Leuprorelin Drugs Market Size to Boost USD 4.78 Billion by 2034

Leuprorelin Drugs Market Size, Shares and Recent Developments

The global leuprorelin drugs market size was estimated at US$ 2.60 billion in 2023 and is projected to grow to US$ 4.78 billion by 2034, rising at a compound annual growth rate (CAGR) of 5.7% from 2024 to 2034. The demand for leuprorelin drugs is growing in the market because these drugs are highly useful in various hormone-related health problems.

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Market Overview

The FDA has authorized leuprolide as a gonadotropin-releasing hormone (GnRH) agonist for the treatment of endometriosis, breast cancer, paraphilia, hypersexuality, central precocious puberty, and prostate cancer. The leuprorelin drugs market is growing as a result of the usage of these medications in all applications. The new generation's central precocious puberty is increasing as a result of consuming foods like eggs, milk, poultry, and other foods made by injecting hormones. In addition, recent years have seen a significant increase in transgender operations and the usage of leuprorelin medications for hormone treatment in transgender people who are male to female.

Leuprorelin Drugs Market Trends

• In December 2023, Daewoong Pharmaceutical Co. Ltd. of South Korea and Zydus Lifesciences Ltd. signed a licensing agreement to jointly develop and market a generic form of leuprolide acetate for depot suspension, which is used to treat endometriosis, advanced prostate cancer, and uterine leiomyomata (fibroids).
• In September 2023, Astellas Pharma Inc. declared that its Type II version of XTANDI® (enzalutamide) has been approved by the European Medicines Agency (EMA) for use in treating patients with hormone-sensitive prostate cancer that has not spread.

Growing Cases of Gender-Affirming Surgeries Promoting the Market

In recent years, the number of gender-affirming surgeries has grown, and the number is estimated to grow significantly in the future. Hormone therapy is a common practice in such cases, and leuprorelin drugs are used for that. These are used to suppress the production of testosterone and estrogen, which is a common practice in gender-affirming surgeries.  As more and more people are going to have the surgeries, the demand for leuprorelin drugs is going to grow, ultimately impacting the leuprorelin drugs market positively.

For instance,

• In the U.S., up to 78% of persons identify as transgender or nonbinary (TNB), meaning that their gender identification or expression deviates from the sex that society expects them to have at birth. At least 13,394 gender reassignment surgeries were performed nationally between 2019 and 2023 on people who were 17.5 years of age or less, with the youngest being seven years old.

Leuprorelin Drugs Market Challenge: Side Effects of the Drugs

Leuprorelin medications have a number of negative effects that may deter many people from using them. Certain metabolic conditions, including diabetes or hyperglycemia (high blood glucose), hyperlipidemia, cirrhosis, or non-alcoholic liver disease, may be exacerbated or brought on by leuprolide.

Regional Insights

North America dominated the leuprorelin drugs market in 2023.

The market is strongly growing in the region due to advanced healthcare infrastructure and awareness among citizens. Apart from this, due to the growing cases of prostate cancer and breast cancer in the region, organizations and the government are taking initiatives to provide proper healthcare.

The U.S. is expected to see 609,820 cancer deaths and 1,958,310 new cancer cases in 2023. The American Cancer Society projects that there will be around 299,010 new instances of prostate cancer and 35,250 prostate cancer-related deaths in the United States in 2024. Approximately one in eight men may receive a prostate cancer diagnosis at some point in their lives. However, a man's age, race or ethnicity, and other characteristics can all affect his risk of prostate cancer. According to the latest data available, 42,211 females in the U.S. lost their lives to breast cancer in 2022, while 272,454 new cases of the disease were recorded in 2021.

One of the most prevalent malignancies to be identified, it is also one of the main causes of cancer-related deaths for men in Canada. Among other things, early identification and therapy may have an impact on prostate cancer survival. According to Canadian statistics, 1 in 8 men (12%) may receive a prostate cancer diagnosis at some point in their lives.

Asia Pacific is expected to grow at the fastest rate during the forecast period.

The leuprorelin drugs market is growing strongly due to growing investments in healthcare and growing cases of prostate and breast cancer. Apart from this, Asia Pacific consists of 2nd and 3rd largest pharmaceutical industries known for the production of drugs on a large scale for exporting worldwide. This indicates that leuprorelin drugs may be produced on a large scale in the region. The major countries that contribute to the growth of the leuprorelin drugs market include China, India, Japan, and South Korea.

In India, the cases of prostate cancer were 43,691 in 2022, and testis cancer cases were 4521. And the cases of breast cancer in India in 2022 were 221,757. It is estimated that the cases are going to rise significantly in the future, which will increase the demand for leuprorelin drugs in India.

Segmental Insights

By type, the injections segment held the largest share of the leuprorelin drugs market and is estimated to remain dominant during the forecast period. There are several advantages of giving drugs using injections, which promote the growth of the segment. Injections are useful in uniformly spreading drugs in the desired location. The medication acts quickly compared to tablets. Due to the high demand for injections, pharmaceutical companies produce them more often.

For instance,

• In August 2024, Meitheal Pharmaceuticals announced the launch of its Leuprolide Acetate Injection, 14mg per 2.8 mL kits.

By application, the prostate cancer segment dominated the leuprorelin drugs market and is estimated to remain dominant during the forecast period. The fifth most common cause of death globally and the second most common cancer diagnosis in males is prostate cancer. Prostate cancer cells develop more rapidly when male hormones like testosterone are present. The progression of prostate cancer can be slowed by lowering the body's testosterone levels. People with late-stage prostate cancer often benefit from hormone therapy, including Lupron, when used in conjunction with other treatments.

For instance,

• In April 2023, as measured by the primary endpoint of metastasis-free survival (MFS), Astellas Pharma Inc. and Pfizer Inc. found that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% when compared to placebo plus leuprolide in men with non-metastatic hormone-sensitive prostate cancer (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001).

Recent Developments

• In November 2022, Leuprolide Acetate Injection Depot 22.5mg was introduced by Cipla Limited and its fully-owned subsidiary Cipla USA Inc. A New Drug Application (NDA) filed under the 505(b)(2) regulatory pathway served as the basis for the product's approval by the US Food and Drug Administration (the "US FDA").
• In March 2022, CAMCEVITM (leuprolide) 42mg injectable emulsion was launched in the United States for the treatment of advanced prostate cancer in adults, according to Accord BioPharma, the U.S. specialty branch of Intas Pharmaceuticals, Ltd.

Top Companies in the Leuprorelin Drugs Market

• Takeda Pharmaceutical
• Beijing Biote Pharmaceutical
• Accord BioPharma
• Sun Pharmaceutical
• AbbVie
• Cipla
• Tolmar
• Merck
• Eugia Pharma
• Foresee Pharmaceuticals
• Livzon Pharmaceuticals

Segments Covered in the Report

By Type

• Injections
• Tablets
• Implants

By Application

• Advanced Prostate Cancer
• Central Precocious Puberty
• Uterine Fibroids
• Endometriosis
• Other

By Region

• North America
  • U.S.
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait