Global Pharmaceutical Cleaning Validation Market Size Expected to Reach USD 22.29 Billion by 2028 | CAGR: 5.6%: Polaris Market Research


According to the research report, the global Pharmaceutical Cleaning Validation Market size and share was valued at USD 14.53 Billion in 2020 and is projected to reach USD 22.29 Billion by 2028, to grow at a CAGR of 5 .6% over the forecast period.

According to the research report, the global pharmaceutical cleaning validation market size and share was valued at USD 14.53 billion in 2020 and is expected to reach USD 22.29 billion by 2028to grow to a 5.6% CAGR during the forecast period.

Cleaning validation is recorded evidence with a high degree of assurance, and one can continuously clean a system or instrument to pre-established acceptable limits. The objective of Good Manufacturing Practices (GMP) involves the prohibition of possible contamination or cross-contamination of pharmaceutical products and raw materials. Pharmaceutical products can be degraded by the heterogeneity of substances such as pollutants linked to old products, microbes, remnants of cleaning agents, airborne materials such as particles, lubricants and dust. Validation of cleaning procedures will provide equipment that is clean and suitable for its intended use.

Cleaning validation is a systematic approach to ensuring that the cleaning process is reliable and repeatable. The cleaning validation process requires a series of documented proofs. It includes a corporate cleaning validation policy, a cleaning validation master plan and cleaning procedures that incorporate the time from the end of production to the start of the cleaning procedure and the cleaning processes used for each manufacturing system and each piece of equipment. These processes must be directed through the production and quality functions.

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Report Highlights

  • Market intelligence to ensure effective decision-making
  • Analysis of trends and growth opportunities
  • Market valuation based on segment and region revenue forecasts
  • Market share analysis and competitive strategy
  • Listing product innovation to stay ahead
  • Impact of covid-19 and how to survive in these rapidly changing markets

The main players in the global market are:

  • Avomeen
  • Chopped
  • PLC of the Intertek group
  • Kymos SL
  • Lucideon Limited
  • Merck KGaA
  • ProPharma Group
  • QPharma Inc.
  • SGS S.A.
  • Shimadzu Company
  • Suez
  • Teledyne Tekmar
  • water company

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Important Questions Answered by the Market Report

  • What is the size and growth of the market?
  • Which region is considered the largest Pharmaceutical Cleaning Validation Market share?
  • Who are the key players in the Pharmaceutical Cleaning Validation Market?
  • How will the market evolve in the coming years?
  • What are the market drivers and constraints?
  • Which regional market will show the strongest growth?
  • What will be the CAGR and market size throughout the forecast period?

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Pharmaceutical Cleaning Validation Market: Growth Factors

The growing demand for drugs is driving an increase in the cleaning validation market to ensure drug safety, leftover observation, adulteration, and potential alternative pollutants that could generate cross-contamination from the previously manufactured batch. Therefore, the validation of cleaning produces an integral process, of which the need for awareness and instruction of market players increases.

The massive advance of pharmaceutical manufacturing facilities, the increasing pervasiveness of diseases and the growing failing global population, rising healthcare expenditures and increasing market funding to connect regulatory standards set by international governing bodies such as the US FDA and the European Medicines Agency (EMA). The market has grown due to pharmaceuticals accelerating the need for cleaning validation to ensure product safety, observe likely contamination, and determine pollutants.

The covid-19 pandemic has dramatically changed the healthcare industry and hugely impacted global businesses and the economy. The pharmaceutical companies dominating the necessary resources are focusing on building up the establishment of various therapies and treatment alternatives to stem the pandemic. It has positively influenced the cleaning validation market and multiplied the quality and safety of products produced by these pharmaceutical companies.

Global Pharmaceutical Cleaning Validation Market: Report Scope

Report attribute


Market Size Value 2020

$14.53 billion

Market Outlook for 2028

$22.29 billion

Expected CAGR Growth

5.6% from 2021 to 2028

Year of reference


Forecast period

2021 – 2028

Segments Covered

By product, by test, by region

Key companies

Avomeen, Hach, Intertek Group PLC, Kymos SL, Lucideon Limited, Merck KGaA, ProPharma Group, QPharma, Inc., SGS SA, Shimadzu Corporation, Suez, Teledyne Tekmar and Waters Corporation.

Regional scope

North America, Europe, Asia-Pacific, Latin America, Middle East and Africa

Personalization options

Custom purchase options are available to meet your research needs.

Pharmaceutical Cleaning Validation Market: Key Segmentation

  • Overview by product, test and region

By product, the small molecule drugs segment dominated the market, which was considered the largest revenue share. Large volumes of compact drugs are manufactured every year, accounting for the largest market share in the segment. Thus, the increasing production levels of compact molecule drugs underpin the development of the demand for cleaning validation. By test, product-specific analytical test segments dominated the market due to ultraviolet spectroscopy, high performance liquid chromatography, near infrared spectroscopy, mid-infrared spectroscopy, and capillary zone electrophoresis. These segments are commonly used in cleaning validation.

By region, North America dominates the market owing to the increasing adoption of cleaning validation by pharmaceutical manufacturing companies to meet the stringent regulatory merit legislated by the US FDA. The existence of international and local pharmaceutical companies, rising healthcare expenditures, increasing burden of disease and increasing levels of awareness drive the regional revenue share. Asian countries are also seeing an increasing demand for pharmaceutical cleaning validation procedures, and there is a gradual development. The existence of large pharmaceutical manufacturing plants and increasing funding from international pharmaceutical companies are the major frameworks pushing the regional growth.

Browse all “Pharmaceutical Cleaning Validation Market Share, Size, Trends, Industry Analysis Report, By Product (Small Molecule Drug, Peptides, Proteins, Cleaning Detergent); Per trial; By region; Sector forecasts, 2021 – 2028 » Report at

The market mainly depends on the product, the test and the region

Pharmaceutical Cleaning Validation Market: By Product

  • small molecule drug
  • peptides
  • Proteins
  • Cleaning detergent

Pharmaceutical Cleaning Validation Market: By Test

  • Non-specific tests
    • Total Carbon (TC) Analysis
    • Total Organic Carbon (TOC) Analysis
    • Non Purgeable Organic Carbon (NPOC)
    • Conductivity
    • Others
  • Product specific analytical tests
    • UV-Visible Spectroscopy (UV/VIS)
    • High Performance Liquid Chromatography (HPLC)
    • Liquid Chromatography/Mass Spectrometry (LC/MS)
    • Others

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