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市场调查报告书
商品编码
1553599

药品清洗验证市场规模、份额、趋势分析报告：按产品、验证测试、地区、细分市场预测，2024-2030 年

Pharmaceutical Cleaning Validation Market Size, Share & Trends Analysis Report By Product (Small Molecule, Cleaning Detergent, Peptides, Proteins), By Validation Test, By Region, And Segment Forecasts, 2024 - 2030
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10个工作天内

价格
简介目录

药品清洗验证市场成长与趋势：

Grand View Research, Inc.最新报告显示，预计到2030年，全球药品清洗验证市场规模将达284亿美元，2024年至2030年复合年增长率为6.7%。

世界各地的製药公司正在加强其研发设施并推动创新，以加速药物发现和开发。

药品製造领域的这一新一轮变革得到了许多科学突破的支持。美国FDA 透过选择更务实的监管方法来支持这些进步，加速治疗和救命药物的生产量。药品的需求不断增长，导致对清洗验证的需求激增，以确保药品安全并监测残留物、杂质和其他潜在污染物。由于清洗验证是药品製造过程中的重要过程，因此越来越需要提高意识并教育市场相关人员。

国际製药工程学会 (ISPE) 于 2019 年 9 月举办了第一届 ISPE 亚太地区药品製造会议，并于 2020 年 9 月举办了第二届，以提高人们对药物发现、核准和测试管理的认识。

药品生产中采用清洗验证的监管标准主要由美国食品药物管理局(美国 FDA) 和欧洲药品管理局 (EMA) 制定和修订。在开发基于风险的清洗验证标准以防止联合製造设施中的交叉污染方面，EMA 处于领先地位。

药品检验合作计画 (PIC/S) 紧跟着 EMA 的脚步，于 2018 年 6 月制定了与清洗验证相关的新指南，以防止交叉污染，并在共用製造设施中建立了健康标准暴露限值(HBEL )。接下来，发布了备忘录，概述了供监管机构审查的清单。上述因素导致製药公司对清洗验证的需求增加，对市场成长有正面影响。製药业比其他行业更重要，监管标准对企业要求更高，因为违规会对人类健康产生负面影响。

此外，领先的公司正在专注于开发更先进的分析测试产品以改进程式。公司正在单独或与其他主要参与者合作加速产品开发。例如，2020年12月，苏伊士推出了面向生命科学和製药行业的最新Sievers TOC线上分析仪M500。这款先进的分析仪透过将分析时间缩短 50% 来提高效率，并包括 Wi-Fi 功能、增强的安全功能以保护资料以及改进的资料传输等数位升级。同样，2020年8月，堀场製作所和岛津製作所结成策略联盟，结合两家公司的资源和能力，开发和销售LC-拉曼分析和测量设备。预计此类倡议将在预测期内推动市场成长和开拓。

药品清洗验证市场报告亮点

  • 小分子药物领域占据市场主导地位，2023 年收益占有率为 46.1%。
  • 2023 年，按产品分類的分析测试部门的收益占有率为 64.5%。这一优势归因于製药公司对先进高效液相层析(HPLC) 和紫外光谱的日益偏好。
  • 由于 FDA 和加拿大卫生部的严格规定，製药公司采用了更多的清洗验证，因此北美在 2023 年占据了市场主导地位。

目录

第一章调查方法和范围

第 2 章执行摘要

第 3 章 药品清洗验证市场变数、趋势与范围

  • 市场介绍/系统展望
  • 市场规模及成长前景
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 药品清洗验证市场分析工具
    • 波特的分析
    • PESTEL分析

第 4 章 製药清洗验证市场：按产品估计和趋势分析

  • 细分仪表板
  • 药品清洗验证市场：2024 年和 2030 年按产品分類的变化分析
  • 硬体
  • 软体
  • 服务
  • 小分子药物
  • 胜肽
  • 蛋白质
  • 清洗清洁剂

