The Pharmaceutical Cleaning Validation market was valued at around USD 15.7 Billion in 2021. With a projected CAGR of 6.8% for the next ten years, the market is likely to reach a valuation of nearly USD 32.3 Billion by the end of 2032.
The recent surge in stringent guidelines and regulations has triggered the demand for Cleaning Validations in the Pharmaceutical Industry.
| Attributes | Details |
|---|---|
| Pharmaceutical Cleaning Validation Market Size (2022E) | USD 16.7 Billion |
| Projected Market Value (2032F) | USD 32.3 Billion |
| Global Market Growth Rate (2022 to 2032) | 6.8% CAGR |
| North America Market Share (2021) | 40% |
| Key Companies Profiled | Shimadzu Corporation; Intertek Group PLC; Merck KGaA; SUEZ; Hach; Avomeen LLC; QPharma Inc.; SGS SA; ProPharma Group; Kymos S.L.; Waters Corporation; Lucideon Limited |
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The global market for Cleaning Validations in the Pharmaceutical industry expanded at a CAGR of 6% from 2017 to 2021. The market growth is projected to augment because of updates and revisions to existing cleaning validation guidelines in the pharmaceutical sector along with the release of new guidelines.
It is anticipated that organizations like the European Medicines Agency (EMA) will be instrumental in the increase in avenues for the key industry players shaping the Pharmaceutical Cleaning Validation Market in the forthcoming years.
The global Pharmaceutical Cleaning Validation market is predicted to surge ahead at a CAGR of 6.8% and record sales worth USD 32.3 Billion by the end of 2032. The USA will continue to be the largest market throughout the analysis period accounting for over USD 5.1 Billion absolute dollar opportunity in the coming 10-year epoch.
European Medicines Agency (EMA) is the pacesetter with regard to the development of risk-based cleaning validation guidelines for the prevention of cross-contamination in numerous shared facilities for manufacturing across the globe.
In May 2020, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), initiated documents containing guidelines and QnAs pertaining to the Implementation of Risk-based Prevention of Cross-Contamination in Production and the setting of Health-Based Exposure Limits (HBEL) in order to identify risks in the manufacturing of various pharmaceutical products in numerous shared facilities.
These regulations are based on the 2018 EMA guidelines. In 2021, the FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new novel therapeutics. As of November 2021, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued recommendations for the approval of as many as 57 new medicines, vaccines, and therapeutic biologics, of which around 36 had been granted marketing authorization.
Owing to these newly approved drugs and therapeutics, the Pharmaceutical Cleaning Validation Market is set to witness growth during the forthcoming years, in order to keep up with the strict guidelines of regulatory agencies such as EMA and the USA FDA for cleaning validation processes.
The driving factors behind the growth of the Pharmaceutical Cleaning Validation Market in the Asia-Pacific region during the forthcoming years are recognized to be the augmented funding by the intercontinental Pharmaceutical corporations in big production enterprises.
In September 2019, the primordial ISPE Asia-Pacific Pharmaceutical Manufacturing Conference was arranged by the International Society of Pharmaceutical Engineering, and the following year, in September 2020, the second edition. Included among the considerable points of discussion were the control of cross-contamination and cleaning validation. As of 2020, the net sales of Shimadzu Corporation in Japan witnessed an increase of around 3% in comparison to the previous year.
Shimadzu Corporation’s sales in China rose by an extensive 20% in 2020 relative to that of 2019. This increase is mainly attributed to the increased requirement for Liquid chromatographs and mass spectrometers owing to Pharmacopoeia revisions.
The Pharmaceutical Cleaning Validation Market in China is projected to witness a growth of 8.6% CAGR during the coming 10-year epoch to reach a total market valuation of USD 4.1 Billion by the end of 2032. This is among the various attributes responsible for the growth of the Pharmaceutical Cleaning Validation Market in Asia-Pacific during the forthcoming years.
With a market share of approximately more than 40%, the Pharmaceutical Cleaning Validation Market in the North American region is expected to maintain its dominant position in the market during the forthcoming years. The binding guidelines of authorization organizations like the USA FDA and Health Canada have generated and augmented the requirement for cleaning validation processes in the Pharmaceutical Industry for the prevention of cross-contamination and expanding their control processes related to product quality.
The Cleaning Validation Guide (GUI-0028) published by Health Canada in June 2021, with its revised guidelines, lays heavy emphasis on a Cleaning Validation Master Plan or any equivalent document, outlining the general cleaning policies at the manufacturing site for any and all players in the Pharmaceutical Industry.
The FDA ensures complete compliance with the CGMP regulations by thoroughly examining the manufacturing procedures in the Pharmaceutical Industry. This is attributed to its Code of Federal Regulations (CFR). The 21 CFR Part 211 contains the Current Good Manufacturing Practice (CGMP) rules for Finished Pharmaceuticals. This is projected to be advantageous for the Pharmaceutical Cleaning Validation Market in the North-American region.
The USA is projected to keep its market share of over 30% in the Global Pharmaceutical Cleaning Validation Market intact with a CAGR of 6.5% during the forthcoming years. It is anticipated that the Pharmaceutical Cleaning Validation Market in the country will reach total market revenue of USD 10.9 Billion by experiencing an absolute dollar opportunity of USD 5.1 Billion during the forecast period.
Purdue University, collaborated with the USA pharmacopeia, beginning in August 2021, following impetus from Aprecia Pharmaceuticals, to advance the pharmaceutical validation market technology forum.
Taking into account February 2021, Article of Aptitude Health, the USA FDA’s Center for Drug Evaluation and Research (CDER) approved as many as 53 novel drugs, both as new molecular entities (NMEs) and new therapeutic biologics in 2020.
This is forecasted to have a positive impact on the role of the USA in the Global Cleaning Validation Demand in the Pharmaceutical Industry owing to the guidelines of the FDA, which emphasize strict adherence to the Cleaning Validation Procedures.
The market in the United Kingdom is projected to reach a valuation of USD 1.5 Billion by 2032. With a CAGR of 8% from 2022 to 2032, the market in the country is expected to gross an absolute dollar opportunity of USD 824 Million.
In Japan, the market is expected to reach USD 1.2 Billion by 2032, growing at a CAGR of 6.7% during the forecast period. From 2022 to 2032, the market is likely to register an absolute dollar opportunity of USD 577 Million.
The market in South Korea is expected to reach a valuation of USD 614 Million by 2032. With a CAGR of 6.3% during the forecast period, the market is likely to gross an absolute dollar opportunity of USD 281 Million.
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The Product-specific Analytical Tests segment is anticipated to expand with a CAGR of 6.4% by the end of 2032. The Product-Specific Analytical Test segment is forecasted to benefit from the increase in the requirement for High-Performance Liquid Chromatography (HPLC) testing, due to its growing importance in the procedures related to drug approvals.
The customary use of High-Performance Liquid Chromatography (HPLC) testing during the manufacturing procedures of the Pharmaceutical Industry finds additional corroboration in the fact that it provides required precise results, further helping the key market players to be on par with the various guidelines of the regulatory agencies during the upcoming 10-year forecast epoch.
The Small Molecule Drug segment is forecasted to grow with an 8.1% CAGR during the 10-year epoch. Factors like the FDA’s Center for Drug Evaluation and Research (CDER) granting authorization to as many as 53 recent drugs, 38 of which were small molecule drugs in 2020 are projected to be advantageous to the Small Molecule Drug segment by Product-type of the Pharmaceutical Cleaning Validation Market during the forthcoming years.
Even in 2021, with 34 approvals the small molecule drugs made up half of as many as 50 novel drug approvals. Due to the stringent guidelines and regulations of the authorities like the EMA (European Medicines Agency) and the USA FDA (USA Food and Drug Administration), the requirement for better cleaning validation in these increasing levels of production of Small Molecule Drugs is set to rise, leading to better avenues for the key players of the Pharmaceutical Cleaning Validation Industry during the upcoming 10-year forecast epoch.
Shimadzu Corporation, Intertek Group PLC, Merck KGaA, SUEZ, Hach, Avomeen LLC, QPharma Inc., SGS SA, ProPharma Group, Kymos S.L., Waters Corporation, and Lucideon Limited are among the key players in the global pharmaceutical cleaning validation market.
Some of the recent developments in the market are:
The Pharmaceutical Cleaning Validation market was valued at USD 15.7 Billion in 2021.
The Pharmaceutical Cleaning Validation industry is set to witness a growth rate of 6.8% over the forecast period and be valued at USD 32.3 Billion by 2032.
Shimadzu Corporation, Intertek Group PLC, Merck KGaA, Suez, Hach, Avomeen, QPharma Inc., SGS SA, ProPharma Group, Kymos S.L., Waters Corporation, and Lucideon Limited are among the key players shaping the Pharmaceutical Cleaning Validation Industry.
The continuous revision and expansion of guidelines for cleaning validation by regulatory agencies such as EMA and the U.S. FDA and the increase in the number of approved therapeutics and medicines are anticipated to favorably impact the global demand for cleaning validation in the Pharmaceutical Industry.
The market in the USA is expected to reach a valuation of USD 10.9 Billion during the forecast period along with a CAGR of 6.5%
The Asia Pacific market is expected to grow significantly during the forecast period mainly due to increasing awareness of the requirement of cleaning validation processes in the Pharmaceutical Industry, especially in China.
| Market Size (2023) | USD 206.44 billion |
|---|---|
| Anticipated Market Value (2033) | USD 282.88 billion |
| Market Projected Growth Rate (2023 to 2033) | 3.2% |
| Expected Market Value (2023) | USD 8653.0 million |
|---|---|
| Anticipated Forecast Value (2033) | USD 12002.3 million |
| Projected CAGR (2023 to 2033) | 3.3% |
| Market Value (2022) | USD 10,126.71 Million |
|---|---|
| Market Forecast Value (2032) | USD 28,754 Million |
| Market Expected CAGR (2022 to 2032) | 11% |
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Pharmaceutical Cleaning Validation Market
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