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Europe In-vitro Diagnostics Market: By Product and Services: Reagents and Kits, Instruments, Software and Services; By Technology: Immunoassay/Immunochemistry, Others; By Application; By End Use; Regional Analysis; Historical Market and Forecast (2018-2028); Market Dynamics; Competitive Landscape; Industry Events and Developments
Europe In-vitro Diagnostics Market Outlook
The Europe in-vitro diagnostics market is expected to grow at a CAGR of 4.2% during the period 2023-2028. Analysis of human samples offers physicians with vital information to properly diagnose, treat, and prevent illnesses. Several leading companies offer in-vitro diagnostic (IVD) solutions that deliver rapid, sensitive results while minimizing cost and complexity. Modern in-vitro diagnostics (IVDs) enable better diagnosis for prevention and management of infectious and chronic diseases. These factors are expected to drive market growth.
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Market Likely to be Driven by Need for Efficient and Accurate Diagnostics, and Advancements in Technology
In-vitro diagnostics (IVD) refer to tests carried out on samples such as blood or tissue taken from the human body. In vitro diagnostics can detect diseases, infections, or other conditions, and may be used to monitor a person’s overall health to help treat, cure, or prevent illnesses.
In-vitro means ‘in glass’, indicating that these tests are generally carried out in test tubes and similar equipment, as against in vivo tests, that are performed in the body itself. In-vitro diagnostics may also be employed in precision medicine to determine patients likely to benefit from particular treatments or therapies. These in-vitro diagnostics could include next generation sequencing tests, which scan a person’s DNA to detect genomic variations. Some tests are carried out in a laboratory or other health professional settings, while others may be conducted by consumers at home. The tests themselves can be conducted on a wide range of instruments, varying from small, handheld tests to more complex laboratory instruments.
Diagnosis drives patient, financial and health systems impact, and enables universal health coverage. However, proper diagnosis is an area of concern, particularly in primary healthcare settings in low- and middle-income countries. In such countries, a wide range of IVDs is available to test patients in the primary care setting where laboratories are scarce or not available.
Introduction of New Regulation and Companies’ Adherence Thereto Expected to Drive Market Growth
In 2021, European Commission proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation to avoid disruption in the supply of these essential healthcare products.
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) established a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is suggested that nearly 70% of clinical decisions are made using in-vitro diagnostic medical devices. While the proposal did not modify any requirements of the In Vitro Diagnostic (IVD) Regulation in substance, it altered the transitional provisions to enable the Regulation's progressive rollout. The length of the proposed transition periods depended on device type; higher risk devices like HIV or hepatitis tests (class D) and particular influenza tests (class C), had a transition period until May 2025 and 2026; lower risk devices like class B and A sterile devices had a transition period until May 2027.
In 2022, MedTech Europe welcomed the In Vitro Diagnostic Medical Devices Regulation and urged continued work to deploy the new regulatory system. These developments are expected to drive the Europe in-vitro diagnostics market. In 2022, Roche reported that the company was on its way to full IVDR compliance having taken all the necessary steps to successfully meet IVDR. The company’s journey started in 2017 with six quality management systems (QMS) and more than 2,500 material numbers to change to the new regulation. In 2020, the company reached important milestones with the designation of its two notified bodies and the first QMS audits passed. At the end of 2021, Roche successfully passed its six QMS audits and received its six IVDR QMS certificates.
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Market Segmentation
By product and services, the market is segmented into:
- Reagents and Kits
- Instruments
- Software and Services
By technology, the market is classified into:
- Immunoassay/Immunochemistry
- Clinical Chemistry
- Molecular Diagnostics
- Haematology
- Microbiology
- Blood Glucose Self-monitoring
