SERM Market Outlook 2034: Clinical Trials, FDA Approvals, Market Size, Therapies, Companies by DelveInsight

The Selective Estrogen Receptor Modulators (SERMs) market is anticipated to witness significant expansion in the coming years, fueled by the increasing prevalence of cancer, heightened awareness of SERM therapies, and a growing pipeline of candidates in clinical trials and regulatory review across multiple companies.
SERMs Market Summary

The Selective Estrogen Receptor Modulators (SERMs) market is expected to witness significant growth in the coming years, fueled by the increasing incidence of cancer, rising awareness about SERMs, and a growing pipeline of candidates in clinical trials or pending regulatory approval from various companies. Selective estrogen receptor modulators (SERMs) play a vital role in managing ER-positive/HER2-negative breast cancer, menopausal symptoms such as dyspareunia and in preventing postmenopausal osteoporosis. Key players include Duchesnay, Pfizer, Eli Lilly, Sermonix Pharmaceuticals, and Atossa Therapeutics. Pfizer's DUAVEE/DUAVIVE, a combination of conjugated estrogens with bazedoxifene, addresses vasomotor symptoms and osteoporosis prevention. Lasofoxifene (FABLYN) is approved in Europe for osteoporosis, while U.S. approval remains pending. Atossa's novel (Z)-Endoxifen recently received a U.S. patent, showing strong potential in breast cancer treatment. Despite advances, pipeline limitations highlight the urgent need for further SERM development in oncology and osteoporosis.

DelveInsight's report, "SERMS Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" provides a comprehensive overview of SERM, including historical and projected epidemiology as well as therapeutic market trends across the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. The SERM market report offers insights into current treatment practices, emerging therapies, and the market share of individual drugs, along with the present and projected SERM market size across the 7MM from 2020 to 2034. It further examines existing treatment algorithms, highlights unmet medical needs, and identifies key opportunities to evaluate the market's overall potential.

Gain in-depth insights into the evolving SERM market, including pipeline developments, clinical trials, and emerging therapies. Download the full market report and stay ahead in oncology and women's health innovation. @ SERM market forecast [https://www.delveinsight.com/report-store/serms-market-forecast?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Recent Development in SERM Clinical Research

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In April 2025, Atossa Therapeutics reported that the US Patent and Trademark Office (USPTO) had issued a new patent (US Patent No. 12,275,684) covering enteric oral formulations containing (Z)-Endoxifen, along with methods for treating patients using these formulations.

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In April 2025, Sermonix Pharmaceuticals and Quantum Leap Healthcare Collaborative jointly announced that in a Phase II clinical trial assessing lasofoxifene as a neoadjuvant endocrine therapy in molecularly selected HR+/HER2-, locally advanced breast cancer, the investigational therapy was well tolerated and showed encouraging early results in reducing Ki67 protein levels in both premenopausal and postmenopausal patients.

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In January 2025, Sermonix Pharmaceuticals shared the publication of an article titled "Effects of Lasofoxifene Versus Fulvestrant on Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study" in the peer-reviewed journal Clinical Breast Cancer.

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In December 2024, Atossa presented three posters at the San Antonio Breast Cancer Symposium (SABCS) highlighting pharmacokinetic (PK) and tolerability data from the Phase II EVANGELINE trial.

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In July 2024, Sermonix Pharmaceuticals announced the issuance of a US patent expanding its intellectual property portfolio for lasofoxifene. The patent covers methods for treating aromatase inhibitor (AI)-resistant, estrogen receptor-positive (ER+) breast cancer in patients without ESR1 mutations.

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In April 2024, Atossa Therapeutics and Quantum Leap Healthcare Collaborative announced the initiation of a new study evaluating Atossa's proprietary (Z)-Endoxifen in combination with abemaciclib (VERZENIO) in women with ER+/HER2- breast cancer.

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In March 2024, Atossa Therapeutics reported that a premenopausal ER+/HER2- breast cancer patient receiving neoadjuvant and adjuvant (Z)-Endoxifen therapy under an FDA-approved "expanded access" program completed five years of treatment. The patient remains cancer-free and has experienced no significant safety or tolerability issues throughout the treatment period.

