You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

Drug Price Trends for NDC 59651-0276


✉ Email this page to a colleague

« Back to Dashboard


Best Wholesale Price for NDC 59651-0276

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 59651-0276

Last updated: August 13, 2025

Introduction

NDC 59651-0276 corresponds to Alectinib, a targeted therapy primarily used in the treatment of ALK-positive non-small cell lung cancer (NSCLC). Since its FDA approval, Alectinib has gained widespread adoption owing to its superior efficacy and favorable safety profile compared to earlier treatments. This analysis offers a comprehensive overview of the current market landscape, competitive positioning, pricing strategies, and projections for Alectinib over the next five years.


Market Overview

Therapeutic Area and Patient Demographics

Alectinib (developed by Genentech/Roche) belongs to the ALK inhibitor class, indicated specifically for patients with ALK-positive NSCLC, accounting for approximately 3-5% of all lung cancers. The global incidence of NSCLC exceeds 2 million annually, with ALK mutations present in roughly 4-5% of these cases, translating to an estimated 80,000 to 100,000 eligible patients worldwide per year.

The increasing prevalence of these mutations and the approval of more sensitive diagnostic assays (e.g., FISH, IHC, NGS) have expanded the diagnosed patient base. Additionally, growing awareness and broader screening initiatives are contributing to improved detection rates, augmenting the market potential.

Regulatory Status and Indications

Initially approved by the FDA in 2015 for ALK-positive metastatic NSCLC, subsequent approvals have expanded Alectinib’s indications, including use as a first-line therapy (e.g., FDA approval in 2019). Europe and other jurisdictions follow similar regulatory pathways, aligning with evolving clinical guidelines from NCCN and ESMO, which now favor Alectinib as a preferred first-line treatment due to superior progression-free survival (PFS) and overall response rates (ORR) [1].

Market Drivers

  • Clinical efficacy: Demonstrated superior PFS and CNS penetration capabilities.
  • Regulatory endorsements: Broad approvals bolster market acceptance.
  • Diagnostic advancements: Rise in screening enhances detected patient counts.
  • Competitive dynamics: Entry of brigatinib and lorlatinib offers alternatives, intensifying market competition.

Competitive Landscape

Key Competitors

  • Alectinib (NDC 59651-0276): Market leader in first-line ALK-positive NSCLC.
  • Brigatinib (Alunbrig): Approved for ALK-positive NSCLC resistant/intolerant to crizotinib; competing in second-line settings.
  • Lorlatinib (Lorbrena): Designed for advanced disease, especially in resistant cases with CNS metastasis.
  • Crizotinib (Xalkori): The first ALK inhibitor, now superseded as first-line due to superior agents.

Market Share Dynamics

Alectinib has maintained a predominant position, capturing approximately 70-80% of the ALK inhibitor market, stimulated by positive phase III trial outcomes (e.g., ALEX trial) [2]. Lorlatinib has steadily increased its share in refractory or resistant cases, while brigatinib remains a significant second-line competitor.


Pricing and Reimbursement Landscape

Current Pricing Structure

In the U.S., the Wholesale Acquisition Cost (WAC) for Alectinib is approximately $13,000 – $15,000 per month, translating to roughly $150,000 – $180,000 annually (taking into account typical dosage of 600 mg twice daily).

International pricing varies significantly due to pricing regulations, reimbursement policies, and market negotiations. Examples include:

  • Europe: Negotiated discounts; publicly available prices often range €80,000 – €120,000 annually.
  • Japan and other Asian markets: Prices are generally lower, reflecting local healthcare economic factors.

Reimbursement & Accessibility

Insurance coverage is robust in high-income countries, with payers providing favorable reimbursement for Alectinib due to its clinical benefits. However, access barriers exist in low- and middle-income countries, limiting market penetration.

Pricing Trends and Market Incentives

The ongoing patent exclusivity, expected until approximately 2030, sustains high pricing. Nevertheless, biosimilar or generic entrants are unlikely in the short term due to the complexity of biosimilars and patent protections.


Market Projections (2023-2028)

Key Assumptions

  • Continuation of current approval status.
  • Steady recognition of Alectinib as the standard first-line therapy.
  • Incremental improvements in diagnostic capabilities leading to increased diagnosis.
  • Market penetration influenced by competitor activities and emerging therapies.

Forecasted Growth Trajectory

The global market for ALK inhibitors is projected to grow at a Compound Annual Growth Rate (CAGR) of 8-10% over the next five years, driven by increased diagnosis, expanding indications, and ongoing clinical acceptance.

  • 2023 Market Size: Estimated at $2.5 billion, with Alectinib accounting for approximately $2 billion of this.
  • 2028 Projection: Expected market size of $4.5 – $5 billion, with Alectinib maintaining roughly 80% market share, corresponding to $3.6 – $4 billion.

Revenue Projections

Assuming an average annual treatment cost of $150,000, and considering an approximate 15,000–20,000 patients globally receiving Alectinib true to recent epidemiological estimates, revenues are poised for consistent growth aligned with the broader market expansion.

Impact of Competitive Dynamics

As lorlatinib and brigatinib consolidate their positions, particularly in resistant cases, the share of Alectinib may plateau or slightly decline in certain niches. Nevertheless, its role as a first-line agent and the anticipated durability of its patent exclusivity are expected to sustain high revenue levels.


Implications for Stakeholders

  • Pharmaceutical companies: Continued innovation and strategic pricing will be essential to retain market dominance.
  • Payers and insurers: Cost negotiations will be critical to maintaining affordable access amid high drug prices.
  • Patients and providers: Advances in diagnostic technologies will facilitate earlier treatment initiation, reducing disease burden.

Key Takeaways

  • Market dominance: Alectinib remains the first-line therapy of choice for ALK-positive NSCLC, with >70% market share.
  • Pricing stability: High drug prices projected to persist through patent exclusivity, with incremental pressure from generics unlikely before 2030.
  • Growth prospects: The global ALK inhibitor market is expected to grow at a CAGR of 8-10%, with Alectinib generating multi-billion dollar revenues.
  • Competitive landscape: Emerging therapies like lorlatinib will influence niche markets, emphasizing the need for strategic differentiation.
  • Market expansion: Increased diagnostic penetration and approval in new geographies will boost overall market size, benefiting Alectinib’s revenue streams.

FAQs

1. How does Alectinib’s efficacy compare to other ALK inhibitors?
Alectinib demonstrated superior progression-free survival and CNS penetration in clinical trials (notably the ALEX trial), positioning it as a preferred first-line agent over crizotinib and competing effectively with newer therapies like lorlatinib.

2. What factors could impact Alectinib’s market share over the next five years?
Emergence of biosimilars, patent expirations, regulatory changes, advancements in diagnostic techniques, and competition from next-generation ALK inhibitors will influence its market share.

3. Are there significant price reductions anticipated for Alectinib?
While minor discounts and negotiations are common, substantial price reductions are unlikely before patent expiry. Market pressures or biosimilar entries can change this landscape.

4. What is the outlook for Alectinib in emerging markets?
Market growth is expected as diagnostic capabilities improve, although higher prices and reimbursement challenges may pose barriers. Local manufacturing and tiered pricing could enhance access.

5. How will clinical advancements influence the use of Alectinib?
Innovations improving early detection, combination therapies, or overcoming resistance mechanisms could expand or modify Alectinib’s role, impacting long-term market dynamics.


References

[1] National Comprehensive Cancer Network (NCCN). Non-Small Cell Lung Cancer Guidelines. 2022.
[2] Camidge, D.R., et al. "Alectinib versus crizotinib in untreated ALK-positive lung cancer." New England Journal of Medicine, 2019.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.