Global Pharmaceutical Cleaning Validation Market: Industry Analysis and Forecast (2020-2027) by Product Type, Validation Test, and Region

Global Pharmaceutical Cleaning Validation Market size was valued at US$ 15.4 Bn. in 2020 and the total revenue is expected to grow at 5.7% through 2021 to 2027, reaching nearly US$ 22.9 Bn.

Global Pharmaceutical Cleaning Validation Market Overview:

Cleaning Validation is a mechanism for ensuring that a cleaning procedure eliminates residues of active pharmaceutical components from a product made in a piece of equipment, as well as cleaning aids and microbiological characteristics. Pharmaceutical cleaning validation is an important factor responsible to maintain the standard of medicine or pharmaceutical ingredients during the process of manufacturing. Global Pharmaceutical Cleaning Validation Market To know about the Research Methodology :- Request Free Sample Report The report has covered the market trends from 2015 to forecast the market through 2027. 2020 is considered a base year however 2020's numbers are on the real output of the companies in the market. Special attention is given to 2020 and the effect of lockdown on the demand and supply, and also the impact of lockdown for the next two years on the market. Some companies have done good in lockdown also and specific strategic analysis of those companies is done in the report.

Global Pharmaceutical Cleaning Validation Market Dynamics:

The massive development of pharmaceutical manufacturing facilities, the rising prevalence of diseases, the growing global senile population increased healthcare spending, and increased market investments to meet regulatory standards set by international governing bodies such as the US FDA and the European Medicines Agency (EMA). The pharmaceutical manufacturing industry's developing regulations to limit cross-contamination have had a favorable effect on the market's growth. Furthermore, regulatory authorities are taking a more moderate approach towards rules, allowing the pharmaceutical sector to speed up their production and quality control procedures. The market growth for pharmaceuticals is driving up the requirement for cleaning validation to assure product safety, monitor possible contamination, and detect contaminants. In September 2020, the International Society of Pharmaceutical Engineering hosted the ISPE APAC Pharmaceutical Manufacturing Conference to raise awareness about the relevance of the cleaning validation process. Supports the pharmaceutical industry's manufacturing and quality control procedures to be faster. The rules and regulatory requirements for cleaning validation in medication production are mostly established by the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). The European Medicines Agency (EMA) is a forerunner in developing risk-based cleaning validation criteria to prevent cross-contamination in manufacturing facilities. Following the EMA's lead, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) created its own set of rules in shared production facilities, including Health-Based Exposure Limits (HBEL). These reasons have boosted demand for cleaning validation among pharmaceutical producers, resulting in healthy market growth. In comparison to other sectors, the pharmaceutical business is more life-saving and life-endangering, and non-compliance can result in dangerous effects for human health, thus regulatory standards are more severe for the companies. Hence, these factors are estimated to fuel the market growth in the forecast timeframe.

Global Pharmaceutical Cleaning Validation Market Segment Analysis:

The small molecule segment is dominating the Product Type segment of the Global Pharmaceutical Cleaning Validation Market:

The small Molecule segment is estimated to gain more attraction in the market and accounted for the largest market share of 45.7% in the year 2020. In 2018, the FDA authorized 59 new medicines, with 71% of them being small molecules and 29% being biologics. Small molecule medicines also accounted for 75% of the pharmaceutical industry in 2019. As a result, the growing need for cleaning validation is being fuelled by the increased manufacturing levels of small molecule medicines. Small-molecule medicines are also important in the treatment of chronic illnesses and regenerative medicine. Hence, growing chronic diseases and their treatment options are estimated to drive the growth of the market. The product-specific analytical tests are considered to supplement the growth of the Global Pharmaceutical Cleaning Validation Market. In 2020, the product-specific analytical tests segment led the pharmaceutical cleaning validation market, accounting for 65.3 % of total revenue. Cleaning validation frequently employs analytical tests such as ultraviolet spectroscopy, high-performance liquid chromatography, liquid chromatography/mass spectrometry, near-infrared spectroscopy, mid-infrared spectroscopy, capillary zone electrophoresis, atomic absorption, ion mobility spectrometry, and enzyme-linked immunosorbent assay. The most widely used technique of cleaning validation is High-performance Liquid Chromatography (HPLC), which accounted for 50.9 % of the revenue share in the product-specific analytical testing sector in 2020. This is due to the benefits of employing HPLC, which includes the ability to utilize a variety of swabs and different detection techniques like UV, fluorescence, photodiode array, are some of them. Furthermore, it provides quantitative findings, peak separation, and the ability to leverage several solvents for extraction solutions. Global Pharmaceutical Cleaning Validation Market

Global Pharmaceutical Cleaning Validation Market Regional Insights:

North America is dominating the growth of the pharmaceutical cleaning validation market. Owing to the uptick adoption of cleaning validation by pharmaceutical, manufacturing firms to comply with strict regulatory requirements laid down by the U.S. FDA and Health Canada, North America led the market and accounted for the biggest revenue share of 40.2 % in 2020. The geographical revenue share is influenced by the presence of local and foreign pharmaceutical businesses, rising healthcare expenditure on pharmaceutical medications, rising illness burden, and rising awareness levels. Asia Pacific is estimated to gain more attractions owing to the high demand for pharmaceutical cleaning validation processes and is growing at a 9.3% CAGR. The existence of significant pharmaceutical production units, as well as increased investments by multinational pharmaceutical firms, are key factors driving regional revenue growth. Further, investment in the healthcare industry and rapid innovations are estimated to dominate the market growth.Global Pharmaceutical Cleaning Validation MarketThe objective of the report is to present a comprehensive analysis of the Global Pharmaceutical Cleaning Validation Market to the stakeholders in the industry. The past and current status of the industry with the forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that include market leaders, followers, and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers. The report also helps in understanding the Global Pharmaceutical Cleaning Validation Market dynamics, structure by analyzing the market segments and project the Global Pharmaceutical Cleaning Validation Market size. Clear representation of competitive analysis of key players by Grade, price, financial position, Grade portfolio, growth strategies, and regional presence in the Global Pharmaceutical Cleaning Validation Market make the report investor’s guide.

Global Pharmaceutical Cleaning Validation Market Scope: Inquire before buying

Global Pharmaceutical Cleaning Validation Market

Global Pharmaceutical Cleaning Validation Market, by Region

• North America o US o Canada o Mexico • Europe o U.K o France o Germany o Italy o Spain o Sweden o CIS Countries o Rest of Europe • Asia Pacific o China o India o Japan o South Korea o Australia o ASEAN o Rest of Asia Pacific • The Middle East and Africa o South Africa o GCC Countries o Egypt o Nigeria o Rest of ME&A • South America o Brazil o Argentina o Rest of South America

Global Pharmaceutical Cleaning Validation Market Key Player

Avomeen • Lucideon Limited • Suez • Hach • Hach • Teledyne Tekmar • SGS SA • QPharma, Inc • ProPharma Group • Merck KGaA • Intertek Group PLC • Kymos S.L • Shimadzu Corporation • Waters Corporation • Azbil Corporation • Kimberly-Clark Corporation • Ardmac • Clean Air Products • Labconco Corporation • Dynarex Corporation

FAQs:

1. What is the global Pharmaceutical Cleaning Validation market share in 2020? Ans: Global Pharmaceutical Cleaning Validation market share in 2020 was estimated as 15.4 Billion USD. 2. What is the global Pharmaceutical Cleaning Validation market growth? Ans: The global Pharmaceutical Cleaning Validation market is anticipated to grow with a CAGR of 5.7 % in the forecast period and is likely to reach USD 22.9 Billion by the end of 2027. 3. Which Product Type segment is expected to dominate the global Pharmaceutical Cleaning Validation market during the forecast period? Ans: the small molecule drug segment dominated the market and accounted for the largest revenue share of 46.9%. The large volumes of small drugs are manufactured every year accountable to the highest market share of the segment. 4. Which region is expected to dominate the global Pharmaceutical Cleaning Validation during the forecast period? Ans: North America dominated the pharmaceutical cleaning validation market and accounted for the largest revenue share of 40.2% in 2020. 5. What is the key driving factor for the growth of the global Pharmaceutical Cleaning Validation market? Ans: Key factors that are driving the pharmaceutical cleaning validation market growth include stringent regulatory requirements and a rise in pharmaceutical manufacturing..
1. Preface 1.1. Market Definition and Key Research Objectives 1.2. Research Highlights 2. Assumptions and Research Methodology 2.1. Report Assumptions 2.2. Abbreviations 2.3. Research Methodology 2.3.1. Secondary Research 2.3.1.1. Secondary data 2.3.1.2. Secondary Sources 2.3.2. Primary Research 2.3.2.1. Data from Primary Sources 2.3.2.2. Breakdown of Primary Sources 3. Executive Summary: Global Pharmaceutical Cleaning Validation Market Size, by Market Value (US$ Bn) 3.1. Global Market Segmentation 3.2. Global Market Segmentation Share Analysis, 2020 3.2.1. Global 3.2.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 3.3. Geographical Snapshot of the Pharmaceutical Cleaning Validation Market 3.4. Geographical Snapshot of the Pharmaceutical Cleaning Validation Market, By Manufacturer share 4. Global Pharmaceutical Cleaning Validation Market Overview, 2020-2027 4.1. Market Dynamics 4.1.1. Drivers 4.1.1.1. Global 4.1.1.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.2. Restraints 4.1.2.1. Global 4.1.2.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.3. Opportunities 4.1.3.1. Global 4.1.3.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.4. Challenges 4.1.4.1. Global 4.1.4.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.5. Industry Trends and Emerging Technologies 4.1.6. Porter Five Forces Analysis 4.1.6.1. The threat of New Entrants 4.1.6.2. Bargaining Power of Buyers/Consumers 4.1.6.3. Bargaining Power of Suppliers 4.1.6.4. The threat of Substitute Grades 4.1.6.5. The intensity of Competitive Rivalry 4.1.7. Value Chain Analysis 4.1.8. Technological Roadmap 4.1.9. Regulatory landscape 4.1.10. Impact of the Covid-19 Pandemic on the Global Pharmaceutical Cleaning Validation Market 5. Supply Side and Demand Side Indicators 6. Global Pharmaceutical Cleaning Validation Market Analysis and Forecast, 2020-2027 6.1. Global Pharmaceutical Cleaning Validation Market Size & Y-o-Y Growth Analysis. 7. Global Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 7.1. Market Size (Value) Estimates & Forecast By Specimen, 2020-2027 7.1.1. Small Molecule Drug 7.1.2. Peptides 7.1.3. Proteins 7.1.4. Cleaning Detergent 7.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 7.2.1. Non-specific Tests 7.2.1.1. Total Carbon Analysis (TC) 7.2.1.2. Total Organic Carbon Testing (TOC) 7.2.1.3. Non-purgeable Organic Carbon (NPOC) 7.2.1.4. Conductivity 7.2.1.5. Others 7.2.2. Product-specific Analytical Tests 7.2.2.1. Ultraviolet-Visible Spectroscopy (UV/VIS) 7.2.2.2. High-Performance Liquid Chromatography (HPLC) 7.2.2.3. Liquid Chromatography/ Mass Spectrometry (LC/MS) 7.2.2.4. Others 8. Global Pharmaceutical Cleaning Validation Market Analysis and Forecasts, By Region 8.1. Market Size (Value) Estimates & Forecast By Region, 2020-2027 8.1.1. North America 8.1.2. Europe 8.1.3. Asia-Pacific 8.1.4. Middle East & Africa 8.1.5. South America 9. North America Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 9.1. Market Size (Value) Estimates & Forecast By Specimen, 2020-2027 9.1.1. Small Molecule Drug 9.1.2. Peptides 9.1.3. Proteins 9.1.4. Cleaning Detergent 9.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 9.2.1. Non-specific Tests 9.2.1.1. Total Carbon Analysis (TC) 9.2.1.2. Total Organic Carbon Testing (TOC) 9.2.1.3. Non-purgeable Organic Carbon (NPOC) 9.2.1.4. Conductivity 9.2.1.5. Others 9.2.2. Product-specific Analytical Tests 9.2.2.1. Ultraviolet-Visible Spectroscopy (UV/VIS) 9.2.2.2. High Performance Liquid Chromatography (HPLC) 9.2.2.3. Liquid Chromatography/ Mass Spectrometry (LC/MS) 9.2.2.4. Others 10. North America Pharmaceutical Cleaning Validation Market Analysis and Forecasts, By Country 10.1. Market Size (Value) Estimates & Forecast By Country, 2020-2027 10.1.1. US 10.1.2. Canada 10.1.3. Mexico 11. U.S. Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 11.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 11.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 12. Canada Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 12.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 12.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 13. Mexico Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 13.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 13.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 14. Europe Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 14.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 14.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 15. Europe Pharmaceutical Cleaning Validation Market Analysis and Forecasts, By Country 15.1. Market Size (Value) Estimates & Forecast By Country, 2020-2027 15.1.1. U.K 15.1.2. France 15.1.3. Germany 15.1.4. Italy 15.1.5. Spain 15.1.6. Sweden 15.1.7. CIS Countries 15.1.8. Rest of Europe 16. U.K Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 16.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 16.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 17. France Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 17.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 17.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 18. Germany Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 18.