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市場調查報告書
大分子藥物的給藥機制
Delivery Mechanisms for Large Molecule Drugs: Successes and failures of leading technologies and key drivers for market success
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大分子藥物的給藥機制 是由出版商Business Insights在2009年01月所出版的。
這份英文市場調查報告書包含138 pages 價格從美金3835起跳。
本報告書內容包括:大分子藥物的給藥機制開發分析、成本及風險分析、新興技術發展、未來預測等。內容綱要摘記如下:
實施概要
第1章 介紹
第2章 促進新平台開發的因素
- 摘要
- 介紹
- 大分子市場的長
- 醫療實驗投資金額
- 臨床上的潛在需求
- 提高患者的適合性
- 安定性、生物可利用性、毒性
- 提高功效
第3章 風險、成本、技術的成熟度
- 摘要
- 介紹
- 新技術失敗的風險
- 未知的藥物藥動學
- 法規限制的框架變動
- 個案研究:胰島素給藥及投資人心理
- 成本及收益對創新決策產生的影響
- 對於不成熟技術的顧慮
- 給藥技術的成熟
第4章 主要新興技術
- 摘要
- 預測市場影響
- 改善溶解度的奈米科技
- 發展中的奈米科技產業
- 開發產品線
- 主要的臨床應用
- 非口服給藥系統
- 皮膚平台系統
- 奈米結構材料
- 新的口服藥給藥系統
- 奈米殼、奈米薄膜、主動式控制
- 微電子技術的最新動向
第5章 全身標的技術
第6章 使用方便性
第7章 總論
附錄
圖表
Abstract
Large molecule drug markets have emerged as a key contender for R&D investment
where small molecule pipelines are seeing growing generic pressures and
reduced new drug approvals. Biotechnology companies, with a strong pipeline
presence of large molecule biologic drugs, have benefited from strengthened
market positioning. However, with drug failure rates for this immature
industry high existing large molecule delivery is focused on the established
parenteral route. Emerging drug delivery technologies are looking to improve
measures of safety, efficacy, convenience and compliance in both new and
existing drug candidates and products. For marketed products reformulations
with new delivery technologies will extend the period of patent protection. In
chronic diseases where patient compliance surrounding dosing strategies and
ease of administration are key, limitations on further market growth these new
formulas will be key to boosting volume sales of large molecule products. In
R&D pipelines novel application of delivery technologies will expose new
methods to reformulate failed or discontinued drugs and mask their unfavorable
effects, expanding the market of potential drug candidates.
Table of Contents
Executive summary
- Introduction
- Drivers for new platform developments
- Resistors of change
- Key emerging technologies
- Systemic targeting technologies
- Ease of use systems
- Conclusions
Chapter 1 - Introduction
- Introduction
- The emergence of large molecule therapeutics
- Definitions
- Technology platform definitions
- Product coverage
- Market coverage
- Leading technologies coverage
- The measures for market success
Chapter 2 - Drivers of new platform developments
- The growth of the large molecule market
- Therapy area growth drivers
- Clinical development spend
- Cost-effective manufacturing
- Existing failure rates
- Unmet clinical needs
- Boosting patient compliance
- Overcoming stability, bioavailability and toxic effects
- Improving efficacy
Chapter 3 - Risk, costs and technology maturity
- Risk of failure with new technologies
- Unknown drug candidate pharmacokinetics
- Solubility and instability with oral candidates
- Bioavailability
- Toxicity and unknown long-term effects
- The shifting regulatory framework
- Case study: Insulin delivery and investor confidence
- The impact of cost and revenue on the decision to innovate
- Immaturity concerns
- Maturity of the delivery technologies
Chapter 4 - Key emerging technologies
- Summary
- The forecast market impact
- Nanotechnology to enhance solubility profiles
- The evolving nanotechnology industry
- The development pipeline
- Leading clinical applications
- Parenteral delivery systems
- Dermal platform systems
- Nanostructured materials; oral and depot system use
- Novel oral drug delivery systems
- Investigative nanoshells, nanofilms and active control
- Advances in microelectronics
- Existing electronic applications
- The development pipeline for microelectronics
- Microchip technologies
- Inkjet technology for drug delivery
Chapter 5 - Systemic targeting techniques
- Systemic passive targeting techniques
- Stealth technologies: Immune system evasion
- PEGylation technologies
- PEGylation in clinical pipelines
- Preclinical PEGylation investigation
- Next generation PEGylation
- Systemic active targeting techniques
- Antibody techniques
- Antibody fragments
- Binding specificity
- Novel combination technologies to improve targeting
- Cost-effective manufacture
- The development pipeline
- The emergence of IgG4 antibody therapies
- Small modular Immunopharmaceuticals as antibody alternatives
- Pipeline novel conjugate technologies
- Antibody fragments in targeted carrier systems
- Investigational protein carrier Prodrug complexes
- Clotting factor conjugate targeting
- Molecular trojan horse techniques
Chapter 6 - Ease of use systems
- Pulmonary delivery technologies
- Particle engineering technologies for pulmonary delivery
- Vaporization techniques and delivery control
- Applications of electronics
- Needle-free transdermal delivery
- Leading technology platforms
- Needle-free pressure-based systems
- Microinjection platforms for intra-epidermal delivery
- EMEA filing for first microinjection system
- technology platform
- Electrotransport systems
- Electroporation in transdermal delivery
- TransPharma Medical ltd' s RF-Microchannel technology
- Novel approaches to active intra-epidermal delivery
- Laser drug delivery systems
- Thermal energy platform
Chapter 7 - Conclusions
- Introduction
- Pharma vs biotech large molecule R&D investment
- Leading technologies
- Growth in particle engineering technologies
- The impact of new routes of administration
- Large molecule drug delivery market growth and maturity
- Current and future market impact
- Therapy area impact
- Timeline of impact
- Summary of technology success and impact
Appendix
- Methodology
- MedTRACK platform identification
List of Figures
- Figure 1.1: The role of drug delivery in the product R&D pipeline
- Figure 1.2: Biopharmaceutical company dependence on large molecule drugs*
- Figure 1.3: Defining the pathway from proprietary technology to clinical
use
- Figure 2.4: The global pipeline for chemical and biologic drugs, October
2008
- Figure 2.5: Number of pipeline biologic drug candidates and products, by
therapy area, October 2008
- Figure 2.6: Pharma R&D spend 2004-2009e
- Figure 2.7: Biotech R&D spend ($bn), 2004-2009e
- Figure 2.8: Pharmacokinetic effects; resistors of market growth and
opportunity for new technologies
- Figure 3.9: Key innovative technologies, clinical drug failures and
discontinued products, November 2008
- Figure 3.10: Development pipeline for insulin devices, human insulins and
analogues, October 2008
- Figure 3.11: Discontinued insulin devices, human insulins and analogues,
platforms for delivery, per year 2001-2008
- Figure 3.12: Key particle engineering technologies; industry size and
maturity
- Figure 3.13: Key route of administration technologies; industry size and
maturity
- Figure 4.14: Investment deals and clinical applications in nanotechnology
drug delivery platforms, 2002-Q2 2008
- Figure 4.15: Product pipeline; large molecule nanotechnology innovations
- Figure 4.16: Maturity of electronic active delivery platforms in
transmembrane and pulmonary delivery systems
- Figure 5.17: The market advantage of targeted drugs
- Figure 5.18: Passive targeting strategies for large molecule delivery
- Figure 5.19: The benefits of PEGylation to improve pharmacological profiles
- Figure 5.20: Active targeting strategies for large molecule delivery
- Figure 5.21: The global MAb product pipeline by phase, Q4 2008
- Figure 5.22: Antibody fragmentation platforms Competitive advantage
- Figure 5.23: Antibody fragments: separating targeting domains
- Figure 6.24: Transdermal and transmembrane active platform technologies,
November 2008
- Figure 6.25: Investment in and maturity of active transdermal delivery
- Figure 7.26: Big biotech v big pharma large molecule patent applications,
2003-2007, global
- Figure 7.27: Particle engineering technologies in drug R&D pipelines, by
phase, October 2008
- Figure 7.28: Industry growth and investment, leading innovative drug
delivery platforms
- Figure 7.29: Growth in technology deals; 1998-2007
- Figure 7.30: Impact of new technology platforms developments on therapy
area pipelines
- Figure 7.31: Therapy area focus of innovative technology product
candidates, October 2008
- Figure 7.32: New medical device technologies, anticipated market impact
- Figure 7.33: Emerging particle engineering technologies, anticipated
market impact
- Figure 7.34: The impact of new delivery technologies; timeline for success
- Figure 7.35: Measures of technology success
List of Tables
- Table 1.1: Nektar' s leading innovative technology pipeline
- Table 1.2: Needle free delivery; Key routes of administration
- Table 1.3: Technology market coverage
- Table 2.4: The global pipeline for chemical and biologic drugs, October
2008
- Table 3.5: Key innovative technologies, clinical drug failures and
discontinued products,November 2008
- Table 3.6: Key route of administration technologies; industry size and
maturity
- Table 4.7: Nanotechnology drug delivery platforms, large molecule vs small
molecule applications, November 2008
- Table 4.8: Nanoparticles as drug delivery carriers
- Table 4.9: Leading clinical parenteral drug delivery
- Table 5.10: Clinical PEGylation stealth targeting technologies
- Table 5.11: Antibody fragment products, clinical applications
- Table 5.12: Armagen' s proprietary CNS product pipeline: Trojan horse
conjugate delivery
- Table 6.13: Small molecule success of membrane transport technologies,
November 2008
- Table 6.14: Clinical use electronic pulmonary delivery technologies
- Table 6.15: Transdermal and transmembrane active platform technologies,
November 2008
- Table 6.16: Novel electroporation platforms; transdermal alternatives
- Table 7.17: Innovative technology products in R&D pipelines, October 2008
- Table 7.18: Industry maturity and investment, leading innovative drug
delivery platforms
- Table 7.19: Growth in technology deals, 1998-2007
- Table 7.20: Therapy area focus of innovative technology product
candidates, October 2008
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