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The European Monoclonal Antibodies Therapeutics MarketPublished by: Frost & Sullivan Published: Oct. 25, 2004 Table of Contents1. Executive Summary 1. Executive Summary 1. Executive Summary 2. Glossary of Terms 1. Abbreviations 1. Abbreviations 3. Research and Forecasting Methodology 1. Frost & Sullivan's 12-step Market Engineering Research Methodology 1. Frost & Sullivan's 12-step Market Engineering Research Methodology 2. Step 1: Define Market Problems; Needs and Opportunities 3. Step 2: Define Objectives and Goals of the Research Project 4. Step 3: Design Optimal Research Team 5. Step 4: Launch Data Collection Phase 6. Step 5: Select Interview Strategy and Design of Survey 7. Step 6: Test the Survey Design 8. Step 7: Conduct Primary Market Research 9. Step 8: Research Analysis: Finding "Point A" 10. Step 9: Market Forecasting: Finding "Point B" 11. Step 10: Develop Strategic Recommendations 12. Step 11: Confirm Results with Quality Control 13. Step 12: Market Monitoring and Customer Feedback Review 2. Frost & Sullivan's Market Engineering Forecasting Methodology 1. Overview 2. Strategic Significance of the Market Engineering Forecast 3. Judging Credibility and Accuracy of Market Engineering Forecasts 4. Forecast Assumptions 4. Monoclonal Antibodies - An Overview 1. Therapeutic Monoclonal Antibodies 1. Overview - Monoclonal Antibodies 2. Market Overview 3. Technology Trends 4. The Road Ahead 5. Challenges Affecting the Therapeutic Monoclonal Antibodies Market 1. Industry Challenges and Issues 1. Challenges Facing the European monoclonal antibodies therapeutics market 2. Time Frame Analysis 1. Time-frame Analysis of Industry Challenges 6. Products in Development in the Global Therapeutic Monoclonal Antibody Market 1. Overview of Products in Development 1. Oncology Products 2. Autoimmune and Inflammatory Disorders Products 3. Organ Transplant Products 4. Cardiovascular Disorder Products 5. Infectious Disease Products 2. Players in Therapeutic Antibody Development 1. Participants in Therapeutic Monoclonal Antibody Development 7. Analysis of the European Therapeutic Monoclonal Antibody Market 1. Introduction 1. Introduction 2. Research Measurement System 1. Market Engineering Measurement 3. Market Drivers and Restraints 1. Market Drivers 2. Market Restraints 4. Market Forecasts 1. Forecasting Assumptions 2. Total Revenue Forecasts 3. Revenue Forecasts by Segments 5. Pricing and Reimbursement Analysis 1. Pricing and Reimbursement Analysis 8. Competitive Analysis of the European Therapeutic Monoclonal Antibody Market 1. Competitive Structure 1. Competitive Structure 2. Market Share Analysis 1. Market Share Analysis 9. European Therapeutic Monoclonal Antibodies Market for Oncology 1. Introduction 1. Introduction 2. Market Engineering Research Measurement System 1. Market Engineering Research Measurement System 3. Market Forecasts 1. Revenue Forecasts 4. Major Products Forecasts 1. Existing Products 2. Future Products 5. Competitive Analysis 1. Competitive Structure 2. Market Share Analysis 10. European Therapeutic Monoclonal Antibodies Market for Use in Autoimmune and Inflammatory Disease 1. Introduction 1. Introduction 2. Market Engineering Research Measurement System 1. Market Engineering Research Measurement System 3. Market Forecasts 1. Revenue Forecasts 4. Major Products Forecasts 1. Existing Products 2. Future Products 5. Competitive Analysis 1. Competitive Structure 2. Market Share Analysis 11. European Therapeutic Monoclonal Antibodies Market for Use in Organ Transplant 1. Introduction 1. Introduction 2. Market Engineering Research Measurement System 1. Market Engineering Research Measurement System 3. Market Forecasts 1. Revenue Forecasts 4. Major Products Forecasts 1. Existing Products 2. Future Products 5. Competitive Analysis 1. Competitive Structure 12. European Therapeutic Monoclonal Antibodies Market for Use in Cardiovascular Disorders 1. Introduction 1. Introduction 2. Market Engineering Research Measurement System 1. Market Engineering Research Measurement System 3. Market Forecasts 1. Total Revenue Forecasts 4. Competitive Analysis 1. Competitive Structure 13. European Therapeutic Monoclonal Antibodies Market for Use in Infectious Disease 1. Introduction 1. Introduction 2. Market Engineering Research Measurement System 1. Market Engineering Measurements 3. Market Forecasts 1. Revenue Forecasts 4. Competitive Analysis 1. Competitive Analysis 14. Market Engineering Strategy for the European Therapeutic Monoclonal Antibody Market 1. Introduction to Strategic Recommendations 