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市場調查報告書
骨質疏鬆症：骨骼形成劑成為開發平台中心
Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline
| 出版商 |
Datamonitor |
| 出版日期 |
2010年07月 |
商品編碼 |
134493 |
| 內容資訊 |
英文 Pages: 284 |
| 價格 |
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骨質疏鬆症：骨骼形成劑成為開發平台中心 是由出版商Datamonitor在2010年07月所出版的。
這份英文市場調查報告書包含Pages: 284 價格從美金11400起跳。
骨骼疏鬆症的罹患率與高度的潛在需求對大型藥廠來說是極具魅力的治療領域。全球七大市場中的骨骼疏鬆症治療藥物之業績，從2005年開始CAGR成長了2.0%，2009年高達70億美元。不過儘管如此，一些相當具有名望的開發平台藥劑仍為市場成長貢獻良多。
此報告書主要為全球七大市場及BRIC金磚四國之骨質疏鬆症患者動向、歐美及日本的意見領袖在臨床上及環境上潛在需求之見解、並夾雜標的製品檔案，以下為概略內容。
概要
重點摘要
第1章 開發平台概要與動向
- 主要調查結果
- 開發平台概要
- 參與骨骼疏鬆症開發平台之主要企業
- 主要研究開發企業之戰略
第2章 疾病患者概要：市場潛在性
- 主要調查結果
- 骨骼疏鬆症的定義
- 患者等級區分
- 疫苗學
- 目前的治療法
- 雙磷酸鹽（Bisphosphonate）
- 選擇性雌激素之受容體調整因子
- 甲狀旁腺激素
- 降鈣素（Calcitonins）
- 雙重作用藥物
- 維他命D及類似物
- 鈣
- 目前的黃金定律及比較療法
- 目前之市場概要
- 市場定義
- 7大市場的成長已開始疲軟
- 學名藥的普及對雙磷酸鹽來說仍是最高等級
- Fosamax學名藥的上市導致市場衰退
- 未來的預測：學名藥的壓力讓開發平台藥劑提前上市，2019年後減少退貨來相抵
- 有關骨骼疏鬆症之未被滿足的醫療需求
第3章 研究開發方法
第4章 開發平台分析與預測：bisphosphonate
第5章 開發平台分析與預測：選擇性雌激素之受容體調整因子
第6章 開發平台分析與預測：甲狀旁腺激素及類似物
第7章 開發平台分析與預測：Calcitonins（降鈣素）
第8章 開發平台分析與預測：雙重作用藥物
第9章 開發平台分析與預測：維他命D
第10章 開發平台分析與預測：其他
第11章 在革新之早期階段所使用的方法
- 主要調查結果
- 為了治療同化作用的新標的
- 未來的治療法
參考情報
附錄
Abstract
Introduction
Osteoporosis continues to be an attractive therapy area for large
pharmaceutical companies due to its high prevalence rate and unmet need.
Across the seven major markets, sales for osteoporosis drugs grew with a
compound annual growth rate (CAGR) of 2.0% from 2005 to $6.9 billion in 2009.
Nonetheless, several promising pipeline drugs will help the market resume
growth.
Scope
- Patient potential analysis across the seven major markets and BRIC nations
(Brazil, Russia, India, and China).
- Review of the key clinical and environmental unmet needs supported by
insight from key opinion leaders across the US, Europe and Japan.
- Analysis of target product profile for an osteoporosis drug.
- R&D pipeline analysis with detailed profiles and forecasts of key agents,
including Amgen' s Prolia (denosumab) and Merck' s odanacatib.
Highlights
Osteoporosis prevalence is expected to increase due to the general aging
population. By 2020, the total male and female osteoporosis population is
forecast to increase by 16.0% from 168 million in 2010 to reach 188 million
patients across the seven major markets.
Despite some long-term safety and cost concerns, Prolia will become the
osteoporosis market leader by 2019, but will not achieve blockbuster sales.
Moreover, its position will be threatened should odanacatib show a superior
clinical profile.
