Pharmaceutical Cleaning Validation Market Expected to Reach US ~$22.29 Billion and CAGR 5.6% by 2028

The global pharmaceutical cleaning validation market size is expected to reach USD 22.29 billion by 2028 according to a new study by Polaris Market Research.

Major factors such as the rapid development of the pharma production services and facilities tied with growing investments and expenditure in the healthcare sector are impelling the market demand. Besides, rising government support and approvals of evolving products such as small molecules, peptides, etc., for the development of the pharmaceutical industry as well as rising demand for cleaning validation are contributing to the market growth across the globe.

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The peptide segment is projected to rise at a significant pace in the forecasting period due to its advantages. It is produced at low cost and offers more activity per mass, along with the increasing government approvals for the adoption of the segment fuels the segment growth in the approaching years.

The increasing number of regulatory standards for the risk-based cleaning validation standards brings an upsurge in the demand across the globe. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (U.S. FDA) are actively executing certain guidelines and regulatory standards intended for the risk-based validation standards to prevent cross-contamination across manufacturing services.

Likewise, Pharmaceutical Inspection Co-operation Scheme (PIC/S) set up its individual guidelines set and launch Health-Based Exposure Limits (HBEL) across mutual manufacturing amenities followed by the EMA. Accordingly, these factors propel the demand for cleaning validation for pharmaceutical manufacturers and contribute to industry development in the near future.

Some of the Major Players operating in the global market include Lucideon Limited, Shimadzu Corporation, Hach, Intertek Group PLC, Kymos S.L., Avomeen, Waters Corporation, ProPharma Group, QPharma, Inc., SGS SA, Teledyne Tekmar, Suez, and Merck KGaA are some of the key players operating in the global market.

There are numerous industry competitors introducing innovative products for expanding their business operations around the world. For instance, in August 2021, Purdue University came into partnership with the US Pharmacopeia after receiving incentives from Aprecia Pharmaceuticals to introduce a pharmaceutical validation industry technology forum.

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Polaris Market Research has segmented the pharmaceutical cleaning validation market report on the basis of product, test, and region:

 

Pharmaceutical Cleaning Validation, Product Outlook (Revenue, USD Billion, 2016 – 2028)

  • Small Molecule Drug
  • Peptides
  • Proteins
  • Cleaning Detergent

Pharmaceutical Cleaning Validation, Test Outlook (Revenue, USD Billion, 2016 – 2028)

  • Non-Specific Tests
    • Total Carbon Analysis (TC)
    • Total Organic Carbon Testing (TOC)
    • Non-purgeable Organic Carbon (NPOC)
    • Conductivity
    • Others
  • Product-Specific Analytical Tests
    • Ultraviolet-Visible Spectroscopy (UV/VIS)
    • High-Performance Liquid Chromatography (HPLC)
    • Liquid Chromatography/ Mass Spectrometry (LC/MS)
    • Others

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