Insulin human - Biologic Drug Details

Summary for insulin human

Tradenames:	5
High Confidence Patents:	10
Applicants:	4
BLAs:	4
Suppliers: see list	5
Recent Clinical Trials:	See clinical trials for insulin human
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin human

Recent Clinical Trials for insulin human

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Pichamol Jirapinyo, MD, MPH	Phase 4
Western University, Canada	Phase 3
Royal North Shore Hospital	Phase 2

See all insulin human clinical trials

Recent Litigation for insulin human

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pandora Marketing LLC	2024-01-31
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12

See all insulin human litigation

Pharmacology for insulin human

Established Pharmacologic Class	Insulin
Chemical Structure	Insulin

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 human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	5,462,535	2012-10-31	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	5,626,566	2014-05-06	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	5,693,027	2014-12-02	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	5,980,491	2016-07-05	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	6,074,372	2017-06-09	Company disclosures

3) Low Certainty: US Patents for insulin human 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
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10,004,686	2025-05-23	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10,220,075	2034-12-02	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10,220,076	2034-05-15	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10,259,856	2028-03-18	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10,272,050	2034-10-14	Patent claims search

International Patents for insulin human

Country	Patent Number	Estimated Expiration
Australia	6820500
Denmark	1570876
Japan	H05501370
New Zealand	235917
Spain	2338792

Market Dynamics and Financial Trajectory of Human Insulin

Market Overview

The human insulin market is poised for significant growth, driven by several key factors. Here are the core dynamics and financial projections shaping this industry.

Increasing Prevalence of Diabetes

The global prevalence of diabetes is a major driver of the human insulin market. According to the International Diabetes Federation, approximately 537 million adults lived with diabetes in 2021, and this number is projected to rise to 643 million by 2030 and over 700 million by 2045[1][3][5].

Market Size and Growth Projections

• The global human insulin market was valued at USD 17.1 billion in 2023 and is projected to reach USD 24.0 billion by 2033, growing at a CAGR of 3.4% from 2024 to 2033[3].
• Another forecast suggests the market could exceed USD 46.7 billion by 2033, with a CAGR of 4.8% from 2024 to 2033[2].
• A more aggressive projection estimates the market to reach USD 92.63 billion by 2031, with a CAGR of 8.5% from 2024 to 2031[5].

Market Segmentation

By Type

• The market is segmented into different types of insulin, including long-acting, rapid-acting, and short-acting insulins. The type 1 diabetes segment holds the dominant share, with 57.8% of the market, due to the necessity of daily insulin injections for these patients[1].

By Distribution Channel

• Retail and online pharmacies dominate the market, accounting for 59.2% of insulin revenues. This is further bolstered by affordable options from giants like Walmart and Amazon[1].

Key Drivers

Launch of Novel Insulin Products

• The introduction of new and innovative insulin products is a primary driver of market growth. These include advanced formulations such as analog insulins and novel delivery systems[2][3][4].

Aging Population and Lifestyle Changes

• The increasing geriatric population and changes in lifestyle, such as sedentary behavior and unhealthy dietary habits, contribute to the rising incidence of diabetes, thereby driving the demand for human insulin[3].

Government Initiatives and Healthcare Investments

• Government initiatives for diabetes awareness and treatment, along with increasing investments in healthcare infrastructure, especially in emerging economies, are significant growth drivers[2][3].

Regional Dynamics

North America

• North America currently dominates the market, accounting for 40.7% of the global share in 2023. This is due to the rapid adoption of advanced technologies for disease treatment[2].

Asia Pacific

• The Asia Pacific region is expected to be the fastest-growing market due to improving access to healthcare, growing medical tourism, and increasing healthcare spending in countries like China and India[5].

Competitive Landscape

• Major players in the human insulin market include Eli Lilly and Company, Sanofi, Novo Nordisk A/S, Pfizer, Biocon, and others. These companies are innovating and expanding their product portfolios to capture market share[3].

Market Challenges

Cost and Accessibility

• The high cost of insulin remains a significant barrier, particularly in low- and middle-income countries, limiting access and adherence to treatment[3][5].

Regulatory Guidelines

• Stringent regulatory guidelines for product approval pose challenges for new insulin therapies and products. Regulators demand extensive clinical trial data to establish safety and efficacy before granting marketing authorization[5].

Market Opportunities

Growing Preference for Fast-acting and Long-acting Insulin

• There is a growing preference for fast-acting and long-acting insulins, which is driving innovation in insulin formulations and delivery systems[5].

Increasing Investments in Healthcare Infrastructure

• Increasing investments in healthcare infrastructure in emerging economies present significant opportunities for market growth. Countries like Brazil, India, South Africa, and China are witnessing rapid growth in their healthcare industries[2][3].

Technological Innovations

• Advances in insulin delivery devices and continuous glucose monitoring systems are significantly driving the market by facilitating better disease management for patients[4].

"Technological innovations, including delivery devices and continuous glucose monitoring systems, also significantly drive the market by facilitating better disease management for patients."[4]

Macroeconomic Factors

• Economic stability, GDP growth, and government healthcare policies directly impact healthcare expenditure, including spending on diabetes management and insulin therapy. Demographic trends such as aging populations and urbanization also contribute to the increasing prevalence of diabetes[2].

Key Takeaways

• The human insulin market is driven by the increasing prevalence of diabetes, launch of novel insulin products, and growing investments in healthcare infrastructure.
• The market faces challenges such as high costs and stringent regulatory guidelines but presents opportunities in emerging economies and through technological innovations.
• Major players are innovating and expanding their product portfolios to capture market share.

FAQs

What is the projected market size of the human insulin market by 2033?

The human insulin market is projected to reach USD 24.0 billion by 2033, growing at a CAGR of 3.4% from 2024 to 2033, or it could exceed USD 46.7 billion with a CAGR of 4.8% during the same period[2][3].

Which region dominates the human insulin market?

North America currently dominates the market, accounting for 40.7% of the global share in 2023[2].

What are the main drivers of the human insulin market?

The main drivers include the increasing prevalence of diabetes, the launch of novel insulin products, and growing investments in healthcare infrastructure, especially in emerging economies[2][3].

What are the significant challenges facing the human insulin market?

The high cost of insulin and stringent regulatory guidelines are significant challenges. Inadequate health funding and diagnostic limitations, particularly in emerging regions, also impede market growth[3][5].

Which companies are major players in the human insulin market?

Major players include Eli Lilly and Company, Sanofi, Novo Nordisk A/S, Pfizer, Biocon, and others[3].

Sources

1. GlobeNewswire: Human Insulin Market to Hit USD 24.6 Billion by 2032, Fueled by Rising Diabetes Cases and Innovation[1].
2. GlobeNewswire: Human Insulin Market Size to Surpass USD 46.7 Billion by 2033, Owing to the Increasing Prevalence of Diabetes[2].
3. Allied Market Research: Human Insulin Market Size, Share | Growth | Forecast - 2033[3].
4. Grand View Research: Insulin Market Size, Share & Growth | Industry Report, 2030[4].
5. Coherent Market Insights: Human Insulin Drug Market - Share, Size and Industry Analysis[5].