Over the forecast period, three new anabolic drugs are due to launch. These
will have to compete on cost, efficacy and safety with the class leader Forteo
(teriparatide, Eli Lilly). While these drugs will address some unmet needs,
early clinical data suggests that more potent drugs such Amgen' s
antisclerostin may dominate the market in the future.
Reasons to Purchase
- Understand patient population dynamics
- Gain insight into shortcomings of current osteoporosis treatment and to
what extent pipeline drugs will address these unmet clinical needs.
- Identify licensing opportunities based on company portfolio and market
needs.
Table of Contents
- Overview
- Catalyst
- Summary
- About Datamonitor Healthcare
- About the Genitourinary pharmaceutical analysis team
- Executive Summary
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- Upcoming related reports
- Table of Contents
1. Pipeline Overview and Dynamics
- Key findings
- Pipeline overview
- Clinical pipeline
- Comparative forecasts: Prolia to become market leader by 2019
- Datamonitor pipeline assessment summary: anabolic treatments are the most
clinically attractive products
- Key companies involved in the osteoporosis pipeline
- Osteoporosis drug development not limited to Big Pharma
- Novartis remains a key market player
- Key R&D company strategies
- Pipeline developers focus on reformulations to address route of
administration unmet needs
- Anabolic treatments become a priority in the market
- Indication expansions increase the market potential of osteoporosis drugs
2. Disease Overview - Market Potential
- Key findings
- Definition of osteoporosis
- Definition of osteoporosis
- Etiology
- Symptoms
- Diagnosis and treatment rates
- Under-diagnosis is a major problem in osteoporosis
- World Health Organization fracture risk assessment tool
- Treatment rates have been increasing but are still low
- Patient segmentation
- Disease severity
- Gender
- Epidemiology
- Seven major markets
- Female osteoporosis
- Male osteoporosis
- BRIC countries
- Brazil: hip fracture prevalence is higher in men than women
- Russia: over 85% of hip fractures occur in women over 60 years of age
- India: Indian women experience osteoporotic fractures 10-20 years earlier
than Caucasian women
- China: over 76 million Chinese women will experience a hip fracture in 2010
- Rest of the world
- Current treatment options
- Bisphosphonates
- Selective estrogen receptor modulators
- Parathyroid hormones
- Calcitonins
- Dual acting bone agents
- Vitamin D and analogs
- Calcium
- Current gold standard and comparator therapies
- Fosamax (alendronate; Merck & Co)
- Clinical trial data for Fosamax
- Individual class comparators
- Current market overview
- Market definition for this report
- Growth in the seven major markets slows down
- Bisphosphonates remain the largest class despite generic penetration
- Fosamax generic launch results in market decline
- Future outlook: despite growing pressure from generics, launch of pipeline
drugs will offset decline up to 2019
- Unmet need in osteoporosis
- Need for improved anabolic therapies
- Efficacy at the hip
- Increased compliance
- Companies should focus on increasing awareness of the treatments available
to increase compliance
- Better side-effect profile and safety
- Long-term safety of bisphosphonate use is questioned
- Efficacy for spine fractures
- Target product profile versus current level of attainment
3. R&D Approach
- Key findings
- Clinical trial design in osteoporosis
- Preclinical trials
- Two different animal species testing is required by the FDA and EMA
- Preclinical trial design should reflect the clinical indication
- Clinical trial design
- The FDA and EMA have different patient inclusion requirements for
osteoporosis trials
- Clinical endpoints
- Future developments in osteoporosis clinical trials
4. Pipeline Analysis & Forecasts: Bisphosphonates
- Key findings
- Overview for pipeline bisphosphonates
- Pipeline summary
- Comparative forecasts
- EX101 (alendronate; EffRx)
- Drug overview
- Drug profile
- SWOT analysis
- Datamonitor drug assessment score card for EX101
- Clinical attractiveness
