Tildrakizumab-asmn - Biologic Drug Details

Summary for tildrakizumab-asmn

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for tildrakizumab-asmn

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 tildrakizumab-asmn Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tildrakizumab-asmn 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
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067		2028-02-21	DrugPatentWatch analysis and company disclosures
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067		2031-02-21	DrugPatentWatch analysis and company disclosures
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067		2032-12-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for tildrakizumab-asmn 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

International Patents for tildrakizumab-asmn

Country	Patent Number	Estimated Expiration
Lithuania	2426144
Japan	2017060482
European Patent Office	2059534
European Patent Office	2426144
South Africa	200906224

Supplementary Protection Certificates for tildrakizumab-asmn

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
401 50017-2018	Slovakia		PRODUCT NAME: TILDRAKIZUMAB; REGISTRATION NO/DATE: EU/1/18/1323 20180919
SPC/GB19/004	United Kingdom		PRODUCT NAME: TILDRAKIZUMAB; REGISTERED: UK EU/1/18/1323 (NI) 20180919; UK FURTHER MA ON IPSUM 20180919
PA2018015,C2059534	Lithuania		PRODUCT NAME: TILDRAKIZUMABAS; REGISTRATION NO/DATE: EU/1/18/1323 20180917
LUC00092	Luxembourg		PRODUCT NAME: TILDRAKIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/18/1323 20180919
PA2018015	Lithuania		PRODUCT NAME: TILDRAKIZUMABAS; REGISTRATION NO/DATE: EU/1/18/1323 20180917

Market Dynamics and Financial Trajectory for the Biologic Drug: Tildrakizumab-asmn

Last updated: July 28, 2025

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Introduction

Tildrakizumab-asmn (brand name: Ilumya), developed by Sun Pharmaceutical Industries, is a biologic therapy targeting interleukin-23 (IL-23) for the treatment of plaque psoriasis. Since its approval by the U.S. Food and Drug Administration (FDA) in 2018, it has emerged as a notable player within the IL-23 inhibitor class, competing with established biologics like guselkumab, risankizumab, and risankizumab. This report analyzes the evolving market dynamics and projects the financial trajectory for tildrakizumab-asmn, considering factors such as clinical efficacy, competitive landscape, regulatory progress, market penetration, and pricing strategies.

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Market Landscape for IL-23 Inhibitors in Psoriasis

The biologic segment targeting IL-23 has experienced exponential growth, driven by the molecule's pivotal role in psoriasis pathophysiology. IL-23 inhibitors are characterized by their high efficacy, favorable safety profile, and infrequent dosing schedule, typically administered quarterly or biannually. The global psoriasis market is projected to reach USD 14.4 billion by 2025, with biologics constituting over 80% of this valuation, reflecting their dominance over traditional systemic therapies.

Key competitors include guselkumab (Janssen), risankizumab (AbbVie), and newer entrants like mirikizumab (Lilly). These drugs have demonstrated superior efficacy, rapid onset of action, and sustained remission rates, which influence market share dynamics.

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Market Dynamics of Tildrakizumab-asmn

1. Clinical Efficacy and Safety Profile

Tildrakizumab delivers a targeted blockade of IL-23 p19 subunit, resulting in significant improvements in Psoriasis Area and Severity Index (PASI) scores. Phase III trials (reSURFACE 1 and 2) showed PASI 75 response rates reaching approximately 64-66% at 12 weeks, comparable to other IL-23 inhibitors but slightly lower than risankizumab’s response rates (around 75%).

Its safety profile is consistent with other IL-23 drugs, with the most common adverse events being nasopharyngitis, headaches, and mild infections. Its biweekly or quarterly dosing provides convenience, influencing patient adherence and physician prescribing patterns.

2. Regulatory and Geographic Expansion

Post-approval, Sun Pharma has periodically expanded indications and geographic reach, initially focusing on the U.S. before extending into European and other emerging markets. Regulatory approvals in India, Japan, and Latin America are underway or granted, fostering increased access.

3. Market Penetration Strategies

Sun Pharma emphasizes cost competitiveness, leveraging lower manufacturing costs and strategic pricing to penetrate markets dominated by pricier biologics. The company’s valuation of tildrakizumab’s commercial potential hinges on its positioning as a cost-effective alternative without compromising efficacy.

4. Competitive Challenges

While effective, tildrakizumab faces stiff competition from agents with higher PASI response rates and broader marketed portfolios. Pfizer and AbbVie, with their respective IL-23 biologics, benefit from aggressive marketing and extensive clinical trial data. Intense competition pressures pricing strategies and restricts rapid market share expansion.

5. Pricing and Reimbursement Landscape

Pricing remains a pivotal factor. Tildrakizumab is competitively priced relative to other biologics, especially in emerging markets where cost is a critical barrier. Reimbursement policies favor biologics with proven safety and efficacy, but reimbursement rates are variable globally, influencing market penetration.

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Financial Trajectory

1. Revenue Forecasts

Initial sales post-approval have been modest, with estimates around USD 50-100 million in 2020, primarily driven by the U.S. and select European markets. As market access expands and physician familiarity increases, projections estimate a compound annual growth rate (CAGR) of approximately 20-25% over the next five years.

By 2025, revenues could potentially exceed USD 500 million if Sun Pharma successfully expands geographical presence and maintains clinical relevance amid competition. The growth is contingent on:

• Market penetration speed
• Competitive positioning
• Reimbursement landscape
• Patient adherence

2. Market Share Projections

Currently, tildrakizumab holds an estimated 2-3% share within the IL-23 inhibitor market. Competitive shifts could alter this figure; however, Sun Pharma’s cost-effective approach aims to capture a tipping point, especially in price-sensitive markets.

3. Cost of Goods Sold (COGS) and Profitability

Sun Pharma’s manufacturing scale and cost efficiency support potentially high margins. As market volume expands, economies of scale should reduce COGS further, improving profitability. However, significant marketing and distribution costs, along with ongoing R&D investments, temper immediate profitability.

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Future Opportunities and Challenges

Opportunities:

• Expansion into new indications: Crohn's disease and other inflammatory conditions where IL-23 plays a pathogenic role present expansion opportunities.
• Biosimilar development: Potential future biosimilar entry could pressure prices but also opens licensing opportunities.
• Strategic alliances: Collaborations with payers and healthcare providers can facilitate uptake.

Challenges:

• High competition: Dominance of risankizumab and guselkumab in efficacy and market share.
• Pricing pressures: Particularly in mature markets like the U.S. and Europe, where biologic pricing is under scrutiny.
• Market saturation: With several IL-23 inhibitors approved, differentiating tildrakizumab requires strategic innovation.

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Conclusion

Tildrakizumab-asmn’s market dynamics are shaped by its strategic positioning as a cost-effective IL-23 inhibitor amid stiff competition. Its clinical profile, combined with strategic geographic expansion, could fuel sustained financial growth. Nonetheless, aggressive competitors and pricing pressures necessitate continued innovation and market differentiation.

The financial trajectory indicates potential for significant revenue growth, especially if Sun Pharma leverages geographic expansion and formulary acceptance. However, capturing substantial share in a crowded IL-23 class demands focused marketing and reimbursement strategies.

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Key Takeaways

• Market potential remains significant, driven by the global psoriasis treatment market’s growth and IL-23's therapeutic prominence.
• Tildrakizumab’s cost advantage positions it favorably in emerging markets and price-sensitive healthcare systems.
• Clinical efficacy is on par with competitors, but industry leadership hinges on broader geographic access and market penetration.
• Competitive dynamics, especially from risankizumab and guselkumab, require strategic differentiation.
• Revenue projections suggest a steady CAGR of approximately 20-25% over five years, contingent upon market access and competitive strengths.

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FAQs

1. How does tildrakizumab-asmn compare to other IL-23 inhibitors in efficacy?
Tildrakizumab demonstrates PASI75 response rates of approximately 64-66%, slightly lower than risankizumab (~75%), but offers a comparable safety and dosing profile, making it a viable alternative especially in cost-sensitive markets.

2. What are the primary factors influencing its market growth?
Key factors include geographic expansion, reimbursement policies, competitive efficacy, pricing strategies, and insurance coverage.

3. Are there any new indications for tildrakizumab?
Currently approved primarily for psoriasis, ongoing research explores potential in other inflammatory conditions such as psoriatic arthritis and Crohn's disease.

4. How does Sun Pharma plan to differentiate tildrakizumab in a crowded market?
Through cost leadership, strategic pricing, expanding geographic access, and emphasizing its convenience and safety profile.

5. What are the main risks to its financial success?
Intense market competition, pricing pressures, regulatory hurdles, and patent expirations represent key risks impacting future revenues.

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References

[1] Sun Pharmaceutical Industries. (2018). FDA Approves Tildrakizumab for Moderate to Severe Plaque Psoriasis.
[2] Melin, A., et al. (2020). Efficacy and Safety of Tildrakizumab in Psoriasis: A Review. Journal of Dermatological Treatment.
[3] Global Psoriasis Market Report, 2022-2025. (Research and Markets)
[4] Sun Pharma Investors’ Presentation. (2022). Strategic Insights into Tildrakizumab.