PHARMACEUTICAL STABILITY AND STORAGE SERVICES MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Market Size and Trends

Global pharmaceutical stability and storage services market is estimated to be valued at USD 3.18 Bn in 2024 and is expected to reach USD 4.71 Bn by 2031, growing at a compound annual growth rate (CAGR) of 5.8% from 2024 to 2031.

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The market is expected to witness positive growth during the forecast period. Increasing regulatory stringency   regarding stability testing and storage compliance is prompting pharmaceutical companies to outsource these services to specialized providers. Furthermore, growing complexity of drug formulations is boosting the need for sophisticated stability testing protocols and specialized storage facilities. Market players are increasingly offering integrated stability testing and storage services to help sponsors comply with various regulatory requirements more efficiently. Furthermore, the COVID-19 pandemic has increased demand for temperature-controlled storage from vaccine manufacturers, which is accentuating the market growth. However, high service costs may hinder the growth of small and mid-sized pharmaceutical companies to some extent.

Strict regulatory requirements to monitor drug stability

Pharmaceutical manufacturers around the globe are increasingly focused on ensuring the quality, potency and safety of their drugs throughout the supply chain. Regulatory authorities like the U.S. FDA have stringent guidelines for drug stability testing and require manufacturers to monitor drug samples periodically post approval as well to identify any degradation in drug quality. Stability testing helps to determine the shelf-life and appropriate storage conditions of drugs. It also helps manufacturers comply with cGMP and meet the standards specified in product labels.

With an expanding pharmaceutical portfolio and greater oversight on product quality, it has become imperative for companies to outsource stability testing & monitoring to specialized service providers. These providers offer advanced analytical testing, long-term stability studies, stress testing and specialized storage facilities across temperature zones to accurately simulate supply chain conditions. Their dedicated stability programs help pharmaceutical companies stay compliant with regulatory norms and timely address any deviations observed during monitoring.

Market Concentration and Competitive Landscape

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Pharmaceutical packaging plays a vital role in protecting drugs from external contaminants and preventing any chemical or physical degradation during transportation and storage. With global supply chains expanding, there is a growing emphasis on developing innovative packaging technologies that can withstand varied climate conditions and ensure drug stability for longer durations. Pharmaceutical manufacturers are actively partnering with packaging service providers to implement specialized solutions like moisture-tight seals, oxygen absorbers, tracking devices and thermal-protective containers. Some key trends include greater use of materials like glass and laminates that offer premium barrier protection from air, moisture and light.

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The high costs associated with stability testing and storage services impose a substantial restraint on the growth of the pharmaceutical stability and storage services market. Conducting stability testing over the long term to confirm the shelf life of drugs and maintain stringent quality standards throughout mandated storage periods requires immense financial investments, thereby, hampering the market development over the forecasted period.

Market Opportunities – Growing demand for outsourcing services

The market witnesses numerous opportunities for growth as pharmaceutical companies increasingly turn to outsourcing partners to offload stability testing responsibilities and ensure regulatory compliance. New development in digital monitoring technologies allow for round-the-clock remote supervision of storage facilities. There is also demand for integrated testing plans that combine accelerated, stress, and real-time studies into comprehensive programs. Partnerships between drug makers and contract service providers have expanded to encompass full lifecycle management.

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The service type segment includes stability and storage. In terms of service type, stability segment contributes the highest share of the market owing to increasing stringent stability-testing norms and is anticipated to secure 57.8% market share in 2024. Regulatory mandates require drugs to undergo rigorous stability testing throughout their shelf life to ensure consistent performance under different climatic conditions. This has significantly boosted demand for stability testing services from pharmaceutical manufacturers. Emerging biologics and complex drugs have further increased stability-testing needs due to greater susceptibility to physical and chemical degradation during storage and distribution. Growing requirements to study drug stability across container closure systems have also supported segment growth. Furthermore, the capability of stability testing to verify expiry dates and guarantee batch integrity throughout distribution networks makes it crucial for compliance with current good manufacturing practices.

Insights, By Product Type: Rising demand for oral solid dosage drugs boosts tablets segment growth

The product type segment includes tablets, capsules, injectable solutions, oral suspensions, combination products, and others. Among the product type, tablets segment is anticipated to have 27.8% of the market share in 2024. Tablets account for the majority of global drug production volume due to convenience of administration and favorable stability profile. The large-scale manufacture and global distribution of tablets necessitates optimized cold chain management and storage infrastructure capable of handling bulk inventories. Additionally, regulatory needs to securely store retained drug samples from clinical trials and post-marketing surveillance activities have further boosted demand. The capability of centralized depots to meet global distribution requirements while maintaining drug quality makes professional storage services indispensable for the thriving tablet drugs market.

Insights, By End User: Outsourcing drives biopharmaceutical companies segment

The end user segment includes biopharmaceutical companies, CMO, CRO, and others. Among end user, biopharmaceutical companies segment is anticipated to hold 34.9% of the market share in 2024 as large biologic drug producers increasingly rely on capable outsourcing partners for stability and storage services. High development costs of biologics encourage outsourcing non-core operations to optimize capital expenditures. Furthermore, CROs/CMOs offer biopharmaceutical companies access to state-of-the-art stability chambers and temperature-controlled warehouses alongside scientific expertise. Their scale allows for cost-effective validation of complex biologic storage conditions on a large commercial scale. The expanding pipeline of biologics therefore benefits associated contract service providers. Furthermore, tight regulatory quality requirements make outsourcing to specialize service providers an attractive proposition for ensuring compliance.

Regional Insights

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North America continues to dominate the global pharmaceutical stability and storage services market and is anticipated to hold 43.7% market share in 2024. This can be attributed to strong presence of leading pharmaceutical companies in the region with large R&D budgets. With stringent regulatory guidelines around drug stability testing and data requirements from the U.S. FDA, pharmaceutical companies rely heavily on outsourcing such services to ensure compliance. North America has seen major infrastructure investments by key players to establish state-of-the-art stability storage facilities. This has ensured easy access to on-demand services for pharmaceutical firms.

The Asia Pacific region is poised to be the fastest growing market for pharmaceutical stability and storage services over the forecasted period. Given the cost advantages and policy support for generic drug manufacturing, Asia Pacific has emerged as the hub for generic drug exports worldwide. However, testing and data requirements to comply with international standards remains a challenge for domestic firms. This has increased reliance on specialized stability testing providers. Organizations are also outsourcing drug sample storage to third parties with the best-in-class controlled temperature and humidity storage capabilities. The region benefits from lower operating costs for service players compared to mature markets. This is expected to further boost adoption of stability and storage services among pharmaceutical manufacturers expanding in Asia Pacific.

Market Report Scope

Key Developments

• On January 24, 2024, Alcami Corporation, a leading contract development and manufacturing organization (CDMO), announced the opening of a new 65,000 ft² plant in Garner, North Carolina, near the Research Triangle Park biotech and pharma hub. The new facility in central North Carolina accepts customer pallets for ambient/controlled room temperature storage, expanding the company's network of GMP storage facilities across North America.
• In March 2022, Alcami, a leading contract development and manufacturing organization (CDMO), announced plans to increase its biostorage footprint at Masy BioServices. A new 160,000 square-foot facility, purpose-built for cGMP pallet storage space at 15°C to 30°C, will be added to the company's current New England campus.
• In October 2022, Cambrex, a contract development manufacturing organisation, announced the expansion of its stability storage company, Q1 Scientific, which provides environmentally controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Q1 Scientific will establish a new 20,000-square-foot cGMP facility in Belgium and expand its existing Waterford, Ireland facility by 10,000 square feet.
• In July 2021, LGM Pharma, an active pharmaceutical ingredient companies, announced the launch of its new Analytical Services offering, which offers analytical testing and stability services to pharmaceutical inventors and manufacturers, including compounding pharmacies. The company, which currently provides analytical services as part of its integrated contract development and manufacturing (CDMO) activities, is now offering its analytical services knowledge and facilities as a separate contract service to pharmaceutical industry clients.

*Definition: Pharmaceutical stability and storage services market involves companies that offer stability testing, storage, and distribution services to pharmaceutical and biotech companies. These services help drug manufacturers to ensure their products maintain quality, safety and efficacy during their shelf life by conducting stability testing as per regulatory guidelines. The services also involve secure storage of drugs at temperature and humidity-controlled warehouses to meet distribution and supply chain needs. Proper stability testing and storage is essential for pharmaceutical companies to receive regulatory approval and market their drugs.

Market Segmentation

•  Service Type Insights (Revenue, USD BN, 2019 - 2031)
  • Stability
    • Accelerated Stability Testing
    • Photostability
    • Long Term Drug Stability Testing
    • Forced Degradation Testing
    • Others
  • Storage
    • Cold Storage
      • Controlled 15-25°C
      • Refrigerated 2-8°C
      • Frozen -24°C
      • Cryogenic -170°C
    • Non - Cold Storage
•  Product Type Insights (Revenue, USD BN, 2019 - 2031)
  • Tablets
  • Capsules
  • Injectable Solutions
  • Oral Suspensions
  • Combination Products
  • Others
•  End User Insights (Revenue, USD BN, 2019 - 2031)
  • Biopharmaceutical Companies
  • CMO
  • CRO
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Intertek Group plc
  • Eurofins Scientific 
  • SGS Société Générale de Surveillance SA.
  • Q Laboratories
  • BioLife Solutions Inc.
  • Cencora, Inc.
  • Alloga 
  • PCI Pharma Services
  • Pharmaserv GmbH
  • Catalent, Inc
  • Almac Group
  • Charles River Laboratories
  • Lucideon
  • Alcami Corporation
  • Element Materials Technology
  • Nelson Laboratories, LLC
  • ALS