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Europe In-vitro Diagnostics Market Report and Forecast 2024-2032

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    Report

  • 150 Pages
  • September 2024
  • Region: Europe
  • Expert Market Research
  • ID: 5912690
The Europe in-vitro diagnostics market was valued at USD 29 billion in 2023. It is expected to grow at a CAGR of 4.2% during the period 2024-2032 and attain a market value of USD 42 billion by 2032.

Europe In-Vitro Diagnostics Market Analysis

The Europe in-vitro diagnostics (IVD) market is a crucial segment of the broader medical diagnostics industry, providing vital tools for the detection and management of diseases. In-vitro diagnostics involve tests performed on samples such as blood, urine, or tissue that are taken from the human body. These tests are essential for disease diagnosis, treatment monitoring, and overall health management. The European market for IVD is known for its advanced technology and high adoption rate of innovative diagnostic solutions, driven by a well-established healthcare infrastructure and increasing awareness about early disease detection.

Market Drivers

Technological Advancements: The continuous innovation in diagnostic technologies, including molecular diagnostics, next-generation sequencing (NGS), and point-of-care (POC) testing, has significantly enhanced the accuracy and speed of diagnostics. These advancements have facilitated early disease detection and personalised treatment plans.

Ageing Population: Europe has a significant ageing population, leading to a higher prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer. The growing need for efficient and accurate diagnostics to manage these conditions is a major driver for the IVD market.

Government Initiatives and Funding: European governments and health organisations are actively promoting the adoption of advanced diagnostics through funding and supportive regulations. This has encouraged research and development activities and the integration of new technologies into the healthcare system.

Rise in Infectious Diseases: The recent outbreaks of infectious diseases, including COVID-19, have highlighted the importance of robust diagnostic systems. The pandemic has accelerated the demand for rapid and accurate diagnostic tests, thereby boosting the IVD market.

Challenges

Regulatory Hurdles: The stringent regulatory framework in Europe can delay the approval and market entry of new diagnostic tests. Compliance with diverse regulations across different countries adds to the complexity and cost for manufacturers.

High Costs: The development and implementation of advanced diagnostic technologies can be expensive. High costs associated with these technologies may limit their adoption, especially in lower-income regions within Europe.

Data Privacy Concerns: With the increasing use of digital platforms and electronic health records, data privacy and security have become significant concerns. Ensuring compliance with the General Data Protection Regulation (GDPR) and protecting patient information is a critical challenge.

Market Fragmentation: The European IVD market is highly fragmented, with numerous small and medium-sized enterprises (SMEs) alongside large multinational corporations. This fragmentation can lead to intense competition and pricing pressures.

Future Opportunities

Personalised Medicine: The shift towards personalised medicine, which tailors treatment based on individual patient characteristics, presents significant growth opportunities. Advanced IVD tests that provide detailed genetic and molecular information are crucial for personalised treatment plans.

Integration of AI and Machine Learning: The integration of artificial intelligence (AI) and machine learning (ML) into diagnostic tools can enhance the accuracy and efficiency of diagnostics. These technologies can assist in data analysis, predictive diagnostics, and decision-making processes.

Expansion of Point-of-Care Testing: Point-of-care testing (POCT) offers immediate results and can be conducted at or near the site of patient care. The expansion of POCT in primary care settings, remote areas, and home healthcare can significantly improve access to diagnostics.

Collaborations and Partnerships: Collaborations between diagnostic companies, research institutions, and healthcare providers can drive innovation and accelerate the development of new diagnostic solutions. Strategic partnerships can also help in expanding market reach and enhancing product offerings.

Emerging Markets: While Western Europe dominates the IVD market, there are substantial growth opportunities in Eastern Europe. Improving healthcare infrastructure and increasing healthcare expenditure in these regions can drive the adoption of advanced diagnostic technologies.

Europe In-Vitro Diagnostics Market Trends

The Europe in-vitro diagnostics (IVD) market is evolving rapidly, influenced by technological innovations and changing healthcare dynamics. Here are some insightful market trends shaping the future of this industry:

Market Trends

Rise of Molecular Diagnostics: Molecular diagnostics are becoming increasingly important due to their precision and ability to detect genetic mutations and infectious agents at an early stage. Techniques such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) are widely adopted, offering rapid and accurate diagnostics, which are crucial for personalised medicine and targeted therapies.

