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Opportunity Analyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecast to 2024

Summary

GlobalData estimates the 2014 sales for growth hormone deficiency (GHD) at approximately $1.26 billion across the 7MM covered in this report. The market will grow moderately at a CAGR of 4.08% during the 10-year forecast period, generating sales of approximately $1.88 billion at the end of 2024. The US market is expected to grow the fastest of the three regions, recording a CAGR of 4.88% and generating around 59% of global sales in 2024. The major driver for this growth across the 7MM will be the launch of long-acting biobetter growth hormones (GH), which will rapidly take away shares from the currently marketed daily injectable growth hormones.

Highlights

Key Questions Answered

- Overall, the greatest unmet need in the GHD space is the issue with treatment adherence and compliance. There are other prominent unmet needs highlighted by the Key Opinion Leaders (KOLs). What are these? Will the pipeline drugs fulfil these unmet needs of the market?
- The 10-year forecast period will mark the launch of six pipeline long-acting GH drugs. How will the sales of the existing drugs be impacted? Which of the pipeline drugs will have the highest peak sales at the highest CAGR, and why?
- What are the roles of payers in this highly competitive disease space? How does this affect market shares of the GH brands, especially in the US? What are the chances of reimbursement for the long-acting GH drugs in pipeline?

Key Findings

- The major driver for growth in the GHD market during the forecast period will be the launch of six long-acting GH biobetters with less frequent dosing regimens. These will not only boost the use of GH, but will in addition increase adherence and compliance in patients.
- KOLs interviewed by GlobalData opined that these long-acting biobetters will eventually replace most of the patient shares of currently marketed GH drugs during the forecast period.
- In other interviews, US payers revealed to GlobalData the current trend of GH manufacturers negotiating with insurance companies as a means of gaining market access for their particular brand.
- Low disease awareness and stringent regulatory policies lead to sub-optimal dosing and treatment outcomes in the Japanese market.
- Companies in the early-stage GHD space demonstrate two major trends – development of long-acting GH formulations and innovation in GH delivery strategies.

Scope

- Overview of GHD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized GHD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the GHD 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 GHD 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

- 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 GHD therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the GHD 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 7MM GHD therapeutics market from 2014-2024.
- 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

