INCRELEX Drug Profile

Summary for Tradename: INCRELEX

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for INCRELEX
Recent Clinical Trials:	See clinical trials for INCRELEX

See drug prices for INCRELEX

Recent Clinical Trials for INCRELEX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	Phase 1/Phase 2
Autism Science Foundation	Phase 2
International Rett Syndrome Foundation	Phase 2

See all INCRELEX 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 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 INCRELEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INCRELEX 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
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2014-10-28	DrugPatentWatch analysis and company disclosures
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2015-10-20	DrugPatentWatch analysis and company disclosures
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2016-05-03	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for INCRELEX 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
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2036-12-20	Patent claims search
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2036-08-10	Patent claims search
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2038-12-19	Patent claims search
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2037-11-08	Patent claims search
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2038-07-09	Patent claims search
Ipsen Biopharmaceuticals, Inc.	INCRELEX	mecasermin	Injection	021839		2038-09-17	Patent claims search

Market Dynamics and Financial Trajectory for INCRELEX (mecasermin)

Last updated: April 13, 2026

What is INCRELEX and How Does It Fit into the Market?

INCRELEX (mecasermin) is a recombinant human insulin-like growth factor-1 (IGF-1) indicated for growth failure in children with severe primary IGF-1 deficiency or Laron syndrome, an ultra-rare genetic disorder. Approved by the FDA in 2005, it is marketed by Ipsen. Its primary use is in pediatric patients with growth failure when recombinant human growth hormone therapy is unsuitable or ineffective.

The global market for pediatric growth failure treatments primarily comprises growth hormone products. INCRELEX targets a niche subset with IGF-1 deficiency, representing less than 1% of the overall pediatric growth therapy market but holding significant market exclusivity due to its orphan status.

What Are the Drivers and Constraints Impacting INCRELEX's Market?

Key Market Drivers

• Orphan Drug Status: INCRELEX benefits from orphan designation, which provides market exclusivity until 2025 in the U.S. and similar periods in Europe. This limits direct competition and supports premium pricing.
• Unmet Clinical Need: Laron syndrome’s rarity and limited treatment options drive demand, especially among specialist centers.
• Expanding Diagnostic Capabilities: Increased awareness and improved genetic testing facilitate diagnosis, potentially expanding the treated patient pool.

Constraints and Challenges

• Limited Patient Population: Laron syndrome affects approximately 1 in 1 million to 10 million worldwide, restricting the potential market size.
• Pricing Pressures: High treatment costs lead to reimbursement challenges, especially in price-sensitive healthcare systems.
• Limited Indications: The drug's use remains confined mostly to pediatric patients with specific deficiencies, restricting broader market penetration.

How Does the Market Composition and Competition Landscape Look?

Market Composition

Segment	Market Share (%)	Key Attributes
Pediatric Growth Disorder	~98%	Mostly growth hormone treatments, with INCRELEX as a niche option
Rare Genetic Disorders	~2%	Laron syndrome, other rare IGF-1 deficiencies

Main Competitors

• Pegvisomant (Somavert): For acromegaly, not pediatric growth failure but competes on IGF-related pathways.
• Off-label uses of IGF-1 in other pediatric growth deficiencies, though not approved.
• Emerging biosimilars or alternatives: None as of 2023, due to orphan status and complex manufacturing.

What Are the Financial Trajectories for INCRELEX?

Revenue and Sales Trends

Data from Ipsen’s 2022 annual report indicate:

• Global sales: Approximately €70 million (~$74 million USD).
• Market growth: Limited growth driven by stable demand, constrained by small patient population.
• Pricing: Approximate annual treatment cost ranges from $230,000 to $290,000 per patient, depending on dosing and region.

Revenue Drivers

• Pricing adjustments: Variations based on healthcare system negotiations.
• Patient access: Expanding diagnostics may modestly increase eligible patient numbers.
• Orphan drug exclusivity: Supports sustained premium pricing until patent or exclusivity expiry around 2025.

Investment and R&D Outlook

• Pipeline activity: No significant new indications or formulations announced.
• Potential value inflections: Pricing strategy adjustments and expanded diagnostic coverage could influence revenue stability.

Cost Considerations

• Manufacturing complexity: Biologic nature entails high production costs.
• Regulatory development: Costs for maintaining orphan status and potential label expansions.

What Are the Future Risks and Opportunities?

Risks

• Patent Expiration: Market exclusivity lapses around 2025, risking generic or biosimilar competition.
• Regulatory Changes: Stricter pricing regulations in key markets could pressure margins.
• Market Size: Limited number of patients constrains growth regardless of demand.

Opportunities

• Label Expansion: Possible approval for other IGF-1 deficiency indications.
• Global Market Penetration: Emerging economies increasing diagnostic access.
• Biologic Advances: Next-generation biosimilars could offer price competition after exclusivity lapses.

Summary Table of Market Metrics

Metric	Value	Source
Global sales (2022)	€70 million (~$74 million USD)	Ipsen Annual Report 2022
Patient population estimate	Fewer than 1,000 globally	Rare Disease Registries
Pricing per patient/year	$230,000 - $290,000	Market estimates from healthcare data
Patent expiration / exclusivity	2025	FDA and EMA filings

Key Takeaways

• INCRELEX operates within a niche, driven by rare genetic disorders.
• Sales are stable but limited by extremely small patient populations.
• Orphan status and high price support revenue, but patents expiry poses long-term risk.
• Market expansion potential relies on diagnostic improvements and possible label changes.
• Competition remains minimal but might increase post-2025 through biosimilars or other innovations.

FAQs

1. How many patients are eligible for INCRELEX worldwide?
Estimated fewer than 1,000 children globally, limited by the rarity of Laron syndrome.

2. What is the primary driver of INCRELEX revenue?
Orphan drug exclusivity and high treatment costs sustain revenue levels.

3. Will biosimilar competition threaten INCRELEX?
Possible after patent expiration (~2025), but biosimilar development in rare diseases faces regulatory hurdles.

4. Are there any approved expanded indications for INCRELEX?
No, current approvals are specific to growth failure due to severe primary IGF-1 deficiency.

5. Could market growth for INCRELEX increase?
Potentially, through improved diagnosis, broader awareness, and label expansion, but growth remains constrained by patient size.

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References

[1] Ipsen. (2022). Annual Report 2022. Ipsen.