本報告已在2011年07月19日停止出版。
骨質疏鬆症的治療由於新藥的開發逐漸受到大眾矚目。主要受到矚目的新藥雙磷酸鹽，預計在 2011 年的獲利會達到 47 億美金，而 SERM 也會有達到 42 億美金的規模。
專門在醫療、IT、金融服務等產業裡進行調查分析並且提供高可靠情報的Datamonitor（總公司：倫敦），針對骨質疏鬆症的最新治療藥與研究開發動向及市場預測進行調查分析，並統整其結果出版了一份名為 "Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications Drive Market Growth" 的調查報告書。
此報告書使用 61 張圖表、250 頁的篇幅，針對骨質疏鬆症的潛在患者及最新的治療藥 物進行詳盡地探討，並且提供至 2011 年為止的未來預測。本報告書最特別的是針對主要的 4 種藥品以不同的章節進行詳細地探討，其概略架構如下所示。
1.摘要
2.骨質疏鬆症的潛在患者
3.研究開發研究
4.新藥分析
- 新藥的概要
- 主要企業：Novartis、GSK、Merck
- 商業策略
5.雙磷酸鹽的分析及未來預測
6.SERM（選擇性雌激素受體調節分子）的分析及未來預測
7.抑鈣素的分析及未來預測
8.PTH（副甲狀腺賀爾蒙）的分析及未來預測
9.其他醫藥品的分析及未來預測
10.最新企劃
11.學識經驗豐富者的意見
INTRODUCTION
Osteoporosis therapy is the focus of attention of significant R&D
activity, with drugs in development both in existing classes offering advantages
over marketed products and novel drugs exploiting genomics programs and a deeper
understanding of bone biology.
SCOPE OF THE REPORT
- Epidemiology of osteoporosis in the seven major markets by disease
severity, identification of niche populations and unmet needs
- Detailed profiles of drugs in Phase II and above - clinical data, patient
potential, marketing factors, satisfaction of unmet needs
- Primary research with key osteoporosis opinion leaders providing insight
on future market entrants and innovative R&D projects in the disease
area
- Global sales forecasts for key pipeline drugs, currently marketed products
and classes
REPORT HIGHLIGHTS
Novel bisphosphonates, Zometa and Boniva, with innovative dosing regimens and
delivery methods, will lead growth in the osteoporosis market; R&D
osteoporosis drugs will reach sales of $4.7 billion by 2011. Driven by new
market leader Evista, which will lead Pfizer's lasofoxifene and Wyeth's
bazedoxifene by targeting multiple indications, the SERMs drug class will be
valued at $4.2 billion by 2011. The early-stage pipeline consists largely of
drug candidates in new therapeutic classes, in particular cathepsin K
inhibitors, osteoprotegerin and calcilytics. While these drugs have the
potential to change the face of osteoporosis treatment in the long term,
innovative approaches will likely be costly to patients, limiting potential.
KEY REASONS TO BUY THIS REPORT
- Validate internal forecasts against drug/class sales model and assess
market potential for pipeline products
- Analyze competitive environment at time of product launch to inform best
strategy for market entry
- Highlight key R&D trends and company involvement in the market to
inform licensing decisions and identify potential partners based on R&D
activity
Table of Contents
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the osteoporosis market
- Innovative bisphosphonates, Zometa (zoledronate) and Boniva (ibandonrate), with their novel dosing regimens and delivery methods, will drive growth in the osteoporosis market, as sales will reach $10.4 billion by 2011
- Driven by new market leader Evista (raloxifene), which will stay one step ahead of lead Pfizer's lasofoxifene and Wyeth's bazedoxifene by targeting multiple indications, the SERMs drug class will be valued at $4.2 billion by 2011
- The osteoporosis early stage pipeline consists largely of drug candidates in new therapeutic classes, in particular cathepsin K inhibitors, osteoprotegerin and calcilytics. While these drugs have the potential to change the face of osteoporosis treatment in the long term, innovative approaches will likely be costly to patients, limiting potential
- Summary
- Key metrics
CHAPTER 2 PATIENT POTENTIAL
- Definition of osteoporosis
- Epidemiology of osteoporosis
- Methodological difficulties in assessing prevalence
- Prevalence of osteoporosis and osteopenia in postmenopausal women
- Segmentation of osteoporosis
- Prevalence of osteoporosis and osteopenia in men
- Osteoporosis population forecast
- Osteoporotic fractures, their implications and minor risk groups
- Niche populations
- Unmet need in osteoporosis
CHAPTER 3 R&D APPROACH
- Classification of pipeline products
- Bisphosphonates
- SERMs
- Calcitonins
- Parathyroid hormone and analogues
- Hormone therapy
- Clinical trial design in osteoporosis
- Clinical trial guidelines
- Trial design and implementation in osteoporosis: the future?
- Clinical trial endpoints in osteoporosis
- Fracture rate
- Changes in BMD
- Biochemical markers of bone turnover
- Changes in bone microarchitecture
CHAPTER 4 OSTEOPOROSIS PIPELINE ANALYSIS
- Pipeline overview
- Key companies involved in the osteoporosis pipeline
- Novartis
- GSK
- Merck – a notable absentee
- Strategies for success in osteoporosis
- Dosing variations in the bisphosphonate class
- Multiple indications strategy in osteoporosis
CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for the bisphosphonate class
- Pipeline summary
- Definition of current comparator therapy
- Comparative analysis
- Bonviva (ibandronate)
- Forecasts to 2011
- Zometa (zoledronate)
- Other late stage drugs
- Minodronate
- Apomine
- Clodronate
- Comparison of key compounds in the bisphosphonate class
- Unmet needs
- Marketing strength
- Comparative forecasts
CHAPTER 6 SERMS LATE-STAGE ANALYSIS AND FORECASTS
- Overview table
- Definition of current comparator therapy
- Comparative analysis
- Lasofoxifene
- Forecasts to 2011
- Bazedoxifene
- Drug overview
- Forecasts to 2011
- Other late stage drugs
- Comparison of key compounds in the SERM class
- Unmet needs
- Marketing strength
- Comparative forecasts
CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Definition of current comparator therapy
- Comparative analysis
- Fortical
- Forecasts to 2011
- Other drugs in the calcitonin class
CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for PTH class
- Definition of current comparator therapy
- Comparative analysis
- Preos (rhPTH 1-84)
- Satisfaction of unmet needs
- Forecasts to 2011
- Other drugs in the PTH class
- Asahi teriparatide/PTH (1(34)
- Comparative forecasts
CHAPTER 9 'OTHER' DRUGS LATE STAGE ANALYSIS AND FORECASTS
- Overview
- Definition of current comparator therapy
- Comparative analysis
- Forecasts to 2011
- Additional drugs in the 'other' class
- Nitroflurbiprofen
- Osteoprotegerin
- SomataKine (IGF 9606)
CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS
- Key phase I and preclinical compounds in osteoporosis
- Cathepsin K inhibitors
- Novartis - AAE581
- GSK - SB-462795
- Merck/Celera
- Calcilytics
- Calcitonin
- PTH
- Src kinase inhibitors
- PPAR gamma modulators
- Vitronectin receptor antagonists
- Long-acting proteins
- Wyeth looking away from hormones to new horizons?