Growth in Point-of-Care Testing (POCT): The demand for point-of-care testing is on the rise, driven by the need for immediate diagnostic results, especially in critical care and emergency settings. POCT enables faster decision-making and treatment initiation, improving patient outcomes. The trend towards decentralised healthcare and home testing also supports the growth of POCT.

Integration of Artificial Intelligence (AI) and Machine Learning (ML): AI and ML are revolutionising the IVD market by enhancing the accuracy and efficiency of diagnostic processes. These technologies are used for data analysis, pattern recognition, and predictive diagnostics, aiding in early disease detection and personalised treatment plans. AI-powered diagnostic tools are becoming more prevalent in clinical laboratories and hospitals.

Adoption of Digital Pathology: Digital pathology is transforming traditional pathology by enabling the digitisation of slides and data for analysis. This trend allows pathologists to analyse samples remotely, collaborate more effectively, and utilise AI tools for better diagnostic accuracy. Digital pathology enhances workflow efficiency and is gaining traction in Europe.

Personalised Medicine and Companion Diagnostics: The move towards personalised medicine is driving the development of companion diagnostics, which are tests designed to determine the suitability of specific treatments for individual patients. This trend is particularly significant in oncology, where targeted therapies require precise diagnostics to identify suitable candidates for treatment.

Europe In-Vitro Diagnostics Market Segmentation

Market Breakup by Product Type

  • Reagents and Kits
  • Instruments
  • Software and Services
The Europe in-vitro diagnostics (IVD) market is segmented into reagents and kits, instruments, and software and services. Reagents and kits dominate due to their extensive use in diagnostic tests, driven by the rising prevalence of chronic diseases. Instruments are witnessing growth due to technological advancements and the increasing adoption of automated systems. Software and services are expanding rapidly, fuelled by the integration of AI and data analytics, enhancing diagnostic accuracy and efficiency. These segments collectively propel market growth, with a forecasted increase due to advancements in technology, rising healthcare awareness, and a growing emphasis on early disease detection.

Market Breakup by Technology

  • Immunoassay/ Immunochemistry
  • Clinical Chemistry 
  • Molecular Diagnostics
  • Haematology
  • Microbiology
  • Blood Glucose Self-Monitoring
  • Coagulation and Haemostasis
  • Urinalysis
  • Others
The Europe in-vitro diagnostics (IVD) market is segmented by technology into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, haematology, microbiology, blood glucose self-monitoring, coagulation and haemostasis, urinalysis, and others. Immunoassays and immunochemistry lead due to their widespread application in disease detection and monitoring. Molecular diagnostics is growing rapidly, driven by advancements in genetic testing and personalised medicine. Clinical chemistry and haematology benefit from routine use in hospitals and laboratories. Blood glucose self-monitoring sees significant demand due to rising diabetes prevalence. The growth in these technologies is poised to drive market expansion, emphasising technological innovation and improved healthcare outcomes.

Market Breakup by Therapeutic Area

  • Infectious Diseases
  • Diabetes
  • Cardiology
  • Oncology
  • Autoimmune Diseases
  • Nephrology
  • Others
The Europe in-vitro diagnostics (IVD) market is segmented by therapeutic area into infectious diseases, diabetes, cardiology, oncology, autoimmune diseases, nephrology, and others. Infectious diseases dominate due to the ongoing need for rapid and accurate diagnostic tests, especially highlighted by the COVID-19 pandemic. Diabetes diagnostics see sustained demand driven by the high prevalence of the condition. Cardiology and oncology are experiencing growth due to advancements in biomarkers and personalised medicine approaches. Autoimmune diseases and nephrology segments are expanding as awareness and early diagnosis improve. These therapeutic areas collectively drive market growth, emphasising the importance of early and precise disease detection.

Market Breakup by End User

  • Hospitals
  • Laboratories
  • Homecare
  • Others
The Europe in-vitro diagnostics (IVD) market is segmented by end user into hospitals, laboratories, homecare, and others. Hospitals dominate due to the high volume of diagnostic tests performed in these settings, driven by the need for accurate and timely disease diagnosis. Laboratories also hold a significant share, benefiting from advancements in automation and high-throughput technologies. Homecare diagnostics are rapidly growing, spurred by the increasing preference for convenient and cost-effective home-based testing, particularly for chronic disease management. These end-user segments collectively propel market growth, with innovations in technology and a focus on patient-centric care driving future expansion.

