Pharmaceutical Stability and Storage Services:  A Guide to Selecting the Right Partner

Your guide to choosing the right partner for pharmaceutical stability and storage services

Keeping medicines strong, safe, and effective is a big deal in the medicine world, especially when creating and making them. There are special services that help store medicines properly, making sure they stay good and follow all the important rules. This in-depth guide aims to provide an insightful overview for selecting the ideal partner, offering clarity on understanding pharmaceutical stability and storage services.

An introduction to Pharmaceutical Stability and Storage

Pharmaceutical stability is a product’s ability to maintain its physical, chemical, microbiological, toxicological, protective, and informational specifications. 

Drug stability is the ability of a pharmaceutical dosage form to maintain its properties during storage and use.

Storage is the placement of samples into environmentally controlled chambers to determine how the quality of the substance or product varies with time under the influence of environmental factors such as temperature, humidity and light.

Together, these services plays an important role in safeguarding patient safety, preventing product recalls, and ensuring market success.

Source: Q1 Scientific

Key subcategories

In this complex area, different types of services are there to meet specific needs.

• Stability testing: Comprehensive assessments of drug products and substances under accelerated or real-time conditions to predict their shelf life and identify potential degradation pathways.

• Controlled-environment storage: Maintaining precise temperature, humidity, and light conditions to guarantee product stability from raw materials to finished goods.

• Sample management: Secure and documented handling of stability study samples from receipt and storage to retrieval and analysis.

• Data integrity and reporting: Comprehensive data management systems and reports ensuring regulatory compliance and transparent communication.

Market trends

The medicine industry is really important for keeping people healthy. Making sure medicines stay good and work well over time is super important, especially with complicated drugs and strict rules. That’s where special services for storing medicines safely come in. They make sure the medicines stay good and follow all the important rules.

The global pharmaceutical stability and storage services market size was reached at USD 3.06 billion in 2022 and it is expected to hit around USD 5.24 billion by 2032 growing at a CAGR of 5.6% from 2023 to 2032.

Source: Precedence research

Key Insights

• North America generated more than 54% of the revenue share.

• Asia Pacific is expected to expand at the biggest CAGR of around 7% between 2023 and 2032.

• The stability services segment captured more than 73% of the revenue share in 2022.

• The storage services segment is projected to grow at the fastest rate between 2023 and 2032.

• The small molecule segment generated the highest revenue share of around 64% in 2022.

• The large molecule segment is predicted to expand at the fastest rate between 2023 and 2032.

• The in-house mode segment contributed the highest share of around 61% in 2022.

• The outsourcing mode segment is expected to grow at the fastest rate between 2023 and 2032.

The market can be segmented by

• Service: Stability testing, controlled-environment storage, sample management, data integrity and reporting.

Global Pharmaceutical Stability and Storage Services Market, By Services, 2022-2032 (USD Million)

• Molecule: Small molecules, large molecules.

Global Pharmaceutical Stability and Storage Services Market, By Molecules, 2022-2032 (USD Million)

• Mode: In-house, outsourced

Global Pharmaceutical Stability and Storage Services Market, By Modes, 2022-2032 (USD Million)

Drivers of Growth

The major key drivers of pharmaceutical stability and storage services are:

• Stringent regulations: Evolving regulatory requirements necessitate rigorous stability testing and documentation, driving reliance on specialized service providers.

• Rising complexity of molecules: The increasing prevalence of biologics and combination products with intricate stability profiles necessitates specialized expertise.

• Globalisation of supply chains: Managing temperature-sensitive materials across long distances demands robust storage and logistics solutions.

• Cost optimisation: Outsourcing stability testing and storage frees up internal resources while potentially offering cost efficiencies.

Benefits of pharmaceutical Stability and Storage Services

For pharmaceutical companies, partnering with a good storage service brings lots of advantages.

• Enhanced product quality and stability: Precise environmental control and expert testing provide unparalleled product protection.

• Reduced development and launch timeframes: Streamlined testing processes and efficient sample management accelerate timelines.

• Minimised regulatory risks: Compliance-driven systems and expert guidance navigate regulatory complexities.

• Cost-effective solutions: Outsourcing avoids investment in expensive infrastructure and skilled personnel.

• Improved focus on core competencies: Companies can devote resources to core R&D and manufacturing activities.

Challenges

Some of the challenges faced by pharmaceutical stability and storage services

• Competition: The market is highly competitive, with a large number of service providers offering similar services.

• Technological advancements: The need to keep up with the latest technological advancements in stability testing and storage equipment can be expensive.

• Regulatory changes: Evolving regulations can create uncertainty and require service providers to adapt their offerings.

Opportunities

The market for services that keep medicines safe and stored well is full of exciting opportunities.