Opportunity Analyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecast to 2024
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 15
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Symptoms 22
3.3 Diagnosis 22
3.4 Prognosis 23
3.5 Quality of Life 23
4 Epidemiology 25
4.1 Disease Background 25
4.1.1 GHD in Children 25
4.1.2 GHD in Adults 26
4.2 Risk Factors and Comorbidities 26
4.3 Global Trends 28
4.3.1 GHD in Children 29
4.3.2 GHD in Adults 31
4.4 Forecast Methodology 32
4.4.1 Sources Used 36
4.4.1.1 7MM 36
4.4.1.2 Diagnosed Cases of GHD in Children 37
4.4.1.3 Diagnosed Cases of GHD in Adults 38
4.4.1.4 GHD Etiological Classification in Children 38
4.4.1.5 GHD Etiological Classification in Adults 39
4.4.2 Sources Not Used 40
4.4.3 Forecast Assumptions and Methods 41
4.4.3.1 Temporal Trends 41
4.4.3.2 Sex-Specific Trends 41
4.4.3.3 Diagnosed Prevalent Cases of GHD in Children 41
4.4.3.4 Diagnosed Prevalent Cases of GHD in Adults 42
4.4.3.5 GHD Etiological Classification in Children 43
4.4.3.6 GHD Etiological Classification in Adults 43
4.5 Epidemiological Forecast of GHD (2014-2024) 44
4.5.1 Diagnosed Prevalent Cases of GHD 44
4.5.2 Diagnosed Prevalent Cases of GHD by Sex 46
4.5.3 Diagnosed Prevalent Cases of GHD by Age 47
4.5.3.1 Diagnosed Prevalent Cases of GHD in Children 47
4.5.3.2 Diagnosed Prevalent Cases of GHD in Adults 49
4.5.4 Age-Adjusted Diagnosed Prevalence of GHD 50
4.5.5 Diagnosed Prevalent Cases of GHD in Children by Etiological Classification 51
4.5.6 Diagnosed Prevalent Cases of GHD in Adults by Etiological Classification 52
4.6 Discussion 53
4.6.1 Epidemiological Forecast Insight 53
4.6.2 Limitations of the Analysis 54
4.6.3 Strengths of the Analysis 55
5 Competitive Assessment 56
5.1 Overview 56
5.2 Treatment Algorithm 56
5.3 Market Access, Reimbursement, and Clinical Practice 58
5.4 Product Profiles — Recombinant Human Growth Hormones 60
5.4.1 Overview 60
5.4.1.1 Genotropin 61
5.4.1.2 Humatrope 62
5.4.1.3 Norditropin 62
5.4.1.4 Nutropin AQ 63
5.4.1.5 Saizen 64
5.4.1.6 Tev-Tropin/Zomacton/Growject 64
5.4.1.7 Omnitrope Biosimilar 65
5.4.2 Efficacy 68
5.4.2.1 Pediatric GHD 68
5.4.2.2 Adult GHD 68
5.4.3 Safety 69
5.4.3.1 Pediatric GHD 69
5.4.3.2 Adult GHD 69
5.4.4 SWOT Analysis 70
6 Unmet Needs Assessment and Opportunity Analysis 71
6.1 Overview 71
6.2 Improved Adherence and Compliance 72
6.2.1 Unmet Needs 72
6.2.2 Gap Analysis 74
6.2.3 Opportunity 74
6.3 Early Diagnosis 75
6.3.1 Unmet Needs 75
6.3.2 Gap Analysis 75
6.3.3 Opportunity 76
6.4 Disease Awareness and Regulatory Policy in Japan 76
6.4.1 Unmet Needs 76
6.4.2 Gap Analysis 77
6.4.3 Opportunity 77
6.5 Insurance Policies that Impact Patient Access 78
6.5.1 Unmet Needs 78
6.5.2 Gap Analysis 79
6.5.3 Opportunity Analysis 79
6.6 Safer Treatments for Cancer Survivors 79
6.6.1 Unmet needs 79
6.6.2 Gap Analysis 80
6.6.3 Opportunity Analysis 80
7 RandD Strategies 81
7.1 Overview 81
7.1.1 Development of Long-Acting Biobetter Growth Hormones 81
7.1.2 Novel Drug Delivery Strategies 82
7.1.3 Targeting the Growth Hormone Releasing Hormone 83
7.1.4 Licensing and Acquisitions 83
7.2 Clinical Trial Design 84
7.2.1 Current Clinical Trial Design 84
7.2.2 Future Clinical Trial Design 85
8 Pipeline Assessment 88
8.1 Overview 88
8.2 Promising Drugs in Clinical Development 89
8.2.1 Somatropin Biopartners 91
8.2.1.1 Overview 91
8.2.1.2 Efficacy 92
8.2.1.3 Safety 92
8.2.1.4 SWOT Analysis 93
8.2.2 NNC0195-0092 93
8.2.2.1 Overview 93
8.2.2.2 Efficacy 95
8.2.2.3 Safety 95
8.2.2.4 SWOT Analysis 95
8.2.3 MOD-4023 96
8.2.3.1 Overview 96
8.2.3.2 Efficacy 97
8.2.3.3 Safety 97
8.2.3.4 SWOT Analysis 98
8.2.4 VRS-317 98
8.2.4.1 Overview 98
8.2.4.2 Efficacy 99
8.2.4.3 Safety 99
8.2.4.4 SWOT Analysis 100
8.2.5 ACP-001 100
8.2.5.1 Overview 100
8.2.5.2 Efficacy 101
8.2.5.3 Safety 101
8.2.5.4 SWOT Analysis 102
8.2.6 TV-1106 102
8.2.6.1 Overview 102
8.2.6.2 Efficacy 103
8.2.6.3 Safety 103
8.2.6.4 SWOT Analysis 104
8.3 Innovative Early-Stage Approaches 104
9 Pipeline Valuation Analysis 107
9.1 Clinical Benchmark of Key Pipeline Drugs 107
9.2 Commercial Benchmark of Key Pipeline Drugs 109
9.3 Competitive Assessment 112
9.4 Top Line Ten Year Forecast 113
9.4.1 US 118
9.4.2 5EU 119
9.4.3 Japan 120
10 Appendix 122
10.1 Bibliography 122
10.2 Abbreviations 130
10.3 Methodology 133
10.4 Forecasting Methodology 133
10.4.1 Diagnosed GHD patients 133
10.4.2 Percent Drug-Treated Patients 133
10.4.3 Drugs Included in Each Therapeutic Class 134
10.4.4 Launch and Patent Expiry Dates 134
10.4.5 General Pricing Assumptions 135
10.4.6 Individual Drug Assumptions 136
10.4.7 Pricing of Pipeline agents 139
10.5 Physicians Included in This Study 141
10.6 Payers Included in This Study 142
10.7 Primary Research - Prescriber Survey 143
10.8 About the Authors 144
10.8.1 Analyst 144
10.8.2 Epidemiologist 144
10.8.3 Therapy Director - CVMD 145
10.8.4 Global Head of Healthcare 145
10.9 About GlobalData 146
10.10 Disclaimer 146

