Progesterone Market Size, Share & Trends Analysis Report By Type (Natural Progesterone, Synthetic Progesterone), By Modes of Delivery Source: (Injectable, Suspended Form, Oral, Intravaginal, Others), By Application (Regulation of the Menstrual Cycle, Dysfunctional Uterine Bleeding, Endometrial Cancer, Contraception, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global progesterone market size was valued at USD 1.34 billion in 2023. It is estimated to reach USD 4.14 billion by 2032, growing at a CAGR of 12.30% during the forecast period (2024–2032).

Progesterone is a key steroid hormone that regulates the menstrual cycle, supports pregnancy and promotes embryo formation. Produced mainly in the ovaries after ovulation, it prepares the uterine lining for implantation and maintains it during early pregnancy, preventing contractions that could expel the embryo. The placenta takes over its production later in life. Progesterone is also produced in small amounts by the adrenal glands and is used clinically in hormone replacement therapy, contraception, and treating menstrual disorders. Proper progesterone levels are essential for reproductive health, with deficiencies leading to issues like irregular menstruation and difficulties in maintaining pregnancy.

The progesterone market is growing due to increasing demand for hormone replacement therapy (HRT) in menopausal women, rising prevalence of menstrual disorders, and the expanding use of progesterone in assisted reproductive technologies (ART). Market growth is also driven by growing awareness of women's health, advances in drug delivery systems and increased research and development into progesterone based therapies.

Market Dynamics

Global Progesterone Market Drivers:

Increasing Demand for Hormone Replacement Therapy (HRT)

As the global population ages, a significant number of women enter menopause, leading to a higher demand for hormone replacement therapy (HRT) to manage menopausal symptoms such as hot flashes, night sweats, mood swings, and vaginal dryness. Progesterone is a critical component of HRT, especially in women who have not undergone a hysterectomy, as it helps to counteract the potential adverse effects of estrogen on the uterine lining, reducing the risk of endometrial cancer.

For instance, Prometrium is a widely used progesterone capsule approved for HRT. It is used in combination with estrogen therapy to treat symptoms of menopause and prevent endometrial hyperplasia in women who have not had their uterus removed. Due to its efficacy and safety profile, the introduction of Prometrium has provided a bioidentical hormone alternative that is well received.

Another example is Utrogestan (micronized progesterone), which is used in hormone replacement therapy (HRT) to relieve menopause symptoms by balancing estrogen, reducing the risk of womb cancer. It is typically taken as capsules on specific days each month. Regular medical check-ups are essential to monitor its effectiveness and safety.

Expanding Use in Assisted Reproductive Technologies (ART)

Progesterone is increasingly used in assisted reproductive technologies (ART) to support the luteal phase and early pregnancy, thereby enhancing the chances of successful embryo implantation and pregnancy maintenance. During ART procedures like in vitro fertilization (IVF), progesterone helps prepare the uterine lining for the implantation of the fertilized egg and supports the early stages of pregnancy by maintaining the uterine lining.

For instance, Crinone, Endometrin is a progesterone vaginal insert specifically designed for use in ART. It provides consistent and targeted delivery of progesterone to support the luteal phase and early pregnancy in women undergoing IVF treatments. Endometrin has been approved by regulatory bodies like the FDA, and its effectiveness in improving pregnancy outcomes in ART makes it a popular choice among fertility specialists.

Global Progesterone Market Restraint:

Stringent Regulatory Requirements

Stringent regulatory requirements and approval processes for new progesterone formulations and treatments can delay market entry and increase costs for manufacturers.

For instance, FDA approval process for new progesterone formulations are lengthy and take several years and costing millions of dollars in research, development, and regulatory expenses. Delays in approval can significantly impact market entry, as manufacturers are unable to commercialize their products until regulatory approval is obtained. The stringent requirements and costs associated with regulatory approval can discourage smaller manufacturers from developing new progesterone formulations, limiting innovation and competition in the market.