1.Specialisation for Complex Molecules:

The rising wave of biologics and combination drugs brings immense therapeutic potential, but their intricate stability profiles demand specialized expertise. Providers who can cater to these specific needs, offering tailored testing protocols and controlled storage environments, stand to gain a significant advantage.

2.Embracing Regulatory Evolution:

Regulations in this domain are constantly evolving, creating demand for agile service providers adept at navigating the changing landscape. Those who stay abreast of regulatory updates and proactively adapt their services to comply will attract partners seeking assurance and expertise.

3. Tech-Savvy Solutions:

Integration of cutting-edge technologies like automated sample management systems, real-time data monitoring, and advanced analytical instruments can revolutionise stability testing and storage. Providers investing in such technological advancements will not only boost efficiency and accuracy but also attract tech-driven pharmaceutical companies.

4. Global Reach and Partnerships:

With globalised supply chains and geographically dispersed operations, pharmaceutical companies require seamless stability and storage solutions across borders. Providers who cultivate strategic partnerships and establish a robust global network will be well-positioned to cater to this growing need.

5. Sustainability in the Spotlight:

Sustainability is taking centre stage in the pharmaceutical industry, and stability and storage providers can capitalise on this trend by offering eco-friendly solutions. This encompasses energy-efficient storage facilities, waste reduction strategies, and green packaging options.

6. Data-Driven Insights and Analytics:

Leveraging data effectively can unlock valuable insights for optimising stability programs and predicting potential degradation pathways. Providers who invest in data analysis tools and offer data-driven insights to clients will stand out in the crowd.

7. Cost-Effective Outsourcing Models:

Cost pressures remain a constant challenge for pharmaceutical companies. Providers who develop innovative and flexible outsourcing models, balancing affordability with high-quality services, will attract value-conscious partners seeking cost-efficient solutions.

8. Integrated Service Packages:

Offering comprehensive packages that combine different stability services, like testing, storage, and sample management, under one roof will provide enhanced convenience and streamline processes for pharma companies.

9. Patient-Centric Approach:

Ultimately, the goal of all pharmaceutical research and development is to improve patient outcomes. Providers who can demonstrate how their stability and storage services contribute to enhanced product quality and patient safety will resonate with ethically conscious companies.

10. Niche Market Diversification:

Beyond the mainstream, opportunities exist in specialized niches like personalised medicine, gene therapy, and rare disease treatments. Providers who dedicate resources and expertise to these emerging areas can carve out a lucrative market share.

Key players

Some of the major key players in pharmaceutical stability and storage services are:

• Catalent, Inc.

• Charles River Laboratories International, Inc

• Almac Group

• Eurofins Scientific

• Lucideon Limited

• Intertek Group Plc

• Alcami Corporation

• Element Materials Technology

• Q1 Scientific

• BioLife Solutions

• Masy BioServices

• Roylance Stability Storage Limited

• Reading Scientific Services Ltd.

• Als Ltd.

• Auriga Research Private Limited

• Q Laboratories

• Precision Stability Storage

• PD Partners

How to find the best pharmaceutical stability and storage services partner

1. Self-Assessment: Define Your Needs and Priorities

• Types of drugs and studies: Do you primarily deal with small molecules, biologics, or combinations? What specific testing protocols are needed?

• Storage needs: Temperature, humidity, light control, and sample volume requirements are crucial factors.

• Compliance considerations: Which regulatory guidelines need to be adhered to?

• Budget and timelines: Be realistic about your financial constraints and desired project duration.

2. Market Research

• Industry directories and databases: Utilize resources like Global Health Intelligence or BioPharm Insight to identify potential partners.

• Research competitor selections: Analyse who your major competitors choose for stability and storage services.

• Attend industry events and conferences: Network with service providers and gain insights through presentations and discussions.

3. Shortlist Your Candidates

• Experience and expertise: Evaluate their track record with similar drug types and studies.

• Facility certification and compliance: Confirm adherence to relevant regulatory standards and industry best practices.

• Technology and equipment: Assess their capabilities in terms of environmental control, analytical instrumentation, and data management systems.

• Cost and service packages: Compare pricing models and offerings to find the best fit for your budget and needs.

4. Deep Dive

• Craft a comprehensive RFP: Outline your specific needs, expectations, and evaluation criteria.

• In-depth interviews: Engage in detailed discussions with shortlisted providers to assess their communication style, responsiveness, and client approach.

• Facility visit and reference checks: Schedule a visit to their facilities and seek feedback from their existing clients.

5. Making the Choice

• Balance technical expertise with cultural fit: Choose a partner with not only the required skills but also a collaborative and responsive communication style.

• Transparency and data integrity: Prioritise providers who prioritise data security and offer clear communication about testing procedures and results.

• Long-term vision: Focus on building a lasting partnership with a provider who demonstrates a commitment to growth and innovation alongside your evolving needs.

Use online review platforms and industry forums to gather additional insights and feedback from other pharmaceutical companies about their experiences with different stability and storage services providers.