Europe Diagnostic Antibodies Market Size, Share & Industry Analysis, By Type (Monoclonal Antibodies, Polyclonal Antibodies, Recombinant Antibodies, Conjugated Antibodies, and Others), By Technology (Flow Cytometry, ELISA, Immunohistochemistry, Western Blot, and Others), By Source (Mouse, Rabbit, Goat, Human, and Others), By Application (Oncology, Immunology, Infectious Diseases, and Others), By End-user (Hospitals & Diagnostic Laboratories, Pharmaceutical and Diagnostic Companies {IVD Companies and Others}, and Academic & Research Institutions), and Regional Forecast, 2025-2032

The Europe diagnostic antibodies market size was valued at USD 3.01 billion in 2024. The market is projected to grow from USD 3.22 billion in 2025 to USD 5.18 billion by 2032, exhibiting a CAGR of 7.0% during the forecast period.

Diagnostic antibodies are antibodies used in medical and laboratory tests to detect, measure, or identify specific molecules, pathogens, or immune responses associated with diseases. They serve as highly specific affinity ligands that can bind to almost any target, including small drug molecules, proteins, pathogens, or biomarkers, making them essential tools in diagnostics. They are used in diagnostic procedures such as immunoprecipitation & immunohistochemistry (IHC), immunoblotting, enzyme-linked immunosorbent assay (ELISA), flow cytometry, and others.

Europe diagnostic antibodies market is experiencing rapid growth due to several factors, including rising chronic disease prevalence, increased funding for research & development (R&D), adoption of precision medicine, and the rise in infectious disease testing, including post-COVID-19 surveillance. Additionally, the growing demand for personalized medicine and advancements in antibody testing technologies are contributing to the market expansion. Moreover, initiatives by the key players in the market are expected to fuel the market growth. Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., and Agilent Technologies, Inc. are some of the key participants operating in the market.

MARKET DYNAMICS

MARKET DRIVERS

Increasing Incidence of Infectious and Chronic Diseases Alongside Growing Awareness to Drive Demand for Diagnostic Antibodies

The market is experiencing a significant boost due to the growing number of infectious and chronic diseases and heightened public awareness.

• According to a February 2025 European Centre for Disease Prevention and Control (ECDC) report, sexually transmitted infections such as gonorrhea and syphilis are on the rise, with gonorrhea cases increasing by 31.0% in 2023, as compared to 2022 and over 300% since 2014. Similarly, the World Health Organization (WHO) data from February 2025 indicates that chronic diseases cause 90% of deaths in the EU, with cardiovascular diseases and cancers accounting for nearly two-thirds. Multi-morbidity affects about 37% of Europeans aged 65 and over, exacerbated by high alcohol and tobacco use.

This rising disease burden drives demand for advanced diagnostics for early detection and management. The increasing geriatric population, more susceptible to these conditions, further fuels the demand. Heightened public and healthcare provider awareness promotes diagnostic testing, including immunodiagnostics and biomarker-based tests. The COVID-19 outbreak also exponentially increased the awareness and demand for new diagnostic tests.

MARKET RESTRAINTS

High Development Costs to Limit Market Growth

Developing monoclonal antibody-based diagnostic reagents requires significant research and development investment, covering antibody discovery, validation, and navigating complex regulatory approval processes. These activities are both costly and time-consuming, posing substantial barriers to market entry for many organizations. The manufacturing of monoclonal antibodies (mAbs) involves intricate processes such as cell culture and purification, which further drives up operational expenses.

• For example, the cost of producing purified antibodies often exceeds USD 50 per gram, with some estimates ranging from USD 4,650 to over USD 114 million per gram, depending on production scale and context. The need for specialized facilities and high-quality raw materials, such as cell culture media and bioreactor systems, adds to these costs.