1.1 List of Tables
Table 1: Risk Factors for GHD 27
Table 2: 7MM, Sources for the Diagnosed Cases of GHD in Children 33
Table 3: 7MM, Sources for the Prevalent Cases of GHD Diagnosed in Adults 34
Table 4: 7MM, Sources for the Etiological Classifications of Diagnosed Prevalent Cases of GHD in Children 35
Table 5: 7MM, Sources for the Etiological Classifications of Diagnosed Prevalent Cases of GHD in Adults 36
Table 6: 7MM, Diagnosed Prevalent Cases of GHD, All Ages, Both Sexes, N, Selected Years 2014-2024 45
Table 7: 7MM, Diagnosed Prevalent Cases of GHD by Sex, Children and Adults, N (Row %), 2014 46
Table 8: 7MM, Diagnosed Prevalent Cases of GHD in Children, Both Sexes, Ages ?18 Years, N,Selected Years 2014-2024 48
Table 9: 7MM, Diagnosed Prevalent Cases of GHD in Adults, Both Sexes, Ages >18 Years, N, Selected Years 2014-2024 49
Table 10: 7MM, Diagnosed Prevalent Cases of GHD by Etiological Classification, N (Col %), Both Sexes, Ages ?18, 2014 52
Table 11: 7MM, Diagnosed Prevalent Cases of GHD in Adults by Etiological Classification, N (Row %), Both Sexes, Ages >18, 2014 53
Table 12: GHD Treatment Guidelines Available 57
Table 13: Leading Treatments for GHD 58
Table 14: Product Profiles of Marketed Recombinant Growth Hormones for GHD Treatment 67
Table 15: SWOT Analysis of Marketed Recombinant Human Growth Hormones, 2014 70
Table 16: Unmet Needs in GHD 72
Table 17: Examples of Pivotal Trials for Approved Treatments for Growth Hormone Deficiency 85
Table 18: Growth Hormone Deficiency — Late Stage Pipeline, 2014 89
Table 19: Product Profile — Somatropin Biopartners 92
Table 20: Somatropin Biopartners SWOT Analysis, 2015 93
Table 21: Product Profile — NNC0195-0092 94
Table 22: NNC0195-0092 SWOT Analysis, 2015 95
Table 23: Product Profile — MOD-4023 97
Table 24: MOD-4023 SWOT Analysis, 2015 98
Table 25: Product Profile — VRS-317 99
Table 26: VRS-317 SWOT Analysis, 2015 100
Table 27: Product Profile — ACP-001 101
Table 28: ACP-001 SWOT Analysis, 2015 102
Table 29: Product Profile — TV-1106 103
Table 30: TV-1106 SWOT Analysis, 2015 104
Table 31: Early-Stage Pipeline Products in GHD 104
Table 32: Clinical Benchmark of Key Pipeline Drugs for GHD 108
Table 33: Clinical Benchmark of Key Pipeline Drugs for GHD (Cont.) 108
Table 34: Commercial Benchmark of Key Pipeline Drugs for GHD 110
Table 35: Commercial Benchmark of Key Pipeline Drugs for GHD (Cont.) 111
Table 36: Top Line Sales Forecasts ($m) for GHD, 2014-2024 115
Table 37: Key Events Impacting Sales for GHD, 2014-2024 117
Table 38: Growth Hormone Deficiency Market — Drivers and Barriers, 2014-2024 118
Table 39: Key Launch Dates 134
Table 40: Key Patent Expiration Dates 135
Table 41: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 143

1.2 List of Figures
Figure 1: Overview of the GH/IGF-1 Pathway and Physiological Regulation of GH Secretion 21
Figure 2: 7MM, Diagnosed Prevalence of GHD in Children, Both Sexes, Ages ?18 Years 30
Figure 3: 7MM, Diagnosed Prevalence of GHD in Adults, Both Sexes, Ages >18 Years 31
Figure 4: Case-Flow for GHD Epidemiological Forecast 33
Figure 5: 7MM, Diagnosed Prevalent Cases of GHD, Both Sexes, All Ages, N, 2014-2024 45
Figure 6: 7MM, Age-Specific Diagnosed Prevalent Cases of GHD, Both Sexes, Ages ?18 Years, 2014 48
Figure 7: 7MM, Age-Specific Diagnosed Prevalent Cases of GHD, Both Sexes, Ages >18 Years, 2014 50
Figure 8: 7MM, Age-Standardized Diagnosed Prevalence of GHD, All Ages, by Sex, 2014 51
Figure 9: GHD Treatment Algorithm 57
Figure 10: Competitive Assessment of Key Pipeline Drugs for GHD, 2014-2024 112
Figure 11: Sales for GHD in the US, 5EU, and Japan, 2014-2024 116

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