1. Market Research
  2. > Pharmaceutical
  3. > Therapy Market Trends
  4. > OpportunityAnalyzer: Cushing’s Syndrome - Opportunity Analysis and Forecasts to 2018

OpportunityAnalyzer: Cushing’s Syndrome - Opportunity Analysis and Forecasts to 2018

Summary

GlobalData estimates that the 2013 sales for the Cushing’s syndrome (CS) therapeutic market was approximately $179m across the 6MM covered in this report. Pharmaceutical and biotechnology companies that are investing their attention, time, and financial resources in the CS field, have adopted a myriad of research and development (R&D) strategies. One notable example is the fact that drug developers are focused on developing superior, next-generation inhibitors of cortisol synthesis in the adrenal glands. Steroidogenesis inhibitors were responsible for approximately 28% of total drug sales in the 6MM in 2013, equating to around $50m. As a consequence of this trend, GlobalData expects overall revenues generated by this drug class to increase by approximately 390% to reach around $247m, encompassing 49% of total drug sales in the 6MM in 2018. The expansion in this segment of the CS market is fuelled by the introduction of premium-priced pharmacological agents such as Novartis’ LCI699 and Cortendo AB’s NormoCort (COR-003) in the US, as well as the arrival of HRA Pharma’s Ketoconazole HRA (ketoconazole) to the European CS stage. One of the greatest unmet needs in this indication is a lack of effective drugs directed against the underlying cause of Cushing’s disease (the pituitary tumor). Despite this demand, pharmaceutical companies are continuing to adopt a strategy that simply targets the adrenal glands. As a result, there is a vast amount of room for new or existing players to penetrate the market and capture considerable patient share.

Highlights

Key Questions Answered

- Although the current standard of care (ketoconazole) is cheap and reasonably effective in most CS patients, it possesses worrying safety profiles, inconvenient dosing schedules, is difficult to obtain and can display waning efficacy over time. Newer medical treatments, for example, Novartis’ Signifor (pasireotide) and Corcept Therapeutics’ Korlym (mifepristone) address only some of these issues; yet, present their own limitations. The CS market is still marked by the existence of a multitude of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the CS market?
- The late-stage CS pipeline is sparsely populated; however, those drugs in development will be a strong driver of CS market growth. Which of these drugs will attain high sales revenues during 2013-2018? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

Key Findings

- One of the main drivers influencing growth in the Cushing’s syndrome market will be the introduction of second-generation steroidogenesis inhibitors, LCI699 and NormoCort (COR-003), in the US, which will rival existing standard of care medical treatments.
- Another strong driver will be the arrival of Corcept Therapeutics’ Korlym (mifepristone) and HRA Pharma’s Ketoconazole HRA (ketoconazole) to the European CS market. Both drugs will stimulate significant growth here.
- The launch of Novartis’ Signifor LAR (pasireotide) in the 6MM will equip physicians with a less frequently administered formulation of Signifor.
- Reasons for inadequate CS treatment include poor physician awareness of the condition, delayed diagnosis, a lack of efficacious drugs for individuals suffering from severe hypersecretion, and a shortage of effective medicines targeting the source of Cushing's disease.

Scope

- Overview of Cushing’s syndrome, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized Cushing’s syndrome therapeutics market revenues, annual cost of therapies 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 Cushing’s syndrome 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 Cushing’s syndrome 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 Cushing’s syndrome therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Cushing’s syndrome 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.
- Track drug sales in the 6MM Cushing’s syndrome 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

