Extractable and Leachable Testing Services Market – By Product Type (Container Closure Systems, Single-use Systems, Drug Delivery Systems), Application (Parenteral Drug Products, Orally Inhaled & Nasal Drug Products) – Global Forecast 2024 – 2032

Extractable and Leachable Testing Services Market – By Product Type (Container Closure Systems, Single-use Systems, Drug Delivery Systems), Application (Parenteral Drug Products, Orally Inhaled & Nasal Drug Products) – Global Forecast 2024 – 2032

Extractable and Leachable Testing Services Market Size

Extractable And Leachable Testing Services Market size was valued at around USD 866.2 million in 2023 and is anticipated to register a CAGR of over 13.6% between 2024 and 2032. Extractable and leachable testing services are vital analytical procedures across industries such as pharmaceuticals, food packaging, cosmetics, and medical devices, ensuring the safety and compliance of products.

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With increased recognition and investment, these services have seen advancements in methodologies, equipment, and expertise, benefiting pharmaceuticals, vaccines, and medical device testing services sectors. This progress has enabled accelerated research and development efforts, fostered the delivery of innovative drugs, vaccines, and medical devices while upheld rigorous safety and compliance standards. For instance, according to the World Health Organization (WHO) in 2021 reported a significant surge in vaccine distribution, with approximately 16 billion doses supplied globally, valued at USD 141 billion.
 

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This marks a substantial increase compared to the market volume in 2019, which stood at USD 5.8 billion doses. Therefore, there is a rising need for innovative approaches and advancements in extractable and leachable testing services to ensure the safety, quality, and regulatory compliance of the increasing volume of vaccines being produced and distributed worldwide.Furthermore, growing pharmaceutical and biotechnology industry, which estimated to reach 952 billion by 2027, widespread adoption of single-use technology, among other contributing factors propelling the growth of the market.

Extractable and Leachable Testing Services Market Trends

The growth of the pharmaceutical and biotechnology industry offers significant benefits for extractable and leachable testing services. With a growing emphasis on ensuring product safety, effectiveness, and regulatory compliance, there is an increased demand for these services.

• With advancements in novel drug delivery systems, biologics, and combination products, there is a need for specialized testing to assess the compatibility of these complex formulations with packaging materials and ensure product stability.
• Further, comprehensive extractable and leachable testing can identify potential risks associated with chemical interactions between drug products and packaging materials, helping companies mitigate these risks early in the development process and avoid costly product recalls or regulatory issues.
• Additionally, extractable and leachable testing services contribute to maintaining high-quality standards throughout the product lifecycle, from development and manufacturing to distribution and storage, ensuring that products meet the highest safety and quality requirements.

Extractable and Leachable Testing Services Market Analysis

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Based on product type, the market is segmented into container closure systems, single-use systems, drug delivery systems, and other product types. The container closure systems segment is estimated to account for USD 868.5 million by 2032.

• Container closure systems act as a protective barrier, shielding products from external contaminants such as impurities, microorganisms, and physical harm. This containment ensures product integrity during storage and transport, minimizing the likelihood of extractables and leachable contaminating the product, thereby preserving its quality.
• Container closure systems contribute to product stability by minimizing exposure to external factors that could degrade the product.
• Further, by identifying and quantifying potential extractables and leachable early in the development process, container closure systems allow manufacturers to implement risk mitigation strategies. This proactive approach helps prevent product recalls, safeguard consumer health, and maintain brand reputation.

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Based on application, the extractable and leachable testing services market is bifurcated into parenteral drug products, orally inhaled and nasal drug products (OINDPs), and ophthalmic drug products. The orally inhaled and nasal drug products (OINDPs) segment accounted for USD 374.8 million in 2023.

• OINDPs are administered directly into the respiratory system via inhalation, bypassing the gastrointestinal tract. This route of administration can lead to different profiles compared to orally administered drugs, making specialized testing necessary.
• Further, they often exert their effects locally in the respiratory tract, where they are deposited upon inhalation. Understanding the potential extractables and leachable specific to this route of administration is crucial for ensuring safety and efficacy.
• Moreover, OINDPs are often administered using specialized devices such as smart inhalers or nasal sprays. Compatibility between the drug product and the device, as well as the materials used in the device construction, thereby propels the segmental growth of the market.

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North America extractable and leachable testing services market accounted for USD 351 million revenue in 2023 and is predicted to witness substantial market expansion.

• The region boasts advanced technological infrastructure, including state-of-the-art laboratories equipped with cutting-edge analytical instrumentation and automation technologies.
• Government funding playing a crucial role in supporting research initiatives and advancing technological capabilities in this sector. For instance, according to National Institute of Food and Agriculture (NIFA), in 2022, the U.S. Department of Agriculture (USDA) has allocated USD 9.5 million to bolster the expansion of sustainable bioproduct manufacturing ac qross the U.S.
• Further, North America benefits from a robust regulatory framework that drives continuous innovation and ensures adherence to rigorous standards, enhancing the quality and safety of pharmaceutical products.

Extractable and Leachable Testing Services Market Share

The extractable and leachable testing services industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced devices based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Extractable and Leachable Testing Services Market Companies

Some of the eminent market participants operating in the extractable and leachable testing services industry include

• BA Sciences                     
• Eurofins Scientific                       
• Intertek Group plc   
• Limerston Capital LLP                  
• Merck & Co., Inc.                        
• Pacific Biolabs, Inc.
• SGS Societe Generale de Surveillance SA                                                 
• Sotera Health Co                        
• West Pharmaceutical Services, Inc.                   
• Wickham Micro Limited                          
• WuXi AppTec Co., Ltd.        

Extractable and Leachable Testing Services Industry News

• In January 2024, Limerston Capital finalized the acquisition of Source BioScience's Stability Storage business, signaling its dedication to the healthcare, testing, and certification sectors. The newly established standalone entity, Astoriom, enables focused efforts on biorepository operations, aiming to expand its presence in lucrative pharmaceutical and biologic markets.
• In November 2022, Merck completed the second phase of its Biologics Testing Center in China, marking the establishment of its first biosafety laboratories in this market. The expansion benefited the company by enhancing its presence in the Chinese market, facilitating easier access to critical testing services for clients, and supporting the growth of its biologics testing capabilities in the region.

The extractable and leachable testing services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 – 2032 for the following segments

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Market, By Product Type

• Container closure systems           
• Single-use systems           
• Drug delivery systems
• Other product types

Market, By Application

• Parenteral drug products                                
• Orally inhaled and nasal drug products (OINDPs)                                      
• Ophthalmic drug products

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa