Pharmaceutical Stability and Storage Services Industry Driven by Biosimilars and Vaccine Demand

Published Date : 05 May 2023

The global pharmaceutical stability and storage services industry revenue will gain around USD 5.4 billion by 2032 from USD 3.01 billion in 2022 and is growing at a remarkable CAGR of 6.02% from 2023 to 2032.

The industry is being driven by an increase in innovative clearance applications, consolidation, and internationalization of the large and small molecule sectors.

Market Growth:

Testing for stability is crucial when creating a medicinal product. The results of stability testing show how the medicinal product responds to environmental factors like heat, pH, humidity, and radiation. Understanding how a medicinal product will change over time is essential for patient safety, and instructions on how to store and discard the product are needed.

Your real-time stability testing, long-term, intermediate, accelerated stability studies, forced-degradation, photo-stability, in-use, or follow-up stability testing trial requirements should be handled by a seasoned stability study service partner who provides effective study management, flexible storage conditions, and testing capabilities that meet all regulatory requirements. To create and verify stability-indicating techniques and carry out analysis of leachable compounds that move from pharmaceutical packaging into the product, stability testing can present significant analytical challenges.

Regional Snapshot:

In the industry for pharmaceutical stability & preservation, North America generated the most income. This is because there are many medicinal companies in Canada and the United States. It is expected that the existence of major industry participants in the area who provide stability & storage services will significantly aid industry growth. It is anticipated that the existence of major industry players providing stability and storage services in this area will greatly help industry growth. During the projection period, Asia-Pacific is anticipated to expand at the greatest CAGR. The pharmaceutical industry in this area is expanding at the fastest rate in the entire globe due to the existence of China, India, and Japan. Public sector efforts to lower medical costs and increase access to high-quality drugs have facilitated the growth of.

Pharmaceutical Stability and Storage Services Industry Report Scope:

Report Coverage Details
Market Revenue in 2023 USD 3.19 Billion
Projected Forecast Revenue in 2032 USD 5.4 Billion
Growth Rate from 2023 to 2032 CAGR of 6.02%
Largest Market North America
Base Year 2022
Forecast Period 2023 to 2032
Regions Covered North America, Europe, Asia-Pacific, Latin America and Middle East & Africa

Market Dynamics:

Drivers: Increasing demand for vaccine and biosimilar

The need for business As government officials step up their immunization campaigns, there will likely be a rise in COVID-19 vaccines that are stable and can be kept for a long time. In recent years, the pharmaceutical business has significantly increased the amount invested in research and development. The number of drugs will likely grow due to the increasing research and development costs. Another element influencing industry development is the requirement for stability testing before each step of a clinical trial can be approved. The demand for biosimilars has considerably grown in recent years due to their close resemblance to biologics and usually reduced cost. The use of biosimilars in the treatment of persistent illnesses like cancer and autoimmune diseases has grown significantly.

Restraints: Lack of skilled labor

Pharmaceutical stable and storing service providers struggle to find and keep highly qualified employees. In the pharmaceutical, biotechnology, medical device, contract research, academic, and research sectors, these businesses vie for the services of qualified and seasoned scientists. The lack of qualified experts in this area is a result of the pharmaceutical industry's growth toward innovative molecular structures and methods of action.


Defining requirements for worldwide industry stability testing has become a recent trend in multipurpose pharmaceutical companies. For this reason, businesses are creating procedures to handle a single set of extreme environmental circumstances. Because all tests are carried out in one facility, it prevents the region's stable testing from being repeated and makes the best use of resources. It has been demonstrated that testing under three environmental conditions temperature, humidity, and light has a more detrimental effect on drug molecules and goods than humidity alone.

Covid-19's Impact:

The COVID-19 pandemic has increased the demand for COVID-19 medicines on a worldwide scale. The need for commercial COVID-19 vaccine stability and storage is expected to grow as the government pushes vaccination more aggressively. The cost of pharmaceutical R&D has considerably grown in recent years. The number of medicines undertaking clinical trials is expected to increase as R&D spending rises. Stability testing is necessary before each step of clinical research can be approved, which is accelerating industry development.

Service Insights:

The industry leader and one that will produce the largest revenue share over the projection period is the stable category. Pharmaceutical firms that are looking for regulatory bodies' industry permits must assess and document a critical stability testing parameter. Stability testing's industry demand is rising as a result of clinical studies' need for it at every stage. During the projection period, the storage industry sector is expected to have the greatest CAGR.

Molecule Insights:

The largest income portion came from the small molecule industry. Because small molecules make up about 90% of all pharmaceutical medicines, the creation of small-molecule pharmaceuticals has progressed significantly. It helps with cancer, diabetes, migraines, and other prevalent diseases. The demand for routine testing and storing is influenced by small-molecule medications used to address widespread illnesses and disorders. Large molecules are predicted to experience the greatest CAGR growth during the projection period.

Mode Insights:

The worldwide industry's biggest revenue share was produced by the in-house industry. Most pharmaceutical makers carry out stable testing internally because it is necessary for all medications and all stages of clinical trials. One of the reasons pharmaceutical firms take into account in-house stability testing services is the perception that owning a stability chamber to carry out stability studies is more cost-effective in the long run. It will be more convenient for pharmaceutical firms that can handle the early setup expenses to hire internal staff to conduct stability testing.

Recent Development:

  • Almac Group finished the initial phase of the development of its GMP API plant in December 2022.
  • In North Carolina, Alcami opened a CGMP Bio preservation Laboratory in 2022.
  • Cambrex bought the Irish storage firm Q1 Scientific in June 2022.
  • In February 2022, Charles River Laboratories International, Inc. stated that Alderley Park at Bruntwood SciTech would become available for production.
  • In September 2021, BioLife Solutions bought the bulk of Sexton Biotechnologies.

Major Key Players:

  • 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

Market Segmentation:

By Services

  • Stability
  • Drug Substance
  • Stability indicating method validation.
  • Accelerated stability testing.
  • Photostability Testing
  • Other stability testing methods
  • Storage
  • Cold
  • Non-cold

By Molecule

  • Small Molecule
  • Research Products
  • Commercial Products
  • Large Molecule
  • Research Products
  • Commercial Products

By Mode

  • In-house
  • Outsourcing

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