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市場調查報告書
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997339

市場關注點:軸向脊柱關節炎(axSpA)

Market Spotlight: Axial Spondyloarthritis (axSpA)

出版日期: | 出版商: Datamonitor Healthcare | 英文 52 Pages | 商品交期: 最快1-2個工作天內

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簡介

根據2018年的預測,估計全球有590萬名20歲以上的成年人患有強直性脊柱炎,到2027年,這一數字預計將增至640萬人。我會的。

軸性脊柱關節炎(axSpA)領域中批准的藥物包括腫瘤壞死因子-ALPHA,前列腺素E受體1,前列腺素E受體2,白介素17,IL-17受體,並靶向JAK/STAT。這些通常是皮下給予的,其餘的是靜脈內,口服和經皮導管/注射劑。

德國是強直性脊柱炎臨床試驗數量的全球領導者,而韓國是亞洲的領導者。

這份市場聚焦報告分析了軸向脊椎關節炎(axSpA)市場,包括主要的非處方藥和管線藥物,近期事件和分析師意見,臨床試驗以及即將到來的監管事件,它提供了成功的10年期疾病流行率預測以及針對特定藥物的收入預測。

目錄

內容

概述

要點

疾病背景

  • 定義
  • 患者細分
  • 症狀
  • 危險因素
  • 診斷

處理

  • NSAID
  • DMARD
  • 類固醇
  • 手術

流行病學

  • 軸向性脊柱關節炎的流行病學

非處方藥

管道醫學

最近發生的事件和分析師的觀點

  • Xeljanz/Xeljanz XR用於軸突性脊柱關節炎(2020年11月6日)
  • 軸索性關節炎的Cosentyx(2019年11月12日)
  • Rinvoq治療軸向脊柱關節炎(2019年11月12日)
  • Taltz治療軸突性脊柱關節炎(2019年11月12日)
  • 軸突性關節炎的Inflectra(2019年9月19日)
  • 軸索性關節炎的Cosentyx(2019年9月17日)

即將發生的重大事件

重大監管事件

  • 山德士確認在加拿大推出Humila Rival
  • Celltrion贏得全球首個高濃度Humira生物仿製藥的批准
  • Henlius在中國獲得阿達木單抗的批准
  • 艾伯維(AbbVie)的Rinvoq與積極的增長計劃保持一致
  • Celltrion的Remsima SC批准的其他適應症 FDA批准Mylan的Humila生物仿製藥
  • 日本批准首批Humira生物仿製藥
  • 諾華,Ultragenyx的新適應症
  • Mylan And Lupine準備發佈UE Etanercept
  • 邁蘭和羽扇豆接受歐盟Etanercept
  • Adalimumab歸檔對Celltrion眼睛的 "競爭力"

成功的可能性

收入機會

臨床試驗情況

  • 按狀態贊助
  • 階段贊助者

參考

  • 處方信息

附錄

數字列表

表列表

目錄
Product Code: DMKC0213546

Overview:

This Market Spotlight report covers the Axial Spondyloarthritis (axSpA) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.

Datamonitor Healthcare estimates that in 2018, there were 5.9 million prevalent cases of ankylosing spondylitis in adults aged 20 years and older worldwide, and forecasts that number to increase to 6.4 million prevalent cases by 2027.

The approved drugs in the axial spondyloarthritis (axSpA) space target tumor necrosis factor-alpha, prostaglandin E receptor 1, prostaglandin E receptor 2, interleukin 17, IL-17 receptor, and JAK/STAT. These are commonly administered via the subcutaneous route, with the remainder being intravenous, oral, and percutaneous catheter/injection formulations.

The greatest proportion of industry-sponsored drugs in active clinical development for axSpA are in the NDA/BLA phase. Therapies in development for axSpA focus on targets such as JAK/STAT, interleukin 17, and granulocyte-macrophage colonystimulating factor. These drugs are administered via the oral, intravenous, subcutaneous, and topical routes.