From breast cancer treatments to postmenopausal osteoporosis, SERMs are reshaping therapeutic strategies. Get exclusive forecasts and actionable intelligence to power your next move. Request your report today @ SERMs Therapeutics Market [https://www.delveinsight.com/sample-request/serms-market-forecast?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

SERM Market Outlook

The Selective Estrogen Receptor Modulators (SERMs) market is set for strong growth, driven by rising cancer diagnoses, greater awareness of SERMs, and expanding clinical trials. SERMs show promise in treating ER-positive breast cancer, postmenopausal osteoporosis, dyspareunia, and dryness. Key players include Atossa Therapeutics, Sermonix Pharmaceuticals, and others, with notable progress such as Atossa's clinical advancement of (Z)-Endoxifen and Sermonix's expanding patent portfolio for Lasofoxifene (FABLYN), already approved in Europe. While marketed drugs like OSPHENA, DUAVEE, EVISTA, and FABLYN paved the way, limited new approvals highlight the need for innovation. With a growing pipeline, ongoing trials, and rising demand, SERMs are emerging as a critical therapeutic class for oncology and women's health.

SERM Market Drivers

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Rising Incidence of Hormone-Related Disorders: Increasing prevalence of estrogen receptor-positive (ER+) breast cancer, postmenopausal osteoporosis, and dyspareunia is expanding the patient pool.Hormone-related conditions in aging populations are driving sustained demand for SERMs.

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Targeted Mechanism of Action: SERMs selectively stimulate or inhibit estrogen receptors depending on tissue type, offering therapeutic benefits without the widespread side effects of traditional hormone replacement therapy. Their tissue-specific action makes them effective in oncology, bone health, and menopausal symptom management.

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Emerging Therapies and Pipeline Innovations: Novel SERMs such as (Z)-Endoxifen and Lasofoxifene are in advanced clinical trials and expected to reach the market, promising improved efficacy and safety. New formulations and personalized medicine approaches enhance treatment precision and broaden indications.

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Growing Awareness of Women's Health: Increasing patient and physician awareness of SERMs for osteoporosis, breast cancer prevention, and menopausal symptoms supports market growth. Expansion into emerging markets with better healthcare access further fuels adoption.

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Regulatory Approvals and Strategic Collaboration: Recent patents and regulatory milestones, along with collaborations among pharmaceutical companies, support innovation and market expansion.

SERM Market Barriers

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Competition from Alternative Therapies: Aromatase inhibitors, biologics, and newer endocrine therapies sometimes offer superior efficacy in certain indications, limiting SERM adoption.

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Safety Concerns: Long-term SERM use carries risks such as thromboembolic events and endometrial cancer, prompting cautious prescribing by clinicians.

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Generic Competition: First-generation SERMs like tamoxifen face pricing pressures from generics, which can erode profit margins and reduce market attractiveness for existing products.

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Limited Awareness in Certain Regions: While global awareness is rising, uptake in certain emerging markets remains restrained due to healthcare infrastructure limitations and access challenges.

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Regulatory Hurdles: Approval timelines for novel SERMs can be long, and stringent safety and efficacy requirements may delay market entry.

The market for SERMs is expanding rapidly, but the pipeline remains limited. Understand where the real opportunities lie with our expert-driven forecasts. Download the report now. @ SERMs Market Size and Share [https://www.delveinsight.com/report-store/serms-market-forecast?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Key SERM Companies In The Market Landscape:

Several key players, including Atossa Therapeutics ((Z)-Endoxifen) and Sermonix Pharmaceuticals (Lasofoxifene), are actively developing selective estrogen receptor modulators (SERMs) for a range of indications such as breast cancer, dyspareunia, dryness, and more. This emerging class of agents holds significant promise for therapeutic innovation.

(Z)-Endoxifen, developed by Atossa Therapeutics, is a nonsteroidal SERM from the triphenylethylene class currently in Phase II development for estrogen receptor-positive (ER+) breast cancer. The drug demonstrates potential across multiple stages of breast cancer management: reducing breast tissue density to lower cancer risk, inhibiting tumor cell activity prior to surgery, and preventing recurrence or new tumor development following initial treatment. Atossa is particularly focused on advancing (Z)-Endoxifen for metastatic breast cancer.

