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市场调查报告书
商品编码
1845749
全球製程分析技术市场规模(按产品/服务、检测法、最终用户、技术、区域覆盖范围和预测)Global Process Analytical Technology Market Size By Products and Services, By Measurement, By End User, By Technique, By Geographic Scope And Forecast |
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预计 2024 年製程分析技术 (PAT) 市场规模将达到 121.3 亿美元,到 2031 年将达到 177.4 亿美元,2024 年至 2031 年的复合年增长率为 10.1%。
推动製药业采用製程分析技术系统的关键因素是製程分析化学(製程分析仪)的创新及其捕获和解读大量数据的能力。本报告对全球过程分析技术 (PAT) 市场进行了全面评估,包括关键细分市场、趋势、市场驱动因素、限制因素、竞争格局以及影响市场的关键因素。
定义全球製程分析技术 (PAT) 市场
FDA 将 PAT 描述为一种透过观察关键品质参数 (CPP) 以及原材料和加工材料的性能特征来建立、评估和控製製药生产过程的系统。此方法主要着重于透过识别关键品质参数、对其进行适当且及时的监控来理解流程,从而减少过度加工、提高一致性、最大限度地减少废品并提高检查效率。该系统透过利用即时资讯来减少製程变异性和产能,从而促进和支持持续的流程改进,并要求彻底了解操作中涉及的所有步骤。
PAT 提供广泛的尖端工具,以系统化、风险感知的方式支援药品的开发、生产和品管。根据其结构,这些工具可分为以下几类:知识管理工具、流程和终点监控工具、多元资料分析监控工具以及现代流程分析仪和流程分析化学工具。该系统中的技术可以提供一种有效且高效的数据收集方法,以了解製程开发和风险降低策略,并实现持续改进和知识共用。
全球製程分析技术(PAT)市场概览
推动製药业采用製程分析技术系统的主要因素是製程分析化学(製程分析仪)的创新及其获取和解读大量数据的能力。流程分析技术 (PAT) 的一个根本优势在于,其品质根植于产品之中,而非在产品分销前进行评估。它能够减少批次废品,缩短生产週期,并提高自动化。流程分析技术 (PAT) 市场的扩张源自于製药和生物製药产业高昂的研发成本。过去几十年来,製药公司大幅增加了研发投入。
阻碍小型製药公司采用製程分析技术的主要因素之一是缺乏具备丰富实务经验并了解功能和控制系统的合格技术专家/操作员。此外,所有流程分析技术产品和服务都需要持续的技术支持,因为一般公司员工需要协助才能妥善处理服务需求。加强政府对药品生产的监管将大大促进过程分析技术市场的发展。例如,2011年1月,美国食品药物管理局发布了针对人用和兽用药品及生物製药生产的製程验证建议,强调企业需要透过实施修改来定期延长製程生命週期,以确保快速解决生产问题的主要原因。
Process Analytical Technology (PAT) Market size was valued at USD 12.13 Billion in 2024 and is projected to reach USD 17.74 Billion by 2031, growing at a CAGR of 10.1% from 2024 to 2031.
The primary factors boosting the adoption of process analytical technology systems in the pharmaceutical sector are innovations in process analytical chemistry (process analyzers) and its capacity to capture & interpret large volumes of data. The Global Process Analytical Technology (PAT) Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market. substantial role in the market.
Global Process Analytical Technology (PAT) Market Definition
The FDA describes PAT as a system for creating, evaluating, and managing pharmaceutical manufacturing processes through the observation of key quality parameters (CPP) and performance characteristics of raw and processed materials. This method primarily focuses on understanding the processes by identifying the critical quality parameters, monitoring them appropriately and promptly, and providing improved efficacy in testing while reducing over-processing, boosting uniformity, and minimizing rejects. This mechanism facilitates and supports continuous process manufacturing improvement by utilizing real-time information to reduce process variance and manufacturing capability and calls for a complete understanding of all the many processes involved in the operation.
PAT offers a wide variety of cutting-edge tools to help develop, manufacture, and quality control medicines in a risk-aware, systematic way. Using its structure, these tools can be divided into the following categories: Tools for knowledge management, tools for monitoring and controlling processes and endpoints, tools for monitoring and controlling multivariate data analysis, and tools for modern process analyzers or process analytical chemistry. This technology within the system can provide effective and efficient ways to collect data to understand process development and risk-reduction strategies and achieve continuous improvement and knowledge sharing.
Global Process Analytical Technology (PAT) Market Overview
The primary factors boosting the adoption of process analytical technology systems in the pharmaceutical sector are innovations in process analytical chemistry (process analyzers) and its capacity to capture & interpret large volumes of data. The fundamental benefit of PAT is that quality is integrated into the product rather than being assessed before distribution. It aids in reducing batch rejection, shortening manufacturing cycle times, and boosting automation. The expansion of the Process Analytical Technology (PAT) Market relies on the amount of money spent on research and development (R&D) in the pharmaceutical and biopharmaceutical industries due to the high operating and capital expenditures. Over the past few decades, pharmaceutical companies have dramatically boosted their investment in research and development.
One major factor preventing some small pharma companies from implementing process analytical technology is the need for qualified technical experts/operators with thorough working experience and comprehension of functionality and control systems. Additionally, since regular company employees need help to adequately handle the servicing requirements, all process analytical technology products and services require ongoing technical support. The market for process analytical technologies may benefit significantly from increased government regulations regarding the production of pharmaceuticals and drugs. For instance, the USFDA released Process Validation recommendations for the production of human and animal pharmaceutical and biological products in January 2011, which underlined the requirement for businesses to routinely reinforce the process lifecycle by making modifications to ensure the main causes of manufacturing problems are rapidly resolved.
The Global Process Analytical Technology (PAT) Market is Segmented on the basis of Products and Services, Measurement, End User, Technique, and Geography.
Products
Services
Based on Products and Services, the market is segmented into Products and Services. Products accounted for the largest market share and are projected to grow at a CAGR of 9.68% during the forecast period. Process Analytical Technology (PAT) has been gaining importance in the biotech community because of its potential to provide continuous real-time quality assurance resulting in improved operational control and compliance. With the rising evolution in biopharmaceutical manufacturing, there is increasing use of PAT as it applies to the processes that produce biotech products and therapeutic products.
On-line
In-line
At-line
Off-line
Based on Measurement, the market is segmented into On-line, In-line, At-line, Off-line. On-line accounted for the largest market share and is projected to grow at the highest CAGR of 10.61% during the forecast period. Integrating online measurement and modeling of critical quality attributes with automated feedback control of the process parameters impacting these attributes should reduce product variability. On-line, the sample is diverted from the main process analyzed and may be returned.
Pharmaceutical Manufacturers
Biopharmaceutical Manufacturers
Contract Research and Manufacturing Organizations
Others
Based on End User, the market is segmented into Pharmaceutical Manufacturers, Biopharmaceutical Manufacturers, Contract Research and Manufacturing Organizations, and Others. Pharmaceutical Manufacturers accounted for the largest market share and are projected to grow at a CAGR of 9.78% during the forecast period. Process analytical technologies (PAT) play an important role in the process development and scale-up of asymmetric syntheses of chiral molecules including active pharmaceutical ingredients in the pharmaceutical industry.
Spectroscopy
Chromatography
Particle Size Analysis
Capillary Electrophoresis
Others
Based on Technique, the market is segmented into Spectroscopy, Chromatography, Particle Size Analysis, Capillary Electrophoresis, and Others. Spectroscopy accounted for the largest market share and is projected to grow at the highest CAGR of 10.96% during the forecast period. Spectroscopy is referred to as the study using precise color bands as generalized from visible light of the electromagnetic spectrum for describing experimental spectroscopic methods.
North America
Europe
Asia Pacific
Latin America
Middle East and Africa
Based on regional analysis, the Global Process Analytical Technology (PAT) Market is classified into On the basis of regional analysis, the market is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. North America accounted for the largest market share and is projected to grow at a CAGR of 9.46% during the forecast period. The North American region is emerged as one of the prominent contributors to the global Process Analytical Technology (PAT) Market.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players.