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OpportunityAnalyzer : 후기 만성신장질환 시장 분석과 예측(-2026년)

OpportunityAnalyzer: Late-Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026

리서치사 GlobalData
발행일 2017년 12월 상품 코드 622439
페이지 정보 영문 195 Pages
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OpportunityAnalyzer : 후기 만성신장질환 시장 분석과 예측(-2026년) OpportunityAnalyzer: Late-Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026
발행일 : 2017년 12월 페이지 정보 : 영문 195 Pages

후기 만성신장질환(CKD) 치료제 시장은 9.5%의 연평균 성장률(CAGR)로 성장하여 2026년에는 약 105억 달러의 매출 규모에 이를 것으로 예측됩니다.

후기 만성신장질환(CKD)의 이환 상황과 치료제 시장에 대해 조사했으며, 질환 개요, 환자 인구 추정과 예측, 현재의 치료 옵션, 미충족 요구와 시장 기회, 기업의 R&D 전략, 파이프라인 의약품 프로파일, 비교 분석 등의 정보를 전해드립니다.

제1장 목차

제2장 주요 요약

제3장 서론

제4장 질환 개요

  • 병인 및 병태생리
  • 증상
  • 진단 및 모니터링
  • 예후 및 QOL

제5장 역학

  • 질환의 배경
  • 위험인자와 병존증
  • 과거 추정
  • 예측 방법
  • 역학적 예측
    • CKD 총유병자수 : 단계 I-IV별
    • CKD 총유병자수 : 단계 I-IV별, 연령층별
    • CKD 총유병자수 : 단계 I-IV별, 성별
    • CKD 총유병자수 : 단계별
    • CKD 진단 유병자수 : 단계 I-IV별
  • 논의

제6장 현재 치료 옵션

  • 개요
  • 치료 가이드라인과 주요 처방약
    • 부갑상선 기능 항진증, 고인혈증
    • 고칼륨혈증
  • 임상적 진료
    • 부갑상선 기능 항진증, 고인혈증
    • 고칼륨혈증
  • Calcimimetics
    • Sensipar(cinacalcet hydrochloride)
  • 비타민 D 스테롤
    • 활성형/천연형 비타민 D
    • 비타민 D 수용체 작용제
  • 인 결합제
    • 개요
    • 칼슘계 인 결합제
    • 알루미늄계 인 결합제
    • 마그네슘계 인 결합제
    • Renvela/Renagel(sevelamer carbonate/hydrochloride)
    • Fosrenol(lanthanum carbonate)
    • Velphoro(sucroferric oxyhydroxide)
    • Auryxia(ferric citrate)
  • 칼륨 결합제
    • 수지
    • Veltassa(patiromer sorbitex calcium)

제7장 미충족 요구와 시장 기회 분석

  • 개요
  • 부갑상선 기능 항진증에 최적인 인 관리
    • 미충족 요구
    • 격차 분석
    • 시장 기회
  • 새로운 고칼륨혈증 치료
    • 미충족 요구
    • 격차 분석
    • 시장 기회
  • 복약 순응도의 개선
    • 미충족 요구
    • 격차 분석
    • 시장 기회
  • 약제 비용과 시장 접근
    • 미충족 요구
    • 격차 분석
    • 시장 기회

제8장 R&D 전략

  • 개요
    • 라이선싱과 얼라이언스
    • 투석전 및 투석 단계에서의 치료 안전성과 순응도 최적화
    • 새로운 인 결합제의 개발 : 여전히 미충족 요구로서 남아
  • 임상시험 설계
    • 부갑상선 기능 항진증
    • 고인혈증
    • 고칼륨혈증

제9장 파이프라인 분석

  • 개요
  • 임상 개발 단계에서 유망한 약제
    • Parsabiv(etelcalcetide hydrochloride)
    • Evocalcet
    • DP-001
    • PT20
    • Tenapanor hydrochloride
    • Alpharen(fermagate)
    • Lokelma(sodium zirconium cyclosilicate)
  • 혁신적 초기 단계 어프로치
    • Renazorb(SPI-014)

제10장 파이프라인 평가 분석

  • 주요 파이프라인 의약품의 임상적 벤치마킹
  • 주요 파이프라인 의약품의 상업적 벤치마킹
  • 경쟁 분석
  • 톱 라인 10개년 예측
    • 미국
    • EU 5개국
    • 일본

제11장 부록

KSM 18.04.16

CKD-induced hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) therapeutics had sales of approximately $4.2B in 2016 across the seven major markets (7MM) covered in this report; i.e., the US, the five major European markets (5EU: France, Germany, Italy, Spain, and UK), and Japan. In the 2016 base year, around 62% of market share was attributed to HPT therapy sales, whereas HP and HK held around 38% and 0.1% of the market, respectively.