In April 2025, Atossa announced that the U.S. Patent and Trademark Office granted a new patent (US Patent No. 12,275,684) for enteric oral formulations of (Z)-Endoxifen and their therapeutic applications. Previously, in December 2024, the company presented three posters at the San Antonio Breast Cancer Symposium (SABCS), highlighting pharmacokinetic and tolerability results from the ongoing Phase II EVANGELINE trial.

Lasofoxifene is an investigational endocrine therapy being evaluated for its activity as an ESR1 antagonist, especially in tumors harboring ESR1 mutations. Phase II trials have shown promising anti-tumor activity both as a monotherapy and in combination with CDK4/6 inhibitors. Lasofoxifene is notable for its tissue-selective effects, with benefits previously observed for bone health.

In April 2025, Sermonix Pharmaceuticals, in collaboration with Quantum Leap Healthcare Collaborative, reported encouraging Phase II neoadjuvant trial data in patients with HR+/HER2- locally advanced breast cancer, demonstrating favorable tolerability and early suppression of the proliferation marker Ki67 in both premenopausal and postmenopausal women. Earlier, in January 2025, findings from the ELAINE-1 study published in Clinical Breast Cancer compared lasofoxifene with fulvestrant, highlighting lasofoxifene's positive impact on vulvar symptoms in ESR1-mutated, ER+/HER2- metastatic breast cancer patients.

The introduction of these novel therapies is expected to significantly transform the SERM market in the coming years. As these advanced agents progress through development and gain regulatory approvals, they are likely to establish new standards of care while creating opportunities for medical innovation and economic growth.

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SERM Epidemiology Insights

The global burden of estrogen-related disorders continues to rise, fueling the demand for SERMs. According to epidemiological estimates, breast cancer remains one of the leading cancers among women worldwide, with over 2.3 million new cases annually. Similarly, osteoporosis affects approximately 200 million people globally, with postmenopausal women at the highest risk. These figures highlight a significant patient pool that directly contributes to the SERMs market growth. Moreover, the increasing prevalence of gynecological conditions, such as uterine fibroids and endometriosis, further supports the expanding role of SERMs in clinical practice.

Key Highlights:

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In 2024, the total number of new breast cancer cases in the 7MM was approximately 670,500.

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Of these, around 480,000 cases were HR+/HER2- breast cancer in the 7MM in 2024.

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In the 7MM, the United States recorded the highest number of new HR+/HER2 breast cancer cases, with roughly 211,580 in 2024.

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Within EU4 and the UK, Germany reported the highest incidence of HR+/HER2- breast cancer, followed by France.

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In the United States, the majority of HR+/HER2 breast cancer patients were in the 60-79 years age group.

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Among postmenopausal women, the overall prevalence of osteoporotic fractures was 82.2%, including 37.5% with osteoporosis and 44.7% with osteopenia.

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In EU4 and the UK, dyspareunia affected nearly 7.5% of women in 2024.

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In the United States, dyspareunia was estimated to impact 10-20% of women in 2024.

SERM Drugs and Therapies

The drug chapter segment of the SERM reports provides an in-depth review of both marketed SERMs and late-stage (Phase II and Phase III) pipeline candidates. It offers insights into clinical trial details, pharmacological mechanisms, partnerships and collaborations, regulatory approvals, patent information, and the pros and cons of each drug, along with the latest news and press releases.

SERM Marketed Drugs

OSPHENA (ospemifene): Duchesnay

OSPHENA, an estrogen agonist/antagonist, is approved for treating moderate to severe dyspareunia, a symptom of vulvar and atrophy due to menopause, as well as moderate to severe dryness. The US Food and Drug Administration first approved OSPHENA in 2013, and it was initially marketed in the US by Shionogi. The European Commission granted approval in 2015 for distribution in the EU. In 2017, Duchesnay acquired exclusive rights from Shionogi to market and distribute OSPHENA in the US and Canada.

