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시장 스포트라이트 : 전신홍반루푸스(SLE)

Market Spotlight: Systemic Lupus Erythematosus (SLE)

리서치사 Datamonitor Healthcare
발행일 2020년 04월 상품 코드 939988
페이지 정보 영문 48 Pages
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US $ 1,318 ₩ 1,579,000 PDF by E-mail (Single User License)


시장 스포트라이트 : 전신홍반루푸스(SLE) Market Spotlight: Systemic Lupus Erythematosus (SLE)
발행일 : 2020년 04월 페이지 정보 : 영문 48 Pages

전신홍반루푸스(SLE) 영역에서 승인된 약물은 B세포 활성화인자, 글루코코르티코이드 수용체, 부신피질자극호르몬방출인자 및 코르티코트로핀방출호르몬을 표적으로 하고 있습니다. 이 약물은 피하, 정맥내, 근육내 및 경구 경로로 투여됩니다. 미국은 세계에 다수의 SLE 임상시험을 선도하고 있습니다. 독일은 유럽의 주요 시장을 선도하고, 한국은 아시아에서 최고의 지위를 차지하고 있습니다.

전신홍반루푸스(SLE)의 주요 출시약·파이프라인약, 최근 동향과 애널리스트의 견해, 임상시험, 향후 동향·규제 동향, 성공 가능성, 특허 정보, 라이선싱·자산 취득 거래 및 의약품별 매출 예측 등에 대해 분석하여 전해드립니다.

개요

요점

질환 배경

  • 질환 정의
  • 증상
  • 환자의 서브타입
  • 위험인자
  • 진단

치료

  • 비스테로이드성항염증약(NSAID)과 진통제
  • 코르티코스테로이드
  • 항말라리아약
  • 면역억제제
  • 항응고제
  • 모노클로널 항체
  • Repository corticotropin 주사

역학

출시약

파이프라인약

최근 동향·애널리스트의 견해

  • BIIB059
  • 다중 약제
  • Anifrolumab
  • CC-11050
  • Lupuzor
  • IFNa Kinoid
  • Dapirolizumab Pegol
  • XmAb5871

향후 동향

주요 규제 동향

  • Benlysta는 소아 루푸스의 최초 승인약

성공 확률

라이선싱·자산 인수 거래

모특허

매출 기회

임상시험 환경

  • 스폰서 : 스테이터스별
  • 스폰서 : 단계별
  • 최근 동향

문헌

부록

KSA 20.06.23

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

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

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