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市場調查報告書
商品編碼
1553599

藥品清洗驗證市場規模、佔有率、趨勢分析報告：按產品、驗證測試、地區、細分市場預測，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個工作天內

價格
簡介目錄

藥品清洗驗證市場成長與趨勢：

Grand View Research, Inc.最新報告顯示，預計到2030年，全球藥品清洗驗證市場規模將達284億美元，2024年至2030年複合年成長率為6.7%。

世界各地的製藥公司正在加強其研發設施並推動創新，以加速藥物發現和開發。

藥品製造領域的這一新一輪變革得到了許多科學突破的支持。美國FDA 透過選擇更務實的監管方法來支持這些進步，加速治療和救命藥物的生產量。藥品的需求不斷成長，導致對清洗驗證的需求激增，以確保藥品安全並監測殘留物、雜質和其他潛在污染物。由於清洗驗證是藥品製造過程中的重要過程，因此越來越需要提高意識並教育市場相關人員。

國際製藥工程學會 (ISPE) 於 2019 年 9 月舉辦了第一屆 ISPE 亞太地區藥品製造會議，並於 2020 年 9 月舉辦了第二屆，以提高人們對藥物發現、核准和測試管理的認知。

藥品生產中採用清洗驗證的監管標準主要由美國食品藥物管理局(美國 FDA) 和歐洲藥品管理局 (EMA) 制定和修訂。在開發基於風險的清洗驗證標準以防止聯合製造設施中的交叉污染方面，EMA 處於領先地位。

藥品檢驗合作計畫 (PIC/S) 緊跟著 EMA 的腳步，於 2018 年 6 月制定了與清洗驗證相關的新指南，以防止交叉污染，並在共用製造設施中建立了健康標準暴露限值(HBEL )。接下來，發布了備忘錄，概述了供監管機構審查的清單。上述因素導致製藥公司對清洗驗證的需求增加，對市場成長有正面影響。製藥業比其他行業更重要，監管標準對企業要求更高，因為違規會對人類健康產生負面影響。

此外，領先的公司正在專注於開發更先進的分析測試產品以改進程式。公司正在單獨或與其他主要參與者合作加速產品開發。例如，2020年12月，蘇伊士推出了面向生命科學和製藥行業的最新Sievers TOC線上分析儀M500。這款先進的分析儀透過將分析時間縮短 50% 來提高效率，並包括 Wi-Fi 功能、增強的安全功能以保護資料以及改進的資料傳輸等數位升級。同樣，2020年8月，堀場製作所和島津製作所結成策略聯盟，結合兩家公司的資源和能力，開發和銷售LC-拉曼分析和測量設備。預計此類舉措將在預測期內推動市場成長和開拓。

藥品清洗驗證市場報告亮點

  • 小分子藥物領域佔據市場主導地位，2023 年收益佔有率為 46.1%。
  • 2023 年，按產品分類的分析測試部門的收益佔有率為 64.5%。這一優勢歸因於製藥公司對先進高效液相層析(HPLC) 和紫外光譜的日益偏好。
  • 由於 FDA 和加拿大衛生部的嚴格規定，製藥公司採用了更多的清洗驗證，因此北美在 2023 年佔據了市場主導地位。

目錄

第1章調查方法和範圍

第 2 章執行摘要

第 3 章 藥品清洗驗證市場變數、趨勢與範圍

  • 市場介紹/系統展望
  • 市場規模及成長前景
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 藥品清洗驗證市場分析工具
    • 波特的分析
    • PESTEL分析

第 4 章 製藥清洗驗證市場：按產品估計和趨勢分析

  • 細分儀表板
  • 藥品清洗驗證市場：2024 年和 2030 年按產品分類的變化分析
  • 硬體
  • 軟體
  • 服務
  • 小分子藥物
  • 胜肽
  • 蛋白質
  • 清洗清潔劑

第5章 製藥清洗驗證市場：驗證測試的估計和趨勢分析

  • 細分儀表板
  • 藥品清洗驗證市場：2024 年和 2030 年驗證測試的變化分析
  • 特異性測試
  • 針對產品的分析測試

第6章 藥品清洗驗證市場：區域估計與趨勢分析

  • 2024 年及 2030 年按地區分類的藥品清洗驗證市場佔有率
  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 俄羅斯
    • 丹麥
    • 瑞典
    • 挪威
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 韓國
    • 澳洲
    • 泰國
    • 新加坡
  • 拉丁美洲
    • 巴西
    • 阿根廷
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非
    • 科威特

第7章 競爭格局

  • 主要市場參與企業的最新趨勢和影響分析
  • 公司分類
  • 企業熱力圖分析
  • 公司簡介
    • 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
簡介目錄
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