1. Executive Summary
1.1 Pharmaceutical Stability Testing Market Review
1.2 Aims, Scope and Format of the Report
1.3 Research & Analysis Methods
2. Pharmaceuticals: Stability Testing and Programmes
2.1 An Overview
2.2 New Pharmaceuticals and Stability Testing
2.2.1 Preformulation and Compatibility Studies
2.2.2 Design and Manufacture of Preclinical Formulations
2.2.3 Clinical Formulation Studies
2.2.4 Late Clinical and First Pilot Batch Studies
2.2.5 Marketed Drugs and Stability
2.3 ICH: A Brief History
2.4 ICH Process and Harmonization
2.5 Climatic Conditions and World Zones
2.5.1 ICH and Stability Testing?
2.6 Quality Guidelines for Stability Testing
2.6.1 Stability Testing of New Drug Substances and Products Q1A (R2)
2.6.2 Selection of Batches
2.7 Established Drug Substances and Stability Testing
2.7.1 Accelerated Stability Testing (AST)
2.7.2 Expiration Date
2.7.3 Mean Kinetic Temperature
2.7.4 Real Time (Long-Term) Stability Studies
2.7.5 Stability Tests
2.8 Principle Aims of Stability Testing
2.8.1 Pharmaceutical Test Samples
2.8.2 Stability Test Conditions
2.9 Proposed Storage Conditions and Shelf-Life
3. Pharmaceutical Stability Testing Markets at Global and National Levels
3.1 The World Pharmaceutical Stability Testing Market in 2010
3.2 Growing Market for Pharmaceutical Stability Testing Services
3.2.1 Revenue Forecast for Overall Pharmaceutical Stability Testing Market, 2010-2016
3.2.2 Revenue Forecast for Overall Pharmaceutical Stability Testing Market, 2017-2025
3.3 Breakdown of the Global Pharmaceutical Stability Testing Market
3.3.1 Revenue Forecast for API Stability Testing, 2010-2016
3.3.2 Revenue Forecast for API Stability Testing, 2017-2025
3.3.3 Revenue Forecast for Finished Dosage Form Stability Testing, 2010-2016
3.3.4 Revenue Forecast for Finished Dosage Form Stability Testing, 2017-2025
3.3.5 Revenue Forecast for Biologicals Stability Testing Market, 2010-2016
3.3.6 Revenue Forecast for Biologicals Stability Testing Market, 2017-2025
3.4 National Markets for Pharmaceutical Stability Testing
3.4.1 Leading National Markets for Pharmaceutical Stability Testing, 2010-2025
3.4.2 The Japanese Pharmaceutical Stability Testing Market, 2010-2025
3.4.3 The Leading European Pharmaceutical Stability Testing Markets, 2010-2025
3.4.4 Emerging-Economy Pharmaceutical Markets
3.4.5 The Chinese Pharmaceutical Stability Testing Market, 2010-2025
3.4.6 The Indian Pharmaceutical Stability Testing Market, 2010-2025
4. World Market Prospects at Product Class Level
4.1 Therapeutic Areas Offering Growth Opportunities
4.1.1 The Leading Biotech Therapy Classes, 2010-2025
4.1.2 The Top 10 Biotech Therapy Classes in 2009
4.1.3 The Oncology Class Currently Leads the Biotech Market
4.1.3.1 Long-Term Prospects in Oncology & Implications for Pharmaceutical Stability Testing Market
4.1.4 The Human Insulins Class Will Exhibit Strong Growth
4.1.5 Immunosuppressive Agents, 2010-2025
4.1.6 Autoimmune Agents Show Promising Growth - Will it Last?
4.1.7 Erythropoietin Products - How Will Reported Safety Affect Sales?
4.1.7.1 Erythropoietin Products Forecast, 2010-2025
4.1.8 Immunostimulating Agents - Sales Prospects
4.1.9 The Interferons Class Will Show an Increase in Revenue from 2010-2015
4.1.9.1 Long-Term Forecast for the Interferons Class
4.1.10 Will Pure Vaccine Sales Continue to Decline After 2015?
4.1.10.1 Will Pure Vaccines Sales Continue to Decline After 2015?
4.1.11 Blood Coagulation Factors Will Show Steady Growth
4.1.12 Growth Hormones Forecast, 2010-2025
4.2 Summary of World Market Forecasts
4.2.1 The Top 10 Biotech Therapy Classes, 2010-2025
4.2.2 Pharmaceutical Stability Testing Market: a Rapidly-Expanding Segment of the Global Pharma Sector
5. Some Prominent Companies in the Stability Testing Industry and Market
5.1 Introduction
5.2 Analytical Bio-Chemistry (ABC) Laboratories
5.2.1 An Overview
5.2.2 Facilities
5.2.3 ABC's Services
5.2.4 Stability Programs & Release Testing
5.3 Boston Analytical
5.3.1 An Overview
5.3.2 Stability Testing & Storage
5.4 Chemic Laboratories
5.4.1 An Overview
5.4.2 Services Offered
5.5 Formatech
5.5.1 An Overview
5.5.2 Stability Profiling
5.5.3 Stability Finger Printing
5.5.4 Formatech's Other Services
5.6 Metrics
5.6.1 An Overview
5.6.2 Metric's Capabilities
5.6.3 Stability Services
5.7 Particle Sciences