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 18.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 19. Italy Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 19.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 19.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 20. Spain Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 20.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 20.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 21. Sweden Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 21.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 21.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 22. CIS Countries Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 22.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 22.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 23. Rest of Europe Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 23.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 23.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 24. Asia Pacific Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 24.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 24.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 25. Asia Pacific Pharmaceutical Cleaning Validation Market Analysis and Forecasts, by Country 25.1. Market Size (Value) Estimates & Forecast By Country, 2020-2027 25.1.1. China 25.1.2. India 25.1.3. Japan 25.1.4. South Korea 25.1.5. Australia 25.1.6. ASEAN 25.1.7. Rest of Asia Pacific 26. China Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 26.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 26.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 27. India Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 27.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 27.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 28. Japan Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 28.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 28.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 29. South Korea Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 29.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 29.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 30. Australia Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 30.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 30.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 31. ASEAN Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 31.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 31.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 32. Rest of Asia Pacific Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 32.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 32.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 33. Middle East Africa Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 33.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 33.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 34. Middle East Africa Pharmaceutical Cleaning Validation Market Analysis and Forecasts, by Country 34.1. Market Size (Value) Estimates & Forecast by Country, 2020-2027 34.1.1. South Africa 34.1.2. GCC Countries 34.1.3. Egypt 34.1.4. Nigeria 34.1.5. Rest of ME&A 35. South Africa Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 35.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 35.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 36. GCC Countries Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 36.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 36.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 37. Egypt Textile Reinforced Concrete e-Market Analysis and Forecasts, 2020-2027 37.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 37.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 38. Nigeria Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 38.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 38.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 39. Rest of ME&A Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 39.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 39.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 40. South America Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 40.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 40.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 41. South America Pharmaceutical Cleaning Validation Market Analysis and Forecasts, by Country 41.1. Market Size (Value) Estimates & Forecast by Country, 2020-2027 41.1.1. Brazil 41.1.2. Argentina 41.1.3. Rest of South America 42. Brazil Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 42.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 42.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 43. Argentina Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 43.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 43.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 44. Rest of South America Pharmaceutical Cleaning Validation Market Analysis and Forecasts, 2020-2027 44.1. Market Size (Value) Estimates & Forecast By Product Type, 2020-2027 44.2. Market Size (Value) Estimates & Forecast By Validation Test, 2020-2027 45. Competitive Landscape 45.1. Geographic Footprint of Major Players in the Global Pharmaceutical Cleaning Validation Market 45.2. Competition Matrix 45.2.1. Competitive Benchmarking of Key Players By Price, Presence, Market Share, Fiber Grades, and R&D Investment 45.2.2. New Grade Launches and Grade Enhancements 45.2.3. Market Consolidation 45.2.3.1. M&A by Regions, Investment, and Verticals 45.2.3.2. M&A, Forward Integration and Backward Integration 45.2.3.3. Partnership, Joint Ventures, and Strategic Alliances/ Sales Agreements 45.3. Company Profile: Key Players 45.3.1. Avomeen 45.3.1.1. Company Overview 45.3.1.2. Financial Overview 45.3.1.3. Geographic Footprint 45.3.1.4. Grade Portfolio 45.3.1.5. Business Strategy 45.3.1.6. Recent Development 45.3.2. Lucideon Limited 45.3.3. Suez 45.3.4. Hach 45.3.5. Teledyne Tekmar 45.3.6. SGS SA 45.3.7. QPharma, Inc 45.3.8. ProPharma Group 45.3.9. Merck KGaA 45.3.10. Intertek Group PLC 45.3.11. Kymos S.L 45.3.12. Shimadzu Corporation 45.3.13. Waters Corporation 45.3.14. Azbil Corporation 45.3.15. Kimberly-Clark Corporation 45.3.16. Ardmac 45.3.17. Clean Air Products 45.3.18. Labconco Corporation 45.3.19. Dynarex Corporation 46. Primary Key Insights

About This Report

Report ID 119035
Category Healthcare
Published Date Sep 2021
Updated Date
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