Europe In-Vitro Diagnostics Market Competitive Landscape

The Europe in-vitro diagnostics (IVD) market is highly competitive, with key players including F. Hoffmann-La Roche Ltd, QIAGEN GmbH, BioMérieux, Inc., Siemens Healthineers AG, ELITechGroup, Oncgnostics GmbH, Abbott Laboratories, Danaher Corporation, Sysmex Corporation, and Thermo Fisher Scientific Inc. These companies engage in common market activities such as mergers and acquisitions to expand their market presence and capabilities. They are also heavily involved in research initiatives to innovate and improve diagnostic technologies. Frequent product introductions and partnerships with other firms and research institutions are strategies used to enhance their offerings and market reach, driving competitive growth and technological advancement in the European IVD market.

Key Questions Answered in the Report

  • What is the current and future performance of the Europe In-Vitro Diagnostics market?
  • What are the main challenges facing the Europe In-Vitro Diagnostics market?
  • What are the key drivers of the Europe In-Vitro Diagnostics market?
  • What emerging trends are shaping the future of the Europe In-Vitro Diagnostics market?
  • How is the trend towards personalised medicine influencing the development of companion diagnostics?
  • Why do reagents and kits dominate the IVD market, and how are instruments evolving?
  • How are molecular diagnostics, clinical chemistry, and haematology evolving in the IVD market?
  • What factors are driving the sustained demand for diabetes diagnostics?
  • Why do hospitals dominate the IVD market in terms of diagnostic test volumes?

Key Benefits for Stakeholders

  • The industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the Europe In-Vitro Diagnostics market from 2017-2032.
  • The research report provides the latest information on the market drivers, challenges, and opportunities in the Europe In-Vitro Diagnostics market.
  • The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
  • Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the Europe In-Vitro Diagnostics industry and its attractiveness.
  • The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.


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Table of Contents

1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 In-Vitro Diagnostics Market Overview
3.1 Global In-Vitro Diagnostics Market
3.1.1 Global In-Vitro Diagnostics Market Historical Value (2017-2023)
3.1.2 Global In-Vitro Diagnostics Market Forecast Value (2024-2032)
3.2 Europe In-Vitro Diagnostics Market
3.2.1 Europe In-Vitro Diagnostics Market Historical Value (2017-2023)
3.2.2 Europe In-Vitro Diagnostics Market Forecast Value (2024-2032)
4 Vendor Positioning Analysis
4.1 Key Vendors
4.2 Prospective Leaders
4.3 Niche Leaders
4.4 Disruptors
5 Europe In-Vitro Diagnostics Market Landscape*
5.1 Europe In-Vitro Diagnostics: Developers Landscape
5.1.1 Analysis by Year of Establishment
5.1.2 Analysis by Company Size
5.1.3 Analysis by Region
5.2 Europe In-Vitro Diagnostics: Product Landscape
5.2.1 Analysis by Product Type
5.2.2 Analysis by Technology
5.2.3 Analysis by Therapeutic Area
6 Europe In-Vitro Diagnostics Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
6.2.1 Strengths
6.2.2 Weaknesses
6.2.3 Opportunities
6.2.4 Threats
6.3 PESTEL Analysis
6.3.1 Political
6.3.2 Economic
6.3.3 Social
6.3.4 Technological
6.3.5 Legal
6.3.6 Environment
6.4 Porter’s Five Forces Model
6.4.1 Bargaining Power of Suppliers
6.4.2 Bargaining Power of Buyers
6.4.3 Threat of New Entrants
6.4.4 Threat of Substitutes
6.4.5 Degree of Rivalry
6.5 Key Demand Indicators
6.6 Key Price Indicators
6.7 Industry Events, Initiatives, and Trends
6.8 Value Chain Analysis
7 Europe In-Vitro Diagnostics Market: Trade Data Analysis (HS Code- 38220090)
7.1 Major Exporting Countries
7.1.1 By Value
7.1.2 By Volume
7.2 Major Importing Countries
7.2.1 By Value
7.2.2 By Volume
8 Europe In-Vitro Diagnostics Market Segmentation (2017-2032)
8.1 Europe In-Vitro Diagnostics Market (2017-2032) by Product Type
8.1.1 Market Overview
8.1.2 Reagents and Kits
8.1.3 Instruments
8.1.4 Software and Services
8.2 Europe In-Vitro Diagnostics Market (2017-2032) by Technology
8.2.1 Market Overview
8.2.2 Immunoassay/ Immunochemistry
8.2.3 Clinical Chemistry
8.2.4 Molecular Diagnostics
8.2.5 Haematology
8.2.6 Microbiology
8.2.7 Others
8.3 Europe In-Vitro Diagnostics Market (2017-2032) by Therapeutic Area
8.3.1 Market Overview
8.3.2 Infectious Diseases
8.3.3 Diabetes
8.3.4 Cardiology
8.3.5 Oncology
8.3.6 Autoimmune Diseases
8.3.7 Nephrology
8.3.8 Others
8.4 Europe In-Vitro Diagnostics Market (2017-2032) by End User
8.4.1 Market Overview
8.4.2 Hospitals
8.4.3 Laboratories
8.4.4 Others
8.5 Europe In-Vitro Diagnostics Market (2017-2032) by Country
8.5.1 Market Overview
8.5.2 United Kingdom
8.5.3 Germany
8.5.4 France
8.5.5 Italy
8.5.6 Others
9 United Kingdom In-Vitro Diagnostics Market Segmentation (2017-2032)
9.1 United Kingdom In-Vitro Diagnostics Market (2017-2032) by Product Type
9.1.1 Market Overview
9.1.2 Reagents and Kits
9.1.3 Instruments
9.1.4 Software and Services
9.2 United Kingdom In-Vitro Diagnostics Market (2017-2032) by Technology
9.2.1 Market Overview
9.2.2 Immunoassay/ Immunochemistry
9.2.3 Clinical Chemistry
9.2.4 Molecular Diagnostics
9.2.5 Haematology
9.2.6 Microbiology
9.2.7 Others
9.3 United Kingdom In-Vitro Diagnostics Market (2017-2032) by Therapeutic Area
9.3.1 Market Overview
9.3.2 Infectious Diseases
9.3.3 Diabetes
9.3.4 Cardiology
9.3.5 Oncology
9.3.6 Autoimmune Diseases
9.3.7 Nephrology
9.3.8 Others
9.4 United Kingdom In-Vitro Diagnostics Market (2017-2032) by End User
9.4.1 Market Overview
9.4.2 Hospitals
9.4.3 Laboratories
9.4.4 Others
10 Germany In-Vitro Diagnostics Market Segmentation (2017-2032)
10.1 Germany In-Vitro Diagnostics Market (2017-2032) by Product Type
10.1.1 Market Overview
10.1.2 Reagents and Kits
10.1.3 Instruments
10.1.4 Software and Services
10.2 Germany In-Vitro Diagnostics Market (2017-2032) by Technology
10.2.1 Market Overview
10.2.2 Immunoassay/ Immunochemistry
10.2.3 Clinical Chemistry
10.2.4 Molecular Diagnostics
10.2.5 Haematology
10.2.6 Microbiology
10.3 Germany In-Vitro Diagnostics Market (2017-2032) by Therapeutic Area
10.3.1 Market Overview
10.3.2 Infectious Diseases
10.3.3 Diabetes
10.3.4 Cardiology
10.3.5 Oncology
10.3.6 Autoimmune Diseases
10.3.7 Nephrology
10.3.8 Others
10.4 Germany In-Vitro Diagnostics Market (2017-2032) by End User
10.4.1 Market Overview
10.4.2 Hospitals
10.4.3 Laboratories
10.4.4 Others
11 France In-Vitro Diagnostics Market Segmentation (2017-2032)