5.7.1 An Overview
5.7.2 ICH Stability
5.7.3 Other Services
5.8 Recipharm
5.8.1 An Overview
5.8.2 Stability Studies
5.8.3 Additional Services
5.9 SGS Life Science Services
5.9.1 An Overview
5.9.2 Stability Studies
5.9.3 Other Related Services
5.10 Xcelience
5.10.1 An Overview
5.10.2 Stability Services
5.10.3 Capabilities/Equipment
5.10.4 Other Services
6. Qualitative Analysis of the Pharmaceutical Stability Testing Market
6.1 Introduction
6.2 Strengths and Weaknesses of the Sector
6.2.1 Drivers in the Pharmaceutical Stability Testing Market
6.3 Opportunities
6.3.1 The Effect of Thinner R&D Pipelines in the Pharma Industry
6.3.2 Growing Demand for Biotech Drugs and Targeted Therapy
6.3.3 Development of Biosimilars
6.3.4 Outsourcing of New Services
6.3.4.1 Drug Discovery
6.3.4.2 Stability Testing: In-house vs. Outsourcing
6.3.5 Strains on the Blockbuster Model
6.4 Challenges in the Stability Testing Market
6.4.1 Stricter Regulations
6.4.2 Continuing Challenges for Biotech Drugs
6.4.3 Bioassays: Testing Reference Standards
6.4.4 Homogeneity and Stability of the Biological Reference Standard
6.4.5 Stabilization of Biologicals
6.4.6 Technology Challenges in Stability Testing
6.4.7 Product Aggregation and Sub-Visible Particles
6.4.8 Antibodies and Degradation Challenges
6.4.9 Stress Stability Testing and Biologics
6.4.10 Other Issues: Photostability Testing
6.5 Pharmaceutical Companies and PST CROs - Synergies and Challenges
6.5.1 Increasing Competition: Potential Threat to PST CROs
6.5.1.1 Patheon Forms Alliance with India's Kemwell
6.5.2 Outsourcing to Low-Cost Geographical Areas
6.5.3 Interview with Manish Badonia, Cadila
6.5.3.1 Contract Manufacturing Outsourcing to Asia Will Grow
6.5.3.2 Alliance Formation for Moving Up the Value Chain
6.5.3.3 Quality Control for Contract Research to Improve Further
6.5.4 Low Cost Services in India and China Drive Prices Down But Concerns over IP Remain
6.5.4.1 Main Tendencies in Current Asian IP Law
6.5.4.2 Patent Protection Status in Indian Pharmaceutical Industry
6.5.4.3 Recommendation for Improvement of China's Intellectual Property Rights Situation
6.5.4.4 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China
6.5.4.4.1 International Framework: IP Protection for Contract Manufacturing
6.5.4.4.2 IP Holders Get the Profits
6.5.4.4.3 Changing IP Situation in the Developing Countries
6.5.4.4.4 Innovation-Oriented Industry Development in China
6.5.4.5 Interview with Manish Badonia, Cadila, India
6.5.4.5.1 IP Regime and Protection of Paramount Importance
6.6 Conclusion
7. Conclusions
7.1 The Market Prospects are Favourable
7.2 Commercial Drivers for Pharmaceutical Stability Testing Market
7.3 Prominent Companies in the Market
7.4 Future Outlook and Concluding Remarks
List of Tables
Table 2.1 WHO Classification of Main Climatic Zones
Table 2.2 Mean Climatic Data: Measured in Open Air and Storage Room Conditions
Table 2.3 Calculated Temperature, Mean Kinetic Temp., and Relative Humidity Values and Derived Storage Conditions for Real Time Studies
Table 2.4 Recommendations for Standard Storage Conditions by ICH Q1A (R2), QIF & Temperature Sensitive Products
Table 2.5 Main Objectives of Stability Testing
Table 3.1 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2010-2016
Table 3.2 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2017-2025
Table 3.3 API Stability Testing Market: World Revenue Forecast, 2010-2016
Table 3.4 API Stability Testing Market: World Revenue Forecast, 2017-2025
Table 3.5 Finished Dosage Form PST Market: World Revenue Forecast, 2010-2016
Table 3.6 Finished Dosage Form PST Market: World Revenue Forecast, 2017-2025
Table 3.7 Biologicals Stability Testing Market: World Revenue Forecast, 2010-2016
Table 3.8 Biologicals Stability Testing Market: World Revenue Forecast, 2017-2025
Table 3.9 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2010-2016
Table 3.10 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2017-2025
Table 3.11 Leading Pharmaceutical Stability Testing National Market Forecasts, 2010-2015, 2020 & 2025
Table 4.1 The Top 10 Biotech Therapy Classes, 2009
Table 4.2 Oncology Class: World Sales Forecast, 2010-2016
Table 4.3 Oncology Class: World Sales Forecast, 2017-2025
Table 4.4 Human Insulins Class: World Sales Forecast, 2010-2016
Table 4.5 Human Insulins Class: World Sales Forecast, 2017-2025
Table 4.6 Immunosuppressive Agents Class: World Sales Forecast, 2010-2016
Table 4.7 Immunosuppressive Agents Class: World Sales Forecast, 2017-2025
Table 4.8 Autoimmune Agents Class: World Sales Forecast, 2010-2016
Table 4.9 Autoimmune Agents Class: World Sales Forecast, 2017-2025
Table 4.10 Erythropoietin Products Class: World Sales Forecast, 2010-2016
Table 4.11 Erythropoietin Products Class: World Sales Forecast, 2017-2025
Table 4.12 Immunostimulating Agents Class: World Sales Forecast, 2010-2016
Table 4.13 Immunostimulating Agents Class: World Sales Forecast, 2017-2025
Table 4.14 Interferons Class: World Sales Forecast, 2010-2016
Table 4.15 Interferons Class: World Sales Forecast, 2017-2025
Table 4.16 Pure Vaccines Class: World Sales Forecast, 2010-2016
Table 4.17 Pure Vaccines Class: World Sales Forecast, 2017-2025
Table 4.18 Blood Coagulation Factors Class: World Sales Forecast, 2010-2016
Table 4.19 Blood Coagulation Factors Class: World Sales Forecast, 2017-2025
Table 4.20 Growth Hormones Class: World Sales Forecast, 2010-2016
Table 4.21 Growth Hormones Class: World Sales Forecast, 2017-2025
Table 4.22 Leading Biotech Therapy Classes: World Sales Forecasts, 2010-2016
Table 4.23 Leading Biotech Therapy Classes: World Sales Forecasts, 2017-2025
Table 5.1 List of Companies that Provide Stability Testing Studies, 2010 (Part 1)
Table 5.2 List of Companies that Provide Stability Testing Studies, 2010 (Part 2)
Table 5.3 List of Companies that Provide Stability Testing Studies, 2010 (Part 3)
Table 5.4 List of Companies that Provide Stability Testing Studies, 2010 (Part 4)
Table 6.1 SWOT Analysis for the Pharmaceutical Stability Testing Market, 2010-2025
Table 6.2 Challenges in Regulatory Environment, 2010
Table 6.3 Stability Testing: Business Environment for CROs & Pharma, 2010
Table 6.4 Pharmaceutical Companies' and PST CROs' Perspectives on Costs and Threats, 2010
Table 7.1 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2010, 2012, 2015, 2018, 2020 & 2025
List of Figures
Figure 3.1 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2010-2016
Figure 3.2 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2017-2025
Figure 3.3 API Stability Testing Market: World Revenue Forecast, 2010-2016
Figure 3.4 API Stability Testing Market: World Revenue Forecast, 2017-2025
Figure 3.5 Finished Dosage Form PST Market: World Revenue Forecast, 2010-2016
Figure 3.6 Finished Dosage Form PST Market: World Revenue Forecast, 2017-2025
Figure 3.7 Biologicals Stability Testing Market: World Revenue Forecast, 2010-2016
Figure 3.8 Biologicals Stability Testing Market: World Revenue Forecast, 2017-2025
Figure 3.9 Pharmaceutical Stability Testing Market: World Revenue Forecast, 2010-2025
Figure 3.10 US PST Market: Revenue Forecast, 2010-2025
Figure 3.11 Other Leading PST National Markets: Revenue Forecast, 2010-2025
Figure 3.12 PST Revenue Shares in Leading National Markets, 2010
Figure 3.13 PST Revenue Shares in Leading National Markets, 2015
Figure 3.14 PST Revenue Shares in Leading National Markets, 2020
Figure 3.15 PST Revenue Shares in Leading National Markets, 2025
Figure 4.1 Oncology Class: World Sales Forecast, 2010-2025
Figure 4.2 Human Insulins Class: World Sales Forecast, 2010-2025
Figure 4.3 Immunosuppressive Agents Class: World Sales Forecast, 2010-2025
Figure 4.4 Autoimmune Agents Class: World Sales Forecast, 2010-2025
Figure 4.5 Erythropoietin Products Class: World Sales Forecast, 2010-2025
Figure 4.6 Immunostimulating Agents Class: World Sales Forecast, 2010-2025
Figure 4.7 Interferons Class: World Sales Forecast, 2010-2025
Figure 4.8 Pure Vaccines Class: World Sales Forecast, 2010-2025
Figure 4.9 Blood Coagulation Factors Class: World Sales Forecast, 2010-2025
Figure 4.10 Growth Hormones Class: World Sales Forecast, 2010-2025
Figure 4.11 Leading Biotech Therapy Classes: World Sales Forecast, 2010-2025
Figure 4.12 Top Ten Therapy Classes: World Sales, 2009, 2015 & 2025
Figure 7.1 Pharmaceutical Stability Testing Market: World Revenue Forecast by Category, 2010, 2012, 2015, 2018, 2020 & 2025
Figure 7.2 Pharmaceutical Stability Testing Market: Total World Revenue Forecast, 2010, 2012, 2015, 2018, 2020 & 2025
Figure 7.3 Pharmaceutical Stability Testing Market: Percentage Shares by Category, 2010