By 2026, GlobalData expects the late-stage chronic kidney disease (CKD) market to grow at a strong Compound Annual Growth Rate (CAGR) of around 9.5%, reaching sales of about $10.5B by the end of the forecast period in 2026. In general, the US will contribute the most to CKD market growth, as it is forecast to grow at a CAGR of over 11%, from around $2.5B in 2016. Over the forecast period, the most prominent wave of sales increases will come from the launch of new HK agents and the calcimimetic, Parsabiv (etelcalcetide), which will counteract the loss of market exclusivity of its in-house predecessor, Sensipar (cinacalcet).

The major drivers of CKD market growth over the forecast period are -

  • The launch of Amgen's first intravenous (IV) calcimimetic, Parsabiv, in 2017
  • The recent launch of Veltassa (patiromer sorbitex calcium) in the US in 2016
  • The launch of Lokelma (sodium zirconium cyclosilicate) in all 7MM by 2019
  • An increase in the global prevalence of HPT, HP, and HK
  • The recent launch of Rayaldee (calcifediol ER) in the US in 2016
  • Increased use of new iron-based phosphate binders, Velphoro (sucroferric oxyhydroxide) and Auryxia (ferric citrate)

The major barriers that will restrict the growth of the HPT market during the forecast period are -

  • Amgen's Sensipar losing market exclusivity in the US (2018), 5EU (2019), and Japan (2020)
  • Generic erosion of key players in the phosphate binder space, such as Fosrenol (lanthanum carbonate), Renvela/Renagel (sevelamer), and Velphoro, over the forecast period

The report "OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026", provide -

  • An overview of CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report: OPKO Health, Amgen, Vifor, ZS Pharma, AstraZeneca, AbbVie, Sanofi, Genzyme, Shire, Keryx, Relypsa, Mitsubishi Tanabe, Kyowa Hakko Kirin, Deltanoid, Shield Therapeutics, Ardelyx , Spectrum

Scope

  • Overview of CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia 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. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global T2D therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T2D therapeutics market in 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.
  • Track drug sales in the global T2D therapeutics market from 2016-2026.
  • 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 6
  • 1.2 List of Figures 8

2 Executive Summary 9

  • 2.1 Combined Sales for CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia to Double by 2026 10
  • 2.2 A Continued Focus on Improving the Compliance and Safety of Phosphate Binder Drugs 12
  • 2.3 Novel Therapies Finally Begin to Address Long-Standing Key Unmet Needs in Hyperkalemia 13
  • 2.4 IV Calcimimetic, Parsabiv Expected to Revolutionize the Treatment of Dialysis-Dependent Hyperparathyroidism Patients 14
  • 2.5 What Do Physicians Think? 14

3 Introduction 16

  • 3.1 Catalyst 16
  • 3.2 Related Reports 17

4 Disease Overview 18

  • 4.1 Etiology and Pathophysiology 18
    • 4.1.1 Etiology 18
    • 4.1.2 Pathophysiology 19
  • 4.2 Symptoms 25
  • 4.3 Diagnosis and Monitoring 27
  • 4.4 Prognosis and Quality of Life 31

5 Epidemiology 32

  • 5.1 Disease Background 32
  • 5.2 Risk Factors and Comorbidities 33
  • 5.3 Global and Historical Trends 34
  • 5.4 Forecast Methodology 35
    • 5.4.1 Sources 36
    • 5.4.2 Forecast Assumptions and Methods 40
  • 5.5 Epidemiological Forecast for CKD (2016-2026) 46
    • 5.5.1 Total Prevalent Cases of CKD, Stages I-IV 46
    • 5.5.2 Age-Specific Total Prevalent Cases of CKD, Stages I-IV 47
    • 5.5.3 Sex-Specific Total Prevalent Cases of CKD, Stages I-IV 48
    • 5.5.4 Total Prevalent Cases of CKD by Stage 49
    • 5.5.5 Diagnosed Prevalent Cases of CKD, Stages I-V 50
    • 5.5.6 Diagnosed Prevalent Cases of CKD by Stage 51
  • 5.6 Discussion 52
    • 5.6.1 Epidemiological Forecast Insight 52
    • 5.6.2 Limitations of the Analysis 53
    • 5.6.3 Strengths of the Analysis 54

6 Current Treatment Options 55

  • 6.1 Overview 55
  • 6.2 Treatment Guidelines and Leading Prescribed Drugs 56
    • 6.2.1 Hyperparathyroidism and Hyperphosphatemia 56
    • 6.2.2 Hyperkalaemia 58
  • 6.3 Clinical Practice 60
    • 6.3.1 Hyperparathyroidism and Hyperphosphatemia 60
    • 6.3.2 Hyperkalemia 61
  • 6.4 Calcimimetics 63
    • 6.4.1 Sensipar (cinacalcet hydrochloride) 63
  • 6.5 Vitamin D Sterols 67
    • 6.5.1 Nutritional/Native Vitamin D 67
    • 6.5.2 Vitamin D Receptor Agonists 71
  • 6.6 Phosphate Binding Therapies 75
    • 6.6.1 Overview 75
    • 6.6.2 Calcium-Based Phosphate Binders 76
    • 6.6.3 Aluminum-Containing Phosphate Binders 77
    • 6.6.4 Magnesium-Containing Phosphate Binders 77
    • 6.6.5 Renvela/Renagel (sevelamer carbonate/hydrochloride) 77
    • 6.6.6 Fosrenol (lanthanum carbonate) 81
    • 6.6.7 Velphoro (sucroferric oxyhydroxide) 85
    • 6.6.8 Auryxia (ferric citrate) 88
  • 6.7 Potassium Binding Therapies 93
    • 6.7.1 Resins 93
    • 6.7.2 Veltassa (patiromer sorbitex calcium) 95

7 Unmet Needs and Opportunity Assessment 99

  • 7.1 Overview 99
  • 7.2 Optimal Management of Phosphate in Hyperparathyroidism 100
    • 7.2.1 Unmet Need 100
    • 7.2.2 Gap Analysis 101
    • 7.2.3 Opportunity 102
  • 7.3 Novel Hyperkalemia Treatments 102
    • 7.3.1 Unmet Need 102
    • 7.3.2 Gap Analysis 103
    • 7.3.3 Opportunity 103
  • 7.4 Improved Compliance 104
    • 7.4.1 Unmet Need 104
    • 7.4.2 Gap Analysis 104
    • 7.4.3 Opportunity 105
  • 7.5 Drug Cost and Market Access 105
    • 7.5.1 Unmet Need 105
    • 7.5.2 Gap Analysis 106
    • 7.5.3 Opportunity 107

8 R&D Strategies 108

  • 8.1 Overview 108
    • 8.1.1 Licensing and Alliances 108
    • 8.1.2 Optimizing Treatment Safety and Compliance in Both the Pre-dialysis and Dialysis Setting 109
    • 8.1.3 Development of Various Novel Phosphate Binders Continues as Unmet Needs Remian 111
  • 8.2 Clinical Trial Design 113
    • 8.2.1 Hyperparathyroidism 113
    • 8.2.2 Hyperphosphatemia 114
    • 8.2.3 Hyperkalemia 115

9 Pipeline Assessment 117

  • 9.1 Overview 117
  • 9.2 Promising Drugs in Clinical Development 119
    • 9.2.1 Parsabiv (etelcalcetide hydrochloride) 119
    • 9.2.2 Evocalcet 123
    • 9.2.3 DP-001 124
    • 9.2.4 PT20 128
    • 9.2.5 Tenapanor hydrochloride 131
    • 9.2.6 Alpharen (fermagate) 134
    • 9.2.7 Lokelma (sodium zirconium cyclosilicate) 136
  • 9.3 Innovative Early Stage Approaches 139
    • 9.3.1 Renazorb (SPI-014) 141

10 Pipeline Valuation Analysis 142

  • 10.1 Clinical Benchmark of Key Pipeline Drugs 142
  • 10.2 Commercial Benchmark of Key Pipeline Drugs 146
  • 10.3 Competitive Assessment 150
  • 10.4 Top-Line 10-Year Forecast 153
    • 10.4.1 US 158
    • 10.4.2 5EU 158
    • 10.4.3 Japan 159

11 Appendix 161

  • 11.1 Bibliography 161
  • 11.2 Abbreviations 178
  • 11.3 Methodology 181
    • 11.3.1 Forecasting Methodology 181
    • 11.3.2 Diagnosed Patients 181
    • 11.3.3 Percent Drug-Treated Patients 182
    • 11.3.4 Drugs Included in Each Therapeutic Class 182
    • 11.3.5 Launch and Patent Expiry Dates 183
    • 11.3.6 General Pricing Assumptions 184
    • 11.3.7 Individual Drug Assumptions 184
    • 11.3.8 Generic Erosion 187
    • 11.3.9 Pricing of Pipeline Agents 187
  • 11.4 Primary Research - KOLs Interviewed for This Report 187
  • 11.5 Primary Research - Prescriber Survey 190
  • 11.6 About the Authors 190
    • 11.6.1 Managing Analyst 190
    • 11.6.2 Analyst 191
    • 11.6.3 Therapy Area Director 191
    • 11.6.4 Epidemiologist 191
    • 11.6.5 Director of Epidemiology 192
    • 11.6.6 Global Director of Therapy Analysis and Epidemiology 192
    • 11.6.7 Global Head of Healthcare 192
  • 11.7 About GlobalData 194
  • 11.8 Contact Us 194
  • 11.9 Disclaimer 195

List of Tables

  • Table 1: Late-Stage Chronic Kidney Disease-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia, Key Metrics in the 7MM 9
  • Table 2: Stages of CKD 20
  • Table 3: Common Comorbidities of CKD and ESRD 21
  • Table 4: Degree of HK 23
  • Table 5: Factors Influencing Renal Potassium Excretion 24
  • Table 6: Factors Influencing Potassium Plasma Levels 24
  • Table 7: Symptoms of CKD 26
  • Table 8: Main Conditions Associated with HPT 26
  • Table 9: Common Diagnostic Tests for CKD and Associated Comorbidities 27
  • Table 10: Common Monitoring Procedures for HPT patients. 28
  • Table 11: Recommended Phosphate Maintenance Levels for CKD Patients 28
  • Table 12: Cardiac Monitoring Recommendations in HK Patients 29
  • Table 13: ECG Changes Indicative of Increasing Serum Potassium Levels 30
  • Table 14: Acute versus Chronic HK 30
  • Table 15: KDIGO Classification of CKD 32
  • Table 16: Risk Factors and Comorbidities for CKD 33
  • Table 17: 7MM, Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages ≥20 Years, N, Selected Years from 2016-2026 47
  • Table 18: 7MM, Diagnosed Prevalent Cases of CKD, Stages I-V, Both Sexes, Ages ≥20 Years, N, Selected Years from 2016-2026 51
  • Table 19: Treatment Guidelines for CKD, HPT 57
  • Table 20: Leading Treatments for HPT and HP, 2016 58
  • Table 21: Treatment Guidelines for CKD, HPT 59
  • Table 22: Interventions for the treatment of acute or chronic HK 60
  • Table 23: Product Profile - Sensipar 65

Table 24: Sensipar SWOT Analysis 67

  • Table 25: Nutritional Vitamin D Sterols 69
  • Table 26: Product Profile - Rayaldee 69

Table 27: Rayaldee SWOT Analysis 70

  • Table 28: Common VDRAs 72
  • Table 29: Product Profile - VDRAs 73

Table 30: Paricalcitol SWOT Analysis 75

  • Table 31: Product Profile - Sevelamer 79

Table 32: Sevelamer SWOT Analysis 81

  • Table 33: Product Profile - Fosrenol 83

Table 34: Fosrenol SWOT Analysis 84

  • Table 35: Product Profile - Velphoro 86

Table 36: Velphoro SWOT Analysis 88

  • Table 37: Product Profile - Auryxia 90

Table 38: Auryxia SWOT Analysis 92

  • Table 39: Product Profile - Resins 93
  • Table 40: Auryxia SWOT Sodium polystyrene sulfonate 95
  • Table 41: Product Profile - Veltassa 96

Table 42: Veltassa SWOT Analysis 98

  • Table 43: Key Late-Stage Pipeline Agents for HPT 119
  • Table 44: Product Profile - Parsabiv 121

Table 45: Etelcalcetide SWOT Analysis 122

  • Table 46: Product Profile - Evocalcet 123

Table 47: Evocalcet SWOT Analysis 124

  • Table 48: Product Profile - DP-001 126

Table 49: DP-001 SWOT Analysis 128

  • Table 50: Product Profile - PT20 130

Table 51: PT20 SWOT Analysis 131

  • Table 52: Product Profile - Tenpanor 133

Table 53: Tenapanor SWOT Analysis 134

  • Table 54: Product Profile - Alpharen 135

Table 55: Alpharen SWOT Analysis 136

  • Table 56: Product Profile - Lokelma 137

Table 57: Lokelma SWOT Analysis 139

  • Table 58: Early Stage Pipeline Products for HPT, HP, and HK. 140
  • Table 59: Clinical Benchmarking of Key Marketed & Pipeline Products (Phosphate binders) 143
  • Table 60: Clinical Benchmarking of Key Marketed and Pipeline Products (calcimimetics) 144
  • Table 61: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols) 145
  • Table 62: Clinical Benchmarking of Key Marketed and Pipeline Products (potassium binders) 146
  • Table 63: Commercial Benchmarking of Key Marketed & Pipeline Products (Phosphate binders) 147
  • Table 64: Commercial Benchmarking of Key Marketed & Pipeline Products (calcimimetics) 148
  • Table 65: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols) 149
  • Table 66: Commercial benchmarking of SOC and newly launched/pipeline potassium binders. 149
  • Table 67: Key Events Impacting Sales for HPT, HP, and HK, 2016-2026 157
  • Table 68: HPT Market - Global Drivers and Barriers, 2016?2026 157
  • Table 69: Key Launch Dates for HPT, HP, and HK 183
  • Table 70: Key Patent Expirations for HPT, HP, and HK 183
  • Table 71: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 190

List of Figures

  • Figure 1: Global Sales Forecast by Country in 2016 and 2026 11
  • Figure 2: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026 12
  • Figure 3: The Pathogenesis of HPT 22
  • Figure 4: The Pathogenesis of HK 25
  • Figure 5: 7MM, Age-Standardized Total Prevalence of CKD, Stages I-IV, Ages ≥20 Years, 2016 35
  • Figure 6: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD Stages I-IV 36
  • Figure 7: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD by Stage 37
  • Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD Stages I-IV 38
  • Figure 9: 7MM, Sources Used to Forecast the Number of CKD Cases on Dialysis 39
  • Figure 10: 7MM, Sources Used to Forecast the Number of New Kidney Transplants 40
  • Figure 11: 7MM, Age-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages ≥20 Years, N, 2016 48
  • Figure 12: 7MM, Sex-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages ≥20 Years, N, 2016 49
  • Figure 13: 7MM, Total Prevalent Cases of CKD by Stage, Both Sexes, Ages ≥20 Years, N, 2016 50
  • Figure 14: 7MM, Diagnosed Prevalent Cases of CKD by Stage, Both Sexes, Ages ≥20 Years, N, 2016 52
  • Figure 15: Unmet Need and Opportunity in CKD 99
  • Figure 16: Overview of the Development Pipeline in CKD-Induced HPT, HP, and HK 118
  • Figure 17: Competitive Assessment of Key Pipeline Phosphate Binders 150
  • Figure 18: Competitive Assessment of Key Pipeline Calcimimetics 151
  • Figure 19: Competitive Assessment of Key Pipeline Vitamin D Sterols 152
  • Figure 20: Competitive Assessment of Key Pipeline Potassium Binders 153
  • Figure 21: Global Sales Forecast by Country in 2016 and 2026 155
  • Figure 22: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026 156
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