Global Pharmaceutical Cleaning Validation Market Size, Share, Trends, Industry Growth by Product Type (Small Molecule Drug, Peptides, Proteins, Cleaning Detergent), by Validation Test (Non-specific, Product-specific Analytical Tests), by Region, and Forecast to 2027
Report ID: RC147202 | Report Format: PDF + Excel | Starting Price: 3600/- USD | Last Updated: June 24th, 2023The global pharmaceutical cleaning validation market size is accounted to grow at a significant CAGR of around 6% during the forecast period 2021 to 2027. The rapid growth in pharmaceutical manufacturing coupled with the growing investment is a major factor to drive the market growth. Furthermore, the rising prevalence of diseases and the growing geriatric population across the globe is further anticipated to fuel the market growth. Moreover, the growing healthcare expenditure and the increasing investment in research & development are expected to propel the market growth over the forecast period.
Market Drivers:
Regulatory Compliance: The pharmaceutical industry is subject to stringent regulations and guidelines, such as Good Manufacturing Practices (GMP), that require thorough cleaning validation of equipment, facilities, and manufacturing processes. Compliance with these regulations is essential to ensure product quality, patient safety, and regulatory approval. The need to meet regulatory standards drives the demand for pharmaceutical cleaning validation services.
Increasing Complexity of Pharmaceutical Manufacturing: Pharmaceutical manufacturing processes are becoming increasingly complex, with the use of advanced manufacturing technologies, specialized equipment, and intricate production systems. Cleaning validation is necessary to ensure proper cleaning of these complex systems, preventing cross-contamination, residue buildup, and microbial contamination. As manufacturing processes become more sophisticated, the demand for cleaning validation services rises.
Product Safety and Quality Assurance: Maintaining product safety and quality is of paramount importance in the pharmaceutical industry. Effective cleaning validation helps ensure that equipment and manufacturing facilities are free from any residues, contaminants, or allergens that could compromise the safety and quality of pharmaceutical products. The focus on product safety and quality assurance drives the need for cleaning validation.
Risk Mitigation: Cleaning validation plays a crucial role in risk mitigation within the pharmaceutical manufacturing process. Failure to adequately clean and validate equipment can lead to cross-contamination, batch failures, product recalls, and regulatory penalties. Pharmaceutical companies seek to mitigate these risks by implementing robust cleaning validation programs to ensure proper cleaning procedures and documentation.
Increasing Demand for High-Potency Drugs: The growing demand for high-potency drugs, such as biologics, cytotoxic drugs, and hormones, presents unique challenges in terms of manufacturing and cleaning. These drugs require stringent cleaning procedures to eliminate traces of active pharmaceutical ingredients (APIs) and minimize the risk of cross-contamination. Cleaning validation becomes even more critical in the production of high-potency drugs, driving the demand for related services.
Advancements in Analytical Techniques: The development of advanced analytical techniques, such as high-performance liquid chromatography (HPLC), mass spectrometry, and surface swabbing methods, has enhanced the capabilities of cleaning validation. These techniques enable accurate detection and quantification of residues, contaminants, and cleaning agents. The availability of advanced analytical tools and methods drives the demand for cleaning validation services.
Outsourcing and Contract Manufacturing: The trend of outsourcing pharmaceutical manufacturing and contract manufacturing organization (CMO) services has increased in recent years. Outsourcing companies and CMOs rely on third-party cleaning validation services to ensure compliance with regulatory requirements and maintain product quality standards. The outsourcing of cleaning validation activities contributes to the growth of the cleaning validation market.
Focus on Operational Efficiency: Efficient cleaning validation processes and practices help streamline pharmaceutical manufacturing operations. Implementing effective cleaning procedures and validation protocols ensures timely equipment turnaround, reduces downtime, and optimizes production efficiency. Pharmaceutical companies emphasize operational efficiency, and cleaning validation is an integral part of achieving efficient manufacturing processes.
