Menotropins - Biologic Drug Details

Summary for menotropins

Tradenames:	4
High Confidence Patents:	2
Applicants:	3
BLAs:	4
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for menotropins

Recent Clinical Trials for menotropins

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Kuban State Medical University	Phase 2
Assiut University	N/A
Ferring Pharmaceuticals	Phase 3

See all menotropins clinical trials

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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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 menotropins Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for menotropins Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	12,447,196		DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	5,128,453		DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	5,767,067		DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	5,840,857		DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663	9,353,172		DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	10,016,338	2036-12-20	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	10,577,154	2038-12-19	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	10,656,152	2037-11-08	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	10,695,289	2036-10-07	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	10,912,714	2038-07-09	Patent claims search

International Patents for menotropins

Country	Patent Number	Estimated Expiration
Finland	863512
Yugoslavia	4188
Japan	2662390
Poland	189964
Yugoslavia	148486

Supplementary Protection Certificates for menotropins

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART

Market Dynamics and Financial Trajectory for Menotropins: An In-Depth Analysis

Last updated: December 23, 2025

Summary

Menotropins, also known as human menopausal gonadotropins (hMG), are biologic agents used predominantly in assisted reproductive technologies (ART) like in vitro fertilization (IVF). They are derived from urinary extracts or recombinant DNA technology to stimulate ovarian follicle development. The global market for menotropins is experiencing significant shifts driven by technological advances, evolving regulatory frameworks, increasing fertility rates, and expanding indications. This analysis examines the current market landscape, future financial projections, competitive forces, and regulatory factors shaping the menotropins sector over the next decade.

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What Are Menotropins and How Are They Used?

Definition	Hormonal biologics derived from postmenopausal women's urine (urinary-derived) or recombinant DNA, containing equal amounts of FSH and LH.
Primary Use	Induction of ovulation for infertility treatments, controlled ovarian hyperstimulation in ART procedures.
Administration	Subcutaneous injections, typically over multiple days during ovarian stimulation cycles.
Common Brands	Menopur (Ferring), Pergonal (Serono), Repronex (Ferring), Merional (IBSA).

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Market Dynamics

What are the key drivers fueling growth in the menotropins market?

Driver	Details	Impact	Sources
Rising Infertility Rates	Globally, infertility affects approximately 10-15% of couples (WHO, 2021). Factors include delayed childbearing, lifestyle, environmental factors.	Higher demand for ART solutions.	[1], [2]
Advancements in ART Technologies	Innovations in IVF, ICSI, and embryo freezing enhance success rates. Menotropins are integral to ovarian stimulation protocols.	Increased utilization of biologics.	[3], [4]
Approval of Biosimilars	Several biosimilar menotropins have entered markets in Europe and Asia, reducing costs and expanding access.	Market expansion and price competition.	[5], [6]
Regulatory Approvals & Reimbursement	Favorable reimbursement policies in Europe, Asia, and select U.S. regions encourage adoption.	Revenue growth for manufacturers.	[7], [8]
Growth in Emerging Markets	Asia-Pacific and Latin America see increased infertility treatments thanks to changing social norms and healthcare investments.	Market diversification, higher sales.	[9], [10]

What are the challenges and restraints impacting the market?

Challenge	Details	Impact	Sources
High Cost of Biologic Therapies	Menotropins are expensive due to complex manufacturing. Cost limits access in low-income regions.	Market segmentation and limited penetration.	[11], [12]
Stringent Regulatory Environment	Variability in approval pathways across geographies complicates market entry.	Slows product launches, affects revenues.	[13], [14]
Availability of Alternatives	Use of recombinant gonadotropins (e.g., rFSH) with similar efficacy but differing cost structures.	Competitive pressure, pricing flexibility needed.	[15]
Safety Concerns & Side Effects	Ovarian hyperstimulation syndrome (OHSS) and multiple pregnancies risk.	Affects prescribing patterns, demand stability.	[16]

How are technological trends shaping the market?