- Key research impacts on osteoporosis
- Impacts of clinical trial issues
CHAPTER 11 OPINION LEADER TRANSCRIPTS
- Key opinion leader 1 - Belgium
- Unmet needs
- Pipeline
- Novel drug targets
- Clinical trial design
- Key opinion leader 2 – US
- Unmet needs
- Clinical trial design
- Key opinion leader 3 – US
- Unmet needs
- Pipeline
- Novel drug targets
- Clinical trial design
- Key opinion leader 4 – US
- Unmet needs
- Pipeline
- Novel drug targets
- Clinical trial design
- Contributing experts
- Bibliography
- Epidemiology
- Clinical trial data
- Report methodology
List of Tables
- Table 1: Key parameters of the osteoporosis market
- Table 2: Forecast key pipeline products in osteoporosis to 2011
- Table 3: Causes of secondary (Type III) osteoporosis
- Table 4: WHO classification of osteoporotic bone loss
- Table 5: Epidemiology overview of osteoporosis
- Table 6: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003
- Table 7: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003
- Table 8: Estimated forecast of the osteoporosis and osteopenia populations over 50 years in the seven major markets, 000s, 2003(11
- Table 9: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003
- Table 10: Overview of currently marketed bisphosphonates indicated for use in osteoporosis
- Table 11: Overview of currently marketed SERMs indicated for use in osteoporosis
- Table 12: Overview of currently marketed SERMs indicated for use in osteoporosis
- Table 13: Quantitative measures used for clinical efficacy endpoints in osteoporosis
- Table 14: R&D pipeline in osteoporosis, 2003
- Table 16: Key bisphosphonate products in late-stage R&D pipeline 2003
- Table 17: Defining the gold standard: key clinical trial results for Fosamax
- Table 18: Dose ranging study results for 20mg and placebo with ibandronate, % change from baseline
- Table 19: Results at 2 and 3-years in study comparing 3-monthly i.v. ibandronate, and daily oral alfacalcidol, % BMD relative to baseline, 2003
- Table 20: Novartis's HORIZON trial design, 2003
- Table 21: Difference between two treatment groups at 48 months, mean % change in BMD from baseline
- Table 22: Global sales forecasts for the bisphosphonate class, 2003(11
- Table 23: Overview of the SERMs in late stage development for the prevention or treatment of osteoporosis
- Table 24: Evista: key facts
- Table 25: Global sales forecasts for the SERM class, 2003(11
- Table 26: Overview of the calcitonins in late stage development for the prevention or treatment of osteoporosis
- Table 27: Miacalcin: key facts
- Table 28: Global sales forecast for the calcitonin class, 2003(11
- Table 29: Summary of the PTH drugs in late stage development for osteoporosis
- Table 30: Forteo: key facts
- Table 31: Results of PATH trial, %, 2003
- Table 32: Global sales forecast for the PTH class, 2003(11
- Table 33: Summary of other late stage drugs in development for osteoporosis, 2003
- Table 34: Study population, design and end points.
- Table 35: PREVOS change in BMD results, % from baseline
- Table 36: STRATOS mean annual change in BMD, % from baseline
- Table 37: Drugs in phase I and preclinical development for osteoporosis, 2003
List of Figures
- Figure 1: Summary of osteoporosis pipeline by development phase, mechanism of action and company category, 2003
- Figure 2: Drug launches and events in the osteoporosis market from 2003
- Figure 3: Schematic of key current and pipeline drugs, their targets and their effect on bone formation and resorption
- Figure 4: Osteoporosis drugs and their overlap into other indications
- Figure 5: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003
- Figure 6: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003
- Figure 7: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003
- Figure 8: Clinical unmet needs in osteoporosis
- Figure 9: Boniva satisfaction of unmet needs in osteoporosis – comparative analysis vs. Fosamax
- Figure 10: Global market forecast and events for Boniva, 2005(2011
- Figure 11: Zometa satisfaction of unmet needs – comparative analysis vs. Fosamax
- Figure 12: Global market forecast and events for Zometa to 2011
- Figure 13: Comparison of key compounds in the bisphosphonate class currently in late stage development, 2003
- Figure 14: Comparative analysis of lasofoxifene and Evista
- Figure 15: Global market forecast and events for lasofoxifene to 2011
- Figure 16: Bazedoxifene satisfaction of unmet needs – comparative analysis vs. Evista
- Figure 17: Global market forecasts and events for bazedoxifene to 2011
- Figure 18: Comparison of key compounds in the SERM class currently in late stage development, 2003
- Figure 19: Fortical satisfaction of unmet needs – comparative analysis vs. Miacalcin
- Figure 20: Global market forecasts and events for Fortical to 2011
- Figure 21: Preos satisfaction of unmet needs – comparative analysis vs. Forteo
- Figure 22: Global market forecast and events for Preos to 2011
- Figure 23: Protos satisfaction of unmet needs – comparative analysis with Fosamax
- Figure 24: Global market forecast and events for Protos to 2011
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