North America And Europe Pharmaceutical Stability & Storage Services Market Size, Share & Trends Analysis Report By Services (Stability, Storage), By Molecule (Large Molecule, Small Molecule), By Country, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The North America and Europe pharmaceutical stability & storage services market size was valued at USD 1.32 billion in 2024 and is expected to grow at a CAGR of 6.4% from 2025 to 2030. The growing biopharmaceutical sector, increasing pharmaceutical R&D spending, and rising outsourcing trends are major factors driving market growth in these regions. Increasing demand for biosimilars is expected to drive market growth. Biosimilars gained significant popularity in treating cancer, autoimmune diseases, and other chronic diseases. As biosimilars are cheaper than biologics, the demand for biosimilars has significantly increased in the past few years.

The COVID-19 pandemic has significantly increased the demand for biological medicines, which require major pharmaceutical expenditure as they provide treatment for complex conditions. According to data published by AJMC (The Centers for Biosimilars), in 2022, biologics accounted for 35% of the total pharmaceutical expenditure. Despite biosimilars contributing USD 10.9 billion annually to spending in Europe, the wide-ranging impact of these drugs on patients, payers, and the healthcare system is substantial. This expenditure on medicine can be attributed to increased stability testing, as medicines are tested in different climatic conditions inside a chamber. This is expected to aid in the growth of the pharmaceutical stability and storage services market.

Pharmaceutical and biotechnology companies heavily invest in R&D to ensure their products' safety, efficacy, and regulatory compliance. Stability testing and storage services are integral to this process, as they provide critical data on pharmaceutical products' stability profile and shelf life. Robust stability studies are conducted to evaluate the effects of environmental factors on drug substances & formulations, and storage conditions are optimized to maintain product integrity throughout their shelf life.

Service Insights

The stability testing services segment dominated the market and accounted for the largest revenue share, 73.8%, in 2024. Stability testing provides data on the changes in the quality of a drug product or drug substance over time, as influenced by various environmental factors, including temperature, humidity, and light. Its objective is to determine a re-test period for the drug substance or shelf life for the drug product, along with the recommended storage conditions for it.

The storage segment is expected to grow at a CAGR of 5.8% over the forecast period. Most players outsource their drug stability and storage management functions, as this offers several advantages, such as cost reduction, risk mitigation, and operational efficiency, which can drive segment growth. By partnering with companies with GMP-compliant facilities and experienced staff, organizations can streamline their stability studies and focus on their core competencies.

Molecules Insights

The small molecules segment dominated the North American and European pharmaceutical stability and storage services market, with the largest revenue share of 79.4% in 2024. Most pharmaceutical medications comprise small molecules, about 90% of all drugs. These medications treat fever, migraines, cancer, diabetes, and other common disorders. Small-molecule medications are used to treat numerous illnesses and disorders, which increases the need for stable testing and storage.

The large molecules segment is expected to grow at a significant CAGR of 8.8% from 2025 to 2030. The increasing demand for biological products such as tissues, recombinant therapeutic proteins, blood & blood components, allergens, somatic cells, and vaccinations drives segment growth. FDA states that biologics, despite being difficult and time-consuming to develop, may eventually prove to be the most effective means of treating various medical illnesses and diseases for which no other medicines are available.

Country Insights

North America dominated the market for pharmaceutical stability and storage services between North America and Europe, contributing a revenue share of 58.1% in 2024. The pharmaceutical industry in North America has been witnessing significant growth due to various factors such as a rapidly aging population, increasing prevalence of chronic diseases, and advancements in drug development. This growth leads to a higher demand for stability testing and storage services to ensure the quality and efficacy of pharmaceutical products.

U.S. Pharmaceutical Stability and Storage Services Market Trends

The pharmaceutical stability and storage services market in the U.S. led the North American market. It held the largest revenue share in 2024, driven by significant investments in advanced infrastructure and the growing complexity of drug formulations. Companies are establishing state-of-the-art facilities with real-time monitoring systems and automated testing technologies to meet stringent FDA regulations. Furthermore, the increasing pipeline of biologics and specialty drugs with specific storage needs drives demand for customized solutions. Moreover, pharmaceutical firms' rise in outsourcing stability services further supports market growth, ensuring compliance and operational efficiency.

Europe Pharmaceutical Stability and Storage Services Market Trends

The European pharmaceutical stability and storage services market is expected to grow at a CAGR of 6.2% over the forecast period. Europe has robust regulations governing the storage and stability of pharmaceutical products, such as Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Compliance with these regulations is essential for pharmaceutical companies to ensure the' quality, efficacy, and safety of their products. This drives the demand for specialized stability and storage services that meet this region's regulatory requirements.

Germany Pharmaceutical Stability and Storage Services Market Trends

Germany's pharmaceutical stability and storage services market held the largest revenue share and dominated the European market in 2024. This growth is attributed to its robust pharmaceutical manufacturing base and emphasis on technological innovation. In addition, adopting advanced systems like automated stability testing equipment and smart storage solutions enhances operational efficiency. Furthermore, Germany’s focus on biopharmaceuticals, including monoclonal antibodies and gene therapies, necessitates precise storage conditions to maintain product integrity. Moreover, compliance with stringent European Medicines Agency (EMA) regulations also propels demand for high-quality stability services, fostering growth in this technologically advanced market.

Key North America And Europe Pharmaceutical Stability & Storage Services Company Insights

Key players in the market undertake various strategic initiatives to maintain their position. For instance, in January 2022, Catalent announced the expansion of its large-scale isolator unit manufacturing facilities at Malvern, Pennsylvania, and Dartford, U.K. This is expected to help the company in its drug development process and the production of drug compounds. Moreover, in December 2022, Alcami constructed a new 65,000 sq. ft. cGMP biostorage facility. The company expanded its production space to strengthen its position in the market. Some prominent players in the North America and Europe pharmaceutical stability & storage services market include Intertek Group plc, Lucideon Limited, Alcami Corporation, BioLife Solutions, Inc., and others.

• Eurofins Scientific offers comprehensive solutions for biopharmaceutical product testing. The company provides advanced biochemistry, chemistry, molecular and cell biology, and microbiology testing capabilities. It operates in stability testing, storage, method development, and validation segments. Eurofins ensures secure storage with cutting-edge

• Intertek Group plc delivers pharmaceutical stability and storage services to maintain product quality and compliance. The company operates across segments, including stability testing, consulting, regulatory support, and specialized biopharmaceutical storage solutions.

Recent Developments

• In July 2024, Alcami introduced new conditions and services at its advanced pharma storage facility in Garner, North Carolina. The facility enhances its pharmaceutical stability and storage services with expanded capacity and state-of-the-art technology.

• In July 2024, Catalent completed an expansion of its clinical supply facility in Schorndorf, Germany, worth USD 25 million. This expansion adds 32,000 sq. ft. to the site, improving its pharmaceutical stability and storage services with increased temperature-controlled storage between 15 and 25 degrees Celsius.

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

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

This report forecasts revenue growth at regional and country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the North America and Europe pharmaceutical stability and storage services market report based on service, molecule, and country:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Stability Testing

    • Drug Substance

    • Stability Indicating Method Validation

    • Accelerated Stability Testing

    • Photo Stability Testing

    • Other Stability Testing Methods

  • Storage

    • Cold

    • Non-cold

• Molecule Outlook (Revenue, USD Million, 2018 - 2030)

  • Small Molecule

    • Research Products

    • Commercial Products

  • Large Molecule

    • Research Products

    • Commercial Products

• Country Outlook (Revenue, USD Million, 2018 – 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Norway

    • Sweden