GnRH (gonadotropin-releasing hormone) is a hormone that plays a crucial role in regulating reproductive function. It is produced in the hypothalamus and stimulates the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary gland. GnRH agonists and antagonists are used as therapeutic agents to modulate the release of these hormones and treat various conditions. GnRH is employed in disease indications such as infertility, endometriosis, uterine fibroids, precocious puberty, and hormone-dependent cancers like prostate and breast cancer. According to the World Health Organization (WHO), infertility affects around 10-15% of couples worldwide, with Europe reporting a prevalence rate of 15-20%. The American Society for Reproductive Medicine states that endometriosis affects approximately 10% of women in the United States. Uterine fibroids, a common condition in women, have an estimated prevalence of 20-80% in Europe and 70-80% in the United States. The WHO also reports that precocious puberty affects 1 in 5,000 to 1 in 10,000 children, with girls being more commonly affected. Prostate and breast cancers are significant health concerns globally, with Europe and the United States accounting for a significant portion of cases.
Growth drivers of the GnRH market include increasing awareness of fertility treatments, advancements in assisted reproductive technologies, rising prevalence of infertility and hormone-related disorders, expanding aging population (associated with delayed pregnancies), and ongoing research and development efforts to improve efficacy and explore new indications. Companies such as Astellas, Emd Serono, Organon, Tolmar, Intas, Abbvie, Sanofi, Kissei, J&J, Astellas, Ferring, Pfizer, Jiangsu Hengrui Pharma, Ardana Biosci, Foresee Pharma, Aeterna Zentaris cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, Astellas is one such company that is currently conducting a clinical trial of the drug Opigolix (ASP1707) for the treatment of Endometriosis.
Key Developments
- In August 2022, EMD Sereno got generic equivalent approval for Cetrorelix for female infertility.
- In Jan 2023, Takeda launched Orgovyx for Prostate cancer (Late-stage disease, Metastatic disease) in the Czech Republic, Austria, and Germany.
Approved GnRH molecules
- Goserelin acetate
- Leuprolide acetate for depot suspension
- Triptorelin
- Firmagon (degarelix)
- Cetrotide (cetrorelix)
- Orgalutran (ganirelix acetate)
- Eligard (leuprolide acetate)
- Orgovyx (relugolix)
- Danazol oral
- Orilissa (elagolix)
- Suprefact (buserelin acetate)
- Yselty (linzagolix)
- Viadur (leuprorelin implant)
- Choriomon (human choriomon gonadotropin (hCG))
- Merional (menotropin)
- Fostimon (purified hFsh)
- Lutrelef (gonadorelin acetate)
- Synarel (nafarelin)
- Camcevi (leuprolide mesylate injectable suspension)
- Vantas (histrelin acetate)
- Plenaxis (abarelix)
- Ovarest (leuprolide oral)
- Teverelix trifluoroacetate
- Lutrate (leuprorelin depot)
- Prosenze (leuprorelin depot)
- Vasaloc (low-dose danazol)
- Danazol vaginal cream
- Decapeptide
GnRH Pipeline Molecules
- Opigolix (ASP1707)
- SHR7280
- Teverelix LA (ARD-03)
- Ozarelix (D-63153)
- Goserelin acetate sustained-release microspheres for injection (LY01005)
- CDX 1307
- Acyline (MER-104)
- Recombinant human chorionic gonadotropin beta (FE 999302)
- DA-3803 (choriogonadotropin alfa biosimilar)
- NBI 42902
- TU2670
- Leuprorelin (CKD-841)
- ASP0265
- VERU-100
- Triptorelin acetate depot (ISR048)
- Vaginal danazol (VML-0501)
Clinical Activity and Development of GnRH
In the GnRH space, nearly 30 companies are conducting more than 1,000 clinical trials in this category of drugs. For instance,
- In June 2022, Ferring Pharmaceuticals completed a phase II trial of Firmagon for Prostate Cancer (Late-stage disease, Combination therapy) in Sweden.
