Pharmaceutical Stability & Storage Services Market Size, Share & Trends Analysis Report By Services (Stability, Storage), By Molecule (Large Molecule, Small Molecule), By Mode, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global pharmaceutical stability & storage services market size was valued at USD 2.7 billion in 2021 and is expected to expand at a CAGR of 5.6% from 2022 to 2030. The global market has noticed critical growth on account of the rising R&D investments by pharmaceutical companies owing to the high burden of chronic and infectious diseases. Pharmaceutical organizations are increasingly focusing on their R&D activities to stay competitive & flexible. As per the estimates of Evaluate Pharma, the pharmaceutical R&D spending accounted for USD 182 billion, in 2018, whereas in 2021 it increased by 16.5% and accounted for USD 212 billion.

The COVID-19 pandemic has significantly impacted the storage and stability market. During the crisis, global pharmaceutical stability and storage services providers played a predominant role in meeting the needs of pharmaceutical companies, biotech companies, contract research organizations, and other end users. These organizations have been actively working towards the development of pharmaceutical samples, APIs, small & large molecules, and other pharmaceutical products.

In recent years the demand for biosimilar has improved significantly, as they are highly similar to biologics and are generally cheaper than biologics. Biosimilar has gained significant popularity in treating cancer, autoimmune diseases, and other chronic diseases. The high burden of these diseases globally is expected to fuel the demand for biosimilars and thus promote the demand for stability and storage of biosimilars. Different regulatory authorities have different data requirements and testing rules for testing stability, which makes it difficult to market products, especially across different markets. This is expected to boost the demand for outsourcing services in the market.

The COVID-19 pandemic has significantly increased demand for biological medicines like vaccines, as of 15^th April 2022, over 349 vaccines were under development as per the WHO. This is expected to improve the demand for stability and storage of COVID-19 vaccines in clinical trials. Owing to the high burden of COVID-19, many COVID-19 vaccines received emergency approval. Such actions are likely to contribute to the demand for stability and storage of commercial vaccines.

Service Insights

The stability segment dominated the market and accounted for the largest revenue share of 72.8% in 2021.  Stability testing is an important parameter that must be analyzed and reported by pharmaceutical companies aiming to gain marketing approvals from the regulatory authorities. The mandatory requirement for stability testing in each phase of the clinical studies is further improving its demand in the market.

The storage segment is expected to register the fastest CAGR of 6.3% during the forecast period. Pharmaceutical drugs are stored in cold and non-cold conditions under environmentally controlled chambers to check whether the quality of the drug changes with time under the environmental conditions of humidity, temperature, and light.  The majority of small molecule drugs are required to be stored in non-cold conditions and the high existence of commercially available small molecules is driving the demand for non-cold storage in the market.

Molecule Insights

The small molecule segment accounted for the maximum revenue share of 63.6% in 2021. Over the last three decades, small molecule drug development has advanced dramatically. Small molecules consist of approximately 90% of the total pharmaceutical drugs. It is used in the treatment of fever, migraine, cancer, diabetes, and other common diseases. The use of small-molecule drugs in the treatment of common diseases and disorders is contributing to its demand for stable testing and storage.

The large molecule segment is expected to rise with the fastest CAGR of 6.6%over the forecast period. Large molecules are widely used in the treatment of cancer, infectious diseases, and autoimmune diseases among others. The high burden of these diseases is expected to improve the demand for large molecules and thus is likely to promote the demand for stability and storage of large molecules.

Mode Insights

The in-house segment accounted for the maximum revenue share of 60.2% in the global market in 2021. The majority of pharmaceutical manufacturers choose in-house stability testing, as these tests are required to be performed for all drugs and in all phases of clinical studies. Owning a stability chamber for performing stability studies is considered cheaper in the long run, which is one of the reasons that pharmaceutical companies consider in-house services for stability testing. An in-house team performing stability testing will be more convenient for those pharmaceutical companies that can afford the initial setup cost; these factors are driving the demand for in-house services in the market.

The outsourcing segment is expected to rise with the fastest CAGR of 6.2% during the forecast period. Complications associated with stability testing are driving the demand for outsourcing in the market.  Different regulatory authorities have different data requirements and testing rules, which makes it difficult to market products, especially in different markets. For instance, even though EMA and FDA follow ICH guidelines for stability testing, they still have different microbiological requirements for stability tests. Such differences make stability testing complicated, which increases the demand for outsourcing services.

Regional Insights

North America held the largest revenue share 53.7% of the pharmaceutical stability and storage market. This can be attributed to the significant number of pharmaceutical companies in the U.S. and Canada. The presence of major market players providing stability and storage services in this region is expected to contribute significantly to the market growth.

Asia Pacific is expected to grow at the fastest CAGR of 6.8% over the forecast. The region is the fastest growing pharmaceutical market, due to the presence of countries like China, India, and Japan. The initiatives by public organizations to reduce the prices of drugs so as to provide better access to quality medicines have contributed to the market growth. The region is also focused on clinical research. For instance, according to Global data, China had accounted for 26% of global clinical trials trial activity in 2021, and the significant number of clinical trials in these countries are likely to profit the Asia Pacific market.

Key Companies and Market Share Insights

Companies are undergoing expansions, acquisitions, and partnerships among others in the market to stay competitive. For instance, in September 2021, BioLife Solutions announced the acquisition of Sexton Biotechnologies. This acquisition will help in strengthening cell and gene therapy and broader biopharmaceutical. Similarly, in February 2022, Charles River Laboratories International, Inc. announced the expansion of its manufacturing capacity in Bruntwood SciTech’s Alderley Park. Some prominent players in the global pharmaceutical stability & storage services market include:

• Catalent Inc.

• Almac Group

• Charles River Laboratories International, Inc.

• Eurofins Scientific SE

• Intertek Group plc

• Lucideon Limited

• Alcami Corporation

• Element Materials Technology

• BioLife Solutions

• Q1 Scientific

• Masy BioServices

• Reading Scientific Services Ltd.

• Roylance Stability Storage Limited

• ALS Ltd.'s

• Q Laboratories

• Auriga Research Private Limited

• PD Partners

• Precision Stability Storage

Pharmaceutical Stability & Storage Services Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels 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 global pharmaceutical stability & storage services market report on the basis of services, molecule, mode, and region:

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

  •  Stability

    • Drug Substance

    • Stability Indicating Method Validation

    • Accelerated Stability Testing

    • Photostability 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

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

  •  In-house

  • Outsourcing

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

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia