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

Europe In-vitro Diagnostics Market Size

The Europe in-vitro diagnostics market is expected to grow at a CAGR of 4.2% during the forecast period of 2024-2032, driven by the increasing healthcare needs, the rising development of advanced diagnostic technologies, and regulatory improvements in the region.

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Europe In-vitro Diagnostics Market Outlook

• The increasing burden of infectious diseases such as influenza, HIV, and the recent COVID-19 pandemic, is contributing significantly to the market growth.

• The rising development of advanced in-vitro diagnostic technologies and the growing adoption of automated systems and robotic technologies in diagnostic laboratories are major trends poised to aid market expansion in the forecast period.

• The market value is influenced by the rise in new product launches, increasing preference for home-based testing solutions, and evolving regulatory framework in the region.

Europe In-vitro Diagnostics Market Overview

In-vitro diagnostics (IVD) include 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 can 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 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 healthcare 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.

The Europe in-vitro diagnostics market is driven by the increasing prevalence of chronic diseases and the growing aging population fuelling the demand for diagnostic tests to monitor and manage various medical conditions. The rising burden of infectious diseases such as influenza, HIV, and the recent COVID-19 pandemic, is contributing to the expansion of the global in-vitro diagnostic market. The growing demand for home-based diagnostic tests, particularly for chronic disease management, is set to elevate the market value. Other factors that influence the market dynamics include increased public health campaigns, the rising adoption of digital health technologies, and growth in strategic collaborations between diagnostic companies.

Europe In-vitro Diagnostics Market Growth Drivers

Introduction of New Regulations and Companies’ Adherence are Expected to Drive Market Growth

In 2021, the 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 2023, 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 augment the Europe in-vitro diagnostics market size.

In 2023, 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. The proactive approach of several key market players to IVDR compliance coupled with their commitment to ensure product quality and regulatory requirements is poised to fuel market growth.

Growth in Strategic Partnerships to Meet Rising Europe In-vitro Diagnostics Market Demand

In April 2024, Revvity's German-based subsidiary EUROIMMUN (a leading provider of high-quality in-vitro diagnostic products) partnered with ALPCO-GeneProof (a major immunodiagnostics and molecular diagnostics company) to boost the availability of GeneProof PCR kits across the European Union. This collaboration aims to leverage ALPCO-GeneProof's advanced molecular diagnostic technologies and EUROIMMUN's robust distribution network and infrastructure capabilities to expand CE-IVD-certified molecular assay products. According to the agreement, ALPCO-GeneProof will offer 42 molecular diagnostic assays including GeneProof PCR kits with assays for transplant and immunocompromised patients, bloodborne pathogens, and neuroinfections, among others. The rise in such strategic partnerships among prominent diagnostic companies is anticipated to stimulate market growth and innovation.

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Europe In-vitro Diagnostics Market Trends

The market is witnessing several trends and developments to improve the current scenario in Europe. Some of the notable trends are as follows:

Europe In-vitro Diagnostics Market Segmentation

Market Breakup by Product Type

• Reagents and Kits

• Instruments

• Software and Services

Market Breakup by Technology

• Immunoassay/Immunochemistry

• Clinical Chemistry

• Molecular Diagnostics

• Haematology

• Microbiology

• Others

Market Breakup by Therapeutic Area

• Infectious Diseases

• Diabetes

• Cardiology

• Oncology

• Autoimmune Diseases

• Nephrology

• Others

Market Breakup by End User

• Hospitals

• Laboratories

• Others

Market Breakup by Country

• United Kingdom

• Germany

• France

• Italy

• Others

Europe In-vitro Diagnostics Market Share

Market Segmentation Based on Product Type is Set to Witness Substantial Growth

Based on the product type, the market is segmented into reagents and kits, instruments, and software and services. Reagents and kits of in-vitro diagnostic tests are experiencing a substantial market demand due to the increasing number of screening procedures and routine diagnostic tests. The segment also benefits from the development of assays that have multiplex testing capabilities and the launch of point-of-care (POC) testing kits for quick diagnosis.

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Europe In-vitro Diagnostics Market Analysis by Region

In Europe, the market breakup by country includes the United Kingdom, Germany, France, Italy, and others. The demand for in-vitro diagnostic products is high in the United Kingdom, owing to the presence of a well-developed healthcare system and the increased focus of the government on promoting regular screening initiatives. Germany is also a major market driven by robust research efforts in advancing medical diagnostics and a significant influx of capital to accelerate the growth of personalized medicine and precision diagnostics.

Leading Players in the Europe In-vitro Diagnostics Market

The key features of the market report comprise patent analysis and strategic initiatives by the leading key players. The major companies in the market are as follows:

F. Hoffmann-La Roche Ltd

Swiss multinational holding healthcare company F. Hoffmann-La Roche Ltd has a prominent presence in the market and operates under two divisions: Pharmaceuticals and Diagnostics. One of its key products is the in-vitro immunoassay Elecsys® Anti-SARS-CoV-2 for qualitative detection of antibodies to SARS-CoV-2.

QIAGEN GmbH

Leading provider of sample and assay technologies, QIAGEN GmbH specializes in the field of molecular diagnostics, applied testing, and research. The company is popular for its infectious disease diagnostics platforms including syndromic testing platform QIAstat-Dx®.

BioMérieux, Inc.

In vitro diagnostics provider BioMérieux, Inc. is a multinational biotechnology company headquartered in France. The company is engaged in continuous innovation in the field of infectious disease diagnostics and significantly contributes to the Europe in-vitro diagnostics market growth.

Siemens Healthineers AG

Headquartered in Germany, Siemens Healthineers AG is a Medtech company known for its robust portfolio of in-vitro diagnostic solutions, including laboratory diagnostics and point-of-care tests. The company is focused on exploring AI-powered diagnostic tools and software.

Other key players in the market include ELITechGroup, Oncgnostics GmbH, Abbott Laboratories, Danaher Corporation, Sysmex Corporation, and Thermo Fisher Scientific Inc.

Key Highlights of the Report

Key Questions Answered in the Europe In-vitro Diagnostics Market Report

• What was the Europe in-vitro diagnostics market value in 2023?
• What is the Europe in-vitro diagnostics market forecast outlook for 2024-2032?
• What are the regional markets covered in the EMR report?
• What is market segmentation based on product type?
• What is the market breakup based on technology?
• What is market segmentation based on the therapeutic area?
• Who are the major end users in the market?
• What are the major factors aiding the Europe in-vitro diagnostics market demand? 
• How has the market performed so far and how is it anticipated to perform in the coming years?
• What are the market's major drivers, opportunities, and restraints? 
• Which regional market is expected to lead the market share in the forecast period? 
• Which country is expected to experience expedited growth during the forecast period? 
• How do the prevalence and incidence of chronic diseases affect the market landscape?
• What are the major Europe in-vitro diagnostics market trends?
• How does the rise in the geriatric population impact the market size?
• Which product type will dominate the market share? 
• Which technology type will experience the highest demand in the market segment?
• Which therapeutic area is expected to have a high market value in the coming years?
• Which end user is projected to contribute to the highest market growth?
• Who are the key players involved in the Europe in-vitro diagnostics market?
• What is the patent landscape of the market?
• What are the current unmet needs and challenges in the market?
• How are partnerships, collaborations, mergers and acquisitions among the key market players shaping the market dynamics?