These high upfront investments and ongoing operational expenses can limit the ability of smaller biotechnology firms to compete, potentially reducing innovation and diversity in the market. Additionally, the elevated costs can hinder the widespread adoption of antibody-based diagnostics, restricting their use in routine clinical settings and limiting their potential benefits for disease detection and monitoring. This dynamic may slow the growth and innovation in the European diagnostic antibodies market.

MARKET OPPORTUNITIES

Growing Strategic Initiatives Among Key Players to Fuel Product Launches

The market is witnessing strategic collaborations and partnerships among leading biotechnology firms, research institutions, and healthcare organizations. These alliances are fostering innovation and expediting the development of advanced diagnostic solutions by enabling companies to access and integrate cutting-edge technologies into their product portfolios.

• For instance, in July 2024, BioPorto A/S and Immundiagnostik, Inc. announced a collaboration to expand their renal research offerings across the globe.

Increased investment in research and development is also driving the introduction of novel antibody-based diagnostics, particularly in high-need areas such as oncology, infectious diseases, and autoimmune disorders. Regulatory support and more streamlined approval processes are further encouraging market entry and the launch of innovative diagnostic products, enhancing the Europe diagnostic antibodies market growth.

MARKET CHALLENGES

Regulatory Hurdles May Restrict Market Growth

The European Medicines Agency (EMA) and related national authorities enforce stringent regulatory procedures for diagnostics, including requirements for clinical validation, CE-IVD marking, and comprehensive post-market surveillance. These processes add significant complexity, cost, and time to the product development cycle. The companion diagnostics requires additional steps involving scientific consultation with the EMA or a designated national authority to assess the device’s compatibility with the associated medicinal product, which can extend review timelines by several months.

Ethical and Sourcing Concerns Can Lead to Hurdles in Market Growth

Ethical concerns over animal-based antibody production and the use of hybridoma technology have led to growing demand for recombinant antibodies, which are more expensive and require different infrastructure.

EUROPE DIAGNOSTIC ANTIBODIES MARKET TRENDS

Technological Advancements is a Key Market Trend

The integration of advanced technologies, such as multiplex immunoassays and recombinant antibody engineering, is transforming antibody development. The Fab fragments, scFv, diabodies, and nanobodies enable improved tissue penetration and assay flexibility, while recombinant antibodies offer superior specificity and reproducibility compared to traditional animal-derived antibodies. These innovations are making antibody-based diagnostics indispensable for both research and clinical applications, fueling market growth as demand rises for more accurate and reliable diagnostic tools.

Shift Toward Personalized Medicine to Determine Growth Trajectory

As the healthcare industry increasingly adopts personalized treatment protocols, these antibodies play a pivotal role in companion diagnostics, helping determine the suitability of specific therapies based on patient biomarkers.

• For instance, monoclonal antibodies are routinely used to identify HER2 status in breast cancer patients, guiding targeted therapy decisions. This trend is driving demand for highly specific antibody reagents that can support individualized care, positioning the antibody diagnostics market at the forefront of precision medicine initiatives and expanding its relevance across oncology and other therapeutic areas.

Rise in Point-of-Care Diagnostics is Emerging as a Key Market Trend

The surge in demand for rapid, decentralized diagnostic solutions has led to the widespread adoption of antibody-based point-of-care (POC) tests. These tests enable early detection of infectious and chronic diseases directly at the bedside or in remote settings, reducing reliance on centralized laboratories.

• For instance, in October 2022, F. Hoffmann-La Roche Ltd. launched the SARS-CoV-2 Rapid Antibody Test 2.0, which has received the CE mark indicating it meets the European Union (EU) safety, health, and environmental standards. This shift is expanding the market for antibody-based diagnostics, especially in resource-limited environments where rapid results are critical.

Expansion in Autoimmune and Cancer Diagnostics to Foster Market Growth

The application of monoclonal and polyclonal antibodies in the diagnosis of autoimmune diseases such as lupus and rheumatoid arthritis and various cancers is rapidly expanding. This growth is driven by both the increasing prevalence of these conditions and advances in biomarker discovery. As a result, the diagnostics antibodies market is experiencing significant expansion in these therapeutic areas, responding to unmet clinical needs and supporting improved patient outcomes.