1. Introduction to Strategic Recommendations 2. Strategic Analysis 1. Market Maturation Process 2. Strategic Anticipation 3. End-user Priorities 3. Strategic Recommendations 1. Porters Five Forces Analysis and Recommendations 2. Recommendations for the Sales and Marketing Department 3. Other Strategic Recommendations 15. Frost & Sullivan Awards for the European Therapeutic Monoclonal Antibodies 1. Awards for the European mAb Therapeutic Markets 1. Frost & Sullivan Awards 2. Business Development Strategy Leadership Award 3. Product Line Strategy Leadership Award 4. Competitive Strategy Leadership Award 5. Growth Strategy Leadership Award 6. Market Leadership Award 16. Database of Key Industry Participants 1. Database of Key Industry Participants 1. List of Key Industry Participants 17. Decision Support Databases 1. Biotechnology Decision Support Databases 1. Number of Biotechnology Companies 2. Government R&D Investment in Biotechnology 3. Private Investment in Biotechnology 2. Pharmaceutical Decision Support Databases 1. Pharmaceutical R&D Expenditure 2. Mortality due to Breast Cancer 3. Mortality due to Colon Rectum Cancer AbstractResolving the Issues Surrounding Clinical Trials Must Receive Top PriorityExpensive, lengthy and complex clinical trials prove to be a significant challenge while developing therapeutic monoclonal antibodies (mAbs). It could take between 8 and 16 years and around $500 million to $1 billion to develop a commercially viable mAb therapy. Companies need to look at projects that can justify the high development costs, considering that 75 per cent of the costs are upfront payments and failure rates are extremely high even in late stage trials. Moreover, documented methods used for design, conduct and analysis in clinical trails require greater validation. For higher accuracy of results, companies must also strive to gain control over clinical trial enrolment, co-ordination and sample size. This research examines the emerging and innovative technologies for producing monoclonal antibodies. It discusses the impact of various market drivers and restraints and evaluates the challenges that the industry faces in terms of gaining commercial success. Revenue forecasts for the European mAb therapeutics market are also provided for the oncology, autoimmune and inflammatory disorder, organ transplant, cardiovascular disorders and infectious disease segments. Companies Must Establish a Favourable Cost-Benefit Ratio for mAb Drugs Due to the high development costs involved, most companies adopt a premium pricing strategy for monoclonal antibody products. Moreover, many of the mAb drugs need to be used in combination with the traditional immuno-suppression regimen, increasing the overall treatment cost. "In Europe, although monoclonal antibodies may possess clear advantages over conventional drugs, lower priced small molecule drugs remain the first line treatment choice," says the analyst of the research. In order to expand the customer base and increase reimbursements, companies need to highlight the benefits of using mAb therapies as opposed to conventional drugs. For example, mAbs minimise the side effects and are more likely to be cost-effective in the long run in terms of preventing recurrences and long hospital stays. They also possess the capabilities to extend survival rate for terminally ill patients - something conventional small molecule drugs have failed to accomplish. The onus is on the companies developing mAb therapies to ensure quick and widespread acceptance through detailed and clear pharmacoeconomic analysis. Constant Efforts in Improving the Efficacy of mAb Therapeutics Likely to Prove Beneficial for Sustained Growth Despite the challenges associated with costs and lengthy clinical trials, companies are keeping a positive frame of mind and are working towards improving the technology for producing mAbs. Companies have moved from highly toxic murine products towards chimeric, humanised and human mAbs that are more effective and less immunogenic. Moreover, their ability to target specific antigens involved in the pathology of diseases has made mAb drugs a phenomenal success in clinical applications. Biotechnology companies producing mAb therapies are also looking to extend their reach in the market by establishing strategic alliances with larger pharmaceutical companies. "In such a partnership, established pharmaceutical companies use their sales and marketing experience and product expertise to market the mAb drugs produced by the biotech firms," explains the analyst.
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