Product Code: GVR-4-68040-123-7
North America And Europe Pharmaceutical Stability & Storage Services Market Growth & Trends:
The North America and Europe pharmaceutical stability & storage services market size is expected to reach USD 3.22 billion by 2030, according to a new report by Grand View Research, Inc.. The market is expected to grow at a CAGR of 5.5% from 2023 to 2030. Stringent regulatory requirements, increasing R&D investments, and globalization of clinical trials are some of the major factors driving market growth.
The rising demand for biosimilars is expected to drive market advancement. In recent years, the approval rate for biosimilars has significantly improved. As per the Amgen Biosimilars Trend Report published in 2020, there was an increase in the number of biosimilar approvals by 65% since the preceding year in the U.S. As of 2023, 41 biosimilars were approved in the U.S., and over 70 were approved in the EU. The growing approval of biosimilars is likely to positively impact the market.
The stability of pharmaceuticals plays a crucial role in determining the strength and effectiveness of the medication. However, ensuring stability poses challenges due to varying data requirements and testing regulations imposed by different regulatory bodies, making it particularly difficult to market products in diverse regions. While both the EMA and FDA adhere to the ICH guidelines for stability testing, they maintain distinct microbiological limits for these tests. Consequently, certain evaluations that are optional in the United States become mandatory in the European Union, and vice versa. These disparities complicate stability testing procedures, leading to an increased need for outsourcing such testing services.
Several companies are involved in strategies such as acquisitions, collaborations, and new service launches to gain positions in the market. For instance, in March 2023, BioLife Solutions introduced the Ultraguard -70°C Phase Change Material (PCM) Accessory to offer backup cooling in ULT Freezers and act as a dry ice substitute for benchtop biologic material storage. Moreover, in October 2022, CSafe and BioLife Solutions, Inc. formed a partnership to enhance supply chain solutions for cell and gene therapy. CSafe joined BioLife's global partner network of companies offering cold chain solutions for the cell and gene therapies market.
North America And Europe Pharmaceutical Stability & Storage Services Market Report Highlights:
- The stability segment dominated the regional market in 2022. The rapid growth in the demand for biopharmaceuticals and personalized medicines is driving advancements in pharmaceutical stability services
- Based on service, the storage segment is expected to witness the highest CAGR of 6.1% over the forecast period, owing to the increasing focus on generics and biosimilars in developing regions
- The small molecules segment dominated the market in 2022. Recent advances in forecasting, structure-based design, imaging, automation, artificial intelligence, and machine learning have become critical facilitators for increasing small molecule lead optimization's pace and success rates
- The large molecule segment also holds a significant share in the market. This is due to the increasing adoption of large molecules such as proteins, nucleic acids, carbohydrates, living cells, and tissues
- In 2022, the in-house segment held the largest market share. Most 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
- North America dominated the market, accounting for the largest revenue share of 71.51% in 2022, due to the presence of several major market players providing stability and storage services in the region
- Europe is also expected to account for a significant share of the market in the coming years. The UK has a strong emphasis on R&D in the pharmaceutical sector. As companies invest in developing new drugs and conducting clinical trials, there is an increased demand for stability testing and storage services to support these activities
Table of Contents
Chapter 1 Methodology and Scope
- 1.1 Market Segmentation and Scope
- 1.2 Market Definitions
- 1.3 Research Methodology
- 1.4 Information Procurement
- 1.4.1 Information analysis
- 1.4.2 Market formulation & data visualization
- 1.4.3 Data validation & publishing
- 1.5 Research Scope and Assumptions
- 1.5.1 Approach 1: Commodity Flow Analysis
- 1.5.2 Approach 2: Hybrid Model Analysis
- 1.5.3 Hybrid Model market estimation
- 1.5.4 Region/Country-based segment share calculation
- 1.5.5 Multivariate analysis
- 1.5.6 CAGR Calculation
- 1.6 List of Secondary Sources
- 1.7 Objectives
- 1.7.1 Objective - 1
- 1.7.2 Objective - 2
- 1.7.3 Objective - 3
- 1.7.4 Objective - 4
Chapter 2 Executive Summary
- 2.1 Market Snapshot
- 2.2 Segment Snapshot
- 2.3 Segment Snapshot
- 2.4 Competitive Landscape Snapshot
Chapter 3 Pharmaceutical Stability & Storage Services Market Variables, Trends, & Scope
- 3.1 Market Lineage Outlook
- 3.1.1 Parent market outlook
- 3.1.2 Ancillary Market Outlook
- 3.2 Pharmaceutical Stability & Storage Services Market
- 3.3 Market Dynamics
- 3.3.1 Market driver impact analysis
- 3.3.1.1 High R&D spending of pharmaceutical & biotechnology companies
- 3.3.1.2 Growing demand for outsourcing stability testing due to the high complexity associated with drug stability
- 3.3.1.3 Growing demand for biosimilars
- 3.3.2 Market restraint analysis
- 3.3.2.1 Stringent regulations for Pharmaceutical Stability and Storage Services of drugs
