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注目市場の分析:全身性エリテマトーデス(SLE)

Market Spotlight: Systemic Lupus Erythematosus (SLE)

出版日: | 発行: Datamonitor Healthcare | ページ情報: 英文 41 Pages | 納期: 即日から翌営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=105.84円
注目市場の分析:全身性エリテマトーデス(SLE)
出版日: 2020年08月10日
発行: Datamonitor Healthcare
ページ情報: 英文 41 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

全身性エリテマトーデス(SLE)領域で承認された薬物は、B細胞活性化因子、グルココルチコイド受容体、コルチコトロピン放出因子、およびコルチコトロピン放出ホルモンを標的としています。これらの薬物は、皮下、静脈内、筋肉内、および経口経路で投与されます。 米国は、世界的に多数のSLE臨床試験をリードしています。ドイツは欧州の主要市場をリードし、韓国はアジアでトップの地位を占めています。

当レポートでは、全身性エリテマトーデス(SLE)の主な上市薬・パイプライン薬、近年の動きとアナリストの見解、臨床試験、近い将来の動き・規制の動向、成功の可能性、特許情報、ライセンス供与・資産取得取引、および医薬品別の収益予測などについて分析しています。

概要

要点

疾患の背景

  • 疾患の定義
  • 症状
  • 患者のサブタイプ
  • 危険因子
  • 診断

治療

  • 非ステロイド性抗炎症薬(NSAID)と鎮痛剤
  • コルチコステロイド
  • 抗マラリア薬
  • 免疫抑制剤
  • 抗凝固剤
  • モノクローナル抗体
  • リポジトリコルチコトロピン注射

疫学

上市薬

パイプライン薬

近年の動き・アナリストの見解

  • BIIB059
  • 多重薬剤
  • Anifrolumab
  • CC-11050
  • Lupuzor
  • IFNa Kinoid
  • Dapirolizumab Pegol
  • XmAb5871

近い将来の動き

主な規制の動き

  • Benlystaは小児ループスの最初の承認薬に

成功確率

ライセンシング・資産買収取引

親特許

収益機会

臨床試験環境

  • スポンサー:ステイタス別
  • スポンサー:フェーズ別
  • 近年の動き

文献

付録

目次
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 4.5%, and the average probability a drug advances from Phase III is 40%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.

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

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)

KEY UPCOMING EVENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • AbbVie Pays $60m To Option Alpine's Lupus Candidate

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: Key upcoming events in SLE
  • Figure 8: Probability of success in the SLE pipeline
  • Figure 9: Clinical trials in SLE
  • Figure 10: Top 10 drugs for clinical trials in SLE
  • Figure 11: Top 10 companies for clinical trials in SLE
  • Figure 12: Trial locations in SLE
  • Figure 13: SLE trials status
  • Figure 14: 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: Historical global sales, by drug ($m), 2015-19
  • Table 10: Forecasted global sales, by drug ($m), 2020-24
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