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市场调查报告书
骨质疏松症治疗药物的研究开发趋势
R&D Trends: Osteoporosis - Strong pipeline bodes well for future treatment
| 出版商 |
Datamonitor |
| 出版日期 |
2011年11月 |
商品编码 |
180915 |
| 内容信息 |
英文 Pages: 49 |
| 价格 |
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骨质疏松症治疗药物的研究开发趋势 是由出版商Datamonitor在2011年11月所出版的。
这份英文市场调查报告书包含Pages: 49 价格从美金3800起跳。
在这12个月中新药的发行被认定、骨质疏松症的生产线朝有希望进展。此外、临床/前临床的生产线中、应对于尚未被满足的需求进行计画、企业要持续对于安全、有效果且容易取得的同化作用新药进行开发。
本报告书内容包括:骨质疏松症治疗药的研究开发生产线的主要趋势之考察、新疗法、既存疗法的评价、到目前为止所实施的临床试验、所终止的临床试验等评价之R&D决策者的支持、今后20年的预测等汇整、内容纲要摘记如下:
第1章 概要
第2章 实施摘要
第3章 临床生产线的概要
- 骨质疏松症的生产线
- 骨质疏松症的生产线为活跃
- 再吸收阻碍药市场的竞争增加因此专注于同化作用剂的开发
- 作用的机制
- 最近所终止的最终阶段开发药物
第4章 对象产品的介绍
第5章 骨质疏松症的临床试验设计
- 前临床试验
- 须对FDA和EMA 2种类对动物进行实验
- 前临床试验设计中应反应临床的适应
- 临床试验
- FDA和EMA中骨质疏松症的对象患者必要条件的差异
- 临床评価项目
- 今后的临床试验设计开发
第6章 创新的初期阶段之对策
第7章 骨质疏松症治疗的未来
- 筛选和骨质疏松症诊断
- 治疗成果的变化
- 新治疗策略
- 治疗加密的早期阶段中同化作用疗法将会被采用
- 复合疗法
- 个别化医疗
参考文献
附录
Description
Introduction
Over the last 12 months, there have been encouraging developments in the osteoporosis pipeline, with new therapies either receiving regulatory approval or launching. Moreover, both in the clinical and preclinical pipeline, companies continue their quest to bring to market a new, safe, effective, and affordable anabolic drug to address unmet need in the osteoporosis market.
Features and benefits
- Understand key dynamics in the R&D pipeline for new osteoporosis therapies
- Benchmark novel and existing therapies using the target product profile identified by Datamonitor
- Support R&D decision making by evaluating osteoporosis clinical trial designs that have set a precedent, as well as analysis of discontinued projects
- Access Datamonitor's prediction of how the treatment landscape may change in the next 20 years
Highlights
- The osteoporosis pipeline remains well stocked, with several products continuing their clinical trials and no significant discontinuations. There most exciting novel candidates with new mechanisms of action continue to be the new antiresorptives cathepsin K inhibitors and the anti-sclerostin monoclonal antibodies anabolics.
- The osteoporosis treatment paradigm has been largely static for the past 20 years, but this trend is likely to change as new drugs reach the market. It is probable that the fracture prevention strategy will evolve from just focusing on increasing bone mineral density to improving the bone quality and strength.
- The major change in the treatment of osteoporosis will be the launch of new efficacious and safe anabolic treatments, allowing physicians to use these treatments earlier in the algorithm and in a wider category of patients. In particular companies are targeting the Wnt pathway, bone morphogenetic proteins, and insulin-like growth factor.
Your key questions answered
- What are the key trends in the osteoporosis pipeline?
- What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?
- How will new osteoporosis treatments evolve in the next 20 years?
- What are the requirements of European and US regulatory bodies to ensure approval of a novel candidate?
TOC
Executive Summary
- Strategic scoping and focus
- Datamonitor key findings
- Related reports
OVERVIEW
CLINICAL PIPELINE OVERVIEW
- Osteoporosis pipeline
- The osteoporosis pipeline remains robust
- Companies are focusing on developing anabolics as competition in the antiresorptive market increases
- Mechanism of action
- Late-stage development compounds recently discontinued
TARGET PRODUCT PROFILE
- Comparator therapies
- Fosamax (alendronate; Merck & Co)
- Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN OSTEOPOROSIS
- Preclinical trials
- Two different animal species tests are required by both the FDA and EMA
- Preclinical trial design should reflect the clinical indication
- Clinical trials
- The FDA and EMA have different patient inclusion requirements for osteoporosis trials
- Clinical endpoints
- Future developments in clinical trial design
- Trial endpoints unlikely to change
INNOVATIVE EARLY-STAGE APPROACHES
- New targets for osteoporosis treatments
- Targets for antiresorptive treatment
- Targets for anabolic treatment
THE FUTURE OF TREATMENT OF OSTEOPOROSIS
- Screening and osteoporosis diagnosis
- Increased use of FRAX will lead to more osteoporosis prevention
- Change in treatment outcomes
- New treatment strategies
- Anabolic treatments are likely to be used earlier in the treatment algorithm
- Combination therapies
- Personalized medicine
BIBLIOGRAPHY
APPENDIX
- Contributing experts
- Conferences attended
- Report methodology
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