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 |
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.
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:
Table 1: Global Market Value (US$ Million) Forecast by Region, 2017 to 2032
Table 2: Global Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 3: Global Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 4: North America Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 5: North America Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 6: North America Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 7: Latin America Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 8: Latin America Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 9: Latin America Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 10: Europe Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 11: Europe Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 12: Europe Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 13: East Asia Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 14: East Asia Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 15: East Asia Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 16: South Asia Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 17: South Asia Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 18: South Asia Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 19: Oceania Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 20: Oceania Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 21: Oceania Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Table 22: MEA Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 23: MEA Market Value (US$ Million) Forecast by Validation Test, 2017 to 2032
Table 24: MEA Market Value (US$ Million) Forecast by Product Type, 2017 to 2032
Figure 1: Global Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 2: Global Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 3: Global Market Value (US$ Million) by Region, 2022 to 2032
Figure 4: Global Market Value (US$ Million) Analysis by Region, 2017 to 2032
Figure 5: Global Market Value Share (%) and BPS Analysis by Region, 2022 to 2032
Figure 6: Global Market Y-o-Y Growth (%) Projections by Region, 2022 to 2032
Figure 7: Global Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 8: Global Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 9: Global Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 10: Global Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 11: Global Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 12: Global Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 13: Global Market Attractiveness by Validation Test, 2022 to 2032
Figure 14: Global Market Attractiveness by Product Type, 2022 to 2032
Figure 15: Global Market Attractiveness by Region, 2022 to 2032
Figure 16: North America Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 17: North America Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 18: North America Market Value (US$ Million) by Country, 2022 to 2032
Figure 19: North America Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 20: North America Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 21: North America Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 22: North America Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 23: North America Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 24: North America Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 25: North America Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 26: North America Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 27: North America Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 28: North America Market Attractiveness by Validation Test, 2022 to 2032
Figure 29: North America Market Attractiveness by Product Type, 2022 to 2032
Figure 30: North America Market Attractiveness by Country, 2022 to 2032
Figure 31: Latin America Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 32: Latin America Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 33: Latin America Market Value (US$ Million) by Country, 2022 to 2032
Figure 34: Latin America Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 35: Latin America Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 36: Latin America Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 37: Latin America Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 38: Latin America Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 39: Latin America Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 40: Latin America Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 41: Latin America Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 42: Latin America Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 43: Latin America Market Attractiveness by Validation Test, 2022 to 2032
Figure 44: Latin America Market Attractiveness by Product Type, 2022 to 2032
Figure 45: Latin America Market Attractiveness by Country, 2022 to 2032
Figure 46: Europe Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 47: Europe Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 48: Europe Market Value (US$ Million) by Country, 2022 to 2032
Figure 49: Europe Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 50: Europe Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 51: Europe Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 52: Europe Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 53: Europe Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 54: Europe Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 55: Europe Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 56: Europe Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 57: Europe Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 58: Europe Market Attractiveness by Validation Test, 2022 to 2032
Figure 59: Europe Market Attractiveness by Product Type, 2022 to 2032
Figure 60: Europe Market Attractiveness by Country, 2022 to 2032
Figure 61: East Asia Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 62: East Asia Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 63: East Asia Market Value (US$ Million) by Country, 2022 to 2032
Figure 64: East Asia Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 65: East Asia Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 66: East Asia Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 67: East Asia Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 68: East Asia Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 69: East Asia Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 70: East Asia Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 71: East Asia Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 72: East Asia Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 73: East Asia Market Attractiveness by Validation Test, 2022 to 2032
Figure 74: East Asia Market Attractiveness by Product Type, 2022 to 2032
Figure 75: East Asia Market Attractiveness by Country, 2022 to 2032
Figure 76: South Asia Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 77: South Asia Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 78: South Asia Market Value (US$ Million) by Country, 2022 to 2032
Figure 79: South Asia Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 80: South Asia Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 81: South Asia Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 82: South Asia Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 83: South Asia Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 84: South Asia Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 85: South Asia Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 86: South Asia Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 87: South Asia Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 88: South Asia Market Attractiveness by Validation Test, 2022 to 2032
Figure 89: South Asia Market Attractiveness by Product Type, 2022 to 2032
Figure 90: South Asia Market Attractiveness by Country, 2022 to 2032
Figure 91: Oceania Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 92: Oceania Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 93: Oceania Market Value (US$ Million) by Country, 2022 to 2032
Figure 94: Oceania Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 95: Oceania Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 96: Oceania Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 97: Oceania Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 98: Oceania Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 99: Oceania Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 100: Oceania Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 101: Oceania Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 102: Oceania Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 103: Oceania Market Attractiveness by Validation Test, 2022 to 2032
Figure 104: Oceania Market Attractiveness by Product Type, 2022 to 2032
Figure 105: Oceania Market Attractiveness by Country, 2022 to 2032
Figure 106: MEA Market Value (US$ Million) by Validation Test, 2022 to 2032
Figure 107: MEA Market Value (US$ Million) by Product Type, 2022 to 2032
Figure 108: MEA Market Value (US$ Million) by Country, 2022 to 2032
Figure 109: MEA Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 110: MEA Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 111: MEA Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 112: MEA Market Value (US$ Million) Analysis by Validation Test, 2017 to 2032
Figure 113: MEA Market Value Share (%) and BPS Analysis by Validation Test, 2022 to 2032
Figure 114: MEA Market Y-o-Y Growth (%) Projections by Validation Test, 2022 to 2032
Figure 115: MEA Market Value (US$ Million) Analysis by Product Type, 2017 to 2032
Figure 116: MEA Market Value Share (%) and BPS Analysis by Product Type, 2022 to 2032
Figure 117: MEA Market Y-o-Y Growth (%) Projections by Product Type, 2022 to 2032
Figure 118: MEA Market Attractiveness by Validation Test, 2022 to 2032
Figure 119: MEA Market Attractiveness by Product Type, 2022 to 2032
Figure 120: MEA Market Attractiveness by Country, 2022 to 2032
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.
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