第五章 製药清洗验证市场：验证测试的估计和趋势分析

  • 细分仪表板
  • 药品清洗验证市场：2024 年和 2030 年验证测试的变化分析
  • 特异性测试
  • 针对产品的分析测试

第六章 药品清洗验证市场：区域估计与趋势分析

  • 2024 年及 2030 年按地区分類的药品清洗验证市场占有率
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 丹麦
    • 瑞典
    • 挪威
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 泰国
    • 新加坡
  • 拉丁美洲
    • 巴西
    • 阿根廷
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 南非
    • 科威特

第七章 竞争格局

  • 主要市场参与企业的最新趋势和影响分析
  • 公司分类
  • 企业热力图分析
  • 公司简介
    • Lucideon Limited
    • Hach
    • Teledyne Technologies Incorporated
    • SGS Societe Generale de Surveillance SA
    • Intertek Group PLC
    • Reading Scientific Services Ltd
    • Ecolab
    • Shimadzu Corporation
    • Waters Corporation
    • UFAG LABORATORIEN AG
简介目录
Product Code: GVR-4-68039-507-3

Pharmaceutical Cleaning Validation Market Growth & Trends:

The global pharmaceutical cleaning validation market size is expected to reach USD 28.40 billion by 2030, registering to grow at a CAGR of 6.7% from 2024 to 2030 according to a new report by Grand View Research, Inc. Global pharma companies are focusing their efforts on their R&D facilities and pushing for innovation to boost drug discovery and development.

This new wave of transformation in pharma manufacturing is being supported by several scientific breakthroughs. The U.S. FDA is supporting these advancements by opting for a more pragmatic approach to regulation which assists the sector in accelerating the throughput of therapeutics and lifesaving medicines. The rising demand for medicinal drugs is contributing to the surge in demand for cleaning validation to ensure drug safety, monitor residues, impurities, and other potential contaminants, which could cause cross-contamination from the previous manufactured batch. Since cleaning validation makes an integral process in pharmaceutical manufacturing processes, the need for spreading awareness and educating market players of the same is growing.

The International Society for Pharmaceutical Engineering (ISPE) to spread awareness on drug discovery, approvals, and inspection management organized its inaugural ISPE APAC Pharmaceutical Manufacturing Conference in September 2019 and its second edition in September 2020, wherein, one of the key topics covered were cleaning validation and cross-contamination control.

The regulatory standards about the adoption of cleaning validation in drug manufacturing are established and revised majorly by the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA). The EMA is a frontrunner when it comes to developing risk-based cleaning validation standards to prevent cross-contamination in shared manufacturing facilities.

Pharmaceutical Inspection Co-operation Scheme (PIC/S) followed EMA's lead and laid down its own set of new guidelines in association with cleaning validation to prevent cross-contamination and establish Health-Based Exposure Limits (HBEL) in share manufacturing facilities in June 2018. Next, an AIDE-MEMOIRE was published to outline the checklist that regulators would be meticulously inspecting. The abovementioned factors have resulted in boosting the demand for cleaning validation for drug manufacturing companies and have positively impacted the growth of the market. Since the pharmaceutical industry is more crucial compared to other industries and non-compliance could lead to negative consequences on human health, the regulatory standards are more stringent for the companies.

Moreover, key players are focused on developing more advanced analytical testing products to improve procedures. Companies are either solely or partnering with other key players to accelerate product development. For instance, in December 2020, Suez launched their latest Sievers TOC online analyzer, the M500 for the life science and pharmaceutical industries. This advanced analyzer enhances efficiency by cutting down analysis time by 50% and includes digital upgrades like Wi-Fi capabilities, enhanced security features to protect data integrity, and improved data transfer. Similarly, in August 2020 HORIBA Ltd and Shimadzu Corporation entered a strategic collaboration to develop and distribute LC-Raman analytical and measuring instruments using the combined resources and capabilities of the two companies. Such initiatives are expected to boost the growth and development of the market during the forecast period.

