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루게릭병(ALS) : 시장 기회 분석과 향후 예측(-2027년)

Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027

리서치사 GlobalData
발행일 2018년 07월 상품 코드 731759
페이지 정보 영문 95 Pages
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루게릭병(ALS) : 시장 기회 분석과 향후 예측(-2027년) Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027
발행일 : 2018년 07월 페이지 정보 : 영문 95 Pages

세계 주요 국가(미국, 유럽(프랑스, 독일, 이탈리아, 스페인, 영국), 일본)의 루게릭병(ALS) 치료제 시장 규모는 2017년 기준 약 1억 8,700만 달러에 이르렀습니다. 또 향후 10년간 연평균 복합 성장률(CAGR)은 19.4%, 2027년 시장 규모는 12억 달러에 이를 것으로 추정됩니다.

루게릭병(ALS: Amyotrophic Lateral Sclerosis) 치료제에 관한 최신 연구개발 동향과 향후 시장 동향 전망을 분석했으며, 질환 개요, 현재 치료법, 미충족 요구 및 시장 기회 평가, 향후 10년간 환자수 및 시장 규모 예측, 임상시험 진행 상황, 신규 치료제 파이프라인 평가, 향후 시장 및 기술 동향 등에 대해 전해드립니다.

제1장 목차

제2장 루게릭병(ALS) : 개요

제3장 서론

제4장 질환 개요

  • 병태와 병인
  • 병기 분류
  • 증상
    • 합병증
  • 삶의 질(QoL)

제5장 역학

  • 질환의 배경
  • 위험요인과 공존증
  • 과거의 세계적 동향
    • 미국, 유럽 주요 5개국(EU5), 일본
  • 예측 방법
    • 정보 출처
    • 예측 전제조건 및 방법
  • ALS의 역학적 예측(통산 11년간)
    • 진찰 환자수
    • 진찰 환자수 : 연령층별
    • 진찰 환자수 : 남녀별
    • 진찰 환자수 : 질환 종류별
    • ALS 유병률
  • 논의
    • 역학적 예측 결과에 관한 고찰
    • 분석의 한계
    • 분석의 강점

제6장 현재의 치료 옵션

  • 개요

제7장 미충족 요구와 시장 기회 평가

  • 개요
  • 보다 신속한 진단 방법
  • 치료제
  • 환자의 여생 연장
  • ALS 관련 바이오마커 분류

제8장 연구개발(R&D) 전략

  • 개요
    • 새로운 표적
    • 근본적 치료 요법
    • 재처방
  • 임상시험 설계
    • 엔드포인트
    • 임상시험 기간
    • 임상시험 참여자(환자) 모집

제9장 파이프라인 제품 평가

  • 개요
  • 혁신적인 조기 단계 접근

제10장 파이프라인 평가 분석

  • 주요 파이프라인 약제의 임상 측면 비교 기준
  • 주요 파이프라인 약제 상업 측면 비교 기준
  • 비교 분석
  • 주요 국가 시장 예측(향후 10년간)
    • 미국
    • 유럽 주요 5개국(EU5)
    • 일본

제11장 부록

LSH 18.11.08

List of Tables

  • Table 1: ALS: Key Metrics in the 7MM 6
  • Table 2: Gene Involved in the Familial Forms of ALS 16
  • Table 3: Symptoms of ALS 19
  • Table 4: Risk Factors and Comorbidities for ALS 22
  • Table 5: Leading Treatments for ALS, 2018 43
  • Table 6: Treatment Guidelines for ALS 45
  • Table 7: Comparison of Therapeutic Classes in Development for ALS, 2017-2027 65
  • Table 8: Innovative Early-Stage Approaches for ALS, 2018 67
  • Table 9: Clinical Benchmark of Key Pipeline Drugs - ALS 70
  • Table 10: Commercial Benchmark of Key Pipeline Drugs - ALS 71
  • Table 11: Key Events Impacting Sales for ALS, 2017-2027 74
  • Table 12: ALS Market - Global Drivers and Barriers, 2017-2027 75
  • Table 13: Key Historical and Projected Launch Dates for ALS 85
  • Table 14: Key Historical and Projected Patent Expiry Dates for ALS 86
  • Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 90

List of Figures

  • Figure 1: Global Sales Forecast by Country for ALS in 2017 and 2027 8
  • Figure 2: Competitive Assessment of Marketed and Pipeline Drugs, Benchmarked Against the SOC, Rilutek 10
  • Figure 3: Overview of the human body and muscles involved in ALS 15
  • Figure 4: Pathophysiology of ALS 17
  • Figure 5: Staging Systems for ALS 18
  • Figure 6: 7MM, Age-Standardized Diagnosed Prevalence of ALS, Ages ≥40 Years, 2017 24
  • Figure 7:Sources Used for Diagnosed Prevalent Cases of ALS 26
  • Figure 8:Sources Used for Diagnosed Prevalent Cases of ALS Type 27
  • Figure 9: 7MM, Diagnosed Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017 34
  • Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of ALS, Men and Women, 2017 35
  • Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017 36
  • Figure 12: 7MM, Diagnosed Prevalent Cases of ALS by Type, Men and Women, Ages ≥40 Years, 2017 37
  • Figure 13: 7MM, Total Prevalent Cases of ALS, Men and Women, Ages ≥40 Years, 2017 38
  • Figure 14: Unmet Needs and Opportunities in ALS 47
  • Figure 15: Overview of the Development Pipeline in ALS 64
  • Figure 16: Key Phase II and III Trials for Promising Pipeline Agents 65
  • Figure 17:Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Rilutek 72
  • Figure 18: Global (7MM) Sales Forecast by Country for ALS in 2017 and 2027 74

Amyotrophic Lateral Sclerosis (ALS) drug sales in 2017 were approximately $187M across the seven major markets - the US, 5EU (France, Germany, Italy, Spain and the UK), and Japan. Over the 10-year forecast period, the market is expected to grow to $1.2B at a CAGR of 19.4%. This growth will be driven by the launch of six late-stage pipeline products. Currently, the highest-selling drug in the market is Mitsubishi's Radicava (edaravone).

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron degenerative disease which affects both upper motor neurons (UMN) and lower motor neurons (LMN). It is a progressive disease, with patients becoming increasingly dependent on carers and physicians as time from onset increases, and ultimately, it is fatal. ALS can be split into two origins, hereditary - which is known as FALS (Familial ALS) or idiopathic - known as SALS (sporadic ALS).

The major drivers of growth in the Amyotrophic Lateral Sclerosis (ALS) market during the forecast period include -

  • The launch of five pipeline agents that aim to extend patient survival. These drugs will be used as adjunctive therapies to Rilutek and Radicava.
  • The launch of BrainStorm Therapeutics' NurOwn stem cell therapy, which has the potential to significantly slow the progression of the disease and is, expected to expand the market in the future. Biologic products have a high cost of therapy and as such are expected to generate high sales.

The major barriers to growth in the Amyotrophic Lateral Sclerosis (ALS) market during the forecast period will be -

  • Major brands are expected to see their patents expire throughout the forecast period, which will act as a barrier as cheap generic versions of the drug will enter the market.
  • Due to the rarity of the disease, recruiting a representative patient sample for clinical trials can be difficult and may slow the clinical trial development process.

The report "Amyotrophic Lateral Sclerosis: Opportunity Analysis and Forecast to 2027", is aimed to -

  • Assess the current competitive landscape and its evolution over the forecast period (2017-2027)
  • Evaluate the significance of late-stage pipeline products entering the ALS market and determine how these products will impact the future treatment landscape
  • Highlight the significant unmet needs in the ALS market
  • Identify any opportunities in the ALS market

Companies Mentioned: Sanofi, Mitsubishi Tanabe, Brainstorm Therapeutics, ViroMed, Ionis Pharmaceuticals, Genevrone Biopharmaceuticals, Biogen, Orphazyme, Orion Pharmaceuticals, KringlePharma, Aquestive Therapeutics, Apotex, Valeant Pharmaceuticals, Neuralstem, Impicit Bioscience, Roche, Treeway BV, Cytokientics, AB Science, Concordia Healthcare Corp

Scope

  • Overview of ALS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized ALS therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in two patient segments (familial and sporadic) forecast from 2017 to 2027.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the ALS therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ALS therapy. The most promising candidates in Phase III development are profiled.
  • Analysis of the current and future market competition in the global ALS therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

  • 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 global ALS therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ALS therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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

1 Table of Contents 2

  • 1.1 List of Tables 5
  • 1.2 List of Figures 5

2 Amyotrophic Lateral Sclerosis: Executive Summary 6

  • 2.1 Global ALS Market Expected to Experience Explosive Growth by 2027 7
  • 2.2 Pharmaceutical Companies Target Novel MOAs in a Market with Few Approved Therapies 8
  • 2.3 Several Key Unmet Needs Identified in the ALS Market, Providing Opportunity for New Players 9
  • 2.4 Several Different Classes in the ALS Pipeline Look to Fill the Gaps in the Market 9
  • 2.5 What Do Physicians Think? 10

3 Introduction 13

  • 3.1 Catalyst 13
  • 3.2 Related Reports 14
  • 3.3 Upcoming Related Reports 14

4 Disease Overview 15

  • 4.1 Etiology and Pathophysiology 15
    • 4.1.1 Etiology 15
    • 4.1.2 Pathophysiology 17
  • 4.2 Classification or Staging Systems 18
  • 4.3 Symptoms 19
    • 4.3.1 Complications 19
  • 4.4 Quality of Life 20

5 Epidemiology 21

  • 5.1 Disease Background 21
  • 5.2 Risk Factors and Comorbidities 21
  • 5.3 Global and Historical Trends 22
    • 5.3.1 US 24
    • 5.3.2 5EU 25
    • 5.3.3 Japan 25
  • 5.4 Forecast Methodology 25
    • 5.4.1 Sources 26
    • 5.4.2 Forecast Assumptions and Methods 27
  • 5.5 Epidemiological Forecast for ALS (2017-2027) 33
    • 5.5.1 Diagnosed Prevalent Cases of ALS 33
    • 5.5.2 Age-Specific Diagnosed Prevalent Cases of ALS 34
    • 5.5.3 Sex-Specific Diagnosed Prevalent Cases of ALS 35
    • 5.5.4 Diagnosed Prevalent Cases of ALS by Type 36
    • 5.5.5 Total Prevalent Cases of ALS 37
  • 5.6 Discussion 38
    • 5.6.1 Epidemiological Forecast Insight 38
    • 5.6.2 Limitations of Analysis 40
    • 5.6.3 Strengths of Analysis 41

6 Current Treatment Options 42

  • 6.1 Overview 42

7 Unmet Needs and Opportunity Assessment 46

  • 7.1 Overview 46
  • 7.2 Faster Diagnosis 47
  • 7.3 Curative Agent 49
  • 7.4 Extended Patient Survival 51
  • 7.5 Identification of Biomarkers Associated with ALS 52

8 R&D Strategies 55

  • 8.1 Overview 55
    • 8.1.1 Novel Targets 55
    • 8.1.2 Disease-Modifying Therapies 56
    • 8.1.3 Reformulations 58
  • 8.2 Clinical Trials Design 59
    • 8.2.1 Endpoints 60
    • 8.2.2 Length of Clinical Trials 61
    • 8.2.3 Patient Recruitment 61

9 Pipeline Assessment 63

  • 9.1 Overview 63
  • 9.2 Innovative Early-Stage Approaches 66

10 Pipeline Valuation Analysis 68

  • 10.1 Clinical Benchmark of Key Pipeline Drugs 68
  • 10.2 Commercial Benchmark of Key Pipeline Drugs 70
  • 10.3 Competitive Assessment 72
  • 10.4 Top-Line 10-Year Forecast 73
    • 10.4.1 US 75
    • 10.4.2 5EU 76
    • 10.4.3 Japan 76

11 Appendix 78

  • 11.1 Bibliography 78
  • 11.2 Abbreviations 83
  • 11.3 Methodology 84
    • 11.3.1 Forecasting Methodology 84
    • 11.3.2 Diagnosed Patients 84
    • 11.3.3 Percent Drug-Treated Patients 85
    • 11.3.4 Drugs Included in Each Therapeutic Class 85
    • 11.3.5 Launch and Patent Expiry Dates 85
    • 11.3.6 General Pricing Assumptions 86
    • 11.3.7 Individual Drug Assumptions 87
    • 11.3.8 Generic Erosion 88
    • 11.3.9 Pricing of Pipeline Agents 88
  • 11.4 Primary Research - KOLs Interviewed for This Report 89
    • 11.4.1 KOLs 89
    • 11.4.2 Payers 90
  • 11.5 Primary Research - Prescriber Survey 90
  • 11.6 About the Authors 91
    • 11.6.1 Analyst 91
    • 11.6.2 Therapy Area Director 91
    • 11.6.3 Epidemiologist 91
    • 11.6.4 Managing Epidemiologist 92
    • 11.6.5 Global Director of Therapy Analysis and Epidemiology 93
    • 11.6.6 Global Head and EVP of Healthcare Operations and Strategy 93
  • 11.7 About GlobalData 94
  • 11.8 Contact Us 94
  • 11.9 Disclaimer 95
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