의약품 세정 밸리데이션 시장 규모, 점유율, 동향 분석 리포트 : 제품별, 밸리데이션 시험별, 지역별, 부문 예측(2024-2030년)

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