High-impact upcoming events in the axSpA space comprise topline Phase III trial results for bimekizumab, Cosentyx, and Rinvoq; and expected PDUFA dates for Rinvoq and Xeljanz/Xeljanz XR.

The overall likelihood of approval of a Phase I arthritis asset is 8.4%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.2 years in the overall autoimmune/immunology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for ankylosing spondylitis have been in the late phases of development, with 82% of trials in Phase III-IV, and only 18% in Phase I-II.

Germany has a significant lead in the number of ankylosing spondylitis clinical trials globally, while South Korea has the top spot in Asia.

Clinical trial activity in the ankylosing spondylitis space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for ankylosing spondylitis, with 28 trials.

Pfizer leads industry sponsors with the highest overall number of clinical trials for ankylosing spondylitis, followed by AbbVie

TABLE OF CONTENTS

CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis

TREATMENT

  • NSAIDs
  • DMARDs
  • Steroids
  • Surgery

EPIDEMIOLOGY

  • Epidemiology of axial spondyloarthritis

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
  • Cosentyx for Axial Spondyloarthritis (November 12, 2019)
  • Rinvoq for Axial Spondyloarthritis (November 12, 2019)
  • Taltz for Axial Spondyloarthritis (November 12, 2019)
  • Inflectra for Axial Spondyloarthritis (September 19, 2019)
  • Cosentyx for Axial Spondyloarthritis (September 17, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Sandoz Confirms Launch Of Humira Rival In Canada
  • Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
  • Henlius Gets Green Light For Adalimumab In China
  • AbbVie's Rinvoq Advances Along Aggressive Growth Plan
  • Extra Indications Approved For Celltrion's Remsima SC
  • FDA Approves Mylan's Humira Biosimilar
  • Japan Approves First Humira Biosimilar
  • New Indications For Novartis, Ultragenyx
  • Mylan And Lupin Prepare To Launch EU Etanercept
  • Mylan And Lupin Get EU Etanercept Nod
  • Celltrion Eyes 'Competitive Edge' With Adalimumab Filing

PROBABILITY OF SUCCESS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of ankylosing spondylitis, 2018-27
  • Figure 2: Overview of pipeline drugs for axSpA in the US
  • Figure 3: Pipeline drugs for axSpA, by company
  • Figure 4: Pipeline drugs for axSpA, by drug type
  • Figure 5: Pipeline drugs for axSpA, by classification
  • Figure 6: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020): Phase III - Ankylosing Spondylitis (A3921120)
  • Figure 7: Cosentyx for Axial Spondyloarthritis (November 12, 2019): Phase III - PREVENT
  • Figure 8: Rinvoq for Axial Spondyloarthritis (November 12, 2019): Phase II/III - SELECT Axis 1
  • Figure 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019): Phase III - PREVENT
  • Figure 10: Key upcoming events in axSpA
  • Figure 11: Probability of success in the arthritis pipeline
  • Figure 12: Clinical trials in ankylosing spondylitis
  • Figure 13: Top 10 drugs for clinical trials in ankylosing spondylitis
  • Figure 14: Top 10 companies for clinical trials in ankylosing spondylitis
  • Figure 15: Trial locations in ankylosing spondylitis
  • Figure 16: Ankylosing spondylitis trials status
  • Figure 17: Ankylosing spondylitis trials sponsors, by phase

LIST OF TABLES

  • Table 1: Prevalent cases of ankylosing spondylitis, 2018-27
  • Table 2: Marketed drugs for axSpA
  • Table 3: Pipeline drugs for axSpA in the US
  • Table 4: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
  • Table 5: Cosentyx for Axial Spondyloarthritis (November 12, 2019)
  • Table 6: Rinvoq for Axial Spondyloarthritis (November 12, 2019)
  • Table 7: Taltz for Axial Spondyloarthritis (November 12, 2019)
  • Table 8: Inflectra for Axial Spondyloarthritis (September 19, 2019)
  • Table 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019)
  • Table 10: Historical global sales, by drug ($m), 2015-19
  • Table 11: Forecasted global sales, by drug ($m), 2021-25