Increasing Pharmaceutical Industry Expenditure: The pharmaceutical industry continues to experience significant growth and investment. Increasing expenditure on research and development, manufacturing facilities, and quality assurance initiatives drives the demand for cleaning validation services. As pharmaceutical companies invest in expanding their operations and ensuring compliance, the need for cleaning validation increases.
Globalization and Harmonization of Standards: The globalization of the pharmaceutical industry and the harmonization of regulatory standards across regions contribute to the demand for cleaning validation services. Harmonization of standards, such as those implemented by international regulatory bodies like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), emphasizes the need for consistent cleaning validation practices worldwide.
Market Snapshot:
Benchmark Year | 2022 | ||
Market Size | lock | ||
Market Growth (CAGR) | ~ 6% (2023-2030) | ||
Largest Market Share | North America | ||
Analysis Period | 2020-2030 | ||
Market Players | Avomeen, Lucideon Limited, Hach Company, SGS SA, and Teledyne Tekmar |
Market Insights:
The global pharmaceutical cleaning validation market is bifurcated into product type, validation test, and geography. On the basis of product type, the market is further segmented into small molecule drugs, peptides, proteins, and cleaning detergent. The small molecule drug segment dominated the global market in 2020 and accounted to hold the largest revenue share of around half of the market by the end of the analysis period. Smaller drugs are manufactured in large quantities every year, which is a major factor to drive the segment growth. Furthermore, the rising prevalence of chronic diseases coupled with the growing production level of small molecule drugs is anticipated to fuel the segment growth over the forecast period.
On the basis of the validation test, the market is bifurcated into non-specific and product-specific analytical tests. The product-specific analytical tests segment dominated the global pharmaceutical cleaning validation market in 2020 and expected to hold the largest market share of around two-third of the market by the end of the analysis period. The increasing demand for high-performance liquid chromatography is one of the prominent factor to drive the segment growth.
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The pharmaceutical cleaning validation comprehensive study analyzes industry trends, market size, competitive analysis, and market forecast – 2021 to 2027. Research Corridor report provides detailed premium insight into the global market and reveals the potential revenue streams, commercial prospects, market drivers, challenges, opportunities, issues, and events affecting the industry. In addition, the report has a dedicated section covering market forecasts and analysis for leading geographies, profiles of major companies operating in the market and expert opinion obtained from interviews with industry executives and experts from prominent companies.
The pharmaceutical cleaning validation market research report presents the analysis of each segment from 2018 to 2027 considering 2020 as the base year for the research. The compounded annual growth rate (CAGR) for each respective segment is calculated for the forecast period from 2021 to 2027.
Historical & Forecast Period
- 2018-19 – Historical Year
- 2020 – Base Year
- 2021-2027 – Forecast Period
Market Segmentation:
By Product Type:
- Small Molecule Drug
- Peptides
- Proteins
- Cleaning Detergent
By Validation Test:
- Non-specific Tests
- Product-specific Analytical Tests
By Region:
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
Geographic Coverage
Geographically, North America dominated the global pharmaceutical cleaning validation market in 2020 and is estimated to hold the largest revenue share of over one-third of the market by the end of the analysis period. The increasing adoption of the methodology by many pharmaceutical companies coupled with the stringent regulatory standard is a major factor to drive the market growth in the region. Furthermore, the growing disease burden, increasing expenditure in healthcare, and the presence of global pharmaceutical players are further anticipated to boost market growth in North America.
Competitive Assessment
Some of the major market players operating in the global pharmaceutical cleaning validation market are Avomeen, Lucideon Limited, Hach Company, SGS SA, and Teledyne Tekmar. Companies are exploring markets through expansion, new investment, the introduction of new services, and collaboration as their preferred strategies. Players are exploring new geography through expansion and acquisition to gain a competitive advantage through joint synergy.
Key Companies:
- Avomeen
- Lucideon Limited
- Hach Company
- SGS SA
- Teledyne Tekmar
- QPharma, Inc.
- Merck KGaA
- ProPharma Group
- Kymos S.L.
