Insulin glulisine - Biologic Drug Details

Summary for insulin glulisine

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

Pharmacology for insulin glulisine

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 glulisine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin glulisine Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	6,221,633	2017-06-20	Company disclosures

3) Low Certainty: US Patents for insulin glulisine Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,004,686	2025-05-23	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,016,338	2033-03-11	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,155,799	2034-07-21	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,172,922	2034-05-08	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,241,117	2032-04-18	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,335,489	2032-01-09	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,398,781	2029-01-28	Patent claims search

International Patents for insulin glulisine

Country	Patent Number	Estimated Expiration
Slovakia	83698
Germany	59812316
Denmark	0885961
France	05C0009
Germany	19726167
Austria	E283919
European Patent Office	0885961

Supplementary Protection Certificates for insulin glulisine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
251	Finland
CA 2005 00018	Denmark		PRODUCT NAME: INSULIN GLULISIN
SPC004/2005	Ireland		SPC004/2005: 20060308, EXPIRES: 20190926
SZ 2/2005	Austria		PRODUCT NAME: INSULIN GLULISINE
05C0009	France		PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001 20040929
2005C/006	Belgium		PRODUCT NAME: INSULIN GLULISINE; AUTHORISATION NUMBER AND DATE: EU/1/04/285/001 20040928
C00885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005

Insulin glulisine Market Analysis and Financial Projection

Insulin Glargine and the Broader Insulin Market: Understanding the Dynamics and Financial Trajectory

Introduction

The insulin market, including insulin glargine, is a complex and dynamic sector driven by several key factors, including the rising prevalence of diabetes, technological advancements, and the impact of biosimilars. Here, we will delve into the market dynamics and financial trajectory of insulin glargine, drawing parallels with the broader insulin market.

Global Insulin Glargine Market Size and Growth

The global insulin glargine market is projected to grow significantly over the next few years. By 2024, the market is estimated to be valued at USD 1.54 billion and is expected to reach USD 2.09 billion by 2029, growing at a CAGR of 6.28% during the forecast period[1][4].

Drivers of Market Growth

Rising Prevalence of Diabetes

The increasing prevalence of diabetes, particularly Type 2 diabetes, is a major driver of the insulin glargine market. Diabetes patients often require multiple daily injections or insulin pump therapy to manage their blood glucose levels, which drives the demand for insulin products[1].

Technological Advancements

Advancements in drug delivery devices, such as wearable and smart insulin pens and pumps, are also boosting the market. These technologies enhance patient compliance and improve the overall management of diabetes[4].

Impact of Biosimilars

The introduction of biosimilar insulin glargine products has been a significant factor in market growth. Biosimilars offer affordable alternatives to branded insulin products, increasing accessibility for patients. For example, products like Basaglar and Semglee have entered the market at discounted prices compared to the reference product, Lantus[3][4].

Market Leaders and Competition

The global insulin glargine market is moderately consolidated, with major players such as Sanofi, Novo Nordisk, and Eli Lilly dominating the market. These companies have strong supply chains and branding, which helps them maintain substantial market penetration. Collaborations, such as the alliance between Eli Lilly and Boehringer Ingelheim for Basaglar, and Biocon's collaboration with Mylan for Semglee, further strengthen their market positions[1].

Pricing Dynamics and Rebates

List Prices vs. Net Prices

Despite rising list prices of insulin products, the net prices have actually decreased due to significant increases in manufacturer rebates, discounts, and other price concessions. For instance, the average annual net cost per treatment for insulin products in the U.S. decreased by 20% from $1,319 per year in Q1 2007 to $1,055 per year in Q1 2021[2].

Role of Pharmacy Benefit Managers (PBMs)

PBMs play a crucial role in negotiating rebates and discounts with insulin manufacturers. The PBM market is consolidated, with three major entities having significant leverage in these negotiations. This leads to intense competition among insulin manufacturers to secure preferred formulary placement, resulting in lower net prices for health plans[2].

Regional Market Analysis

North America

North America, particularly the U.S., dominates the global insulin glargine market due to its large diabetic population and the presence of leading insulin manufacturers like Sanofi, Eli Lilly, and Novo Nordisk. These companies have robust production and distribution infrastructure, which supports the regional market[4].

Asia Pacific

The Asia Pacific region, especially China and India, is expected to be the fastest-growing market for insulin glargine. Factors such as rapid urbanization, rising income levels, and an increasing geriatric population contribute to the rising prevalence of diabetes in this region. Improving healthcare access and regional trade agreements also facilitate greater market access for insulin glargine products[4].

Financial Trajectory

Gross vs. Net Spending

The total gross spending on insulin analogs in the U.S. has increased significantly from $68 million in Q1 2007 to $7.8 billion in Q1 2021. However, the net spending has increased more slowly due to the large differential between gross and net costs, driven by increased rebates and discounts[2].

Cost Savings from Biosimilars

The entry of biosimilar products is expected to generate significant cost savings. For example, the biosimilar market in the U.S. is projected to save over $180 billion by 2027, despite an overall spending increase of $49 billion over the same period[3].

Regulatory Environment

Approval Process

The approval process for insulin products is stringent, which can slightly hamper market growth. However, the transition date of March 23, 2020, opened up a new regulatory pathway for insulin manufacturers to bring biosimilar insulins to the market, facilitating greater competition and affordability[2][3].

Technological and Clinical Innovations

Drug Delivery Devices

Advancements in drug delivery devices, such as smart insulin pens and pumps, are enhancing patient compliance and the overall management of diabetes. These innovations are expected to continue supporting market growth[4].

Clinical Differentiation

While there is limited clinical differentiation among insulin products within the same class, new launches and follow-on products have introduced some meaningful differences. For instance, the introduction of ultra-long-acting insulin molecules has expanded treatment options for patients[2].

Key Takeaways

• The global insulin glargine market is expected to grow at a CAGR of 6.28% from 2024 to 2029.
• The rising prevalence of diabetes and technological advancements in drug delivery devices are key drivers of market growth.
• Biosimilar products are significantly impacting the market by offering affordable alternatives and driving cost savings.
• The market is moderately consolidated with major players like Sanofi, Novo Nordisk, and Eli Lilly.
• Pricing dynamics are influenced by manufacturer rebates, discounts, and PBM negotiations.

FAQs

What is the projected market size of the global insulin glargine market by 2029?

The global insulin glargine market is expected to reach USD 2.09 billion by 2029[1].

How do biosimilars impact the insulin glargine market?

Biosimilars offer affordable alternatives to branded insulin products, increasing accessibility and driving cost savings. For example, products like Basaglar and Semglee have entered the market at discounted prices[3][4].

What role do Pharmacy Benefit Managers (PBMs) play in the insulin market?

PBMs negotiate rebates and discounts with insulin manufacturers, leading to intense competition among manufacturers to secure preferred formulary placement and resulting in lower net prices for health plans[2].

Which regions are expected to see significant growth in the insulin glargine market?

North America currently dominates the market, but the Asia Pacific region, particularly China and India, is expected to be the fastest-growing market due to socio-economic factors and improving healthcare access[4].

How have technological advancements impacted the insulin glargine market?

Technological advancements in drug delivery devices, such as smart insulin pens and pumps, have enhanced patient compliance and the overall management of diabetes, supporting market growth[4].

Sources

1. Mordor Intelligence: Insulin Glargine Market - Size & Share - Mordor Intelligence
2. Milliman: Analysis of insulin competition and costs in the United States
3. Drug Topics: A Biosimilar Wave Looms Large Over US Biologics Market
4. Coherent Market Insights: Insulin Glargine Market Size & Share Analysis - Growth Trends