in Europe In-Vitro Diagnostics Market

Market Forecast (2032) US$ 36.93 billion
CAGR 4.5%
By Product & Services Reagent (80.8%)
By Technique Immunodiagnostics (29.0%)
By End Users  Hospitals (41.5%)
By Application Infectious Diseases Diagnostics (47.4%)
Top Trends
  • Increasing focus on personalized medicine and point-of-care testing
  • Growing adoption of automated instruments and multi-test platforms
  • Rising demand for molecular diagnostics and immunodiagnostics
Top Drivers
  • High prevalence of chronic and infectious diseases in Europe
  • Technological advancements in IVD products (portability, accuracy, cost-effectiveness)
  • Government initiatives and funding to support early diagnosis and treatment
Top Challenges
  • Lower penetration of IVD products from established players in certain regions (e.g., APAC)
  • Stringent regulatory requirements and compliance with new standards (e.g., IVDR)
  • Competition from local players offering lower-cost instruments in some markets

Stringent Regulations in Europe in-Vitro Diagnostics Market

The regulatory landscape across Europe in-vitro diagnostics market is in flux. As of February 2023, an estimated 1,500 IVD devices certified under the previous IVDD standard have not yet transitioned to the new IVDR standard in Europe. A significant 78.1% of respondents in a European Commission study faced challenges in obtaining IVDR accreditation. The post-Brexit UK market introduces another layer of regulation: Until June 30, 2023, CE-marked IVD devices will be accepted, but a UKCA mark will be mandatory afterward. The COVID-19 pandemic highlighted the crucial role of rapid IVD testing in combating outbreaks of contagious respiratory diseases. While techniques like RT-PCR are considered highly reliable, they face challenges due to complex workflows and high costs. This underscores the value of rapid IVD tests in managing infectious diseases.

Diagnosis and Disruption: The Changing Face of Europe’s In-Vitro Diagnostics Market Landscape

urope’s in-vitro diagnostics market is a lucrative and dynamic space, with the “Big Five” countries (UK, Germany, France, Italy, Spain) holding approximately 70% of the market share. Technological advancements, such as next-generation sequencing (with investments exceeding $500 million in 2021) and AI-driven diagnostics (garnering $120 million in investment), are fueling innovation and growth. The COVID-19 pandemic significantly impacted the market, leading to a 12% year-on-year growth in 2021 driven by the demand for testing kits. Europe met 40% of the global demand for COVID-19 kits that year, but non-COVID related diagnostics saw a noticeable 7% decline.

Competition is fierce, with dominant players like Roche, Siemens, and Becton Dickinson commanding nearly 50% of the market revenue in 2022.  However, a record $800 million in venture capital funding for IVD innovation in Europe in 2022 signals potential disruption from startups.  Importantly, a patient-centric shift is underway. The 18% surge in home-based IVD kit sales in 2021 and the growth of wearable diagnostics (sales surpassing $100 million in 2022 with a 20% increase) emphasize the demand for personalized, convenient healthcare solutions.

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Reagents are the Most Sold Product in Europe’s In-Vitro Diagnostics Market, Generate More than 80.8% Revenue

Reagents are the most consumed products in Europe’s in-vitro diagnostics market due to several key factors. First and foremost, reagents are essential for performing the full spectrum of diagnostic tests, from routine blood panels to specialized cancer biomarker assays. These tests provide critical insights to diagnose conditions ranging from mild infections to life-threatening diseases, and the sheer variety and volume of IVD testing drives significant reagent consumption. For example, common tests like metabolic panels, complete blood counts, and diabetes screening are performed frequently and at high volumes, requiring a steady supply of reagents.

Moreover, reagents are consumed each time a test is run, representing a recurring cost and high-volume product compared to the instruments that use them. IVD companies often generate 75% or more of their revenue from recurring sales of consumables like reagents and assays, rather than instruments. Many IVD manufacturers even lease their testing equipment to labs and hospitals, tying the lease to long-term contracts to purchase the associated reagents and assays.

Strict quality and regulatory requirements also contribute to the high consumption of reagents in the in-vitro diagnostics market. Reagents are tightly regulated as medical devices to ensure consistent quality and reliable test results. This means reagents have a limited shelf life and are not easily substituted, securing ongoing demand. In Europe, the new In Vitro Diagnostic Regulation (IVDR) introduced more stringent requirements for IVD products, including improved traceability and performance evidence, when fully implemented in 2022.

Furthermore, the trend towards automation and high-throughput testing in diagnostic laboratories drives increased reagent consumption. Advanced IVD instruments allow many samples to be tested quickly and accurately, but they require a large and continuous supply of reagents to operate at maximum capacity. As labs automate to improve efficiency, reagent usage increases in parallel. For instance, high-throughput instruments like Roche’s cobas analyzers can run hundreds of tests per hour, consuming reagents rapidly as they improve lab productivity.