11.1 France In-Vitro Diagnostics Market (2017-2032) by Product Type
11.1.1 Market Overview
11.1.2 Reagents and Kits
11.1.3 Instruments
11.1.4 Software and Services
11.2 France In-Vitro Diagnostics Market (2017-2032) by Technology
11.2.1 Market Overview
11.2.2 Immunoassay/ Immunochemistry
11.2.3 Clinical Chemistry
11.2.4 Molecular Diagnostics
11.2.5 Haematology
11.2.6 Microbiology
11.2.7 Others
11.3 France In-Vitro Diagnostics Market (2017-2032) by Therapeutic Area
11.3.1 Market Overview
11.3.2 Infectious Diseases
11.3.3 Diabetes
11.3.4 Cardiology
11.3.5 Oncology
11.3.6 Autoimmune Diseases
11.3.7 Nephrology
11.3.8 Others
11.4 France In-Vitro Diagnostics Market (2017-2032) by End User
11.4.1 Market Overview
11.4.2 Hospitals
11.4.3 Laboratories
11.4.4 Others
12 Italy In-Vitro Diagnostics Market Segmentation (2017-2032)
12.1 Italy In-Vitro Diagnostics Market (2017-2032) by Product Type
12.1.1 Market Overview
12.1.2 Reagents and Kits
12.1.3 Instruments
12.1.4 Software and Services
12.2 Italy In-Vitro Diagnostics Market (2017-2032) by Technology
12.2.1 Market Overview
12.2.2 Immunoassay/ Immunochemistry
12.2.3 Clinical Chemistry
12.2.4 Molecular Diagnostics
12.2.5 Haematology
12.2.6 Microbiology
12.2.7 Others
12.3 Italy In-Vitro Diagnostics Market (2017-2032) by Therapeutic Area
12.3.1 Market Overview
12.3.2 Infectious Diseases
12.3.3 Diabetes
12.3.4 Cardiology
12.3.5 Oncology
12.3.6 Autoimmune Diseases
12.3.7 Nephrology
12.3.8 Others
12.4 Italy In-Vitro Diagnostics Market (2017-2032) by End User
12.4.1 Market Overview
12.4.2 Hospitals
12.4.3 Laboratories
12.4.4 Others
13 Regulatory Framework
13.1 Regulatory Overview
13.2 European Medicines Agency
14 Patent Analysis
14.1 Analysis by Type of Patent
14.2 Analysis by Publication Year
14.3 Analysis by Issuing Authority
14.4 Analysis by Patent Age
14.5 Analysis by CPC Analysis
14.6 Analysis by Patent Valuation
14.7 Analysis by Key Players
15 Strategic Initiatives
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Supplier Landscape
16.1 Market Share Analysis, By Region (Top 5 Companies)
16.2 F. Hoffmann-La Roche Ltd
16.2.1 Financial Analysis
16.2.2 Product Portfolio
16.2.3 Demographic Reach and Achievements
16.2.4 Mergers and Acquisitions
16.2.5 Certifications
16.3 QIAGEN GmbH
16.3.1 Financial Analysis
16.3.2 Product Portfolio
16.3.3 Demographic Reach and Achievements
16.3.4 Mergers and Acquisitions
16.3.5 Certifications
16.4 BioMérieux, Inc .
16.4.1 Financial Analysis
16.4.2 Product Portfolio
16.4.3 Demographic Reach and Achievements
16.4.4 Mergers and Acquisitions
16.4.5 Certifications
16.5 Siemens Healthineers AG
16.5.1 Financial Analysis
16.5.2 Product Portfolio
16.5.3 Demographic Reach and Achievements
16.5.4 Mergers and Acquisitions
16.5.5 Certifications
16.6 ELITechGroup
16.6.1 Financial Analysis
16.6.2 Product Portfolio
16.6.3 Demographic Reach and Achievements
16.6.4 Mergers and Acquisitions
16.6.5 Certifications
16.7 Oncgnostics GmbH
16.7.1 Financial Analysis
16.7.2 Product Portfolio
16.7.3 Demographic Reach and Achievements
16.7.4 Mergers and Acquisitions
16.7.5 Certifications
16.8 Abbott Laboratories
16.8.1 Financial Analysis
16.8.2 Product Portfolio
16.8.3 Demographic Reach and Achievements
16.8.4 Mergers and Acquisitions
16.8.5 Certifications
16.9 Danaher Corporation
16.9.1 Financial Analysis
16.9.2 Product Portfolio
16.9.3 Demographic Reach and Achievements
16.9.4 Mergers and Acquisitions
16.9.5 Certifications
16.10 Sysmex Corporation
16.10.1 Financial Analysis
16.10.2 Product Portfoliozz
16.10.3 Demographic Reach and Achievements
16.10.4 Mergers and Acquisitions
16.10.5 Certifications
16.11 Thermo Fisher Scientific Inc
16.11.1 Financial Analysis
16.11.2 Product Portfolio
16.11.3 Demographic Reach and Achievements
16.11.4 Mergers and Acquisitions
16.11.5 Certifications
17 Europe In-Vitro Diagnostics Market - Distribution Model (Additional Insight)
17.1 Overview
17.2 Potential Distributors
17.3 Key Parameters for Distribution Partner Assessment
18 Key Opinion Leaders (KOL) Insights (Additional Insight)

Companies Mentioned

  • F. Hoffmann-La Roche Ltd
  • QIAGEN GmbH
  • BioMérieux, Inc.
  • Siemens Healthineers AG
  • ELITechGroup
  • Oncgnostics GmbH
  • Abbott Laboratories
  • Danaher Corporation
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc

Methodology

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