市场调查报告书
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1463674
到 2030 年北美生物分析测试服务市场预测 - 区域分析 - 按服务分类;疾病适应症;和最终用户North America Bioanalytical Testing Services Market Forecast to 2030 - Regional Analysis - by Services ; Disease Indication ; and End User |
2022年北美生物分析测试服务市值为17.9803亿美元,预计2030年将达到39.7142亿美元;预计2022年至2030年CAGR为10.4%。
製药公司不断增加的研发活动外包推动了北美生物分析测试服务市场
製药公司将非其内部结构核心的研发活动外包。外包杂项活动使他们能够有效地专注于其内部核心能力,从而使药物开发过程更好、更具成本效益。此外,外包製造活动以及研发可以缩短週转时间,增加他们的专业知识,并消除大量资本投资的需要,从而使他们受益。根据 BioPlan Associates 对生物製药产能和生产的调查,分析测试/生物测定是 2022 年外包最多的服务,其次是毒性测试、验证服务、产品表征等。虽然发展中国家是透过合约製造对生物分析测试服务需求的最大贡献者,但美国仍然是潜在的外包目的地。调查中 39.6% 的非美国受访者更愿意外包给美国设施。因此,外包的做法在全球范围内越来越流行,特别是在发展中国家,从而有利于生物分析测试服务市场的成长。製药公司正在广泛实施品质源自于设计(QbD)概念,这进一步推动製药公司采用外包服务,以提高其生产流程的稳健性,并确保最佳的产品品质和製造生产力。 QbD 得到美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构的支持。多年来,随着 ICH Q9(品质风险管理)、ICH Q8(R2,药品开发)和 ICH Q10(药品品质系统)的发布,这一概念在製药业获得了广泛关注。根据 ICH Q10 指南,分析方法对于药品品质系统至关重要。在製造中实施分析 QbD (AQbD) 可确保产品品质和效能。外包生物分析测试服务可以帮助製药公司避免对分析设备和熟练专业人员的大量投资,从而降低业务风险,特别是当产品处于开发的早期阶段时。由于专业的分析测试服务提供者俱有快速提供优异结果的关键能力,製药公司越来越多地考虑将生物分析测试服务外包给第三方服务供应商,这推动了市场的成长。
北美生物分析测试服务市场概况
北美占据生物分析测试服务市场的最大份额,其中美国、加拿大和墨西哥是该地区市场成长的主要贡献者。製药业的不间断增长、各种疾病发病率的上升对开发新药的需求不断增加、政府医疗保健支出的增加以及为保证药品质量而对外包活动的日益偏好是有利的因素北美生物分析测试服务市场的增长。
北美生物分析测试服务市场收入及 2030 年预测(百万美元)
北美生物分析测试服务市场细分
北美生物分析测试服务市场根据测试类型、疾病适应症、最终用户和国家进行细分。
根据测试类型,北美生物分析测试服务市场分为药物动力学、生物标记、免疫原性、病毒学测试、基于细胞的测定等。 2022 年,基于细胞的检测领域占据最大的市场份额。
根据疾病适应症,北美生物分析测试服务市场分为心血管、神经系统疾病、代谢失调、呼吸系统疾病、自体免疫疾病、肿瘤、性健康、骨骼疾病等。 2022 年,肿瘤学领域占据最大的市场。
根据最终用户,北美生物分析测试服务市场分为製药和生物製药公司、合约研究组织(CRO)、合约开发和製造组织(CDMO)等。 2022 年,製药和生物製药公司领域占据最大的市场份额。
按国家/地区划分,北美生物分析测试服务市场分为美国、加拿大和墨西哥。 2022年,美国在北美生物分析测试服务市场份额中占据主导地位。
SGS SA、康龙化成北京有限公司、Element Materials Technology Group Ltd、CD BioSciences Inc、Charles River Laboratories International Inc、Eurofins Scientific SE、Labcorp Drug Development Inc、Syneos Health Inc、KCAS Bioanalytical and Biomarker Services LLC、ICON Plc 和Intertek Group Plc 是北美生物分析测试服务市场上的一些领先公司。
表中的内容
The North America bioanalytical testing services market was valued at US$ 1,798.03 million in 2022 and is expected to reach US$ 3,971.42 million by 2030; it is estimated to grow at a CAGR of 10.4% from 2022 to 2030.
