세계의 바이오 분석 시험 서비스 시장 보고서 - 규모, 점유율, 동향, 예측 : 분자 유형, 시험 유형, 워크플로우, 지역별(2025-2033년)

The global bioanalytical testing services market size was valued at USD 3,406.88 Million in 2024. The market is expected to reach USD 7,394.44 Million by 2033, exhibiting a CAGR of 8.54% during 2025-2033. North America currently dominates the market, holding a significant market share in 2024. The market is fueled by increasing needs for pharmaceutical and biotechnology research, which requires precise testing to prove product safety and efficacy. Moreover, continual technological improvements, such as automation and high-throughput screening, also drive the market expansion by increasing testing ability and decreasing turnaround time. Apart from this, emerging drug development and safety testing regulations are also augmenting the bioanalytical testing services market share.

The market is fueled by the rising need for biologics and biosimilars, requiring precise analytical testing for regulatory approval. Moreover, increased investment in personalized medicine and targeted therapy is fueling the demand for targeted bioanalytical assays for the monitoring of pharmacokinetics and pharmacodynamics. Furthermore, stringent regulatory standards across the world oblige pharmaceutical and biotechnology firms to implement strong bioanalytical test services. As per an industry report published in March 2024, approximately 300 Million people globally are estimated to be suffering from rare diseases. Growing incidences of rare diseases also boost research activity, increasing demand for quality and thorough bioanalytical support. Furthermore, advancements in high-throughput screening, mass spectrometry, and automated sample analysis are improving test efficiency and accuracy, thereby enhancing the bioanalytical testing services market outlook.

In the United States, the market is primarily driven by the country's well-established pharmaceutical and biotechnology sectors, which demand extensive testing to ensure drug safety and efficacy. A surge in clinical trials, particularly for complex biologics and gene therapies, is intensifying the need for advanced bioanalytical evaluations. In line with this, the increased funding and investment aimed at accelerating drug development and precision medicine further stimulate market growth. Notably, in July 2025, AstraZeneca announced plans to invest USD 50 Billion in the United States by 2030, focusing on expanding its manufacturing and research capabilities. The cornerstone of this investment is a new multi-billion-dollar drug substance manufacturing facility in Virginia, aimed at producing treatments for chronic diseases. This expansion includes enhancements to existing R&D centers in Maryland and Massachusetts, as well as the development of new manufacturing sites in California, Indiana, and Texas. Additionally, increasing collaborations between contract research organizations and pharmaceutical companies bolsters the availability and sophistication of bioanalytical services, positioning the U.S. as a key market hub.

Bioanalytical Testing Services Market Trends:

Growing Prevalence of Chronic Illnesses

The increasing incidence of chronic diseases such as cardiovascular disease, diabetes, cancer, and autoimmune diseases is one of the key drivers for the market. Industry reports estimate that by 2025, almost three-quarters of the world's population will be living with one or more chronic diseases, highlighting the need for effective diagnostic and monitoring tools. Since these conditions are long-term and require exact therapeutic monitoring, the pharmaceutical and biotechnology industries increasingly use bioanalytical testing to assess drug safety, efficacy, and optimal dosage. Bioanalytical assays assist in tracking biomarkers, drug levels, and patient response, and allow for personalized treatment programs and better therapeutic outcomes. In addition, the rise in chronic disease prevalence has fueled increased investment in clinical trials, specifically for new biologics and targeted therapies, which involve significant pharmacokinetic and pharmacodynamic scrutiny. This has made it necessary for high-throughput, precise, and reproducible bioanalytical services with a large patient cohort capability.

Expansion of Point-of-Care (POC) Diagnostics

Point-of-care (POC) diagnostic technologies growth is revolutionizing the industry by facilitating quick, decentralized, and patient-oriented testing. According to industry reports, the global POC diagnostics market was worth USD 53.11 Billion in 2024 and is expected to be USD 102.4 Billion by 2033, with a CAGR of 7.6% between 2025 and 2033. POC diagnostics enable drugs to be quickly evaluated for drug levels, biomarkers, and therapeutic response, lowering the dependency on central laboratories and speeding up clinical decision-making. Such bioanalytical testing services trends are most applicable for personalized medicine, in which prompt information on pharmacokinetics and pharmacodynamics is necessary for the optimal adaptation of treatment protocols. Merging POC diagnostics with sophisticated bioanalytical platforms, including miniaturized immunoassays and mass spectrometry instruments with onboard mobility, increases the precision and validity of testing outside the conventional laboratory environment. Moreover, the implementation of POC solutions in hospitals, outpatient clinics, and home care settings is accelerating demand for bioanalytical support services that verify, calibrate, and standardize these technologies.

Technological Advancements in Bioanalytical Platforms

Technological advancements in bioanalytical platforms are significantly influencing bioanalytical testing services market growth by improving accuracy, sensitivity, and throughput. Moreover, innovations in mass spectrometry, liquid chromatography, high-resolution imaging, and multiplexed immunoassays enable more precise detection of drugs, metabolites, and biomarkers, including in low-concentration samples. These advancements allow for more complex pharmacokinetic and pharmacodynamic analyses, which are critical for biologics, biosimilars, and targeted therapies. Additionally, automation and high-throughput screening capabilities reduce turnaround times, minimize human error, and support large-scale clinical trials. Apart from this, integration of artificial intelligence and data analytics further enhances the interpretation of complex datasets, enabling predictive modeling and more informed decision-making in drug development.

Bioanalytical Testing Services Industry Segmentation:

Analysis by Molecule Type:

• Small Molecule
• Large Molecule
  • LC-MS Studies
  • Immunoassays
  • Others

Small Molecule leads the market in 2024 due to their long-established role in pharmaceutical research and therapeutic development. These compounds form the foundation of many traditional drugs, making their analysis essential for ensuring safety, efficacy, and compliance with global regulatory standards. Bioanalytical testing for small molecules primarily focuses on pharmacokinetics, bioequivalence, and drug-drug interaction studies, which are crucial for supporting clinical trials and securing market approvals. Advanced techniques such as chromatography, mass spectrometry, and ligand-binding assays are extensively employed to provide accurate and sensitive results. The importance of small molecules is further underscored by the continuous demand for generics, which drives the need for robust bioequivalence testing. Moreover, the relatively simpler structure of small molecules compared to biologics allows for standardized testing protocols, enabling faster turnaround times and cost efficiency.

Analysis by Test Type:

• ADME
  • In-Vivo
  • In-Vitro
• PK
• PD
• Bioavailability
• Bioequivalence
• Others

Bioavailability leads the market in 2024. The segment directly measures the rate and extent to which an active pharmaceutical ingredient becomes available in systemic circulation. This evaluation is fundamental for determining the efficacy, dosage accuracy, and therapeutic equivalence of both new drug entities and generic formulations. Regulatory agencies mandate bioavailability studies to ensure that approved drugs achieve the intended therapeutic effect without compromising patient safety. The importance of this test type has grown with the increasing demand for generics, where proving equivalence to branded counterparts is essential. Techniques such as liquid chromatography and mass spectrometry are widely used to provide precise measurements of drug concentration in biological samples. Moreover, bioavailability studies are vital during clinical trials to optimize formulations, assess drug absorption, and guide dosage regimens.

Analysis by Workflow:

• Sample Preparation
  • Protein Precipitation
  • Liquid-Liquid Extraction
  • Solid Phase Extraction
• Sample Analysis
  • Hyphenated Technique
  • Chromatographic Technique
  • Electrophoresis
  • Ligand Binding Assay
  • Mass Spectrometry
  • Nuclear Magnetic Resonance
• Others

Sample analysis leads the market in 2024. This workflow involves the systematic examination of biological samples, such as blood, plasma, or tissue, to quantify the presence and concentration of drugs, metabolites, or biomarkers. Accurate sample analysis is essential for generating reliable pharmacokinetic, pharmacodynamic, and toxicological data, which underpin regulatory submissions and clinical decision-making. The importance of this workflow has grown with the rising complexity of modern therapeutics, including biologics and biosimilars, necessitating high-precision analytical techniques like chromatography, mass spectrometry, and immunoassays. Moreover, efficient sample analysis workflows enhance turnaround times, reduce errors, and support large-scale studies, making them critical for both contract research organizations and pharmaceutical companies. By ensuring data integrity and reproducibility, sample analysis workflows reinforce the overall reliability and credibility of bioanalytical testing services globally.

Regional Analysis:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

In 2024, North America accounted for the largest market share. The presence of a large number of contract research organizations and specialized laboratories has enabled efficient outsourcing of bioanalytical testing, supporting both small molecules and biologics development. Stringent guidelines from regulatory bodies, such as the FDA, have increased the demand for high-quality, compliant testing services, making the region a benchmark for global standards. Additionally, North America's focus on innovation, adoption of cutting-edge analytical technologies, and investment in research and development has accelerated the growth of complex bioanalytical workflows, including pharmacokinetic, pharmacodynamic, and biomarker analysis. The region also benefits from a strong pipeline of novel drugs and biosimilars, further driving demand. Consequently, North America continues to represent a critical and influential segment in shaping trends and standards in the global market.

