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Last Updated: February 10, 2025

Choriogonadotropin alfa - Biologic Drug Details


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Summary for choriogonadotropin alfa
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for choriogonadotropin alfa
Recent Clinical Trials for choriogonadotropin alfa

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Sports Medicine Research and Testing LaboratoryEarly Phase 1
Sheba Medical CenterPhase 4
One FertilityPhase 2

See all choriogonadotropin alfa clinical trials

Pharmacology for choriogonadotropin alfa
Established Pharmacologic ClassGonadotropin
Chemical StructureGonadotropins
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for choriogonadotropin alfa Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for choriogonadotropin alfa Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for choriogonadotropin alfa Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Choriogonadotropin Alfa

Introduction to Choriogonadotropin Alfa

Choriogonadotropin alfa, a recombinant form of human chorionic gonadotropin (hCG), is a crucial biologic drug used in the treatment of infertility. It is produced through genetic modification of Chinese Hamster Ovary (CHO) cells and is known for its high purity and consistent biological activity[2][4].

Market Size and Growth

The global infertility drugs market, which includes choriogonadotropin alfa, was valued at USD 3,480.14 million in 2022. This market is expected to expand at a compound annual growth rate (CAGR) of 6.1% from 2023 to 2030, reaching USD 5.6 billion by 2030[1].

Dominance of Gonadotropins

Gonadotropins, the class of drugs to which choriogonadotropin alfa belongs, dominated the infertility drugs market with a revenue share of 39.70% in 2022. This dominance is attributed to the high efficacy and immediate results of gonadotropins, making them highly prescribed and used in infertility treatments[1].

Regional Market Dynamics

North America

North America holds a significant share of the infertility drugs market, accounting for 38.2% of the revenue in 2022. The region's strong research activities and the rapid uptake of new infertility medicines are key drivers of this market segment[1].

Asia Pacific

The Asia Pacific region is expected to witness a growth rate of 6.9% over the forecast period. This growth is driven by the presence of key players and strategic initiatives to develop and commercialize new infertility drugs. For instance, the approval of several drugs for extra infertility treatment indications in Japan has boosted the market in this region[1].

Production and Quality Control

Choriogonadotropin alfa is produced through a rigorous process involving the expansion of genetically modified CHO cells. The drug is secreted into the cell culture medium and then purified using chromatographic steps, ensuring high purity and consistent product characteristics. The biological activity of choriogonadotropin alfa is calibrated against international reference preparations, ensuring its efficacy and safety[2][4].

Clinical Use and Efficacy

Choriogonadotropin alfa stimulates late follicular maturation and the resumption of oocyte meiosis, initiating the rupture of the pre-ovulatory ovarian follicle. It acts as an analogue of luteinizing hormone (LH) and binds to the LH/hCG receptor of the granulosa and theca cells of the ovary. This mechanism is crucial for supporting the first trimester of pregnancy by maintaining the viability of the corpus luteum[2][4].

Safety and Monitoring

While choriogonadotropin alfa is highly effective, it requires careful monitoring to minimize the risk of ovarian hyperstimulation syndrome (OHSS). Mild to moderate ovarian enlargement may occur, but this generally regresses without treatment within a few weeks. Physicians must carefully monitor ovarian response to avoid overstimulation[2].

Financial Trajectory

Revenue Projections

The revenue from gonadotropins, including choriogonadotropin alfa, is expected to grow significantly due to their high efficacy and increasing demand. The overall infertility drugs market is projected to reach USD 5.6 billion by 2030, with gonadotropins likely to remain a major contributor to this revenue[1].

Market Leaders

Companies like Merck, which is a global leader in fertility drugs and treatments, play a significant role in the financial trajectory of choriogonadotropin alfa. Merck's fertility franchise, including drugs like GONAL-f®, has contributed substantially to the company's performance, with over 4 million babies born with the help of these treatments[5].

Investment and Expansion

Investments in biopharmaceutical manufacturing and research are crucial for the growth of the choriogonadotropin alfa market. Companies are expanding their production capacities and investing in digital business models and data analysis to support the development and commercialization of new infertility treatments[5].

Competitive Landscape

The market for biologic therapeutic drugs, including choriogonadotropin alfa, is highly competitive. Key players are focusing on strategic partnerships, acquisitions, and the development of new products to maintain their market position. For example, collaborations between companies like Ferring B.V. and Igenomix to develop novel therapeutic products for infertility treatment are indicative of the competitive and innovative environment in this market[1][5].

Future Outlook

The future outlook for choriogonadotropin alfa is promising, driven by increasing demand for infertility treatments, advancements in biotechnology, and strategic investments by key players. As the global population faces demographic changes and lifestyle adjustments that contribute to infertility, the market for effective treatments like choriogonadotropin alfa is expected to continue growing.

Key Takeaways

  • Market Growth: The global infertility drugs market, including choriogonadotropin alfa, is expected to grow at a CAGR of 6.1% from 2023 to 2030.
  • Dominance of Gonadotropins: Gonadotropins, such as choriogonadotropin alfa, dominate the market due to their high efficacy.
  • Regional Dynamics: North America and Asia Pacific are key regions driving the market growth.
  • Production Quality: Choriogonadotropin alfa is produced with high purity and consistent biological activity.
  • Clinical Use: It is crucial for stimulating follicular maturation and supporting early pregnancy.
  • Financial Trajectory: The revenue from gonadotropins is expected to grow significantly, driven by increasing demand and strategic investments.

FAQs

What is the current market size of the infertility drugs market?

The global infertility drugs market was valued at USD 3,480.14 million in 2022 and is expected to reach USD 5.6 billion by 2030[1].

Which segment dominates the infertility drugs market?

The gonadotropin segment, which includes choriogonadotropin alfa, dominates the market with a revenue share of 39.70% in 2022[1].

What are the key regions driving the growth of the infertility drugs market?

North America and Asia Pacific are the key regions driving the growth of the infertility drugs market[1].

How is choriogonadotropin alfa produced?

Choriogonadotropin alfa is produced through the expansion of genetically modified Chinese Hamster Ovary (CHO) cells and purified using chromatographic steps[2][4].

What are the potential risks associated with choriogonadotropin alfa treatment?

The treatment can lead to ovarian hyperstimulation syndrome (OHSS), which requires careful monitoring to minimize the risk[2].

Which companies are key players in the market for choriogonadotropin alfa?

Companies like Merck and Ferring B.V. are key players in the market, investing heavily in research and development of infertility treatments[1][5].

Sources

  1. Grand View Research: Infertility Drugs Market Size, Share & Growth Report, 2030.
  2. DailyMed: OVIDREL - choriogonadotropin alfa injection, solution.
  3. BCC Research: Biologic Therapeutic Drugs: Technologies and Global Markets.
  4. Health Canada: choriogonadotropin alfa - PRODUCT MONOGRAPH.
  5. Merck Group: Combined Management Report 2021.

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