Increasing Outsourcing of R&D Activities by Pharmaceutical Companies fuel the North America Bioanalytical Testing Services Market
Pharmaceutical companies outsource research & development activities that are not core to their internal structure. Outsourcing miscellaneous activities allows them to efficiently focus on their internal core competencies for making the drug development process better and more cost effective. Moreover, outsourcing manufacturing activities, along with R&D, benefits them by lowering the turnaround period, adding to their expertise, and eliminating the need for large capital investments. According to the Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates, analytical testing/bioassay was the most outsourced service in 2022, followed by toxicity testing, validation services, product characterization, and others. While developing nations are the largest contributors to the demand for bioanalytical testing services through contract manufacturing, the US remains a potential outsourcing destination. 39.6% of non-US respondents in the survey preferred outsourcing to US-based facilities. Thus, the practice of outsourcing is gaining popularity worldwide, especially in developing countries, thereby favoring the growth of the bioanalytical testing services market. Pharmaceutical businesses are widely implementing the quality-by-design (QbD) concept, which is further propelling the adoption of outsourcing services by pharmaceutical companies to increase the robustness of their production processes and ensure optimal product quality and manufacturing productivity. QbD is supported by regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The concept has gained traction in the pharmaceutical industry over the years with the publication of ICH Q9 (Quality Risk Management), ICH Q8 (R2, Pharmaceutical Development), and ICH Q10 (Pharmaceutical Quality System). According to the ICH Q10 guidelines, analytical methods are essential to the pharmaceutical quality system. Analytical QbD (AQbD) implementation in manufacturing ensures product quality and performance. Outsourcing bioanalytical testing services helps pharmaceutical businesses reduce business risks by avoiding major investments in analytical equipment and skilled professionals, especially while the product is in the early phase of development. Due to the availability of specialized analytical testing service providers with crucial competencies to quickly provide excellent results, pharmaceutical companies are increasingly considering outsourcing bioanalytical testing services to third-party service providers, which fuels the market growth.
North America Bioanalytical Testing Services Market Overview
North America holds the largest share of the bioanalytical testing services market, with the US, Canada, and Mexico being the major contributors to the market growth in this region. The uninterrupted growth of the pharmaceuticals industry, the increasing need for developing novel drugs due to an upsurge in the incidences of various diseases, rising healthcare expenditure by governments, and a growing preference for outsourcing activities for the quality assurance of pharmaceutical products are the factors favoring the growth of the bioanalytical testing services market in North America.
North America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Million)
North America Bioanalytical Testing Services Market Segmentation
The North America bioanalytical testing services market is segmented based on test type, disease indication, end user, and country.
Based on test type, the North America bioanalytical testing services market is segmented into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment held the largest market share in 2022.
Based on disease indication, the North America bioanalytical testing services market is segmented into cardiovascular, neurological disorders, metabolic disorders, respiratory diseases, autoimmune disorder, oncology, sexual health, bone disease, and others. The oncology segment held the largest market share in 2022.
Based on end user, the North America bioanalytical testing services market is segmented into pharmaceutical and biopharmaceutical companies, contract research organization (CRO), contract development and manufacturing organization (CDMO), and others. The pharmaceutical and biopharmaceutical companies segment held the largest market share in 2022.
Based on country, the North America bioanalytical testing services market is segmented into the US, Canada, and Mexico. The US dominated the North America bioanalytical testing services market share in 2022.
SGS SA, Pharmaron Beijing Co Ltd, Element Materials Technology Group Ltd, CD BioSciences Inc, Charles River Laboratories International Inc, Eurofins Scientific SE, Labcorp Drug Development Inc, Syneos Health Inc, KCAS Bioanalytical and Biomarker Services LLC, ICON Plc, and Intertek Group Plc are some of the leading companies operating in the North America bioanalytical testing services market.
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