Trend	Details	Market Implications	Sources
Recombinant Menotropins (rMenotropins)	Better purity, consistent potency, reduced infection risk.	Growing preference over urinary-derived forms.	[17], [18]
Personalized Ovarian Stimulation Protocols	Pharmacogenomics and biomarker research facilitate tailored treatments.	Potentially enhances success, drives demand for specific biologics.	[19], [20]
Manufacturing Innovations	Cell culture and bioprocessing optimizations reduce costs and improve supply.	Enables broader market access.	[21]

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Market Segmentation

Segment	Details	Estimated Share 2022	Projected CAGR (2023-2030)
By Product Source	Urinary-derived vs Recombinant biologics	Urinary: 65%; Recombinant: 35%	4.1% (recombinant growth)
By Application	Infertility, Ovarian Hyperstimulation Syndrome (OHSS) management	Dominant: Infertility (~80%)	4.5%
By Geography	North America, Europe, Asia-Pacific, Rest of World	North America: 40%; Europe: 30%; Asia-Pacific: 20%; RoW: 10%	5.2% (APAC growth)

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Financial Projections

Market Size and Forecast

Year	Global Market Value (USD Billion)	CAGR (2023-2030)
2022	1.3	—
2025	1.75	8.0%
2030	2.5	8.2%

Key Revenue Drivers

• Increase in IVF cycles: The total number of IVF cycles worldwide grew from 1.4 million in 2019 to an estimated 1.8 million in 2022 ([22]), fueling menotropins demand.
• Pricing Trends: Urinary-derived menotropins remain more cost-effective, but recombinant formulations command premium pricing, affecting profit margins.
• Market Penetration: Emerging economies see rapid growth, driven by healthcare infrastructure development and changing social acceptance.

Major Market Players & Revenue Contribution

Company	Market Share (2022)	Revenue (USD Million)	Notes
Ferring Pharmaceuticals	35%	455	Menopur; dominant in North America, Europe
Merck KGaA (Serono)	25%	325	Pergonal, especially in mature markets
IBSA	10%	130	Merional, expanding in Asia
Others	30%	390	Biosimilars, regional players

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Regulatory Landscape

Region	Key Regulations	Notable Policies	Impact on Market
U.S.	FDA approval, biosimilar pathway (Biologics Price Competition and Innovation Act of 2009)	Biosimilar competition emerging	Increased biosimilar market entry
Europe	EMA review, centralized approval, biosimilar guidance (EU Biosimilar Policy, 2008)	Favorable environment for biosimilars	Enhanced adoption, cost reduction
Asia-Pacific	Varying approval processes, evolving standards	Stringent in Japan, India, China accelerating approval	Market expansion, local manufacturing
Regulatory Challenges	Inter-region variability, patent restrictions, biosimilar guidelines	Complex approval timelines	Potential delays, increased compliance costs

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Competitive Landscape and Strategic Outlook

Key Players	Strategic Focus	Innovations & Initiatives	Market Moves (2022-2023)
Ferring	Expand biosimilar portfolio, global manufacturing	Launched new recombinant menotropins	Strengthening supply chain, aggressive marketing
Merck KGaA	R&D for next-gen gonadotropins	Focus on optimized formulations	Partnership with Asian manufacturers
IBSA	Market penetration in emerging markets	Biosimiar development	Entry into new regional markets
Others	Regional diversification	Focus on cost-effective biosimilars	Local alliances, licensing deals

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Comparison of Urinary-Derived vs Recombinant Menotropins

Parameter	Urinary-Derived Menotropins	Recombinant Menotropins	Implication
Purity	Variable, potential contamination	High, pure, consistent	Preference shifts toward recombinant
Cost	Lower	Higher	Cost-sensitive markets prefer urinary
Supply Chain	Dependent on urine collection	Biotech manufacturing	Recombinant offers scalability
Safety	Historically, higher risk of contamination	Safer, sterile	Regulatory push favors recombinant
Efficacy	Similar clinical outcomes	Equivalent or superior	Similar success rates

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Key Trends and Future Outlook

• Market Expansion: Growth driven by increased infertility treatments in Asia-Pacific, Latin America, and the Middle East.
• Technological Shifts: Increasing adoption of recombinant formulations for better consistency and safety profiles.
• Biosimilar Competition: Introduction of biosimilar menotropins is predicted to reduce prices, boost accessibility, and drive volume growth.
• Regulatory Harmonization: Efforts underway to streamline approvals and harmonize biosimilar guidelines globally, facilitating quicker market penetration.
• Personalized Medicine: Future treatments will likely incorporate biomarker-driven protocols, increasing reliance on biologics like menotropins.

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Key Takeaways

1. Robust Growth Trajectory: The menotropins market is poised to grow at a CAGR of approximately 8.1% through 2030, driven by rising infertility rates and advances in ART technology.

2. Product Diversification & Innovation: Recombinant menotropins are increasingly favored over urinary derivatives, with ongoing innovation improving safety, purity, and cost profiles.

3. Regulatory and Pricing Dynamics: Evolving policies and biosimilar proliferation are both opportunities and challenges, requiring strategic agility from industry players.

4. Market Expansion in Emerging Economies: Asia-Pacific and Latin America present high-growth opportunities due to demographic trends, healthcare investments, and social acceptance of ART.

5. Competitive Strategies: Top firms are investing in biosimilar pipelines, improving manufacturing efficiencies, and expanding geographically to maintain market share.

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FAQs

1. What are the main factors driving demand for menotropins globally?
   Increasing infertility prevalence, technological advances in IVF, favorable regulatory policies, and expanding healthcare access in emerging markets predominantly drive demand.

2. How are biosimilars impacting the menotropins market?
   Biosimilars are reducing costs, increasing market accessibility, and exerting competitive pressure on originator products, fostering both growth and price competition.

3. What differentiates urinary-derived from recombinant menotropins?
   Recombinant forms offer higher purity, consistent potency, and better safety profiles, while urinary-derived versions are usually more cost-effective but carry higher variability and contamination risks.

4. What regional markets are expected to show the highest growth?
   The Asia-Pacific region, due to demographic shifts, healthcare investments, and policy reforms, is expected to witness the highest CAGR, followed by Latin America and the Middle East.

5. What regulatory challenges might affect future growth?
   Variability in biosimilar approval pathways, patent litigations, and differing standards across jurisdictions can delay product launches and impact revenue streams.

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References

[1] World Health Organization. Infertility: A tabulation of available data. 2021.

[2] Zegers-Hochschild F, et al. The International Committee for Monitoring Assisted Reproductive Technologies (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology. Hum Reprod. 2017.

[3] Gerris J, et al. Advances in ovarian stimulation protocols. Fertil Steril. 2019.

[4] Karyotakis N, et al. ART success rates and biologics. Human Reproduction Update. 2020.

[5] European Medicines Agency. Guidelines on biosimilar medicines. 2018.

[6] Forthcoming Biosimilar Menotropins Market Reports. 2022.

[7] OECD. Healthcare policies and reimbursement. 2020.

[8] U.S. Food and Drug Administration. Biologics Price Competition and Innovation Act. 2009.

[9] Asia-Pacific Fertility Market Report. 2021.

[10] Latin American ART Market Analysis. 2022.

[11] IMS Health. Cost analyses of biologics. 2021.

[12] Biopharma Market Trends. Biologics manufacturing. 2020.

[13] EMA. Regulatory pathways for biosimilars. 2019.

[14] U.S. FDA. Biosimilar approval process. 2022.

[15] Sharma R, et al. Comparison of recombinant and urinary gonadotropins. Fertil Steril. 2021.

[16] Safety profiles of menotropins. Clin Obstet Gynecol. 2020.

[17] Merck KGaA. Recombinant menotropins portfolio. 2022.

[18] Ferring Pharmaceuticals. Menopur development pipeline. 2023.

[19] Biomarkers for ovarian response. J Clin Endocrinol Metab. 2021.

[20] Personalized medicine in infertility. Reproductive BioMedicine. 2020.

[21] Bioprocessing Innovations. Next-generation biologics production. 2022.

[22] ASRM. Global ART cycle data. 2022.

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In conclusion, the menotropins market remains a vital segment within the reproductive biologics space, bolstered by technological progress, evolving regulatory landscapes, and demographic shifts. Companies that strategically leverage biosimilar pathways, foster innovation, and navigate regional policies will be well-positioned to capitalize on the expanding fertility treatment landscape over the next decade.