The
pharmaceutical stability and storage services market involves testing, packaging,
and storage services for pharmaceutical drug products to ensure their quality
and stability throughout their shelf life. These services play a crucial role
in maintaining the safety, efficacy and quality of pharmaceuticals. There is a
growing need for such services as pharmaceutical manufacturers focus on drug
development and new product launches at a faster pace. Stability testing helps
determine a drug's shelf life by verifying that the medicinal characteristics
of the product don't change over time under specific storage or environmental
conditions. In addition, it ensures that these drugs comply with stringent
regulations and meet necessary standards. Storage services include proper
packaging and warehousing of drugs under controlled temperature, humidity and
lighting conditions to keep them fresh.
The
global pharmaceutical stability and storage services market is estimated to be
valued at US$ 3.18 Bn in 2024 and is
expected to exhibit a CAGR of 5.8%
over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the
Pharmaceutical
Stability And Storage Services Market Demand are 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. The pharmaceutical
stability testing services market offers immense growth opportunities owing to
rising drug pipelines and regulatory compliance requirements. Global
pharmaceutical companies are rapidly expanding their stability testing
facilities and capabilities across major markets to deal with the evolving
regulatory landscape and keep pace with the industry.
The key opportunities in the market include rising investments by pharma
companies in new product development and clinical trials. Increased
regulatorystringency is also boosting demand for comprehensive stability
testing and specialized storage services. Further, growing generics market and
biosimilars production offer lucrative opportunities. Pharma companies are
increasingly outsourcing stability testing and specialized storage to free
internal resources for core activities and gain expertise.
Globally, players are expanding across North America, Asia, and Europe through strategic
partnerships, collaborations, and acquisitions. For instance, PCI Pharma
Services expanded its global stability testing lab capacity by opening a new
facility in Shanghai, China to address the rising needs of regional and
multinational clients. The globalization of clinical trials and manufacturing
also drives the need for harmonized stability programs across locales,
benefiting global service providers.
Market Drivers:
- Growing pharmaceutical industry and R&D investments in drug
development
- Stringent regulatory requirements for stability testing and storage
conditions
Market Restrains:
- High set up and maintenance costs associated with stability testing
facilities
- Shortage of specialized capabilities and experts in emerging markets
Segment Analysis
The pharmaceutical stability and storage services market is dominated by
drug stability testing sub segment. Drug stability testing involves testing
drug products under controlled environmental conditions over time to assess the
quality of a drug substance. It helps in determining the shelf life of drugs
and helps to ensure the safety and effectiveness of drugs till the end of their
shelf life. This sub segment accounts for majority share owing to regulatory
mandates requiring drug stability testing before commercialization and
periodically during commercial life cycle of drugs.
The contract manufacturing organizations sub segment is also gaining traction.
Many pharmaceutical companies are outsourcing stability studies and storage to
free up internal capabilities and focus on core competencies. CMO's provide
storage facilities and services like temperature and humidity controlled
storage, sample management and retrieval which ensures integrity of drug
samples under testing.
Global Analysis
North America dominates the global pharmaceutical stability and storage
services market owing to stringent regulatory environment. Presence of major
pharmaceutical companies and regulatory agencies like FDA in the region drives
high demand for stability and storage services. Europe is the second largest
market driven by stringent EMA regulations for drug testing and approvals. Asia
Pacific is fastest growing region for pharmaceutical stability and storage
services market driven by growth of pharmaceutical industry, increase in
generic drug production and rise of local CROs and CMOs in countries like India
and China. Growing pharmaceutical manufacturing in Latin America and Middle
East and Africa also contributes to growth of regional markets.
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