Progesterone Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Sales Channel (Direct, Indirect), By End Use (Hormone Replacement Therapy, Infertility Treatment, Menstrual Disorders, Premenstrual Syndrome (PMS), Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 226.13 Million
CAGR (2026-2031)	2.93%
Fastest Growing Segment	Menstrual Disorders
Largest Market	Asia Pacific
Market Size (2031)	USD 268.91 Million

Market Overview

The Global Progesterone Market is projected to grow from USD 226.13 Million in 2025 to USD 268.91 Million by 2031 at a 2.93% CAGR. Progesterone is an endogenous steroid hormone essential for regulating the menstrual cycle, pregnancy maintenance, and embryogenesis, which is commercially utilized in hormone replacement therapy and assisted reproductive technology. The global market is primarily propelled by the rising prevalence of infertility and the expanding aging female population requiring clinical management for menopausal symptoms. Furthermore, renewed confidence in the safety profile of hormonal treatments has accelerated patient adoption rates. According to The Menopause Society, in 2025, the usage of hormone therapy among women aged 40 to 60 increased to 13%, reflecting a significant recovery in therapeutic uptake driven by evolving medical guidelines.

Despite these growth factors, the market faces a substantial impediment regarding the potential health risks associated with long-term administration. Persistent concerns and regulatory scrutiny concerning adverse effects, specifically the elevated risk of breast cancer and cardiovascular complications linked to prolonged steroid hormone use, continue to create hesitancy among healthcare providers and limit the duration of treatment prescriptions.

Key Market Drivers

The Expansion of Assisted Reproductive Technologies (ART) and Infertility Treatments acts as a primary catalyst for the market, as progesterone administration is critical for luteal phase support and establishing viable pregnancies during IVF cycles. This reliance is intensifying as patient access to fertility services broadens globally, necessitating higher volumes of vaginal, injectable, and oral progesterone formulations. According to the Society for Assisted Reproductive Technology, April 2025, in its annual national data release, the total number of IVF cycles performed at member clinics rose to 432,641 in 2023, representing a significant year-over-year increase that directly correlates with higher therapeutic consumption. To meet this specific clinical need, manufacturers are introducing targeted innovations; for instance, according to Besins Healthcare, April 2025, the company launched Prometrium 400mg soft vaginal capsules in the UK, the first licensed progesterone treatment specifically designed to prevent miscarriage in women with early pregnancy bleeding.

Rising Global Demand for Hormone Replacement Therapy (HRT) significantly propels market growth, driven by an aging female demographic seeking effective management for menopausal symptoms and long-term health preservation. In these regimens, progesterone is indispensable for women with an intact uterus to prevent estrogen-induced endometrial hyperplasia, thereby sustaining long-term prescription renewal rates. This trend is evidenced by substantial prescription volume growth in key markets. According to the NHS Business Services Authority, October 2025, in the 'Hormone Replacement Therapy - England' report, the total number of HRT items prescribed rose to 14.7 million in 2024/25, marking an 11% increase from the previous year. Such robust uptake underscores the molecule's enduring commercial relevance in mature healthcare systems.

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Key Market Challenges

The Global Progesterone Market faces a substantial impediment due to the persistent health risks associated with long-term hormone administration, specifically the potential for an increased incidence of breast cancer and cardiovascular complications. These safety concerns significantly influence clinical decision-making, leading healthcare providers to limit the duration of prescriptions and adopt conservative treatment protocols. Consequently, this medical caution restricts the recurring revenue potential from long-term maintenance therapies, directly hampering the overall volume of progesterone consumed globally as physicians prioritize patient safety over extended therapeutic regimens.

The severity of these concerns is underscored by recent data highlighting the prevalence of hormone-sensitive malignancies, which sustains the apprehension regarding prolonged steroid usage. According to the American Cancer Society, in 2025, an estimated 316,950 new cases of invasive breast cancer were diagnosed in women in the United States. This substantial burden of disease reinforces the regulatory and clinical scrutiny surrounding hormone replacement therapies, compelling physicians to rigorously enforce shorter treatment courses to minimize carcinogenic risks. As a result, the market experiences a constrained growth trajectory, as the window for safe therapeutic application remains tightly bounded by these overriding safety considerations.

Key Market Trends

The Global Progesterone Market is witnessing a decisive shift towards bioidentical micronized progesterone, fundamentally altering the product mix as patients and clinicians increasingly prioritize safety and tolerability over synthetic progestins. This trend is anchored in the clinical preference for molecules that structurally mimic endogenous hormones, thereby mitigating the perceived risks of breast cancer and venous thromboembolism associated with traditional synthetic alternatives. This commercial pivot is substantiated by the financial performance of companies specializing in these formulations, who are seeing rapid revenue expansion from their bioidentical portfolios. According to Nasdaq, August 2025, in the 'TherapeuticsMD Swings to Profit in Q2' report, the company's license revenue, driven by its portfolio of bioidentical hormone therapies, surged to $1.0 million in the second quarter of 2025, reflecting a robust 334% increase compared to the previous year.