Some examples of the most sold reagents in Europe include:

  1. Immunoassay reagents: Used for detecting and measuring specific proteins, hormones, and other biomarkers in patient samples. These reagents are commonly used in tests for infectious diseases, thyroid function, and fertility.
  2. Clinical chemistry reagents: Used in tests that measure levels of enzymes, electrolytes, and other metabolites in blood and urine samples. These reagents are essential for assessing organ function, monitoring disease progression, and guiding treatment decisions.
  3. Hematology reagents: Used in tests that analyze blood cells, platelets, and coagulation factors. These reagents support the diagnosis and monitoring of conditions like anemia, leukemia, and bleeding disorders.
  4. Molecular diagnostic reagents: Used in tests that detect and measure specific DNA or RNA sequences associated with infectious diseases, genetic disorders, and cancer. These reagents have seen increased demand due to the COVID-19 pandemic and the growing importance of personalized medicine.

Infectious Diseases Contribute 47.4% to Europe In-vitro Diagnostics Market

A promising outlook exists for a high demand for in-vitro diagnostics (IVD) tests for infectious diseases in Europe. Several factors drive this, including the continued persistence of COVID-19, the threat of emerging mosquito-borne illnesses, and ongoing concerns regarding prevalent diseases like influenza, tuberculosis, HIV/AIDS, and hepatitis C.

Despite high vaccination rates against COVID-19 in countries like Portugal (87.6%), Malta (85.7%), Denmark (83.3%), and Spain (83.3%), the virus remains a significant concern. As of May 2, 2023, the UK had the highest number of confirmed COVID-19 cases in Europe at over 24 million, followed by France (39.5 million), Germany (38.1 million), and Italy (25.6 million). Furthermore, the growing prevalence of travel-related infections in Europe, particularly seasonal influenza (increasing from 0% in 1998-2002 to 1.9% in 2019-2023) and arboviral infections like dengue and chikungunya (increasing by 2.6% and 1% respectively over the past 20 years) underscores the necessity for accurate and readily available diagnostic tools.

Specific infectious diseases present a significant burden on European nations. Among them, influenza causes an estimated 4-50 million symptomatic cases and 15,000-70,000 deaths yearly within the European Union and European Economic Area. Tuberculosis remains a challenge in the Europe in-vitro diagnostics market, with Romania reporting the highest rate (28.2 cases per 100,000 population in 2020), followed by Lithuania (17.1), and Latvia (12.6). HIV/AIDS diagnoses remain a concern, with Malta reporting the highest rate of new HIV diagnoses in 2020 at 15.9 per 100,000 population, followed by Latvia (13.2) and Estonia (11.1). Additionally, an estimated 3.9 million people are chronically infected with hepatitis C virus in the EU/EEA as of 2019, with the prevalence ranging from 0.1% in the Netherlands to a concerning 4.4% in Italy.

The data on diagnostic testing reinforces the demand for IVD solutions. In 2022, over 1.6 million tuberculosis laboratory tests were conducted in 22 EU/EEA countries, demonstrating the scale of infectious disease screening. Approximately 120 million HIV tests performed annually within the WHO European Region, along with an estimated 32.6 million HCV RNA tests in 2022, further highlight the vast demand for IVD tests in managing a range of infectious diseases.

Europe In-Vitro Diagnostics Market Key Players

  • Abbott
  • Agilent Technologies, Inc.
  • Becton Dickinson and Company
  • bioMérieux SA
  • Bio-Rad Laboratories, Inc.
  • Charles River Laboratories
  • Danaher Corporation
  • F. Hoffmann-La Roche Ltd.
  • Qiagen
  • Quest Diagnostics
  • Quidel Corp.
  • Siemens Healthineers
  • Sysmex Corp.
  • Other Prominent Players

Key Segmentation:

By Product & Services

  • Reagents
  • Instruments
  • Software
  • Services

 By Technique

  • Immunodiagnostics
  • Hematology
  • Molecular Diagnostics
  • Tissue Diagnostics
  • Clinical Chemistry
  • Others

By Application

  • Cancer diagnostics
  • Blood glucose monitoring
  • Human genetic testing
  • Immunoassays
  • Hepatitis tests
  • Infectious Diseases diagnostics
  • Cardiac Diseases
  • Nephrological Diseases
  • Gastrointestinal Diseases
  • Others

By End User

  • Standalone Laboratories
  • Hospitals
  • Academic And Medical Schools
  • Point Of Care
  • Others

By Europe

  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe

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About Astute Analytica

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