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North America And Europe 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, 2023 - 2030

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    Report

  • 133 Pages
  • September 2023
  • Region: Europe, North America
  • Grand View Research
  • ID: 5893336
Description Jump to:
The North America and Europe pharmaceutical stability & storage services market size is expected to reach USD 3.22 billion by 2030. 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
List of Tables
Table 1. List of Secondary Sources
Table 2. List of Abbreviations
Table 3. North America and Europe Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 4. North America and Europe Pharmaceutical Stability & Storage Services Market by Molecule, 2018 - 2030 (USD Million)
Table 5. North America and Europe Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 6. North America and Europe Pharmaceutical Stability & Storage Services Market by Region, 2018 - 2030 (USD Million)
Table 7. North America Pharmaceutical Stability & Storage Services Market by Country, 2018 - 2030 (USD Million)
Table 8. North America Pharmaceutical Stability & Storage Services Market by Service, 2018 - 2030 (USD Million)
Table 9. North America Pharmaceutical Stability & Storage Services Market by Molecule, 2018-2030 (USD Million)
Table 10. North America Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 11. U.S. Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 12. U.S. Pharmaceutical Stability & Storage Services Market by Molecule, 2018 - 2030 (USD Million)
Table 13. U.S. Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 14. Canada Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 15. Canada Pharmaceutical Stability & Storage Services Market by Molecule, 2018 - 2030 (USD Million)
Table 16. Canada Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 17. Europe Pharmaceutical Stability & Storage Services Market by Country, 2018 - 2030 (USD Million)
Table 18. Europe Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 19. Europe Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 20. Europe Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 21. Germany Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 22. Germany Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 23. Germany Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 24. UK Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 25. UK Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 26. UK Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 27. France Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 28. France Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 29. France Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 30. Italy Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 31. Italy Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 32. Italy Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 33. Spain Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 34. Spain Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 35. Spain Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 36. Denmark Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 37. Denmark Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 38. Denmark Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 39. Sweden Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 40. Sweden Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 41. Sweden Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
Table 42. Norway Pharmaceutical Stability & Storage Services Market by Services, 2018 - 2030 (USD Million)
Table 43. Norway Pharmaceutical Stability & Storage Services Market by Molecules, 2018 - 2030 (USD Million)
Table 44. Norway Pharmaceutical Stability & Storage Services Market by Mode, 2018 - 2030 (USD Million)
List of Figures
Fig. 1 Information Procurement
Fig. 2 Primary Research Pattern
Fig. 3 Market Research Approaches
Fig. 4 Value Chain-Based Sizing & Forecasting
Fig. 5 Market Formulation & Validation
Fig. 6 Pharmaceutical Stability & Storage Services Market: Market Segmentation
Fig. 7 Market Driver Relevance Analysis (Current & Future Impact)
Fig. 8 Market Restraint Relevance Analysis (Current & Future Impact)
Fig. 9 Market Challenge Relevance Analysis (Current & Future Impact)
Fig. 10 Penetration & Growth Prospect Mapping
Fig. 11 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
Fig. 12 Porter’s Five Forces Analysis
Fig. 13 Market Penetration vs. Growth Prospect Mapping, 2021
Fig. 14 Regional Marketplace: Key Takeaways
Fig. 15 North America and Europe Pharmaceutical Stability & Storage Services Market for Stability, 2018 - 2030 (USD Million)
Fig. 16 North America and Europe Pharmaceutical Stability & Storage Services Market for Drug Substance, 2018 - 2030 (USD Million)
Fig. 17 North America and Europe Pharmaceutical Stability & Storage Services Market for Stability indicating method validation , 2018 - 2030 (USD Million)
Fig. 18 North America and Europe Pharmaceutical Stability & Storage Services Market for Accelerated stability testing , 2018 - 2030 (USD Million)
Fig. 19 North America and Europe Pharmaceutical Stability & Storage Services Market for Photostability Testing , 2018 - 2030 (USD Million)
Fig. 20 North America and Europe Pharmaceutical Stability & Storage Services Market for Other stability testing methods, 2018 - 2030 (USD Million)
Fig. 21 North America and Europe Pharmaceutical Stability & Storage Services Market for Storage, 2018 - 2030 (USD Million)
Fig. 22 North America and Europe Pharmaceutical Stability & Storage Services Market for Cold storage, 2018 - 2030 (USD Million)
Fig. 23 North America and Europe Pharmaceutical Stability & Storage Services Market for Non-cold storage, 2018 - 2030 (USD Million)
Fig. 24 North America and Europe Pharmaceutical Stability & Storage Services Market for Small Molecule, 2018 - 2030 (USD Million)
Fig. 25 North America and Europe Pharmaceutical Stability & Storage Services Market for Research Products, 2018 - 2030 (USD Million)
Fig. 26 North America and Europe Pharmaceutical Stability & Storage Services Market for Commercial Products, 2018 - 2030 (USD Million)
Fig. 27 North America and Europe Pharmaceutical Stability & Storage Services Market for Large Molecule, 2018 - 2030 (USD Million)
Fig. 28 North America and Europe Pharmaceutical Stability & Storage Services Market for Research Products, 2018 - 2030 (USD Million)
Fig. 29 North America and Europe Pharmaceutical Stability & Storage Services Market for Commercial Products, 2018 - 2030 (USD Million)
Fig. 30 North America and Europe Pharmaceutical Stability & Storage Services Market for In-house services, 2018 - 2030 (USD Million)
Fig. 31 North America and Europe Pharmaceutical Stability & Storage Services Market for Outsourcing services, 2018 - 2030 (USD Million)
Fig. 32 Regional Outlook, 2021 & 2030
Fig. 33 North America Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 34 U.S. Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 35 Canada Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 36 Europe Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 37 Germany Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 38 UK Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 39 France Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 40 Italy Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 41 Spain Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 42 Denmark Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 43 Sweden Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)
Fig. 44 Norway Pharmaceutical Stability & Storage Services Market, 2018 - 2030 (USD Million)

Companies Mentioned

  • Eurofins Scientific
  • Intertek Group plc
  • Lucideon Limited
  • Element Materials Technology
  • Q1 Scientific
  • Reading Scientific Services Ltd.
  • Catalent, Inc.
  • Quotient Sciences
  • Recipharm AB
  • Almac Group
  • Alcami Corporation
  • BioLife Solutions, Inc.
  • Sampled (Roylance Stability Storage Limited)
  • Precision Stability Storage
  • Broughton

Methodology

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Table Information

Report AttributeDetails
No. of Pages133
PublishedSeptember 2023
Forecast Period2022 - 2030
Estimated Market Value ( USD ) in 2022 $ 2.1 Billion
Forecasted Market Value ( USD ) by 2030 $ 3.22 Billion
Compound Annual Growth Rate5.5%
Regions CoveredEurope, North America
No. of Companies Mentioned15

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