Pharmaceutical Stability and Storage Services Market

Market Overview

The global pharmaceutical stability and storage services market size was valued at USD 2.47 billion in 2021. It is projected to reach USD 4.48 billion by 2030, growing at a CAGR of 6.85% during the forecast period (2022–2030).

Stability and storage service providers rely heavily on pharmaceutical firms, biotechnology firms, contract research organizations, and end users. These organizations have exerted significant effort to produce pharmaceutical samples, APIs, small and large compounds, and other pharmaceutical products. The global pharmaceutical industry has grown significantly due to rising R&D spending due to the high prevalence of chronic and infectious diseases.

Stability and storage requirements are mandated in various regions. Different regulatory authorities have varying data requirements and testing regulations for testing stability. Even though the FDA and EMA adhere to the ICH guidelines for stability testing, their microbiological limits for stability testing differ. This has increased the demand for outsourcing stability testing services and is expected to affect the market positively. Each clinical trial stage must complete stability testing before approval, which fuels the market's growth. The increasing prevalence of diseases is likely to increase the demand for biosimilars and biosimilar stability and storage.

Market Dynamics

Global Pharmaceutical Stability and Storage Services Market Drivers

Rapid Demand for Vaccines

Demand for commercial COVID-19 vaccines that are stable and can be stored for an extended period is likely to increase as the government authorities ramp up their vaccination efforts. The amount spent on research and development in the pharmaceutical industry has seen significant growth in recent years. It is anticipated that the rising spending on research and development will increase the number of drugs. To receive approval for each phase of a clinical trial, one must first conduct stability testing, another factor driving the market growth. Additionally, compared to biological drugs, the cost of biosimilar drugs is much lower because they are nearly identical copies of biological drugs.

Increasing Demand for Biosimilar

Due to their close resemblance to biologics and typically lower cost, the demand for biosimilars has significantly increased in recent years. Biosimilar has gained considerable traction in treating cancer, autoimmune diseases, and other chronic conditions. The demand for biosimilars is expected to rise along with the need for their stability and storage due to these diseases' widespread prevalence worldwide. Marketing products across markets is challenging because various regulatory authorities have different data requirements and testing guidelines for determining a product's stability. This is anticipated to increase market demand for outsourcing services.

Global Pharmaceutical Stability and Storage Services Market Restraint

Rare Highly Skilled Workers

Providers of pharmaceutical stability and storage services face difficulties attracting and retaining highly skilled personnel. These companies compete for qualified and experienced scientists in pharmaceutical, biotechnology, medical device, contract research, and academic and research institutions. The expansion of the pharmaceutical industry toward novel molecular structures and mechanisms of action contributes to the shortage of skilled specialists in this field. To create training programs tailored to the healthcare industry, pharmaceutical companies, CROs, and healthcare analytical testing companies must work together.

Regional Analysis

The global pharmaceutical stability and storage services market is segmented into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

North America is the most dominant in the global pharmaceutical stability and storage market regarding revenue. This is due to numerous pharmaceutical companies in the United States and Canada. The presence of significant market participants offering stability and storage services in this region is anticipated to contribute to market expansion significantly. Asia-Pacific is expected to grow at the highest CAGR during the forecast period. Due to the presence of China, India, and Japan, this region has the fastest-growing pharmaceutical market in the world. The initiatives of public organizations to reduce drug prices to improve access to quality medications have contributed to the expansion of the market.

Segmental Analysis

The global pharmaceutical stability and storage services market analysis is segmented into services, molecules, and modes.

Based on service, the market is categorized into stability and storage.

The stability segment dominates the market and will generate the highest revenue share during the forecast period. Pharmaceutical companies seeking marketing approvals from the regulatory authorities must analyze and report on a crucial stability testing parameter. The requirement for stability testing during each phase of clinical studies is increasing its market demand. The storage market segment is anticipated to record the highest CAGR during the forecast period. Pharmaceutical drugs are stored in cold and non-cold environments within environmentally controlled chambers to determine whether the quality degrades over time due to humidity, temperature, and light changes.

Based on molecules, the market is divided into small molecules and large molecules.

The small molecule segment accounted for the highest revenue share. The development of small molecule drugs has advanced dramatically as small molecules account for approximately 90% of all pharmaceutical drugs. It treats fever, migraines, cancer, diabetes, and other common ailments. Small-molecule drugs that treat common diseases and disorders contribute to regular testing and storage demand. The segment of large molecules is anticipated to grow at the highest CAGR during the forecast period. Numerous diseases, including cancer, infectious, and autoimmune diseases, are commonly treated with large molecules. The high prevalence of these diseases is anticipated to increase the demand for large molecules.

Based on the mode, the market is bifurcated into in-house and outsourcing.

The in-house sector generated the largest revenue share in the global market. As these tests are required for all drugs and all phases of clinical studies, most pharmaceutical manufacturers conduct stability testing in-house. Owning a stability chamber to conduct stability studies is viewed as more cost-effective in the long run, which is one of the reasons pharmaceutical companies consider in-house stability testing services. Pharmaceutical companies that can afford the initial setup costs will find it more convenient to have an in-house team perform stability testing. These factors drive the market demand for in-house services.

Recent Developments

• June 2022- Catalent and MigVax Signed Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19. Catalent, the global leader in enabling biopharma, cell, gene, and consumer health, partnered to optimize the development, launch, and supply of better patient treatments across multiple modalities.
• May 2022- Catalent Launched the UpTempo Virtuoso™ AAV Platform to Reduce Gene Therapy Development Time and Accelerate the Path to Clinic. Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize the development, launch, and supply of better patient treatments across multiple modalities, introduced its new, UpTempo Virtuoso™ platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors.
• April 2022- Charles River and Valo Launched Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets.