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

Published By :

GlobalData

Published Date : Jun 2017

Category :

Metabolic Disorders

No. of Pages : 216 Pages

Growth hormone deficiency (GHD) is a rare endocrine disorder characterized by inadequate secretion of growth hormone (GH) from the anterior pituitary gland. It is a heterogeneous disorder that may present in childhood (pediatric GHD) or later in adult life (adult GHD). Reduced GH secretion predominantly results in stunted linear growth in children; therefore, the standard-of-care GH replacement therapy serves to normalize height in children. Adults with GHD generally demonstrate biochemical abnormalities, which can also be successfully treated with recombinant GH. GlobalData estimates the 2016 sales for GHD at approximately $1.42 billion across the 7MM covered in this report. The market will grow moderately at a CAGR of 3.9% during the 10-year forecast period, generating sales of approximately $2.08 billion at the end of 2026. The US market is expected to grow the fastest of the three regions, recording a CAGR of 4.4% and generating around 69% of global sales in 2026. This growth will be driven primarily by the highly anticipated arrivals of the long-acting GHs and the resultant increase in compliance with and adherence to therapy. Although the more convenient long-acting GHs are expected to markedly change the GHD treatment landscape, and eventually replace daily GHs, market growth will be restricted by the continued negotiations between distributers and payers, which is expected to keep the prices of these new drugs at bay.

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 four 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? What are the chances of reimbursement for the long-acting GH drugs in pipeline?

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.

Companies mentioned

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 

Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Growth Hormone Deficiency: Executive Summary
2.1 GHD Market Will Exhibit Moderate Growth Between 2016 and 2026
2.2 Long-Acting Growth Hormones Will Fuel Market Growth and Improve the Treatment Landscape for GHD Patients
2.3 Payer Preferences Heavily Influence Market Shares of GH Drugs in the US
2.4 Disease Awareness and Stringent Regulatory and Insurance Policies Are Major Challenges in the GHD Market
2.5 Opportunities for New Entrants After the Launch of Long-Acting GHs Will Be Low During the Forecast Period
2.6 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Symptoms
4.3 Prognosis
4.4 Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 GHD in children
5.5 GHD in adults
5.6 Forecast Methodology
5.6.1 Sources
5.6.2 Forecast Assumptions and Methods
5.7 Epidemiological Forecast for GHD (2016-2026)
5.7.1 Diagnosed Prevalent Cases of GHD
5.7.2 Age-Specific Diagnosed Prevalent Cases of GHD
5.7.3 Sex-Specific Diagnosed Prevalent Cases of GHD
5.7.4 Idiopathic and Organic GHD in Children
5.7.5 Congenital and Acquired GHD Out of Organic GHD in Children
5.7.6 Idiopathic and Acquired GHD in Adults
5.7.7 Onset Timing
5.8 Discussion
5.8.1 Epidemiological Forecast Insight
5.8.2 Limitations of Analysis
5.8.3 Strengths of the Analysis
6 Current Treatment Options
6.1 Overview
6.2 Diagnosis and Treatment
6.2.1 Diagnosis
6.2.2 Treatment Guidelines and Leading Prescribed Drugs
6.3 Clinical Practice
6.4 Market Access and Reimbursement
6.5 Product Profiles – Recombinant Human Growth Hormones
6.5.1 Overview
6.5.2 Genotropin
6.5.3 Humatrope
6.5.4 Norditropin
6.5.5 Nutropin AQ
6.5.6 Saizen
6.5.7 Zomacton/Growject
6.5.8 Omnitrope
6.5.9 Valtropin Biosimilar
6.5.10 Efficacy
6.5.11 Safety
6.5.12 SWOT Analysis
6.6 Product Profiles – Long-Acting Recombinant Human Growth Hormones
6.6.1 Somatropin Biopartners (LB-03002)
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Improved Adherence to Therapy
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Disease Awareness and Physician Education
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Insurance Policies that Impact Patient Access
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Early Diagnosis
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 Simpler and Safer Diagnostic Test
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity
7.7 Safer Treatment for Cancer Survivors
7.7.1 Unmet Need
7.7.2 Gap Analysis
7.7.3 Opportunity
7.8 Improved Way of Measuring Adherence
7.8.1 Unmet Need
7.8.2 Gap Analysis
7.8.3 Opportunity
8 R&D Strategies
8.1 Overview
8.1.1 Development of Long-Acting Growth Hormones
8.1.2 Novel Drug Delivery Strategies
8.1.3 Novel Diagnostic Methods
8.1.4 Adherence-Monitoring Electronic Devices
8.1.5 Licensing and Acquisitions
8.2 Clinical Trials Design
8.2.1 Current Clinical Trial Design
8.2.2 Future Clinical Trial Design
9 Pipeline Assessment
9.1 Overview
9.2 Somapacitan (NNC0195-0092)
9.2.1 Overview
9.2.2 Efficacy
9.2.3 Safety
9.2.4 SWOT Analysis
9.3 Lagova (MOD-4023)
9.3.1 Overview
9.3.2 Efficacy
9.3.3 Safety
9.3.4 SWOT Analysis
9.4 Somavaratan (VRS-317)
9.4.1 Overview
9.4.2 Efficacy
9.4.3 Safety
9.4.4 SWOT Analysis
9.5 TransCon Growth Hormone (ACP-001)
9.5.1 Overview
9.5.2 Efficacy
9.5.3 Safety
9.5.4 SWOT Analysis
9.6 Innovative Early-Stage Approaches
10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10-Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.3.1 Forecasting Methodology
11.3.2 Diagnosed Patients
11.3.3 Percent Drug-Treated Patients
11.3.4 Drugs Included in Each Therapeutic Class
11.3.5 Launch and Patent Expiry Dates
11.3.6 General Pricing Assumptions
11.3.7 Individual Drug Assumptions
11.3.8 Pricing of Pipeline Agents
11.4 Primary Research – KOLs Interviewed for This Report
11.5 Payers Included in This Study
11.6 Primary Research – Prescriber Survey
11.7 About the Authors
11.7.1 Analyst
11.7.2 Therapy Area Director
11.7.3 Epidemiologist
11.7.4 Managing Epidemiologist
11.7.5 Global Director of Therapy Analysis and Epidemiology
11.7.6 Global Head of Healthcare
11.8 About GlobalData
11.9 Contact Us
11.10 Disclaimer

