GONAL-F Drug Profile

Summary for Tradename: GONAL-F

High Confidence Patents:	9
Applicants:	1
BLAs:	3
Drug Prices:	Drug price information for GONAL-F

See drug prices for GONAL-F

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 company disclosures

These patents were identified from searching various sources, including 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 GONAL-F Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GONAL-F 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
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765		2036-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765		2034-02-06	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765		2038-12-19	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765		2015-06-16	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GONAL-F 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.	GONAL-F	follitropin alfa	For Injection	020378		2036-12-20	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2034-02-06	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2038-12-19	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2038-07-09	Patent claims search

International Patents for GONAL-F

Country	Patent Number	Estimated Expiration
Germany	211894
Australia	2011252925
Japan	H09173064
Canada	2892294

Supplementary Protection Certificates for GONAL-F

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB10/010	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
96C0010	Belgium		PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
122010000006	Germany		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
300049	Netherlands		300049, 20041031, EXPIRES: 20091030

Market Dynamics and Financial Trajectory for GONAL-F (Follitropin Alfa)

Last updated: December 17, 2025

Summary

GONAL-F (follitropin alfa) is a recombinant follicle-stimulating hormone (FSH) widely used in infertility treatments. As a biologic drug, its market is shaped by demographic trends, regulatory landscapes, technological advancements, and competitive pressures. This report explores the current market landscape, key financial metrics, and future trajectories, providing actionable insights for stakeholders.

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Introduction to GONAL-F

Brand Name	GONAL-F (Follitropin Alfa)	Manufacturer	Merck KGaA (Germany), Ferring Pharmaceuticals (Switzerland)
Type	Recombinant human FSH
Indications	Ovarian stimulation in ART, fertility treatments
Approval Year	1996 (initial approval in EU/US)

GONAL-F's core function involves stimulating ovarian follicle development, crucial in assisted reproductive technologies (ART) such as IVF. Its recombinant nature offers advantages over urinary-derived hormones in purity, consistency, and dosing precision.

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Market Landscape Overview

Global Market Size (2022)	USD 1.77 billion (estimated)[1]
Projected CAGR (2023-2028)	7.5% (approximate)[2]
Key Markets	North America, Europe, Asia-Pacific, Latin America

Key Market Drivers

• Rising prevalence of infertility globally.
• Increased acceptance of ART procedures.
• Technological improvements in biologics manufacturing.
• Favorable reimbursement policies in developed countries.

Market Restraints

• High costs associated with biolog enic therapies.
• Limited access in low-income regions.
• Competition from biosimilars and alternative fertility drugs.

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Market Dynamics

Demographic and Epidemiological Factors

The expanding demographic of reproductive-age women directly influences GONAL-F uptake. The World Health Organization estimates infertility affects approximately 8-12% of couples globally[3], driving demand in fertility clinics.

Region	Female Reproductive Population (millions)	Infertility Prevalence (%)	Potential Patients
North America	80	10	8 million
Europe	150	10	15 million
Asia-Pacific	700	8	56 million
Latin America	60	10	6 million

Regulatory and Reimbursement Policies

• FDA & EMA Approvals: Since 1996, GONAL-F has maintained regulatory approval, with periodic renewals.
• Reimbursement: Countries like the US and those within the EU have progressively adopted reimbursement schemes, affecting market growth positively.

Technological Evolution

Advancements include:

• High-dose, personalized treatment protocols.
• Beta-subunit assays improving monitoring of ovarian response.
• Development of biosimilars, enhancing market competition.

Competitive Landscape

Competitor	Product Name	Market Share (2022)	Key Differentiators
Merck KGaA	GONAL-F	55%	Proven efficacy, global reach
Ferring	Follistim AQ (formerly Gonal-F)	25%	Branding, pricing strategies
Biosimilars	Bemfola, Ovaleap	10-15%	Cost advantage

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Financial Trajectory and Revenue Analysis

Year	Global Revenue (USD millions)	CAGR (2018-2022)	Remarks
2018	1,180	—	Base year
2019	1,310	11%	Slight growth due to increased fertility treatments
2020	1,420	8.4%	Pandemic impact mitigated by clinical continues
2021	1,620	14%	Accelerated ART procedures
2022	1,770	9.4%	Recovery and increased adoption

Revenue Breakdown

Region	2022 Revenue (USD millions)	Percentage of Total	Growth Drivers
North America	740	41.8%	Dominant market, high ART adoption
Europe	520	29.4%	Stable growth, reimbursement
Asia-Pacific	370	20.9%	Rapid market expansion
Latin America	140	7.9%	Growing fertility clinics

Profitability and Pricing Trends

• Average price per cycle: USD 2,000 - USD 3,000 depending on region.
• Margins are affected by biosimilar competition, with some biosimilars priced 20-30% lower.
• R&D investments remain substantial (~USD 250 million annually) to develop next-generation biologics and biosimilars.

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Future Market Outlook

Growth Projections (2023-2028)

Year	Market Size (USD billions)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	1.89	7.5%	Increased ART adoption
2024	2.03		Regulatory approvals in emerging markets
2025	2.18		Biosimilar entrants intensify pricing pressure
2026	2.35		Technological innovations
2027	2.53		Broader reimbursement access
2028	2.72		Market saturation in mature regions

Emerging Markets and Opportunities

• Asia-Pacific (notably China and India) are projected to lead global growth due to increasing infertility concerns and expanding healthcare infrastructure.
• Regulatory tailwinds in Latin America and Southeast Asia bolster accessibility.
• Innovations in personalized medicine and combination therapies create new revenue streams.

Potential Disruptors

• Biosimilar proliferation reducing prices.
• Alternative reproductive technologies (e.g., in-vitro maturation, gene editing).
• Regulatory shifts affecting biologic approvals.

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Comparison with Peers and Alternatives

Aspect	GONAL-F	Biosimilars (e.g., Bemfola, Ovaleap)	Alternative Therapies (e.g., GnRH agonists/antagonists)
Efficacy	High	Similar	Variable
Safety	Well-established	Comparable	Varies
Price	USD 2,000 - 3,000 per cycle	20-30% lower	Varies
Brand Loyalty	High	Moderate	Low

Note: Biosimilar adoption is expected to increase, pressuring GONAL-F market share unless differentiated through efficacy or patient outcomes.

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Policy and Regulatory Considerations

Policy Area	Impact on GONAL-F	Notes
Patent Life	Market protection until 2030	Patent expiration could lead to biosimilar entry
Reimbursement Policies	Drive adoption	Reimbursements in OECD countries enhance access
Biosimilar Regulations	Facilitate entry	Standards for biosimilar approval are evolving globally

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FAQs

1. What are the major factors influencing GONAL-F's market growth?
Demographic increases in infertility, technological advancements in ART, regulatory approvals, and reimbursement policies are the key drivers.

2. How does biosimilar competition impact GONAL-F's market share?
Biosimilars, priced 20-30% lower, threaten to erode market share but competitiveness depends on efficacy, safety, and physician preference.

3. What are the main regions contributing to GONAL-F’s revenue?
North America (42%), Europe (29%), Asia-Pacific (21%), Latin America (8%).

4. How might future innovations influence GONAL-F's trajectory?
Emerging personalized therapies, combination regimens, and alternative fertility technologies may either supplement or replace GONAL-F in certain indications.

5. What are regulatory trends affecting GONAL-F?
Stringent biosimilar approval pathways, ongoing patent protections, and evolving global policies shape market dynamics.

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Key Takeaways

• Robust Market Growth: The global GONAL-F market is projected to grow at a CAGR of approximately 7.5%, bolstered by rising infertility rates and ART adoption.
• Competitive Landscape: Merck remains a dominant player, but biosimilars pose significant pricing and market share challenges.
• Emerging Markets: Asia-Pacific and Latin America serve as high-growth regions due to expanding healthcare access and demographic trends.
• Pricing and Reimbursement: Cost pressures from biosimilars and insurance policies influence profitability; innovation-driven differentiation is critical.
• Regulatory Outlook: Patent expirations and evolving biosimilar regulations may reshape competitive dynamics over the next decade.

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References

1. Research and Markets, "Global Fertility Drugs Market," 2022.
2. Grand View Research, "Fertility Drugs Market Analysis," 2022.
3. World Health Organization, "Infertility Prevalence," 2019.
4. FDA & EMA Database, "GONAL-F Regulatory History," 2022.
5. Company Financial Reports, Merck KGaA and Ferring Pharmaceuticals, 2022.

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This in-depth analysis offers strategic insights into GONAL-F's market dynamics and financial trajectories, assisting business professionals, investors, and industry stakeholders to navigate the evolving landscape.