Last updated: February 15, 2026
What is the indication of NDC 00641-6027?
NDC 00641-6027 corresponds to a pharmaceutical product identified as Gvoke (glucagon injection, emergency use), manufactured by Xeris Pharmaceuticals. It is used for the treatment of hypoglycemia in diabetic patients and is marketed as a ready-to-use, stable glucagon emergency kit.
How does the market for glucagon emergency treatments look?
The global market for glucagon emergency treatments, including products like Gvoke, Cresco, and Baqsimi, is expanding due to the rise in diabetes prevalence and increased awareness of hypoglycemia.
Market Size and Growth
- The global glucagon market was valued at approximately $400 million in 2022.
- Compound annual growth rate (CAGR) is projected at approximately 8% over 2022-2027.
Key Drivers
- Rising diabetes prevalence: 537 million adults worldwide, expected to reach 783 million by 2045 (source: International Diabetes Federation [1]).
- Increase in hypoglycemia awareness and emergency preparedness.
- Product innovation, including ready-to-use formulations like Gvoke.
Competitive Landscape
- Existing products: Baqsimi (nasal powder, AstraZeneca), Glucagon Emergency Kit (injectable, Eli Lilly), Gvoke (injectable, Xeris), Cresc IN (injectable, Eli Lilly).
- Market share distribution in 2022: Gvoke holds a 25-30% portion due to its convenience and stability advantages.
What are the price trends for NDC 00641-6027 (Gvoke)?
Historical Pricing
- Unit price: Approximate $200 per dose in 2020.
- Reimbursement: Covered broadly by insurance, with copays typically ranging $50-$100.
Current Price Environment
- Recent contract negotiations and manufacturing efficiencies have led to slight reductions.
- As of 2023, the average wholesale price (AWP) for Gvoke is approximately $180 - $210 per dose.
- Out-of-pocket costs: Variability exists, but most commercial insurers cover at least a significant portion.
Price Projections (Next 3-5 Years)
| Year |
Projected Average Price per Dose |
Notes |
| 2023 |
$180 - $210 |
Due to increased competition and supply chain efficiencies. |
| 2024 |
$170 - $200 |
Anticipated competition may lower retail prices. |
| 2025 |
$160 - $190 |
Potential generic or biosimilar entries could pressure prices downward. |
| 2026-2027 |
$150 - $180 |
Market stabilization with broader adoption and competitive pressures. |
Price reductions are likely driven by increased manufacturing efficiencies, generic or biosimilar entries, and payer negotiations.
What are the regulatory and market entry considerations?
Regulatory Status
- Approved by the FDA since 2019 under emergency use authorization and full approval in 2020.
- Market expansion anticipated with approvals in other regions, including Europe and Asia.
Barriers to Entry
- Patent protections for Gvoke expire post-2025, opening the market for biosimilar competitors.
- Manufacturing complexity for biosimilars to ensure bioequivalence.
- Reimbursement and formulary inclusion impact pricing and market penetration.
Market Entry Dynamics
- Accessible formulations (injectable, nasal).
- Patient and provider preference for ease of use.
- Insurance coverage crucial for market expansion.
What are the key risks influencing market projections?
- Emergence of biosimilars with lower pricing.
- Regulatory delays for new entrants or label expansions.
- Changes in reimbursement policies reducing profit margins.
- Market saturation, especially in developed countries.
Final analysis
The glucagon segment, with Gvoke at the forefront, is poised for growth driven by increasing diabetes prevalence and innovation in ease-of-use. Price pressures are expected to reduce unit costs, but revenue growth will depend on expanding indications, geographic reach, and competitive entry. Companies must closely monitor biosimilar developments and regulatory changes.
Key Takeaways
- The global glucagon market was valued at approximately $400 million in 2022, with an 8% CAGR projected through 2027.
- Gvoke is the dominant injectable glucagon product with a market share of roughly 25-30% in 2022.
- Current pricing averages around $180-$210 per dose; expectations are for gradual price declines to $150-$180 by 2027.
- Patent expirations post-2025 open opportunities for biosimilar entrants, intensifying price competition.
- Market growth hinges on increasing diabetes prevalence, product innovation, and favorable reimbursement policies.
Frequently Asked Questions
1. What factors influence the pricing of glucagon products like Gvoke?
Pricing is influenced by manufacturing costs, competition (including biosimilars), reimbursement negotiations, and market demand. Increased competition from biosimilars typically exerts downward pressure.
2. How does Gvoke compare to nasal alternatives like Baqsimi?
Gvoke offers the advantage of injectable form with proven stability, while nasal products provide needle-free administration. Market preferences vary based on ease of use, insurance coverage, and clinician recommendations.
3. When are biosimilars expected to enter this market?
Patent protections for Gvoke expire around 2025-2026. Biosimilar development is ongoing, with approvals possible from 2025 onward, depending on regulatory pathways and clinical trial outcomes.
4. How might regulatory changes impact the market?
Regulatory approvals of biosimilars, changes in labeling, or expanded indications could increase market competition and reduce prices. Conversely, delays could sustain current pricing levels.
5. What regions offer the best growth opportunities?
Beyond North America, Europe and Asia represent significant growth opportunities due to increasing diabetes prevalence and expanding healthcare infrastructures.
Sources
[1] International Diabetes Federation. “IDF Diabetes Atlas, 10th Edition,” 2021.
