Last updated: August 8, 2025
Introduction
The pharmaceutical landscape continually evolves, driven by innovations, regulatory changes, and market dynamics. This report provides a comprehensive market analysis and price projection for the drug with National Drug Code (NDC) 00173-0826. Detailed insights into the drug’s therapeutic class, current market position, competitive landscape, regulatory environment, and economic factors underpin our projections. This evaluation aims to empower stakeholders with data-driven foresight critical for strategic decision-making.
Product Profile and Therapeutic Context
NDC 00173-0826 corresponds to Stelara (Ustekinumab), a monoclonal antibody indicated for multiple autoimmune conditions, such as psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis. Ustekinumab functions by targeting interleukins IL-12 and IL-23, crucial in immune pathway modulation, thereby reducing inflammation and disease activity.
Since its FDA approval in 2009, Stelara has established a strong presence within immunology treatment armamentarium due to its demonstrated efficacy and favorable administration profile. Its subcutaneous injection formulation enables outpatient management, bolstering adherence and therapeutic outcomes.
Market Dynamics
Market Size and Demand Drivers
Post-approval, Stelara’s market share has expanded consistently owing to:
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Growing prevalence of autoimmune disorders, notably psoriasis, which affects approximately 2-3% of the global population [1].
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Enhanced treatment guidelines favoring biologics over traditional systemic therapies, due to superior efficacy and safety profiles.
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Expanding indications, particularly in Crohn’s disease and ulcerative colitis, increasing the receptor pool.
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Strategic pipeline developments, including biosimilars, which could influence future pricing strategies.
In 2022, global sales of Ustekinumab exceeded $8 billion, with the U.S. constituting roughly 60% of this figure [2].
Competitive Landscape
Key competitors include:
- Humira (adalimumab): Preeminent TNF-alpha inhibitor with broad autoimmune indications.
- Cosentyx (secukinumab): IL-17A inhibitor.
- Taltz (ixekizumab): IL-17A inhibitor.
- Siliq (brodalumab): IL-17 receptor antagonist.
However, Stelara's distinctive mechanism targeting IL-12/23 offers unique positioning, particularly in patients unresponsive to other biologics.
Pricing and Reimbursement Environment
Current Pricing
In the U.S., the average wholesale price (AWP) for Ustekinumab (per 45 mg and 90 mg doses) runs approximately $2,500 to $4,500 per dose, with variations based on dosage and patient-specific factors. Commercial insurers and Medicare generally reimburse at negotiated rates substantially below AWP.
Pricing Trends
Recent years have seen stabilized yet high price points, with minimal discounts granted directly to patients due to patent protections and high efficacy. The 2020-2022 period featured modest increases (~2-3%) in drug list prices, aligned with inflationary adjustments.
Biosimilar Impact
While biosimilar development for Ustekinumab is ongoing, the complex manufacturing process delays generic entry, providing continued pricing power for the innovator. Nonetheless, biosimilars are projected to enter the market post-2024, potentially exerting downward pressure on prices.
Regulatory and Patent Landscape
Patent Expiry and exclusivity: Stelara’s primary patents expire in the late 2020s, with certain formulations and manufacturing process patents extending beyond that period, providing a protected market for the foreseeable future.
Regulatory developments: The FDA’s evolving biosimilar pathway and increased emphasis on cost-effective therapies suggest a potential shift toward biosimilar acceptance and reimbursement modifications.
Market Projections
Short-term (2023-2025)
- Stable revenue trajectory, with global sales maintaining at $8-$9 billion annually.
- Pricing remains relatively stable, supported by robust demand and limited biosimilar competition.
- Market penetration deepens as guidelines increasingly endorse biologics as first-line therapies, especially in moderate-to-severe cases.
Medium-term (2026-2030)
- Potential biosimilar entry around 2024-2025. Initial biosimilar products could retail at 20-30% lower than the innovator, gradually eroding market share.
- Price adjustments: Possible 2-5% annual price reductions driven by biosimilar competition, payer negotiations, and market saturation.
- Market growth rate: Expected to stabilize at 3-4% annually owing to increasing autoimmune disease prevalence and approved indications.
Long-term (2030 and beyond)
- Market evolution will rely heavily on biosimilar penetration, patents' fate, and emerging therapies such as oral immunomodulators.
- Innovator’s price: Likely to decline by 40-60% over the next decade, aligned with biosimilar adoption and cost containment pressures.
- Market size: Could decline if biosimilars gain dominant market share, but remains significant given the growing autoimmune disease burden.
Financial Impact and Pricing Strategies
To preserve competitiveness, industry leaders may adopt strategies such as:
- Value-based contracting with payers.
- Patient assistance programs to mitigate affordability challenges.
- Lifecycle management via expanded indications and combination therapies.
In view of these factors, projected average wholesale prices for Stelara in 2030 could approximate $1,300 to $2,000 per dose, considering biosimilar competition and market dynamics.
Key Considerations for Stakeholders
- Investors should monitor biosimilar development milestones and regulatory approvals, given their disruptive potential.
- Manufacturers must strategize around patent protections and lifecycle extension to maximize revenue.
- Payers will increasingly leverage biosimilars for cost savings, influencing future reimbursement patterns.
- Healthcare providers need to stay apprised of evolving formularies and therapeutic options to optimize patient outcomes and manage costs.
Conclusion
NDC 00173-0826, representing Stelara (Ustekinumab), remains a cornerstone biologic in autoimmune therapy. While current pricing sustains high revenues, imminent biosimilar competition forecasted post-2024 portends significant price erosion. Strategic positioning, including biosimilar adoption and value-based models, will be critical for continued profitability. Stakeholders should proactively adapt to these market shifts to optimize financial outcomes and patient care.
Key Takeaways
- Stelara is a leading IL-12/23 inhibitor with a strong market presence, driven by expanding indications and epidemiology.
- Current prices hover around $2,500–$4,500 per dose, supported by patent protections.
- Biosimilar entry, expected around 2024-2025, could reduce prices by 20-30%, influencing revenue and market share.
- Price projections indicate a gradual decline over the next decade, with average prices potentially halving by 2030.
- Strategic measures—biosimilar integration, value-based agreements—are essential to sustaining growth amid competitive pressures.
FAQs
1. When will biosimilars for Ustekinumab become available?
Gen biosimilar applications for Ustekinumab are under review, with approvals anticipated around 2024-2025, depending on regulatory processes.
2. How will biosimilar competition affect Ustekinumab pricing?
Biosimilars are expected to introduce a 20-30% price reduction initially, pressuring traditional list prices and negotiated reimbursement rates.
3. What are the key drivers for Ustekinumab’s market growth?
Increasing prevalence of autoimmune diseases, expanded indications, and clinical preference for biologics support continued growth.
4. How might regulatory changes impact Ustekinumab’s market?
Evolving biosimilar pathways and cost-containment policies could accelerate biosimilar adoption and influence pricing dynamics.
5. What strategies can manufacturers employ to maintain profitability?
Lifecycle extension, expanding indications, innovative formulations, and value-based contracting will be crucial.
References
[1] World Health Organization. “Global Prevalence of Psoriasis.” 2021.
[2] IQVIA. “2022 Biopharmaceutical Market Review.” 2022.
