Last Updated: May 30, 2026

HUMULIN 70/30 Drug Profile


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Summary for Tradename: HUMULIN 70/30
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for HUMULIN 70/30
Recent Clinical Trials for HUMULIN 70/30

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Portal Diabetes, Inc.PHASE1
Stanford UniversityPHASE1
Laboratorios Pisa S.A. de C.V.PHASE1

See all HUMULIN 70/30 clinical trials

Pharmacology for HUMULIN 70/30
Established Pharmacologic ClassInsulin
Chemical StructureInsulin
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
  2. 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.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including 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.

  5. Patents from broad patent text search
  6. 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 HUMULIN 70/30 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HUMULIN 70/30 Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HUMULIN 70/30 Derived from Patent Text Search

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for Humulin 70/30

Last updated: April 7, 2026

What Are the Key Market Factors Influencing Humulin 70/30?

Humulin 70/30 is a premixed human insulin analog combining 70% intermediate-acting insulin NPH with 30% rapid-acting insulin. It was developed by Eli Lilly and entered the market in the early 1980s. Its market activity hinges on the following elements:

  • Global Diabetes Prevalence: As of 2022, approximately 537 million adults have diabetes worldwide, with projections reaching 643 million by 2030, according to the International Diabetes Federation (IDF) [1].

  • Insulin Market Growth: The global insulin market was valued at USD 30 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 9% through 2030 [2].

  • Therapeutic Shifts: Increasing adoption of long-acting and ultra-long-acting insulins (e.g., insulin degludec, insulin glargine U300) affects demand for premixed insulins like Humulin 70/30.

  • Patent and Generic Competition: Eli Lilly's patent for Humulin 70/30 expired in 2014, opening the market to biosimilars and generics, which exert pricing pressure and impact market share [3].

  • Regulatory Environment: Approval pathways for biosimilars in the U.S. (by FDA) and beyond influence market entry timelines, competition levels, and pricing strategies.

  • Physician and Patient Preferences: Trends favoring simplified dosing regimens, intensive therapy, and newer insulins reduce reliance on premixed formulations.

How Does the Financial Trajectory Look?

Revenue and Market Share

Humulin 70/30's revenues have declined since biosimilar entries. Lilly's total insulin revenue was USD 6 billion in 2022. Although a specific breakdown for Humulin 70/30 is unavailable, historically, it accounted for a substantial segment of Lilly's insulin portfolio, estimated at USD 1-1.5 billion annually pre-2014.

Post-2014 biosimilar introductions (e.g., Semglee from Mylan/Adamis, authorized generics) resulted in price reductions and volume shifts. Lilly's insulin sales decline is partly attributable to these factors, with an estimated 10-15% annual revenue erosion since 2014.

Pricing Trends

Humulin 70/30's wholesale acquisition cost (WAC) in the U.S. was approximately USD 275 per 10 mL pen in 2020, with discounts and insurance negotiations reducing actual patient cost. Biosimilars have introduced price competition, delivering discounts exceeding 50% in some cases.

Market Penetration and Future Potential

While Humulin 70/30 maintains usage in specific populations—such as patients with stable insulin needs who prefer premixed regimens—its market penetration is decreasing. Total global units sold may decrease by approximately 5-8% annually over the next five years, given the shift toward basal-bolic regimens and newer insulin analogs.

Financial Outlook

Eli Lilly’s insulin revenue is projected to plateau or decline gradually over the next five years unless new indications, formulations, or markets emerge. Innovator products like Humulin 70/30 are unlikely to return to previous revenue peaks without significant reformulation or pricing strategies, which are improbable given biosimilar competition.

How Do Competitive Dynamics and Regulatory Factors Impact Financials?

  • Biosimilar Expansion: The approval of biosimilars in multiple markets drives price competition. In the U.S., the Affordable Care Act encourages biosimilar uptake; 2020-2022 saw rapid growth of biosimilar insulin sales, decreasing Humulin 70/30's market share.

  • Pricing Policies: Legislative measures to curb insulin prices, such as those in the U.S. (e.g., inflation caps), could further compress revenue.

  • Market Diversification: Emerging markets may offer growth opportunities for older formulations like Humulin 70/30 due to affordability considerations. The Asian-Pacific market is expected to grow at a CAGR exceeding 12% through 2030.

What Are the Key Risks and Opportunities?

Risks

  • Ongoing biosimilar erosion of market share and revenues.

  • Shift toward newer insulin classes reduces demand.

  • Price controls and reimbursement pressures.

Opportunities

  • Expansion into emerging markets.

  • Development of fixed-dose combinations or novel formulations.

  • Targeting patients with limited access to newer insulins.

Summary Table: Key Market Data

Metric 2022 Data Projected (2025/2030) Source
Global insulin market value USD 30 billion USD 40 billion (by 2030) [2]
Worldwide diabetes prevalence 537 million adults 643 million adults [1]
Lilly insulin revenue (total) USD 6 billion Stable/declining [4]
Estimated Humulin 70/30 revenue (annual) USD 1-1.5 billion USD 0.8-1.2 billion (2025) Estimated (historical data)
Biosimilar market share in insulin (2022) 20% of total insulin sales >35% by 2030 [2]

Key Takeaways

  • Natural market expansion driven by rising diabetes prevalence sustains long-term demand but shifts favor toward newer, more convenient insulin formulations.

  • Patent expirations and biosimilar entries have significantly reduced prices and impacted revenues for Humulin 70/30.

  • Eli Lilly's future revenues from Humulin 70/30 will likely decline unless the company invests in formulations, indications, or markets with less competition.

  • The U.S. and European markets face regulatory and pricing challenges that suppress profit margins.

  • Emerging markets may provide growth avenues, especially where affordability influences prescribing patterns.

FAQs

1. Will Humulin 70/30 remain relevant in the next decade?
Its relevance will diminish due to competition from biosimilars and newer insulin analogs, but it may retain niche use where cost and regimen simplicity are prioritised.

2. How does biosimilar competition affect pricing?
Biosimilars typically reduce prices by 50% or more, pressuring the original product to lower prices or lose market share.

3. Are there any upcoming regulatory changes that could impact Humulin 70/30?
Regulatory efforts to accelerate biosimilar approval and price controls are ongoing in regions like the U.S. and EU, likely further impacting revenues.

4. What market segments are still viable for Humulin 70/30?
Patients in markets with limited access to newer insulins and those preferring premixed regimens constitute the primary remaining segments.

5. Could Eli Lilly reformulate Humulin 70/30 for newer indications?
While theoretically possible, such strategies face regulatory hurdles and may not offset revenue declines from existing formulations.


References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th edition.

[2] Grand View Research. (2023). Insulin Market Size, Share & Trends Analysis Report.

[3] U.S. Food and Drug Administration. (2014). Biosimilar Approval Pathways.

[4] Eli Lilly. (2023). Annual Report.

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