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Pharmaceutical Stability Testing: Commercial Prospects 2011-2025
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Our report gives you the following advantages:You can have our report today Our new study can benefit everybody interested in drug and facilities approval, drug formulation, manufacturing, packaging and storage. You can assess the opportunities, requirements and challenges in pharma stability testing now. You can find answers and trends - we aim to save you time and aid your decisions. Order our report now, making sure you don't miss out. Please let us help today. Visiongain is a trading partner with the US Federal Government CCR Ref number: KD4R6 132 seiten | |||||||||||
| Inhalt der Studie: |
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 repo.....
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: • 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. Report Highlights 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 BioStructures [Studien Infos ausblenden] |
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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 [Inhaltsverzeichnis ausblenden] |
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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 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 [Tabellenverzeichnis ausblenden] |
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