Global Pharmaceutical Cleaning Validation Market Grows Steadily at a CAGR of 5.3%

Introduction

Pharmaceutical cleaning validation is a systematic and scientific approach to ensure that equipment, facilities, and utensils used in pharmaceutical manufacturing are thoroughly cleaned and free from any residues that could compromise product quality and patient safety. It involves establishing documented evidence that cleaning procedures are effective in removing contaminants and achieving predetermined acceptable cleanliness levels.

The cleaning validation process begins with developing a cleaning procedure that outlines the specific cleaning agents, methods, and parameters to be used. This procedure is designed based on the equipment, the substances it comes into contact with, and the cleaning challenges associated with the manufacturing process. It considers factors such as the solubility and nature of the residues, surface materials, and the effectiveness of different cleaning agents.

Market Dynamics

Rise in Pharmaceutical Manufacturing Drives the Global Market

The rise in pharmaceutical manufacturing activities globally has been a significant driver for adopting cleaning validation in the pharmaceutical industry. With the increasing demand for pharmaceutical products to cater to growing healthcare needs, pharmaceutical companies are expanding their manufacturing capabilities and setting up new production facilities. This expansion includes the development of new drug formulations, the introduction of advanced manufacturing technologies, and the scaling up of production volumes.

Additionally, the rise in pharmaceutical manufacturing activities globally is a key driver for adopting cleaning validation in the pharmaceutical industry. It enables pharmaceutical companies to ensure efficient drug production, maintain product quality, and comply with regulatory requirements. With the growing demand for pharmaceutical products and the increasing focus on patient safety, cleaning validation contributes significantly to maintaining the integrity and reliability of the pharmaceutical manufacturing process.

Increasing Outsourcing of Cleaning Validation Creates Tremendous Opportunities

The increasing outsourcing of cleaning validation in the pharmaceutical industry offers several more benefits and opportunities for specialized service providers. Firstly, outsourcing cleaning validation allows pharmaceutical companies to access a diverse pool of experienced professionals. Service providers employ a group of specialists who possess in-depth knowledge and expertise in cleaning validation. These professionals have extensive experience working with various pharmaceutical manufacturers, equipment, and cleaning processes. Their specialized knowledge and skills enable them to handle complex challenges and develop tailored cleaning validation strategies for clients.

Moreover, service providers often invest in state-of-the-art technologies and equipment to enhance their cleaning validation capabilities. By outsourcing to these providers, pharmaceutical companies gain access to advanced analytical techniques, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS). These sophisticated technologies enable accurate and reliable detection and quantification of residues, ensuring that cleaning processes meet the required standards.

Regional Analysis

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. Several aspects contribute to North America's dominant position in the global pharmaceutical cleaning validation market and the evolving landscape of cleaning validation procedures. One significant factor is the sophisticated healthcare infrastructure in North America. The region is known for its advanced pharmaceutical and medical device industries, with well-established manufacturing facilities and stringent regulatory standards. A robust healthcare infrastructure enables efficient drug production and drives the demand for effective cleaning validation procedures to guarantee patient safety and product quality.

North America also faces a high disease burden, necessitating the development and manufacturing of a wide range of pharmaceutical and medical device solutions. As a result, the demand for cleaning validation products and services is consistently high to meet the requirements of a diverse and demanding healthcare market. The concentration of major key pharmaceutical companies in North America further contributes to the growth of the cleaning validation market in the region. These companies significantly influence the adoption and implementation of cleaning validation procedures, leading to increased demand for related products and services.

Europe is anticipated to exhibit a CAGR of 3.6% over the forecast period. Several key factors contribute to this growth and the evolving landscape of European cleaning validation. The healthcare industry in Europe faces various challenges, including rising costs, an increasing prevalence of chronic conditions, a rapidly aging population, and the demand for optimal medical treatments. These factors pressure healthcare systems and necessitate developing and manufacturing high-quality pharmaceutical products.

In addition, effective cleaning validation processes ensure product quality and patient safety in this demanding healthcare environment. The move towards value-based healthcare in Europe further drives the demand for better patient outcomes at a more sustainable cost. This shift emphasizes the importance of efficient manufacturing processes, including robust cleaning validation, to optimize resource utilization and ensure the delivery of effective and affordable treatments. The focus on value-based healthcare creates opportunities for innovative cleaning validation solutions that support cost-effectiveness and quality improvement initiatives.

Key Highlights

• The global pharmaceutical cleaning validation market 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).
• Based on product type, the global pharmaceutical cleaning validation 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.
• Based on validation tests, the global pharmaceutical cleaning validation market is bifurcated into Nonspecific 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.
• 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.

Competitive Players

1. Lucideon Limited
2. Suez
3. Hach
4. Teledyne Tekmar
5. SGS SA
6. QPharma, Inc
7. ProPharma Group
8. Merck KGaA
9. Intertek Group PLC
10. Kymos S.L
11. Shimadzu Corporation
12. Waters Corporation.

Recent Developments

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.

• In November 2022, Expleo is to provide its Life Sciences expertise to LFB, a pharmaceutical company specializing in manufacturing blood plasma-derived medicinal products. As part of the agreement, Expleo contributed to the definition and management of strategy and procedures relating to ‘cleaning validation’ in a new LFB plant in Arras, France.

Segmentation

1. By Product
   1. Small Molecule Drug
   2. Peptides
   3. Proteins
   4. Cleaning Detergent
2. By Validation Test
   1. Non-specific Tests
      1. Total Carbon Analysis (TC)
      2. Total Organic Carbon Testing (TOC)
      3. Non-purgeable Organic Carbon (NPOC)
      4. Conductivity
      5. Others
   2. Product-specific Analytical Tests
      1. Ultraviolet-Visible Spectroscopy (UV/VIS)
      2. High Performance Liquid Chromatography (HPLC)
      3. Liquid Chromatography/ Mass Spectrometry (LC/MS)
      4. Others