Extractable And Leachable Testing Services Market To Reach $2.57 Billion By 2030

Extractable And Leachable Testing Services Market Growth & Trends

The global extractable and leachable testing services market size is expected to reach a value of USD 2.57 billion by 2030, according to a new report by Grand View Research, Inc., exhibiting a CAGR of 15.13% from 2023 to 2030. The market is expanding due to several factors, including the rising demand for biopharmaceuticals and the increasing concern about cross-contamination and patient safety. E&L testing ensures the identification of potential sources of contamination and helps in delivering safe and compatible drug products.

The significant growth in bioprocess engineering innovations has driven notable advancements in single-use systems. The increased adoption of biopharmaceuticals has further fueled progress in this field. Additionally, a growing number of studies evaluating the efficacy of single-use bioprocesses are raising awareness about these technologies. Single-use systems offer numerous advantages, including reduced risk of cross-contamination, faster turnaround times, cost-effectiveness, and greater flexibility in adjusting production volumes. Thus, the rising demand for single-use systems is anticipated to propel the growth of the market over the period of time.

Furthermore, the evolving regulatory norms have created significant demand for E&L testing capabilities to analyze healthcare products. This encouraged E&L testing service providers to develop precise and custom testing solutions. For instance, in November 2022, Smithers organized the Europe E&L conference in Germany. The company has been organizing such events past 15 years. These conferences focus on the growing importance of E&L testing and updates about dynamic regulations for E&L testing. Thus, such initiatives are anticipated to fuel the growth of the market over the forecast period.

The leachable and extractable testing services are crucial in identifying foreign substances in single-use systems and finished formulations that could potentially impact human health. However, these services are complex and subject to change due to factors like evolving regulatory requirements, diverse product types, various analytical techniques, and result variations. Service providers must navigate these variables appropriately. For instance, a wide range of analytical techniques, including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis. Selecting the right analytical techniques for specific product types can be a challenging and intricate task.

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Extractable And Leachable Testing Services Market Report Highlights

• Based on product type, the container closure systems segment dominated with a market share of 31% in 2022, primarily due to its capacity to offer long-term stability.

• On the basis of application, the orally inhaled and nasal drug products segment accounted for the highest market share of 41.88% in 2022. The large share is mainly driven by the growing demand for novel drug delivery methods.

• In 2022, North America held the leading position with a revenue share of 43.71%. A large share of the region's widespread adoption of innovative technologies and biopharmaceuticals for clinical analysis and treatment. Additionally, government initiatives aimed at boosting research and development centers are expected to further drive market growth in the region. These factors are anticipated to boost the market for extractable and leachable testing services in the region over the forecast period.

• During the forecast period, the Asia Pacific demonstrated a significant growth among regions, with a remarkable CAGR of 15.32%. The region's rapid expansion in the biopharmaceutical industry results from the increasing demand for vaccine production, which, in turn, is driving the surge in the extraction and leachable testing services for such therapies.

Extractable And Leachable Testing Services Market Segmentation

Grand View Research has segmented the global extractable and leachable testing services market based on product type, application, and region:

Extractable And Leachable Testing Services Product Type Outlook (USD Million; 2018 - 2030)

• Container Closure Systems

• Drug Delivery Systems

• Single-use Systems

• Others

Extractable And Leachable Testing Services Application Outlook (USD Million; 2018 - 2030)

• Parenteral Drug Products

• Orally Inhaled and Nasal Drug Products (OINDP)

• Ophthalmic

Extractable And Leachable Regional Services Regional Outlook (USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• MEA

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Extractable And Leachable Testing Services Market 

• Eurofins Scientific

• Intertek Group plc

• SGS Société Générale de Surveillance SA

• WuXi AppTec

• Merck KGaA

• West Pharmaceutical Services, Inc

• Wickham Micro Limited (Medical Engineering Technologies Ltd.)

• Pacific Biolabs

• Boston Analytical

• Sotera Health (Nelson Laboratories, LLC)