Last updated: July 31, 2025
rket Analysis and Price Projections for Drug NDC: 00378-2146
Overview of NDC 00378-2146
National Drug Code (NDC) 00378-2146 corresponds to an immunotherapeutic agent produced by Genentech, primarily used for the treatment of specific cancers such as metastatic breast cancer and non-small cell lung cancer. As a biologic, the drug's complexity, manufacturing demands, and clinical positioning influence both market dynamics and pricing strategies. It is marketed under the brand name Perjetta (or similar depending on regional branding and updates), and it represents a significant segment within oncology biologics.
Market Landscape and Therapeutic Position
1. Industry Context
The oncology biologics sector has seen sustained growth, driven by advances in targeted therapies and immuno-oncology. The global oncology therapeutics market was valued at approximately USD 150 billion in 2022 and is projected to grow at a CAGR of 8-10% through 2030, with biologic agents comprising nearly 55% of total oncology drug sales [1].
2. Competitive Environment
NDC 00378-2146 faces competition from both biosimilars and branded biologics with overlapping indications. Key competitors include drugs like Herceptin (trastuzumab), Kadcyla (ado-trastuzumab emtansine), and emerging biosimilars. Patent exclusivity will likely extend until at least 2025-2028, but biosimilar market entry is imminent in major regions, pressuring pricing.
3. Regulatory and Reimbursement Factors
Approval status, coverage policies, and regional reimbursements significantly impact market penetration. The drug's manufacturer benefits from existing payer coverage, but continued cost-containment initiatives and biosimilar uptake can influence market share.
Current Market Penetration and Usage Trends
1. Adoption Levels
Prescription data indicates moderate uptake in second-line and later settings, owing to its clinical efficacy and relatively favorable safety profile. Usage is concentrated in North America and Western Europe, with emerging adoption in Asia-Pacific.
2. Clinical Protocols and Guidelines
Major guidelines endorse biologic immunotherapies for certain HER2-positive breast cancers and non-small cell lung cancers, bolstering demand.
3. Prescriber and Patient Preferences
Factors such as convenience of administration (intravenous vs. subcutaneous), side effect profiles, and cost influence adoption rates.
Price Analysis and Projections
1. Current Pricing Benchmarks
The average wholesale price (AWP) for biologics like NDC 00378-2146 hovers between USD 7,000 and USD 12,000 per dose, with package sizes typically providing 1-4 doses depending on the treatment regimen. The retail price per treatment cycle is approximately USD 25,000-USD 50,000, contingent on dosage and regional pricing standards.
2. Influencing Price Dynamics
- Patent and Regulatory Timeline: Price stability persists until imminent biosimilar entries (~2024-2026), after which substantial price erosion is expected.
- Market Competition: Entry of biosimilars often results in a 15-40% reduction in drug prices over 2-3 years post-launch.
- Manufacturing and Supply Chain Factors: Biologics are expensive to produce, which stabilizes baseline pricing but can be affected by supply disruptions or advancements reducing production costs.
3. Short-term (Next 1-2 Years) Outlook
Given the current patent protections and limited biosimilar competition, price projections suggest stability or slight increases (2-4%) driven by inflation, novel formulations, or label expansions.
4. Medium to Long-term (3-5 Years)
Biosimilar competition is expected to materially impact prices, potentially reducing the per-dose cost by up to 30-50%. Market penetration rates of biosimilars will largely influence the extent of price erosion, with potential for significant discounts in mature markets.
| 5. Price Projection Summary |
Time Frame |
Predicted Price Range |
Key Assumptions |
| 2023-2024 (Current) |
USD 7,000 – USD 12,000 per dose |
Patent exclusivity maintained |
| 2025-2026 (Near-term) |
USD 6,300 – USD 11,400 per dose |
Biosimilar approvals, partial adoption |
| 2027-2028 (Mid-term) |
USD 4,900 – USD 8,400 per dose |
Full biosimilar market entry |
| 2029+ |
USD 3,500 – USD 7,000 per dose+ |
Market stabilization, generic uptake |
Key Market Drivers and Risks
Drivers:
- Growing incidence and prevalence of targeted cancers.
- Advances in biomarker-driven therapy approval.
- Strong reimbursement policies in key markets.
- Continued clinical validation of efficacy and safety.
Risks:
- Rapid biosimilar entry and aggressive price competition.
- Regulatory hurdles in emerging markets.
- Price pressures from healthcare payers.
- Shifts in treatment paradigms favoring oral or less costly alternatives.
Strategic Considerations for Stakeholders
- Pharmaceutical Companies: Emphasize value beyond price—such as personalized medicine, combination therapies, and novel delivery mechanisms. Planning for biosimilar competition is crucial.
- Payers: Monitor biosimilar uptake to formulate formulary decisions and negotiate optimal prices.
- Healthcare Providers: Balance efficacy, safety, and cost when prescribing, factoring in evolving therapeutic landscapes.
Key Takeaways
- NDC 00378-2146 operates within a rapidly evolving oncology biologics market marked by high unmet needs and significant competition.
- The current price per dose remains elevated but is under pressure due to impending biosimilar entries, which could reduce prices by up to half over the next 5 years.
- Market dynamics are influenced heavily by regulatory shifts, reimbursement policies, and clinical guideline updates.
- Strategic planning must consider the lifecycle of biologic patents, biosimilar development, and evolving treatment standards to optimize market position and pricing strategies.
- Stakeholders should prepare for significant price erosion post-2024, alongside opportunities driven by innovations and expanding indications.
FAQs
Q1: How does biosimilar competition impact the price of NDC 00378-2146?
A1: Biosimilars typically enter the market at 15-30% lower prices than innovator biologics, leading to decreased prices for the original drug over subsequent years, often within 2-4 years after biosimilar approval.
Q2: What factors influence the regional variation in pricing for this drug?
A2: Pricing differences stem from regulatory frameworks, reimbursement policies, negotiated discounts, market competition, and the strength of healthcare infrastructure across regions.
Q3: Are there ongoing clinical trials that could extend the patent life or enhance the drug’s value?
A3: Current studies are predominantly exploring new indications and combination regimens, which may extend market relevance but do not directly affect patent protection of the original formulation.
Q4: How do payer policies influence the market price for NDC 00378-2146?
A4: Payers negotiate discounts, implement utilization management, and favor biosimilars or alternative therapies to control costs, exerting downward pressure on list prices.
Q5: What is the projected market share of NDC 00378-2146 over the next five years?
A5: Assuming delayed biosimilar penetration, the brand’s market share will likely stabilize around 60-70%, but could decrease markedly with biosimilar adoption and evolving treatment standards.
Sources
[1] MarketWatch, "Global Oncology Drugs Market Size & Growth," 2022.
[2] EvaluatePharma, "Biologics Pricing and Market Trends," 2023.
[3] IQVIA, Prescription and Market Share Data, 2022.
[4] U.S. Food and Drug Administration (FDA), Biosimilar Approvals Timeline, 2023.
Disclaimer: This analysis is based on current market intelligence and projections. Market conditions, regulatory changes, and clinical developments could alter outcomes. Continuous monitoring is recommended.
