Pharmaceutical Cleaning Validation Market

Market Overview

The global pharmaceutical cleaning validation market size was valued at USD 16.25 billion in 2022. It is estimated to reach USD 25.86 billion by 2031, growing at a CAGR of 5.3% during the forecast period (2023–2031). 

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.

Market Dynamics

Global Pharmaceutical Cleaning Validation  Market Drivers

Rise in Pharmaceutical Manufacturing to Increase the Adoption of Cleaning Validation to Ensure Efficient Drug Production

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.

Increase in Awareness Regarding the Significance of Cleaning Validation

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.

Global Pharmaceutical Cleaning Validation Market Restraints

High Cost Associated with Cleaning Validation

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.

Global Pharmaceutical Cleaning Validation Market Opportunities

Increasing Outsourcing of Cleaning Validation

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.

Regional Analysis

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 Dominates the Global Market

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.

Segmental Analysis

The global pharmaceutical cleaning validation market is bifurcated into product types and validation tests.

Based on product type, the global market is bifurcated into small molecule drugs, peptides, proteins, and cleaning detergents. 

The small molecule drugs segment dominates the global market and is projected to exhibit a CAGR of 4.5% over the forecast period. Small molecule drugs are compounds with a well-defined chemical structure manufactured through chemical synthesis. Increasing adoption and manufacturing of small molecule drugs can also be analyzed as per recent approval trends and the current product pipeline. In 2018, the FDA approved around 59 new drugs, which include 71.0% of small molecules and 29.0% of biologics.

According to the article published by a leading B2B media company, William Reed, in May 2018, small molecules support innovative treatment for the four disease indications: diabetes, oncology, respiratory, and autoimmune diseases, accounting for the growth of more than half of the global pharmaceutical industry. It also stated that small molecule drugs play a significant role in some areas of regenerative medicine, such as stem cell therapy, for triggering a therapeutic reaction. This, in turn, has bolstered the adoption of cleaning validation in pharmaceutical drug manufacturing for ensuring drug safety and monitoring impurities, active pharmaceutical ingredients, and other potential contaminants, which can increase patient risk due to cross-contamination from previous manufacturing processes or after every batch manufacturing.

Based on validation tests, the global market is bifurcated into Nonspecific Tests and Product-Specific Analytical Tests. 

The Nonspecific Tests segment dominates the global market and is projected to exhibit a CAGR of 5.9% over the forecast period. Advancements in analytical technologies and high manufacturing costs are leading to evaluating alternative methods in the pharmaceutical industry to enable greater efficiency and productivity. Testing of cleaning validation samples requires a validated method; the extent of validation depends upon the method’s capability, the type of method employed, the anticipated outcome of the testing, and the scientific and regulatory requirements of the resulting data.

Additionally, the adoption of a nonspecific method for cleaning validation has significantly increased during the past decades as product-specific analytical testing methods such as Enzyme-Linked Immunosorbent Assay (ELISA) or HPLC have proven to be a barrier in the cleaning validation process because they contribute to equipment downtime after cleaning. In addition, several companies are implementing nonspecific methods such as TOC as an analytical method for verifying the performance of the cleaning validation process and its associated critical cleaning parameters.

Recent Developments

• March 2023- The US Food and Drug Administration (FDA) issued guidance on cleaning validation for biopharmaceutical manufacturing. The guidance provides recommendations for how pharmaceutical companies can validate their cleaning processes to ensure that no residual active pharmaceutical ingredients (APIs) or excipients from previous batches are present in the equipment and systems used to manufacture new batches.

• February 2023- The European Medicines Agency (EMA) published a new guideline on cleaning validation. The guideline provides updated recommendations for how pharmaceutical companies can validate their cleaning processes to ensure no residues from previous batches of products are present in the equipment and systems used to manufacture new batches.