Uterine fibroids are characterized by heavy menstrual bleeding (menorrhagia), pelvic pressure due to increased uterine bulk, abdominal and back pain, and fertility issues. Disease management may include procedures for fibroid removal (e.g., laproscopic, myomectomy, hysterectomy) or pharmacological approaches to manage more-disruptive symptoms like menorrhagia (e.g., hormonal contraceptives like progestin-only birth control pills). Owing to reproductive concerns, some patients avoid procedures and rely solely on pharmacological options. Although these pharmacotherapies are effective in reducing menorrhagia, they fail to reduce fibroid tumor volume or resolve bulk symptoms. Over the next ten years, we expect that the launch of several gonadotropin-releasing hormone (GnRH) antagonists, including Myovant/Takeda’s relugolix, ObsEva/Kissei’s linzagolix, and AbbVie’s elagolix, will offer a new class of therapies for the long-term management of uterine fibroids.

Questions Answered:

  • How will the launches of GnRH antagonists affect the use of traditional pharmacological treatments and procedures in patients with symptomatic uterine fibroids?
  • What clinical role will second-generation, oral GnRH antagonist therapies play in the management of uterine fibroids?
  • How have recent concerns regarding selective progesterone receptor modulators like ulipristal (Esmya) affected physicians’ prescription of them?
  • What are the greatest remaining unmet needs, and how well will emerging therapies address these needs?

Market covered: United States, France, Germany, Italy, Spain, and United Kingdom.

Primary research: Six country-specific interviews with thought-leading gynecologists specializing in uterine fibroids and supported by survey data collected for this study.

Epidemiology: Total prevalent, diagnosed prevalent, and drug-treated cases of uterine fibroids by country.

Market forecast: Drug-level sales and patient share of key uterine fibroids therapies in 2028.

Emerging therapies: Phase III/PR: 3; Phase II: 1; coverage of select preclinical and Phase I products.

Key companies: Allergan, Gedeon Richter, Bayer HealthCare, AbbVie, Myovant, ObsEva.

Key drugs: Ulipristal, telapristone, vilaprisan, elagolix, relugolix, linzagolix.

Table of contents

  • Disease Landscape & Forecast
    • Commercial Outlook
      • Key Findings
      • Drivers and Constraints
        • What Factors Are Driving Sales in Uterine Fibroids?
        • What Factors Are Constraining Sales in Uterine Fibroids?
      • Selective Progesterone Receptor Modulator-Specific Trends
      • Gonadotropin-Releasing Hormone Antagonists-Specific Trends
      • Alternative Market Scenarios
    • Forecast
    • Etiology and Pathophysiology
      • Disease Overview
      • Etiology
      • Pathophysiology
      • Clinical Presentation of Uterine Fibroids
      • Key Pathways and Drug Targets
    • Epidemiology Overview
      • Key Findings
      • Epidemiology Populations
        • Total Prevalent Cases
        • Diagnosed Prevalent Cases
        • Drug-Treated Cases of Uterine Fibroids
    • Current Treatment
      • Key Findings
      • Diagnosis
        • Treatment Providers and Referral Patterns
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • Selective Progesterone Receptor Modulators
        • Gonadotropin-Releasing Hormone Agonists
        • Hormonal Contraceptives
        • Antifibrinolytic Agents
        • Nonsteroidal Anti-Inflammatory Agents
        • Surgical Treatments
        • Minimally Invasive Procedures
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Region-Specific Treatment Practice
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in Uterine Fibroids
    • Emerging Therapies
      • Key Findings
      • Key Emerging Therapies
        • Selective Progesterone Receptor Modulators
        • Gonadotropin-Releasing Hormone Antagonists
      • Early-Phase Pipeline Analysis
      • Patient Registries
        • Patient Organizations
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
      • Looking for More?
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Uterine Fibroids Bibliography

Author(s): Laura Darnieder; Ema Rodrigues, DSc, MPH

Laura Darnieder is a Business Insights Analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, where she is focused on providing market forecasts within the niche biopharmaceutical space. Prior to joining DRG, Laura earned a in Neuroscience from Tufts University Sackler School of Graduate Biomedical Sciences. Her research focused on the role of stress neuropeptides and inhibitory signaling in alcohol dependence and drug addiction. She also holds a , summa cum laude, in Psychobiology and Linguistics from Binghamton University (SUNY).

Ema is an epidemiologist with expertise in forecasting incident and prevalent populations within oncology, as well as some cardiovascular indications such as venous thromboembolism. She has significant experience with statistical methods such as multivariate linear regression, conditional logistic regression, principal components analysis, mixed models, hierarchical modeling, and path analysis to account for the complex relationships among various predictors of health outcomes, particularly correlated variables. She completed her master’s and doctoral degree (MPH, ) in Environmental Health at Boston University School of Public Health, where she worked on projects investigating significant predictors of various health outcomes including central nervous system cancer, cognitive function, and birth outcomes.