OpportunityAnalyzer: Cushing’s Syndrome - Opportunity Analysis and Forecasts to 2018
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 19
3.2 Prognosis 21
3.3 Quality of Life 22
3.4 Symptoms 23
3.5 Diagnosis 25
4 Epidemiology 30
4.1 Disease Background 30
4.2 Risk Factors and Comorbidities 31
4.3 Global Trends 32
4.3.1 US 32
4.3.2 5EU 32
4.4 Forecast Methodology 33
4.4.1 Sources Used 36
4.4.2 Sources Not Used 38
4.4.3 Forecast Assumptions and Methods - Prevalent Cases 39
4.4.4 Forecast Assumptions and Methods - Immediate TSS Outcomes 40
4.5 Epidemiological Forecast for Cushing's Syndrome (2013-2023) 40
4.5.1 Cushing's Syndrome 40
4.5.2 Cushing's Disease 46
4.5.3 Ectopic Adrenocorticotropic Hormone Cushing's Syndrome 51
4.5.4 Adrenal Adenoma Cushing's Syndrome 57
4.5.5 Adrenal Carcinoma Cushing's Syndrome 62
4.5.6 Age-Standardized Diagnosed Prevalence Rates 67
4.5.7 Immediate Transsphenoidal Adenomectomy Surgery Outcomes 69
4.6 Discussion 70
4.6.1 Epidemiological Forecast Insight 70
4.6.2 Limitations of the Analysis 71
4.6.3 Strengths of the Analysis 72
5 Current Treatment Options 73
5.1 Overview 73
5.2 Treatment Approach 74
5.3 Product Profiles - Major Brands 78
5.3.1 Signifor (pasireotide) and Signifor LAR (pasireotide) 78
5.3.2 Korlym (mifepristone) 87
5.3.3 Ketoconazole and Ketoconazole HRA (ketoconazole) 96
5.3.4 Metopirone (metyrapone) 103
5.3.5 Lysodren (mitotane) 109
6 Unmet Needs Assessment and Oppportunity Analysis 114
6.1 Overview 114
6.2 Unmet Needs Analysis 115
6.2.1 Unmet Need: Effective Drugs Directed against the Underlying Cause of Cushing's Disease 115
6.2.2 Unmet Need: Few Drugs - Especially Those for Severe Cushing's Syndrome - Possess Favorable Safety and Efficacy 116
6.2.3 Unmet Need: Physician Awareness of Cushing's Syndrome Symptomatology 118
6.2.4 Unmet Need: Accelerated Referral Systems to Specialists in Secondary and Tertiary Care Settings 119
6.2.5 Unmet Need: Uniform Guidelines Unambiguously Defining Treatment and Remission 121
6.3 Opportunity Analysis 121
6.3.1 Opportunity: Development of Improved Adrenocorticotropic Hormone Modulator Drugs 121
6.3.2 Opportunity: Reformulation of the Steroidogenic Inhibitors into Longer-Acting Release Treatments 122
6.3.3 Opportunity: Development of Universally Accepted Tests and Measures for Better Diagnosis and Monitoring of Cushing's Syndrome Activity and Treatment Response 122
6.3.4 Opportunity: Prospective, Randomized Trials for Off-Label Cushing's Syndrome Agents 123
6.3.5 Opportunity: Gaining Understanding of the Pathophysiology of Cushing's Syndrome 124
7 Research and Development Strategies 125
7.1 Overview 125
7.1.1 Inhibitors of Cortisol Synthesis in the Adrenal Glands 125
7.1.2 Licensing Agreements, Partnerships, and Alliances 126
7.1.3 Secondary Indications 127
7.2 Clinical Trial Design 128
7.2.1 Selecting Suitable Comparator Arms 128
7.2.2 Evaluating and Determining Appropriate Clinical Trial Endpoints 129
7.2.3 Accurately Representing the Patient Population in Clinical Trials 131
8 Pipeline Assessment 135
8.1 Overview 135
8.2 Promising Drugs in Clinical Development 135
8.2.1 NormoCort (COR-003) 136
8.2.2 LCI699 141
8.3 Innovative Early-Stage Approaches 146
8.3.1 Somatoprim (DG3173) 147
8.3.2 Anti-Sense Technology and RNA Interference 147
8.3.3 Retinoic Acid 148
8.3.4 Other Early-Stage Approaches and Non-Pharmacotherapies 149
9 Pipeline Valuation Analysis 151
9.1 Clinical Benchmark of Key Pipeline Drugs 151
9.2 Commercial Benchmark of Key Pipeline Drugs 153
9.3 Competitive Assessment 154
9.4 Top-Line Five-Year Forecast 156
9.4.1 US 158
9.4.2 5EU 159
10 Appendix 161
10.1 Bibliography 161
10.2 Abbreviations 178
10.3 Methodology 180
10.4 Forecasting Methodology 180
10.4.1 Diagnosed Cushing's Syndrome Patients 180
10.4.2 Percent Drug-Treated Patients 181
10.4.3 Drugs Included in Each Therapeutic Class 181
10.4.4 Launch and Patent Expiry Dates 182
10.4.5 General Pricing Assumptions 183
10.4.6 Individual Drug Assumptions 183
10.4.7 Pricing of Pipeline agents 187
10.5 Physicians and Specialists Included in This Study 189
10.6 About the Authors 190
10.6.1 Analyst 190
10.6.2 Therapy Director 190
10.6.3 Epidemiologist 191
10.6.4 Global Head of Healthcare 192
10.7 About GlobalData 193
10.8 Disclaimer 193

