Pharmaceutical Cleaning Validation Market Size, Share & Trends Analysis Report By Product Type (Small Molecule Drug, Proteins, Peptides), By Validation Test, By Region, And Segment Forecasts, 2021 - 2028

Report 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.

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.

COVID-19 pharmaceutical cleaning validation market impact: 7.9% increase in 2020

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.

Product Type Insights

In 2020, the small molecule drug segment dominated the market and accounted for the largest revenue share of 46.9%. The large volumes of small drugs are manufactured every year accountable for the highest market share of the segment. For instance, the FDA approved around 59 new drugs in 2018, wherein 71% are small molecules, and 29% are biologics. Similarly, in 2019 small molecule drugs accounted for 75% of the pharmaceutical market. Therefore, the rising production levels of small molecule drugs are supporting the growth of cleaning validation demand. In addition, small-molecule drugs play a vital role in chronic diseases as well as regenerative medicine.

However, the peptide segment is expected to witness the fastest CAGR of 9.4% over the forthcoming years. Furthermore, peptides offer various advantages as compared to small molecule drugs. Since they are naturally occurring biologics, they are safer with greater selectivity, efficacy, and specificity. An increase in the number of approvals of peptide drugs for marketing authorization is among a few key factors expected to drive the growth of the segment in forthcoming years.

Validation Tests Insights

The product-specific analytical tests segment dominated the pharmaceutical cleaning validation market and accounted for the largest revenue share of 65.3% in 2020. Analytical tests, such as ultraviolet spectroscopy, high-performance liquid chromatography, liquid chromatography/mass spectrometry, near-infrared spectroscopy, mid-infrared spectroscopy, capillary zone electrophoresis, atomic absorption, ion mobility spectrometry, and enzyme-linked immunosorbent assay, are commonly used in cleaning validation.

Among these, High-performance Liquid Chromatography (HPLC) is the most commonly used method of cleaning validation and accounted for 50.9% of the revenue share in 2020 among the product-specific analytical tests segment. This is attributed to the advantages of using HPLC including large types of swabs that can be used, and multiple methods for detection such as UV, fluorescence, photodiode array, evaporative light scattering, refractive index, and corona charged aerosol detection, among others. Moreover, it offers quantitative results, peak separation, and different solvents for extraction solutions that can be used.

However, the non-specific tests segment is expected to witness significant growth over the forthcoming years as they provide the quantitative value of the complete formulation and degradation. Among the various non-specific tests, Total Organic Carbon (TOC) testing is gaining popularity since they are a cost-effective and time-saving test. As per a GR Healthcare whitepaper, operating costs for TOC analysis are 40-80% lesser than HPLC tests and 70-80% quicker analysis time compared to other conventional tests.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 40.2% in 2020 owing to the high adoption of cleaning validation by pharmaceutical manufacturing companies to comply with stringent regulatory standards laid down by the U.S. FDA and Health Canada. The presence of local and international pharmaceutical companies, growing healthcare expenditure on pharmaceutical drugs, increasing disease burden and rising awareness levels is contributing to the regional revenue share.

However, Asian countries are witnessing high demand for pharmaceutical cleaning validation processes and are gradually developing at a CAGR of 9.3%. The presence of large pharmaceutical manufacturing plants and increasing investments by international pharma companies are key parameters driving regional growth.

Key Companies & Market Share Insights

The key players are primarily focused on developing cleaning validation products and services for the pharmaceutical manufacturing industry to comply with regulatory standards, enhance product outcomes, and prevent cross-contamination, thereby positively impacting the market growth in the forthcoming years. Some of the prominent players in the 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

Pharmaceutical Cleaning Validation Market Report Scope

Segments Covered in the Report 

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research, Inc. has segmented the global pharmaceutical cleaning validation market report on the basis of product type, validation test, and region:

• Product Type Outlook (Revenue, USD Million, 2016 - 2028)

  • Small Molecule Drug

  • Peptides

  • Proteins

  • Cleaning Detergent

• Validation Test Outlook (Revenue, USD Million, 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

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Singapore

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • Saudi Arabia

    • South Africa

    • UAE