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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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		2009-02-09	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991		2014-10-14	DrugPatentWatch analysis and 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		2037-02-17	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991		2036-12-20	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991		2038-12-19	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991		2037-02-17	Patent claims search
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991		2038-07-09	Patent claims search

International Patents for insulin isophane human and insulin human

Country	Patent Number	Estimated Expiration
Czechoslovakia	90589
Czech Republic	278561
China	1035055
Australia	2375392
China	1025719

Market Dynamics and Financial Trajectory for Biologic Drugs: Insulin Isophane Human and Insulin Human

Last updated: July 29, 2025

Introduction

Insulin therapies, notably insulin isophane human (commonly known as NPH insulin) and insulin human (rapid-acting formulations), are cornerstone treatments for diabetes mellitus, a chronic condition affecting millions globally. The landscape of these biologics is shaped by factors fluctuating market demand, evolving technological paradigms, regulatory influences, and economic considerations. This analysis elucidates the current market dynamics and prognosticates the financial trajectories for these pharmaceuticals, providing business insights for stakeholders.

Market Landscape and Drivers

Global Burden of Diabetes and Treatment Necessities

The prevalence of diabetes surpasses 460 million worldwide, with projections exceeding 700 million by 2045 [1]. Insulin remains essential, with approximately 80-90% of Type 1 diabetic patients relying solely on insulin therapy and a substantial cohort of Type 2 diabetics requiring injectable medications as the disease advances.

Advancements in Insulin Formulations

Traditionally, insulin isophane human (NPH) and insulin human have been the backbone of insulin therapy, offering affordability and reliability. However, the advent of ultra-long-acting and rapid-acting analogs has introduced alternatives with superior pharmacokinetic profiles. Despite this, NPH and human insulin retain significant market share, mainly in emerging markets due to cost advantages.

Market Drivers

• Cost Sensitivity in Emerging Markets: Many developing countries with burgeoning diabetic populations favor biosimilar and human insulin formulations due to their lower manufacturing costs and pricing.
• Innovations and Patent Expirations: The expiry of patents for many insulin analogs has opened the market to biosimilars, intensifying competition.
• Rising Healthcare Spending and Awareness: Increased screening programs and awareness campaigns drive insulin prescriptions.
• Regulatory Support: Favorable policies to facilitate biosimilar approval are expanding market access.

Market Challenges and Constraints

• Pricing Pressures: Governments and payers exert pressure to lower insulin prices, affecting profit margins.
• Manufacturing Complexities: As biologics, insulin formulations require sophisticated manufacturing processes, with biosimilar development demanding high technical expertise.
• Intellectual Property Barriers: Patent litigations and exclusivity rights influence market entry timelines for biosimilars.
• Patient Adoption: Preference for newer analogs over human insulin due to dosing convenience and perceived efficacy.

Financial Trajectory and Market Projections

Current Market Valuation

The global insulin market was valued at approx. USD 20 billion in 2022, with human insulin and NPH insulin accounting for roughly 40-50% of this market [2]. Key players include Novo Nordisk, Sanofi, Eli Lilly, and emerging biosimilar manufacturers.

Growth Outlook (2023-2030)

Analysts project a compound annual growth rate (CAGR) of approximately 4-6% for the insulin market over the next decade, driven by increasing diabetic populations, especially in Asia-Pacific and Africa, and ongoing biosimilar proliferation.

• Emerging Markets Dominate Growth: Rapid urbanization and expanding healthcare infrastructure will propel demand, particularly for low-cost human insulin formulations.
• Shift Towards Biosimilars: Patent expirations of several insulin analogs between 2020 and 2025 will catalyze biosimilar entry. For instance, biosimilars of insulin glargine are anticipated to account for 20-30% of the insulin market by 2025 [3].

Revenue Breakdown and Key Trends

• Price Trends: Despite overall growth, unit prices are expected to decline 10-15% annually for biosimilars due to increased competition.
• Market Share Dynamics: Human insulin and NPH insulin are projected to witness gradual decline from approximately 50% in 2022 to roughly 35% by 2030, yet they will remain vital in price-sensitive segments.
• Innovative Formulations' Impact: The adoption of newer analogs, such as insulin degludec and aspart, will modulate revenue streams, especially in developed markets.

Strategic Insights for Stakeholders

• Biotech and Pharma Companies: Emphasize biosimilar development, optimizing manufacturing efficiencies to mitigate price erosion.
• Manufacturers of Human Insulin: Focus on emerging markets, leveraging cost advantages and local partnerships.
• Regulators: Facilitate expedited approval pathways for biosimilars, ensuring safety and efficacy standards.
• Healthcare Payers: negotiate pricing effectively and promote personalized insulin regimens to optimize health outcomes and control costs.

Impact of Regulatory and Policy Changes

Government policies in key markets such as the U.S., Europe, and India influence market dynamics profoundly. Initiatives like the Diabetes Digital Prevention Program in the U.S. and India’s push for domestically produced biosimilars are expected to reshape supply chains and affordability models [4].

Market Risks and Opportunities

• Risks: Regulatory delays, supply chain disruptions, and shifts in reimbursement policies.
• Opportunities: Digital health integration, personalized medicine, and innovative delivery devices improve adherence and expand market reach.

Conclusion

The market for insulin is at a pivotal juncture, characterized by aging biologics facing competition from biosimilars, new formulations, and digital health solutions. Cost competitiveness in emerging markets sustains significant demand for insulin isophane human and insulin human, while innovation and policy reforms offer pathways for growth and consolidation.

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Key Takeaways

• The insulin market is projected to grow at a CAGR of 4-6% globally through 2030 driven by rising diabetes prevalence, particularly in emerging economies.
• Human insulin and NPH insulin will retain substantial market segments due to their affordability, despite increasing competition from biosimilars and analogs.
• Patent expirations are catalyzing biosimilar proliferation, prompting price competition and market share shifts.
• Strategic investments in biosimilar manufacturing and regulatory advocacy are critical for stakeholders aiming to sustain profitability.
• Policy reforms and digital health integration present opportunities for expanded access and personalized therapies.

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FAQs

1. What factors are primarily influencing the decline of human insulin market share?
   The development of insulin analogs with improved pharmacokinetics, coupled with higher patient convenience and adherence, has gradually shifted market preference away from human insulin formulations, especially in developed regions.

2. How are biosimilars impacting the global insulin market?
   Biosimilars have increased competition, reduced prices, and expanded access in many markets, particularly emerging economies, while also pressurizing established manufacturers to innovate and optimize cost efficiencies.

3. What emerging markets are poised for the highest growth in insulin demand?
   Countries like India, China, and parts of Africa exhibit the fastest growth due to expanding diabetic populations, urbanization, and governmental efforts to improve healthcare infrastructure.

4. Will the cost of insulin decrease significantly in the future?
   Yes. Increased biosimilar deployment, patent expiries, and policy measures aimed at affordability are likely to drive down insulin prices, especially in price-sensitive markets.

5. What role will digital health solutions play in the future of insulin therapy?
   Digital health tools such as smart insulin pens, continuous glucose monitors, and telemedicine platforms are expected to improve adherence, optimize dosing, and expand access, thereby influencing demand and market dynamics.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] MarketWatch. (2022). Global Insulin Market Size, Share & Trends Analysis Report.
[3] GlobalData. (2023). Biosimilar Insulin Market Forecast.
[4] World Health Organization. (2021). Policies to Improve Access to Insulin.

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Note: This article is intended for informational purposes and does not constitute investment advice. Market conditions are subject to change based on technological, regulatory, and economic developments.