North America And Europe Pharmaceutical Stability & Storage Services Market To Reach $3.22 Billion By 2030

North America And Europe Pharmaceutical Stability & Storage Services Market Growth & Trends

The North America and Europe pharmaceutical stability & storage services market size is expected to reach USD 3.22 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to grow at a CAGR of 5.5% from 2023 to 2030. Stringent regulatory requirements, increasing R&D investments, and globalization of clinical trials are some of the major factors driving market growth.

The rising demand for biosimilars is expected to drive market advancement. In recent years, the approval rate for biosimilars has significantly improved. As per the Amgen Biosimilars Trend Report published in 2020, there was an increase in the number of biosimilar approvals by 65% since the preceding year in the U.S. As of 2023, 41 biosimilars were approved in the U.S., and over 70 were approved in the EU. The growing approval of biosimilars is likely to positively impact the market.

The stability of pharmaceuticals plays a crucial role in determining the strength and effectiveness of the medication. However, ensuring stability poses challenges due to varying data requirements and testing regulations imposed by different regulatory bodies, making it particularly difficult to market products in diverse regions. While both the EMA and FDA adhere to the ICH guidelines for stability testing, they maintain distinct microbiological limits for these tests. Consequently, certain evaluations that are optional in the United States become mandatory in the European Union, and vice versa. These disparities complicate stability testing procedures, leading to an increased need for outsourcing such testing services.

Several companies are involved in strategies such as acquisitions, collaborations, and new service launches to gain positions in the market. For instance, in March 2023, BioLife Solutions introduced the Ultraguard -70°C Phase Change Material (PCM) Accessory to offer backup cooling in ULT Freezers and act as a dry ice substitute for benchtop biologic material storage. Moreover, in October 2022, CSafe and BioLife Solutions, Inc. formed a partnership to enhance supply chain solutions for cell and gene therapy. CSafe joined BioLife's global partner network of companies offering cold chain solutions for the cell and gene therapies market.

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North America And Europe Pharmaceutical Stability & Storage Services Market Report Highlights

• The stability segment dominated the regional market in 2022. The rapid growth in the demand for biopharmaceuticals and personalized medicines is driving advancements in pharmaceutical stability services

• Based on service, the storage segment is expected to witness the highest CAGR of 6.1% over the forecast period, owing to the increasing focus on generics and biosimilars in developing regions

• The small molecules segment dominated the market in 2022. Recent advances in forecasting, structure-based design, imaging, automation, artificial intelligence, and machine learning have become critical facilitators for increasing small molecule lead optimization’s pace and success rates

• The large molecule segment also holds a significant share in the market. This is due to the increasing adoption of large molecules such as proteins, nucleic acids, carbohydrates, living cells, and tissues

• In 2022, the in-house segment held the largest market share. Most pharmaceutical manufacturers choose in-house stability testing, as these tests are required to be performed for all drugs and in all phases of clinical studies

• North America dominated the market, accounting for the largest revenue share of 71.51% in 2022, due to the presence of several major market players providing stability and storage services in the region

• Europe is also expected to account for a significant share of the market in the coming years. The UK has a strong emphasis on R&D in the pharmaceutical sector. As companies invest in developing new drugs and conducting clinical trials, there is an increased demand for stability testing and storage services to support these activities

North America And Europe Pharmaceutical Stability & Storage Services Market Segmentation

Grand View Research has segmented the North America and Europe pharmaceutical stability & storage services market based on service, molecules, mode, and region:

North America And Europe Pharmaceutical Stability & Storage Services Outlook (Revenue, USD Million, 2018 - 2030)

• Stability

  • Drug Substance

  • Stability indicating method validation

  • Accelerated stability testing

  • Photostability Testing

  • Other stability testing methods

• Storage

  • Cold

  • Non-cold

North America And Europe Pharmaceutical Stability & Storage Services Molecules Outlook (Revenue, USD Million, 2018 - 2030)

• Small Molecule

  • Research Products

  • Commercial Products

• Large Molecule

  • Research Products

  • Commercial Products

North America And Europe Pharmaceutical Stability & Storage Services Mode Outlook (Revenue, USD Million, 2018 - 2030)

• In-house

• Outsourcing

North America And Europe Pharmaceutical Stability & Storage Services Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

List of Key Players in the North America And Europe Pharmaceutical Stability & Storage Services Market

• Eurofins Scientific

• Intertek Group plc

• Lucideon Limited

• Element Materials Technology

• Q1 Scientific

• Reading Scientific Services Ltd.

• Catalent, Inc.

• Quotient Sciences

• Recipharm AB

• Almac Group

• Alcami Corporation

• BioLife Solutions, Inc.

• Sampled (Roylance Stability Storage Limited)

• Precision Stability Storage

• Broughton