GlobalData estimates the 2013 sales for acromegaly and gigantism at approximately $588m across the 6MM covered in this report. The market will grow moderately at a CAGR of 3.74% during the five year forecast period, generating sales of approximately $707m at the end of 2018. Growing at a CAGR of 4.58% and generating around 68% of global sales in 2018, the US market will experience twice the rate of growth of the 5EU market. Two major trends are visible among the pipeline drugs and research and development (R&D) strategies employed by companies in this chronic disease space a focus towards the treatment of refractory patients and the improvement of drug delivery mechanisms to increase patient convenience.

Highlights

Key Questions Answered

• Although the standard treatments are effective in most patients, a growing number of patients are being discovered who remain uncontrolled by current therapy. Treatment of this patient segment presents a major unmet need in this market. 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 five-year forecast period will mark the patent expirations of the major branded drugs in this market and the launch of three pipeline agents. 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 major R&D strategies employed by companies in this disease space? What do KOLs think of these strategies? What are other opportunities for new entrants seeking to enter this market?

Key Findings

• One of the main drivers of the acromegaly and gigantism market during the forecast period will be the increased use of somatostatin analogs with better administration or dosing regimens; due to the recent focus on improving patient convenience for this chronic disease area.
• Another strong driver will be the treatment of refractory patient segments, which will lead to an overall increase in the drug treatment rate.
• Greater disease awareness and management of comorbidities are two of the biggest unmet needs in this market.
• Variation in clinical trial methodologies have hindered direct comparison of drug efficacy rates. Trial design needs to be improved by incorporating more randomized, head-to-head, prospective studies.
• The dominant trend among the pipeline drugs is towards development of novel drug delivery methods, rather than the exploration of new mechanisms of action.

Scope

• Overview of acromegaly and gigantism, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
• Annualized acromegaly and gigantism therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for five years to 2018.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the acromegaly and gigantism 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 acromegaly and gigantism 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 acromegaly and gigantism therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the acromegaly and gigantism 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 6MM acromegaly and gigantism therapeutics market from 2013-2018.
• 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 10
1.1 List of Tables 14
1.2 List of Figures 16

2 Introduction 17
2.1 Catalyst 17
2.2 Upcoming Related Reports 18

3 Disease Overview 19
3.1 Etiology and Pathophysiology 20
3.1.1 Etiology 20
3.1.2 Pathophysiology 21
3.2 Symptoms 22
3.3 Prognosis 23
3.4 Quality of Life 23

4 Epidemiology 25
4.1 Disease Background 25
4.2 Risk Factors and Comorbidities 25
4.3 Global Trends 27
4.4 Forecast Methodology 28
4.4.1 Sources Used 29
4.4.2 Sources Not Used 34
4.4.3 Forecast Assumptions and Methods 36
4.5 Epidemiological Forecast for Acromegaly (2013-2023) 46
4.5.1 Diagnosed Prevalent Cases of Acromegaly 46
4.5.2 Age-Specific Diagnosed Prevalent Cases of Acromegaly 48
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Acromegaly 49
4.5.4 Age-Standardized Diagnosed Prevalence of Acromegaly 51
4.6 Epidemiological Forecast for Gigantism (2013-2023) 52
4.6.1 Diagnosed Prevalent Cases of Gigantism 52
4.6.2 Age-Specific Diagnosed Prevalent Cases of Gigantism 54
4.6.3 Sex-Specific Diagnosed Prevalent Cases of Gigantism 55
4.6.4 Age-Standardized Diagnosed Prevalence of Gigantism 57
4.7 Epidemiological Forecast for Acromegaly and Gigantism with Macroadenomas, Microadenomas, and Cases Receiving Any Surgical Treatment (2013-2023) 58
4.7.1 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Macroadenomas 58
4.7.2 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Microadenomas 59
4.7.3 Diagnosed Prevalent Cases of Acromegaly and Gigantism Receiving Any Surgical Treatment 60
4.8 Discussion 61
4.8.1 Epidemiological Forecast Insight 61
4.8.2 Limitations of the Analysis 62
4.8.3 Strengths of the Analysis 63

5 Current Treatment Options 64
5.1 Disease Diagnosis 64
5.2 Criteria for Cure and Treatment Goals 65
5.3 Treatment Overview 65
5.4 Clinical Practice 70
5.5 Product Profiles - Somatostatin Analogs 71
5.5.1 Sandostatin SC and Sandostatin LAR Depot (Octreotide Acetate) 71
5.5.2 Somatuline LA and Somatuline Depot (Lanreotide Acetate) 77
5.6 Product Profile - Growth Hormone Receptor Antagonists 81
5.6.1 Somavert (Pegvisomant) 81
5.7 Product Profiles - Dopamine Agonists 87
5.7.1 Cabergoline and Bromocriptine (Widely Genericized) 87

6 Unmet Needs Assessment and Opportunity Analysis 89
6.1 Overview 89
6.2 Improved Efficacy and Safety 90
6.2.1 Unmet Needs 90
6.2.2 Gap Analysis 91
6.2.3 Opportunity 92
6.3 Treatment of Comorbidities 92
6.3.1 Unmet Needs 92
6.3.2 Gap Analysis 93
6.3.3 Opportunity 94
6.4 Physician and Patient Education 94
6.4.1 Unmet Needs 94
6.4.2 Gap Analysis 95
6.4.3 Opportunity Analysis 96
6.5 Improvement in Assay Standardization 96
6.5.1 Unmet Needs 96
6.5.2 Gap Analysis 97
6.5.3 Opportunity Analysis 98

7 R&D Strategies 99
7.1 Overview 99
7.1.1 Targeting Refractory Patients by Improving Existing Drug Classes 99
7.1.2 Novel Drug Delivery Strategies 100
7.1.3 Reformulation Strategies to Reduce Dosing Frequency 101
7.1.4 Licensing and Acquisitions 102
7.2 Clinical Trial Design 102
7.2.1 Current Clinical Trial Design 103
7.2.2 Future Clinical Trial Design 105

8 Pipeline Assessment 106
8.1 Overview 106
8.2 Promising Drugs in Clinical Development 107
8.2.1 Signifor LAR (Pasireotide) 108
8.2.2 Oral Octreotide (Octreotide Acetate) 112
8.2.3 ATL1103 117
8.3 Other Phase III Trials 120
8.4 Innovative Early-Stage Approaches 121

9 Pipeline Valuation Analysis 124
9.1 Clinical Benchmark of Key Pipeline Drugs 124
9.2 Commercial Benchmark of Key Pipeline Drugs 125
9.3 Competitive Assessment 126
9.4 Top-Line Five-Year Forecast 129
9.4.1 US 133
9.4.2 5EU 134

10 Appendix 136
10.1 Bibliography 136
10.2 Abbreviations 146
10.3 Methodology 149
10.4 Forecasting Methodology 149
10.4.1 Diagnosed Acromegaly and Gigantism Patients 149
10.4.2 Percent of Drug-Treated Patients 150
10.4.3 Drugs Included in Each Therapeutic Class 150
10.4.4 Launch and Patent Expiry Dates 150
10.4.5 General Pricing Assumptions 151
10.4.6 Individual Drug Assumptions 152
10.4.7 Generic Erosion 154
10.4.8 Pricing of Pipeline Agents 155
10.5 Physicians and Specialists Included in this Study 156
10.6 About the Authors 157
10.6.1 Analyst 157
10.6.2 Epidemiologist 157
10.6.3 Therapy Director - CVMD 158
10.6.4 Global Head of Healthcare 158
10.7 About GlobalData 159
10.8 Disclaimer 159

List of Tables

Table 1: Risk Factors and Comorbidities for Acromegaly and Gigantism 26
Table 2: Summary of the Global Reported Cases and Estimated Prevalence of Acromegaly 28
Table 3: Global Consensus Criteria for the Diagnosis and Cure of Acromegaly 29
Table 4: Sources of Acromegaly and Gigantism Prevalence Data in the 6MM 29
Table 5: Sources of Macroadenoma, Microadenoma, and Surgery Data in the 6MM 30
Table 6: 6MM, Diagnosed Prevalent Cases of Acromegaly, Both Sexes, Ages ≥15 Years, N, 2013-2023 47
Table 7: 6MM, Age-Specific Diagnosed Prevalent Cases of Acromegaly, Both Sexes, N (Row %), 2013 48
Table 8: 6MM, Sex-Specific Diagnosed Prevalent Cases of Acromegaly, Ages ≥15 Years, N (Row %), 2013 50
Table 9: 6MM, Diagnosed Prevalent Cases of Gigantism, Both Sexes, All Ages, N, 2013-2023 53
Table 10: 6MM, Age-Specific Diagnosed Prevalent Cases of Gigantism, Both Sexes, N (Row %), 2013 54
Table 11: 6MM, Sex-Specific Diagnosed Prevalent Cases of Gigantism, All Ages, N (Row %), 2013 56
Table 12: Leading Treatments for Acromegaly 67
Table 13: Comparative Assessment of Leading Pharmacological Drug Treatments for Acromegaly 71
Table 14: Product Profile - Sandostatin SC and Sandostatin LAR Depot 74
Table 15: Sandostatin LAR Depot SWOT Analysis, 2014 76
Table 16: Product Profile - Somatuline LA and Somatuline Depot 79
Table 17: Somatuline Depot SWOT Analysis, 2014 81
Table 18: Product Profile - Somavert 84
Table 19: Somavert SWOT Analysis, 2014 86
Table 20: Unmet Needs in Acromegaly 90
Table 21: Examples of Pivotal Trials for Approved Treatments for Acromegaly 104
Table 22: Acromegaly - Late-Stage Pipeline, 2014 107
Table 23: Product Profile - Signifor LAR 110
Table 24: Signifor LAR SWOT Analysis, 2014 112
Table 25: Product Profile - Oral Octreotide 115
Table 26: Oral Octreotide SWOT Analysis, 2014 116
Table 27: Product Profile - ATL1103 118
Table 28: ATL1103 SWOT Analysis, 2014 120
Table 29: Early-Stage Pipeline Products in Acromegaly 121
Table 30: Clinical Benchmark of Signifor LAR and Oral Octreotide 124
Table 31: Clinical Benchmark of ATL1103 125
Table 32: Commercial Benchmark of Signifor LAR and Oral Octreotide 125
Table 33: Commercial Benchmark of ATL1103 126
Table 34: Top-Line Sales Forecasts ($m) for Acromegaly and Gigantism, 2013-2018 131
Table 35: Key Events Impacting Sales for Acromegaly and Gigantism, 2013-2018 132
Table 36: Acromegaly and Gigantism Market - Drivers and Barriers, 2013-2018 132
Table 37: Key Launch Dates 150
Table 38: Key Patent Expiries 151

List of Figures

Figure 1: Overview of GH/IGF-1 Pathway and Targets of Medical Therapy for Acromegaly and Gigantism 21
Figure 2: 6MM, Diagnosed Prevalent Cases of Acromegaly, Both Sexes, Ages ≥15 Years, N, 2013-2023 47
Figure 3: 6MM, Age-Specific Diagnosed Prevalent Cases of Acromegaly, Both Sexes, Ages ≥15 Years, N, 2013 49
Figure 4: 6MM, Sex-Specific Diagnosed Prevalent Cases of Acromegaly, Ages ≥15 Years, N, 2013 50
Figure 5: 6MM, Age-Standardized Diagnosed Prevalence of Acromegaly (Cases per Million Population), Ages ≥15 Years, by Sex, 2013 52
Figure 6: 6MM, Diagnosed Prevalent Cases of Gigantism, Both Sexes, All Ages, N, 2013-2023 53
Figure 7: 6MM, Age-Specific Diagnosed Prevalent Cases of Gigantism, Both Sexes, All Ages, N, 2013 55
Figure 8: 6MM, Sex-Specific Diagnosed Prevalent Cases of Gigantism, All Ages, N, 2013 56
Figure 9: 6MM, Age-Standardized Diagnosed Prevalence of Gigantism (Cases per Million Population), All Ages, by Sex, 2013 57
Figure 10: 6MM, Diagnosed Prevalent Cases of Acromegaly (Ages ≥15 Years) and Gigantism (All Ages) with Macroadenomas, Both Sexes, N, 2013 and 2023 58
Figure 11: 6MM, Diagnosed Prevalent Cases of Acromegaly (Ages ≥15 Years) and Gigantism (All Ages) with Microadenomas, Both Sexes, N, 2013 and 2023 59
Figure 12: 6MM, Diagnosed Prevalent Cases of Acromegaly (Ages ≥15 Years) and Gigantism (All Ages) Receiving Any Surgical Treatment, Both Sexes, N, 2013 and 2023 60
Figure 13: Acromegaly Treatment Management 66
Figure 14: Pharmacological Therapy Management in Acromegaly 68
Figure 15: Competitive Assessment of Signifor LAR and Oral Octreotide, 2013-2018 128
Figure 16: Competitive Assessment of ATL1103, 2013-2018 129
Figure 17: Sales for the Acromegaly and Gigantism Market in the US and 5EU, 2013-2018 131