- Coagulation and Haemostasis
- Urinalysis
- Others
By application, the market is divided into:
- Infectious Diseases
- Diabetes
- Cardiology
- Oncology
- Autoimmune Diseases
- Nephrology
- Others
By end use, the market is segmented into:
- Hospitals
- Laboratories
- Homecare
- Others
By country, the market is divided into:
- United Kingdom
- Germany
- France
- Italy
- Others
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Key Industry Players in the Market
The report presents a detailed analysis of the following key players in the Europe in-vitro diagnostics market, looking into their capacity, and latest developments like capacity expansions, plant turnarounds, and mergers and acquisitions:
- F. Hoffmann-La Roche Ltd
- QIAGEN GmbH
- BioMérieux, Inc
- Siemens Healthineers AG
- ELITechGroup
- Oncgnostics GmbH
- Others
The EMR report gives an in-depth insight into the industry by providing a SWOT analysis as well as an analysis of Porter’s Five Forces model.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
|---|---|
| Base Year | 2022 |
| Historical Period | 2018-2022 |
| Forecast Period | 2023-2028 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product and Services |
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| Breakup by Technology |
|
| Breakup by Application |
|
| Breakup by End Use |
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| Breakup by Region |
|
| Market Dynamics |
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| Competitive Landscape |
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| Companies Covered |
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| Report Price and Purchase Option | Explore our purchase options that are best suited to your resources and industry needs. |
| Delivery Format | Delivered as an attached PDF and Excel through email, with an option of receiving an editable PPT, according to the purchase option. |
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
2 Report Coverage – Key Segmentation and Scope
3 Report Description
3.1 Market Definition and Outlook
3.2 Properties and Applications
3.3 Market Analysis
3.4 Key Players
4 Key Assumptions
5 Executive Summary
5.1 Overview
5.2 Key Drivers
5.3 Key Developments
5.4 Competitive Structure
5.5 Key Industrial Trends
6 Market Snapshot
6.1 Europe
7 Opportunities and Challenges in the Market
8 Europe In-Vitro Diagnostics Market Analysis
8.1 Key Industry Highlights
8.2 Europe In-Vitro Diagnostics Historical Market (2018-2022)
8.3 Europe In-Vitro Diagnostics Market Forecast (2023-2028)
8.4 Europe In-Vitro Diagnostics Market by Product and Services
8.4.1 Reagents and Kits
8.4.1.1 Market Share
8.4.1.2 Historical Trend (2018-2022)
8.4.1.3 Forecast Trend (2023-2028)
8.4.2 Instruments
8.4.2.1 Market Share
8.4.2.2 Historical Trend (2018-2022)
8.4.2.3 Forecast Trend (2023-2028)
8.4.3 Software and Services
8.4.3.1 Market Share
8.4.3.2 Historical Trend (2018-2022)
8.4.3.3 Forecast Trend (2023-2028)
8.5 Europe In-Vitro Diagnostics Market by Technology
8.5.1 Immunoassay/Immunochemistry
8.5.1.1 Market Share
8.5.1.2 Historical Trend (2018-2022)
8.5.1.3 Forecast Trend (2023-2028)
8.5.2 Clinical Chemistry
8.5.2.1 Market Share
8.5.2.2 Historical Trend (2018-2022)
8.5.2.3 Forecast Trend (2023-2028)
8.5.3 Molecular Diagnostics
8.5.3.1 Market Share
8.5.3.2 Historical Trend (2018-2022)
8.5.3.3 Forecast Trend (2023-2028)
8.5.4 Haematology
8.5.4.1 Market Share
8.5.4.2 Historical Trend (2018-2022)
8.5.4.3 Forecast Trend (2023-2028)
8.5.5 Microbiology
8.5.5.1 Market Share
8.5.5.2 Historical Trend (2018-2022)
8.5.5.3 Forecast Trend (2023-2028)
8.5.6 Blood Glucose Self-monitoring
8.5.6.1 Market Share
8.5.6.2 Historical Trend (2018-2022)
8.5.6.3 Forecast Trend (2023-2028)
8.5.7 Coagulation and Haemostasis
8.5.7.1 Market Share
8.5.7.2 Historical Trend (2018-2022)
8.5.7.3 Forecast Trend (2023-2028)
8.5.8 Urinalysis
8.5.8.1 Market Share
8.5.8.2 Historical Trend (2018-2022)
8.5.8.3 Forecast Trend (2023-2028)
8.5.9 Others
8.6 Europe In-Vitro Diagnostics Market by Application
8.6.1 Infectious Diseases
8.6.1.1 Market Share
8.6.1.2 Historical Trend (2018-2022)
8.6.1.3 Forecast Trend (2023-2028)
8.6.2 Diabetes
8.6.2.1 Market Share
8.6.2.2 Historical Trend (2018-2022)
8.6.2.3 Forecast Trend (2023-2028)
8.6.3 Cardiology
8.6.3.1 Market Share
8.6.3.2 Historical Trend (2018-2022)
8.6.3.3 Forecast Trend (2023-2028)
8.6.4 Oncology
8.6.4.1 Market Share
8.6.4.2 Historical Trend (2018-2022)
8.6.4.3 Forecast Trend (2023-2028)
8.6.5 Autoimmune Diseases
8.6.5.1 Market Share
8.6.5.2 Historical Trend (2018-2022)
8.6.5.3 Forecast Trend (2023-2028)
8.6.6 Nephrology
8.6.6.1 Market Share
8.6.6.2 Historical Trend (2018-2022)
8.6.6.3 Forecast Trend (2023-2028)
8.6.7 Others
8.7 Europe In-Vitro Diagnostics Market by End Use
8.7.1 Hospitals
8.7.1.1 Market Share
8.7.1.2 Historical Trend (2018-2022)
8.7.1.3 Forecast Trend (2023-2028)
8.7.2 Laboratories
8.7.2.1 Market Share
8.7.2.2 Historical Trend (2018-2022)
8.7.2.3 Forecast Trend (2023-2028)
8.7.3 Homecare
8.7.3.1 Market Share
8.7.3.2 Historical Trend (2018-2022)
8.7.3.3 Forecast Trend (2023-2028)
8.7.4 Others
8.8 Europe In-Vitro Diagnostics Market by Country
8.8.1 Market Share
8.8.1.1 United Kingdom
8.8.1.2 Germany
8.8.1.3 France
8.8.1.4 Italy
8.8.1.5 Others
9 Regional Analysis
9.1 United Kingdom
9.1.1 Historical Trend (2018-2022)
9.1.2 Forecast Trend (2023-2028)
9.2 Germany
9.2.1 Historical Trend (2018-2022)
9.2.2 Forecast Trend (2023-2028)
9.3 France
9.3.1 Historical Trend (2018-2022)
9.3.2 Forecast Trend (2023-2028)
9.4 Italy
9.4.1 Historical Trend (2018-2022)
9.4.2 Forecast Trend (2023-2028)
10 Market Dynamics
10.1 SWOT Analysis
10.1.1 Strengths
10.1.2 Weaknesses
10.1.3 Opportunities
10.1.4 Threats
10.2 Porter’s Five Forces Analysis
10.2.1 Supplier’s Power
10.2.2 Buyer’s Power
10.2.3 Threat of New Entrants
10.2.4 Degree of Rivalry
10.2.5 Threat of Substitutes
10.3 Key Indicators for Demand
10.4 Key Indicators for Price
11 Competitive Landscape
11.1 Market Structure
11.2 Company Profiles
11.2.1 F. Hoffmann-La Roche Ltd
11.2.1.1 Company Overview
11.2.1.2 Product Portfolio
11.2.1.3 Demographic Reach and Achievements
11.2.1.4 Certifications
11.2.2 QIAGEN GmbH
11.2.2.1 Company Overview
11.2.2.2 Product Portfolio
11.2.2.3 Demographic Reach and Achievements
11.2.2.4 Certifications
11.2.3 BioMérieux, Inc
11.2.3.1 Company Overview
11.2.3.2 Product Portfolio
11.2.3.3 Demographic Reach and Achievements
11.2.3.4 Certifications
11.2.4 Siemens Healthineers AG
11.2.4.1 Company Overview
11.2.4.2 Product Portfolio
11.2.4.3 Demographic Reach and Achievements
11.2.4.4 Certifications
11.2.5 ELITechGroup
11.2.5.1 Company Overview
11.2.5.2 Product Portfolio
11.2.5.3 Demographic Reach and Achievements
11.2.5.4 Certifications
11.2.6 Oncgnostics GmbH
11.2.6.1 Company Overview
11.2.6.2 Product Portfolio
11.2.6.3 Demographic Reach and Achievements
11.2.6.4 Certifications
11.2.7 Others
12 Key Trends and Developments in the Market
List of Key Figures and Tables
1. Europe In-Vitro Diagnostics Market: Key Industry Highlights, 2018 and 2028
2. Europe In-Vitro Diagnostics Historical Market: Breakup by Product and Services (USD Million), 2018-2022
3. Europe In-Vitro Diagnostics Market Forecast: Breakup by Product and Services (USD Million), 2023-2028
4. Europe In-Vitro Diagnostics Historical Market: Breakup by Technology (USD Million), 2018-2022
5. Europe In-Vitro Diagnostics Market Forecast: Breakup by Technology (USD Million), 2023-2028
6. Europe In-Vitro Diagnostics Historical Market: Breakup by End Use (USD Million), 2018-2022
7. Europe In-Vitro Diagnostics Market Forecast: Breakup by End Use (USD Million), 2023-2028
8. Europe In-Vitro Diagnostics Historical Market: Breakup by Country (USD Million), 2018-2022
9. Europe In-Vitro Diagnostics Market Forecast: Breakup by Country (USD Million), 2023-2028
10. Europe In-Vitro Diagnostics Market Structure.
Key Questions Answered in the Report
The Europe in-vitro diagnostics market is projected to grow at a CAGR of 4.2% between 2023 and 2028.
The major drivers of the market include the surging number of pathology labs and services equipped with advanced diagnostics machines, rising prevalence of infectious and chronic diseases, and increasing adoption of point-of-care testing.
The increasing need for efficient and accurate diagnostics, and advancements in technology are the key industry trends propelling the market's growth.
The major regions in the industry are United Kingdom, Germany, France, and Italy, among others.
The various products and services in the market are reagents and kits, instruments, software and services.
Based on technology, the market is segmented into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, haematology, microbiology, blood glucose self-monitoring, coagulation and haemostasis, and urinalysis, among others.
The major applications of the market are infectious diseases, diabetes, cardiology, oncology, autoimmune diseases, and nephrology, among others.
The end-uses of the market are hospitals, laboratories, and homecare, among others.
The major players in the industry are F. Hoffmann-La Roche Ltd, QIAGEN GmbH, BioMérieux, Inc, Siemens Healthineers AG, ELITechGroup, and Oncgnostics GmbH, among others.
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