 

List of Table

Table 1: Growth Hormone Deficiency: Key Metrics in the 7MM
Table 2: Risk Factors and Comorbidities for GHD
Table 3: Diagnosed Prevalent Cases of GHD, Men and Women, All Ages, for 2016–2026.
Table 4: Treatment Guidelines for Growth Hormone Deficiency
Table 5: Approved Drugs for Growth Hormone Deficiency by Class in the Global Markets, 2016
Table 6: Product Profiles of Marketed Daily rGH Hormones for GHD Treatment
Table 7: SWOT Analysis of Marketed Recombinant Human Growth Hormones, 2017
Table 8: Product Profile – Somatropin Biopartners (LB-03002)
Table 9: Unmet Need and Opportunity in Growth Hormone Deficiency, 2017
Table 10: Examples of Pivotal Trials for Approved Treatments for Growth Hormone Deficiency
Table 11: Product Profile – Somapacitan (NNC0195-0092)
Table 12: Somapacitan SWOT Analysis, 2017
Table 13: Product Profile – Lagova (MOD-4023, hGH-CTP)
Table 14: Lagova SWOT Analysis, 2017
Table 15: Product Profile – Somavaratan (VRS-317)
Table 16: Somavaratan SWOT Analysis, 2017
Table 17: Product Profile – TransCon Growth Hormone (ACP-001)
Table 18: TransCon Growth Hormone SWOT Analysis, 2017
Table 19: Innovative Early-Stage Approaches for Growth Hormone Deficiency, 2017
Table 20: Clinical Benchmark of Key Pipeline Drugs – Growth Hormone Deficiency
Table 21: Commercial Benchmark of Key Pipeline Drugs – Growth Hormone Deficiency
Table 22: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, Norditropin
Table 23: Key Events Impacting Sales for Growth Hormone Deficiency, 2016–2026
Table 24: Growth Hormone Deficiency Market – Global Drivers and Barriers, 2016–2026
Table 25: Key Historical and Projected Launch Dates for Growth Hormone Deficiency
Table 26: Key Historical and Projected Patent Expiry Dates for Growth Hormone Deficiency
Table 27: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

 

List of Chart

Figure 1: Global Sales Forecast by Country for Growth Hormone Deficiency in 2016 and 2026
Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, Norditropin
Figure 3: Overview of the GH/IGF-1 Pathway and Physiological Regulation of GH Secretion
Figure 4: GH/IGF-1 Axis and Actions in Bone, Muscle, and Body Metabolism
Figure 5: Age-Standardized Diagnosed Prevalence of GHD, Men and Women, All Ages, 2016
Figure 6: Case Flow Map of GHD
Figure 7: Sources Used and Not Used for the Diagnosed Prevalent Cases of GHD in Children
Figure 8: Sources Used and Not Used in the Forecast for Diagnosed Prevalent Cases of GHD in Adults
Figure 9 Sources Used and Not Used in the Forecast for Type of GHD in Children
Figure 10 Sources Used and Not Used in the Forecast for Type of GHD in Adults
Figure 11 Sources Used and Not Used in the Forecast for Onset Timing of GHD in Adults
Figure 12: Age-Specific Diagnosed Prevalent Cases of GHD, Men and Women, All Ages, 2016
Figure 13: Sex-Specific Diagnosed Prevalent Cases, Men, Women, All Ages, 2016
Figure 14: Diagnosed Prevalent Cases of GHD in Children Segmented into Idiopathic and Organic GHD, Boys and Girls, Ages ?18 years, 2016.
Figure 15: Diagnosed Prevalent Cases of Congenital or Acquired GHD Out of Organic GHD, Boys and Girls, Ages ?18 years, 2016
Figure 16: Idiopathic and Acquired GHD in Adults, Men and Women, Ages ?19 Years, 2016.
Figure 17: Diagnosed Prevalent Cases by Onset Timing, Men and Women, Ages ?19 Years, 2016.
Figure 18: Growth Hormone Deficiency Treatment Algorithm
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
Figure 20: Global (7MM) Sales Forecast by Country for Growth Hormone Deficiency in 2016 and 2026
Figure 21: Global Sales Forecast by Drugs for Growth Hormone Deficiency, 2016 and 2026
Figure 22: Sales Forecast by Class for Growth Hormone Deficiency in the US, 2016 and 2026

 

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