Follicle-stimulating Hormones Market Size, Share, and Industry Analysis, By Treatment (Recombinant FSH and Urinary FSH), By Treatment Type (Infertility Treatment and Assisted Reproductive Technology), By End User (Hospitals and Fertility Centers), and Regional Forecast till 2032

The global follicle-stimulating hormones market is witnessing significant growth due to the increasing infertility rates and advancements in the reproductive technologies across the globe. Follicle-stimulating hormone (FSH) is a crucial glycoprotein hormone produced by the anterior pituitary gland, playing a significant role in the reproductive systems of both males and females. Low FSH Levels in women affects fertility. Follicle-stimulating hormone (FSH) injections are given in women to stimulate the ovaries to produce eggs, which is essential for women with anovulatory infertility.

• FSH is often used in conjunction with other hormones to prepare the ovaries for procedures such as in vitro fertilization.

The market growth is further driven by an increased awareness of fertility treatments and technological advancements in FSH production such as recombinant FSH.

Follicle-stimulating Hormones Market Driver

Increasing Infertility Rates to Drive Market Growth

The follicle-stimulating hormone (FSH) market is experiencing notable growth, driven by various factors, especially the increasing infertility rate. This increase is attributed to factors such as lifestyle changes, environmental stressors, and delayed childbearing, leading to a higher demand for fertility treatments that utilize FSH.

• As per WHO report in March 2024, the prevalence of infertility is rising globally, affecting approximately 1 in 6 adults boosting the demand for IVF and the FSH.

Additionally, there is an increasing awareness and acceptance of advanced fertility treatments among healthcare professionals and patients. This shift is driving the demand for FSH as a critical component in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) that poses a robust growth over the coming years.

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The bar graph shows an age-standardized infertility rate in 2021 in the Asia Pacific countries. The report stated that infertility represents a significant global public health concern, impacting approximately 15% of couples of reproductive age worldwide. The data is sourced from China CDC Weekly.

Follicle-stimulating Hormones Market Restraint

Risks and High Cost Associated with Therapies to Limit Adoption

The cost associated with FSH injections and fertility treatments can be prohibitive for many patients. This financial barrier may limit access to necessary therapies, particularly in lower-income regions.

• For instance, according to an article published in July 2023, the total costs for one assisted reproductive technology cycle with a fresh ET leading to a live birth varied between USD 4,465 to USD 13,384. This used FSH for the procedure.

Additionally, the patients undergoing FSH treatment may experience side effects such as ovarian hyperstimulation syndrome (OHSS), which can deter some individuals from pursuing these therapies. Concerns about safety and efficacy may impact the patient willingness to engage with FSH-based treatments and affecting the market growth.

Follicle-stimulating Hormones Market Opportunity

Significant Population in Key Regions to Drive Demand for these Products in the Future

Regions such as Asia Pacific and Latin America present significant growth opportunities due to rising infertility rates and improving healthcare infrastructure. Increased healthcare spending and government initiatives aimed at enhancing reproductive health services are likely to drive market expansion in these regions.

Additionally, ongoing R&D efforts focused on improving FSH formulations and delivery methods are likely to yield new products that meet diverse patient needs, further stimulating market growth.

Segmentation

Key Insights

The report covers the following key insights:

• Prevalence of Infertility, By Key Countries, 2023
• Number of Fertility Centers, By Key Countries, 2023
• Number of IVF Procedures, By Key Countries, 2023
• Key Industry Developments, By Key Players
• Impact of COVID-19 on the Market

Analysis by Type

Based on type, the market is subdivided into recombinant FSH and urinary FSH.

The recombinant FSH segment held significant revenue in the market. The segment growth is attributed to its efficacy in stimulating ovarian function and higher pregnancy rates compared to urinary FSH. Additionally, rising number clinical trials using recombinant FSH is expected to fuel the growth.

• For instance, in October 2024, Intas Pharmaceuticals Ltd received CDSCO approval for phase I clinical trial for 300IU recombinant FSH in India. This expected to fuel the segment growth.

Analysis by Application

Based on application, the market is divided into infertility treatment and assisted reproductive technology.

The assisted reproductive technology (ART) held a substantial share in the market. ART encompasses procedures such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), where FSH plays a critical role in ovarian stimulation. The growing reliance on ART due to lifestyle changes and delayed childbearing is a key factor driving segment growth.

Analysis by End User

Based on end user, the market is fragmented into hospitals and fertility centers.

The fertility centers segment held a prominent share of the market. These institutions are primary providers of fertility treatments, benefiting from advanced healthcare infrastructure and access to a broad patient base. Additionally, new center opening is expected to fuel the segment growth.

• For instance, in April 2024, Kindbody Opens State-of-the-Art Fertility Clinic and IVF Lab in Columbus, Ohio. Such opening increases the demand for FSH.

Regional Analysis

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Based on region, the market has been studied across North America, Europe, Asia Pacific, South America, and the Middle East & Africa.

North America dominated the market in 2023. The region is expected to benefit from high awareness levels regarding the fertility treatments, favorable reimbursement policies, and a robust healthcare infrastructure. The region's aging population further contributes to the rising demand for fertility solutions.

• For instance, as per Office on Women’s Health 2019 report, 10% of women aged 15 to 44 reported infertility problems in the U.S. This high prevalence of infertility is expected to boost regional market growth.

Europe held the second largest share of the global market and the region shows a significant increase in the ART utilization driven by rising infertility rates and advancements in reproductive technologies.

In the Middle East & Africa, the rapid urbanization and lifestyle changes are leading to increased infertility rates. However, the rising awareness levels regarding the reproductive health services are expected to boost the regional market growth.

Key Players Covered

The global follicle-stimulating hormones market is partially consolidated with few key players.

The report includes the profiles of the following key players:

• Intas Pharmaceuticals Ltd (India)
• Organon group of companies (U.S.)
• Merck KGaA (Germany)
• LG Chem (Korea)
• Ferring Pharmaceuticals (Switzerland)
• Merck & Co., Inc. (U.S.)
• Lupin (India)
• Mankind (India)

Key Industry Developments

• In September 2024, Organon entered into licensing agreement with Bao Pharmaceutical for Innovative Investigational Asset in Assisted Reproductive Technology (ART), SJ02, and a Long-Acting FSH in BLA Process in China Mainland.
• In November 2021, Organon group of companies and Forendo Pharma announced that the companies entered into a definitive agreement. Under the agreement, Organon would acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health.