Becaplermin - Biologic Drug Details

Summary for becaplermin

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for becaplermin

Recent Clinical Trials for becaplermin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Virchow Group	Phase 1/Phase 2
Adocia	Phase 1/Phase 2
Bedford Research Corporation, Inc.

See all becaplermin 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 becaplermin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for becaplermin 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
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	5,457,093	2013-10-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for becaplermin 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
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,111,968	2036-08-10	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,118,956	2035-11-30	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,143,755	2037-12-08	Patent claims search
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	10,350,093	2035-12-23	Patent claims search

International Patents for becaplermin

Country	Patent Number	Estimated Expiration
South Africa	968398
Portugal	859596
Spain	2167611
Greece	880100617

Supplementary Protection Certificates for becaplermin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C990016	Netherlands		PRODUCT NAME: BECAPLERMINUM; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
99C0034	Belgium		PRODUCT NAME: BECAPLERMIN; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
SPC/GB99/023	United Kingdom		PRODUCT NAME: BECAPLERMIN; REGISTERED: UK EU/1/99/101/001 19990329
SZ 36/1999	Austria		PRODUCT NAME: BECAPLERMIN

Market Dynamics and Financial Trajectory for the Biologic Drug: Becaplermin

Last updated: July 28, 2025

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Introduction

Becaplermin, commercially known as Regranex, is a recombinant human platelet-derived growth factor used primarily for the treatment of diabetic foot ulcers (DFUs). Approved by the U.S. Food and Drug Administration (FDA) in 1997, becaplermin represents a niche but strategically significant segment within biologics targeting wound healing and regenerative therapies. Given the rising global prevalence of diabetes mellitus and associated complications, understanding the market dynamics and financial prospects surrounding becaplermin is imperative for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Market Overview

Therapeutic Context and Clinical Validation

DFUs affect approximately 15% of diabetic patients overall, with a significant proportion progressing to infections, gangrene, and eventually amputations if untreated or inadequately managed (1). Becaplermin offers a targeted regenerative approach, stimulating cellular proliferation, and accelerating wound closure, which is essential in reducing morbidity associated with diabetic foot complications.

Clinical trials have demonstrated that becaplermin expedites wound healing compared to placebo, with the primary limitation being its modest incremental benefit and concerns over potential malignancy risk with extended use (2). Its positioning as a biologic significantly influences its market status; as a recombinant growth factor, it occupies a specialized niche within wound care therapeutics.

Market Penetration and Utilization

Despite initial promising sales trajectories, becaplermin witnessed fluctuating adoption rates. Factors limiting broader utilization include cost considerations, safety concerns regarding malignancies, and the advent of alternative therapies such as skin substitutes, hyperbaric oxygen therapy, and newer biologics.

In 2022, the global market for growth factors in wound care was valued at approximately USD 400 million and is projected to grow at a compound annual growth rate (CAGR) of 5-7% through 2030 (3). Becaplermin's share within this segment remains relatively modest primarily due to market hesitancy stemming from safety profiles and competition from emerging biologics.

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Market Dynamics

Drivers

• Increasing Incidence of Diabetes and Complications: The global diabetic population exceeds 537 million, with projections reaching 700 million by 2045 (4). Rising prevalence directly correlates with increased DFU cases, fueling demand for effective wound healing agents like becaplermin.

• Advancements in Wound Care: Innovations in biologic formulations and combination therapies have enhanced treatment efficacy, indirectly supporting the continued relevance of growth factors.

• Healthcare Policy and Reimbursement Trends: Governments and insurance providers are prioritizing wound management strategies that reduce hospital stays and prevent amputations, positioning becaplermin as a cost-effective intervention if safety concerns are addressed.

Challenges

• Safety Concerns: The FDA issued warnings in 2008 regarding a potential increased risk of cancer associated with repeated use of becaplermin, particularly with prolonged application beyond recommended doses. Although causality remains inconclusive, this has curtailed widespread adoption (5).

• Market Competition: Emerging therapies, such as recombinant human epidermal growth factors, bioengineered skin substitutes (e.g., Apligraf), and platelet-rich plasma therapies, have gained traction, offering alternative mechanisms for wound closure.

• Pricing and Reimbursement: Becaplermin remains expensive relative to traditional wound care, limiting its cost-effectiveness in resource-constrained settings.

• Regulatory and Patent Status: Patent expirations and regulatory hurdles in key markets threaten exclusivity, encouraging biosimilar development and further market fragmentation.

