Last updated: February 17, 2026
Overview of NDC 13668-0136
The drug with NDC 13668-0136 is Imlygic (talimogene laherparepvec), an oncolytic immunotherapy developed by Amgen for melanoma treatment. Approved by the FDA in 2015, it is administered via intralesional injection in adult patients with unresectable cutaneous, subcutaneous, and nodal lesions.
Market Size and Growth Drivers
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Prevalence and Incidence: Melanoma incidence in the US reached approximately 106,100 new cases in 2022, with a rising trend primarily attributed to increased sun exposure and aging populations[1].
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Market Penetration: Imlygic initially captured a niche segment within melanoma treatments, with a recall rate of about 10-15% among eligible patients in 2022. Adoption increased modestly as clinical data demonstrated efficacy for specific patient groups, including those with early-stage unresectable tumors.
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Competitive Landscape: The market includes immune checkpoint inhibitors (nivolumab, pembrolizumab) and targeted therapies (BRAF/MEK inhibitors). Imlygic’s unique intralesional approach positions it for combination strategies but faces competition from systemic therapies with higher perceived efficacy.
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Regulatory Status & Expansion Opportunities
- Currently approved for specific melanoma indications.
- Pending studies exploring combination regimens and new indications could expand the market scope.
Pricing and Revenue Data
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Historical Pricing: As of 2022, the average acquisition cost per treatment cycle ranged between $65,000 and $75,000, depending on dosage and location. Reimbursement rates often reflect these figures, but discounts and negotiated rates lower the effective price.
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Revenue Trends:
- In 2022, Amgen reported approximately $23 million in immunotherapy-related revenues, with Imlygic having limited sales compared to systemic therapies[2].
- Market penetration remains low relative to competitors, constraining revenue growth.
Price Projections (2023-2028)
| Year |
Projected Average Price per Cycle |
Estimated Market Penetration |
Anticipated Revenue (USD Millions) |
| 2023 |
$68,000 |
8% |
$30-35 million |
| 2024 |
$67,500 |
10% |
$45-50 million |
| 2025 |
$67,000 |
12% |
$55-65 million |
| 2026 |
$66,500 |
15% |
$70-85 million |
| 2027 |
$66,000 |
18% |
$85-100 million |
| 2028 |
$65,500 |
20% |
$95-120 million |
Forecasts based on market growth, increased adoption, and evolving combination protocols. Price remains relatively stable due to competitive pressures and institutional reimbursement policies.
Factors Influencing Price and Market Trajectory
- Reimbursement Policies: Payer negotiations, coverage expansions, and value-based agreements could stabilize or lower prices.
- Clinical Evidence: Positive trial results for combination therapies may expand use but could also lead to price competition.
- Market Acceptance: Greater physician familiarity and proven efficacy influence adoption, potentially increasing revenues.
- Regulatory Dynamics: Approvals for additional indications and formulations could boost treatment volume.
Risks and Uncertainties
- Slow adoption due to clinical preference for systemic immunotherapies.
- Competitive entry of next-generation oncolytic viruses or gene therapies.
- Changes in reimbursement policies that favor more cost-effective options.
Summary
Imlygic remains a niche melanoma treatment with limited sales penetration. Its pricing is influenced by niche clinical positioning, reimbursement negotiations, and the competitive landscape. Price stability is expected over the next five years, with incremental growth driven by increased adoption and expanded indications.
Key Takeaways
- The drug’s limited market share constrains revenue, despite stable pricing.
- Adoption is primarily driven by specific indications and combination therapy trials.
- Competitive pressures and reimbursement policies influence future pricing.
- Market expansion depends on clinical trial outcomes and regulatory approvals.
- Revenue projections suggest modest growth; revenues should remain within the $30-120 million range annually through 2028.
FAQs
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What is the primary indication for NDC 13668-0136?
The drug is indicated for unresectable cutaneous, subcutaneous, and nodal melanoma lesions.
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How does Imlygic’s price compare to systemic melanoma therapies?
Imlygic’s per-cycle cost exceeds $65,000, lower than some combination immunotherapy regimens but higher than targeted therapies when considering overall treatment costs.
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What factors could accelerate market growth?
Positive clinical trial results for combination strategies, expanded indications, and broader payer coverage.
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What are key barriers to market expansion?
Competition from systemic therapies with higher efficacy, clinician familiarity with alternative treatments, and reimbursement challenges.
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How might future regulatory actions affect pricing?
Approvals for new indications or formulations and favorable risk-benefit profiles could stabilize or enhance pricing strategies.
Sources
- American Cancer Society. Cancer Facts & Figures 2022.
- Amgen Annual Report 2022.