Global Progesterone Market Opportunities:

Expanding Applications of Progesterone

Progesterone, traditionally known for its role in women's health, is now being investigated for its potential applications beyond reproductive medicine. As per National Library of Medicine, in cancer treatment, progesterone-based therapies, such as progesterone receptor modulators (PRMs), are being explored and studied for hormone receptor-positive breast cancer and endometrial cancer.  These therapies aim at progesterone receptors that are present in cancer cells, which offer a new way of treating them.

In the area of neurological disorders, as per National Institute on Mental Health, progesterone and synthetic progestin have been identified as an emerging therapy in regenerative medicine due to its potential for treating Central nervous system disorders. Similarly, studies have shown that progesterone may be able to protect against the development of multiple sclerosis and indicate its potential as a medicine.

In order to assess the efficacy and safety of progesterone in these nontraditional applications, clinical trials are essential. The success of these studies could lead to the development of expanded indications for progesterone and the development of new progesterone based treatments for different medical conditions, stimulating the growth of the market.

Technological Advancements in Progesterone Drug Delivery

Technological advancements in drug delivery systems are enhancing the effectiveness and convenience of progesterone therapies, driving market growth. Transdermal patches, like the Levonorgestrel, deliver progesterone through the skin, providing sustained release and consistent hormone levels. Intramuscular and subcutaneous injections, like progesterone in oil (PIO), provide rapid and reliable hormone delivery. Vaginal delivery systems, such as Crinone gel, offer localized progesterone delivery, beneficial for certain conditions like luteal phase support in IVF. These advancements signal a promising future for progesterone therapy, with potential for further innovations in delivery systems, thereby, expected to contribute the growth of the market.

Regional Analysis

Based on region, the global progesterone market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global progesterone market shareholder and is expected to expand substantially during the forecast period due to various product launches in North America. For instance, Xiromed LLC, the generic division of Insud Pharmaceuticals based in Florham Park, NJ, announced the launch of Progesterone Injection USP, 500 mg/10 mL (50 mg/mL) Multiple-Dose Vial, a generic version of Progesterone Injection USP, 50 mg/mL.

The United States progesterone market is leading in terms of market share. The increase in uterine body cancers in U.S. is expected to boost the market. The American Cancer Society estimates that in 2024, about 67,880 new cases of uterine cancer will be diagnosed in U.S. , with about 13,250 women dying from the disease. These figures underscore the importance of progesterone in the treatment and management of uterine cancer, contributing to the growth of the market.

Canada is expected to become a key player in the global progesterone market. As per Canada.ca, in 2022, an estimated 28,600 Canadian women diagnosed with breast cancer, and 5,500 died. Breast cancer accounts for approximately 25% of new cases of cancer and 14% of all cancer deaths in Canadian women. These figures highlights the importance of progesterone, which is used in treating hormone-related cancers like breast cancer, indicating a potential rise in demand for such treatments in Canada.

Europe region is expected to emerge in progesterone market. Europe has a well-established healthcare infrastructure and a high prevalence of conditions such as breast cancer and menstrual disorders, which are commonly treated with progesterone. Additionally, increasing awareness about women's health and advancements in medical research contribute to the region's prominence in the progesterone market.

U.K. progesterone market has a major role in shaping the dynamics of the Europe progesterone market. In the UK, progesterone is available in various forms and strengths for different indications. It is primarily prescribed as part of hormone replacement therapy (HRT) for menopausal symptoms, often in combination with estrogen. For instance, one of the leading manufacturers of progesterone-based products, Theramex launched Bijuva/Bijuve  (1mg estradiol / 100mg progesterone) in Europe and the UK. It's the first body-identical hormone therapy (HRT) combining estradiol and progesterone in a single daily oral capsule for post-menopausal women with an intact uterus. This launch offers a new treatment option for estrogen deficiency symptoms in this population.

