Insulin isophane human and insulin human - Biologic Drug Details

Summary for insulin isophane human and insulin human

Tradenames:	2
High Confidence Patents:	2
Applicants:	2
BLAs:	2
Suppliers: see list	3

Pharmacology for insulin isophane human and 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 isophane human and insulin human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin isophane human and 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 70/30	insulin isophane human and insulin human	Injection	019991	4,973,318	2008-02-10	Company disclosures
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	5,462,535		Company disclosures

3) Low Certainty: US Patents for insulin isophane human and 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 70/30	insulin isophane human and insulin human	Injectable Suspension	019717	10,660,941	2036-02-19	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	10,016,338	2033-03-11	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	10,577,154	2029-05-13	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	10,660,941	2036-02-19	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	10,912,714	2038-07-09	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	11,298,293		Patent claims search

International Patents for insulin isophane human and insulin human

Country	Patent Number	Estimated Expiration
European Patent Office	0327910
Brazil	8907240
Greece	3004398
Denmark	69288
Hungary	T54064
Yugoslavia	47418

Insulin isophane human and insulin human Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Insulin Isophane Human and Insulin Human

Market Overview

The global market for human insulin, including insulin isophane human (also known as neutral protamine Hagedorn or NPH insulin), is experiencing significant growth driven by several key factors. The market was valued at approximately USD 29.2 billion in 2023 and is projected to reach USD 46.7 billion by 2033, growing at a CAGR of 4.8% from 2024 to 2033[2].

Increasing Prevalence of Diabetes

One of the primary drivers of the human insulin market is the escalating prevalence of diabetes worldwide. According to recent statistics, about 537 million adults are living with diabetes, with projections indicating a rise to 643 million by 2030[3]. This increasing patient population, particularly among the aging demographic, is driving up the demand for effective insulin therapies.

Growing Awareness and Need for Glycemic Control

The growing awareness about the importance of effective glycemic control in managing diabetes and preventing complications is another significant driver. Insulin isophane human, with its intermediate-acting profile, helps maintain stable blood sugar levels and reduces the risk of hypoglycemia. This has led to an increased emphasis on patient education and self-management of diabetes, further contributing to the adoption of insulin isophane human injections[1].

Market Segmentation

The human insulin market is segmented based on product type, application, end-user, and region. For insulin isophane human, product types include single-dose vials, multi-dose vials, and prefilled syringes. Applications include type 1 diabetes, type 2 diabetes, and gestational diabetes. End-users include hospitals, clinics, pharmacies, and home care settings[1].

Regional Analysis

North America

North America dominates the market, with the United States being the largest contributor. The region's advanced healthcare system, favorable reimbursement policies, and the presence of key market players have fueled the adoption of human insulin products, including insulin isophane human[1][2].

Europe

Europe follows North America in terms of market share. Countries such as Germany, France, and the United Kingdom have significant market presence due to well-established healthcare systems and supportive regulatory environments[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth rate during the forecast period. Factors such as the increasing prevalence of diabetes, rapid urbanization, and changing lifestyles are driving market growth in this region. Countries like China, India, and Japan are major contributors to this growth[1].

Latin America and Middle East & Africa

These regions are emerging markets with a growing burden of diabetes and improving healthcare infrastructure. However, challenges such as limited healthcare budgets, inadequate reimbursement policies, and the presence of counterfeit insulin products may hinder market growth in these areas[1].

Financial Trajectory

Market Size and Growth

The global human insulin market, including insulin isophane human, is forecasted to exceed USD 46.7 billion by 2033, growing at a CAGR of 4.8% from 2024 to 2033. The isophane protamine biosynthetic human insulin injection market specifically is projected to reach USD 4.6 billion by 2033, growing at a CAGR of 4.8% from 2024 to 2033[1][2].

Revenue Distribution

Hospital pharmacies currently generate the most revenue for the human insulin market, claiming around 60.5% of the market share. However, online pharmacies are expected to lead in revenue generation in the future due to their accessibility and convenience, as well as the involvement of major online retailers like Amazon and Walmart[2][3].

