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Last Updated: December 22, 2024

Gonadorelin acetate - Generic Drug Details


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What are the generic sources for gonadorelin acetate and what is the scope of patent protection?

Gonadorelin acetate is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for gonadorelin acetate.

Summary for gonadorelin acetate
Recent Clinical Trials for gonadorelin acetate

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SponsorPhase
University of Colorado, DenverN/A

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US Patents and Regulatory Information for gonadorelin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring LUTREPULSE KIT gonadorelin acetate INJECTABLE;INJECTION 019687-001 Oct 10, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ferring LUTREPULSE KIT gonadorelin acetate INJECTABLE;INJECTION 019687-002 Oct 10, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Gonadorelin acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Gonadorelin Acetate

Market Size and Growth Projections

The gonadorelin acetate market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 147.4 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Infertility and Hormonal Abnormalities

The global rise in infertility and hormonal disorders is a major driver of the gonadorelin acetate market. Improved diagnostic methods and growing awareness of hormonal abnormalities have led to more people receiving diagnoses, thereby increasing the demand for gonadorelin therapy[3].

Advancements in Healthcare Infrastructure

Enhancements in healthcare infrastructure, particularly in emerging economies, have made diagnosis and treatment more accessible. This increased accessibility is a significant factor in the market's growth[3].

Aging Population

The aging population is experiencing more age-related hormonal illnesses such as menopause and andropause, which increases the demand for therapies based on gonadorelin[3].

Technological Advancements

Ongoing research and development have led to the creation of new formulations, delivery systems, and more potent forms of gonadorelin. These advancements are expected to increase the market potential of the drug[3].

Regulatory Environment

Regulatory approvals and norms play a crucial role in the market dynamics of gonadorelin acetate. Changes in regulations, including approval procedures and reimbursement guidelines, can impact market demand[3].

Market Segmentation

The gonadorelin acetate market is segmented based on several criteria:

By Application

  • Gonadorelin Acetate Injection
  • Gonadorelin Acetate Nasal Spray
  • Gonadorelin Acetate Capsules These applications cater to various therapeutic needs, including fertility treatments, hormone replacement, diagnostic testing, and endometriosis[1].

By Product

  • Fertility Treatments
  • Hormone Replacement
  • Diagnostic Testing
  • Endometriosis These product segments highlight the diverse therapeutic uses of gonadorelin acetate[1].

By Geography

The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its unique market dynamics and growth prospects[1][3][4].

Challenges and Limitations

Despite the growth potential, the gonadorelin acetate market faces several challenges:

High Treatment Costs

Gonadorelin treatments can be costly, especially for those without sufficient insurance coverage. This high cost restricts access to care, particularly in underdeveloped regions or areas with inadequate medical resources[3].

Side Effects and Safety Issues

Like any prescription medication, gonadorelin acetate can have side effects or safety issues. These concerns can affect patient and healthcare provider willingness to use the drug[3].

Adherence Issues

Gonadorelin therapy often requires precise dose schedules and delivery techniques, which can be challenging for patients to adhere to. Ineffective adherence can hinder market expansion and affect treatment outcomes[3].

Ethical and Social Considerations

Ethical issues, such as off-label use or the use in assisted reproductive technologies, can influence patient and healthcare provider attitudes towards gonadorelin acetate, potentially limiting market growth in certain demographics or regions[3].

Competitive Landscape

The gonadorelin acetate market is competitive, with several major players:

  • Ferring Pharmaceuticals
  • Ipsen
  • Takeda
  • Merck
  • Pfizer
  • Roche
  • AbbVie
  • Bayer
  • Novartis
  • Teva Pharmaceuticals
  • Xuchang Shangke Chemical
  • Bachem
  • Aspen Oss
  • Shenzhen JYMed Technology
  • Toronto Research Chemicals
  • LKT Laboratories
  • Hemmo Pharmaceuticals
  • Angle BioPharma[1][3][4].

These companies engage in price strategies, product innovation, and market competitiveness, influencing the overall market dynamics.

Clinical Research and Trials

Ongoing clinical research and trials are crucial for uncovering novel therapeutic uses for gonadorelin acetate. These initiatives aim to optimize treatment regimens and outcomes, further expanding the market potential of the drug[1][3].

Regulatory Impact

The regulatory environment significantly influences the gonadorelin acetate market. Regulatory approvals for new formulations and expanded indications are key drivers of market growth. However, strict safety and efficacy standards and prolonged approval procedures can also act as barriers to market expansion[3].

Patient Preferences and Compliance

Patient preferences for specific formulations or delivery techniques can impact market demand. For instance, the development of subcutaneous pumps has improved patient compliance by making the treatment more manageable, although practical concerns such as sterility and mixing issues still exist[2].

Key Takeaways

  • The gonadorelin acetate market is projected to grow significantly, driven by increasing prevalence of infertility and hormonal abnormalities, advancements in healthcare infrastructure, and technological advancements.
  • The market is segmented by application, product, and geography, with diverse therapeutic uses.
  • High treatment costs, side effects, adherence issues, and ethical considerations are key challenges.
  • The competitive landscape is dominated by several major pharmaceutical companies.
  • Ongoing clinical research and regulatory approvals are crucial for market growth.

FAQs

1. What is the projected market size of gonadorelin acetate by 2031? The gonadorelin acetate market is expected to reach USD 147.4 billion by 2031[1].

2. What are the main drivers of the gonadorelin acetate market growth? The main drivers include the increasing prevalence of infertility and hormonal abnormalities, advancements in healthcare infrastructure, an aging population, and technological advancements[3].

3. What are the primary challenges facing the gonadorelin acetate market? Challenges include high treatment costs, side effects and safety issues, adherence issues, and ethical and social considerations[3].

4. Which companies are major players in the gonadorelin acetate market? Major players include Ferring Pharmaceuticals, Ipsen, Takeda, Merck, Pfizer, Roche, AbbVie, Bayer, Novartis, and Teva Pharmaceuticals, among others[1][3][4].

5. How does the regulatory environment impact the gonadorelin acetate market? The regulatory environment significantly influences the market through approvals for new formulations and indications, as well as strict safety and efficacy standards that can act as barriers to market expansion[3].

Cited Sources:

  1. Market Research Intellect - Gonadorelin Acetate Market Size, Growth & Trends https://www.marketresearchintellect.com/product/global-gonadorelin-acetate-market-size-and-forecast/
  2. University of Maryland, Baltimore - Gonadorelin acetate - Summary Report https://archive.hshsl.umaryland.edu/bitstream/handle/10713/17671/Gonadorelin%20acetate_Final_2021_10.pdf
  3. Verified Market Research - In-Depth Industry Outlook: Gonadorelin Market Size, Forecast https://www.verifiedmarketresearch.com/product/gonadorelin-market/
  4. Regional Research Reports - Gonadorelin Acetate Market Trends, Size, Share, and Forecast to 2030 https://www.regionalresearchreports.com/industry-reports/gonadorelin-acetate-market/HC-1023

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