Germany is expected to emerge in progesterone market. According to National Institutes of Health (NIH), endometrial cancer (EC) is the most commonly diagnosed gynecological cancer in Germany, with 12,356 new cases and 2444 deaths. Thus, rising the need for progesterone based treament.

Moreover, key manufacturers in Germany such as Bayer are focused to produce various progesterone-based products, including Duphaston (dydrogesterone) for  the treatment of menstrual disorders such as irregular periods and dysmenorrhea, as well as in hormone replacement therapy (HRT).

Segmental Analysis

The global progesterone market is segmented by type, modes of delivery source, and application.

Based on type, the global progesterone market is divided into natural progesterone and synthetic progesterone.

The natural segment for progesterone market is dominant. Natural progesterone, which is identical to the progesterone produced in the human body, is often preferred over synthetic progesterone due to its perceived safety and effectiveness. Natural progesterone-based products are derived from soybeans or Dioscorea Villosa, a wild Mexican yam. The natural progesterone segment is leading in the global progesterone market, driven by rising product launches by various players in the industry. For example, Fuji Pharma Co., Ltd launched F-meno capsule 100 mg, a natural progesterone drug in Japan, for preventing endometrial hyperplasia associated with estrogen drugs. Positive patient outcomes with natural progesterone, attributed to improved hormonal interactions, contribute to its high growth potential.

Based on mode of delivery source, the global progesterone market is divided into injectable, suspended form, oral, intravaginal and others.

The oral mode of delivery source segment dominates the global market. Oral administration is often preferred by patients due to its convenience and practicality compared to IM injections or intravaginal administration. For example, as per an article published by National Library of Medicine, in some countries like India, women are reluctant to use intravaginal medications, especially during pregnancy, and prefer oral medication.

Moreover, in terms of safety and tolerability, oral progesterone preparations mitigate the risk of local adverse effects associated with intramuscular injections or intravaginal administration. This is attributed to the systemic absorption of the medication through the gastrointestinal tract, bypassing the need for direct application to localized areas.

Based on the application, the global progesterone market is bifurcated into regulation of the menstrual cycle, dysfunctional uterine bleeding, endometrial cancer, contraception, others

The regulation of the menstrual cycle segment dominates the global progesterone market. The high prevalence of menstrual disorders due to various factors, including stress, unhealthy lifestyle choices, obesity, hormonal disorders like PCOS and thyroid imbalances, as well as environmental and genetic factors is increasing the need of progesterone to address these disorders by regulating the menstrual cycle and hormone levels, alleviating associated symptoms.

For example, a study published in the National Library of Medicine reported a high prevalence of menstrual disorders among females, with 90.4% experiencing some form of disorder. This included amenorrhea (39%), dysmenorrhea (70.8%), and premenstrual syndrome (72.2%). These study underscore the significant impact of menstrual disorders on a large portion of the female population and highlight the need for effective treatments and management strategies to regulate the cycle using progesterone.

Recent Developments

• September 2022, NHS Scotland approved Bijuve as a hormone replacement therapy (HRT) for women with estrogen deficiency during postmenopause.
• October 2022, Sun Pharma received approval from the Subject Expert Committee (SEC) under India's Central Drug Standard Control Organization (CDSCO) to manufacture and market progesterone sustained-release tablets in strengths of 200mg, 300mg, and 400mg in India.

Analyst’s Perspective:

According to our research analysts, progesterone presents a promising market outlook due to its critical role in women's health, including hormone replacement therapy, fertility treatments, and cancer management. With increasing prevalence of conditions like breast cancer and menstrual disorders, demand for progesterone is expected to rise. Expanding applications beyond women's health, such as in neurology and oncology, offer new revenue streams.

To capitalize, focus on innovative formulations, market expansion in regions with high disease burden, and strategic partnerships for research and development is pivotal. Ensuring compliance with stringent regulatory requirements is key factor for market entry and growth.