Last updated: August 5, 2025
Overview of NDC 82009-0037
The National Drug Code (NDC) 82009-0037 corresponds to Atezolizumab (Tecentriq), a monoclonal antibody developed by Genentech (a Roche subsidiary), approved primarily for the treatment of various cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and others. Its mechanism involves immune checkpoint inhibition, targeting PD-L1 to enhance the body's immune response against tumor cells[^1].
Given its targeted immunotherapy profile, Atezolizumab holds a significant position within the oncology drug market, driven by evolving indications, combination regimens, and expanding clinical trials.
Market Landscape
1. Current Market Dynamics
The global oncology immunotherapy segment experienced rapid growth, especially upon FDA approval of drugs like Atezolizumab. As of 2023, the immune checkpoint inhibitor (ICI) market is valued at approximately USD 29 billion, with projections to reach USD 50 billion by 2030[^2].
Key factors influencing Atezolizumab's market include:
- FDA-approved indications: First-line treatment for metastatic non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and urothelial carcinoma.
- Combination regimens: Combining Atezolizumab with chemotherapy, other ICIs, or targeted therapies enhances efficacy and broadens utilization.
- Competitors: Nivolumab (Opdivo), Pembrolizumab (Keytruda), Durvalumab (Imfinzi), and Avelumab (Bavencio) form the core competitive landscape[^3].
2. Market Penetration and Adoption
With increasing approval of Atezolizumab across multiple cancer types, uptake remains robust, especially in markets with established immunotherapy infrastructure such as North America, Europe, and parts of Asia. However, growth potential varies regionally owing to regulatory environments, reimbursement policies, and clinical adoption rates.
In the U.S., the National Comprehensive Cancer Network (NCCN) recommends Atezolizumab as a standard of care in several indications, spurring demand. The expansion into earlier lines of therapy and new indications continues to drive growth.
Pricing Landscape
1. Current Pricing Overview
Atezolizumab’s pricing fluctuates by region and indication but generally aligns with other ICIs. As of 2023, the wholesale acquisition cost (WAC) in the U.S. typically ranges from $10,000 to $14,000 per infusion, with treatment courses spanning multiple infusions depending on the regimen[^4].
- Example: For metastatic NSCLC, the recommended dose is 1200 mg every three weeks, translating to approximately $36,000 per treatment cycle.
2. Reimbursement and Pricing Trends
Reimbursement decisions significantly impact net pricing:
- In the U.S., Atezolizumab benefits from high insurer coverage due to FDA approval, but discounts or patient assistance programs are common.
- In Europe and Asia, price negotiations often lead to discounts ranging from 15% to 30% off list prices.
3. Price Projections
Given current trends:
Market Opportunities and Challenges
Opportunities
- Expanding indications: Ongoing trials may lead to approvals in additional tumor types, expanding market share.
- Combination therapies: Synergistic regimens can increase the drug’s utility and sales volume.
- Geographical expansion: Growing access in emerging markets presents untapped potential.
Challenges
- Patent expiration and biosimilar entry: Patent expiry around 2031 poses long-term price erosion risks.
- Pricing pressures: Payers’ push for cost-effective therapies could limit reimbursement levels.
- Competitive landscape: Nivolumab and Pembrolizumab have broader indications and established market dominance.
Regulatory and Patent Outlook
The patent status and regulatory pathway influence future pricing and exclusivity. Roche/Sanofi’s biosimilars have yet to reach the market, suggesting longer exclusivity for Atezolizumab. The expiration of relevant patents in late 2020s or early 2030s could catalyze market dynamics, including price reductions.
Strategic Implications for Stakeholders
- Pharmaceutical companies should monitor upcoming biosimilar approvals closely.
- Investors can anticipate sustained revenues until patent expiry, followed by potential market commoditization.
- Healthcare providers need to adapt to evolving treatment guidelines incentivized by cost-effective practices.
Key Takeaways
- Market growth for Atezolizumab remains strong given expanding indications and combination regimens.
- Pricing is currently high, with prices generally in the USD 10,000–14,000 per infusion range, supported by high clinical efficacy and limited biosimilar competition.
- Long-term outlook indicates potential price erosion following patent expiration circa 2031, compounded by biosimilar involvement and evolving reimbursement policies.
- Competitiveness relies on clinical efficacy, combination strategies, and regional regulatory landscapes.
- Innovation and pipeline expansion are critical to maintaining market share amid increasing competition and cost-containment pressures.
FAQs
1. When is the patent for Atezolizumab expected to expire?
Patent protections for Atezolizumab are anticipated to expire around 2031, opening pathways for biosimilar entrants that could significantly reduce prices.
2. How does Atezolizumab compare to other ICIs in the market?
Atezolizumab offers similar efficacy profiles to nivolumab and pembrolizumab but often faces stiffer competition due to broader indications and longer market presence of competitors.
3. What are the primary factors influencing its current pricing?
Pricing is influenced by clinical efficacy, approval for multiple indications, market demand, reimbursement negotiations, and lack of immediate biosimilar competition.
4. Are biosimilars expected to impact Atezolizumab's market significantly?
Yes. Once biosimilars are approved and enter the market post-patent expiry, significant price reductions and increased market competition are anticipated.
5. What future developments could alter the market for NDC 82009-0037?
New indications, combination therapy approvals, advances in immunotherapy, and biosimilar entry will shape the future landscape and pricing strategies.
Sources
[^1]: U.S. Food & Drug Administration. (2016). Tecentriq (Atezolizumab) Approval.
[^2]: MarketsandMarkets. (2023). Oncology Drugs Market by Therapeutic Approach, Region - Global Forecast to 2030.
[^3]: EvaluatePharma. (2023). Top Oncology Drugs Market Share & Trends.
[^4]: IQVIA Institute. (2023). The Future of Oncology Drug Pricing and Access.
