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市場調查報告書

疾病分析:骨質疏鬆症

Disease Analysis: Osteoporosis

出版商 Datamonitor Healthcare 商品編碼 939981
出版日期 內容資訊 英文 49 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:骨質疏鬆症 Disease Analysis: Osteoporosis
出版日期: 2020年05月08日內容資訊: 英文 49 Pages
簡介

本報告提供全球骨質疏鬆症治療藥臨床實驗形勢與市場趨勢預測相關分析,彙整疾病概要和流行病學的預測,目前主要治療藥 (已上市/開發中產品) 和臨床實驗的進展,目前未滿足需求和未來的市場機會,臨床實驗/市場將來相關專家的見解等資訊,為您概述為以下內容。

概要

疾病的背景情況

  • 疾病定義
  • 患者的分類

治療方法

  • 生活方式和飲食療法
  • 藥理學性治療
  • 治療層級
  • 美國的治療指南概要
  • 歐洲的治療指南概要

流行病學

  • 盛行率的調查手法

已上市醫藥品

成藥

開發平台醫藥品

法規上主要的動向

成功的可能性

臨床實驗環境

  • 臨床試驗贊助者的分類:各狀況
  • 臨床試驗贊助者的分類:各期

醫藥品的評估模式

共識的預測

近幾年的市場趨勢和分析師的見解

今後的市場主要動向

未滿足需求

參考文獻

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0210772

Latest key takeaways:

Datamonitor Healthcare estimates that in 2018, there were 345.8 million prevalent cases of osteoporosis among adults aged 50 years and older worldwide, and forecasts that number to increase to 427.8 million prevalent cases by 2027. The osteoporosis market is set for moderate growth during the forecast period of 2018-27, primarily driven by growth of Amgen's Prolia in the US, Japan, and EU until its loss of patent exclusivity allows biosimilars to enter the market.

Although the uptake of anabolic therapies will increase in terms of volumes, the market value is expected to decrease, due primarily to Forteo's loss of exclusivity coupled with the arrival of two cheaper anabolic therapies in the US. While Tymlos is expected to take significant market share from Forteo due to its competitive efficacy profile, Evenity's restricted patient population as a result of the black box warning of increased risk of myocardial infarction, stroke, and cardiovascular death will severely limit its market uptake.

Use of anabolic therapies remains limited due to their nature as injectable therapies (daily in the case of Forteo and Tymlos), which is associated with poor compliance and adherence. Radius Health is aiming to overcome this with a transdermal formulation of Tymlos. Once approved, the favorable delivery route of the transdermal patch will enable it to capture the majority of the anabolic market in the US.

The overall likelihood of approval of a Phase I osteoporosis asset is 6.3%, and the average probability a drug advances from Phase III is 72.2%. Osteoporosis drugs, on average, take 10.4 years from Phase I to approval, compared to 9.4 years in the overall endocrine space.

The US, Canada, and the UK have seen the greatest number of osteoporosis trials, globally. Within Asia, Japan has the top spot.

Clinical trial activity in the osteoporosis space is dominated by completed trials. Novartis has the highest number of completed clinical trials for osteoporosis, with 120 trials.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Disease definition
  • Patient segmentation

TREATMENT

  • Lifestyle and dietary measures
  • Pharmacological treatment
  • Treatment classes
  • Summary of US treatment guidelines
  • Summary of EU treatment guidelines

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Henlius Has Denosumab Application Accepted In China
  • EU Approvals: Evenity Cleared For Severe Osteoporosis
  • Mochida Debuts Japanese Teriparatide Biosimilar
  • Pfenex Expects To Be Alone With Teriparatide
  • Evenity Gets CHMP Nod On Second Pass
  • Pfenex Gets US Teriparatide Nod
  • Japan Approves Biosimilar Teriparatide And Darbepoetin
  • Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating
  • Amgen/UCB To Appeal EMA's 'Over Cautious' Evenity Rejection
  • Alvogen And Pfenex Have Teriparatide Filing Accepted By EMA
  • Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs
  • Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Growth of Prolia in the US will be a major driver of market growth
  • Lower price of injectable Tymlos will lead to reduction in anabolic sales
  • Tymlos transdermal patch will change the dynamic of the US osteoporosis market
  • Biosimilars will become strong resistors to US market growth
  • EU anabolic market decline will be steeper due to EMA rejection of Tymlos

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Evenity for Osteoporosis (January 16, 2019)
  • Evenity for Osteoporosis (January 14, 2019)

KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of osteoporosis, 2018-27
  • Figure 2: Overview of pipeline drugs for osteoporosis in the US
  • Figure 3: Pipeline drugs for osteoporosis, by company
  • Figure 4: Pipeline drugs for osteoporosis, by drug type
  • Figure 5: Pipeline drugs for osteoporosis, by classification
  • Figure 6: Probability of success in the osteoporosis pipeline
  • Figure 7: Clinical trials in osteoporosis
  • Figure 8: Top 10 drugs for clinical trials in osteoporosis
  • Figure 9: Top 10 companies for clinical trials in osteoporosis
  • Figure 10: Trial locations in osteoporosis
  • Figure 11: Osteoporosis trials status
  • Figure 12: Osteoporosis trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for osteoporosis
  • Figure 14: Market dynamics in osteoporosis
  • Figure 15: Future trends in osteoporosis
  • Figure 16: Key upcoming events in osteoporosis
  • Figure 17: Unmet needs in osteoporosis

LIST OF TABLES

  • Table 1: World Health Organization definitions of bone mass based on BMD
  • Table 2: Summary of US treatment guidelines
  • Table 3: Summary of EU treatment guidelines
  • Table 4: Prevalent cases of osteoporosis, 2018-27
  • Table 5: Marketed drugs for osteoporosis
  • Table 6: Pipeline drugs for osteoporosis
  • Table 7: Historical global sales, by drug ($m), 2014-18
  • Table 8: Forecasted global sales, by drug ($m), 2020-24
  • Table 9: Evenity for Osteoporosis (January 16, 2019)
  • Table 10: Evenity for Osteoporosis (January 14, 2019)