- 3.3.2.2 Issues Associated with stability chambers
- 3.3.3 Industry Trends
- 3.3.3.1 Expansion of cold chain logistics
- 3.3.4 Opportunity Analysis
- 3.3.4.1 Increasing demand for personalized medicine
- 3.4 Porter's Five Forces Analysis
- 3.5 PESTEL Analysis
- 3.6 Impact of COVID-19 on North America and Europe Pharmaceutical Stability & Storage Services Market
Chapter 4 North America and Europe Pharmaceutical Stability & Storage Services Market: Segment Analysis, by Services, 2018 - 2030 (USD Million)
- 4.1 North America and Europe Pharmaceutical Stability & Storage Services Market: Services Movement Analysis
- 4.2 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Services (USD Million)
- 4.2.1 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Stability Type (USD Million)
- 4.2.2 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Storage Type (USD Million)
- 4.3 Stability
- 4.3.1 Drug Substance
- 4.3.2 Stability indicating method validation
- 4.3.3 Accelerated stability testing
- 4.3.4 Photostability Testing
- 4.3.5 Other stability testing methods
- 4.4 Storage
- 4.4.1 Cold
- 4.4.2 Non-cold
Chapter 5 North America and Europe Pharmaceutical Stability & Storage Services Market: Segment Analysis, by Molecule, 2018 - 2030 (USD Million)
- 5.1 North America and Europe Pharmaceutical Stability & Storage Services Market by Molecule: Key Takeaways
- 5.2 Molecule Movement Analysis & Market Share, 2022 & 2030
- 5.3 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Molecule (USD Million)
- 5.3.1 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Small Molecules (USD Million)
- 5.3.2 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Large Molecules (USD Million)
- 5.4 Small Molecule
- 5.4.1 Small Molecule market estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.4.2 Research Products
- 5.4.2.1 Research Products market estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.4.3 Commercial Products
- 5.4.3.1 Commercial Products market estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.5 Large Molecule
- 5.5.1 Large Molecule market estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.5.2 Research Products
- 5.5.2.1 Research Products market estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.5.3 Commercial Products
- 5.5.3.1 Commercial Products market estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6 North America and Europe Pharmaceutical Stability & Storage Services Market: Segment Analysis, by Mode, 2018 - 2030 (USD Million)
- 6.1 North America and Europe Pharmaceutical Stability & Storage Services Market by Mode: Key Takeaways
- 6.2 Mode Movement Analysis & Market Share, 2022 & 2030
- 6.3 North America and Europe Pharmaceutical Stability & Storage Services Market Estimates & Forecast, By Mode (USD Million)
- 6.4 In-House
- 6.4.1 In-House market estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5 Outsourcing
- 6.5.1 Outsourcing market estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 7 North America and Europe Pharmaceutical Stability & Storage Services Market: Regional Estimates and Trend Analysis, by Services, by Molecule, by Mode.
- 7.1 North America and Europe Pharmaceutical Stability & Storage Services Market: Regional Outlook
- 7.2 North America
- 7.2.1.1 North America Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.2.2 U.S.
- 7.2.2.1 Key Country Dynamics
- 7.2.2.2 Competitive Scenario
- 7.2.2.3 Regulatory Framework
- 7.2.2.4 U.S. Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.2.3 Canada
- 7.2.3.1 Key Country Dynamics
- 7.2.3.2 Competitive Scenario
- 7.2.3.3 Regulatory Framework
- 7.2.3.2 Canada Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.3 Europe
- 7.3.1.1 Europe Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.3.2 UK
- 7.3.2.1 Key Country Dynamics
- 7.3.2.2 Competitive Scenario
- 7.3.2.3 Regulatory Framework
- 7.3.2.4 UK Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.3.3 Germany
- 7.3.3.1 Key Country Dynamics
- 7.3.3.2 Competitive Scenario
- 7.3.3.3 Regulatory Framework
- 7.3.3.4 Germany Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.3.4 France
- 7.3.4.1 Key Country Dynamics
- 7.3.4.2 Competitive Scenario
- 7.3.4.3 Regulatory Framework
- 7.3.4.4 France Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.3.5 Italy
- 7.3.5.1 Key Country Dynamics
- 7.3.5.2 Competitive Scenario
- 7.3.5.3 Regulatory Framework
- 7.3.5.4 Italy Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million
- 7.3.6 Spain
- 7.3.6.1 Key Country Dynamics
- 7.3.6.2 Competitive Scenario
- 7.3.6.3 Regulatory Framework
- 7.3.6.4 Spain Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million
- 7.3.7 Denmark
- 7.3.7.1 Key Country Dynamics
- 7.3.7.2 Competitive Scenario
- 7.3.7.3 Regulatory Framework
- 7.3.7.4 Denmark Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million
- 7.3.8 Sweden
- 7.3.8.1 Key Country Dynamics
- 7.3.8.2 Competitive Scenario
- 7.3.8.3 Regulatory Framework
- 7.3.8.4 Sweden Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million
- 7.3.9 Norway
- 7.3.9.1 Key Country Dynamics
- 7.3.9.2 Competitive Scenario
- 7.3.9.3 Regulatory Framework
- 7.3.9.4 Norway Pharmaceutical Stability & Storage Services market estimates and Forecasts, 2018 - 2030 (USD Million
Chapter 8 Competitive Landscape
- 8.1 Heat Map Analysis
- 8.2 Participants Overview
- 8.3 Financial Performance
- 8.4 Service Benchmarking
- 8.5 Strategy Mapping
- 8.5.1 Acquisition
- 8.5.2 Expansion
- 8.5.3 Partnership & Collaboration
- 8.5.4 Product Launch
- 8.6 Company Market Share Analysis (2022)
- 8.7 List of Players