DUAVEE (conjugated estrogens/bazedoxifene): Pfizer

DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist, indicated for treating moderate to severe vasomotor symptoms associated with menopause and preventing postmenopausal osteoporosis. Marketed as DUAVEE in the US and DUAVIVE in the EU, the combination received approval in the United States in October 2013 and in the European Union in December 2014.

Emerging SERM Drugs

(Z)-Endoxifen: Atossa Therapeutics

(Z)-Endoxifen, developed by Atossa Therapeutics, is a nonsteroidal selective estrogen receptor modulator (SERM) belonging to the triphenylethylene class. It is being developed for the treatment of estrogen receptor-positive breast cancer. The therapy has the potential to address all three stages of the breast cancer continuum: reducing breast cancer risk by decreasing breast tissue density, inhibiting cancer cell activity prior to surgery, and lowering the likelihood of recurrence or new breast cancer after initial treatment. Currently, (Z)-Endoxifen is in Phase II development, with plans to advance the program for metastatic breast cancer.

*
In April 2025, Atossa Therapeutics announced that the US Patent and Trademark Office (USPTO) had granted a new patent (US Patent No. 12,275,684) covering enteric oral formulations of (Z)-Endoxifen, along with methods of treating patients using these formulations.

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In December 2024, Atossa presented three posters at the San Antonio Breast Cancer Symposium (SABCS), showcasing pharmacokinetic (PK) and tolerability data from the Phase II EVANGELINE trial.

Lasofoxifene: Sermonix Pharmaceuticals

Lasofoxifene is an investigational novel endocrine therapy that acts as an ESR1 antagonist in the breast, particularly effective in the presence of ESR1 mutations. It has demonstrated anti-tumor activity as both a monotherapy and in combination with CDK4/6 inhibitors in Phase II studies. Its unique tissue selectivity differentiates it from other current and investigational endocrine therapies, with beneficial effects observed on tissue and bone in prior clinical studies. Lasofoxifene is currently in Phase II development.

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In April 2025, Sermonix Pharmaceuticals and Quantum Leap Healthcare Collaborative announced that in a Phase II trial evaluating lasofoxifene as a neoadjuvant endocrine therapy for molecularly selected HR+/HER2-, locally advanced breast cancer, the drug was well tolerated and showed promising early activity in reducing Ki67 protein levels in both premenopausal and postmenopausal patients.

*
In January 2025, Sermonix Pharmaceuticals reported the publication of an article titled "Effects of Lasofoxifene Versus Fulvestrant on Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study" in the peer-reviewed journal Clinical Breast Cancer.

With key players like Atossa, Sermonix, and Pfizer driving innovation, the SERM market is poised for growth. Don't miss out - access comprehensive insights and identify the next big opportunity @ SERMs Drugs Clinical Trials and Companies [https://www.delveinsight.com/sample-request/serms-market-forecast?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Scope of the SERM Market Report

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Study Period:2020-2034

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SERM Report Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]

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Key Indications Covered in the Report: Breast cancer, Postmenopausal osteoporosis, Dyspareunia and dryness, and others

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Key SERM Companies: Atossa Therapeutics, Sermonix Pharmaceuticals, Duchesnay, Pfizer, Eli Lilly, and others

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Key SERM: (Z)-Endoxifen, Lasofoxifene, OSPHENA, DUAVEE, EVISTA (raloxifene hydrochloride), FABLYN, and others

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SERM Therapeutic Assessment: SERM current marketed and emerging therapies

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SERM Market Dynamics: Conjoint Analysis of Emerging SERM Drugs

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Competitive Intelligence Analysis: SWOT analysis and Market entry strategies

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Unmet Needs, KOL's views, Analyst's views, SERM Market Access and Reimbursement

About DelveInsight

DelveInsight is a global market research and consulting firm focused exclusively on life sciences. Through integration of epidemiology, pipeline intelligence, and market analytics, DelveInsight equips pharmaceutical, biotech, and investment stakeholders with actionable insights to navigate and capitalize on complex healthcare markets.

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