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Financial Trajectory

Historical Performance

Initially, becaplermin saw robust sales post-approval, driven by clinical promise and unmet need. However, sales plateaued due to safety warnings and competitive pressures. In 2010, Johnson & Johnson (J&J), the primary marketer, reported that becaplermin's sales declined by approximately 9%, primarily attributable to decreased reimbursement and safety concerns (6).

Current and Future Revenue Projections

Forecasts estimate that becaplermin’s annual revenue will stabilize around USD 50-70 million globally in the coming years, assuming no major safety incidents and moderate adoption in emerging markets. The CAGR is projected at approximately 3-4%, influenced heavily by:

• Increasing diabetic prevalence in emerging markets with limited access to advanced wound care products.
• Potential formulation or delivery innovations that enhance safety and efficacy.
• Strategic partnerships or licensing agreements enabling broader distribution.

In contrast, in mature markets like North America and Europe, sales are plateauing due to safety concerns and saturation. Nevertheless, niche applications in specialized wound care clinics may sustain steady revenue streams for select manufacturers.

Impact of Biosimilars and Patent Landscape

Biosimilar development could challenge the pricing power of innovator companies, especially if patent protections expire or are challenged through legal avenues. As of 2023, patent exclusivity for becaplermin in the US is expected to expire in the mid-2020s, opening avenues for biosimilar manufacturers to enter the market (7).

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Strategic Factors Influencing Future Market Trajectory

• Safety and Efficacy Optimization: Further research into dosing strategies and patient selection could mitigate safety risks and improve clinical outcomes, boosting market confidence.

• Regulatory Environment: Clearer guidelines and post-marketing surveillance will influence physician adoption, especially in jurisdictions with stringent safety standards.

• Innovation and Formulation Advances: Development of combination biologics or sustained-release formulations could extend therapeutic benefits and reduce adverse effects.

• Market Penetration in Emerging Economies: As diabetes prevalence surges in regions like Asia-Pacific and Latin America, affordability and supply chain improvements could expand becaplermin's utilization.

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Conclusion

Becaplermin's market dynamics are shaped by the growing global diabetes burden, safety concerns, emerging therapies, and patent landscapes. While its clinical niche remains, financial prospects are moderate, with steady but limited growth expected in the foreseeable future. Actions that improve safety profiles, foster innovation, and expand access in emerging markets could enhance its market trajectory. However, competition and regulatory challenges will continue to define its strategic positioning.

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Key Takeaways

• The global diabetic population’s expansion drives demand for wound healing biologics like becaplermin, though safety concerns hinder full market potential.
• Market saturation in developed countries limits revenue growth, with emerging markets presenting new opportunities.
• Patent expirations and biosimilar emergence threaten existing pricing structures, exerting downward pressure on revenues.
• Innovation in delivery mechanisms and combination therapies may rejuvenate the product’s market relevance.
• Strategic focus on safety, efficacy, and affordability will be decisive in shaping becaplermin’s financial future.

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FAQs

1. What are the main safety concerns associated with becaplermin?
The primary safety concern relates to a potential increased risk of malignancy, particularly with prolonged use beyond recommended dosages, as highlighted by the FDA warning issued in 2008.

2. How does becaplermin compare with alternative wound healing therapies?
While becaplermin offers targeted growth factor stimulation, alternatives like skin substitutes and hyperbaric oxygen therapy may vary in efficacy, safety profiles, and cost-effectiveness, influencing clinician preferences.

3. What is the impact of patent expiration on becaplermin’s market?
Patent expiration in key markets could lead to biosimilar entrants, increasing competition and reducing pricing power for original formulations.

4. Are there ongoing developments to improve becaplermin?
Research focuses on optimizing dosing regimens, developing combination therapies, and refining delivery systems to enhance safety and effectiveness.

5. Which regions offer the most growth opportunities for becaplermin?
Emerging markets with rising diabetes prevalence and less saturated wound care markets, such as Asia-Pacific and Latin America, present significant growth opportunities, provided affordability and infrastructure support availability.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
2. Driver V, et al. Efficacy and Safety of Becaplermin in Diabetic Foot Ulcers: A Meta-Analysis. Diabetes Care. 2004.
3. Market Research Future. Growth Factors Market for Wound Care Analysis, 2022.
4. International Diabetes Federation. IDF Diabetes Atlas, 2022.
5. FDA. Information on Becaplermin and Cancer Risk. 2008.
6. Johnson & Johnson Annual Report, 2010.
7. U.S. Patent and Trademark Office. Patent Status and Expiry Dates for Becaplermin.