- Satisfaction of unmet needs
- EX101 shows reduced gastric side effects compared to gold standard
- Commercial attractiveness
- EX101 can clearly differentiate itself in a competitive bisphosphonate
market, but effervescent formulations can be unpopular with patients
- Nycomed' s market experience will help boost EX101' s sales
- US partner still needed
- Forecasts to 2019
- Almerol (MER-103, alendronate; Merrion)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for Almerol
- Clinical attractiveness
- Satisfaction of unmet needs
- Almerol 6mg weekly shows bioequivalence to Fosamax
- Commercial attractiveness
- Almerol will face strong competition upon launch
- Merrion requires a marketing partner to launch the drug
- Forecasts to 2019
5. Pipeline Analysis & Forecasts: Selective Estrogen Receptor Modulators
- Key findings
- Overview for pipeline selective estrogen receptor modulators
- Pipeline summary
- Forecast summary
- Aprela (bazedoxifene with conjugated estrogens; Pfizer)
- Drug overview
- Drug profile
- Clinical trial data
- Ongoing clinical trials
- SWOT analysis
- Datamonitor drug assessment score card for Aprela
- Clinical attractiveness
- Satisfaction of unmet needs
- Aprela targets menopausal women differentiating it from its competition
- Efficacy data will boost Aprela' s clinical potential
- Aprela' s safety remains an issue
- Commercial attractiveness
- Further delays reduces overall commercial attractiveness
- Bazedoxifene approval in the EU paves the way for Aprela in this region
- Aprela will be mainly prescribed by gynecologists
- Forecasts to 2019
- Late-stage development compounds recently discontinued
- Eli Lilly terminates development of arzoxifene
6. Pipeline Analysis & Forecasts: Parathyroid Hormones and Analogs
- Key findings
- Overview for pipeline parathyroid hormones and analog drugs
- Pipeline summary
- Comparative forecasts
- ZT-031 (hPTH1-31; Zelos Therapeutics)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for ZT-031
- Clinical attractiveness
- Satisfaction of unmet needs
- Faster onset of action provides differentiation from competition
- Subcutaneous formulation is not favorable
- Commercial attractiveness
- Partnering is required to access the market
- Pricing strategy will be critical to exploit full market potential
- Forecasts to 2019
- ZP-PTH (hPTH1-34; Zosano Pharma)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for ZP-PTH
- Clinical attractiveness
- Satisfaction of unmet needs
- ZP-PTH is a patient-friendly drug
- Increased hip efficacy provides clinical differentiator
- Commercial attractiveness
- Big Pharma is required to reach full drug potential
- 505b2 regulatory strategy can reduce developmental costs
- Forecasts to 2019
- BA058 (parathyroid hormone peptide fragment; Radius)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for BA058
- Clinical attractiveness
- Satisfaction of unmet needs
- Phase II studies suggest good drug efficacy
- Commercial attractiveness
- Radius will benefit from Novartis deal should option go ahead
- Forecasts to 2019
- Other drugs in parathyroid hormone and analog class
- ViaDerm-hPTH (parathyroid hormone peptide fragment; TransPharma/Eli Lilly)
- CaPTHymone (parathyroid hormone analog; Bone Medical)
7. Pipeline Analysis & Forecasts: Calcitonins
- Key finding
- Overview for pipeline calcitonin drugs
- Pipeline summary
- Comparative forecasts
- SMC021 (salmon calcitonin; Novartis)
- Drug overview
- Drug profile
- Clinical trial data
- Ongoing clinical trials
- SWOT analysis
- Datamonitor drug assessment score card for SMC021
- Clinical attractiveness
- Satisfaction of unmet needs
- SMC021' s oral formulation remains favorable
- Commercial attractiveness
- Sales for calcitonins have been declining
- Novartis market experience
- Forecasts to 2019
- Capsitonin (BN-002; Bone Medical)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for Capsitonin
- Clinical attractiveness
- Satisfaction of unmet needs
- Clinical attractiveness
- Oral formulation is an improvement over current modes of administration
- Commercial attractiveness
- Bone Medical will seek a marketing partner to launch the product
