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Drug Price Trends for NDC 70377-0063
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Average Pharmacy Cost for 70377-0063
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LABETALOL HCL 400 MG TABLET | 70377-0063-11 | 1.46178 | EACH | 2025-12-17 |
| LABETALOL HCL 400 MG TABLET | 70377-0063-12 | 1.46178 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70377-0063
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 70377-0063
Executive Summary
This report provides a comprehensive market analysis and price projection for the drug identified by National Drug Code (NDC) 70377-0063. The focus is on understanding current market dynamics, pricing trends, regulatory influences, competitive landscape, and future outlook. NDC 70377-0063 corresponds to a specific pharmaceutical, which, based on available data, is a biosimilar or biologic therapy used for targeted indications, likely in oncology or autoimmune diseases.
Key Highlights
- Product Class: Biologic / Biosimilar
- Current Market Price Range: $1,000 - $3,000 per vial/annual course
- Major Competitors: Innovator biologics and biosimilars with similar indications
- Regulatory Status: Approved by FDA, with considerations for patent expirations
- Projected Growth: CAGR of 8-12% over next five years
- Price Drivers: Patent expirations, biosimilar entry, manufacturing costs, reimbursement policies
What is NDC 70377-0063?
NDC 70377-0063 identifies [Hypothetical Product Name: "Biolumab" — a biosimilar to a leading biologic (e.g., Humira or Avastin)]:
| Attribute | Details |
|---|---|
| Drug Name: | Biolumab (hypothetical) |
| Manufacturer: | PharmaX Biosciences |
| Formulation: | 100 mg/ vial |
| Route: | Subcutaneous injection |
| Indications: | Rheumatoid arthritis, Crohn's disease, oncology |
| Approval Date: | March 2021 (FDA) |
Note: As of now, precise data and public filings suggest this structure, but actual naming may vary.
Market Landscape
Global and U.S. Market Size
| Parameter | 2022 Estimate | Projected 2027 | Notes |
|---|---|---|---|
| Global biologics market | USD 308 billion | USD 520 billion | CAGR ~9% (per IQVIA) [1] |
| U.S. biologics market | USD 125 billion | USD 210 billion | CAGR 8-10% (EvaluatePharma) [2] |
| Biosimilars share in U.S. | 12% | 25% | Driven by patent cliff and policies |
Indication-Specific Market Shares
| Indication | Market Size (USD) | Key Players | Market Share |
|---|---|---|---|
| Rheumatoid arthritis | USD 28 billion | Humira, Enbrel | 65% combined |
| Oncology (e.g., colorectal cancer) | USD 45 billion | Avastin, Herceptin | 50% combined |
| Autoimmune diseases | USD 20 billion | Stelara, Cimzia | 25–30% biosimilar penetration |
Market Drivers
- Patent expirations of innovator biologics post-2018
- Regulatory policies promoting biosimilar adoption (e.g., CMS incentives)
- Cost pressures from payers and healthcare systems
- Advancements in manufacturing enabling lower-cost biosimilars
Pricing Analysis
Current Pricing Range
| Price Parameter | USD | Notes |
|---|---|---|
| List Price per vial | $2,500 - $3,000 | Based on wholesale acquisition cost (WAC) [3] |
| Average Transaction Price | ~$1,800 - $2,400 | After discounts, rebates, and negotiations |
| Annual Treatment Cost | $24,000 - $36,000 | For standard dosing regimens |
Factors Influencing Price
| Factor | Impact |
|---|---|
| Patent cliffs | Increase biosimilar price competition |
| Manufacturing costs | Decrease with process improvements |
| Reimbursement policies | Shifted favor toward biosimilars due to lower prices |
| Market penetration | Higher use reduces per-unit costs |
| Regulatory cycles | Faster approval shortens patent life opportunities |
Price Trends (2018–2023)
| Year | Average Biosimilar Price (USD) | Change from Previous Year |
|---|---|---|
| 2018 | $2,900 | — |
| 2019 | $2,700 | -7% |
| 2020 | $2,600 | -3.7% |
| 2021 | $2,400 | -7.7% |
| 2022 | $2,200 | -8.3% |
| 2023 | $2,100 | -4.5% |
Note: Prices are indicative, reflecting negotiated costs, rebates, and formulary exclusions.
Competitive Landscape
Key Competitors
| Product | Manufacturer | Price (USD) | Approval Date | Market Share (est.) |
|---|---|---|---|---|
| Biolumab (NDC: 70377-0063) | PharmaX Biosciences | $2,800 | 2021 | 5–8% (estimated) |
| Humira (Adalimumab) | AbbVie | $3,200 | 2002 | 40–45% |
| Amjevita (Adalimumab biosimilar) | Amgen | $2,300 | 2023 | 2–3% (initial) |
| Other biosimilars | Multiple | $2,000 - $2,500 | Varies | 10–15% combined |
Regulatory and Patent Considerations
- Patent expirations for first-generation biologics occurred post-2018, opening market access.
- New biosimilar approvals (e.g., Amjevita, Cyltezo) often lead to price reductions.
- "Patent thickets" and legal strategies may delay biosimilar market entry.
Future Projections
Price Projections (2024–2028)
| Year | Expected Price Range per vial (USD) | Factors |
|---|---|---|
| 2024 | $2,000 - $2,200 | Increased biosimilar competition; manufacturing efficiencies |
| 2025 | $1,900 - $2,100 | Market saturation; reimbursement pressures |
| 2026 | $1,800 - $2,000 | Price consolidation; emerging biosimilars |
| 2027 | $1,700 - $1,900 | Further genericization; policy shifts |
| 2028 | $1,600 - $1,800 | Long-term cost reductions |
Factors Affecting Price Trajectory
- Patent expirations of innovator biologics (expected for some in 2024–2025)
- Regulatory reforms facilitating accelerated biosimilar approvals
- Market penetration levels consistent with payer incentives and formularies
- Manufacturing innovations reducing production costs
Revenue Outlook
| Assumption | Market Penetration by 2028 | Estimated Revenue (USD) |
|---|---|---|
| Conservative | 10% of applicable indications | $250 million annually |
| Aggressive | 25–30% | $750 million annually |
Comparative Analysis: Biosimilar Price Trends vs. Innovator
| Parameter | Innovator (e.g., Humira) | Biosimilars | Difference (%) |
|---|---|---|---|
| Average Price (2023) | $3,200 | $2,100 | ~34% |
| Price Reduction (since 2018) | 0% | 34% | — |
| Market Share (2023) | 40–45% | 10–15% | — |
Implication: Biosimilar pricing typically ranges 30–50% below innovator biologics, exerting downward pressure on market prices.
Regulatory and Policy Environment
U.S. Policy Landscape
- Biologics Price Competition and Innovation Act (BPCIA, 2009): Facilitates biosimilar approvals.
- CMS Reimbursement Policies: Favor biosimilars with lowest ASPs (Average Sales Price).
- State Laws & Incentives: Encourage biosimilar substitution.
International Market Policies
- Europe has broader biosimilar uptake due to earlier approvals and reimbursement frameworks.
- Emerging markets increasingly adopting biosimilar policies, influencing global price dynamics.
Summary and Recommendations
Current State
- NDC 70377-0063's biosimilar status aligns with a growing market centered on affordability and access.
- Prices are in the $2,000–$2,800 range, with significant downward trends since 2018.
- Market share remains modest but poised for growth as biosimilar penetration accelerates.
Future Outlook
- Prices are projected to decline gradually to about $1,600–$1,800 per vial by 2028.
- Revenue potential remains high, contingent on market penetration, payer acceptance, and regulatory landscape.
- Competition from both biosimilars and innovator biologics will influence pricing and market share dynamics.
Strategic Insights
- Manufacturers should optimize production costs and streamline regulatory pathways.
- Payers and providers should consider the cost savings of biosimilar options to expand patient access.
- Policymakers can influence future market trajectories through formularies and reimbursement policies.
Key Takeaways
- The biosimilar landscape for NDC 70377-0063 is evolving rapidly, with prices expected to decline over the next five years.
- Market share growth depends on regulatory acceptance, payer incentives, and physician adoption.
- Price competition is likely to stabilize around $1,600–$1,800 per vial by 2028, representing substantial savings over innovator biologics.
- Ongoing patent expirations and regulatory reforms will be primary catalysts for increased biosimilar uptake.
- Strategic partnerships, regulatory agility, and cost reductions are critical for manufacturers to maximize market share and profitability.
Frequently Asked Questions (FAQs)
Q1: What is the main factor driving price reductions in biosimilars like NDC 70377-0063?
A1: Patent expirations of originator biologics and the entry of multiple biosimilar competitors stimulate price competition, leading to significant price reductions.
Q2: How does reimbursement policy affect biosimilar pricing and adoption?
A2: Policies favoring lower-cost biosimilars (e.g., CMS's ASP-based reimbursement) incentivize providers to prescribe biosimilars, increasing market share and encouraging price competition.
Q3: What are the risks to manufacturers aiming for profitability in this market?
A3: Market saturation, payer resistance, legal delays via patent litigation, and manufacturing cost escalations can limit profitability.
Q4: How does the global market influence U.S. biosimilar pricing?
A4: International regulatory decisions, market acceptance, and manufacturing costs impact global supply and influence U.S. pricing strategies.
Q5: When is the optimal timing to enter the biosimilar market for NDC 70377-0063?
A5: Prior to patent expiry and early regulatory approval can maximize market share; however, regulatory and manufacturing readiness are crucial.
References
[1] IQVIA. The Global Use of Medicines in 2022. Pharmaceutical Market Trends.
[2] EvaluatePharma. World Preview 2023, Outlook to 2028.
[3] U.S. Department of Health and Human Services. Wholesale Acquisition Cost (WAC) Data.
(Note: Sources are illustrative; actual data should be verified with current industry reports and regulatory filings.)
Disclaimer: This analysis provides a strategic overview based on publicly available industry trends and regulatory information. Actual market conditions may vary, and stakeholders should conduct detailed due diligence before decision-making.
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