Key Regional Takeaways:

United States Bioanalytical Testing Services Market Analysis

The market in the United States is experiencing robust growth, driven by the rising demand for precision medicine and the expanding pipeline of biologics and biosimilars. According to the industry reports, as of December 2024, there were 64 approved biosimilars in the U.S., reinforcing the country's leadership in biologics innovation and the resulting demand for bioanalytical validation. The increasing emphasis on pharmacokinetic and pharmacodynamic studies in drug development has further fueled the need for specialized analytical methods. Additionally, a surge in funding for life sciences research and a strong focus on regulatory compliance have encouraged the outsourcing of bioanalytical testing to ensure standardized data quality. The integration of cutting-edge technologies such as high-throughput screening and LC-MS/MS in analytical workflows is enhancing result accuracy and turnaround time. The market is also benefiting from growing clinical trial activity across a range of therapeutic areas, including oncology, neurology, and metabolic disorders. With pharmaceutical and biopharmaceutical companies increasingly outsourcing analytical operations to reduce internal burdens, contract research organizations (CROs) are expanding their service capabilities to meet evolving client demands. Moreover, digital transformation across laboratories, including automation and data management systems, is streamlining the testing process.

Europe Bioanalytical Testing Services Market Analysis

In Europe, the market is witnessing steady expansion, supported by a mature regulatory landscape and increasing investment in advanced clinical trials. A growing emphasis on early-stage drug development and translational medicine has elevated the demand for comprehensive analytical support services. As per an industry report, up to USD 520 Million of investment is set to support faster patient access to advanced treatments, enhance clinical trials, and strengthen medicine manufacturing in the UK, with 18 new clinical trial hubs being established to accelerate research. The region is also seeing heightened interest in cell and gene therapies, which require sophisticated testing methodologies to assess safety and efficacy profiles. Cross-border research collaborations and pan-European biomedical initiatives are fostering innovation in assay development and validation. Green chemistry principles, sustainability, and artificial intelligence are transforming laboratory operations. The focus on rare diseases and drug development necessitates sensitive analytical procedures. Research institutions are partnering with CROs to optimize resources and improve testing outcomes.

Asia Pacific Bioanalytical Testing Services Market Analysis

The market in the Asia Pacific is expanding rapidly due to increasing clinical research activities and the emergence of local biopharma innovators. The region's growing patient population and genetic diversity make it a prime location for conducting large-scale clinical trials, driving demand for complex analytical testing. According to an industry report, India's pharmaceutical market is projected to reach USD 130 Billion by 2030, supported by over 80 pharma clusters and 10,500 manufacturing units, creating a thriving ecosystem for innovation and advanced testing services. There is a notable shift toward the development of biosimilars and therapeutic monoclonal antibodies, which necessitates specialized analytical techniques. The market is becoming a strategic hub for bioanalytical testing services due to regulatory reforms, government support, cloud-based lab informatics, and advanced nanotechnology-based assays. The region is also attracting international clients for outsourcing and personalized treatment strategies.

Latin America Bioanalytical Testing Services Market Analysis

The Latin America market is gaining momentum, fueled by the region's increasing participation in global clinical trials and a shift toward biopharmaceutical research and rising burden of chronic diseases. Industry research reveals that 45% of Brazilians aged 18 and over suffer from chronic noncommunicable diseases, heightening the need for pharmacokinetic and biomarker-based studies to support therapeutic interventions. The growing prevalence of such conditions has driven demand for specialized analytical services. Academic institutions and regional CROs are playing an essential role in expanding access to bioanalytical services, particularly in early-phase trials. Investment in laboratory infrastructure and quality assurance practices is boosting testing standards in Latin America. Advancements in microfluidics and point-of-care technologies enable rapid sample analysis. Evidence-based healthcare and data-driven research drive collaborations, and Latin America presents growing opportunities in the bioanalytical landscape.

Middle East and Africa Bioanalytical Testing Services Market Analysis

The market in the Middle East and Africa is expanding, driven by the growing focus on healthcare innovation and biomedical research. Increased funding for clinical trial infrastructure and rising demand for quality analytical data in drug development are contributing to market growth. According to an industry report, Saudi Arabia's National Industrial Development and Logistics Program projects that the biotechnology sector, covering personalized medicine, will contribute around USD 5.33 Billion to the country's GDP by 2030, signaling robust growth potential in bioanalytical testing. Efforts to diversify economies through biotechnology and life sciences initiatives are fostering a supportive environment for research collaborations. Digital laboratory systems and remote monitoring improve testing efficiency, while rising infectious diseases demand therapeutic monitoring, and bioequivalence studies are accelerated by strengthening research ecosystems and international partnerships.