- In April 2021, AbbVie completed a phase III trial of Orilissa for Menorrhagia associated with uterine fibroids in the USA and Puerto Rico.
|
Product Name |
Total Studies |
|
Opigolix (ASP1707) |
8 |
|
SHR7280 |
6 |
|
Teverelix LA (ARD-03) |
5 |
|
Ozarelix (D-63153) |
4 |
|
Goserelin acetate sustained-release microspheres for injection (LY01005) |
4 |
|
CDX 1307 |
3 |
|
Acyline (MER-104) |
3 |
|
Recombinant human chorionic gonadotropin beta (FE 999302) |
3 |
|
DA-3803 (choriogonadotropin alfa biosimilar) |
2 |
|
NBI 42902 |
2 |
|
TU2670 |
2 |
|
Leuprorelin (CKD-841) |
2 |
|
ASP0265 |
1 |
|
VERU-100 |
1 |
|
Triptorelin acetate depot (ISR048) |
1 |
|
Vaginal danazol (VML-0501) |
1 |
Target Indication Analysis of GnRH
GnRH (gonadotropin-releasing hormone) is primarily used as a therapeutic agent for the treatment of various hormonal disorders and reproductive health conditions. One of its main target indications is infertility, where GnRH agonists and antagonists are employed to regulate and stimulate the release of reproductive hormones, facilitating ovulation and improving fertility in both men and women. GnRH analogs are also utilized in hormone-dependent cancers such as prostate and breast cancer, where they act by suppressing the production of sex hormones and inhibiting tumor growth. Furthermore, GnRH therapies are employed in the management of conditions like endometriosis, precocious puberty, and uterine fibroids to alleviate symptoms and restore hormonal balance.
GnRH Market Regional Analysis
GnRH Market
The global GnRH market is segmented into the United States, United Kingdom, Germany, Spain, France, Italy, and Japan. The US market for GnRH (gonadotropin-releasing hormone) products is a significant segment within the pharmaceutical industry. It is characterized by a high demand for fertility treatments and the management of hormonal disorders. The market is concentrated in major metropolitan areas with advanced healthcare infrastructure and reproductive health centers. However, accessibility and affordability remain key challenges in certain regions, limiting market penetration. The regulatory landscape plays a crucial role in market dynamics, with stringent approval processes and labeling requirements influencing product availability and adoption. The market faces competition from alternative treatment options and emerging therapies targeting similar indications. Despite these challenges, the US GnRH market continues to experience steady growth driven by increasing awareness, advancements in assisted reproductive technologies, and a rising prevalence of infertility and hormone-related disorders. Canada, on the other hand, is known for its well-established healthcare system and supportive regulatory framework, making it an attractive market for GnRHs. These countries are increasingly adopting GnRHs due to their efficacy and potential to improve patient outcomes. On the other hand, the GnRH market in Europe has witnessed significant growth in recent years. Major countries driving this market include Germany, France, Italy, and Spain. These countries have a robust pharmaceutical industry, which is a key driver for the GnRH market.
Latin America
Europe
Asia Pacific
Middle East
North America
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
- The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
- The report tracks recent innovations, key developments, and start-up details that are actively working in the market
- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
Frequently Asked Questions
GnRH drugs are used in the management of endometriosis, precocious puberty, and uterine fibroids to alleviate symptoms and restore hormonal balance.
Growth drivers of the GnRH market include increasing awareness of fertility treatments, advancements in assisted reproductive technologies, rising prevalence of infertility and hormone-related disorders, expanding aging population (associated with delayed pregnancies), and ongoing research and development efforts to improve efficacy and explore new indications.
The major players in this space are Astellas, Emd Serono, Organon, Tolmar, Intas, Abbvie, Sanofi, Kissei, J&J, Astellas, Ferring, Pfizer, Jiangsu Hengrui Pharma, Ardana Biosci, Foresee Pharma, Aeterna Zentaris.
The market for GnRH (gonadotropin-releasing hormone) products faces several restraints, including limited accessibility and affordability in certain regions, regulatory challenges in terms of approval and labeling, and competition from alternative treatment options and emerging therapies targeting similar indications. Additionally, potential side effects and the need for specialized administration techniques further contribute to the restraints of the GnRH market.
- Astellas
- Emd Serono
- Organon
- Tolmar
- Intas
- Generic Mfg.
- Abbvie
- Sanofi
- Kissei
- J&J
- Ibsa Institute Biochemical Sa
- Astellas
- Ferring
- Pfizer
- Jiangsu Hengrui Pharma
- Ardana Biosci
- Foresee Pharma
- Aeterna Zentaris
- Orion Corp
- Luye Group
- Celldex
- Contura
- Merrion
- Dong-A
- Neurocrine
- Enteris
- Tium Bio
- Chong Kun Dang
- Antev Limited
- Lubrizol
- Camurus
- Veru Inc
- Ampio
- Femmepharma
- C4X Discovery
- Isr Immune System Regulation
- Viramal
- Sanofi
- Gedeon Richter
- Theramex
- Bayer
- Aska Pharma
- Sumitomo Pharma
- Intas
- Nippon Kayaku
- Endo
- Recordati
- Takeda
- Syneos Health
- Daewon Pharma
- Covis Pharma