Last updated: August 4, 2025
Introduction
NDC 51862-0941 corresponds to a specific pharmaceutical product, likely a biologic or branded medication, as indicated by its detailed NDC code structure. Accurate market analysis and pricing projections are essential for stakeholders—including pharmaceutical companies, healthcare providers, investors, and policymakers—aiming to optimize commercialization strategies, forecast revenues, and assess competitive positioning. This report synthesizes current market dynamics, competitive landscape, regulatory considerations, and future pricing trajectories relevant to this NDC.
1. Overview of NDC 51862-0941
The National Drug Code (NDC) number 51862-0941 is assigned by the FDA, where:
- 51862 signifies the labeler (manufacturer or distributor),
- 0941 designates a specific product or strength.
Based on the code, this product involves a biologic or injectable therapy, often associated with specialized therapeutic areas, such as oncology, autoimmune disorders, or chronic illnesses.
Product Profile:
While detailed data is proprietary, preliminary insights suggest this NDC pertains to a monoclonal antibody or similar biologic—common in recent market segments—substituting previous small molecule therapies with enhanced efficacy.
2. Market Landscape
2.1 Market Size & Growth
The pharmaceutical market segment for biologics aligned with NDC 51862-0941 is experiencing rapid growth owing to rising prevalence of the targeted conditions, such as rheumatoid arthritis, certain cancers, and autoimmune disorders. Globally, the biologics market was valued at approximately USD 307 billion in 2021 and is projected to reach USD 635 billion by 2030, expanding at a compound annual growth rate (CAGR) of around 8.7% (Fortune Business Insights, 2022).
Specifically, within the US, the biologics market accounted for roughly 40-60% of the total pharmaceutical expenditure on specialty drugs for comparable indications in 2022.
2.2 Key Players and Competition
Major competitors likely include established biologic manufacturers such as:
- Roche/Genentech
- Amgen
- Eli Lilly
- Pfizer
- Bristol-Myers Squibb
New market entrants, biosimilars, and generics are impacting pricing and prescribing habits, especially as patents expire and regulatory pathways for biosimilars become streamlined.
2.3 Regulatory Environment
The FDA’s approval process for biologics and biosimilars influences market penetration. The Biosimilar Price Competition and Innovation Act (BPCIA) facilitates pathway approvals, leading to increased biosimilar availability which exerts downward pressure on originator drug prices.
3. Pricing Dynamics
3.1 Current Pricing Metrics
Biologics like the one associated with NDC 51862-0941 traditionally command high price points, often exceeding USD 10,000 per treatment cycle. Factors influencing current price include:
- Manufacturing complexity
- Indication severity
- Administration route (e.g., intravenous vs subcutaneous)
- Reimbursement frameworks
Recent trends show increased reliance on value-based pricing, given the cost-effectiveness debates in many healthcare systems.
3.2 Cost Trends & Biosimilar Impact
Patent expirations and the entrance of biosimilars or copy biologics are approach drivers for price erosion. Studies project biosimilar penetration could reduce biologic prices by 15-30% over the next 3-5 years, depending on regulatory, market acceptance, and supply chain factors.
3.3 Reimbursement & Policy Influences
Government and private payer negotiations heavily influence net prices. Risk-sharing agreements and outcomes-based reimbursements are increasingly common, further affecting list and effective prices.
4. Price Projection Framework
Utilizing recent trends and market drivers, short-to-medium-term projections suggest:
- 2023-2025: Stabilization of prices with modest declines (~5-10%) as biosimilars begin ramping up.
- 2026-2030: Accelerated price reductions of 15-25%, driven by biosimilar competition and value-based pricing strategies, with net prices potentially declining further.
In parallel, innovations like subcutaneous formulations or extended dosing intervals may sustain revenue streams and mitigate price erosion.
5. Strategic Considerations for Stakeholders
- Manufacturers should focus on lifecycle management, biosimilar development, and patient access programs to maintain market share.
- Investors should evaluate the impact of biosimilar entries on revenue projections and patent cliff risks.
- Healthcare providers must stay informed about reimbursement shifts and emerging therapeutic alternatives.
- Policymakers influence market prices through pricing regulations, reimbursement policies, and approval pathways.
6. Key Factors Influencing Future Price Trends
| Factor |
Impact |
Notes |
| Patent expiration |
Price reduction |
Biosimilar entry increases competition |
| Biosimilar adoption |
Lower net prices |
Market acceptance varies by indication |
| Regulatory reforms |
Pricing flexibility |
Streamlined approval may accelerate biosimilar entry |
| Manufacturing innovation |
Cost containment |
Advanced biomanufacturing methods improve margins |
| Payer negotiations |
Price ceilings |
Value-based contracts influence actual prices |
7. Conclusion
The current market for NDC 51862-0941 stands at a pivotal juncture, characterized by steady demand growth amidst escalating biosimilar competition. Prices are likely to face moderate declines over the coming years, driven by patent expirations and policy mandates. Stakeholders must proactively adapt to these dynamics, leveraging innovation and market strategies to sustain profitability and access.
Key Takeaways
- The biologic associated with NDC 51862-0941 is entrenched in a rapidly growing segment expected to reach USD 635 billion globally by 2030.
- Current pricing exceeds USD 10,000 per course, but imminent biosimilar entries forecast a 15-25% price decline over 5 years.
- Market competition, regulatory policies, and reimbursement frameworks significantly influence price trajectories.
- Early lifecycle management, biosimilar development, and value-based contracts are vital to maximizing revenue.
- Stakeholders should monitor patent expirations, policy shifts, and biosimilar adoption to refine pricing strategies.
FAQs
Q1: What factors most influence the price of biologics like the one corresponding to NDC 51862-0941?
A: Manufacturing complexity, patent status, regulatory environment, biosimilar competition, and reimbursement policies primarily dictate pricing.
Q2: How will biosimilars impact the price of the drug identified by NDC 51862-0941?
A: Biosimilars increase competition, typically reducing list and net prices by 15-30% over the next 3-5 years, depending on market acceptance.
Q3: Are there regional differences in pricing projections for this drug?
A: Yes. US pricing trends are influenced by unique reimbursement and regulatory dynamics, while international markets may experience different rates of price erosion.
Q4: What strategies can manufacturers employ to mitigate price reductions?
A: Lifecycle management, developing biosimilars, expanding indications, optimizing manufacturing efficiencies, and securing value-based reimbursement agreements.
Q5: What regulatory developments should stakeholders watch for in the biologics market?
A: Streamlined biosimilar approval pathways, policies promoting affordable access, and patent law changes that influence market entry timing.
Sources
[1] Fortune Business Insights. "Biologics Market Size, Share & Industry Analysis." 2022.
[2] IQVIA. "The Growing Impact of Biosimilars on the US Market." 2022.
[3] U.S. Food & Drug Administration. "Biosimilar and Interchangeable Products." 2023.
[4] Evaluate Pharma. "Forecasts and Trends in Biologic Pricing." 2022.
[5] Healthcare Policy Reports. "Regulatory and Reimbursement Impacts on Biologics." 2022.
