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市場調查報告書
商品編碼
1820276
生物分析測試服務市場報告:規模、佔有率、趨勢及預測(按分子類型、測試類型、工作流程和地區),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,全球生物分析測試服務市場規模達34.0688億美元。預計到2033年,該市場規模將達到73.9444億美元,2025-2033年期間的複合年成長率為8.54%。目前,北美佔據市場主導地位,2024年將佔據相當大的市場佔有率。製藥和生物技術研究需求的不斷成長推動了生物分析測試服務市場的發展,這些研究需要精確的測試來證明產品的安全性和有效性。此外,自動化和高通量篩選等持續的技術改進也透過提高測試能力和縮短週轉時間推動了市場擴張。此外,新興的藥物開發和安全測試法規也在擴大生物分析測試服務的市場佔有率。
市場對生物製劑和生物相似藥的需求不斷成長,這需要精確的分析測試才能獲得監管部門的批准,從而推動了這個市場的發展。此外,對個人化醫療和標靶治療的投資增加,也刺激了對用於監測藥物動力學和藥效學的標靶生物分析檢測的需求。此外,世界各地嚴格的監管標準迫使製藥和生物技術公司實施強大的生物分析測試服務。根據 2024 年 3 月發布的行業報告,全球約有 3 億人患有罕見疾病。罕見疾病發病率的上升也促進了研究活動,增加了對高品質和全面生物分析支持的需求。此外,高通量篩選、質譜和自動化樣品分析的進步正在提高測試效率和準確性,從而增強了生物分析測試服務市場前景。
在美國,市場主要由該國成熟的製藥和生物技術產業推動,這些產業需要進行廣泛的測試以確保藥物的安全性和有效性。臨床試驗的激增,尤其是針對複雜生物製劑和基因療法的臨床試驗,加劇了先進生物分析評估的需求。同時,旨在加速藥物開發和精準醫療的資金和投資增加,進一步刺激了市場成長。值得注意的是,阿斯特捷利康於2025年7月宣布,計畫在2030年在美國投資500億美元,重點是擴大其生產和研發能力。這項投資的基石是在維吉尼亞州新建一個價值數十億美元的藥物生產工廠,旨在生產治療慢性疾病的藥物。此次擴建包括馬裡蘭州和麻薩諸塞州現有研發中心的升級改造,以及在加州、印第安納州和德州開發新的生產基地。此外,合約研究組織 (CRO) 與製藥公司之間日益增多的合作,增強了生物分析服務的可用性和完善性,使美國成為重要的市場中心。
慢性病盛行率不斷上升
心血管疾病、糖尿病、癌症和自體免疫疾病等慢性疾病的發生率不斷上升是市場的主要驅動力之一。產業報告估計,到2025年,全球近四分之三的人口將患有一種或多種慢性疾病,凸顯了對有效診斷和監測工具的需求。由於這些疾病具有長期性,需要精確的治療監測,製藥和生物技術產業擴大使用生物分析測試來評估藥物的安全性、有效性和最佳劑量。生物分析檢測有助於追蹤生物標記、藥物濃度和患者反應,並有助於制定個人化治療方案,以獲得更佳的治療效果。此外,慢性病盛行率的上升也推動了臨床試驗的投資增加,特別是針對新型生物製劑和標靶療法的臨床試驗,這些試驗需要大量的藥物動力學和藥效學審查。這使得高通量、精確、可重複且能夠進行大規模患者隊列分析的生物分析服務成為必要。
擴展即時診斷 (POC)
即時診斷 (POC) 技術的發展正在透過促進快速、分散和以患者為中心的檢測來徹底改變產業。根據產業報告,全球 POC 診斷市場在 2024 年的價值為 531.1 億美元,預計到 2033 年將達到 1024 億美元,2025 年至 2033 年期間的複合年成長率為 7.6%。 POC 診斷能夠快速評估藥物的藥物水平、生物標記和治療反應,降低對中央實驗室的依賴並加快臨床決策。此類生物分析測試服務趨勢最適用於個人化醫療,在個人化醫療中,及時獲取藥物動力學和藥效動力學資訊對於最佳調整治療方案至關重要。將 POC 診斷與先進的生物分析平台(包括具有車載移動性的微型免疫測定和質譜儀器)相結合,可以提高傳統實驗室環境之外的測試的精度和有效性。此外,在醫院、門診和家庭護理環境中實施 POC 解決方案正在加速對驗證、校準和標準化這些技術的生物分析支援服務的需求。
生物分析平台的技術進步
生物分析平台的技術進步透過提高準確性、靈敏度和通量,顯著影響著生物分析測試服務市場的成長。此外,質譜、液相層析、高解析度成像和多重免疫分析的創新使得藥物、代謝物和生物標記的檢測更加精確,即使在低濃度樣本中也是如此。這些進步使得更複雜的藥物動力學和藥效動力學分析成為可能,這對於生物製劑、生物相似藥和標靶治療至關重要。此外,自動化和高通量篩選能力可以縮短週轉時間,最大限度地減少人為錯誤,並支援大規模臨床試驗。此外,人工智慧和資料分析的整合進一步增強了對複雜資料集的解讀,從而能夠在藥物開發過程中建立預測模型並做出更明智的決策。
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.