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
Published Date: May - 2025 | Publisher: MIR | No of Pages: 240 | Industry: healthcare | Format: Report available in PDF / Excel Format
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The size of the North America and Europe pharmaceutical stability & storage services market was USD 1.32 billion in 2024 and is anticipated to grow at a CAGR of 6.4% during the period 2025-2035. The expanding biopharmaceutical industry, rising pharmaceutical R&D investments, and enhanced outsourcing trends are key drivers for market growth in these regions. Growing demand for biosimilars is likely to propel market growth. Biosimilars became highly popular for the treatment of cancer, autoimmune diseases, and other chronic illnesses. Since biosimilars are less expensive than biologics, the demand for biosimilars has increased tremendously over the last few years.
The COVID-19 pandemic has raised the demand for biological drugs greatly, as biological drugs need large-scale pharmaceutical spending since they provide therapy for complex ailments. As per information released by AJMC (The Centers for Biosimilars), in 2022, biologics represented 35% of overall pharmaceutical spending. Even though biosimilars add USD 10.9 billion to Europe's spending every year, the far-reaching influence of these medicines on patients, payers, and the healthcare system is enormous. This medical spending can be traced back to greater stability testing, as medicines are subjected to various climatic conditions within a chamber. This is anticipated to contribute to the development of the pharmaceutical stability and storage services market.
Pharmaceutical and biotechnology organizations invest significantly in R&D so that their products remain safe, effective, and compliant with regulatory requirements. Stability testing and storage services form part of this endeavor since they offer valuable information regarding pharmaceutical products' stability profile and shelf life. Sustained stability studies are performed to assess the influence of environmental conditions on drug substances & formulations, and storage conditions are designed to preserve product integrity over their shelf life.
Report Coverage & Deliverables
PDF report & online dashboard will help you understand
- Competitive benchmarking
- Historical data & forecasts
- Company revenue shares
- Regional opportunities
- Latest trends & dynamics
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 segment of small molecules ruled the North American and European market for pharmaceutical stability and storage services, holding the highest revenue share of 79.4% in 2024. The majority of pharmaceutical drugs are small molecules, around 90% of all medicines. They are used to cure fever, migraine, cancer, diabetes, and other disorders. Small-molecule drugs are prescribed to cure various diseases and disorders, hence creating a greater demand for stable storage and testing.
The segment of large molecules is likely to register a high CAGR of 8.8% during the forecast period of 2025 to 2030. The high demand for biological products like tissues, recombinant therapeutic proteins, blood & blood components, allergens, somatic cells, and vaccinations fuels segmental growth. FDA says that biologics, though challenging and time-consuming to develop, might ultimately be the best way to treat many of the medical ailments and diseases for which no other drugs exist.
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.
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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
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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.
Key North America And Europe Pharmaceutical Stability & Storage Services Companies
- 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
Recent Developments
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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.
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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
|
Report Attribute |
Details |
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Market size value in 2025 |
USD 1.41 billion |
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Revenue forecast in 2030 |
USD 1.92 billion |
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Growth rate |
CAGR of 6.4% from 2025 to 2035 |
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Base year for estimation |
2024 |
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Historical data |
2018 - 2023 |
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Forecast period |
2025 - 20305 |
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Quantitative units |
Revenue in USD million/billion, and CAGR from 2025 to 2035 |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, trends |
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Segments covered |
Service, molecule, country |
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Country scope |
U.S.; Canada; Mexico; Germany; UK; France; Italy; Spain; Denmark; Sweden; Norway. |
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Key companies profiled |
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 |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
|
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
North America And Europe Pharmaceutical Stability & Storage Services Market Report Segmentation
Service Outlook (Revenue, USD Million, 2018 - 2035)
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Stability Testing
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Drug Substance
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Stability Indicating Method Validation
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Accelerated Stability Testing
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Photo Stability Testing
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Other Stability Testing Methods
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Storage
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Cold
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Non-cold
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Molecule Outlook (Revenue, USD Million, 2018 - 2035)
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Small Molecule
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Research Products
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Commercial Products
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Large Molecule
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Research Products
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Commercial Products
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Country Outlook (Revenue, USD Million, 2018 – 2035)
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North America
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U.S.
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Canada
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Mexico
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Europe
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UK
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Germany
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France
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Italy
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Spain
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Denmark
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Norway
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Sweden
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