- Intertek Group PLC
Key Questions Answered by Pharmaceutical Cleaning Validation Market Report
- Global pharmaceutical cleaning validation market forecasts from 2021-2027
- Regional pharmaceutical cleaning validation market forecasts from 2021-2027 covering Asia-Pacific, North America, Europe, Middle East & Africa, and Latin America
- Country-level forecasts from 2021-2027 covering 15 major countries from the regions as mentioned above
- Pharmaceutical cleaning validation submarket forecasts from 2021-2027 covering the market by product type, by validation test, and geography
- Various industry models such as SWOT analysis, Value Chain Analysis about pharmaceutical cleaning validation market
- Analysis of the key factors driving and restraining the growth of the global, regional, and country-level pharmaceutical cleaning validation markets from 2021-2027
- Competitive Landscape and market positioning of top 10 players operating in the pharmaceutical cleaning validation market
1. Preface
1.1. Report Description
1.1.1. Purpose of the Report
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I – Secondary Research
1.3.2. Phase II – Primary Research
1.3.3. Phase III – Expert Panel Review
1.4. Assumptions
2. Executive Summary
2.1. Global Pharmaceutical Cleaning Validation Market Portraiture
2.2. Global Pharmaceutical Cleaning Validation Market, by Product Type, 2020 (USD Mn)
2.3. Global Pharmaceutical Cleaning Validation Market, by Validation Test, 2020 (USD Mn)
2.4. Global Pharmaceutical Cleaning Validation Market, by Geography, 2020 (USD Mn)
3. Global Pharmaceutical Cleaning Validation Market Analysis
3.1. Pharmaceutical Cleaning Validation Market Overview
3.2. Market Inclination Insights
3.3. Market Dynamics
3.3.1. Drivers
3.3.2. Challenges
3.3.3. Opportunities
3.4. Attractive Investment Proposition
3.5. Competitive Analysis
3.6. Porter’s Five Force Analysis
3.6.1. Bargaining Power of Suppliers
3.6.2. Bargaining Power of Buyers
3.6.3. Threat of New Entrants
3.6.4. Threat of Substitutes
3.6.5. Degree of Competition
3.7. COVID-19 Impact Analysis
4. Global Pharmaceutical Cleaning Validation Market By Product Type, 2018 – 2027 (USD Mn)
4.1. Overview
4.2. Small Molecule Drug
4.3. Peptides
4.4. Proteins
4.5. Cleaning Detergent
5. Global Pharmaceutical Cleaning Validation Market By Validation Test, 2018 – 2027 (USD Mn)
5.1. Overview
5.2. Non-specific Tests
5.3. Product-specific Analytical Tests
6. North America Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2018 – 2027 (USD Mn)
6.1.1. Overview
6.1.2. North America Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
6.1.3. North America Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
6.1.4. North America Pharmaceutical Cleaning Validation Market by Country (2018-2027 USD Mn)
6.1.4.1. U.S.
6.1.4.1.1. U.S. Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
6.1.4.1.2. U.S. Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
6.1.4.2. Canada
6.1.4.2.1. Canada Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
6.1.4.2.2. Canada Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7. Europe Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2018 – 2027 (USD Mn)
7.1.1. Overview
7.1.2. Europe Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.3. Europe Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7.1.4. Europe Pharmaceutical Cleaning Validation Market by Country (2018-2027 USD Mn)
7.1.4.1. Germany
7.1.4.1.1. Germany Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.4.1.2. Germany Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7.1.4.2. U.K.
