The Europe bioanalytical testing services market size was exhibited at USD 1.35 billion in 2023 and is projected to hit around USD 2.94 billion by 2033, growing at a CAGR of 8.11% during the forecast period 2024 to 2033.
Report Coverage | Details |
Market Size in 2024 | USD 1.46 Billion |
Market Size by 2033 | USD 2.94 Billion |
Growth Rate From 2024 to 2033 | CAGR of 8.11% |
Base Year | 2023 |
Forecast Period | 2024-2033 |
Segments Covered | Molecule, Test, Workflow, Country |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Regional Scope | U.K.; Germany; France; Italy; Spain; Netherlands; Switzerland; Sweden; Denmark; Norway |
Key Companies Profiled | Cerba HealthCare; Charles River Laboratories; Eurofins Scientific; ICON plc; Intertek Group plc; IQVIA Inc.; Labcorp Drug Development; SGS Société Générale de Surveillance SA; Syneos Health; Thermo Fisher Scientific Inc. (PPD, Inc.) |
The industry has been advancing at a fast pace on account of the increasing demand for the analytical testing of biologics and biosimilars. The growing incidence of chronic disorders such as cancer, inflammatory bowel diseases, and rheumatoid arthritis has highlighted the need for biologics. However, the expensive nature of biologics has led drug manufacturers and medical stakeholders to shift their focus toward biosimilars. As a result, advancements in the R&D of biosimilars in recent years is expected to heighten the demand for a range of bioanalytical testing services such as compatibility studies and protein analysis of biosimilars, product release testing, and stability testing.
The European market for bioanalytical testing services accounted for 28.9% of the global revenue share in 2023. The presence of advanced bioanalytical testing service facilities in the region has led to noticeable improvements in areas such as clinical research and drug development, driving market expansion. These services comprise a vital aspect of the analysis of pharmaceutical compounds such as biologics and small molecules, with leading providers offering methods such as immunoassays, chromatography, and biomarker analysis.
Europe is a leading region in terms of drug development, making it a significant opportunity for companies involved in offering bioanalytical testing services to establish their operational base. The increasing focus on understanding drug performance, as well as ensuring its approval and commercialization, is a major driver for this market. Additionally, the rising importance of personalized patient care and medicine has further highlighted the necessity for these solutions in European economies.
In these fields, precision dosing can be achieved by customizing drug dosage as per individual patient needs and depending upon their pharmacokinetic profiles. This helps in improving therapeutic outcomes while also ensuring minimal chances of adverse reactions. Additionally, the continued monitoring required to ensure the maintenance of the efficacy and safety of a drug even after its commercial release drives the demand for bioanalytical testing.
The small molecule segment accounted for the largest market share of 57.25% in 2023. The consistent advancements made in the space of small molecules in recent years, along with unmet medical requirements, are anticipated to boost the segment’s expansion in the coming years. The role of small molecules, for example, chemical probes, has been crucial in understanding disease biology in the biomedical research space. The majority of companies offering testing services in the region have developed their proprietary bioanalytical techniques that have been validated for analyzing small-molecule drugs in plasma/serum, blood, tissue, urine, and feces.
The large molecule segment is anticipated to advance at a comparatively faster CAGR of 9.5% during the forecast period. Large molecules, which are protein-based drugs, are as heavy as 150,000 g/mol, or 150 kDa, and bind to specific cell receptors associated with the disease process. Common bioanalytical studies for large molecules include Liquid Chromatography-Mass Spectrometry (LC-MS) and immunoassays, among others. Immunoassay studies include Pharmacokinetic (PK) studies and Antidrug Antibodies (ADA) studies.
The sample analysis workflow segment held the largest revenue share of 45.9% in 2023. The increasing importance of this workflow process to determine the concentration of chemical elements or compounds is a notable factor driving segment growth. For the purpose of sample analysis, various procedures are being utilized, ranging from simple weighing techniques to complex approaches that incorporate the use of specialized instruments. Sample analysis is a critical aspect in the stages of medication research and marketing, leading to its substantial share in the market.
The sample preparation segment is anticipated to advance at a CAGR of 9.3% from 2024 to 2033. This segment includes processes such as protein precipitation, liquid-liquid extraction, and solid phase extraction. Protein Precipitation (PPT) is an extensively used technique to prepare biological fluid samples for Liquid Chromatography (LC)/Mass Spectrometry (MS) research. Liquid-liquid Extraction (LLE) is generally used for regulated bioanalysis; this method can generate high analyte recoveries and can clean extract, while also being considered an economical option for end-users. Solid phase extraction is a notable sample preparation technology that uses chromatographic packing material, solid particles (usually in a cartridge device) to separate different components present in the sample. It is widely used for solid-based sample preparation in bioanalysis. Proper sample preparation helps minimize matrix risks, and assay variability, and thus provides cleaner samples, thus enhancing the bioanalysis process.
The Absorption, Distribution, Metabolism, and Excretion (ADME) segment accounted for a substantial revenue share in the market in 2023. These are pharmacokinetic (PK) processes that define how the body reacts to a drug. ADME studies are completed during drug discovery & preclinical phases for optimizing drug properties, supporting candidate selection, and designing the clinical phase.ADME data can be collected at different phases during the drug development process. Therapeutic developers may use chemical alterations to drug candidates to optimize ADME qualities during discovery and lead optimization. In vitro and in vivo studies give crucial information needed to meet regulatory expectations and allow drug developers to make informed decisions, as the medicine progresses through preclinical research & clinical phases.
The bioequivalence segment is anticipated to expand at the fastest CAGR from 2024 to 2033 due to the growing production and consumption rate of generics & biosimilars in the region. For instance, Eurofins Scientific, a French company, offers a comprehensive range of bioequivalence analysis to sponsors in biopharmaceutical and pharmaceutical companies across the globe. The company’s bioequivalence analyses supports study design, preclinical & clinical studies, GLP/GCLP compliance, in-house method development (LC/MS/MS) & validation, PK parameters calculation (WinNonlin), bioequivalence assessments, CDISC standards, and biosimilars.
Germany Bioanalytical Testing Services Market Trends
Germany emerged with the leading revenue share in the bioanalytical testing service industry of Europe in 2023. The country is anticipated to play a significant role due to the rising demand for outsourcing services from major companies such as Novartis, Sanofi, Roche, GlaxoSmithKline, and AstraZeneca. Germany’s growing requirement for improved product design, consulting, product maintenance, and related services is expected to be a crucial factor driving market expansion. Advancements in technology & quality clinical resources, along with positive government support and initiatives for clinical research activities, have accelerated the growth of the country’s bioanalytical testing service segment.
France Bioanalytical Testing Services Market Trends
France is expected to witness a substantial growth rate in the regional market during the projection period. The economy boasts an efficient healthcare & reimbursement system and a large patient pool, making it a preferred location for outsourcing clinical trials. In addition, the expansion of facilities by key players, such as SGS, in the bioanalytical testing services sector in France is likely to increase demand for bioanalytical testing services. This expansion positions companies to effectively address the increasing demand for bioanalytical testing services required to support the development of various drugs, including small molecules, peptides, biotherapeutics, and cell & gene therapies.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Europe bioanalytical testing services market
Molecule
Test
Workflow
Country