Request a Free sample to learn more about this report.

IMPACT OF COVID-19

The COVID-19 pandemic had a profound effect on the diagnostics antibodies market in Europe, altering its growth trajectory. During the initial waves, widespread healthcare disruptions led to a notable decline in routine diagnostic testing. However, as the pandemic intensified, the demand for COVID-19 diagnostics, including molecular (RT-PCR), antigen, and serology (antibody) tests, surged dramatically. Additionally, product launches for rapid antigen-antibody diagnostics significantly impacted the market growth.

Furthermore, the governments and healthcare systems prioritized mass testing to monitor and control the spread of the virus, resulting in a rapid expansion of testing infrastructure and a spike in the use of antibody-based diagnostic kits, especially point-of-care solutions that provided faster results. As the pandemic subsided, the market began to normalize, but ongoing research and development efforts, coupled with the growing prevalence of chronic and infectious diseases, continue to drive market growth.

SEGMENTATION ANALYSIS

By Type

Monoclonal Antibodies Segment Dominated Market Due to High Efficiency

Based on type, the market is segmented into monoclonal antibodies, polyclonal antibodies, recombinant antibodies, conjugated antibodies, and others.

The monoclonal antibodies segment dominated the market share in 2024. The rising incidence of autoimmune, chronic, and allergic diseases is a key factor driving market growth in this segment. Monoclonal antibodies, favored for their precision and consistency, are increasingly vital in diagnostics. This demand, combined with new product launches, is expected to propel the segment's expansion further.

• In October 2022, F. Hoffmann-La Roche Ltd. launched Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to detect protein synthesis in tissue samples. This antibody is used for patients with suspected melanoma.

Recombinant antibodies constituted the second-largest segment of the market. This growth is driven by advances in biotechnology that allow for precise antibody engineering. Furthermore, the increasing need to minimize batch-to-batch variability is expected to further boost the growth of the recombinant segment during the forecast period.

The conjugated antibodies segment is expected to grow considerably over the projected period. The conjugated antibodies allow for high multiplex labeling, enabling the simultaneous detection of multiple targets in a single assay.

To know how our report can help streamline your business, Speak to Analyst

By Technology

ELISA Segment Dominates Market Due to Escalated Demand & Cost Effective Nature

Based on the technology, the market is segmented into flow cytometry, ELISA, immunohistochemistry, western blot, and others.

In terms of technology, the ELISA segment accounted for the largest Europe diagnostic antibodies market share in 2024, with the highest CAGR during the forecast period. The high specificity and cost-effectiveness associated with these diagnostics are the primary drivers of this segment’s growth.

The flow cytometry segment held the second-largest revenue share in 2024 and is expected to grow significantly over the projected period. The increasing prevalence of chronic diseases, such as cancer and autoimmune disorders, drives the demand for advanced diagnostic techniques that offer detailed cellular characterization and analysis.

The immunohistochemistry (IHC) segment holds a significant share of the market and is expected to witness robust growth over the forecast period. This growth is primarily attributed to the increasing adoption of IHC in clinical diagnostics and research, especially for cancer and infectious disease detection. Additionally, the new product launches are fueling the segment growth.

• For instance, in February 2025, Leica Biosystems launched two primary antibodies, PD-L1 and HER2 for delivery of immunohistochemistry assays for cancer research and diagnostics.

By Source

Rabbit Segment Dominated in 2024 Due to High Affinity

By source, the market is classified into mouse, rabbit, goat, human, and others.

The rabbit segment accounted for the largest market share in 2024, with the highest CAGR during the forecast period. This dominance is due to rabbit antibodies, especially rabbit monoclonal antibodies, having a high affinity for their target antigens. Additionally, technological developments and the rise in approvals and product launches with diagnostic antibodies are expected to boost the market growth.

The mouse segment held the second-largest revenue share in the European market. The mouse have a high reproduction rate and are smaller in size, making them cost-effective for antibody production.

The human segment is anticipated to grow considerably during the forecast period. This growth is anticipated due to the rise in the use of human antibodies in research activities and in the development of diagnostics. Additionally, the technological advancements in recombinant protein production are expected to boost the demand for human-engineered antibody production for their higher specificity, which is expected to fuel the segmental growth over the forecast period.

By Application

Infectious Diseases Segment Dominated Market in 2024 Owing to High Product Demand

By application, the market is segmented into oncology, immunology, infectious diseases, and others.

In 2024, the infectious diseases segment led the Europe market, primarily due to the rising incidence of infectious diseases across European countries. This surge has driven demand for more effective diagnostics and increased testing rates for infectious diseases, positioning the segment as a key driver for the adoption of these antibodies in the region.

The oncology segment is projected to experience moderate growth throughout the forecast period. This is attributed to the considerable prevalence of cancer in Europe, which, along with an increasing number of cancer cases and the introduction of new diagnostic products, is boosting the diagnosis rates. Consequently, there is a growing uptake of immunoassays and antibodies for cancer diagnostics and monitoring in the region.

• For instance, in December 2021, BioGenex launched three new cancer diagnostic antibodies. These antibodies are highly specific intense, and product clean stains. Such launches for cancer diagnostics are expected to fuel the segment's growth over projected years.

By End-user

Widespread Utilization by Pharmaceutical and Diagnostics Companies to Boost Segment’s Dominance in 2024

Based on end-user, the market is classified into hospitals & diagnostic laboratories, pharmaceutical and diagnostic companies, and academic & research institutions. Pharmaceutical and diagnostic companies segment is further classified into IVD companies and others.

The pharmaceutical and diagnostics companies accounted for the largest share of the market. The growth is attributed to the increasing utilization of these antibodies in research and development activities and the manufacturing of IVD kits. Additionally, the increasing strategic collaborations among the key players for the new antibody-based IVD kit development are expected to boost the segment growth.

The academic & research institutions are expected to grow significantly during the forecast period. The major players’ investment in the academic institutes and research institutes is also significantly boosting the segmental growth. Besides, the rising initiatives by the government bodies are also expected to drive the segment during the forecast period.

• For instance, European Rare Diseases Research Alliance (ERDERA) launched USD 9.0 billion for rare disease diagnostics between 2021–2027.

EUROPE DIAGNOSTIC ANTIBODIES MARKET COUNTRY OUTLOOK

Based on country, the market is divided into the U.K., Germany, France, Spain, Italy, Scandinavia, and Rest of Europe. 

Germany

The Germany market was valued at USD 0.78 billion in 2024 and is projected to expand at a higher CAGR during the forecast period. Government support is a significant driver for market growth in Germany, particularly through the establishment of robust regulatory frameworks for diagnostic tools and medical devices. This regulatory environment ensures the safety and efficacy of diagnostic antibodies, facilitating their adoption across healthcare systems. Additionally, the rising prevalence of chronic diseases, increasing diagnosis rates, and the rapid integration of advanced and novel diagnostic tests in healthcare settings are fueling the demand for antibodies in the country.

• For instance, Germany reported 605,805 new cancer diagnoses in 2022, underscoring the growing need for in-vitro diagnostic systems and contributing to the expansion of the in-vitro diagnostics market in Europe.

U.K.

The U.K. holds the position as the second-largest market, supported by a strong CAGR during the forecast period. This growth is attributed to intensified research and development activities, especially in biotechnology and genomics, as well as a well-established regulatory framework that supports innovation and market expansion.

France

France is also expected to experience moderate market growth, driven by its emphasis on cancer treatment and the increasing prevalence of chronic diseases. The country's advanced healthcare infrastructure further supports the adoption of diagnostic antibodies, contributing to overall market expansion in Europe.

COMPETITIVE LANDSCAPE

KEY INDUSTRY PLAYERS

Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., and Agilent Technologies, Inc. Hold Significant Shares Due to Strong Product Portfolio

The Europe market represents a semi-consolidated competitive structure with the presence of major players such as Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Danaher Corporation, and Merck KGaA. Thermo Fisher Scientific Inc. secured the leading share of the Europe market in 2024, a position supported by its strong regional presence and extensive product portfolio. The company's emphasis on high-specificity antibodies and continuous innovation is expected further to strengthen its market position during the forecast period.

Agilent Technologies, Inc. held the second-largest share in the 2024, driven by the introduction of advanced products and strategic initiatives such as acquisitions to broaden its regional offerings. Agilent’s ongoing focus on launching innovative products is anticipated to contribute to market growth. F. Hoffmann-La Roche Ltd. held a significant share of the market, with its growth driven by ongoing portfolio expansion and efforts to strengthen its geographical presence through collaborations. These strategies are supporting the company’s continued market advancement in the region. Other major players, such as Danaher Corporation and Merck KGaA, also held significant market shares in 2024. Both companies are actively pursuing geographical expansion within Europe, primarily through distribution partnerships and the establishment of subsidiaries.

LIST OF KEY MARKET PLAYERS PROFILED

• Thermo Fisher Scientific Inc. (U.S.)


• Bio-Rad Laboratories, Inc (U.S.)


• Agilent Technologies, Inc. (U.S.)


• Danaher Corporation (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Merck KgaA (Germany)


• BioGenex (U.S.)


• Biocult B.V. (Netherlands)


• EXBIO Praha, a.s. (Czech Republic)


• BioPorto A/S (Denmark)


• Creative Diagnostics (U.S.)

KEY INDUSTRY DEVELOPMENTS

• March 2025: EXBIO Praha, a.s. received IVDR compliant for DryFlowEx PNH High-Sensitivity Assay Kit as per ICCS/ESCCA consensus guidelines.


• December 2024: Agilent Technologies Inc. received an In Vitro Diagnostic Regulation (IVDR) certificate for PD-L1 IHC 28-8 pharmDx. It is certified according to the new EU for in vitro diagnostic medical devices (IVDR).


• November 2024: F. Hoffmann-La Roche Ltd. received a CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, which is the first immunohistochemistry test and is widely available in Europe to diagnose Epithelial Ovarian Cancer (EOC) patients.


• October 2020: Thermo Fisher Scientific Inc. introduced two new SARS-CoV-2 antibody tests, the OmniPATH COVID-19 Total Antibody ELISA test and the EliA SARS-CoV-2-Sp1 IgG test.


• September 2020: F. Hoffmann-La Roche Ltd. launched the COVID-19 rapid antigen test in Europe, and they also intended to file an Emergency Use Authorization (EUA) to the FDA.

TRADE PROTECTIONISM AND REGULATORY LANDSCAPE

Europe’s internal market is generally liberalized, but national-level protectionist measures can influence cross-border diagnostics trade. Countries such as France and Germany prioritize local manufacturing and supply chain resilience, especially post-COVID-19. Furthermore, Brexit introduced trade complexities between the U.K. and EU in the diagnostics sector, including customs delays and new registration rules.

Strict regulations around REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) and CE-IVD certification make compliance challenging for non-EU manufacturers. Additionally, the lack of a uniform Europe regulatory framework for industrial enzymes can create challenges for companies navigating different regional requirements.

REPORT COVERAGE

The diagnostic antibodies market report provides an in-depth analysis of the industry. It focuses on market segments, such as type, technology, source, application, and region. Besides, it offers the market forecast in relation to the current market dynamics, the impact of COVID-19, and the latest market trends. Additionally, it consists of the Europe market share by various segments and the factors driving the market growth. It also provides the competitive landscape and company profiles of the market.

To gain extensive insights into the market, Request for Customization

REPORT SCOPE & SEGMENTATION