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市场调查报告书
商品编码
1820276
生物分析测试服务市场报告:规模、份额、趋势及预测(按分子类型、测试类型、工作流程和地区),2025 年至 2033 年Bioanalytical Testing Services Market Report Size, Share, Trends and Forecast by Molecule Type, Test Type, Workflow, and Region, 2025-2033 |
2024年,全球生物分析测试服务市场规模达34.0688亿美元。预计到2033年,该市场规模将达到73.9444亿美元,2025-2033年期间的复合年增长率为8.54%。目前,北美占据市场主导地位,2024年将占据相当大的市场份额。製药和生物技术研究需求的不断增长推动了生物分析测试服务市场的发展,这些研究需要精确的测试来证明产品的安全性和有效性。此外,自动化和高通量筛选等持续的技术改进也透过提高测试能力和缩短週转时间推动了市场扩张。此外,新兴的药物开发和安全测试法规也在扩大生物分析测试服务的市场份额。
市场对生物製剂和生物相似药的需求不断增长,这需要精确的分析测试才能获得监管部门的批准,从而推动了这个市场的发展。此外,对个人化医疗和标靶治疗的投资增加,也刺激了对用于监测药物动力学和药效学的标靶生物分析检测的需求。此外,世界各地严格的监管标准迫使製药和生物技术公司实施强大的生物分析测试服务。根据 2024 年 3 月发布的行业报告,全球约有 3 亿人患有罕见疾病。罕见疾病发病率的上升也促进了研究活动,增加了对高品质和全面生物分析支持的需求。此外,高通量筛选、质谱和自动化样品分析的进步正在提高测试效率和准确性,从而增强了生物分析测试服务市场前景。
在美国,市场主要由该国成熟的製药和生物技术产业推动,这些产业需要进行广泛的测试以确保药物的安全性和有效性。临床试验的激增,尤其是针对复杂生物製剂和基因疗法的临床试验,加剧了先进生物分析评估的需求。同时,旨在加速药物开发和精准医疗的资金和投资增加,进一步刺激了市场成长。值得注意的是,阿斯特捷利康于2025年7月宣布,计画在2030年在美国投资500亿美元,重点是扩大其生产和研发能力。这项投资的基石是在维吉尼亚州新建一个价值数十亿美元的药物生产工厂,旨在生产治疗慢性疾病的药物。此次扩建包括马里兰州和麻萨诸塞州现有研发中心的升级改造,以及在加州、印第安纳州和德州开发新的生产基地。此外,合约研究组织 (CRO) 与製药公司之间日益增多的合作,增强了生物分析服务的可用性和完善性,使美国成为重要的市场中心。
慢性病盛行率不断上升
心血管疾病、糖尿病、癌症和自体免疫疾病等慢性疾病的发生率不断上升是市场的主要驱动力之一。产业报告估计,到2025年,全球近四分之三的人口将患有一种或多种慢性疾病,凸显了对有效诊断和监测工具的需求。由于这些疾病具有长期性,需要精确的治疗监测,製药和生物技术产业越来越多地使用生物分析测试来评估药物的安全性、有效性和最佳剂量。生物分析检测有助于追踪生物标记、药物浓度和患者反应,并有助于制定个人化治疗方案,以获得更佳的治疗效果。此外,慢性病盛行率的上升也推动了临床试验的投资增加,特别是针对新型生物製剂和标靶疗法的临床试验,这些试验需要大量的药物动力学和药效学审查。这使得高通量、精确、可重复且能够进行大规模患者队列分析的生物分析服务成为必要。
扩展即时诊断 (POC)
即时诊断 (POC) 技术的发展正在透过促进快速、分散和以患者为中心的检测来彻底改变产业。根据产业报告,全球 POC 诊断市场在 2024 年的价值为 531.1 亿美元,预计到 2033 年将达到 1024 亿美元,2025 年至 2033 年期间的复合年增长率为 7.6%。 POC 诊断能够快速评估药物的药物水平、生物标记和治疗反应,降低对中央实验室的依赖并加快临床决策。此类生物分析测试服务趋势最适用于个人化医疗,在个人化医疗中,及时获取药物动力学和药效动力学资讯对于最佳调整治疗方案至关重要。将 POC 诊断与先进的生物分析平台(包括具有车载移动性的微型免疫测定和质谱仪器)相结合,可以提高传统实验室环境之外的测试的精度和有效性。此外,在医院、门诊和家庭护理环境中实施 POC 解决方案正在加速对验证、校准和标准化这些技术的生物分析支援服务的需求。
生物分析平台的技术进步
生物分析平台的技术进步透过提高准确性、灵敏度和通量,显着影响着生物分析测试服务市场的成长。此外,质谱、液相层析、高解析度成像和多重免疫分析的创新使得药物、代谢物和生物标记的检测更加精确,即使在低浓度样本中也是如此。这些进步使得更复杂的药物动力学和药效动力学分析成为可能,这对于生物製剂、生物相似药和标靶治疗至关重要。此外,自动化和高通量筛选能力可以缩短週转时间,最大限度地减少人为错误,并支援大规模临床试验。此外,人工智慧和资料分析的整合进一步增强了对复杂数据集的解读,从而能够在药物开发过程中建立预测模型并做出更明智的决策。
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.
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.
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.
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.
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.
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.
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.
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.