MARKET OUTLOOK:

Male hypogonadism is characterized by low serum testosterone and impaired spermatogenesis. Primary male hypogonadism results from an intrinsic abnormality in the testes, while secondary male hypogonadism is a deficit of testosterone driven by changes in pituitary or hypothalamic upstream signaling pathways. Secondary hypogonadism is the predominant form of male hypogonadism in the major markets, and the incidence of secondary hypogonadism increases as a result of the age-related accumulation of comorbidities such as obesity. TRT, which aims to increase overall serum testosterone levels, is the cornerstone therapy for male hypogonadism and is primarily administered via injection or topical means. However, a key drawback of TRTs is decreased spermatogenesis, and some alternative therapies for male hypogonadism focus on the stimulation of gonadotropins in an effort to preserve fertility. Additionally, the FDA recently cautioned against the use of TRT due to the possibility of increased cardiac risk. This study will evaluate physicians’ perception of this warning and how this safety issue will affect the uptake of current and emerging therapies for male hypogonadism.

QUESTIONS ANSWERED:

  • Which testosterone formulations will dominate the TRT market in 2026?
  • What impact will emerging TRTs have on an entrenched market of injectable and topical TRTs?
  • Which alternative therapies are likely to trigger changes in current treatment?
  • How is the prevalent male hypogonadism population in the U.S. and EU5 expected to grow over the next ten years?

PRODUCT DESCRIPTION:

Niche & Rare Disease Landscape & Forecast: Comprehensive market intelligence providing world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Male Hypogonadism - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Commercial Outlook
        • Drivers and Constraints
          • What Factors Are Driving Sales in Male Hypogonadism?
          • What Factors Are Constraining Sales in Male Hypogonadism?
        • Testosterone Replacement Therapy: Specific Trends
          • Testosterone Replacement Therapies
        • Selective Estrogen Receptor Modulators: Specific Trends
          • Selective Estrogen Receptor Modulators
          • Alternative Scenarios for the Male Hypogonadism Market Through 2026
      • Forecast
        • Forecast Sales of Key Classes and Emerging Testosterone Replacement Therapies for Male Hypogonadism
      • Etiology and Pathophysiology
        • Clinical Features of Male Hypogonadism
          • Types of Male Hypogonadism
          • Key Clinical Features of Male Hypogonadism
        • Etiology
          • Known Causes of Male Hypogonadism
          • Expert Insight
          • Expert Insight on the Etiology of Male Hypogonadism
        • Pathophysiology
          • Key Pathways and Drug Targets
          • Epidemiology Overview
            • Key Findings
              • Epidemiology Populations
                • Disease Definition
                • Methods
                • Sources Used for Total Prevalent Cases of Male Hypogonadism
                • Number of Total Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets, 2016-2026 (thousands)
                • Disease Definition
                • Methods
                • Sources Used for Symptomatic Male Hypogonadism
                • Number of Symptomatic Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets, 2016-2026 (thousands)
                • Disease Definition
                • Methods
                • Sources Used for Comorbidities of Male Hypogonadism
                • Number of Total Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets by Comorbidity, 2016-2026 (thousands)
                • Disease Definition
                • Methods
                • Sources Used for Male Hypogonadism Subtype Distribution
                • Number of Total Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets by Subtype, 2016-2026 (thousands)
                • Diagnosed Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets, 2016-2026 (thousands)
                • Drug-Treated Prevalent Cases of Male Hypogonadism in the Major Pharmaceutical Markets, 2016-2026 (thousands)
            • Current Treatment Overview
              • Key Findings
                • Diagnosis
                  • Tests Used for Diagnosis of Male Hypogonadism
                  • Treatment Providers and Referral Patterns
                  • Expert Insight
                  • Expert Insight: Diagnosis of Male Hypogonadism
                • Treatment Goals
                  • Key End Points Used in Clinical Trials for Male Hypogonadism
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drugs or Drug Classes Used for Male Hypogonadism
                  • Current Treatments Used for Male Hypogonadism
                  • Expert Insight
                  • Expert Insight on FDA Decision Regarding Testosterone Replacement Therapies
                  • Expert Insight
                  • Expert Insight: Intramuscular Injections
                  • Advantages and Disadvantages of Testosterone Cypionate and Enanthate
                  • Expert Insight
                  • Expert Insight: Testosterone Cypionate and Enanthate
                  • Advantages and Disadvantages of Testosterone Undecanoate
                  • Expert Insight
                  • Expert Insight: Testosterone Undecanoate
                  • Advantages and Disadvantages of Topical Gels and Creams
                  • Expert Insight
                  • Expert Insight: Topical Gels and Creams
                  • Advantages and Disadvantages of Oral Testosterone Undecanoate
                  • Expert Insight
                  • Expert Insight: Oral Testosterone Undecanoate
                  • Advantages and Disadvantages of Transdermal Patches
                  • Expert Insight
                  • Expert Insight: Transdermal Patches
                  • Advantages and Disadvantages of Testopel
                  • Expert Insight
                  • Expert Insight: Testopel
                  • Advantages and Disadvantages of Natesto
                  • Expert Insight
                  • Expert Insight: Natesto
                  • Advantages and Disadvantages of Striant/Striant SR
                  • Expert Insight
                  • Expert Insight: Striant/Striant SR
                  • Advantages and Disadvantages of Dihydrotestosterone/Androstanolone Gels
                  • Expert Insight
                  • Expert Insight: Dihydrotestosterone/Androstanolone Gels
                  • Advantages and Disadvantages of Gonadotropin/Gonadotrophins
                  • Expert Insight
                  • Expert Insight: Gonadotropins/Gonadotrophins
                  • Advantages and Disadvantages of SERMs and Aromatase Inhibitors
                  • Expert Insight
                  • Expert Insight: SERMs and Aromatase Inhibitors
                • Medical Practice
                  • Overview
                  • Country and/or Regional Guidelines for the Treatment of Male Hypogonadism
                  • Region-Specific Treatment
                  • Generalized Treatment Decision Tree for Male Hypogonadism
              • Unmet Need Overview
                • Key Findings
                  • Attainment of Unmet Needs
                    • Current Attainment of Unmet Needs in Male Hypogonadism
                    • Future Attainment of Unmet Needs in Male Hypogonadism
                    • Top Unmet Needs in Male Hypogonadism: Current and Future Attainment
                    • Expert Insight on Male Hypogonadism Unmet Needs
                • Emerging Therapies Overview
                  • Key Findings
                    • Pipeline Trends in Male Hypogonadism
                  • Key Emerging Therapies
                    • Notable Developments Among Key Emerging Therapies for Male Hypogonadism
                    • Key Emerging Therapies in Development for Male Hypogonadism
                    • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Male Hypogonadism
                    • Expert Insight
                    • Expert Insight on Oral Testosterone Undecanoate
                    • LPCN-1021 Profile
                    • LPCN-1021 Clinical Development
                    • Expectations for Launch and Sales Opportunity of LPCN-1021 in Male Hypogonadism
                    • Jatenzo Profile
                    • Jatenzo Clinical Development
                    • Expectations for Launch and Sales Opportunity of Jatenzo in Male Hypogonadism
                    • LPCN-1111 Profile
                    • LPCN-1111 Clinical Development
                    • Expectations for Launch and Sales Opportunity of LPCN-1111 in Male Hypogonadism
                    • QuickShot T Profile
                    • QuickShot T Clinical Development
                    • Expert Insight
                    • Expert Insight on QuickShot T
                    • Expectations for Launch and Sales Opportunity of QuickShot T in Male Hypogonadism
                    • Enclomiphene Citrate Profile
                    • Enclomiphene Citrate Clinical Development
                    • Key Ongoing Clinical Trials of Enclomiphene Citrate for Treatment of Male Hypogonadism
                    • Expert Insight
                    • Expert Insight on Enclomiphene Citrate
                    • Expectations for Launch and Sales Opportunity of Enclomiphene Citrate in Male Hypogonadism
                    • Corifollitropin Alfa Profile
                    • Corifollitropin Alfa Clinical Development
                    • Key Ongoing Clinical Trials of Corifollitropin Alfa for Treatment of Male Hypogonadism
                    • Expectations for Launch and Sales Opportunity of Corifollitropin Alfa in Male Hypogonadism
                    • BGS-649 Profile
                    • BGS-649 Clinical Development
                    • Key Ongoing Clinical Trials of BGS-649 for Treatment of Male Hypogonadism
                    • Expert Insight
                    • Expert Insight on BGS-649
                    • Expectations for Launch and Sales Opportunity of BGS-649 in Male Hypogonadism
                  • Early-Phase Pipeline Analysis
                    • Notable Developments in the Early-Phase Pipeline for Male Hypogonadism
                    • Select Agents in Early-Phase Development for Male Hypogonadism
                    • Expert Insight on SARMs for the Treatment of Male Hypogonadism
                • Access & Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                  • Methodology
                    • Appendix
                      • Key Abbreviations Related to Male Hypogonadism
                      • Standard Dosing of Key Therapies in the Male Hypogonadism Market
                      • Experts Interviewed
                      • Male Hypogonadism Bibliography

                  Author(s): James Heeres, PhD

                  James is a part of the infectious, niche markets, and rare diseases team at DRG. His work involves evaluating treatment landscape, unmet needs, emerging therapy positioning, commercial potential, drug development opportunities, and company competitiveness. Currently, his concentration is in hepatitis C virus (HCV) infection in US and EU5 markets.

                  James earned his Ph.D. in biochemistry from the University of Illinois at Urbana-Champaign while studying high-throughput screening technologies and small-molecule inhibitors of apoptosis. Prior to joining DRG, his postdoctoral studies involved drug discovery and development in neurodegenerative diseases at both Harvard Medical School and Boston University School of Medicine.