1.1 List of Tables
Table 1: Various Subtypes of Endogenous Cushing's Syndrome 19
Table 2: Symptoms of Cushing's Syndrome 25
Table 3: Risk Factors for Cushing's Syndrome 32
Table 4: 6MM, Sources of CS Prevalence Data 34
Table 5: 6MM, Diagnosed Prevalent Cases of CS, Ages ?18 Years, Both Sexes, N, Selected Years 2013-2023 41
Table 6: 6MM, Age-Specific Diagnosed Prevalent Cases of CS, Both Sexes, N (Row %), 2013 43
Table 7: 6MM, Sex-Specific Diagnosed Prevalent Cases of CS, Ages ?18 Years, N (Row %), 2013 45
Table 8: 6MM, Diagnosed Prevalent Cases of Cushing's Disease, Ages ?18 Years, Both Sexes, N, Selected Years 2013-2023 47
Table 9: 6MM, Age-Specific Diagnosed Prevalent Cases of Cushing's Disease, Both Sexes, N (Row %), 2013 48
Table 10: 6MM, Sex-Specific Diagnosed Prevalent Cases of Cushing's Disease, Ages ?18 Years, N (Row %), 2013 50
Table 11: 6MM, Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ?18 Years, Both Sexes, N, Selected Years 2013-2023 52
Table 12: 6MM, Age-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Both Sexes, N (Row %), 2013 54
Table 13: 6MM, Sex-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ?18 Years, N (Row %), 2013 56
Table 14: 6MM, Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ?18 Years, Both Sexes, N, Selected Years 2013-2023 58
Table 15: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Both Sexes, N (Row %), 2013 59
Table 16: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ?18 Years, N (Row %), 2013 61
Table 17: 6MM, Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ?18 Years, Both Sexes, N, Selected Years 2013-2023 63
Table 18: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Both Sexes, N (Row %), 2013 64
Table 19: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ?18 Years, N (Row %), 2013 66
Table 20: 6MM, Immediate TSS Outcomes, Both Sexes, N, 2013 70
Table 21: Leading Pharmacological Treatments for Cushing's Syndrome 77
Table 22: Product Profile - Signifor 82
Table 23: Signifor SWOT Analysis 86
Table 24: Product Profile - Korlym 91
Table 25: Korlym SWOT Analysis 95
Table 26: Product Profile - Nizoral 100
Table 27: Ketoconazole SWOT Analysis 102
Table 28: Product Profile - Metopirone 106
Table 29: Metopirone SWOT Analysis 108
Table 30: Product Profile - Lysodren 111
Table 31: Lysodren SWOT Analysis 113
Table 32: Overall Unmet Needs - Current Level of Attainment 114
Table 33: Clinical Trial Design of Key Marketed and Pipeline Drugs for Cushing's Syndrome, August 2014 133
Table 34: Cushing's Syndrome - Late Stage Pipeline, 2014 135
Table 35: Product Profile - NormoCort (COR-003) 138
Table 36: NormoCort (COR-003) SWOT Analysis 140
Table 37: Product Profile - LCI699 143
Table 38: LCI699 SWOT Analysis 145
Table 39: Early-Stage Pipeline Products in Cushing's Syndrome 146
Table 40: Clinical Benchmark of Key Pipeline Drugs 152
Table 41: Commercial Benchmark of Key Pipeline Drugs 153
Table 42: Top-Line Sales Forecasts ($) for Cushing's Syndrome, 2013-2018 157
Table 43: Key Events Impacting Sales for Cushing's Syndrome, 2013-2018 157
Table 44: Cushing's Syndrome - Drivers and Barriers, 2013-2018 160
Table 45: Abbreviations 178
Table 46: Key Launch Dates 182
Table 47: Key Patent Expiries 182