7.1.4.2.1. U.K. Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.4.2.2. U.K. Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7.1.4.3. France
7.1.4.3.1. France Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.4.3.2. France Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7.1.4.4. Italy
7.1.4.4.1. Italy Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.4.4.2. Italy Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
7.1.4.5. Rest of Europe
7.1.4.5.1. Rest of Europe Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
7.1.4.5.2. Rest of Europe Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
8. Asia Pacific Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2018 – 2027 (USD Mn)
8.1.1. Overview
8.1.2. Asia Pacific Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
8.1.3. Asia Pacific Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
8.1.4. Asia Pacific Pharmaceutical Cleaning Validation Market by Country (2018-2027 USD Mn)
8.1.4.1. China
8.1.4.1.1. China Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
8.1.4.1.2. China Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
8.1.4.2. Japan
8.1.4.2.1. Japan Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
8.1.4.2.2. Japan Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
8.1.4.3. Rest of Asia Pacific
8.1.4.3.1. Rest of Asia Pacific Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
8.1.4.3.2. Rest of Asia Pacific Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
9. Latin America (LATAM) Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2018 – 2027 (USD Mn)
9.1.1. Overview
9.1.2. Latin America Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
9.1.3. Latin America Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
9.1.4. Latin America Pharmaceutical Cleaning Validation Market by Country (2018-2027 USD Mn)
9.1.4.1. Brazil
9.1.4.1.1. Brazil Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
9.1.4.1.2. Brazil Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
9.1.4.2. Mexico
9.1.4.2.1. Mexico Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
9.1.4.2.2. Mexico Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
9.1.4.3. Rest of Latin America
9.1.4.3.1. Rest of Latin America Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
9.1.4.3.2. Rest of Latin America Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
10. Middle East and Africa Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2018 – 2027 (USD Mn)
10.1.1. Overview
10.1.2. MEA Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
10.1.3. MEA Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
10.1.4. Middle East and Africa Pharmaceutical Cleaning Validation Market, by Country (2018-2027 USD Mn)
10.1.4.1. GCC
10.1.4.1.1. GCC Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
10.1.4.1.2. GCC Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
10.1.4.2. South Africa
10.1.4.2.1. South Africa Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
10.1.4.2.2. South Africa Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
10.1.4.3. Rest of MEA
10.1.4.3.1. Rest of MEA Pharmaceutical Cleaning Validation Market by Product Type (2018-2027 USD Mn)
10.1.4.3.2. Rest of MEA Pharmaceutical Cleaning Validation Market by Validation Test (2018-2027 USD Mn)
11. Company Profiles
11.1. Avomeen
11.1.1. Business Description
11.1.2. Financial Health and Budget Allocation
11.1.3. Product Positions/Portfolio
11.1.4. Recent Development
11.1.5. SWOT Analysis
11.2. Lucideon Limited
11.2.1. Business Description
11.2.2. Financial Health and Budget Allocation
11.2.3. Product Positions/Portfolio
11.2.4. Recent Development
11.2.5. SWOT Analysis
11.3. Hach Company
11.3.1. Business Description
11.3.2. Financial Health and Budget Allocation
11.3.3. Product Positions/Portfolio
11.3.4. Recent Development
11.3.5. SWOT Analysis
11.4. SGS SA
11.4.1. Business Description
11.4.2. Financial Health and Budget Allocation
11.4.3. Product Positions/Portfolio
11.4.4. Recent Development
11.4.5. SWOT Analysis
11.5. Teledyne Tekmar
11.5.1. Business Description
11.5.2. Financial Health and Budget Allocation
11.5.3. Product Positions/Portfolio
11.5.4. Recent Development
11.5.5. SWOT Analysis
11.6. QPharma, Inc.
11.6.1. Business Description
11.6.2. Financial Health and Budget Allocation
11.6.3. Product Positions/Portfolio
11.6.4. Recent Development
11.6.5. SWOT Analysis
11.7. Merck KGaA
11.7.1. Business Description
11.7.2. Financial Health and Budget Allocation
11.7.3. Product Positions/Portfolio
11.7.4. Recent Development
11.7.5. SWOT Analysis
11.8. ProPharma Group
11.8.1. Business Description
11.8.2. Financial Health and Budget Allocation
11.8.3. Product Positions/Portfolio
11.8.4. Recent Development
11.8.5. SWOT Analysis
11.9. Kymos S.L.
11.9.1. Business Description
11.9.2. Financial Health and Budget Allocation
11.9.3. Product Positions/Portfolio
11.9.4. Recent Development
11.9.5. SWOT Analysis
11.10. Intertek Group PLC
11.10.1. Business Description
11.10.2. Financial Health and Budget Allocation
11.10.3. Product Positions/Portfolio
11.10.4. Recent Development
11.10.5. SWOT Analysis
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