Insulin lispro protamine and insulin lispro - Biologic Drug Details

Summary for insulin lispro protamine and insulin lispro

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1

Pharmacology for insulin lispro protamine and insulin lispro

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin 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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 protamine and insulin lispro Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin lispro protamine and insulin lispro Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for insulin lispro protamine and insulin lispro Derived from Patent Text Search

No patents found based on company disclosures

Insulin lispro protamine and insulin lispro Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Insulin Lispro and Insulin Lispro Protamine

Introduction

Insulin lispro and its formulations, such as insulin lispro protamine, are crucial in the management of diabetes, particularly due to their rapid-acting and intermediate-acting properties. Here, we delve into the market dynamics and financial trajectory of these biologic drugs.

Definition and Use of Insulin Lispro

Insulin lispro is a rapid-acting insulin analog, chemically synthesized using recombinant DNA technology. It is designed to have a more rapid onset of action and shorter duration compared to regular human insulin, making it a preferred choice for managing blood glucose levels in diabetic patients[1].

Global Market Size and Growth

The global insulin lispro market is significant and growing. As of 2023, the market size is estimated to be valued at US$ 7.32 billion, with a projected growth to US$ 11.15 billion by 2030 at a Compound Annual Growth Rate (CAGR) of 6.2% from 2023 to 2030[1].

Key Drivers of Market Growth

Several factors contribute to the growth of the insulin lispro market:

• Rising Incidence of Diabetes: The increasing global prevalence of diabetes drives the demand for effective insulin therapies.
• Advancements in Insulin Delivery Devices: Improvements in insulin delivery systems enhance patient compliance and satisfaction.
• Increased Sedentary Lifestyle: Lifestyle changes leading to higher rates of obesity and sedentary behavior contribute to the rise in diabetes cases.
• Biosimilar Development: The emergence of biosimilar versions of insulin lispro is expected to expand market access and reduce costs[1].

Regional Insights

The insulin lispro market is distributed across various regions, with significant shares in North America, Europe, and Asia-Pacific. These regions are driven by high diabetes prevalence, advanced healthcare systems, and increasing awareness and diagnosis of the disease[1].

Market Trends

Biosimilar Impact

Biosimilars of insulin lispro are expected to play a crucial role in the market. Studies suggest that biosimilar insulins could be manufactured at significantly lower costs, potentially reducing treatment costs to ≤US$133 per year for insulin analogues. This could lead to substantial savings globally and increased access to insulin therapy, especially in low-income and middle-income countries[3].

Price Reductions and Affordability Programs

Eli Lilly and Company, a major player in the insulin lispro market, has implemented significant price reductions and affordability programs. In 2023, Lilly announced a 70% price reduction for its most commonly prescribed insulins and expanded its Insulin Value Program to cap patient out-of-pocket costs at $35 or less per month. This move aims to make insulin more accessible and affordable for patients[5].

Financial Trajectory

Current Pricing and Cost Savings

The list price of Insulin Lispro Injection has been reduced significantly. For instance, as of May 1, 2023, the list price of Insulin Lispro Injection 100 units/mL was cut to $25 a vial, making it the lowest list-priced mealtime insulin available. This reduction, along with other affordability programs, has lowered the average monthly out-of-pocket cost for Lilly insulin prescriptions to around $28.05, a 27% decrease over the past four years[4][5].

Economic Value and Cost-Benefit Analysis

Studies have shown that new insulin formulations, such as Humalog Mix 25 (a combination of rapid-acting insulin lispro and intermediate-acting neutral protamine lispro), offer significant economic value. A cost-benefit analysis revealed that patients are willing to pay a premium for these formulations due to their improved efficacy and convenience[2].

Production Costs and Biosimilar Pricing

The production costs for biosimilar insulins are significantly lower than those for branded insulins. For example, the estimated biosimilar prices for insulin analogues, including lispro, could be as low as US$78–133 per patient per year. This pricing structure suggests that with robust competition, current manufacturers could set lower prices while still maintaining profitability[3].

Market Restraints and Challenges

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

• High Development Costs: The development of biosimilars and new insulin formulations involves substantial investment.
• Regulatory Hurdles: Strict regulatory requirements can delay market entry for new products.
• Market Dominance: The global insulin market is dominated by a few large companies, which can limit competition and innovation[1][3].

New Product Launches and Partnerships

The insulin lispro market is dynamic, with continuous new product launches and strategic partnerships. Companies like Eli Lilly, Novo Nordisk, and Sanofi are actively involved in developing new formulations and delivery systems to enhance patient outcomes and market share[1].

Top Companies in the Insulin Lispro Market

Key players in the insulin lispro market include:

• Eli Lilly and Company
• Novo Nordisk A/S
• Sanofi
• Merck & Co., Inc.
• Pfizer Inc.
• Hoffmann-La Roche Ltd.
• AstraZeneca PLC
• Johnson & Johnson Services, Inc.
• Biocon Limited
• Mylan N.V.
• Boehringer Ingelheim International GmbH
• Wockhardt Ltd.
• Lupin Pharmaceuticals, Inc.
• Bioton S.A.
• Gan & Lee Pharmaceuticals
• Ypsomed AG[1].

Conclusion

The insulin lispro market is poised for significant growth driven by increasing diabetes prevalence, advancements in insulin delivery, and the emergence of biosimilars. Despite challenges such as high development costs and regulatory hurdles, the market is expected to expand, particularly with the implementation of affordability programs and price reductions by major manufacturers.

Key Takeaways

• The global insulin lispro market is projected to grow from US$ 7.32 billion in 2023 to US$ 11.15 billion by 2030.
• Biosimilars are expected to significantly reduce treatment costs and increase market access.
• Price reductions and affordability programs by companies like Eli Lilly are making insulin more accessible.
• The market faces challenges such as high development costs and regulatory hurdles.
• New product launches and partnerships are driving innovation in the market.

FAQs

Q: What is the current market size of the global insulin lispro market? A: The global insulin lispro market size is estimated to be valued at US$ 7.32 billion in 2023[1].

Q: What is the projected growth rate of the insulin lispro market from 2023 to 2030? A: The market is projected to grow at a CAGR of 6.2% from 2023 to 2030[1].

Q: How do biosimilars impact the insulin lispro market? A: Biosimilars are expected to reduce treatment costs significantly, potentially to ≤US$133 per year for insulin analogues, and increase market access, especially in low-income and middle-income countries[3].

Q: What recent price reductions have been announced by Eli Lilly for insulin lispro? A: Eli Lilly announced a 70% price reduction for its most commonly prescribed insulins and expanded its Insulin Value Program to cap patient out-of-pocket costs at $35 or less per month[5].

Q: Which companies are the major players in the insulin lispro market? A: Key players include Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Merck & Co., Inc., and others[1].

Sources

1. Coherent Market Insights - Insulin Lispro Market Size, Trends and Forecast to 2030
2. PubMed - The economic value of a new insulin preparation, Humalog Mix 25
3. BMJ Global Health - Production costs and potential prices for biosimilars of human insulin and insulin analogues
4. PR Newswire - Lilly again reduces list price of Insulin Lispro Injection as latest change to affordability options
5. PR Newswire - Lilly Cuts Insulin Prices by 70% and Caps Patient Insulin Out-of-Pocket Costs at $35 Per Month