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OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecasts to 2026

OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecasts to 2026

Summary

Growth hormone deficiency (GHD) is a rare endocrine disorder characterized by inadequate secretion of growth hormone (GH), also called Somatropin, from the anterior pituitary gland located at the base of the brain (NORD, 2016). It is a heterogeneous disorder that may present in childhood as childhood GHD or later in adult life as adult GHD (AGHD) (Child et al., 2016; Molitch et al., 2011; Yuen, 2016). AGHD can be a progression from childhood, called childhood-onset GHD (COGHD), or start in adulthood, adult-onset GHD (AOGHD). The diagnosis of the disease consists of a number of tests; however, due to the lack of standard diagnostic criteria, the prevalence and incidence data vary widely and diagnosis is often delayed. In children, GHD is mostly identified through growth monitoring and is confirmed by a number of tests including insulin tolerance test (ITT), GH-releasing hormone (GHRH)-arginine test, clonidine stimulation test, glucagon stimulation test, and levodopa stimulation test (Stanley et al., 2012).

It is estimated that the 2016 sales for the GHD market at approximately $1.42B across the seven major pharmaceutical markets (7MM), which contains the US, the five majorEuropean markets (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2026, GlobalData expects the overall market to grow at a moderate Compound Annual Growth Rate (CAGR) of 3.9% to reach sales of $2.08B over the 10-year period.

The US market is anticipated to grow the fastest of the three regions, recording a CAGR of 4.4%, while the 5EU and Japan will each record CAGRs of 2.8% and 2.6%, respectively. At the end of 2026, the US will contribute 69.1% of global sales, while the 5EU and Japan will account for 16.1% and 14.8% of sales, respectively. The higher sales numbers for the US can be attributed mainly to the higher price of pharmaceuticals and the greater diagnosed prevalence of GHD in the country.

Growth Hormone Deficiency (GHD) market is highly fragmented and consists of seven brands of recombinant growth hormones (rGHs) administered as daily injections to patients. Among these drugs, the top four revenue generators for 2016 were Novo Nordisk’s Norditropin, Pfizer’s Genotropin, Eli Lilly’s Humatrope, and EMD/Merck Serono’s Saizen, contributing 48%, 15%, 10% and 10% of global sales, respectively. The forecast period from 2016-2026 will be marked by the expirations of the formulation patents for Norditropin, but this loss of patent exclusivity will not have much effect on the sales of the drug, considering previous trends in the market.

The report OpportunityAnalyzer: Growth Hormone Deficiency - Opportunity Analysis and Forecasts to 2026 provides overview of GHD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

In particular, this report provides the following -

  • Annualized GHD 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 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.
Companies mentioned in this report: Novo Nordisk, Pfizer, Genentech/Roche, Ipsen SA, Eli Lilly, EMD Serono, Ferring, JCR Pharmaceuticals, Sandoz, LG Life Sciences, Biopartners GmbH, OPKO Health, Versartis Inc., Ascendis Pharma, Genexine Inc., Hanmi Pharmaceuticals, Aeterna Zentaris, Aileron Therapeutics, Critical Pharmaceuticals Limited, Emisphere Technologies Inc.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 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 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

    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 GHD therapeutics market.
    • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global 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 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.


