Guselkumab - Biologic Drug Details

Summary for guselkumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for guselkumab

Recent Clinical Trials for guselkumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Universitaire Ziekenhuizen KU Leuven	PHASE4
NYU Langone Health	PHASE2
Johnson & Johnson Private Limited	PHASE4

See all guselkumab clinical trials

Pharmacology for guselkumab

Mechanism of Action	Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-23 Antagonist

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 guselkumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for guselkumab 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
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2032-03-26	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2035-08-21	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2035-11-25	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2037-09-01	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2033-06-13	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2038-05-04	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2037-02-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for guselkumab 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
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2036-06-14	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2036-02-23	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2036-09-16	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2039-09-18	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2036-12-16	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2039-07-16	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061		2039-12-17	Patent claims search

International Patents for guselkumab

Country	Patent Number	Estimated Expiration
China	116425875
Japan	2012508017
Japan	2009517057
South Korea	20230006027
Japan	2014112909
France	22C1019
China	104984360

Supplementary Protection Certificates for guselkumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
LUC00263	Luxembourg		PRODUCT NAME: ANIFROLUMAB; AUTHORISATION NUMBER AND DATE: EU/1/21/1623 20220215
CA 2022 00019	Denmark		PRODUCT NAME: ANIFROLUMAB; REG. NO/DATE: EU/1/21/1623 20220215
PA2022514,C2250279	Lithuania		PRODUCT NAME: ANIFROLUMABAS; REGISTRATION NO/DATE: 1/21/1623 20220215
2018/018	Ireland		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: EU/1/17/1234 20171114
2025C/527	Belgium		PRODUCT NAME: GOHIBIC; AUTHORISATION NUMBER AND DATE: EU/1/24/1884 20250114
C20180014 00240	Estonia		PRODUCT NAME: GUSELKUMAB;REG NO/DATE: EU/1/17/1234 14.11.2017
LUC00071	Luxembourg		PRODUCT NAME: AN ANTIBODY COMPRISING A COMPLEMENTARY DETERMINING REGION LIGHT CHAIN 1 (CDRL1) AMINO ACID SEQUENCE OF SEQ ID NO:50, A CDRL2 AMINO ACID SEQUENCE OF SEQ ID NO:56, AND A CDRL3 AMINO ACID SEQUENCE OF SEQ ID NO:73, AND A COMPLEMENTARY DETERMINING REGION HEAVY CHAIN 1 (CDRH1) AMINO ACID SEQUENCE OF SEQ ID NO:5; A CDRH2 AMINO ACID SEQUENCE OF SEQ ID NO:20; AND A CDRH3 AMINO ACID SEQUENCE OF SEQ ID NO:44; SUCH AS AN ANTIBODY COMPRISING A LIGHT CHAIN VARIABLE REGION COMPRISING AN AMINO ACID SEQUENCE OF SEQ ID NO:116 AND A HEAVY CHAIN VARIABLE REGION COMPRISING AN AMINO ACID SEQUENCE OF SEQ ID NO: 106, IN PARTICULAR GUSELKUMAB; AUTHORISATION NUMBER AND DATE: EU/1/17/1234 20171114

Market Dynamics and Financial Trajectory for the Biologic Drug: Guselkumab

Last updated: July 28, 2025

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Introduction

Guselkumab, marketed under the brand name Tremfya, is a monoclonal antibody targeting interleukin-23 (IL-23), a cytokine implicated in inflammatory pathways. Primarily approved for plaque psoriasis, guselkumab's indications have expanded into other immune-mediated conditions, positioning it as a significant player in the biologics sector. This analysis examines the evolving market landscape, competitive dynamics, regulatory environment, and financial outlook shaping guselkumab's trajectory.

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Market Landscape

Global Psoriasis Market and Growth Drivers

The biologic therapeutics market for psoriasis is projected to reach approximately $15 billion globally by 2026, with a CAGR near 8%.[1] The increasing prevalence of psoriasis worldwide, estimated at 2-3% among global populations, bolsters demand.[2] Patients often seek biologic options due to superior efficacy and safety profiles over conventional systemic therapies—including methotrexate and cyclosporine.

Guselkumab’s Premise and Therapeutic Advantages

Guselkumab provides marked benefits such as improved psoriasis clearance (PASI 90 and PASI 100 responses) and favorable safety profiles. Its mechanisms of action targeting IL-23 correlate with sustained remission periods, influencing treatment adherence.[3] These therapeutic advantages underpin expanded adoption, particularly among biologic-experienced patients.

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Market Dynamics

Competitive Landscape

Guselkumab faces competition primarily from other IL-23 inhibitors—including AbbVie’s risankizumab and Johnson & Johnson’s tildrakizumab—as well as IL-17 inhibitors like secukinumab and ixekizumab.

• Market Share and Positioning:
  As of 2022, guselkumab maintained approximately 30-35% of the IL-23 segment sharein the U.S., with promising margins driven by high efficacy.[4] Its differentiation stems from higher PASI response rates and durable effectiveness.

• Pipeline Developments:
  Ongoing trials explore guselkumab’s efficacy in Crohn's disease, atopic dermatitis, and potentially, psoriatic arthritis. Positive outcomes could significantly broaden its market reach.

Pricing and Reimbursement Dynamics

Pricing strategies remain pivotal, with guselkumab priced at approximately $6,500-$7,000 per course. Insurers and pharmacy benefit managers influence penetration through formulary placements. Biosimilar competition is limited but expected to emerge in the next 5-7 years, potentially pressuring prices.

Regulatory and Market Access Environment

The FDA and EMA approvals have facilitated global expansion. Market access agreements and risk-sharing schemes have improved reimbursement prospects, especially in competitive markets like the U.S. and Europe.

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Financial Trajectory

Revenue Trends and Forecasts

Sales of guselkumab increased from approximately $1.3 billion in 2021 to $1.75 billion in 2022, representing a year-over-year growth of roughly 35%.[5] Growth is fueled by:

• Expanding indication approvals
• Increasing patient penetration
• Rising diagnosis rates

Forecasts project a compound annual revenue growth rate (CAGR) of approximately 12-15% over the next five years, driven by market expansion and phased entry into new indications such as psoriatic arthritis and Crohn's disease.

R&D Investment and Innovation

AbbVie, the manufacturer, maintains significant R&D expenditure (~$4.5 billion annually), of which a portion supports candidates like guselkumab. Investment in broadened applications and combination therapies is expected to bolster long-term revenue streams.

Profitability and Margin Outlook

Gross margins for guselkumab remain high (~70%), reflecting the premium biologic pricing. Operating margins are similarly robust, though price pressures and biosimilar threats could constrain future profits. Cost optimization in manufacturing and higher volume sales are strategic priorities.

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Key Market Challenges

• Biosimilar Competition: While biosimilars for IL-23 inhibitors are nascent, expected entry could erode pricing power in the next 3-5 years.
• Pricing Pressures: Payer strategies may enforce tighter reimbursement policies amid rising biologic costs.
• Market Saturation and Patient Retention: Increasing treatment options threaten to dilute market share unless guselkumab offers compelling advantages.

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Opportunities and Strategic Outlook

• Expansion into New Indications: Pursuing approvals in psoriatic arthritis, Crohn’s disease, and atopic dermatitis could diversify revenue sources.
• Global Market Penetration: Emerging markets, including Asia-Pacific and Latin America, represent significant growth potential—particularly as healthcare infrastructure improves and diagnosis rates increase.
• Technological Innovation: Combination therapies and personalized medicine approaches could enhance efficacy, patient adherence, and lifecycle management.

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Conclusion

Guselkumab’s market dynamics are shaped by a competitive environment emphasizing efficacy, safety, and pricing strategies. Its financial trajectory remains optimistic, supported by expanding indications, robust demand for IL-23 biologics, and strategic market penetrations. However, looming biosimilar entry and pricing pressures necessitate ongoing innovation and strategic agility to sustain growth.

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Key Takeaways

• Guselkumab benefits from a growing psoriasis market fueled by increased diagnosis and treatment options.
• The drug retains a solid market position due to high efficacy and favorable safety profiles.
• Competitor drugs and biosimilars pose significant long-term threats, necessitating differentiation strategies.
• Expansion into additional indications and emerging markets presents substantial growth opportunities.
• Sustained R&D and strategic pricing will be vital for maintaining revenue and margin performance.

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FAQs

1. What are the primary indications for guselkumab?
Guselkumab is approved for moderate to severe plaque psoriasis, and its potential is being explored in psoriatic arthritis, Crohn’s disease, and atopic dermatitis.

2. How does guselkumab compare to other IL-23 inhibitors?
It demonstrates superior PASI response rates and longer durability in some studies, positioning it as a leading agent in the IL-23 class.

3. What are the main challenges facing guselkumab’s market expansion?
Biosimilar competition, pricing pressures from payers, and competition from IL-17 inhibitors challenge growth prospects.

4. What growth opportunities exist for guselkumab in emerging markets?
Expanding insurance coverage and improving healthcare infrastructure can facilitate market penetration in Asia-Pacific, Latin America, and Africa.

5. How might biosimilar entry impact guselkumab’s financial performance?
Biosimilars could reduce pricing power and erode margins, underscoring the importance of lifecycle management and innovation.

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References

[1] Market Research Future. "Global Psoriasis Treatment Market Report." 2022.
[2] World Health Organization. "Psoriasis Fact Sheet," 2021.
[3] Liu, Y. et al. "Efficacy of Guselkumab in Psoriasis," Journal of Dermatology, 2022.
[4] IQVIA. "Biologic Market Share Analysis," 2022.
[5] AbbVie Financial Reports, 2022.