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시장 스포트라이트 : 전신홍반루푸스(SLE)

Market Spotlight: Systemic Lupus Erythematosus (SLE)

리서치사 Datamonitor Healthcare
발행일 2021년 05월 상품코드 939988
페이지 정보 영문 40 Pages 배송안내 1-2일 (영업일 기준)
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US $ 1,318 ₩ 1,905,000 PDF (Single User License)


시장 스포트라이트 : 전신홍반루푸스(SLE) Market Spotlight: Systemic Lupus Erythematosus (SLE)
발행일 : 2021년 05월 페이지 정보 : 영문 40 Pages

본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

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

This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, 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, with only one drug in the NDA/BLA phase.

Therapies in development for SLE focus on a wide variety of targets. The largest proportion 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 lenabasum, iscalimab, and BMS-986165; topline Phase IIb trial results for cenerimod; topline Phase III trial results for Benlysta, Olumiant, anifrolumab, and dapirolizumab pegol; an expected patent expiration for INV103; and an estimated PDUFA date as well as expected CHMP filing results for anifrolumab.

The overall likelihood of approval of a Phase I SLE asset is 4.6%, and the average probability a drug advances from Phase III is 45.5%. Drugs, on average, take 10.7 years from Phase I to approval, compared to 9.4 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 69% of trials in Phase I-II, and 31% 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 30 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

  • Lenabasum for SLE (October 6, 2020)
  • BIIB059 for SLE (December 3, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • China Inc. Shines In Latest Batch Of Approvals
  • Aurinia Launches Its First Drug With Lupkynis Approval For Lupus Nephritis
  • GSK Eyes Benlysta Expansion With First US FDA Lupus Nephritis Approval
  • AZ Takes On Lupus With Anifrolumab BLA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
  • With $3bn Viela Acquisition, Horizon Builds A Pipeline
  • Merck KGaA Out-Licenses Troubled Atacicept To Vera
  • AbbVie Pays $60m To Option Alpine's Lupus Candidate

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHY

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: Lenabasum for SLE (October 6, 2020): Phase IIb - Pulmonary Exacerbations
  • Figure 6: BIIB059 for SLE (December 3, 2019): Phase II - LILAC
  • 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: Lenabasum for SLE (October 6, 2020)
  • Table 4: BIIB059 for SLE (December 3, 2019)
  • Table 5: Historical global sales, by drug ($m), 2016-20
  • Table 6: Forecasted global sales, by drug ($m), 2021-25
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