    1 Table of Contents 2
    1.1 List of Tables 7
    1.2 List of Figures 7
    2 Growth Hormone Deficiency: Executive Summary 9
    2.1 GHD Market Will Exhibit Moderate Growth Between 2016 and 2026 10
    2.2 Long-Acting Growth Hormones Will Fuel Market Growth and Improve the Treatment Landscape for GHD Patients 12
    2.3 Payer Preferences Heavily Influence Market Shares of GH Drugs in the US 15
    2.4 Disease Awareness and Stringent Regulatory and Insurance Policies Are Major Challenges in the GHD Market 16
    2.5 Opportunities for New Entrants After the Launch of Long-Acting GHs Will Be Low During the Forecast Period 17
    2.6 What Do Physicians Think? 17
    3 Introduction 22
    3.1 Catalyst 22
    3.2 Related Reports 22
    4 Disease Overview 23
    4.1 Etiology and Pathophysiology 24
    4.1.1 Etiology 24
    4.1.2 Pathophysiology 25
    4.2 Symptoms 28
    4.3 Prognosis 29
    4.4 Quality of Life 30
    5 Epidemiology 32
    5.1 Disease Background 32
    5.2 Risk Factors and Comorbidities 33
    5.3 Global and Historical Trends 35
    5.4 GHD in children 36
    5.5 GHD in adults 37
    5.6 Forecast Methodology 37
    5.6.1 Sources 39
    5.6.2 Forecast Assumptions and Methods 42
    5.7 Epidemiological Forecast for GHD (2016-2026) 48
    5.7.1 Diagnosed Prevalent Cases of GHD 48
    5.7.2 Age-Specific Diagnosed Prevalent Cases of GHD 49
    5.7.3 Sex-Specific Diagnosed Prevalent Cases of GHD 50
    5.7.4 Idiopathic and Organic GHD in Children 51
    5.7.5 Congenital and Acquired GHD Out of Organic GHD in Children 52
    5.7.6 Idiopathic and Acquired GHD in Adults 53
    5.7.7 Onset Timing 54
    5.8 Discussion 55
    5.8.1 Epidemiological Forecast Insight 55
    5.8.2 Limitations of Analysis 56
    5.8.3 Strengths of the Analysis 57
    6 Current Treatment Options 58
    6.1 Overview 58
    6.2 Diagnosis and Treatment 58
    6.2.1 Diagnosis 58
    6.2.2 Treatment Guidelines and Leading Prescribed Drugs 63
    6.3 Clinical Practice 64
    6.4 Market Access and Reimbursement 66
    6.5 Product Profiles - Recombinant Human Growth Hormones 70
    6.5.1 Overview 70
    6.5.2 Genotropin 73
    6.5.3 Humatrope 74
    6.5.4 Norditropin 75
    6.5.5 Nutropin AQ 76
    6.5.6 Saizen 76
    6.5.7 Zomacton/Growject 77
    6.5.8 Omnitrope 78
    6.5.9 Valtropin Biosimilar 80
    6.5.10 Efficacy 80
    6.5.11 Safety 81
    6.5.12 SWOT Analysis 82
    6.6 Product Profiles - Long-Acting Recombinant Human Growth Hormones 83
    6.6.1 Somatropin Biopartners (LB-03002) 83
    7 Unmet Needs and Opportunity Assessment 86
    7.1 Overview 86
    7.2 Improved Adherence to Therapy 89
    7.2.1 Unmet Need 89
    7.2.2 Gap Analysis 92
    7.2.3 Opportunity 94
    7.3 Disease Awareness and Physician Education 96
    7.3.1 Unmet Need 96
    7.3.2 Gap Analysis 98
    7.3.3 Opportunity 99
    7.4 Insurance Policies that Impact Patient Access 101
    7.4.1 Unmet Need 101
    7.4.2 Gap Analysis 105
    7.4.3 Opportunity 106
    7.5 Early Diagnosis 108
    7.5.1 Unmet Need 108
    7.5.2 Gap Analysis 110
    7.5.3 Opportunity 111
    7.6 Simpler and Safer Diagnostic Test 113
    7.6.1 Unmet Need 113
    7.6.2 Gap Analysis 115
    7.6.3 Opportunity 116
    7.7 Safer Treatment for Cancer Survivors 116
    7.7.1 Unmet Need 116
    7.7.2 Gap Analysis 118
    7.7.3 Opportunity 119