Concurrently, the integration of progesterone distribution with telehealth and digital pharmacy channels is reshaping patient access, particularly in response to persistent regional supply chain disruptions. Digital platforms are becoming essential intermediaries, offering streamlined consultation-to-delivery models that bypass traditional brick-and-mortar bottlenecks and enhance adherence through subscription-based services. This operational evolution is further supported by government initiatives designed to lower cost barriers and ensure continuity of care for menopausal women, which digital providers are actively leveraging to maintain stock consistency. According to UK Meds, January 2025, in the 'Is There A HRT Shortage In The UK In 2025?' article, the implementation of the HRT Prescription Prepayment Certificate has successfully facilitated affordable access for over 500,000 women, directly stabilizing demand fulfillment through these modern dispensing corridors.

Segmental Insights

Menstrual disorders are positioned as the fastest-growing segment in the global progesterone market due to the escalating prevalence of hormonal imbalances among women. Factors such as lifestyle changes and increased stress levels contribute to conditions like secondary amenorrhea and abnormal uterine bleeding, necessitating therapeutic intervention. The U.S. Food and Drug Administration supports this utilization by maintaining approvals for progesterone products specifically indicated to restore normal menstrual cycles. This consistent clinical reliance on hormone therapy for cycle regulation fundamentally underpins the rapid expansion of this segment.

Regional Insights

Asia Pacific dominates the Global Progesterone Market, driven by the robust pharmaceutical manufacturing infrastructure in key economies such as China and India. This regional leadership is sustained by the rising prevalence of gynecological disorders and the increasing adoption of hormone replacement therapies. Furthermore, supportive healthcare initiatives aimed at improving women's reproductive health have created a favorable environment for market expansion. The strategic focus on producing cost-effective generic formulations, frequently facilitated by regulatory bodies like the National Medical Products Administration, ensures the region effectively meets both domestic and international demand for progesterone therapeutics.

Recent Developments

• In September 2025, Xiromed LLC announced the launch of its Progesterone Vaginal Insert, 100 mg, in the United States market. This product was introduced as a generic equivalent to Endometrin and was notable for being the first generic approved by the U.S. Food and Drug Administration with a Competitive Generic Therapy designation. The company confirmed that the product is indicated to support embryo implantation and early pregnancy through the supplementation of corpus luteal function as part of Assisted Reproductive Technology treatment programs. The CEO of the company remarked that this launch underscored their commitment to providing affordable fertility treatments for women.
• In April 2025, Besins Healthcare UK announced the launch of Prometrium 400 mg soft vaginal capsules across the United Kingdom, expanding access to this progesterone formulation. The company positioned this product as the first and only licensed treatment in the UK specifically for the prevention of miscarriage in women presenting with early pregnancy bleeding and a history of recurrent miscarriage. This launch was supported by clinical data demonstrating improved live birth rates in the target population. The General Manager of the company stated that this introduction aimed to improve outcomes for women facing early pregnancy complications by providing a high-dose vaginal progesterone option.
• In June 2024, Changchun GeneScience Pharmaceuticals Co., Ltd. (GenSci) reported that its proprietary progesterone injection, Jin Sai Xin, received approval from the National Medical Products Administration in China. This approval established the product as the first aqueous solution progesterone injection available in the region, designed specifically for progesterone supplementation in assisted reproductive technology (ART). The company emphasized that this subcutaneous injection formulation offered advantages over traditional intramuscular oil-based injections or vaginal formulations, potentially improving patient compliance and reducing adverse reactions. The approval represented a strategic expansion of the company's portfolio in the women's health and fertility sector.
• In February 2024, Knight Therapeutics Inc. announced the commercial launch of BIJUVA capsules in Canada, marking a significant development in the hormone therapy landscape. This product is a fixed-dose combination of bio-identical estradiol and bio-identical progesterone in a single oral capsule, indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus. The company highlighted that this formulation offered a convenient once-daily option for patients experiencing hot flashes and night sweats. The launch provided a new therapeutic alternative in the Canadian market, combining two hormones structurally identical to those naturally produced by the body.

Key Market Players

• NAARI PHARMA Pvt. Ltd
• La Chandra Pharmalab Pvt. Ltd.
• BGP Laboratories Private Limited
• Mankind Pharma Ltd
• Bhugan Lifescience Pvt Ltd
• Abcures Biosciences LLP
• Symbiotec Pharmalab
• Granth Pharma Pvt Ltd
• Emote Lifesciences LLP

By Sales Channel	By End Use	By Region
Direct Indirect	Hormone Replacement Therapy Infertility Treatment Menstrual Disorders Premenstrual Syndrome (PMS) Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Progesterone Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Progesterone Market, By Sales Channel:

• Direct
• Indirect

• Progesterone Market, By End Use:

• Hormone Replacement Therapy
• Infertility Treatment
• Menstrual Disorders
• Premenstrual Syndrome (PMS)
• Others

• Progesterone Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE