척수성 근위축증(SMA) 시장 : 시판 및 파이프라인 의약품 평가, 임상시험, 경쟁 구도
Spinal Muscular Atrophy (SMA) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape
상품코드
:
1332126
리서치사
:
GlobalData
발행일
:
2023년 07월
페이지 정보
:
영문
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세계 주요 16개국에서 2023년에 138,844명 이상의 5q SMA(i-Ⅳ형) 환자가 진단될 것으로 예측됩니다. 현재 SMA 치료제로 승인된 약물은 소수에 불과하며, 모두 생존 운동 뉴런(SMN) 단백질의 상향 조절이라는 하나의 중요한 메커니즘에 속하며, SMA의 후기 파이프라인에는 1건의 등록 전 약물과 5건의 임상 3상 단계의 약물이 있습니다. SMA의 임상시험 공간은 상업적 스폰서와 학술적 스폰서가 거의 비슷하게 혼합되어 있으며, 일본이 임상 3상 시험을 수행하는 주요 국가로 부상하고 있습니다. 라이선싱 계약은 SMA 영역에서 세계적으로 가장 두드러진 계약 형태입니다.
이 보고서는 척수성 근위축증(SMA) 시장을 조사했으며, 질환 개요, 시판 중인 의약품 및 파이프라인 의약품 평가, 임상시험 동향, 경쟁 구도 등의 정보를 제공합니다.
목차
제1장 서문
제2장 주요 조사 결과
제3장 질병 상황
제4장 출시 약제 평가
- 주요 출시 약제
- 작용기전별 개요
- 투여 경로별 개요
- 출시 약제 개요와 판매 예측
제5장 가격 결정과 상환 평가
제6장 파이프라인 의약품제 평가
- 제Ⅲ상 파이프라인 의약품제
- 개발 단계별 개요
- 분자 유형별 개요
- 작용기전별 개요
- 투여 경로별 개요
- 의약품 특이적 상전이 성공률(PTSR)과 승인 가능성(LoA)
- 치료 영역 및 적응증 고유 PTSR 및 LoA
제7장 임상시험 평가
- 역사적 개요
- 단계별 개요
- 현황별 개요
- 진행중 및 계획중인 임상시험 단계별 개요
- 가상 컴포넌트를 사용한 임상시험
- 지역 개요
- 지역별 단일국 및 다국적 시험
- 주요 20개 스폰서와 단계별 내역
- 주요 20개 스폰서 현황별 내역
- 엔드포인트 현황별 개요
- 인종 및 민족별 개요
- 등록 데이터
- 임상시험 사이트 주요 20개국
- 세계의 TOP 20 사이트
- 실현 가능성 분석 - 지역 개요
- 실현 가능성 분석 - 벤치마크 모델
제8장 거래 상황
- 지역별 합병, 인수, 전략적 제휴
- 최근의 합병, 인수, 전략적 제휴
제9장 상업적 평가
제10장 향후 시장 성장 촉진요인
제11장 부록
LSH
영문 목차
Abstract
This reports provides a data-driven overview of the current and future competitive landscape in SMA therapeutics.
- More than 138,844 diagnosed prevalent cases of 5q SMA (types I-IV) are anticipated in 2023 in the 16 countries covered in GlobalData's epidemiology forecast for SMA.
- Only a handful of approved therapeutic drugs are currently available for the treatment of SMA, all belonging to a single key mechanism of survival motor neuron (SMN) protein upregulation.
- The late-stage pipeline for SMA includes one drug in pre-registration and five drugs in Phase III.
- The clinical trial space in SMA consists of almost an equal mix of commercial as well as academic sponsors, with Japan emerging as the key country for conducting Phase III trials.
- Licensing agreements were the most prominent deals type ventured in the SMA space globally.
Scope
GlobalData's SMA: Competitive Landscape combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.
Components of the report include -
- Disease Landscape
- Disease Overview
- Epidemiology Overview
- Treatment Overview
- Marketed Products Assessment
- Breakdown by Mechanism of Action, Route of Administration
- Product Profiles with Sales Forecast
- Pricing and Reimbursement Assessment
- Annual Therapy Cost
- Time to Pricing and Time to Reimbursement
- Pipeline Assessment
- Breakdown by Development Stage, Mechanism of Action, Molecule Type, Route of Administration
- Product Profiles with Sales Forecast
- Late-to-mid-stage Pipeline Drugs
- Phase Transition Success Rate and Likelihood of Approval
- Clinical Trials Assessment
- Breakdown of Trials by Phase, Status, Virtual Components, Sponsors, Geography, and Endpoint Status
- Enrolment Analytics, Site Analytics, Feasibility Analysis
- Deals Landscape
- Mergers, Acquisitions, and Strategic Alliances by Region
- Overview of Recent Deals
- Commercial Assessment
- Key Market Players
- Future Market Catalysts
Reasons to Buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the SMA market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SMA market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
Table of Contents
Table of Contents
1 Preface
- 1.1 Contents
- 1.2 Report Scope
- 1.3 List of Tables and Figures
- 1.4 Abbreviations
2 Key Findings
3 Disease Landscape
- 3.1 Disease Overview
- 3.2 Epidemiology Overview
- 3.3 Treatment Overview
4 Marketed Drugs Assessment
- 4.1 Leading Marketed Drugs
- 4.2 Overview by Mechanism of Action
- 4.3 Overview by Route of Administration
- 4.4 Marketed Drugs Profiles and Sales Forecasts
5 Pricing and Reimbursement Assessment
- 5.1 Annual Therapy Cost
- 5.2 Time to Pricing and Reimbursement
6 Pipeline Drugs Assessment
- 6.1 Phase III Pipeline Drugs
- 6.2 Overview by Development Stage
- 6.3 Overview by Molecule Type
- 6.4 Overview by Mechanism of Action
- 6.5 Overview by Route of Administration
- 6.6 Drug Specific Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA)
- 6.7 Therapy Area and Indication-specific PTSR and LoA
7 Clinical Trials Assessment
- 7.1 Historical Overview
- 7.2 Overview by Phase
- 7.3 Overview by Status
- 7.4 Overview by Phase for Ongoing and Planned Trials
- 7.5 Trials with Virtual Components
- 7.6 Geographic Overview
- 7.7 Single-Country and Multinational Trials by Region
- 7.8 Top 20 Sponsors with Breakdown by Phase
- 7.9 Top 20 Sponsors with Breakdown by Status
- 7.10 Overview by Endpoint Status
- 7.11 Overview by Race and Ethnicity
- 7.12 Enrollment Data
- 7.13 Top 20 countries for Trial Sites
- 7.14 Top 20 Sites Globally
- 7.15 Feasibility Analysis - Geographic Overview
- 7.16 Feasibility Analysis - Benchmark Models
8 Deals Landscape
- 8.1 Mergers, Acquisitions, and Strategic Alliances by Region
- 8.2 Recent Mergers, Acquisitions, and Strategic Alliances
9 Commercial Assessment
10 Future Market Catalysts
11 Appendix
- 11.1 Methodology
- 11.2 Methodology - Sales Forecast
- 11.3 Methodology - Pricing and Reimbursement
- 11.4 Methodology - PTSR and LoA Analysis
- 11.5 About the Authors
- 11.6 Contact Us
- 11.7 Disclaimer
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