Pharmaceutical Cleaning Validation Market Report Highlights:

  • The small molecule drugs segment dominated the market and accounted for a revenue share of 46.1% in 2023
  • The product-specific analytical tests segment captured 64.5% revenue share in 2023. This dominance is driven by the growing preference for state-of-the-art High-Performance Liquid Chromatography (HPLC) and UV spectroscopy among pharmaceutical companies.
  • North America dominated the market in 2023 owing to the high adoption of cleaning validation by pharmaceutical companies due to stringent FDA and Health Canada regulations

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Market Definitions
  • 1.3. Research Methodology
    • 1.3.1. Information Procurement
    • 1.3.2. Information or Data Analysis
    • 1.3.3. Market Formulation & Data Visualization
    • 1.3.4. Data Validation & Publishing
  • 1.4. Research Scope and Assumptions
    • 1.4.1. List of Data Sources

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. Pharmaceutical Cleaning Validation Market Variables, Trends, & Scope

  • 3.1. Market Introduction/Lineage Outlook
  • 3.2. Market Size and Growth Prospects (USD Million)
  • 3.3. Market Dynamics
    • 3.3.1. Market Drivers Analysis
    • 3.3.2. Market Restraints Analysis
  • 3.4. Pharmaceutical Cleaning Validation Market Analysis Tools
    • 3.4.1. Porter's Analysis
      • 3.4.1.1. Bargaining power of the suppliers
      • 3.4.1.2. Bargaining power of the buyers
      • 3.4.1.3. Threats of substitution
      • 3.4.1.4. Threats from new entrants
      • 3.4.1.5. Competitive rivalry
    • 3.4.2. PESTEL Analysis
      • 3.4.2.1. Political landscape
      • 3.4.2.2. Economic and Social landscape
      • 3.4.2.3. Technological landscape
      • 3.4.2.4. Environmental landscape
      • 3.4.2.5. Legal landscape

Chapter 4. Pharmaceutical Cleaning Validation Market: Product Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. Pharmaceutical Cleaning Validation Market: Product Movement Analysis, 2024 & 2030 (USD Million)
  • 4.3. Hardware
    • 4.3.1. Hardware Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4. Software
    • 4.4.1. Software Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5. Services
    • 4.5.1. Services Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6. Small Molecule Drug
    • 4.6.1. Small Molecule Drug Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7. Peptides
    • 4.7.1. Peptides Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.8. Proteins
    • 4.8.1. Proteins Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.9. Cleaning Detergent
    • 4.9.1. Cleaning Detergent Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Pharmaceutical Cleaning Validation Market: Validation Test Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. Pharmaceutical Cleaning Validation Market: Validation Movement Analysis, 2024 & 2030 (USD Million)
  • 5.3. Non-Specific Tests
    • 5.3.1. Non-Specific Tests Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4. Product-Specific Analytical Tests
    • 5.4.1. Product-Specific Analytical Tests Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Pharmaceutical Cleaning Validation Market: Regional Estimates & Trend Analysis

