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市場調查報告書

焦點市場分析:全身性紅斑性狼瘡(SLE)

Market Spotlight: Systemic Lupus Erythematosus (SLE)

出版商 Datamonitor Healthcare 商品編碼 939988
出版日期 內容資訊 英文 48 Pages
商品交期: 最快1-2個工作天內
價格
焦點市場分析:全身性紅斑性狼瘡(SLE) Market Spotlight: Systemic Lupus Erythematosus (SLE)
出版日期: 2020年04月28日內容資訊: 英文 48 Pages
簡介

在全身性紅斑性狼瘡(SLE)領域的已批准藥物,以B細胞活性化因子、糖皮質激素受體、促腎上腺皮質激素釋放因子,及促腎上腺皮質激素釋放激素為標的。這些藥物,經由皮下、靜脈內、肌肉內,及口服途徑投藥。 美國,在全球領導多數的SLE臨床試驗。德國領導歐洲的主要市場,韓國在亞洲佔最高的地位。

本報告提供全身性紅斑性狼瘡(SLE)的主要的上市藥、開發平台藥物,近幾年的動向和分析師的見解,臨床試驗,不久的將來的動向、規定趨勢,成功的可能性,專利資訊,授權、資產取得交易,及各類醫藥品的收益預測等相關分析。

概要

要點

疾病的背景

  • 疾病定義
  • 症狀
  • 患者的亞型
  • 危險因素
  • 診斷

治療

  • 非類固醇消炎劑(NSAID)和止痛藥
  • 皮質類固醇
  • 抗瘧疾藥
  • 免疫抑制劑
  • 抗凝固劑
  • 單株抗體
  • Repository corticotropin injection

流行病學

上市藥

開發平台藥物

近幾年的動向、分析師的見解

  • BIIB059
  • 多重藥物
  • Anifrolumab
  • CC-11050
  • Lupuzor
  • IFNa Kinoid
  • Dapirolizumab Pegol
  • XmAb5871

不久將來的動向

主要法規的動向

  • Benlysta成為首批批准的小兒狼瘡治療藥物

成功概率

授權、資產收購交易

本源專利

商機

臨床試驗環境

  • 贊助商:各狀態
  • 贊助商:各階段
  • 近幾年的動向

文件

附錄

目錄
Product Code: DMKC0206778

This Market Spotlight report covers the SLE market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways:

  • The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, and corticotropin releasing hormone. These drugs are administered via the subcutaneous, intravenous, intramuscular, and oral routes.
  • The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II. Therapies in development for SLE focus on a wide variety of targets. The majority of pipeline drugs are administered via the subcutaneous route, with the remainder being intravenous, oral, and intramuscular formulations.
  • High-impact upcoming events for drugs in the SLE space comprise topline Phase II trial results for evobrutinib, lenabasum, iscalimab, and BMS-986165; topline Phase IIa trial results for RSLV-132; topline Phase III trial results for Benlysta and anifrolumab; and an expected patent expiration for INV103.
  • The overall likelihood of approval of a Phase I SLE asset is 3.5%, and the average probability a drug advances from Phase III is 33.3%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
  • There have been 17 licensing and asset acquisition deals involving SLE drugs during 2015-20. The largest deal during the period was the $690m exclusive collaboration and license agreement signed in 2015 between Eli Lilly and Hanmi Pharmaceutical to develop and commercialize HM71224 for potential treatment of rheumatoid arthritis, lupus, lupus nephritis, Sjogren's syndrome, and other related conditions.
  • The distribution of clinical trials across Phase I-IV indicates that the majority of trials for SLE have been in the early and midphases of development, with 68% of trials in Phase I-II, and 32% in Phase III-IV.
  • The US has a substantial lead in the number of SLE clinical trials globally. Germany leads the major European markets, while South Korea has the top spot in Asia. * Clinical trial activity in the SLE space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for SLE, with 29 trials.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.

TABLE OF CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Disease definition
  • Symptoms
  • Patient subtypes
  • Risk factors
  • Diagnosis

TREATMENT

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) and pain relievers
  • Corticosteroids
  • Antimalarial drugs
  • Immunosuppressive agents
  • Anticoagulants
  • Monoclonal antibodies
  • Repository corticotropin injection

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • BIIB059 for SLE (December 3, 2019)
  • Multiple Drugs for SLE (October 24, 2019)
  • Anifrolumab for SLE (August 29, 2019)
  • CC-11050 for SLE (August 26, 2019)
  • Lupuzor for SLE (June 28, 2019)
  • IFNa Kinoid for SLE (April 6, 2019)
  • Dapirolizumab Pegol for SLE (October 23, 2018)
  • XmAb5871 for SLE (October 5, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Benlysta Becomes First Approved Treatment For Pediatric Lupus

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Overview of pipeline drugs for SLE in the US
  • Figure 2: Pipeline drugs for SLE, by company
  • Figure 3: Pipeline drugs for SLE, by drug type
  • Figure 4: Pipeline drugs for SLE, by classification
  • Figure 5: BIIB059 for SLE (December 3 2019): Phase II - LILAC
  • Figure 6: Anifrolumab for SLE (August 29, 2019): Phase III - TULIP SLE 2 (IV)
  • Figure 7: Dapirolizumab Pegol for SLE (October 23, 2018): Phase IIb - SL0023
  • Figure 8: XmAb5871 for SLE (October 5, 2018): Phase II - XmAb5871-04
  • Figure 9: Key upcoming events in SLE
  • Figure 10: Probability of success in the SLE pipeline
  • Figure 11: Licensing and asset acquisition deals in SLE, 2015-20
  • Figure 12: Parent patents in SLE
  • Figure 13: Clinical trials in SLE
  • Figure 14: Top 10 drugs for clinical trials in SLE
  • Figure 15: Top 10 companies for clinical trials in SLE
  • Figure 16: Trial locations in SLE
  • Figure 17: SLE trials status
  • Figure 18: SLE trials sponsors, by phase

LIST OF TABLES

  • Table 1: Marketed drugs for SLE
  • Table 2: Pipeline drugs for SLE in the US
  • Table 3: BIIB059 for SLE (December 3, 2019)
  • Table 4: Multiple Drugs for SLE (October 24, 2019)
  • Table 5: Anifrolumab for SLE (August 29, 2019)
  • Table 6: CC-11050 for SLE (August 26, 2019)
  • Table 7: Lupuzor for SLE (June 28, 2019)
  • Table 8: IFNa Kinoid for SLE (April 6, 2019)
  • Table 9: Dapirolizumab Pegol for SLE (October 23, 2018)
  • Table 10: XmAb5871 for SLE (October 5, 2018)
  • Table 11: Historical global sales, by drug ($m), 2014-18
  • Table 12: Forecasted global sales, by drug ($m), 2020-24