※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.
프리드리히 운동실조증(FRDA)에 대한 역학 예측에 따르면, 2024년 16개국에서 54,000명 이상의 FRDA 환자가 진단될 것으로 예상되며, FRDA의 시판 중인 약물 영역은 두 가지 승인된 약물로 제한되어 있으며, Biogen의 Skyclarys( omaveloxolone)이 FRDA 영역의 주요 약물입니다.
FRDA 영역의 연구 개발 노력은 제한적이며, 현재 등록 전 단계의 약물은 없으며, 임상 3상 단계에 있는 분자는 단 하나뿐입니다. 미국은 FRDA 시험을 수행하는 주요 국가로 부상하고 있습니다. 북미에서는 FRDA 치료제를 개발하는 회사들 사이에서 파트너십이 가장 일반적인 계약 형태였습니다. 유럽에서는 라이선스 계약이 주류를 이루고 있습니다.
이 보고서는 전 세계 프리드리히 운동실조증(FRDA) 시장을 조사하여 질환 개요와 함께 임상시험 동향, 파이프라인 개요, 향후 전망 등을 제공합니다.
목차
제1장 서문
제2장 주요 조사 결과
제3장 질환 상황
제4장 출시 약제 평가
- 주요 출시 약제
- 작용기서별 개요
- 투여 경로별 개요
- 출시 약제 프로파일과 판매량 예측
제5장 약가 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
- 과거 개요
- 단계별 개요
- 상황별 개요
- 진행중 및 계획중인 시험 단계별 개요
- 가상 컴포넌트를 사용한 임상시험
- 지역적 개요
- 지역별 단일국 및 다국적 시험
- 상위 20개사 스폰서와 단계별 내역
- 상위 20개사 스폰서 상황별 내역
- 엔드포인트 상황별 개요
- 인종 및 민족별 개요
- 등록 데이터
- 임상시험 사이트 상위 20개국
- 세계의 상위 20개 사이트
- 실현 가능성 분석 - 지역적 개요
- 실현 가능성 분석 - 벤치마크 모델
제8장 거래 상황
제9장 상업적 평가
제10장 향후 시장 성장 촉진요인
제11장 부록
ksm 24.05.22
This reports provides a data-driven overview of the current and future competitive landscape in FRDA therapeutics.
- More than 54,000 diagnosed prevalent cases of FRDA are anticipated in 2024 in the 16 countries covered in GlobalData's epidemiology forecast for FRDA.
- The marketed drugs space for FRDA is limited to just two approved drugs, Biogen's Skyclarys (omaveloxolone) is the leading drug in FRDA space.
- R&D efforts in the FRDA space are limited, with no pre-registration drugs currently in the pipeline and only one molecule in Phase III.
- The US is emerging as the key country for conducting FRDA trials.
- In North America, partnerships were the most common type of deal among companies developing treatments for FRDA. In Europe, licensing agreements were prevalent.
Scope
GlobalData's FRDA: 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 FRDA market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global FRDA 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