Pharmaceutical Stability Testing: Commercial Prospects 2011-2025
How will the pharma stability testing sector develop from 2010, and where can you find the greatest opportunities there? How will technology suppliers and drug companies benefit? You can have our report now, staying ahead.
Our new report will give you information to benefit your work now:
Pharmaceutical stability testing (PST) is an important component of drug development and manufacturing. This market constitutes one of the fastest growing sectors in the pharmaceutical and biotech sectors, with estimated revenues of $0.95bn (for technology and services) in 2010.
Our report is your connection to the organisations, ideas and activities that are shaping the stability testing sector.
The market for pharmaceutical stability testing has been expanding rapidly, but which segments will grow fastest in years to come? What are the commercial trends to watch? How will the worldwide market for pharmaceutical stability testing perform from 2010 to 2025? This report answers those and other questions.
In our report, you will find out by how much the pharmaceutical stability testing market will grow. You will also study the trends that are driving growth in this sector.
Our new report shows you trends to watch in stability testing. Novel and generic drug producers can benefit from the emerging and established technologies. Developments will occur for biological drugs and small-molecule agents, novel and generic.
You will discover commercial prospects at global, sub-market and regional levels. We show you where the sector is heading.
Analysis and expert views to aid your work - so you won't be left behind
Our new report provides you with revenue forecasts, market share analyses, technological developments and expert opinion. That way, you can assess prospects, opportunities and threats in the sector.
We include 78 tables and figures, as well as two expert interviews (shown in the accompanying lists). You can stay ahead by ordering our report today, benefiting your analyses and commercial ideas.
Pharmaceutical Stability Testing: Commercial Prospects 2011-2025 shows you revenue trends, opportunities and challenges
Our report gives you the following advantages:
Our new report will give you information to benefit your work now:
- Time-saving access to present and future industry trends, harnessing years of analytical knowledge
- Data and discussions to benefit your market research, analyses and decision making
- Tables, charts and lists to help make your reports, proposals, meetings, presentations and selling pitches more influential.
Pharmaceutical stability testing (PST) is an important component of drug development and manufacturing. This market constitutes one of the fastest growing sectors in the pharmaceutical and biotech sectors, with estimated revenues of $0.95bn (for technology and services) in 2010.
Our report is your connection to the organisations, ideas and activities that are shaping the stability testing sector.
The market for pharmaceutical stability testing has been expanding rapidly, but which segments will grow fastest in years to come? What are the commercial trends to watch? How will the worldwide market for pharmaceutical stability testing perform from 2010 to 2025? This report answers those and other questions.
In our report, you will find out by how much the pharmaceutical stability testing market will grow. You will also study the trends that are driving growth in this sector.
Our new report shows you trends to watch in stability testing. Novel and generic drug producers can benefit from the emerging and established technologies. Developments will occur for biological drugs and small-molecule agents, novel and generic.
You will discover commercial prospects at global, sub-market and regional levels. We show you where the sector is heading.
Analysis and expert views to aid your work - so you won't be left behind
Our new report provides you with revenue forecasts, market share analyses, technological developments and expert opinion. That way, you can assess prospects, opportunities and threats in the sector.
We include 78 tables and figures, as well as two expert interviews (shown in the accompanying lists). You can stay ahead by ordering our report today, benefiting your analyses and commercial ideas.
Pharmaceutical Stability Testing: Commercial Prospects 2011-2025 shows you revenue trends, opportunities and challenges
Our report gives you the following advantages:
- You will receive hard data for the pharma stability testing sector - especially our revenue forecasts - helping you to stay ahead
- You will discover revenue trends for the overall market and its main components from 2009 to 2025 - showing you where commercial potential will occur
- You will see the revenue prospects for leading products, technologies and services from 2009 to 2025, with discussions of market potential and competition
- You will examine leading CROs and the technology and services they provide in the stability testing market
- You will find revenue predictions for leading national markets from 2009 to 2025 (US, Japan, UK, Germany, France, Spain, Italy, China and India)
- You will learn how the sector can change and adapt from 2010 to 2025
- You will assess leading organisations in stability testing, discovering their activities and prospects
- You will investigate the drivers, restraints, competition and opportunities influencing the stability testing sector from 2010 onwards
- You will investigate unmet and under-met needs in that sector, with therapeutic requirements and commercial opportunities discussed
- You will analyse opportunities for established companies and new market entrants
- You will view expert opinion from our survey, including interview transcripts
- You will find out where the sector is heading - technology, competition, revenues and other aspects of the industry and market.