    7.8 Improved Way of Measuring Adherence 119
    7.8.1 Unmet Need 119
    7.8.2 Gap Analysis 120
    7.8.3 Opportunity 120
    8 R&D Strategies 121
    8.1 Overview 121
    8.1.1 Development of Long-Acting Growth Hormones 121
    8.1.2 Novel Drug Delivery Strategies 122
    8.1.3 Novel Diagnostic Methods 124
    8.1.4 Adherence-Monitoring Electronic Devices 125
    8.1.5 Licensing and Acquisitions 125
    8.2 Clinical Trials Design 126
    8.2.1 Current Clinical Trial Design 126
    8.2.2 Future Clinical Trial Design 128
    9 Pipeline Assessment 132
    9.1 Overview 132
    9.2 Somapacitan (NNC0195-0092) 138
    9.2.1 Overview 138
    9.2.2 Efficacy 141
    9.2.3 Safety 141
    9.2.4 SWOT Analysis 142
    9.3 Lagova (MOD-4023) 142
    9.3.1 Overview 142
    9.3.2 Efficacy 146
    9.3.3 Safety 147
    9.3.4 SWOT Analysis 148
    9.4 Somavaratan (VRS-317) 148
    9.4.1 Overview 148
    9.4.2 Efficacy 151
    9.4.3 Safety 153
    9.4.4 SWOT Analysis 154
    9.5 TransCon Growth Hormone (ACP-001) 154
    9.5.1 Overview 154
    9.5.2 Efficacy 155
    9.5.3 Safety 156
    9.5.4 SWOT Analysis 157
    9.6 Innovative Early-Stage Approaches 157
    10 Pipeline Valuation Analysis 161
    10.1 Clinical Benchmark of Key Pipeline Drugs 161
    10.2 Commercial Benchmark of Key Pipeline Drugs 163
    10.3 Competitive Assessment 165
    10.4 Top-Line 10-Year Forecast 167
    10.4.1 US 174
    10.4.2 5EU 176
    10.4.3 Japan 177
    11 Appendix 180
    11.1 Bibliography 180
    11.2 Abbreviations 196
    11.3 Methodology 200
    11.3.1 Forecasting Methodology 200
    11.3.2 Diagnosed Patients 200
    11.3.3 Percent Drug-Treated Patients 200
    11.3.4 Drugs Included in Each Therapeutic Class 201
    11.3.5 Launch and Patent Expiry Dates 201
    11.3.6 General Pricing Assumptions 201
    11.3.7 Individual Drug Assumptions 202
    11.3.8 Pricing of Pipeline Agents 207
    11.4 Primary Research - KOLs Interviewed for This Report 208
    11.5 Payers Included in This Study 210
    11.6 Primary Research - Prescriber Survey 211
    11.7 About the Authors 212
    11.7.1 Analyst 212
    11.7.2 Therapy Area Director 212
    11.7.3 Epidemiologist 213
    11.7.4 Managing Epidemiologist 213
    11.7.5 Global Director of Therapy Analysis and Epidemiology 213
    11.7.6 Global Head of Healthcare 214
    11.8 About GlobalData 215
    11.9 Contact Us 215
    11.10 Disclaimer 215
    1.1 List of Tables
    Table 1: Growth Hormone Deficiency: Key Metrics in the 7MM 9
    Table 2: Risk Factors and Comorbidities for GHD 34
    Table 3: Diagnosed Prevalent Cases of GHD, Men and Women, All Ages, for 2016-2026. 49
    Table 4: Treatment Guidelines for Growth Hormone Deficiency 63
    Table 5: Approved Drugs for Growth Hormone Deficiency by Class in the Global Markets, 2016 64
    Table 6: Product Profiles of Marketed Daily rGH Hormones for GHD Treatment 72
    Table 7: SWOT Analysis of Marketed Recombinant Human Growth Hormones, 2017 82
    Table 8: Product Profile - Somatropin Biopartners (LB-03002) 85
    Table 9: Unmet Need and Opportunity in Growth Hormone Deficiency, 2017 89
    Table 10: Examples of Pivotal Trials for Approved Treatments for Growth Hormone Deficiency 128
    Table 11: Product Profile - Somapacitan (NNC0195-0092) 140
    Table 12: Somapacitan SWOT Analysis, 2017 142
    Table 13: Product Profile - Lagova (MOD-4023, hGH-CTP) 146
    Table 14: Lagova SWOT Analysis, 2017 148
    Table 15: Product Profile - Somavaratan (VRS-317) 151
    Table 16: Somavaratan SWOT Analysis, 2017 154
    Table 17: Product Profile - TransCon Growth Hormone (ACP-001) 155
    Table 18: TransCon Growth Hormone SWOT Analysis, 2017 157
    Table 19: Innovative Early-Stage Approaches for Growth Hormone Deficiency, 2017 157
    Table 20: Clinical Benchmark of Key Pipeline Drugs - Growth Hormone Deficiency 162
    Table 21: Commercial Benchmark of Key Pipeline Drugs - Growth Hormone Deficiency 165
    Table 22: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, Norditropin 167
    Table 23: Key Events Impacting Sales for Growth Hormone Deficiency, 2016-2026 173
    Table 24: Growth Hormone Deficiency Market - Global Drivers and Barriers, 2016-2026 174
    Table 25: Key Historical and Projected Launch Dates for Growth Hormone Deficiency 201
    Table 26: Key Historical and Projected Patent Expiry Dates for Growth Hormone Deficiency 201
    Table 27: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 211
    1.2 List of Figures
    Figure 1: Global Sales Forecast by Country for Growth Hormone Deficiency in 2016 and 2026 12
    Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, Norditropin 15
    Figure 3: Overview of the GH/IGF-1 Pathway and Physiological Regulation of GH Secretion 27
    Figure 4: GH/IGF-1 Axis and Actions in Bone, Muscle, and Body Metabolism 28
    Figure 5: Age-Standardized Diagnosed Prevalence of GHD, Men and Women, All Ages, 2016 36
    Figure 6: Case Flow Map of GHD 38
    Figure 7: Sources Used and Not Used for the Diagnosed Prevalent Cases of GHD in Children 39
    Figure 8: Sources Used and Not Used in the Forecast for Diagnosed Prevalent Cases of GHD in Adults 39
    Figure 9 Sources Used and Not Used in the Forecast for Type of GHD in Children 40
    Figure 10 Sources Used and Not Used in the Forecast for Type of GHD in Adults 41
    Figure 11 Sources Used and Not Used in the Forecast for Onset Timing of GHD in Adults 42
    Figure 12: Age-Specific Diagnosed Prevalent Cases of GHD, Men and Women, All Ages, 2016 50
    Figure 13: Sex-Specific Diagnosed Prevalent Cases, Men, Women, All Ages, 2016 51
    Figure 14: Diagnosed Prevalent Cases of GHD in Children Segmented into Idiopathic and Organic GHD, Boys and Girls, Ages ≤18 years, 2016. 52
    Figure 15: Diagnosed Prevalent Cases of Congenital or Acquired GHD Out of Organic GHD, Boys and Girls, Ages ≤18 years, 2016 53
    Figure 16: Idiopathic and Acquired GHD in Adults, Men and Women, Ages ≥19 Years, 2016. 54
    Figure 17: Diagnosed Prevalent Cases by Onset Timing, Men and Women, Ages ≥19 Years, 2016. 55
    Figure 18: Growth Hormone Deficiency Treatment Algorithm 66
    Figure 19: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to be Licensed for Growth Hormone Deficiency in the 7MM During the Forecast Period 136
    Figure 20: Global (7MM) Sales Forecast by Country for Growth Hormone Deficiency in 2016 and 2026 171
    Figure 21: Global Sales Forecast by Drugs for Growth Hormone Deficiency, 2016 and 2026 172
    Figure 22: Sales Forecast by Class for Growth Hormone Deficiency in the US, 2016 and 2026 176

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