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市場調查報告書
商品編碼
1845749

全球製程分析技術市場規模(按產品/服務、檢測法、最終用戶、技術、區域覆蓋範圍和預測)

Global Process Analytical Technology Market Size By Products and Services, By Measurement, By End User, By Technique, By Geographic Scope And Forecast

出版日期: | 出版商: Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

過程分析技術(PAT)市場規模與預測

預計 2024 年製程分析技術 (PAT) 市場規模將達到 121.3 億美元,到 2031 年將達到 177.4 億美元,2024 年至 2031 年的複合年成長率為 10.1%。

推動製藥業採用製程分析技術系統的關鍵因素是製程分析化學(製程分析儀)的創新及其捕獲和解讀大量數據的能力。本報告對全球過程分析技術 (PAT) 市場進行了全面評估,包括關鍵細分市場、趨勢、市場促進因素、限制因素、競爭格局以及影響市場的關鍵因素。

定義全球製程分析技術 (PAT) 市場

FDA 將 PAT 描述為一種透過觀察關鍵品質參數 (CPP) 以及原料和加工材料的性能特徵來建立、評估和控制製藥生產過程的系統。此方法主要著重於透過識別關鍵品質參數、對其進行適當且及時的監控來理解流程,從而減少過度加工、提高一致性、最大限度地減少廢品並提高檢查效率。該系統透過利用即時資訊來減少製程變異性和產能,從而促進和支持持續的流程改進,並要求徹底了解操作中涉及的所有步驟。

PAT 提供廣泛的尖端工具,以系統化、風險感知的方式支援藥品的開發、生產和品管。根據其結構,這些工具可分為以下幾類:知識管理工具、流程和終點監控工具、多元資料分析監控工具以及現代流程分析儀和流程分析化學工具。該系統中的技術可以提供一種有效且高效的數據收集方法,以了解製程開發和風險降低策略,並實現持續改進和知識共用。

全球製程分析技術(PAT)市場概覽

推動製藥業採用製程分析技術系統的主要因素是製程分析化學(製程分析儀)的創新及其獲取和解讀大量數據的能力。流程分析技術 (PAT) 的一個根本優勢在於,其品質根植於產品之中,而非在產品分銷前進行評估。它能夠減少批次廢品,縮短生產週期,並提高自動化。流程分析技術 (PAT) 市場的擴張源自於製藥和生物製藥產業高昂的研發成本。過去幾十年來,製藥公司大幅增加了研發投入。

阻礙小型製藥公司採用製程分析技術的主要因素之一是缺乏具備豐富實務經驗並了解功能和控制系統的合格技術專家/操作員。此外,所有流程分析技術產品和服務都需要持續的技術支持,因為一般公司員工需要協助才能妥善處理服務需求。加強政府對藥品生產的監管將大大促進過程分析技術市場的發展。例如,2011年1月,美國食品藥物管理局發布了針對人用和獸用藥品及生物製藥生產的製程驗證建議,強調企業需要透過實施修改來定期延長製程生命週期,以確保快速解決生產問題的主要原因。

目錄

第 1 章 全球流程分析技術 (PAT) 市場簡介

  • 市場定義
  • 市場區隔
  • 調查時間表
  • 先決條件
  • 限制

第2章:已驗證的市場調查方法

  • 資料探勘
  • 數據三角測量
  • 自下而上的方法
  • 自上而下的方法
  • 調查流程
  • 業界專家的重要見解
  • 資料來源

第3章執行摘要

  • 市場概況
  • 生態測繪
  • 絕對的商機
  • 市場吸引力
  • 全球製程分析技術(PAT)市場的區域分析
  • 全球過程分析技術(PAT)市場類型(百萬美元)
  • 全球過程分析技術(PAT)市場(按技術分類)(百萬美元)
  • 全球過程分析技術(PAT)市場(按行業分類)(百萬美元)
  • 未來市場機遇
  • 全球市場區隔
  • 產品生命線

第4章:全球過程分析技術(PAT)市場展望

  • 過程分析技術(PAT)的全球發展
  • 驅動程式
    • 促進要素1
    • 促進要素2
  • 阻礙因素
    • 阻礙因素1
    • 阻礙因素2
  • 機會
    • 機會 1
    • 機會 2
  • 波特五力模型
  • 價值鏈分析
  • 定價分析
  • 宏觀經濟分析

5. 全球過程分析技術(PAT)市場(按產品和服務)

  • 概述
  • 產品
  • 服務

6. 全球製程分析技術(PAT)市場規模(按測量)

  • 概述
  • 排隊
  • 線上
  • 網路
  • 離線

7. 全球過程分析技術(PAT)市場(按技術)

  • 概述
  • 光譜學
  • 層析法
  • 粒徑分析
  • 電泳
  • 其他

8. 全球過程分析技術(PAT)市場(按最終用戶)

  • 概述
  • 製藥商
  • 生物製藥製造商
  • 受託製造廠商
  • 其他

9. 全球過程分析技術(PAT)市場(按地區)

  • 概述
  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 其他亞太地區
  • 拉丁美洲
    • 巴西
    • 阿根廷
    • 其他拉丁美洲
  • 中東和非洲
    • 阿拉伯聯合大公國
    • 沙烏地阿拉伯
    • 南非
    • 其他中東和非洲地區

第 10 章:全球流程分析技術 (PAT) 市場的競爭格局

  • 概述
  • 各公司市場排名
  • 主要進展
  • 公司地理分佈
  • 公司產業足跡
  • ACE矩陣

第11章 公司簡介

  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Danaher Corporation(Ab Sciex LLC)
  • Bruker Corporation
  • PerkinElmer, Inc.
  • ABB Ltd.
  • Carl Zeiss AG(Zeiss Group)
  • Emerson Electric Co.
  • Mettler-Toledo
  • Shimadzu Corporation

第 11 章:經過驗證的市場情報

  • 關於已驗證的市場情報
  • 動態資料視覺化
簡介目錄
Product Code: 118940

Process Analytical Technology (PAT) Market Size And Forecast

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.

Global Process Analytical Technology (PAT) Market Segmentation Analysis

The Global Process Analytical Technology (PAT) Market is Segmented on the basis of Products and Services, Measurement, End User, Technique, and Geography.

Process Analytical Technology (PAT) Market, By Products and Services

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.

Process Analytical Technology (PAT) Market, By Measurement

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.

Process Analytical Technology (PAT) Market, By End User

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.

Process Analytical Technology (PAT) Market, By Technique

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.

Process Analytical Technology (PAT) Market, By Geography

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.

Key Players

  • The "Global Process Analytical Technology (PAT) Market" study report will provide valuable insight with an emphasis on the global market including some of the major players such as Thermo Fisher Scientific Inc., Agilent Technologies, Inc., Danaher Corporation (Ab Sciex LLC), Bruker Corporation, PerkinElmer, Inc., ABB Ltd., Carl Zeiss AG (Zeiss Group), Emerson Electric Co., Mettler-Toledo, Shimadzu Corporation, Sartorius AG, Hamilton Company, and Repligen Corporation

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.

Key Developments

  • In September 2022, the strategic partnership between Repligen Corporation and DRS Daylight products was made public to increase the range of products based on the Quantum Cascade Laser mid-IR (QCL-IR).
  • In May 2022, Agilent Technologies, Inc. and APC Ltd. announced their partnership to integrate their respective technologies and provide users with particular workflows to assist automated liquid chromatography (LC) process analysis.
  • Ace Matrix Analysis
  • The Ace Matrix provided in the report would help to understand how the major key players involved in this industry are performing as we provide a ranking for these companies based on various factors such as service features & innovations, scalability, innovation of services, industry coverage, industry reach, and growth roadmap. Based on these factors, we rank the companies into four categories as Active, Cutting Edge, Emerging, and Innovators.
  • Porter's Five Forces
  • The image provided would further help to get information about Porter's five forces framework providing a blueprint for understanding the behavior of competitors and a player's strategic positioning in the respective industry. Porter's five forces model can be used to assess the competitive landscape in the Process Analytical Technology (PAT) Market, gauge the attractiveness of a certain sector, and assess investment possibilities.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET

  • 1.1 Market Definition
  • 1.2 Market Segmentation
  • 1.3 Research Timelines
  • 1.4 Assumptions
  • 1.5 Limitations

2 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

  • 2.1 Data Mining
  • 2.2 Data Triangulation
  • 2.3 Bottom-Up Approach
  • 2.4 Top-Down Approach
  • 2.5 Research Flow
  • 2.6 Key Insights from Industry Experts
  • 2.7 Data Sources

3 EXECUTIVE SUMMARY

  • 3.1 Market Overview
  • 3.2 Ecology Mapping
  • 3.3 Absolute Market Opportunity
  • 3.4 Market Attractiveness
  • 3.5 Global Process Analytical Technology (PAT) Market Geographical Analysis (CAGR %)
  • 3.6 Global Process Analytical Technology (PAT) Market, By Type (USD Million)
  • 3.7 Global Process Analytical Technology (PAT) Market, By Technique (USD Million)
  • 3.8 Global Process Analytical Technology (PAT) Market, By Industry (USD Million)
  • 3.9 Future Market Opportunities
  • 3.10 Global Market Split
  • 3.11 Product Life Line

4 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET OUTLOOK

  • 4.1 Global Process Analytical Technology (PAT) Evolution
  • 4.2 Drivers
    • 4.2.1 Driver 1
    • 4.2.2 Driver 2
  • 4.3 Restraints
    • 4.3.1 Restraint 1
    • 4.3.2 Restraint 2
  • 4.4 Opportunities
    • 4.4.1 Opportunity 1
    • 4.4.2 Opportunity 2
  • 4.5 Porters Five Force Model
  • 4.6 Value Chain Analysis
  • 4.7 Pricing Analysis
  • 4.8 Macroeconomic Analysis

5 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET, BY PRODUCTS AND SERVICES

  • 5.1 Overview
  • 5.2 Products
  • 5.3 Services

6 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET, BY MEASUREMENT

  • 6.1 Overview
  • 6.2 In-line
  • 6.3 On-line
  • 6.4 At-line
  • 6.5 Off-line

7 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET, BY TECHNIQUE

  • 7.1 Overview
  • 7.2 Spectroscopy
  • 7.3 Chromatography
  • 7.4 Particle Size Analysis
  • 7.5 Electrophoresis
  • 7.6 Others

8 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET, BY END USER

  • 8.1 Overview
  • 8.2 Pharmaceutical Manufacturers
  • 8.3 Biopharmaceutical Manufacturers
  • 8.4 Contract Research and Manufacturing Organizations
  • 8.5 Others

9 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET, BY GEOGRAPHY

  • 9.1 Overview
  • 9.2 North America
    • 9.2.1 U.S.
    • 9.2.2 Canada
    • 9.2.3 Mexico
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 U.K.
    • 9.3.3 France
    • 9.3.4 Italy
    • 9.3.5 Spain
    • 9.3.6 Rest of Europe
  • 9.4 Asia Pacific
    • 9.4.1 China
    • 9.4.2 Japan
    • 9.4.3 India
    • 9.4.4 Rest of Asia Pacific
  • 9.5 Latin America
    • 9.5.1 Brazil
    • 9.5.2 Argentina
    • 9.5.3 Rest of Latin America
  • 9.6 Middle East and Africa
    • 9.6.1 UAE
    • 9.6.2 Saudi Arabia
    • 9.6.3 South Africa
    • 9.6.4 Rest of Middle-East and Africa

10 GLOBAL PROCESS ANALYTICAL TECHNOLOGY (PAT) MARKET COMPETITIVE LANDSCAPE

  • 10.1 Overview
  • 10.2 Company Market Ranking
  • 10.3 Key Developments
  • 10.4 Company Regional Footprint
  • 10.5 Company Industry Footprint
  • 10.6 ACE Matrix

11 COMPANY PROFILES

  • 11.1 Thermo Fisher Scientific Inc.
    • 11.1.1 Company Overview
    • 11.1.2 Company Insights
    • 11.1.3 Product Benchmarking
    • 11.1.4 Key Developments
    • 11.1.5 Winning Imperatives
    • 11.1.6 Current Focus & Strategies
    • 11.1.7 Threat from Competition
    • 11.1.8 SWOT Analysis
  • 11.2 Agilent Technologies, Inc.
    • 11.2.1 Company Overview
    • 11.2.2 Company Insights
    • 11.2.3 Product Benchmarking
    • 11.2.4 Key Developments
    • 11.2.5 Winning Imperatives
    • 11.2.6 Current Focus & Strategies
    • 11.2.7 Threat from Competition
    • 11.2.8 SWOT Analysis
  • 11.3 Danaher Corporation (Ab Sciex LLC)
    • 11.3.1 Company Overview
    • 11.3.2 Company Insights
    • 11.3.3 Product Benchmarking
    • 11.3.4 Key Developments
    • 11.3.5 Winning Imperatives
    • 11.3.6 Current Focus & Strategies
    • 11.3.7 Threat from Competition
    • 11.3.8 SWOT Analysis
  • 11.4 Bruker Corporation
    • 11.4.1 Company Overview
    • 11.4.2 Company Insights
    • 11.4.3 Product Benchmarking
    • 11.4.4 Key Developments
    • 11.4.5 Winning Imperatives
    • 11.4.6 Current Focus & Strategies
    • 11.4.7 Threat from Competition
    • 11.4.8 SWOT Analysis
  • 11.5 PerkinElmer, Inc.
    • 11.5.1 Company Overview
    • 11.5.2 Company Insights
    • 11.5.3 Product Benchmarking
    • 11.5.4 Key Developments
    • 11.5.5 Winning Imperatives
    • 11.5.6 Current Focus & Strategies
    • 11.5.7 Threat from Competition
    • 11.5.8 SWOT Analysis
  • 11.6 ABB Ltd.
    • 11.6.1 Company Overview
    • 11.6.2 Company Insights
    • 11.6.3 Product Benchmarking
    • 11.6.4 Key Developments
    • 11.6.5 Winning Imperatives
    • 11.6.6 Current Focus & Strategies
    • 11.6.7 Threat from Competition
    • 11.6.8 SWOT Analysis
  • 11.7 Carl Zeiss AG (Zeiss Group)
    • 11.7.1 Company Overview
    • 11.7.2 Company Insights
    • 11.7.3 Product Benchmarking
    • 11.7.4 Key Developments
    • 11.7.5 Winning Imperatives
    • 11.7.6 Current Focus & Strategies
    • 11.7.7 Threat from Competition
    • 11.7.8 SWOT Analysis
  • 11.8 Emerson Electric Co.
    • 11.8.1 Company Overview
    • 11.8.2 Company Insights
    • 11.8.3 Product Benchmarking
    • 11.8.4 Key Developments
    • 11.8.5 Winning Imperatives
    • 11.8.6 Current Focus & Strategies
    • 11.8.7 Threat from Competition
    • 11.8.8 SWOT Analysis
  • 11.9 Mettler-Toledo
    • 11.9.1 Company Overview
    • 11.9.2 Company Insights
    • 11.9.3 Product Benchmarking
    • 11.9.4 Key Developments
    • 11.9.5 Winning Imperatives
    • 11.9.6 Current Focus & Strategies
    • 11.9.7 Threat from Competition
    • 11.9.8 SWOT Analysis
  • 11.10 Shimadzu Corporation
    • 11.10.1 Company Overview
    • 11.10.2 Company Insights
    • 11.10.3 Product Benchmarking
    • 11.10.4 Key Developments
    • 11.10.5 Winning Imperatives
    • 11.10.6 Current Focus & Strategies
    • 11.10.7 Threat from Competition
    • 11.10.8 SWOT Analysis

11. VERIFIED MARKET INTELLIGENCE

  • 11.1 About Verified Market Intelligence
  • 11.2 Dynamic Data Visualization