Bioanalytical Testing Market - Strategic Insights and Forecasts (2026-2031)

Bioanalytical Testing Market Size:

Bioanalytical Testing Market is forecasted to rise at a 15.7% CAGR, reaching USD 9.631 billion in 2031 from USD 4.014 billion in 2025.

Bioanalytical Testing Market Trends:

The bioanalytical testing market is anticipated to grow at a steady pace throughout the forecast period. Bioanalytical testing involves the quantitative measurement of drugs, metabolites, biomarkers, and other substances in biological samples such as blood, plasma, serum, urine, and tissues. The growing demand for personalized medicine, along with the technological advancements in analytics, is a major growth driver of the bioanalytical testing market. Moreover, the growing prevalence of chronic diseases necessitating the need for more clinical trials and drug development is further expected to boost the bioanalytical testing market in the coming years.

Bioanalytical Testing Market Segment Analysis:

• Growing demand for personalized medicine

Personalized medicine, which tailors medical treatments to individual patients based on their genetic makeup and other factors, has been gaining traction. Bioanalytical testing enables the identification of biomarkers and genetic variations that help in customizing treatments for patients, driving the bioanalytical testing market. Various research is ongoing to develop personalized medicine. For instance, in September 2022, the University of California proposed a novel technique for the management of inherited renal diseases by using precision genome editing that is very specific to an individual’s requirements. Moreover, Genomic Medicine Sweden and the Centers for Personalized Medicine of Germany collaborated on strategic and structural efforts to implement precision medicine in February 2022.

• Advancements in analytical technologies

Continuous advancements in analytical instrumentation and techniques have improved the sensitivity, accuracy, and efficiency of bioanalytical testing. This has led to faster and more reliable results, encouraging bioanalytical testing market growth. For example, high-throughput screening (HTS) enables the rapid testing of large libraries of compounds against biological targets. It has expedited drug discovery by allowing researchers to screen thousands of compounds simultaneously, identifying potential drug candidates more efficiently. Moreover, CRISPR-Cas9 has revolutionized gene editing, making it faster and more accessible. It has significantly contributed to understanding gene functions, disease modeling, and potential gene therapies.

• Rising prevalence of chronic diseases

Bioanalytical testing assists in assessing drug candidates and evaluating their impact on the human body. Therefore, the increasing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular disorders, and autoimmune conditions, creates a need for the development of new and effective treatments, thereby propelling the bioanalytical testing market. For instance, according to the WHO estimates, 17.9 million deaths worldwide in 2019 were attributable to cardiovascular diseases (CVDs), representing 32% of all fatalities. Moreover, roughly 10 million deaths, which equate to one in six deaths, were caused by cancer in 2020, making it the top cause of death globally according to the WHO.

• Increasing Drug Development and Clinical Trials

Bioanalytical testing plays a crucial role in evaluating the safety, efficacy, and pharmacokinetics (PK) of the drug candidates during preclinical and clinical stages. Therefore, the increasing clinical trials is expected to boost the bioanalytical testing market. For instance, the number of registered clinical trials increased from 72,534 in 2020 to 78,285 in 2021 in the WHO regions, as per the WHO report. The number of newly recruited trials registered on ICTRP for the majority of WHO regions increased steadily in the past years. Moreover, a new resolution (WHA75.8) on strengthening clinical trials was accepted by the 75th World Health Assembly in September 2022. Its goals were to increase the quality and coordination of research while also supplying high-quality data on health treatments.

Bioanalytical Testing Market Restraints:

The bioanalytical testing market has experienced growth and development however, some restraints or challenges can impact its expansion. For example, bioanalytical testing requires sophisticated instrumentation, skilled personnel, and adherence to stringent regulatory standards, all of which contribute to higher costs. Some bioanalytical tests require specific biological samples, such as rare disease samples or samples from specific patient populations. Access to a sufficient quantity of appropriate samples can be challenging, especially for early-stage research and rare diseases. Additionally, some pharmaceutical companies and research institutions may have in-house bioanalytical testing facilities, which can limit the opportunities for external contract research organizations (CROs) offering such services.

Bioanalytical Testing Market Geographical Outlook:

• North America is Expected to Grow Significantly

North America is expected to hold a significant share of the bioanalytical testing market during the forecast period. The factors attributed to such a share are the rising demand for bioanalytical testing, coupled with ongoing research and clinical trials. For instance, the number of clinical trials increased from 12,656 in 2020 to 14,145 in 2021 in the Americas region, according to the WHO report. Moreover, the growing burden of chronic diseases in the region is further propelling the bioanalytical testing market. For instance, nearly 6 in 10 Americans have at least one chronic disease, according to the recent CDC data.

List of Top Bioanalytical Testing Companies:

• ICON Plc is a global contract research organization (CRO) that provides a wide range of services to support the pharmaceutical, biotechnology, and medical device industries in their drug development and clinical research endeavors. ICON provides bioanalytical testing services to measure drug concentrations and biomarkers in biological samples collected during clinical trials.

• Charles River Laboratories International, Inc. (CRL) provides a comprehensive range of research and development (R&D) services, including preclinical drug development, discovery services, biologics Testing Solutions, endotoxin and microbial detection, and clinical laboratory services.

• IQVIA Holdings Inc. is a top-tier supplier of contract research services, technological solutions, and advanced analytics to the life sciences sector. To support contemporary data initiatives, IQVIA's Clinical Data Analytics Suite (CDAS) offers an intelligent, insight-driven, interoperable, and collaborative data platform.

Bioanalytical Testing Market Key Developments:

• Jun 2025: Bio-Rad Laboratories extended its recombinant anti-idiotypic antibody and SpyCatcher reagent portfolio, adding new tools for PK and ADA bioanalytical assays against complex biologic therapies.

• May 2025: Ardena launched a bioanalytical laboratory in Oss (Netherlands) with expanded LC-MS/MS, immunochemistry, and flow cytometry capacity, enhancing its precision-medicine testing capabilities.

• Feb 2025: Ardena completed the acquisition of Catalent’s Somerset (NJ) facility and announced a new 2,500+ sq ft bioanalytical lab there, to support both small- and large-molecule testing for global clinical trials.

Bioanalytical Testing Market Scope:

Bioanalytical Testing Market Segmentation

• By Molecule Type

  • Small Molecule

  • Large Molecule

• By Analysis Type

  • Discovery Bioanalysis

  • Pre-Clinical Bioanalysis

  • Clinical Bioanalysis

• By Sample Type

  • Blood

  • Urine

  • Saliva

  • Plasma

  • Others

• By Application

  • Oncology

  • Neurology

  • Immunology

  • Metabolic Disorder

  • Infectious Disease

  • Others

• By End-User

  • Pharmaceuticals & Biotech Company

  • Contract Research Organization

  • Others

• By Geography

  • North America

    • USA

    • Canada

    • Mexico

  • South America

    • Brazil

    • Argentina

    • Others

  • Europe

    • Germany

    • France

    • United Kingdom

    • Spain

    • Others

  • Middle East and Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Others

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

    • Indonesia

    • Thailand

    • Others

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