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
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
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, 2010а
COMPANIES LISTED
AAIPharma Services
ABC Laboratories
ABICH Srl
Acceleration
Accugen Laboratories
Accupac
Aizant Drug Research Solutions
Akorn Contract Manufacturing
Alfa Wasserman
Alliance Medical Products
AllTranz
Almac
Alphora Research
Althea Technologies
American Regent
Amide Pharmaceutical
AMRI
AnaBioTec
Analytical Bio-Chemistry (ABC) Laboratories
Analytical Research Laboratories
Analytical Solutions
Anderson Packaging
Apredica
Aptuit
Argenta Manufacturing
Ascent Medical
Avacta Analytical
Avantium Technologies
Avatar Pharmaceutical Services
Aveva Drug Delivery Systems
Avid Bioservices
Avogadro
Azopharma Product Development Group
B. Braun Melsungen
BASi (Bioanalytical Systems)
Baxter Healthcare
BD Biosciences
Beijing Second Pharmaceutical Co.
Ben Venue Laboratories
Bilcare Global Clinical Supplies, Americas
Bio-Concept Laboratories
Bioconvergence LLC (s/b BioConvergence)
Biodel
Biologics Process Development
BioNimbus
Biopharm Match
BioReliance
BioScreen Testing Services
Blue Stream Laboratories
Boehringer Ingelheim
Boehringer Ingelheim Promeco
Boston Analytical
Brecon Pharmaceuticals
Caliper Life Sciences
Calyx Chemicals & Pharmaceuticals
Cambridge Major Laboratories
Cangene Biopharma
Cangene Corporation
Cantest
Carbogen Amcis
Catalent Pharma Solutions
Cedarburg Hauser Pharmaceuticals
Cedarburg Pharmaceuticals
CellzDirect
Celonic
Celsis Analytical Services
Ceutical Laboratories
Charles River Laboratories
ChemCon
Chemi Pharmaceutical
Chemic Laboratories
Chiralabs
Cirion Clinical Trial Services
CMC Biologics A/S
Coldstream Laboratories
Columbia Analytical Services
Confab Laboratories
Consumer Product Testing Co.
Contract Pharmacal Corp
Cook Pharmica
Corden Pharma Group
CoreRx
Corsidus
Covance
CPL-Contract Pharmaceuticals Limited
CRID Pharma
Crystal3 Laboratories
Cyanta Analytical Services
Cytovance Biologics
Dales Pharmaceuticals
Dalton Pharma Services
deCode Chemistry & BioStructures
Deseret Laboratories
Dextra Laboratories
Difarma
Diosynth Biotechnology
Diteba Research Laboratories
Dow Chemical Company (The)
DPT
DSA Consultants
DSM Pharmaceuticals
DT Biologika
EaglePicher Pharmaceutical Services
Ebewe Pharma
Eden Biodesign
Emerson Resources
Encompass Pharma
Eurand
Eurofins AvTech Laboratories
Eurogentec
European Medicines Agency (EMA)
Excel PharmaStudies
Exemplar Pharmaceuticals
Ferro Pfanstiehl Laboratories
Fleming Pharmaceuticals
Florida Biologix
Food and Drug Administration (FDA)
Formatech
Fresenius Kabi Product Partnering
Frontage Laboratories
Fulcrum Pharma Developments
G&W Laboratories
Galenix
GEL Analytics
Genentech (Roche)
Gibraltar Laboratories
Girindus America
Gland Pharma Limited
Glatt Pharmaceutical Services
Goodwin Biotechnology
Gorbec Pharmaceutical Services
Grand River Aseptic Pharmaceutical Packaging
Groupe Parima
GVK Biosciences
Halo Pharmaceutical
Harlan Laboratories
Helsinn Manufacturing Operations
HollisterStier Contract Manufacturing
Hospira One 2 One
Hovione
Huapont Pharm. Co.
Huntingdon Life Sciences
Hyaluron Contract Manufacturing (HCM)
Impact Analytical
Intas Biopharmaceuticals
Integrated Analytical Laboratories
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
IriSys
Irvine Pharmaceutical Services
Johnson Matthey Pharma Services
KBI Biopharma
KP Pharmaceutical Technology
Lancaster Laboratories
Laxai
Legacy Pharmaceutical Packaging
Lomapharm
Lonza
Luitpold Pharmaceuticals
Lyne Laboratories
MEDA Manufacturing
MedPharm
Meridian Life Science
Metrics
Micro Test Laboratories
Micron Technologies
Mikart
Miltenyi Biotec (Bioprocess Division)
Mission Pharmacal
Molecular Profiles
Murty Pharmaceuticals
Newlab Bioquality
Newport Scientific
Nextar Chempharma Solutions
Nicholas Piramal
Northern Lipids
Norwich Pharmaceuticals
NovaTek International
Nupharm Group
Oakwood Laboratories
OctoPlus
Omnia Biologics
Onyx Scientific
Oso BioPharmaceutical Manufacturing
Pace Analytical Life Sciences
PacificGMP
Particle Sciences
Patheon
Penn Pharma
Penniman & Browne
Pfizer
Pharma Services Network
Pharmacore
PharmaForm
Pharmalytica Services
PharmaNet Development Group
Pharmatek Laboratories
Pharmaterials
Pharmavize
PharmaZell
PharmOptima
PII
Pillar5 Pharma
pION
Piramal Healthcare
Precision Stability Storage
Promed
ProtoForm
PYRAMID Laboratories
Q Laboratories
QTI, Quantitative Technologies
Quality Assistance
Quality Chemical Laboratories (QCL)
Quantex Laboratories
Quay Pharma
Raland Technologies
Recipharm
RecipharmCobra Biologics
Regis Technologies
Reig Jofre Group
Ricerca Biosciences
RiconPharma
Roche
Rottendorf Pharma
Rubicon Research
SCM Pharma
Seibersdorf Laboratories
SGS Life Science Services
SICOR Biotech
Siegfried
Sigma-Tau PharmaSource
SL Pharma Labs
Smart Consulting Group
SNBL USA
Solvay
Solvias
Southern Research Institute
SP Formulations
SRI International
Stason Pharmaceuticals
Suven Life Sciences
SWISS CAPS
Synomics Pharma Services
Sypharma
Technoflex
Temmler Pharma
TestPak
TetraGenX
TGA Sciences
Therapex, Div E-Z-EM Canada
Therapure Biopharma
Toxikon
University of Iowa Pharmaceuticals (UIP)
UPM Pharmaceuticals
Vectech
Velesco Pharmaceutical Services
Vetter Pharma International
Warnex
West Pharmaceutical Services
Westech Instrument Services
West-Ward Pharmaceuticals
White Owl Global Services
WindRose Analytica
Wolfe Laboratories
WuXi AppTec
Xcelience
Xcelris Labs
XenoBiotic Laboratories
Xtal BioStructuresа
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, 2010а
COMPANIES LISTED
AAIPharma Services
ABC Laboratories
ABICH Srl
Acceleration
Accugen Laboratories
Accupac
Aizant Drug Research Solutions
Akorn Contract Manufacturing
Alfa Wasserman
Alliance Medical Products
AllTranz
Almac
Alphora Research
Althea Technologies
American Regent
Amide Pharmaceutical
AMRI
AnaBioTec
Analytical Bio-Chemistry (ABC) Laboratories
Analytical Research Laboratories
Analytical Solutions
Anderson Packaging
Apredica
Aptuit
Argenta Manufacturing
Ascent Medical
Avacta Analytical
Avantium Technologies
Avatar Pharmaceutical Services
Aveva Drug Delivery Systems
Avid Bioservices
Avogadro
Azopharma Product Development Group
B. Braun Melsungen
BASi (Bioanalytical Systems)
Baxter Healthcare
BD Biosciences
Beijing Second Pharmaceutical Co.
Ben Venue Laboratories
Bilcare Global Clinical Supplies, Americas
Bio-Concept Laboratories
Bioconvergence LLC (s/b BioConvergence)
Biodel
Biologics Process Development
BioNimbus
Biopharm Match
BioReliance
BioScreen Testing Services
Blue Stream Laboratories
Boehringer Ingelheim
Boehringer Ingelheim Promeco
Boston Analytical
Brecon Pharmaceuticals
Caliper Life Sciences
Calyx Chemicals & Pharmaceuticals
Cambridge Major Laboratories
Cangene Biopharma
Cangene Corporation
Cantest
Carbogen Amcis
Catalent Pharma Solutions
Cedarburg Hauser Pharmaceuticals
Cedarburg Pharmaceuticals
CellzDirect
Celonic
Celsis Analytical Services
Ceutical Laboratories
Charles River Laboratories
ChemCon
Chemi Pharmaceutical
Chemic Laboratories
Chiralabs
Cirion Clinical Trial Services
CMC Biologics A/S
Coldstream Laboratories
Columbia Analytical Services
Confab Laboratories
Consumer Product Testing Co.
Contract Pharmacal Corp
Cook Pharmica
Corden Pharma Group
CoreRx
Corsidus
Covance
CPL-Contract Pharmaceuticals Limited
CRID Pharma
Crystal3 Laboratories
Cyanta Analytical Services
Cytovance Biologics
Dales Pharmaceuticals
Dalton Pharma Services
deCode Chemistry & BioStructures
Deseret Laboratories
Dextra Laboratories
Difarma
Diosynth Biotechnology
Diteba Research Laboratories
Dow Chemical Company (The)
DPT
DSA Consultants
DSM Pharmaceuticals
DT Biologika
EaglePicher Pharmaceutical Services
Ebewe Pharma
Eden Biodesign
Emerson Resources
Encompass Pharma
Eurand
Eurofins AvTech Laboratories
Eurogentec
European Medicines Agency (EMA)
Excel PharmaStudies
Exemplar Pharmaceuticals
Ferro Pfanstiehl Laboratories
Fleming Pharmaceuticals
Florida Biologix
Food and Drug Administration (FDA)
Formatech
Fresenius Kabi Product Partnering
Frontage Laboratories
Fulcrum Pharma Developments
G&W Laboratories
Galenix
GEL Analytics
Genentech (Roche)
Gibraltar Laboratories
Girindus America
Gland Pharma Limited
Glatt Pharmaceutical Services
Goodwin Biotechnology
Gorbec Pharmaceutical Services
Grand River Aseptic Pharmaceutical Packaging
Groupe Parima
GVK Biosciences
Halo Pharmaceutical
Harlan Laboratories
Helsinn Manufacturing Operations
HollisterStier Contract Manufacturing
Hospira One 2 One
Hovione
Huapont Pharm. Co.
Huntingdon Life Sciences
Hyaluron Contract Manufacturing (HCM)
Impact Analytical
Intas Biopharmaceuticals
Integrated Analytical Laboratories
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
IriSys
Irvine Pharmaceutical Services
Johnson Matthey Pharma Services
KBI Biopharma
KP Pharmaceutical Technology
Lancaster Laboratories
Laxai
Legacy Pharmaceutical Packaging
Lomapharm
Lonza
Luitpold Pharmaceuticals
Lyne Laboratories
MEDA Manufacturing
MedPharm
Meridian Life Science
Metrics
Micro Test Laboratories
Micron Technologies
Mikart
Miltenyi Biotec (Bioprocess Division)
Mission Pharmacal
Molecular Profiles
Murty Pharmaceuticals
Newlab Bioquality
Newport Scientific
Nextar Chempharma Solutions
Nicholas Piramal
Northern Lipids
Norwich Pharmaceuticals
NovaTek International
Nupharm Group
Oakwood Laboratories
OctoPlus
Omnia Biologics
Onyx Scientific
Oso BioPharmaceutical Manufacturing
Pace Analytical Life Sciences
PacificGMP
Particle Sciences
Patheon
Penn Pharma
Penniman & Browne
Pfizer
Pharma Services Network
Pharmacore
PharmaForm
Pharmalytica Services
PharmaNet Development Group
Pharmatek Laboratories
Pharmaterials
Pharmavize
PharmaZell
PharmOptima
PII
Pillar5 Pharma
pION
Piramal Healthcare
Precision Stability Storage
Promed
ProtoForm
PYRAMID Laboratories
Q Laboratories
QTI, Quantitative Technologies
Quality Assistance
Quality Chemical Laboratories (QCL)
Quantex Laboratories
Quay Pharma
Raland Technologies
Recipharm
RecipharmCobra Biologics
Regis Technologies
Reig Jofre Group
Ricerca Biosciences
RiconPharma
Roche
Rottendorf Pharma
Rubicon Research
SCM Pharma
Seibersdorf Laboratories
SGS Life Science Services
SICOR Biotech
Siegfried
Sigma-Tau PharmaSource
SL Pharma Labs
Smart Consulting Group
SNBL USA
Solvay
Solvias
Southern Research Institute
SP Formulations
SRI International
Stason Pharmaceuticals
Suven Life Sciences
SWISS CAPS
Synomics Pharma Services
Sypharma
Technoflex
Temmler Pharma
TestPak
TetraGenX
TGA Sciences
Therapex, Div E-Z-EM Canada
Therapure Biopharma
Toxikon
University of Iowa Pharmaceuticals (UIP)
UPM Pharmaceuticals
Vectech
Velesco Pharmaceutical Services
Vetter Pharma International
Warnex
West Pharmaceutical Services
Westech Instrument Services
West-Ward Pharmaceuticals
White Owl Global Services
WindRose Analytica
Wolfe Laboratories
WuXi AppTec
Xcelience
Xcelris Labs
XenoBiotic Laboratories
Xtal BioStructuresа