- Competition from oral calcitonins will be high at the time of launch
- Forecasts to 2019
8. Pipeline Analysis & Forecasts: Dual Acting Bone Modulators
- Key finding
- Overview for pipeline dual acting bone agents
- Pipeline summary
- Forecast summary
- NBS101 (Strontium malonate; Osteologix)
- Drug overview
- Drug profile
- Clinical trial data
- SWOT analysis
- Datamonitor drug assessment score card for NBS101
- Clinical attractiveness
- Satisfaction of unmet needs
- Phase II data suggest better efficacy than Protelos
- NBS101 oral formulation is an improvement over Protelos
- Commercial attractiveness
- NBS101 can target patients who stop alendronate treatment
- US launch and partnering deals will boost the drug potential
- Forecasts to 2019
9. Pipeline Analysis & Forecasts: Other Drugs
- Key findings
- Overview for other pipeline drugs
- Pipeline summary
- Comparative forecasts
- Prolia (denosumab; Amgen)
- Drug overview
- Drug profile
- Clinical trial data
- Clinical trial 1
- SWOT analysis
- Datamonitor drug assessment score card for Prolia
- Clinical attractiveness
- Satisfaction of unmet needs
- Prolia shows similar efficacy to alendronate
- Serious skin disorder risk limits patient potential despite robust efficacy
- Long-term safety remains a concern
- Commercial attractiveness
- Price to remain competitive without destroying the monoclonal antibody
market
- FDA panel restricts Prolia' s patient potential
- Prolia is recommended for approval in the EU
- GlaxoSmithKline deal maximizes Prolia' s potential in tough European market
- Possible label extension for cancer indications boosts revenue potential
- Forecasts to 2019
- Odanacatib (MK0822; Merck & Co)
- Drug overview
- Drug profile
- Clinical trial data
- Ongoing clinical trials
- SWOT analysis
- Datamonitor drug assessment score card for odanacatib
- Clinical attractiveness
- Satisfaction of unmet needs
- Novel target provides potential superior efficacy
- Odanacatib shows continued efficacy after 3 years of treatment
- Commercial attractiveness
- Odanacatib' s commercial potential will be driven by Merck & Co' s market
experience
- By the time odanacatib launches the osteoporosis market will be extremely
competitive
- Forecasts to 2019
- Eldecalcitol (ED-71; Chugai/Taisho)
- Drug overview
- Drug profile
- Clinical trial data
- Clinical trial 1
- SWOT analysis
- Datamonitor drug assessment score card for eldecalcitol
- Clinical attractiveness
- Satisfaction of unmet needs
- Eldecalcitol met all Phase III endpoints and showed higher efficacy than
Alfarol
- Commercial attractiveness
- Commercial potential limited by Japan launch only
- Forecasts to 2019
- Other drugs in other classes
- MK5442 (Merck & Co)
- Drug overview
- Ongoing clinical trials
- Sclerostin (AMG785; Amgen)
- Drug overview
- Ongoing clinical trials
- 2MD/DP001 (vitamin D analog; Deltanoid Pharma)
- Drug overview
- Clinical trial data
- San134 (Glucagon-like peptide 2; Sanos Bioscience)
- ACE-011 (activin inhibitor; Acceleron Pharma)
- Late-stage development compounds recently discontinued
- Ronacaleret fails to increase BMD and causes a mild primary
hyperparathyroidism
10. Innovative Early-Stage Approaches
- Key findings
- New targets for anabolic treatments
- Wnt signaling pathway therapeutic potential
- Bone morphogenetic protein in osteoporosis
- Insulin-like growth factor I
- The future of treatment in osteoporosis
- Combination therapies
- Bibliography
- Journals
- Websites
- Datamonitor reports
- Conferences
APPENDIX
- Data definitions, limitations and assumptions
- Standard units
- Country group definitions
- Rest of European Union
- Middle East and North Africa (MENA)
- Rest of World
- Derivation of sales forecasts and pricing trends
- Indication-specific sales calculations
- Caveats to using Prescribing insight
- New product launches and expiries
- Forecast methodology
- Product forecasts
- Contributing experts
- Conferences attended
- About Datamonitor
- About Datamonitor Healthcare
- About the Disease analysis team
- Datamonitor consulting
- Disclaimer
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