Leuprolide Acetate Global Market Report 2025

The leuprolide acetate market size has grown strongly in recent years. It will grow from $2.54 billion in 2024 to $2.71 billion in 2025 at a compound annual growth rate (CAGR) of 6.9%. Growth during the historic period can be attributed to the increasing prevalence of prostate cancer, a rise in endometriosis diagnoses, the expanding global aging population, regulatory approvals across various regions, and sustained use of leuprolide supported by clinical evidence for its effectiveness in treating hormone-sensitive cancers.

The leuprolide acetate market size is expected to see strong growth in the next few years. It will grow to $3.49 billion in 2029 at a compound annual growth rate (CAGR) of 6.5%. Growth in the forecast period can be attributed to the expansion of leuprolide biosimilars, increased use in fertility treatments, the rising incidence of hormone-sensitive cancers, regulatory approvals for new indications, and government support for rare diseases and pediatric therapies. Key trends expected during this period include the development of combination therapies, advancements in hormone therapy innovation, the creation of slow-release formulations, enhanced collaborations between pharmaceutical and biotechnology companies, and the growing focus on personalized medicine and precision oncology.

The rising prevalence of prostate cancer is expected to drive the growth of the leuprolide acetate market in the coming years. Prostate cancer originates in the glandular cells of the prostate, a male-specific organ located beneath the bladder. The increasing number of prostate cancer cases is largely attributed to the aging population, as the risk of developing this disease escalates with age. Leuprolide acetate supports prostate cancer treatment by lowering testosterone levels, thereby helping to slow or halt tumor growth. It provides a non-surgical treatment option for advanced prostate cancer, contributing to improved patient outcomes and quality of life. For example, in January 2025, the World Cancer Research Fund, a UK-based non-profit organization, reported 1,467,854 new prostate cancer cases and 397,430 related deaths in 2022. As a result, the growing prevalence of prostate cancer is fueling the demand for leuprolide acetate.

Leading companies in the leuprolide acetate market are prioritizing the development of advanced drug delivery systems, such as injection depots, to enhance patient adherence and treatment effectiveness. Injection depots are designed to release medication gradually over a prolonged period following administration, reducing the frequency of dosing. For example, in November 2022, Cipla Limited, an India-based pharmaceutical company, introduced a leuprolide acetate injection depot 22.5 mg in the U.S., approved by the FDA through the 505(b)(2) regulatory pathway. This three-month injectable formulation is intended for the palliative treatment of advanced prostate cancer. It is supplied as lyophilized microspheres in a prefilled syringe, accompanied by a user-friendly reconstitution device, aiming to deliver affordable and high-quality care to patients.

In December 2023, Zydus Lifesciences Ltd., an India-based pharmaceutical company, signed an exclusive licensing agreement with Daewoong Pharmaceutical Co. Ltd. to co-develop and commercialize leuprolide acetate for depot suspension. This partnership is intended to combine Daewoong’s proprietary formulation technology and expertise with Zydus’s robust market presence to deliver an advanced, long-acting hormonal therapy to global markets. Daewoong Pharmaceutical Co. Ltd., based in South Korea, specializes in innovative drug delivery systems and provides leuprolide acetate for hormone-related treatments.

Major players in the leuprolide acetate market are Pfizer Inc., Merck & Co. Inc., AbbVie Inc., Sanofi SA, Novartis AG, Takeda Pharmaceutical Company Limited, Intas Pharmaceuticals Ltd, Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Cipla Limited, Ferring B.V., Hikma Pharmaceuticals PLC, Amneal Pharmaceuticals Inc., Zydus Lifesciences Limited, Alkem Laboratories Ltd, Emcure Pharmaceuticals Ltd, Tolmar Pharmaceuticals Inc., Eugia Pharma Specialties Limited, Fresenius Kabi Oncology Limited, Midas Pharma GmbH, and Samarth Life Sciences Pvt Ltd.

North America was the largest region in the leuprolide acetate market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in leuprolide acetate report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the leuprolide acetate market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Leuprolide acetate is a synthetic gonadotropin-releasing hormone (GnRH) agonist primarily used to suppress hormone production. It functions by initially stimulating and then inhibiting the pituitary gland, leading to a reduction in estrogen and testosterone levels. It is mainly prescribed for hormone-sensitive conditions such as prostate cancer, endometriosis, uterine fibroids, and precocious puberty.

Leuprolide acetate is available in various product forms, including vials, prefilled syringes, and lyophilized powder. Vials are small glass or plastic containers that store the medication in liquid form for injection. The drug can be administered via intramuscular, subcutaneous, intranasal, or implantation methods and is distributed through hospital pharmacies, retail pharmacies, and online platforms. Its key applications include treatment of prostate cancer, endometriosis, uterine fibroids, central precocious puberty, infertility, hormone therapy, and more, serving end users such as hospitals, clinics, home care settings, and research laboratories.

The leuprolide acetate market research report is one of a series of new reports that provides leuprolide acetate market statistics, including leuprolide acetate industry global market size, regional shares, competitors with a leuprolide acetate market share, detailed leuprolide acetate market segments, market trends and opportunities, and any further data you may need to thrive in the leuprolide acetate industry. This leuprolide acetate market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The leuprolide acetate market consists of sales of long-acting depot injections and custom compounded forms. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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