Pharmaceutical Cleaning Validation Market Share, Growth Rate, Comparison, Profit Estimation 2028

Pharmaceutical Cleaning Validation Industry Overview

The global pharmaceutical cleaning validation market size was valued at USD 14.6 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 5.5% from 2021 to 2028.

The rapid growth of pharma manufacturing facilities, the rising prevalence of diseases, the growing global geriatric population, increased healthcare expenditure, and rising investments in the market to comply with regulatory standards set by international governing bodies like U.S. FDA and the EMA.

The evolving regulations in the pharmaceutical manufacturing industry to prevent cross-contamination have positively impacted the growth of the market. Moreover, the governing bodies are opting for a more pragmatic approach to regulations, which supports the pharma industry in accelerating their manufacturing and quality control processes. The rising demand for medicinal drugs is directly contributing to the demand for cleaning validation to ensure the safety of the product, and monitor potential contamination, and impurities. Furthermore, to spread awareness regarding the importance of the cleaning validation process the International Society of Pharmaceutical Engineering organized the ISPE APAC Pharmaceutical Manufacturing Conference in September 2020.

Gather more insights about the market drivers, restrains and growth of the Global Pharmaceutical Cleaning Validation Market

U.S. pharmaceutical cleaning validation market size, by product type, 2018 - 2028 (USD Billion)

The U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) majorly lay down the guidelines and regulatory standards for cleaning validation in drug manufacturing. The EMA is a pioneer in setting regulatory standards for risk-based cleaning validation standards to avoid cross-contamination in manufacturing facilities. Following the EMA, Pharmaceutical Inspection Co-operation Scheme (PIC/S) laid down its own set of guidelines and established Health-Based Exposure Limits (HBEL) in shared manufacturing facilities. These factors have provided an impetus to the demand for cleaning validation for pharmaceutical manufacturers and positively impacted the market growth. Comparatively, the pharma industry is a more lifesaving and life-endangering industry compared to other industries and non-compliance could lead to hazardous consequences to human health, and therefore the regulatory standards are more stringent for the companies.

The pharmaceutical manufacturing industry has experienced positive growth during the pandemic owing to the rising number of drug approvals and the rising innovation and production of Covid-19 vaccines, which in turn has positively impacted the cleaning validation market to ensure patient safety and prevent cross-contamination between production batches. As per an article released by Aptitude Health in February 2021, the U.S. FDA approved more than 50 novel medications and novel therapeutic biologics in 2020. In 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency supported 50 novel medicines, vaccines, and therapeutic biologics.

The rise in pharma and life science product sales is further driving the market growth and demanding drug manufacturing processes. Additionally, demand for Good Manufacturing Practices (GMP) for drug ingredients and drug product manufacturing services has increased and CDMOs have an important role to place in the development of the Covid-19 vaccination as well as therapeutic monoclonal antibody products. This eventually, will boost the demand for medicinal drug manufacturing, which is positively impacting the market.

The ongoing Covid-19 pandemic has significantly transformed the healthcare industry and drastically impacted the global economy and businesses. Various businesses in the healthcare industries are playing a vital role in tackling the burden of the pandemic. The pharmaceutical companies possessing the required resources are focusing on innovating numerous therapies and treatment options to curb the pandemic. For example, Eli Lilly and Gilead Sciences have witnessed favorable market growth and innovation in the field of infectious diseases.

Similarly, pharmaceutical companies have experienced lucrative growth over the pandemic and have expanded their product pipeline, and received several drug approvals from regulatory bodies. This has positively impacted the cleaning validation market and has enhanced the safety and quality of products manufactured by these pharmaceutical companies. Since cleaning validation procedures form a vital part of the drug manufacturing process and ensure the safety, consistency, and efficacy of the pharmaceutical drug, the market has witnessed a positive growth rate during the pandemic.

Cleaning validation is an integral part of pharmaceutical manufacturing processes owing to the benefits offered such as the identification and correction of unsuspected potential problems which could compromise the efficiency, quality, and safety of subsequent batches of product. Adopting the cleaning validation processes has both economic and technical benefits such as prevention of cross-contamination, superior ranking, improved product flow, and a more efficient manufacturing process with cost-efficiency and time-saving. Moreover, the demand for pharmaceutical cleaning validation processes will witness growth in the forthcoming years owing to its advantages such as prevention of cross-contamination and complying with regulatory standards. Companies such as Suez, Hach, Waters Corporation, and Intertek Group PLC are a few big players operating in the market.

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Market Share Insights:

  • December 2019: PCI Pharma Services expanded its U.K. plant to strengthen its high-potency medication research and manufacturing capabilities.

Key Companies profiled:

Some of the prominent players in the global pharmaceutical cleaning validation market include:

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

Order a free sample PDF of the Pharmaceutical Cleaning Validation Market Intelligence Study, published by Grand View Research.

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