Competitive Landscape:

The market is characterized by the presence of numerous contract research organizations, specialized laboratories, and integrated service providers offering comprehensive solutions across drug development stages. Furthermore, companies compete on the basis of technological expertise, regulatory compliance, turnaround times, and the ability to provide customized services for both small molecules and biologics. Apart from this, strategic collaborations, acquisitions, and investments in advanced bioanalytical platforms such as mass spectrometry, immunoassays, and cell-based assays are strengthening market positions. Moreover, the increasing complexity of biologics and biosimilars has intensified the demand for providers with niche expertise in pharmacokinetics, pharmacodynamics, and biomarker analysis. According to the bioanalytical testing services market forecast, the growing outsourcing trend in the pharmaceutical and biotechnology industries is expected to expand competition, as more players invest in capacity expansion and geographical diversification. The market is also witnessing rising emphasis on quality assurance, global regulatory adherence, and cost-efficient service delivery, shaping a dynamic and evolving competitive environment.

The report provides a comprehensive analysis of the competitive landscape in the bioanalytical testing services market with detailed profiles of all major companies, including:

• Almac Group
• Charles River Laboratories International Inc.
• Frontage Laboratories Inc.
• ICON plc
• Intertek Group plc
• Laboratory Corporation of America Holdings
• Pace Analytical Services LLC, PPD Inc.
• PRA Health Sciences
• SGS SA
• Syneos Health
• Toxikon Corporation

Key Questions Answered in This Report

• 1.How big is the bioanalytical testing services market?
• 2.What is the future outlook of the bioanalytical testing services market?
• 3.What are the key factors driving the bioanalytical testing services market?
• 4.Which region accounts for the largest bioanalytical testing services market?
• 5.Which are the leading companies in the global bioanalytical testing services market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Bioanalytical Testing Services Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Molecule Type

• 6.1 Small Molecule
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Large Molecule
  • 6.2.1 Market Trends
  • 6.2.2 Key Segments
    • 6.2.2.1 LC-MS Studies
    • 6.2.2.2 Immunoassays
    • 6.2.2.3 Others
  • 6.2.3 Market Forecast

7 Market Breakup by Test Type

• 7.1 ADME
  • 7.1.1 Market Trends
  • 7.1.2 Key Segments
    • 7.1.2.1 In-Vivo
    • 7.1.2.2 In-Vitro
  • 7.1.3 Market Forecast
• 7.2 PK
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 PD
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 Bioavailability
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast
• 7.5 Bioequivalence
  • 7.5.1 Market Trends
  • 7.5.2 Market Forecast
• 7.6 Others
  • 7.6.1 Market Trends
  • 7.6.2 Market Forecast

8 Market Breakup by Workflow

• 8.1 Sample Preparation
  • 8.1.1 Market Trends
  • 8.1.2 Key Segments
    • 8.1.2.1 Protein Precipitation
    • 8.1.2.2 Liquid-Liquid Extraction
    • 8.1.2.3 Solid Phase Extraction
  • 8.1.3 Market Forecast
• 8.2 Sample Analysis
  • 8.2.1 Market Trends
  • 8.2.2 Key Segments
    • 8.2.2.1 Hyphenated Technique
    • 8.2.2.2 Chromatographic Technique
    • 8.2.2.3 Electrophoresis
    • 8.2.2.4 Ligand Binding Assay
    • 8.2.2.5 Mass Spectrometry
    • 8.2.2.6 Nuclear Magnetic Resonance
  • 8.2.3 Market Forecast
• 8.3 Others
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast

9 Market Breakup by Region

• 9.1 North America
  • 9.1.1 United States
    • 9.1.1.1 Market Trends
    • 9.1.1.2 Market Forecast
  • 9.1.2 Canada
    • 9.1.2.1 Market Trends
    • 9.1.2.2 Market Forecast
• 9.2 Asia-Pacific
  • 9.2.1 China
    • 9.2.1.1 Market Trends
    • 9.2.1.2 Market Forecast
  • 9.2.2 Japan
    • 9.2.2.1 Market Trends
    • 9.2.2.2 Market Forecast
  • 9.2.3 India
    • 9.2.3.1 Market Trends
    • 9.2.3.2 Market Forecast
  • 9.2.4 South Korea
    • 9.2.4.1 Market Trends
    • 9.2.4.2 Market Forecast
  • 9.2.5 Australia
    • 9.2.5.1 Market Trends
    • 9.2.5.2 Market Forecast
  • 9.2.6 Indonesia
    • 9.2.6.1 Market Trends
    • 9.2.6.2 Market Forecast
  • 9.2.7 Others
    • 9.2.7.1 Market Trends
    • 9.2.7.2 Market Forecast
• 9.3 Europe
  • 9.3.1 Germany
    • 9.3.1.1 Market Trends
    • 9.3.1.2 Market Forecast
  • 9.3.2 France
    • 9.3.2.1 Market Trends
    • 9.3.2.2 Market Forecast
  • 9.3.3 United Kingdom
    • 9.3.3.1 Market Trends
    • 9.3.3.2 Market Forecast
  • 9.3.4 Italy
    • 9.3.4.1 Market Trends
    • 9.3.4.2 Market Forecast
  • 9.3.5 Spain
    • 9.3.5.1 Market Trends
    • 9.3.5.2 Market Forecast
  • 9.3.6 Russia
    • 9.3.6.1 Market Trends
    • 9.3.6.2 Market Forecast
  • 9.3.7 Others
    • 9.3.7.1 Market Trends
    • 9.3.7.2 Market Forecast
• 9.4 Latin America
  • 9.4.1 Brazil
    • 9.4.1.1 Market Trends
    • 9.4.1.2 Market Forecast
  • 9.4.2 Mexico
    • 9.4.2.1 Market Trends
    • 9.4.2.2 Market Forecast
  • 9.4.3 Others
    • 9.4.3.1 Market Trends
    • 9.4.3.2 Market Forecast
• 9.5 Middle East and Africa
  • 9.5.1 Market Trends
  • 9.5.2 Market Breakup by Country
  • 9.5.3 Market Forecast

10 SWOT Analysis

• 10.1 Overview
• 10.2 Strengths
• 10.3 Weaknesses
• 10.4 Opportunities
• 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

• 12.1 Overview
• 12.2 Bargaining Power of Buyers
• 12.3 Bargaining Power of Suppliers
• 12.4 Degree of Competition
• 12.5 Threat of New Entrants
• 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

• 14.1 Market Structure
• 14.2 Key Players
• 14.3 Profiles of Key Players
  • 14.3.1 Almac Group
    • 14.3.1.1 Company Overview
    • 14.3.1.2 Product Portfolio
    • 14.3.1.3 SWOT Analysis
  • 14.3.2 Charles River Laboratories International Inc.
    • 14.3.2.1 Company Overview
    • 14.3.2.2 Product Portfolio
    • 14.3.2.3 Financials
    • 14.3.2.4 SWOT Analysis
  • 14.3.3 Frontage Laboratories Inc.
    • 14.3.3.1 Company Overview
    • 14.3.3.2 Product Portfolio
  • 14.3.4 ICON plc
    • 14.3.4.1 Company Overview
    • 14.3.4.2 Product Portfolio
    • 14.3.4.3 Financials
    • 14.3.4.4 SWOT Analysis
  • 14.3.5 Intertek Group plc
    • 14.3.5.1 Company Overview
    • 14.3.5.2 Product Portfolio
    • 14.3.5.3 Financials
    • 14.3.5.4 SWOT Analysis
  • 14.3.6 Laboratory Corporation of America Holdings
    • 14.3.6.1 Company Overview
    • 14.3.6.2 Product Portfolio
    • 14.3.6.3 Financials
    • 14.3.6.4 SWOT Analysis
  • 14.3.7 Pace Analytical Services LLC
    • 14.3.7.1 Company Overview
    • 14.3.7.2 Product Portfolio
  • 14.3.8 PPD Inc.
    • 14.3.8.1 Company Overview
    • 14.3.8.2 Product Portfolio
  • 14.3.9 PRA Health Sciences
    • 14.3.9.1 Company Overview
    • 14.3.9.2 Product Portfolio
    • 14.3.9.3 SWOT Analysis
  • 14.3.10 SGS SA
    • 14.3.10.1 Company Overview
    • 14.3.10.2 Product Portfolio
    • 14.3.10.3 Financials
  • 14.3.11 Syneos Health
    • 14.3.11.1 Company Overview
    • 14.3.11.2 Product Portfolio
    • 14.3.11.3 Financials
    • 14.3.11.4 SWOT Analysis
  • 14.3.12 Toxikon Corporation
    • 14.3.12.1 Company Overview
    • 14.3.12.2 Product Portfolio