Introduction to Menopur
Menopur, a highly purified menotropin (HP-hMG), is a gonadotropin used in assisted reproductive technology (ART) programs to stimulate the development of multiple follicles and achieve pregnancy in ovulatory women. Here, we will delve into recent clinical trials, market analysis, and future projections for Menopur.
Recent Clinical Trials
MEGASET-HR Study
One of the significant clinical trials involving Menopur is the MEGASET-HR study. This multicenter, randomized, open-label, assessor-blind, non-inferiority trial compared the safety and efficacy of Menopur to recombinant follicle stimulating hormone (rFSH) in a predicted high responder population undergoing IVF.
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Key Findings:
- The study included 620 ovulatory women and met its primary non-inferiority endpoint, with Menopur-treated patients achieving a 35.5% ongoing pregnancy rate (OPR) per cycle start after a fresh transfer, compared to 30.7% for rFSH-treated patients[1].
- Cumulative live birth rates were similar between Menopur and rFSH, but Menopur had a lower incidence of ovarian hyperstimulation syndrome (OHSS) and early pregnancy loss rates[1].
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Safety Profile:
- Patients in the Menopur treatment group reported a lower overall incidence of treatment emergent adverse events (TEAEs) and a lower incidence of OHSS compared to the rFSH group[1].
Other Clinical Trials
Another notable trial is the comparison of Menopur liquid and powder formulations in women undergoing ART. This study, though not as extensively detailed, aims to evaluate the efficacy and safety of different formulations of Menopur.
- Study Design:
- The trial involves 405 participants and compares the fixed dose of 225 IU of Menopur liquid and powder for the first five stimulation days[4].
Market Analysis
Global Market Size and Growth
The global Menotropin market, which includes Menopur, is expected to grow significantly over the next few years.
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Current Market Size:
- The global Menotropin market size was estimated at USD xx million in 2024, with North America holding more than 40% of the global revenue[2].
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Growth Projections:
- The market is expected to expand at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031. Regional growth rates vary, with North America expected to grow at a CAGR of 4.2%, Europe at 4.5%, and Asia Pacific at 8.0% during the same period[2].
Regional Market Insights
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North America:
- This region holds a significant share of the global Menotropin market and is expected to continue growing, driven by increasing product launches and rising female infertility rates[2][3].
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Europe and Asia Pacific:
- Europe and Asia Pacific also represent substantial markets, with Europe expected to grow at a CAGR of 4.5% and Asia Pacific at 8.0% from 2024 to 2031[2].
Market Drivers and Barriers
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Drivers:
- The growing number of women postponing pregnancy until later in life, when fertility has decreased, is a key driver. Additionally, advancements in ART treatments and the launch of new therapies contribute to market growth[5].
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Barriers:
- The market is dominated by off-label therapies, and the pipeline for new female infertility treatments is sparse, presenting barriers to the entry of novel therapies. Risks associated with female infertility treatment drugs and product recalls also hinder growth[3][5].
Future Projections
Launch of New Therapies
- Upcoming Launches:
- Ferring Pharmaceuticals’s Menopur is expected to launch in Japan, contributing to the market growth in the Asia Pacific region. Other pipeline drugs, such as Kissei Pharmaceutical’s linzagolix choline and IBSA Institut Biochimique’s subcutaneous progesterone, will also launch in various markets[5].
Market Size Projections
- Female Infertility Treatment Market:
- The female infertility treatment market, which includes Menopur, is expected to grow from $1.6 billion in 2023 to $2.3 billion in 2033, at a CAGR of 3.5% across the 7 major markets (7MM)[5].
Key Takeaways
- Clinical Trials: The MEGASET-HR study highlights the efficacy and safety of Menopur in predicted high responder populations, showing non-inferiority to rFSH and a better safety profile.
- Market Growth: The global Menotropin market is expected to grow at a CAGR of 6.00% from 2024 to 2031, driven by increasing demand and new product launches.
- Regional Insights: North America, Europe, and Asia Pacific are key regions, with varying growth rates and market dynamics.
- Market Barriers: The dominance of off-label therapies and sparse pipeline of new treatments pose significant barriers to market growth.
FAQs
What is Menopur used for?
Menopur is used in assisted reproductive technology (ART) programs to stimulate the development of multiple follicles and achieve pregnancy in ovulatory women.
What were the key findings of the MEGASET-HR study?
The MEGASET-HR study found that Menopur-treated patients had a 35.5% ongoing pregnancy rate per cycle start after fresh transfer, compared to 30.7% for rFSH-treated patients, and a lower incidence of OHSS and early pregnancy loss.
What is the projected growth rate of the global Menotropin market?
The global Menotropin market is expected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031.
Which regions are expected to drive the growth of the Menotropin market?
North America, Europe, and Asia Pacific are expected to be key drivers of the Menotropin market growth, with Asia Pacific showing the highest CAGR of 8.0%.
What are the major barriers to the growth of the female infertility treatment market?
The market is dominated by off-label therapies, and the pipeline for new female infertility treatments is sparse. Additionally, risks associated with treatment drugs and product recalls hinder market growth.
Sources
- Ferring Pharmaceuticals: New Clinical Data Published on Menopur® (menotropins for injection) in a Predicted High Responder Population.
- Cognitive Market Research: Global Menotropin Market Report 2024.
- Coherent Market Insights: Female Infertility Treatment Drugs Market Size & Share Analysis.
- ClinicalTrials.gov: Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART).
- GlobalData: Female infertility market expected to reach $2.3bn across the 7MM by 2033.