1.2 List of Figures
Figure 1: Pathophysiology of Cushing's Syndrome 21
Figure 2: The Diagnosis Algorithm for Cushing's Syndrome 28
Figure 3: The Diagnosis Algorithm for ACTH-Dependent Cushing's Syndrome 29
Figure 4: 6MM, Diagnosed Prevalent Cases of CS, Ages ?18 Years, Both Sexes, N, 2013-2023 42
Figure 5: 6MM, Age-Specific Diagnosed Prevalent Cases of CS, Both Sexes, N, 2013 44
Figure 6: 6MM, Sex-Specific Diagnosed Prevalent Cases of CS, Ages ?18 Years, N, 2013 46
Figure 7: 6MM, Diagnosed Prevalent Cases of Cushing's Disease, Ages ?18 Years, Both Sexes, N, 2013-2023 47
Figure 8: 6MM, Age-Specific Diagnosed Prevalent Cases of Cushing's Disease, Both Sexes, N, 2013 49
Figure 9: 6MM, Sex-Specific Diagnosed Prevalent Cases of Cushing's Disease, Ages ?18 Years, N, 2013 51
Figure 10: 6MM, Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ?18 Years, Both Sexes, N, 2013-2023 53
Figure 11: 6MM, Age-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Both Sexes, N, 2013 55
Figure 12: 6MM, Sex-Specific Diagnosed Prevalent Cases of Ectopic ACTH CS, Ages ?18 Years, N, 2013 57
Figure 13: 6MM, Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ?18 Years, Both Sexes, N, 2013-2023 58
Figure 14: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Both Sexes, N, 2013 60
Figure 15: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Adenoma CS, Ages ?18 Years, N, 2013 62
Figure 16: 6MM, Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ?18 Years, Both Sexes, N, 2013-2023 63
Figure 17: 6MM, Age-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Both Sexes, N, 2013 65
Figure 18: 6MM, Sex-Specific Diagnosed Prevalent Cases of Adrenal Carcinoma CS, Ages ?18 Years, N, 2013 67
Figure 19: 6MM, Age-Standardized Diagnosed Prevalence of CS (%), Ages ?18 Years, 2013 68
Figure 20: 6MM, Age-Standardized Diagnosed Prevalence of Cushing's Disease (%), Ages ?18 Years, 2013 69
Figure 21: Treatment Paradigm for Cushing's Syndrome 76
Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in Cushing's Syndrome, 2013-2018 156

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024

PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024

  • $ 10995
  • Industry report
  • September 2016
  • by Global Data

PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024 Summary Attention deficit hyperactivity disorder (ADHD) is characterized by excessive levels ...

Ulcerative Colitis: KOL Insight

Ulcerative Colitis: KOL Insight

  • $ 8085
  • Industry report
  • September 2016
  • by Firstword Pharma

Are UC biosimilars a real or perceived threat to branded drugs? Ulcerative colitis (UC) treatment is on the brink. Patents are ending on various branded drugs and clearing the way for an influx of biosimilars; ...

Colorectal Cancer KOL Insight 2016

Colorectal Cancer KOL Insight 2016

  • $ 8085
  • Industry report
  • October 2016
  • by Firstword Pharma

KOLs embrace novel MoAs as low survival rates drive search for new treatments Faced with persistently low survival rates, KOLs are calling for new approaches to treat late-stage colorectal cancer (CRC). ...

Hepatitis C: Kol Insight

September 2016 $ 8085

ref:plp2015

Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.