Key Drivers and Restraints

Drivers

• Increasing Prevalence of Diabetes: The rising incidence of type 1 and type 2 diabetes is a primary driver.
• Launch of Novel Insulin Products: Innovations in insulin formulations and delivery systems are driving growth.
• Growing Awareness: Increased awareness about the importance of effective glycemic control and patient education.
• Technological Advancements: Developments in insulin delivery technologies, such as smart insulin pens and continuous glucose monitoring systems, are enhancing market growth[1][2][3].

Restraints

• Inadequate Health Funding: Limited healthcare budgets in emerging regions can hinder market growth.
• Diagnostic Limitations: Challenges in diagnosing and managing diabetes in some regions.
• Stringent Regulatory Requirements: High regulatory barriers for product approval can slow market expansion.
• High Manufacturing Costs: The cost of producing human insulin and its analogs can be a significant challenge[2][4].

Future Outlook

The market outlook for human insulin, including insulin isophane human, is positive. Several factors are expected to contribute to its growth:

• Advancements in Insulin Delivery Technologies: Innovations such as smart insulin pens, continuous glucose monitoring systems, and closed-loop insulin delivery systems will revolutionize diabetes management.
• Integration of Digital Health Solutions: Mobile apps and telemedicine will enhance patient engagement and self-management of diabetes.
• Increasing Investments in Healthcare Infrastructure: Growing healthcare investments in emerging economies will expand access to diabetes treatment[1][2].

Key Trends

• Innovative Insulin Delivery Systems: The introduction of new delivery systems, such as insulin pumps and pens, is a significant trend.
• Growing Public Awareness: Increasing awareness about diabetes management and insulin therapy is driving market growth.
• Online and Retail Pharmacies: The involvement of major online retailers and the growth of retail pharmacies are making insulin more accessible and affordable[2][3].

Distribution Channel Insight

The distribution channel for human insulin is primarily through hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies currently dominate, but online pharmacies are expected to grow significantly due to their convenience and the involvement of major retailers like Amazon and Walmart[2][3].

Key Takeaways

• The global human insulin market, including insulin isophane human, is driven by the increasing prevalence of diabetes and the growing need for effective glycemic control.
• North America and Europe are the dominant regions, with the Asia Pacific region expected to witness the highest growth rate.
• Technological advancements in insulin delivery systems and increasing awareness about diabetes management are key growth drivers.
• Despite growth, the market faces challenges such as inadequate health funding and high manufacturing costs.

FAQs

Q: What is the projected market size for the global human insulin market by 2033?

The global human insulin market is forecasted to exceed USD 46.7 billion by 2033[2].

Q: What are the primary drivers of the human insulin market?

The primary drivers include the increasing prevalence of diabetes, the launch of novel insulin products, growing awareness about glycemic control, and technological advancements in insulin delivery systems[1][2][3].

Q: Which region is expected to witness the highest growth rate in the human insulin market?

The Asia Pacific region is expected to witness the highest growth rate during the forecast period due to the increasing prevalence of diabetes, rapid urbanization, and changing lifestyles[1].

Q: What are the main distribution channels for human insulin?

The main distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies, with online pharmacies expected to grow significantly in the future[2][3].

Q: What are some of the restraints facing the human insulin market?

Restraints include inadequate health funding, diagnostic limitations, stringent regulatory requirements, and high manufacturing costs[2][4].

Sources

1. DataHorizon Research: "Isophane Protamine Biosynthetic Human Insulin Injection Market"
2. GlobeNewswire: "Human Insulin Market Size to Surpass USD 46.7 Billion by 2033"
3. GlobeNewswire: "Human Insulin Market to Hit USD 24.6 Billion by 2032"
4. MarketsandMarkets: "Human Insulin Market Revenue Forecast | Latest Industry Updates"
5. Fortune Business Insights: "Human Insulin Market Size, Share | Global Growth Report [2032]"