PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930156
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930156
The global uterine fibroid drugs market is projected to witness significant growth during the forecast period, driven by rising prevalence of uterine fibroids and increasing demand for non-invasive therapeutic options. The market was valued at USD 2.97 billion in 2025, projected to reach USD 3.38 billion in 2026, and is expected to grow to USD 9.71 billion by 2034, exhibiting a CAGR of 16.28%. North America dominated the market in 2025 with a 45.56% share, attributed to robust healthcare infrastructure, high diagnosis rates, and increasing adoption of innovative therapies.
Uterine fibroids, also known as leiomyomas or myomas, are benign, non-cancerous growths of the uterine smooth muscle and connective tissue. While some cases remain asymptomatic, symptomatic fibroids can cause heavy menstrual bleeding, pelvic pain, anemia, urinary complications, and fertility issues. Factors such as sedentary lifestyle, obesity, delayed menopause, and metabolic disorders are contributing to the rising prevalence of uterine fibroids, boosting the global demand for effective pharmacological interventions.
Key players in the market, including AbbVie Inc., Neurocrine Biosciences, and Sumitomo Pharma, are actively developing pipeline candidates to meet the growing need for effective uterine fibroid treatments.
Market Dynamics
Market Drivers
The rising burden of uterine fibroids is the primary growth driver, affecting up to 70-80% of women by age 50, with a significant proportion experiencing severe symptoms. Women increasingly prefer uterus-preserving and fertility-friendly drug therapies over surgical options. The rising symptomatic patient population widens the addressable market, leading to increased adoption of novel therapies such as GnRH agonists, antagonists, and selective progesterone receptor modulators.
For example, according to the NIH (2020), symptomatic uterine fibroids can cause abnormal uterine bleeding, anemia, pelvic pain, urinary issues, and infertility, highlighting the growing demand for medical interventions.
Market Restraints
Severe adverse effects such as bone density loss, hot flashes, and cardiovascular risks can reduce patient adherence and limit treatment duration. These safety concerns restrict long-term usage and influence physicians' prescribing patterns, particularly for women of reproductive age. For instance, in the ELARIS UF-1 and UF-2 trials (2021), approximately 10% of women discontinued treatment due to adverse reactions.
Market Opportunities
Increasing research initiatives are creating lucrative growth opportunities. Academic collaborations, government funding, and biotech-pharma partnerships are driving the development of next-generation therapies, including injectable alternatives and novel oral GnRH antagonists.
For instance, in May 2022, researchers at Duke University collaborated to develop a minimally invasive, effective injectable therapy for uterine fibroids, expanding treatment options.
Market Challenges
Regulatory stringency and safety risks pose challenges to market growth. Women's health therapies require long-term safety data, especially regarding fertility, hormonal balance, and adverse effects. Regulatory scrutiny increases development costs and timelines, limiting smaller biopharma firms' ability to compete. For example, Kissei Pharmaceutical (2022) faced rigorous review processes for its GnRH antagonist, Linzagolix.
Global Market Trends
A prominent trend is strategic collaborations among key market players, which accelerates R&D, expands market reach, and mitigates development risks. Notable collaborations include Myovant Sciences and Pfizer (2020) for commercialization of relugolix in North America, enabling faster market access and expanded patient reach.
By Drug Class:
By Type:
By Route of Administration:
By Application:
By Distribution Channel:
North America: Market valued at USD 1.35 billion in 2025, projected to USD 1.54 billion in 2026, with the U.S. alone reaching USD 1.46 billion. Growth is supported by high prevalence, advanced healthcare infrastructure, and strategic collaborations.
Europe: Market estimated at USD 0.87 billion in 2026, second-highest growth due to awareness programs, advanced therapies, and reimbursement policies. Major contributors include the U.K., Germany, and France.
Asia Pacific: Market projected to reach USD 0.7 billion in 2026, with India at USD 0.09 billion and China at USD 0.25 billion.
Latin America: Estimated at USD 0.15 billion in 2026, driven by improving healthcare access and awareness.
Middle East & Africa: GCC countries estimated at USD 0.05 billion in 2025.
Competitive Landscape
The market is semi-consolidated, dominated by AbbVie, Neurocrine Biosciences, Sumitomo Pharma, and Pfizer. Strategic activities include R&D investments, collaborations, and patent filings to expand their global presence. For instance, in June 2025, Altin Biosciences received a Notice of Allowance for its lead drug candidate ABC-105/ABC-205 for non-hormonal treatment of uterine fibroids. Other players include Kissei Pharmaceutical, ObsEva SA, and TiumBio.
Key Industry Developments
Conclusion
The global uterine fibroid drugs market is set to grow from USD 2.97 billion in 2025 to USD 9.71 billion by 2034, at a CAGR of 16.28%, driven by increasing prevalence, technological innovation, and expanding treatment options. North America leads due to robust healthcare infrastructure, while emerging markets offer growth potential. Strategic collaborations, R&D investments, and increasing adoption of oral and injectable therapies are expected to further enhance market growth, offering patients effective, non-surgical management of uterine fibroids worldwide.
Segmentation By Drug Class, Type, Route of Administration, Application, Distribution Channel, and Region
By Drug Class * GnRH Antagonists
By Type * Intramural Fibroid
By Route of Administration * Oral
By Application * Shrinkage
By Distribution Channel * Hospital Pharmacies
By Geography * North America (By Drug Class, Type, Route of Administration, Application, Distribution Channel, and Country)