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Last Updated: February 9, 2025

Insulin lispro-aabc - Biologic Drug Details


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Summary for insulin lispro-aabc
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list2
Pharmacology for insulin lispro-aabc
Ingredient-typeInsulin
Established Pharmacologic ClassInsulin Analog
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin lispro-aabc Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin lispro-aabc Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for insulin lispro-aabc Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Insulin Lispro-aabc

Introduction to Insulin Lispro-aabc

Insulin lispro-aabc, marketed as Lyumjev, is a rapid-acting insulin analog developed by Eli Lilly and Company. It is designed to enhance glucose control in adults with type 1 and type 2 diabetes by speeding the absorption of insulin into the bloodstream and reducing hemoglobin A1C levels[4][5].

Market Size and Growth

The global insulin lispro market, which includes Lyumjev, is projected to grow significantly due to the increasing prevalence of diabetes worldwide. As of 2023, the global insulin lispro market is valued at US$ 7.32 billion and is expected to reach US$ 11.15 billion by 2030, growing at a CAGR of 6.2% from 2023 to 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the insulin lispro market:

  • Increasing Prevalence of Diabetes: The rising incidence of diabetes globally is a major driver, as more people require effective insulin therapies.
  • Advancements in Insulin Delivery Devices: Improvements in insulin pumps and other delivery systems enhance the usability and effectiveness of insulin lispro-aabc.
  • Increased Sedentary Lifestyle: A more sedentary lifestyle contributes to higher rates of diabetes, increasing the demand for insulin treatments.
  • Development of Biosimilars: The introduction of biosimilar versions of insulin lispro could expand market access and reduce costs, although the uptake of biosimilars for insulin lispro has been relatively slow, at around 8% compared to other biologics[3].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of insulin lispro-aabc is a critical factor in its market dynamics. Studies have shown that rapid-acting insulin analogs like insulin lispro can reduce the cost associated with severe hypoglycemia episodes. For instance, a Spanish study found that insulin lispro was associated with significant reductions in costs due to reductions in severe hypoglycemia[2].

However, the higher cost of analog insulins compared to human insulins can be a barrier, particularly for populations with lower socioeconomic status. The socioeconomic impact is significant, as some populations may be disproportionately affected by the costs of these treatments[2].

Regulatory Approvals and Expansions

Lyumjev received FDA approval in June 2020 for use in adults with type 1 and type 2 diabetes. It was later approved for administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump in August 2021, expanding its delivery options and enhancing its market potential[4][5].

Competitive Landscape

The insulin lispro market is highly competitive, with several major pharmaceutical companies involved, including Eli Lilly and Company, Sanofi, Novo Nordisk A/S, and others. The competitive landscape is further complicated by the introduction of biosimilars, which can impact market share and pricing strategies[1].

Price Reductions and Access Programs

In an effort to improve access and affordability, Eli Lilly and Company announced significant price reductions for its insulins, including a 70% reduction for its most commonly prescribed insulins and an expansion of its Insulin Value Program, which caps patient out-of-pocket costs at $35 or less per month. Such initiatives can influence market dynamics by making the product more accessible to a broader patient base[1].

Regional Insights

The global insulin lispro market is segmented by region, with varying market shares and growth rates. Understanding regional differences is crucial for tailoring marketing strategies and addressing local healthcare needs[1].

New Product Launches and Innovations

The approval and launch of Lyumjev represent a significant innovation in the insulin lispro market. This new formulation is designed to speed the absorption of insulin into the bloodstream, reducing post-meal blood sugar spikes and improving glycemic control. Such innovations drive market growth by offering improved treatment options for patients[4][5].

Acquisitions and Partnerships

The insulin lispro market is also influenced by strategic acquisitions and partnerships. These collaborations can lead to the development of new products, enhance distribution networks, and improve market penetration[1].

Challenges and Restraints

Despite the growth potential, the insulin lispro market faces several challenges:

  • High Cost of Analog Insulins: The higher cost compared to human insulins can limit access, especially for underserved populations.
  • Socioeconomic Disparities: The cost of analog insulins can disproportionately affect certain socioeconomic groups, impacting health equity[2].
  • Biosimilar Uptake: The slow uptake of biosimilars for insulin lispro, such as the 8% market share, indicates that there is still significant room for growth in this segment[3].

Future Outlook

The future of the insulin lispro-aabc market looks promising, driven by increasing demand for effective diabetes treatments and advancements in insulin delivery technologies. However, the market will need to navigate challenges related to cost, access, and the impact of biosimilars.

Key Takeaways

  • The global insulin lispro market is projected to grow to US$ 11.15 billion by 2030.
  • Insulin lispro-aabc (Lyumjev) offers improved glycemic control and faster absorption.
  • Cost-effectiveness and access programs are crucial for market growth.
  • Biosimilars and regional market dynamics play significant roles in shaping the market.
  • Innovations in insulin delivery and pricing strategies will continue to influence market dynamics.

Frequently Asked Questions (FAQs)

Q: What is insulin lispro-aabc, and how does it differ from regular insulin? A: Insulin lispro-aabc, marketed as Lyumjev, is a rapid-acting insulin analog designed to speed the absorption of insulin into the bloodstream, reducing post-meal blood sugar spikes and improving glycemic control compared to regular human insulin[4].

Q: What are the key drivers of the insulin lispro market growth? A: The key drivers include the increasing prevalence of diabetes, advancements in insulin delivery devices, an increased sedentary lifestyle, and the development of biosimilars[1].

Q: How does the cost of insulin lispro-aabc compare to human insulin? A: Insulin lispro-aabc is generally more expensive than human insulin, although it offers several clinical benefits, including reduced hypoglycemia episodes and faster absorption[2].

Q: What is the impact of biosimilars on the insulin lispro market? A: Biosimilars have a relatively slow uptake in the insulin lispro market, around 8%, but they can expand market access and reduce costs, influencing market dynamics and pricing strategies[3].

Q: What recent developments have enhanced the market potential of Lyumjev? A: The FDA approval for administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump and significant price reductions announced by Eli Lilly and Company have enhanced the market potential of Lyumjev[5].

References

  1. Coherent Market Insights, "Insulin Lispro Market Size, Trends and Forecast to 2030".
  2. Endocrine Society, "Guideline Development Tool - printout - Endocrine Society".
  3. Center for Biosimilars, "Biosimilars Account for 23% Market Share, With Wide Uptake Disparities Across Molecules".
  4. Clinical Trials Arena, "Lyumjev (insulin lispro-aabc) for Type 1 and Type 2 Diabetes".
  5. PR Newswire, "FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps".

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