Introduction to Luveris
Luveris, also known as lutropin alfa, is a recombinant human luteinizing hormone (LH) used in fertility treatments. It is administered in conjunction with follicle-stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women, particularly those with severe LH and FSH deficiency[1][4].
Clinical Trials and Efficacy
Key Studies
The efficacy of Luveris has been evaluated in several clinical studies. One of the main studies involved 38 women with severe LH and FSH deficiency. In this study, 67% of the women who received the approved dose of 75 International Units (IU) of Luveris along with FSH produced functional follicles (eggs ready for release)[1].
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Study 6253: This was a randomized, open-label, dose-finding study conducted in Europe and Israel. It involved 38 women treated with different doses of Luveris (0, 25, 75, or 225 IU) concomitantly with 150 IU of FSH. The primary efficacy endpoint was the development of functional follicles, and the results showed that the 75 IU dose was the most effective[4].
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Study 21008 and Extension Study 21415: These studies further validated the efficacy of Luveris. In Study 21008, women treated with 75 IU of Luveris and 150 IU of FSH showed significant follicular development and clinical pregnancy rates. The extension study, Study 21415, allowed patients to continue treatment and demonstrated that 87.1% of the patients achieved follicular development, 64.5% achieved pregnancy, and 51.6% achieved clinical pregnancy[4].
Pharmacokinetics and Pharmacodynamics
Luveris has a terminal half-life of about 18 hours and is primarily metabolized, with less than 5% of the dose excreted unchanged renally. The primary effect of Luveris is an increase in estradiol secretion by the follicles, which are stimulated by FSH[4].
Market Analysis
Global Infertility Drugs Market
The global infertility drugs market, which includes Luveris, was valued at USD 3,480.14 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.1% from 2023 to 2030, reaching USD 5.6 billion by 2030. The gonadotropin segment, which includes Luveris, accounted for 39.96% of the market share in 2022 due to its high efficacy and immediate results[5].
China's Recombinant Human Lutropin alfa Market
In China, Luveris, marketed by Merck Serono, has been a dominant player in the recombinant human lutropin alfa market since its approval in 2008. By 2017, the sales value of Luveris in China exceeded CNY 30 million. The market is expected to see changes with the entry of generic drugs from Chinese companies such as Livzon Pharmaceutical Group Inc. and GeneScience Pharmaceuticals Co., Ltd.[2].
Market Share and Competition
Merck Serono has been the leading manufacturer of Luveris in China, with a significant market share by both sales value and volume. However, the market is becoming more competitive with the introduction of generic versions by local Chinese companies. This competition is expected to influence the market dynamics and pricing strategies in the coming years[2].
Projections and Future Outlook
Market Growth
The global infertility drugs market, driven by increasing demand and advancements in fertility treatments, is expected to continue growing. The Asia Pacific region, in particular, is anticipated to witness a growth rate of 6.9% over the forecast period, driven by the presence of key players and strategic initiatives to develop new medicinal products[5].
Regulatory Approvals and Expansions
Recent regulatory approvals, such as the label expansion for extra infertility treatment indications in Japan and other regions, are expected to boost the market for novel drugs, including Luveris. These approvals and expansions will likely increase the accessibility and usage of Luveris and other fertility drugs[5].
Technological Advancements
Advancements in clinical trials and drug development technologies are expected to enhance the efficacy and safety of fertility drugs like Luveris. The increasing focus on interventional studies, particularly in the context of novel viral diseases, will drive the demand for more precise and effective treatments[3].
Key Takeaways
- Efficacy: Luveris has shown significant efficacy in stimulating follicular development and achieving clinical pregnancies in women with severe LH and FSH deficiency.
- Market Growth: The global infertility drugs market, including Luveris, is projected to grow at a CAGR of 6.1% from 2023 to 2030.
- Competition: The market in China is dominated by Merck Serono, but is becoming more competitive with the entry of generic drugs from local companies.
- Regulatory Approvals: Recent and anticipated regulatory approvals will expand the market for Luveris and other fertility drugs.
- Technological Advancements: Ongoing advancements in clinical trials and drug development will enhance the efficacy and safety of Luveris.
FAQs
What is Luveris used for?
Luveris is used in fertility treatments to stimulate the development of eggs in the ovaries of adult women, particularly those with severe LH and FSH deficiency.
How is Luveris administered?
Luveris is given once a day by subcutaneous injection, often in conjunction with FSH, and can be self-administered by the patient if properly trained.
What are the key findings from clinical trials of Luveris?
Clinical trials have shown that Luveris, when administered with FSH, can achieve significant follicular development and clinical pregnancy rates in women with severe LH and FSH deficiency.
Who are the major players in the Luveris market in China?
Merck Serono is the dominant player, but local Chinese companies such as Livzon Pharmaceutical Group Inc. and GeneScience Pharmaceuticals Co., Ltd. are also entering the market with generic versions.
What is the projected growth rate of the global infertility drugs market?
The global infertility drugs market is expected to grow at a CAGR of 6.1% from 2023 to 2030, reaching USD 5.6 billion by 2030.
Sources
- European Medicines Agency (EMA). Luveris | European Medicines Agency (EMA).
- GlobeNewswire. China Recombinant Human Lutropin alfa (Luveris) Market Report 2018-2022.
- PR Newswire. Clinical Trials Market Size and Global Forecast Report 2024: Industry Trends, Share, Growth, Insight, Company Analysis 2023-2030.
- FDA. Luveris® (lutropin alfa for injection) - accessdata.fda.gov.
- Grand View Research. Infertility Drugs Market Size, Share & Growth Report, 2030.
