The global pharmaceutical cleaning validation market size was valued at USD 17.11 billion in 2023. It is estimated to reach USD 27.23 billion by 2032, growing at a CAGR of 5.3% during the forecast period (2024–2032).
Increasing demand for cleaning validation in manufacturing units across the pharmaceutical industry is one of the key factors anticipated to drive pharmaceutical cleaning validation growth over the forecast period. Pharmaceutical cleaning validation is a critical process in the pharmaceutical industry that ensures equipment, facilities, and utensils used in manufacturing are thoroughly cleaned to minimize the risk of cross-contamination and ensure product quality and patient safety. During pharmaceutical manufacturing, equipment and surfaces come into contact with various materials, including active pharmaceutical ingredients (APIs), excipients, cleaning agents, and contaminants. Inadequate cleaning can result in the carryover of residues to subsequent batches, potentially leading to product adulteration or unintended drug interactions. Cleaning validation is conducted to provide documented evidence that cleaning procedures consistently and effectively remove these residues to predetermined acceptable levels.
Pharmaceutical cleaning validation is necessary for the pharmaceutical industry to ensure equipment, facilities, and utensils are effectively cleaned. By implementing rigorous cleaning procedures, conducting thorough validation studies, and maintaining comprehensive documentation, pharmaceutical companies can mitigate cross-contamination risks, maintain product quality, and ensure patient safety.
Pharmaceutical companies are always under pressure to accelerate innovation and enhance the rate of introducing new products to the market. Several scientific breakthroughs are fueling pharmaceutical manufacturing innovation. The U.S. FDA supports these advancements by taking a more pragmatic approach to regulation, which assists the sector in accelerating the throughput of therapeutics and lifesaving medicines. Pharmaceutical companies are focused on producing high-quality, safe medications to fulfill worldwide demand.
In addition, process and product standardization are primary objectives to minimize batch-to-batch variability. The rise in the demand and growth in sales of pharmaceutical drugs are leading to an increase in the demand for cleaning validation for ensuring drug safety, monitoring impurities, Active Pharmaceutical Ingredients (APIs), and other potential contaminants that can increase patient risk by resulting in cross-contamination from the previous manufacturing process or after every batch manufacturing.
Various sources of contamination include product flow, raw materials, personnel, and machinery, which are likely to contaminate the overall production cycle, resulting in the contamination of the end product. The rising adoption of cleaning validation is anticipated to ensure the sterility of the final product and overall manufacturing processes.
Cleaning validation is an integral part of the pharmaceutical industry owing to various benefits offered by these methods for identifying and correcting potential problems that have been unsuspected previously and could compromise the efficiency, safety, or quality of subsequent product batches. Several technical and economic benefits are associated with adopting cleaning validation in manufacturing sectors, such as avoiding cross-contamination between production batches, gaining a superior ranking in the market, improving product flow, and developing a more organized manufacturing process with cost-effectiveness and optimum time. These solutions are usually customized as per industry needs and are anticipated to offer the right environment that helps comply with regulatory standards.
Detecting and quantifying residual trace concentrations of excipients, APIs, and washes during cleaning validation operations on pharmaceutical production equipment is one of the most expensive aspects of the industry. In addition, due to extensive lab (HPLC) analytical throughput constraints, present cleaning validation costs are dominated by high labor costs of swabbing and about 90 hours of production equipment downtime. For instance, pill process production in pharmaceutical companies takes around 12 hours to combine and press a tablet, after which the machinery is dismantled and cleaned (4 hours). This is followed by the swabbing process of a 25-cm2 area at 100 to 300 locations within each piece of the manufacturing equipment, extraction of residual contamination picked up by each swab, and conducting validation tests for each sample through the HPLC instrument. This takes around 30 minutes per sample, accounting for 90 hours or four days after producing a single batch of pills for validating adequate equipment cleaning as per internal and FDA regulations in preparation for producing a fresh batch of pills. Combined with the idle time of manufacturing equipment, this process is highly laborious and expensive.
The increasing outsourcing of cleaning validation in the pharmaceutical industry has opened up new opportunities for specialized service providers. Pharmaceutical companies recognize the value of leveraging the expertise and experience of external partners who are well-versed in the complexities of cleaning validation. Outsourcing cleaning validation allows pharmaceutical companies to focus on their core competencies, such as drug development, manufacturing, and quality control, while leaving the intricate and time-consuming cleaning validation to the experts. Service providers specializing in cleaning validation bring extensive knowledge of regulatory requirements, industry standards, and best practices, ensuring that the cleaning processes meet the guidelines and standards set by regulatory bodies such as the FDA and EMA.
The increasing trend of outsourcing cleaning validation in the pharmaceutical industry creates ample opportunities for specialized service providers. These providers offer expertise, experience, advanced technologies, and cost savings, allowing pharmaceutical companies to ensure compliance with regulatory standards while optimizing their operations. The outsourcing model enables pharmaceutical companies to streamline their processes, mitigate risks, and ultimately deliver high-quality, safe products to the market.
| Study Period | 2020-2032 | CAGR | 5.30% |
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 17.11 billion |
| Forecast Year | 2032 | Forecast Year Market Size | USD 27.23 billion |
| Largest Market | North America | Fastest Growing Market | Europe |
Based on region, the global pharmaceutical cleaning validation market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global pharmaceutical cleaning validation market shareholder and is estimated to grow at a CAGR of 6.2% over the forecast period. North America dominated the pharmaceutical cleaning validation market due to sophisticated healthcare infrastructure, high disease burden, and increased demand for pharmaceutical and medical device remedies. The presence of major key pharmaceutical companies in North America directly contributes to the growing demand for cleaning validation products and services. The objective of cleaning validation methods is to cross-check the effectiveness of cleaning processes for controlling potential microbial contamination and removing degradation products, product residuals, excipients, preservatives, and cleaning agents.
Moreover, cleaning validation procedures and methods are vital to the Good Manufacturing Practices (GMP) Compliance program. The cleaning validation procedures in pharmaceuticals have been among the most evolving and debated topics during 2018–2019. The pharmaceutical industry was transitioning from a traditional V model toward a risk and science-based validation model and shifting from its traditional methods to Health Based Exposure Limits (HBEL). Over recent years, major regulators have been revising their pharmaceutical cleaning validation guidelines. For instance, the U.S. FDA declared guidelines on acceptable residue levels, total organic carbon levels, rinse sampling, and continuous process verification.
Europe is anticipated to exhibit a CAGR of 3.6% over the forecast period. The healthcare industry in Europe is under pressure, owing to key factors such as rising costs, increasing prevalence of chronic conditions, rapidly aging population, and growing demand for optimum medical treatments. The industry also faces issues due to structural inefficiencies in certain European countries. The move to value-based healthcare is expected to boost the demand for better patient outcomes at a more sustainable cost. Medicine development and manufacturing in Europe are rapidly developing owing to advancements in science and technology.
Furthermore, per the European Federation of Pharmaceutical Industries and Associations (EFPIA) Report 2019, the pharmaceutical industry is the European Union's main strength. It is valued at USD 309,600 million (EUR 260,000 million) in production, USD 488,047 million (EUR 410,000 million) in export, and USD 363,160 million (EUR 305,000 million) in import. The governing body managing and revising the guidelines and regulations in the European pharmaceutical space is the European Medicines Agency (EMA), a frontrunner in laying down risk-based cleaning validation guidelines to prevent cross-contamination at manufacturing facilities.
The Asia-Pacific healthcare industry is emerging and developing year-on-year owing to advancements in healthcare infrastructure, development of human healthcare resources, increased expenditure on personal health, growing geriatric population, increasing prevalence of chronic diseases, growing R&D facilities, increasing support from public and private organizations, growing medical tourism, and growing healthcare affordability and accessibility. Moreover, the transition toward value-based healthcare is expected to boost the demand for better patient outcomes at a more reasonable cost. The developing science and technology industry is boosting the growth of the Asia-Pacific pharmaceutical industry.
The pharmaceutical market in Latin America is transitioning to become a potential market for investment and growth. The overall healthcare landscape in Latin America is rapidly changing. The growing prevalence of diseases and increasing wealth in different demographic segments drive the need for high-quality manufacturing and distribution. Furthermore, countries in Latin America are receiving investments since the pharmaceutical business in the region is growing and developing.
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The global pharmaceutical cleaning validation market is bifurcated into product types and validation tests.
The pharmaceutical cleaning validation market is segmented into several categories, including small molecule drugs, peptides, proteins, and cleaning detergents. Among these, the small molecule drug segment holds a dominant position. This prominence is attributable to the extensive use and production of small-molecule drugs, which necessitates rigorous cleaning validation to prevent cross-contamination and ensure the drugs' effectiveness and safety. Small molecules are foundational to many treatments across a wide range of therapeutic areas, making their production processes critical. According to the National Center for Biotechnology Information, of the 55 drugs approved this year, 17 are biologics, 9 are TIDES, and 29 are small molecules. This data underscores the substantial number of small molecule drugs entering the market, totalling 38 new chemical entities (NCEs) when combined with TIDES. The high volume of small molecule drug approvals highlights an increasing demand for effective cleaning validation processes to maintain high standards in drug production. Consequently, this segment’s robust growth drives a significant portion of the market for cleaning validation services and products, as ensuring cleanliness and preventing contamination are crucial for the efficacy and safety of these widely used pharmaceuticals.
The pharmaceutical cleaning validation market is segmented by validation tests into non-specific tests and product-specific analytical tests. Non-specific tests include Total Carbon Analysis (TC), Total Organic Carbon Testing (TOC), Non-purgeable Organic Carbon (NPOC), conductivity, and other methods. While these are essential for general cleanliness assessment, the product-specific analytical tests segment dominates the market. This dominance is due to the precision and specificity of tests such as Ultraviolet-Visible Spectroscopy (UV/VIS), High Performance Liquid Chromatography (HPLC), Liquid Chromatography/Mass Spectrometry (LC/MS), and others.
Among these, High Performance Liquid Chromatography (HPLC) is the most widely used method within the product-specific analytical tests segment. HPLC's popularity is driven by its versatility and effectiveness, offering a range of detection methods, including UV, fluorescence, photodiode array, evaporative light scattering, refractive index, and corona charged aerosol detection. It provides quantitative results, excellent peak separation, and the ability to use various solvents for extraction solutions. In addition to HPLC, other analytical tests such as ultraviolet spectroscopy, 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, further highlighting the importance and complexity of ensuring cleanliness in pharmaceutical manufacturing.
