바텐병(BD) 시장 및 파이프라인 약물 평가, 임상시험, 경쟁 상황
Batten Disease (BD) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape
상품코드
:
1376902
리서치사
:
GlobalData
발행일
:
2023년 09월
페이지 정보
:
영문 66 Pages
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
16개 주요 의약품 시장 전체에서 2023년 8,537명의 BD 환자가 진단을 받았으며, 2028년에는 8,717명으로 증가할 것으로 예상되며, 바이오마린의 브리눌라(셀리포나제 알파)만이 BD 치료제로 출시되어 있습니다.
BD의 후기 파이프라인 약물이 부족하여 현재 전 세계적으로 7개의 약품만 2단계에 있습니다.
BD를 대상으로 한 15건의 임상시험이 시작되었거나 계획되어 있으며, 이 중 5건은 완료되었고, 7건은 현재 진행 중입니다. 진행 중인 7건 중 약 71.4%가 I/II상, 28.6%가 I상이며, III상은 없습니다.
이 보고서는 현재와 미래의 바텐병(BD) 치료제의 경쟁 상황에 대한 데이터 기반 개요를 제공합니다.
목차
제1장 서문
제2장 주요 조사 결과
제3장 질병 상황
제4장 출시 약제 평가
- 주요 출시 약제
- 작용기서별 개요
- 투여 경로별 개요
- 출시 약제 프로파일과 매출 예측
제5장 가격 설정과 상환 평가
제6장 파이프라인 약제 평가
- 제Ⅲ상 파이프라인 약제
- 개발 단계별 개요
- 분자 유형별 개요
- 작용기서별 개요
- 투여 경로별 개요
- 의약품 특이적 상전이 성공률(PTSR)과 승인 가능성(LoA)
- 치료 분야 및 적응증 고유의 PTSR 및 LoA
제7장 임상시험 평가
- 역사적 개요
- 단계별 개요
- 상황별 개요
- 진행중 및 계획중인 시험 단계별 개요
- 가상 컴포넌트를 사용한 임상시험
- 지역적 개요
- 지역별 단일국 및 다국적 시험
- 상위 20개 스폰서의 단계별 내역
- 상위 20개 스폰서의 상황별 내역
- 엔드포인트 상황별 개요
- 인종 및 민족별 개요
- 등록 데이터
- 임상시험 사이트 상위 20국
- 세계의 상위 20개 사이트
- 실현 가능성 분석 - 지역적 개요
- 실현 가능성 분석 - 벤치마크 모델
제8장 거래 상황
- 합병, 인수, 전략적 제휴, 지역별
- 최근의 합병, 인수, 전략적 제휴
제9장 상업적 평가
제10장 향후 시장 촉매
제11장 부록
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영문 목차
Abstract
This reports provides a data-driven overview of the current and future competitive landscape in BD therapeutics.
Across the 16 major pharmaceutical markets, GlobalData estimates that there are 8,537 diagnosed prevalent cases of BD in 2023 and the number is expected to increase to 8,717 cases by 2028.
The marketed space for BD treatment is limited only to BioMarin's Brineura (cerliponase alfa).
There is a lack of late-stage pipeline drugs for BD; only seven drugs are currently in Phase II globally.
15 trials have been initiated or planned in BD, five of which have been completed, while seven trials are currently ongoing. Of the seven ongoing trials, approximately 71.4% are in Phase I/II, and 28.6% are in Phase I of development, while no trials are in Phase III development.
Partnership is the most prevalent deal type in Europe (71.4%).
Scope
GlobalData's BD: 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 BD market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global BD 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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