Last updated: April 7, 2026
What is IMJUDO?
IMJUDO (tildrakizumab-asmn) is a biologic monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis. It is marketed by Sun Pharmaceutical Industries through its subsidiary, Sun Pharma Global FZE. IMJUDO targets interleukin-23 (IL-23), a cytokine involved in inflammatory pathways related to psoriasis. It was approved in September 2022, marking its entry into a competitive biologic market.
Market Size and Segmentation
Global Psoriasis Biologics Market
The psoriasis biologics market was valued at approximately USD 12.9 billion in 2022. It expects a compound annual growth rate (CAGR) of 9.3% from 2023 to 2030, reaching USD 26.2 billion by 2030 (Fortune Business Insights, 2023).
Key Players
Major biologic therapies include:
- Humira (adalimumab) – AbbVie
- Cosentyx (secukinumab) – Novartis
- Stelara (ustekinumab) – Janssen
- Taltz (ixekizumab) – Eli Lilly
- Skyrizi (risankizumab-rzaa) – AbbVie
- IMJUDO (tildrakizumab-asmn) – Sun Pharma
These drugs differentiate by IL-23 or IL-17 targets, dosing schedules, and safety profiles.
Market Share Distribution
In 2022, the market share among top biologics was:
| Drug |
Market Share (%) |
Key Features |
| Humira |
24 |
Broad indications, high penetration |
| Cosentyx |
20 |
High efficacy, convenient dosing |
| Stelara |
15 |
Long injection interval |
| Taltz |
10 |
Rapid onset |
| Skyrizi |
8 |
Strong IL-23 inhibition |
| IMJUDO |
<1 |
New entrant, limited coverage |
IMJUDO's initial market penetration remains low, with awareness and physician familiarity as primary barriers.
Launch and Growth Timeline
- September 2022: IMJUDO receives FDA approval.
- Q4 2022: Limited market entry through initial distribution channels.
- 2023: Launch expands across key markets, including Europe and Japan, pending regulatory approval.
- 2024–2026: Expected ramp-up as prescribers gain familiarity and formulary inclusion increases.
Competitive Positioning
IMJUDO competes in a mature segment. Its main differentiators hinge on:
- Mechanism of Action: IL-23 inhibition, similar to Risankizumab and Skyrizi.
- Dosing Schedule: Administered every 12 weeks after initial dosing.
- Pricing Strategy: Positioned competitively, aiming to challenge established brands.
Despite its advantages, it faces hurdles like clinician resistance, formulary exclusivity, and manufacturing capacity constraints.
Revenue Projections
2023–2025 Outlook
| Year |
Estimated Revenue (USD billions) |
Growth Rate (%) |
Assumptions |
| 2023 |
0.15–0.2 |
N/A |
Limited distribution, low awareness |
| 2024 |
0.3–0.5 |
50–100% |
Expanded access, early formulary inclusion |
| 2025 |
0.8–1.2 |
60–140% |
Increased market penetration |
Key Growth Drivers
- Expansion into international markets
- Inclusion in major insurance formularies
- Physician and patient acceptance over competitors
Risks
- Market saturation by established IL-23 inhibitors
- Slower-than-expected adoption
- Price competition from biosimilars or generics in adjacent segments
Regulatory and Reimbursement Environment
IMJUDO benefits from favorable biosimilar pathways, but segmented by country:
- United States: FDA approval, Medicare, and private payor coverage expected to prioritize established brands.
- Europe: EMA approval, reimbursement negotiations hinge on cost-effectiveness.
- Other markets: Regulatory processes vary; faster approvals linked to unmet needs.
Strategic Initiatives
Sun Pharma's key strategies include:
- Expanding clinical trials for additional indications such as psoriatic arthritis
- Building awareness through key opinion leader engagement
- Partnering with distributors for faster market penetration
- Pricing competitively to gain share from existing IL-23 drugs
Key Takeaways
- IMJUDO entered the psoriasis biologics market in September 2022, targeting a USD 12.9 billion segment projected to reach USD 26.2 billion by 2030.
- The biologics market remains dominated by long-established drugs, but new entrants like IMJUDO aim to capture incremental share through dosing convenience and competitive pricing.
- Revenue projections for 2023–2025 remain conservative, with expectations of rapid growth contingent on market acceptance.
- Regulatory and reimbursement hurdles might delay widespread adoption, especially outside the U.S.
- Competition intensity and biosimilar entries pose significant risk to future market share.
FAQs
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What distinguishes IMJUDO from other IL-23 inhibitors? IMJUDO offers a dosing schedule of every 12 weeks, which matches Skyrizi but aims to be competitively priced, targeting patient convenience and compliance.
-
How does IMJUDO price compare to leading biologics? Pricing is aimed to be roughly 10-15% lower than established competitors like Risankizumab, to facilitate rapid adoption and market share capture.
-
What are the main hurdles for IMJUDO’s growth? Physician familiarity and formulary inclusion are primary hurdles, alongside competition from existing long-established IL-23 therapies.
-
What is the outlook for IMJUDO’s international expansion? Regulatory approvals in key markets such as Europe and Japan are anticipated by 2024–2025, which could double its addressable market.
-
What are the potential opportunities for IMJUDO beyond psoriasis? Clinical studies are ongoing for psoriatic arthritis and Crohn’s disease, which could diversify revenue streams if approved.
References
[1] Fortune Business Insights. (2023). Psoriasis Treatment Market Size, Share & Industry Analysis.
[2] U.S. Food and Drug Administration. (2022). FDA approves IMJUDO for psoriasis.
