Europe In-vitro Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Hematology, and Others), By Setting (Laboratories and Point of Care), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, and Others), By End-user (Clinical Laboratories, Hospitals, Physician’s Offices, and Others), and Regional Forecast, 2023-2030

Europe is the second largest region in the global in-vitro diagnostics market. The Europe in-vitro diagnostics market size is projected to record a CAGR of 7.1% during the forecast period. The global market for in-vitro diagnostics is projected to grow from USD 94.67 billion in 2022 to USD 157.02 billion by 2030.

The Europe market is influenced by several factors including the rising prevalence of infectious diseases, introduction of technologically advanced products in the Europe market, high adoption of in-vitro diagnostics products owing to the COVID-19 pandemic, emerging key players to fulfil the surged demand, rise in R&D investments by government & key players, business expansions by market players, changing regulatory environments, and many others. Also, in-vitro diagnostic tests are part of around 70% of clinical decisions, and such high dependency on these tests will make the market grow by many folds.

• For instance, according to the European Blood Alliance, Germany collects around 2.4 million voluntary blood donations annually.


• Similarly, according to a report published by the NHS England, around 800 million tests are performed annually in England and Wales, which includes 130 million hematology tests.

Thus, the rising significance of these tests in disease diagnosis and increasing number of blood donations in the region will likely propel the Europe in-vitro diagnostics market growth during the forecast period.

This report on the European market covers the following countries/regions – the U.K., Germany, France, Italy, Spain, Scandinavia, and the Rest of Europe.

LATEST TRENDS

Increasing Investments for Advancements in Automated In-vitro Diagnostics Systems Offers New Growth Opportunities

A clear understanding of the growing demand for automated instruments and systems encouraged the key players to invest heavily in automation and technology integration. These technologically advanced products are witnessing a high adoption rate as they take less time to process a task, offer error-free results, and can help end-users increase their sample processing capacity.

• For instance, in March 2022, Roche Diagnostics announced the U.K. launch of its cobas 5800 System, a small molecular system. The instrument's improved automation enables it to perform more than 10 million tests monthly on over 1,000 installed systems across the world. It has a high adoption rate across laboratories due to its small size.

The benefits of an automated system, such as raised testing volumes and improved operational efficiency to manage the increasing demand are anticipated to create new opportunities for the market players in the coming years.

DRIVING FACTORS

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Rising R&D Expenditure by Key Players to Introduce New Products Will Drive Market Growth

The sudden surge in demand for in-vitro diagnostic tests and rising competition due to the availability of various in-vitro diagnostics technologies has encouraged the market players to invest more in R&D and develop innovative products. Many European companies involved in in-vitro diagnostics manufacturing increased their investment in R&D, leading to new product launches in the region and contributing to the market growth.

• For instance, in February 2023, bioMérieux SA announced the launch of the MONKEYPOX R-GENE PCR kit, which allows qualitative virus detection. The kit was made available from February 6, 2023 in countries that accept Research Use Only (RUO) products.

Moreover, the rising incidence of cancer is one of the major factors boosting the market growth in Europe.

RESTRAINING FACTORS

Changing Regulatory Environment Creating Operational Barriers May Limit Market Growth 

The market in Europe is facing a crucial regulatory scenario as in 2022, as a long-standing In-Vitro Diagnostic Directive (IVDD) regulation was replaced by In-Vitro Diagnostic Device Regulation (IVDR). The latter constitutes many updates regarding the classification of in-vitro diagnostics as medical devices. Under IVDD regulations, 15% of in-vitro diagnostics devices had to go through notified bodies; however, under IVDR, it’s 85%. The new regulation creates bottlenecks for the market players as many products are anticipated to be taken off the Europe market.

• For instance, according to a news article published in February 2023, it was estimated that 1,500 in-vitro diagnostics certified under IVDD had not yet transitioned to the IVDR certification; these certifications are likely to expire in May 2025.


• For instance, as per a European Commission survey published in 2021, 78.1% of participants responded that they faced various issues that prevented them from starting or completing certification under the IVDR.

Moreover, in the post-Brexit U.K., devices with a valid CE mark will be accepted till June 30, 2023, after which a device will be required to have a UKCA mark. This mark will indicate that the devices are complying with the existing IVDD regulations. This changing regulatory environment impacts the U.K. the most, followed by other European countries, limiting the Europe in-vitro diagnostics market share expansion.

KEY INDUSTRY PLAYERS

In terms of competitive landscape, bioMérieux SA, Qiagen N.V., and F. Hoffmann-La Roche Ltd. are the key players in the Europe market, owing to strong product offerings and active involvement in R&D investments to accelerate the process of product launches and approvals.

Other prominent players, such as Siemens Healthineers AG and DiaSorin S.p.A. are also leading the market due to their strong distribution network and diverse product portfolios. Other major market participants are Danaher Corporation, Bio-Rad Laboratories, Abbott, and others. These companies are focused on strengthening their product portfolios and distribution networks through strategic collaborations and partnerships to increase their share in the Europe market.

LIST OF KEY COMPANIES PROFILED:

• bioMérieux SA (France)


• Qiagen N.V. (Germany)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Siemens Healthineers AG (Germany)


• DiaSorin S.p.A. (Italy)


• Danaher Corporation (U.S.)


• Bio-Rad Laboratories (U.S.)


• Abbott (U.S.)


• Becton Dickinson and Company (U.S.)


• Quidel Corporation (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• February 2023: bioMérieux SA announced that it received the USFDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) certification for its BIOFIRE SPOTFIRE System and BIOFIRE SPOTFIRE Respiratory (R) Panel. The CLIA certification allowed the company to make these products available to non-lab professionals at the point of care.


• October 2022: QIAGEN N.V. received the CE mark for its ipsogen JAK2 RGQ PCR kit and NeuMoDx Systems and reagents under the new European IVDR framework. The kit was certified under class C, and NeuMoDx Systems and reagents were certified under Class A.


• January 2022: Vitro S.A., based in Spain, announced the divestment of Cytognos, S.L., to Becton Dickinson and Company (BD).

REPORT COVERAGE

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The market research report provides qualitative and quantitative insights on the market and a detailed analysis of the market’s size & growth rate for all possible segments in the market. Along with the market’s forecast, the research report provides an elaborative analysis of the market’s competitive landscape and dynamics. Various key insights presented in the report are an overview of the number of tests, price analysis of types of products, regulatory scenario in key countries, pipeline analysis, new product launches, key industry developments – mergers, acquisitions & partnerships, and the impact of COVID-19 on the market.

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