세계의 이염성 백질디스트로피(MLD) 시장 : 출시 약품과 파이프라인 약품 평가, 임상시험, 경쟁 구도
Metachromatic Leukodystrophy (MLD) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape
상품코드
:
1376905
리서치사
:
GlobalData
발행일
:
2023년 10월
페이지 정보
:
영문 65 Pages
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
개요
GlobalData에 의한 MLD의 역학 예측에서는 대상 16개국에서 2023년에 5,500을 넘는 MLD 환자가 진단될 것으로 예측됩니다.
MLD 치료제의 시장 참여는 Orchard Therapeutics의 Libmeldy로만 한정되어 있습니다.
MLD의 단계 3 파이프라인 약품은 부족합니다. 현재 미국에서 등록전 단계에 있는 약제는 1 종류뿐입니다.
과거 10년간 시행된 임상시험은 15건에 불과합니다. 북미는 MLD 임상시험을 시행하는 주요 국가로서 부상하고 있으며, 합계 27 임상시험 시설이 있습니다.
북미의 MLD 분야에서는 파트너십이 가장 현저한 거래 형태가 되고 있습니다.
세계의 당뇨병성 신장 질환(DN) 시장에 대해 조사분석했으며, 질환 상황, 출시 약품과 파이프라인 약품 평가, 현재와 향후 경쟁 구도 등을 제공하고 있습니다.
목차
제1장 서문
제2장 주요 조사 결과
제3장 질환 상황
제4장 출시 약품 평가
- 주요 출시 약품
- 개요 : 작용기서별
- 개요 : 투여 경로별
- 출시 약품 개요와 판매의 예측
제5장 가격결정과 상환 평가
제6장 파이프라인 약품 평가
- 단계 3 파이프라인 약품
- 개요 : 개발 단계별
- 개요 : 분자 유형별
- 개요 : 작용기서별
- 개요 : 투여 경로별
- 약품 고유 단계 이동 성공률(PTSR)과 승인 가능성(LoA)
- 치료 영역과 적응증 고유 PTSR과 LoA
제7장 임상시험 평가
- 과거의 개요
- 개요 : 단계별
- 개요 : 현황별
- 개요 : 진행중/계획 시험 단계별
- 가상 컴포넌트를 사용한 시험
- 지역적 개요
- 단일국·다국간 시험 : 지역별
- 상위 20 스폰서와 내역 : 단계별
- 상위 20 스폰서와 내역 : 현황별
- 개요 : 엔드포인트 현황별
- 개요 : 인종/민족별
- 등록 데이터
- 시험 시설 상위 20개국
- 세계의 상위 20 시설
- 실현 가능성 분석 - 지역적 개요
- 실현 가능성 분석 - 벤치마크 모델
제8장 거래 상황
- 합병, 인수, 전략적 제휴 : 지역별
- 최근 합병, 인수, 전략적 제휴
제9장 상업적 평가
제10장 향후 시장 촉매
제11장 부록
KSA
영문 목차
Abstract
This reports provides a data-driven overview of the current and future competitive landscape in MLD therapeutics.
More than 5,500 diagnosed prevalent cases of MLD are anticipated in 2023 in the 16 countries covered in GlobalData's epidemiology forecast for MLD.
The marketed space for MLD treatment is limited only to Orchard Therapeutics' Libmeldy.
There is a lack of Phase III pipeline drugs for MLD. Only a single drug is currently available in pre-registration stage in the US.
Over the past decade, only 15 clinical trials have been conducted. North America has emerged as the primary country for conducting MLD trials, with a total of 27 trial sites.
Partnerships were the most prominent type of deal ventured in the MLD space in North America.
Scope
GlobalData's MLD: 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 MLD market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MLD 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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