Siltuximab - Biologic Drug Details

Summary for siltuximab

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

Recent Clinical Trials for siltuximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
United States Department of Defense	Phase 2
Recordati Rare Diseases	Phase 2
Massachusetts General Hospital	Phase 2

See all siltuximab clinical trials

Pharmacology for siltuximab

Mechanism of Action	Interleukin-6 Antagonists
Established Pharmacologic Class	Interleukin-6 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. General 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 siltuximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for siltuximab Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for siltuximab Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Siltuximab

Introduction

Siltuximab, marketed under the brand name Sylvant, is a biologic drug used primarily for the treatment of multicentric Castleman's disease (MCD), a rare and debilitating condition. Understanding the market dynamics and financial trajectory of siltuximab is crucial for investors, healthcare providers, and patients alike.

Market Size and Growth

The global siltuximab market has been experiencing steady growth. As of 2023, the market size was valued at USD 100 million and is projected to reach USD 140.71 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Clinical Significance and Efficacy

Siltuximab has demonstrated significant clinical benefits in treating MCD. Clinical trials have shown a statistically significant improvement in symptom control and quality of life for patients receiving siltuximab compared to those on placebo (34% vs. 0%)[3].

Cost-Effectiveness and Economic Considerations

Despite its clinical efficacy, the cost-effectiveness of siltuximab is a subject of debate. The drug is expensive, with costs ranging from $697.70 to $2,790.80 per vial, depending on the dose. At the recommended dose, the daily cost is approximately $265.79, and the 28-day cycle cost is around $7,444.13, considering wastage[3].

The Pan-Canadian Oncology Drug Review (pCODR) Economic Guidance Panel (EGP) has noted that the incremental cost-effectiveness ratio (ICER) of siltuximab is uncertain and likely near the upper bound of acceptable estimates. This uncertainty is largely due to the short trial follow-up period and the lack of demonstrated long-term survival benefits. As a result, pCODR concluded that siltuximab is not cost-effective at the current price[3].

Market Drivers

Several factors drive the demand for siltuximab:

Rare Disease Treatment

Siltuximab is one of the few treatments available for MCD, a rare and serious condition. The lack of alternative treatments makes siltuximab a critical option for patients.

Clinical Benefits

The drug's ability to improve symptom control and quality of life significantly enhances its market appeal.

Regulatory Approvals

Regulatory approvals in various jurisdictions have expanded the market reach of siltuximab.

Market Constraints

Despite the drivers, there are several constraints affecting the market:

High Cost

The high cost of siltuximab is a significant barrier to access, especially in regions with limited healthcare budgets.

Uncertainty in Long-Term Benefits

The lack of long-term survival data and the uncertainty in the duration of therapy create challenges in assessing the drug's cost-effectiveness.

Competition

While siltuximab is currently a dominant player in the MCD treatment market, potential competitors and alternative treatments could impact its market share in the future.

Financial Performance

The financial performance of companies involved in the production and distribution of siltuximab can provide insights into the drug's market dynamics.

Revenue

Companies like Janssen, which markets siltuximab, report revenues from the sale of this drug. However, specific revenue figures for siltuximab are often not disclosed separately.

Cost of Sales

The cost of acquiring, distributing, and administering siltuximab is significant. For example, in the context of other biologic drugs, companies like BeiGene have reported substantial costs associated with acquiring and distributing similar products[2].

Research and Development Expenses

Companies investing in siltuximab and related research face high R&D expenses. These costs are driven by clinical trials, manufacturing, and pre-commercial activities[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of siltuximab. Approvals from regulatory bodies such as the FDA and EMA are essential for expanding the drug's market reach. However, regulatory reviews also scrutinize the drug's cost-effectiveness and long-term benefits, which can impact its market acceptance[3].

Patient and Provider Perspectives

Patient Advocacy

Patient advocacy groups highlight the importance of siltuximab in improving the quality of life for MCD patients. Despite the high cost, these groups often advocate for better access to the drug due to its significant clinical benefits[3].

Healthcare Provider Views

Healthcare providers balance the clinical efficacy of siltuximab against its cost. The drug's high price and the uncertainty in long-term benefits can make it challenging for providers to recommend it widely.

Future Outlook

The future outlook for siltuximab is mixed:

Market Growth

The market is expected to grow, driven by increasing awareness and diagnosis of MCD, as well as the lack of alternative treatments.

Cost Reduction

Any significant reduction in the cost of siltuximab could improve its cost-effectiveness and expand its market reach.

Competitive Landscape

The entry of new treatments or biosimilars could challenge siltuximab's market position.

Key Takeaways

• Market Growth: The siltuximab market is projected to grow at a CAGR of 5% from 2024 to 2031.
• Clinical Efficacy: Siltuximab has shown significant clinical benefits in treating MCD.
• Cost-Effectiveness: The drug is not considered cost-effective at current prices due to high costs and uncertainty in long-term benefits.
• Regulatory Environment: Regulatory approvals and reviews significantly impact the drug's market dynamics.
• Patient and Provider Perspectives: Patients and providers balance the drug's clinical benefits against its high cost.

FAQs

What is siltuximab used for?

Siltuximab is used for the treatment of multicentric Castleman's disease (MCD), a rare and serious condition.

How much does siltuximab cost?

The cost of siltuximab varies but can range from $697.70 to $2,790.80 per vial, with a 28-day cycle cost of around $7,444.13, considering wastage.

Is siltuximab cost-effective?

According to the Pan-Canadian Oncology Drug Review, siltuximab is not considered cost-effective at the current price due to high costs and uncertainty in long-term benefits.

What are the market drivers for siltuximab?

Market drivers include the drug's clinical benefits, its status as a rare disease treatment, and regulatory approvals.

What are the challenges facing the siltuximab market?

Challenges include the high cost of the drug, uncertainty in long-term benefits, and potential competition from new treatments or biosimilars.

Sources

1. Market Research Intellect: Siltuximab Market Analysis, Share Forecast to 2031
2. BeiGene: Fourth Quarter and Full Year 2019 Financial Results
3. Canada's Drug Agency: Siltuximab (Sylvant) MCD - Canada's Drug Agency
4. Cognitive Market Research: Global Siltuximab Market Report 2024 Edition, Market Size, Share, Growth, CAGR, Forecast, Revenue