  • 6.1. Pharmaceutical Cleaning Validation Market Share, By Region, 2024 & 2030 (USD Million)
  • 6.2. North America
    • 6.2.1. North America Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.2.2. U.S.
      • 6.2.2.1. U.S. Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.2.3. Canada
      • 6.2.3.1. Canada Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.2.4. Mexico
      • 6.2.4.1. Mexico Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3. Europe
    • 6.3.1. Europe Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.2. UK
      • 6.3.2.1. UK Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.3. Germany
      • 6.3.3.1. Germany Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.4. France
      • 6.3.4.1. France Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.5. Italy
      • 6.3.5.1. Italy Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.6. Spain
      • 6.3.6.1. Spain Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.7. Russia
      • 6.3.7.1. Russia Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.8. Denmark
      • 6.3.8.1. Denmark Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.9. Sweden
      • 6.3.9.1. Sweden Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.3.10. Norway
      • 6.3.10.1. Norway Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4. Asia Pacific
    • 6.4.1. Asia Pacific Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.2. China
      • 6.4.2.1. China Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.3. Japan
      • 6.4.3.1. Japan Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.4. India
      • 6.4.4.1. India Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.5. South Korea
      • 6.4.5.1. South Korea Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.6. Australia
      • 6.4.6.1. Australia Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.7. Thailand
      • 6.4.7.1. Thailand Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.4.8. Singapore
      • 6.4.8.1. Singapore Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5. Latin America
    • 6.5.1. Latin America Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.5.2. Brazil
      • 6.5.2.1. Brazil Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.5.3. Argentina
      • 6.5.3.1. Argentina Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6. Middle East and Africa
    • 6.6.1. Middle East and Africa Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.2. Saudi Arabia
      • 6.6.2.1. Saudi Arabia Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.3. UAE
      • 6.6.3.1. UAE Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.4. South Africa
      • 6.6.4.1. South Africa Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 6.6.5. Kuwait
      • 6.6.5.1. Kuwait Pharmaceutical Cleaning Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Recent Developments & Impact Analysis by Key Market Participants
  • 7.2. Company Categorization
  • 7.3. Company Heat Map Analysis
  • 7.4. Company Profiles
    • 7.4.1. Lucideon Limited
      • 7.4.1.1. Participant's Overview
      • 7.4.1.2. Financial Performance
      • 7.4.1.3. Product Benchmarking
      • 7.4.1.4. Recent Developments/ Strategic Initiatives
    • 7.4.2. Hach
      • 7.4.2.1. Participant's Overview
      • 7.4.2.2. Financial Performance
      • 7.4.2.3. Product Benchmarking
      • 7.4.2.4. Recent Developments/ Strategic Initiatives
    • 7.4.3. Teledyne Technologies Incorporated
      • 7.4.3.1. Participant's Overview
      • 7.4.3.2. Financial Performance
      • 7.4.3.3. Product Benchmarking
      • 7.4.3.4. Recent Developments/ Strategic Initiatives
    • 7.4.4. SGS Societe Generale de Surveillance SA
      • 7.4.4.1. Participant's Overview
      • 7.4.4.2. Financial Performance
      • 7.4.4.3. Product Benchmarking
      • 7.4.4.4. Recent Developments/ Strategic Initiatives
    • 7.4.5. Intertek Group PLC
      • 7.4.5.1. Participant's Overview
      • 7.4.5.2. Financial Performance
      • 7.4.5.3. Product Benchmarking
      • 7.4.5.4. Recent Developments/ Strategic Initiatives
    • 7.4.6. Reading Scientific Services Ltd
      • 7.4.6.1. Participant's Overview
      • 7.4.6.2. Financial Performance
      • 7.4.6.3. Product Benchmarking
      • 7.4.6.4. Recent Developments/ Strategic Initiatives
    • 7.4.7. Ecolab
      • 7.4.7.1. Participant's Overview
      • 7.4.7.2. Financial Performance
      • 7.4.7.3. Product Benchmarking
      • 7.4.7.4. Recent Developments/ Strategic Initiatives
    • 7.4.8. Shimadzu Corporation
      • 7.4.8.1. Participant's Overview
      • 7.4.8.2. Financial Performance
      • 7.4.8.3. Product Benchmarking
      • 7.4.8.4. Recent Developments/ Strategic Initiatives
    • 7.4.9. Waters Corporation
      • 7.4.9.1. Participant's Overview
      • 7.4.9.2. Financial Performance
      • 7.4.9.3. Product Benchmarking
      • 7.4.9.4. Recent Developments/ Strategic Initiatives
    • 7.4.10. UFAG LABORATORIEN AG
      • 7.4.10.1. Participant's Overview
      • 7.4.10.2. Financial Performance
      • 7.4.10.3. Product Benchmarking
      • 7.4.10.4. Recent Developments/ Strategic Initiatives