Follicle Stimulating Hormone Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Recombinant FSH, Urinary FSH), By Application (Infertility Treatment, Assisted Reproductive Application (ART), Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.91 Billion
CAGR (2026-2031)	5.87%
Fastest Growing Segment	Infertility Treatment
Largest Market	North America
Market Size (2031)	USD 2.69 Billion

Market Overview

The Global Follicle Stimulating Hormone Market will grow from USD 1.91 Billion in 2025 to USD 2.69 Billion by 2031 at a 5.87% CAGR. Follicle Stimulating Hormone is a gonadotropin synthesized by the anterior pituitary gland that plays a critical role in the reproductive system by regulating the growth and maturation of ovarian follicles in females and spermatogenesis in males. The primary drivers propelling the global market include the escalating prevalence of infertility and the societal shift toward delayed childbearing, both of which necessitate the use of assisted reproductive technologies. This increasing demand for fertility interventions is supported by demographic data indicating a worldwide decline in natural birth rates. According to the American Society for Reproductive Medicine, in 2025, the average global fertility rate in 2024 was 2.2 births per woman.

Despite the strong demand dynamics, the market faces a significant impediment regarding the prohibitive costs associated with fertility treatments and the lack of comprehensive insurance reimbursement in many regions. These financial barriers restrict patient access to necessary therapies and create a substantial disparity in treatment availability across different economic landscapes, thereby slowing potential market expansion.

Key Market Drivers

The increasing utilization of Assisted Reproductive Technologies (ART) serves as a fundamental catalyst for market expansion, as these procedures rely heavily on exogenous gonadotropins to induce controlled ovarian hyperstimulation. In clinical settings such as In Vitro Fertilization (IVF), Follicle Stimulating Hormone is essential for recruiting multiple ovarian follicles, thereby maximizing the yield of viable oocytes and improving conception probabilities. This clinical necessity translates directly into sustained pharmaceutical demand as the volume of treatment cycles rises globally. According to the Human Fertilisation and Embryology Authority, June 2024, in the 'Fertility treatment 2022: trends and figures' report, the number of IVF cycles performed in the UK increased to approximately 77,000, reflecting an 11% rise compared to pre-pandemic levels.

Simultaneously, the societal shift toward delayed parenthood significantly amplifies the need for these interventions, as advanced maternal age correlates with diminished ovarian reserve and reduced oocyte quality. This demographic reality forces a greater dependence on high-dosage FSH protocols to achieve successful pregnancy outcomes. The urgency of this driver is underscored by demographic data from East Asia; according to Statistics Korea, August 2024, in the 'Birth Statistics in 2023' report, the total fertility rate dropped to a record low of 0.72 children per woman, signaling a critical need for medical fertility support. This demand creates a robust commercial environment, as evidenced when, according to Organon, in 2024, the company reported that revenue for its Women’s Health segment grew by 5% in the third quarter, driven primarily by strong performance in fertility products.

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Key Market Challenges

The prohibitive costs associated with fertility treatments constitute a substantial barrier restricting the expansion of the Global Follicle Stimulating Hormone Market. Since follicle stimulating hormone is a primary pharmaceutical component in assisted reproductive technology protocols, the high price of these procedures limits the addressable patient base to individuals with significant disposable income. This financial exclusion leads to a reduced volume of treatment cycles initiated globally, directly curbing the demand for the hormone and dampening overall market revenue. The economic burden is particularly acute in regions lacking robust public healthcare funding, forcing patients to pay out-of-pocket for essential therapies, which often results in high treatment dropout rates.

Furthermore, the lack of comprehensive insurance reimbursement exacerbates this challenge by widening the gap between clinical need and treatment access. Without financial assistance, the cumulative expense of necessary multiple cycles becomes untenable for the majority of the population, effectively capping market penetration. According to the American Society for Reproductive Medicine, in 2024, the average cost of a single in vitro fertilization cycle in the United States ranged between $12,000 and $15,000. This substantial financial requirement highlights the severity of the economic impediments that prevent widespread adoption and hamper the growth trajectory of the market.

Key Market Trends

The market entry and commercialization of biosimilar FSH products is fundamentally reshaping the competitive landscape by introducing cost-effective alternatives to established recombinant formulations. As patents for major originator biologics expire, biosimilar manufacturers are aggressively capturing market share through competitive pricing strategies, compelling incumbent firms to increase discount rates to maintain their formulary positions. This price erosion significantly impacts the revenue streams of legacy brands while simultaneously broadening patient access to essential fertility treatments by lowering the overall cost of cycles. According to Organon, February 2025, in the 'Fourth Quarter and Full Year 2024 Results', worldwide sales of its key fertility product Follistim AQ declined by 10% for the full year 2024, a downturn primarily attributed to unfavorable discount rates and intensifying competition within the global sector.

Concurrently, the integration of artificial intelligence for precision dosing regimens is revolutionizing ovarian stimulation protocols by enabling highly personalized treatment plans. Clinicians are increasingly adopting AI-driven algorithms to analyze patient-specific biomarkers, such as baseline hormone levels and follicle counts, to calculate the optimal FSH dosage for each individual cycle. This technological shift minimizes the risks of ovarian hyperstimulation syndrome and improves the efficiency of oocyte retrieval by moving away from standardized, one-size-fits-all dosing models. According to the Journal of IVF-Worldwide, May 2025, in the article 'Global Trends in the Use of Artificial Intelligence (AI) in Reproductive Medicine', the adoption rate of AI tools among fertility specialists for clinical applications such as precision dosing and embryo selection rose to approximately 29.2% in 2025.

Segmental Insights

The Infertility Treatment segment is recognized as the fastest-growing category within the Global Follicle Stimulating Hormone Market, driven by increasing global infertility rates and a demographic shift toward delayed childbearing. This trend has significantly elevated the demand for Assisted Reproductive Technologies, such as In Vitro Fertilization, where Follicle Stimulating Hormone plays a critical role in inducing ovulation. Additionally, the expansion of specialized fertility centers and supportive frameworks from public health organizations are further catalyzing the adoption of these treatments. Consequently, clinical reliance on this hormone for reproductive success continues to strengthen the segment's market position.

Regional Insights

North America maintains a leading position in the global Follicle Stimulating Hormone market, driven primarily by the rising prevalence of infertility and a trend toward delayed parenthood in the United States and Canada. The region benefits from high patient awareness regarding assisted reproductive technologies and a well-structured healthcare system. Furthermore, the US Food and Drug Administration plays a critical role in facilitating market access for new therapeutic options through established approval pathways. These factors, combined with improving insurance coverage for fertility treatments, solidify the region's dominance in this sector.

Recent Developments

• In October 2024, Ferring Pharmaceuticals presented new scientific data regarding its fertility portfolio at the American Society for Reproductive Medicine Scientific Congress held in Denver. The company shared findings from multiple abstracts, including real-world analyses related to ovarian stimulation protocols and the use of gonadotropins such as follitropin delta. These presentations highlighted the organization's dedication to advancing reproductive medicine through rigorous research and the development of personalized treatment approaches. The Senior Medical Director of Reproductive Medicine noted that the disseminated data aimed to equip clinics with valuable insights to enhance patient outcomes in assisted reproductive technology.
• In October 2024, Meitheal Pharmaceuticals expanded its pipeline through an exclusive commercial licensing agreement with Hong Kong King-Friend Industry Co. to market three biosimilars in the United States. The partnership included the rights to distribute a biosimilar candidate for follitropin alpha, a recombinant human follicle stimulating hormone used in fertility treatments. This collaboration aimed to address the lack of available biosimilar options for this specific gonadotropin in the U.S. market at that time. The agreement underscored the company's strategy to deliver affordable healthcare solutions and improve patient access to essential reproductive medicines in the region.
• In June 2024, Organon launched its fertility treatment, Follistim, in the Japanese market following a successful regulatory re-submission. The product, composed of follitropin beta, is a recombinant follicle stimulating hormone indicated for controlled ovarian stimulation in women undergoing assisted reproductive technology procedures. This strategic move represented the first product registered and introduced by the company in Japan since its independence from its parent entity. The launch was positioned to support the country's efforts to address demographic challenges by providing an additional therapeutic option for patients and healthcare providers managing infertility and seeking effective reproductive health solutions.
• In April 2024, IBSA Group announced the regulatory approval and introduction of a new formulation of menotropin in Italy during a press conference held in Milan. This highly purified medicinal product, which contains both follicle stimulating hormone and luteinizing hormone activity, was launched to optimize ovarian stimulation in assisted reproductive technology procedures. The company emphasized the significance of this development in the context of the country's declining birth rates and the recent inclusion of fertility treatments in the national Essential Levels of Assistance. The Head of Research and Development at the firm highlighted their commitment to ensuring high-quality therapeutic options for couples facing infertility challenges.

Key Market Players

• Merck KgAa
• Creative BioMart inc.
• Midas Pharma GmbH
• Genpharm Services
• Livzon Pharmaceutical Group Inc
• Shanghai Techwell Biopharmaceutical Co., Ltd
• Medix Biochemica USA Inc.
• Biogenix Inc.Pvt.Ltd.

By Type	By Application	By Region
Recombinant FSH Urinary FSH	Infertility Treatment Assisted Reproductive Application (ART) Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Follicle Stimulating Hormone Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Follicle Stimulating Hormone Market, By Type:

• Recombinant FSH
• Urinary FSH

• Follicle Stimulating Hormone Market, By Application:

• Infertility Treatment
• Assisted Reproductive Application (ART)
• Others

• Follicle Stimulating Hormone Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE