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Last Updated: December 22, 2024

HUMALOG Drug Profile


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Summary for Tradename: HUMALOG
Recent Clinical Trials for HUMALOG

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Manchester University NHS Foundation TrustN/A
Inreda Diabetic B.V.N/A
National Polytechnic Institute, MexicoPhase 4

See all HUMALOG clinical trials

Pharmacology for HUMALOG
Ingredient-typeInsulin
Established Pharmacologic ClassInsulin 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
  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. General brand-side disclosures
  4. 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.

  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 HUMALOG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

HUMALOG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Humalog

Market Overview of Humalog

Humalog, a short-acting insulin analog developed by Eli Lilly and Company, is a crucial component in the management of diabetes. It is designed to mimic the natural insulin response of the body after a meal, making it an essential treatment option for patients with diabetes.

Market Size and Growth Projections

The global short-acting insulin market, which includes Humalog, is projected to grow from USD 9,257.1 million in 2021 to USD 10,287.9 million by 2030, at a Compound Annual Growth Rate (CAGR) of 1.18%[1].

Humalog's Market Share

Within this market, Humalog holds a significant share. In 2021, the Humalog segment had a market value of USD 2,462.7 million. However, it is expected to decline to USD 1,966 million by 2030, reflecting a CAGR of -2.47% during this period. This decline is partly due to increased competition and pricing pressures[1].

Regional Analysis

United States

The United States is a critical market for Humalog, accounting for over 56% of the global sales of this drug in 2021. The country's large diabetic population, with approximately 9.4% of the total population diagnosed with diabetes, drives this demand. The absence of price regulations on pharmaceuticals like insulin in the U.S. has also contributed to its market dominance, although recent government initiatives aim to reduce insulin prices[4].

Global Market

Beyond the U.S., Humalog is sold in various regions, including Europe, Asia-Pacific, and the Middle-East & Africa. These regions also contribute significantly to the overall revenue, though the U.S. remains the largest market[1].

Financial Performance

Quarterly and Annual Revenue

In the fourth quarter of 2023, worldwide Humalog revenue decreased by 33% compared to the same period in 2022, reaching $366.6 million. In the U.S., the revenue was $167.6 million, a decrease of 33% from the previous year[2].

However, in the third quarter of 2024, Humalog revenue saw a significant increase. Worldwide revenue rose by 35% to $534.6 million, with U.S. revenue increasing by 67% to $323.9 million, driven primarily by higher realized prices due to segment mix[5].

Investment and Production Capacity

Eli Lilly & Company has been investing heavily in expanding its production capacity. In June 2020, the company announced a $400 million investment to enhance its manufacturing capabilities, which is expected to support the demand for Humalog and other insulin products[1].

Market Drivers and Challenges

Drivers

  • Increasing Diabetic Population: The rising prevalence of diabetes globally is a key driver for the demand of short-acting insulins like Humalog.
  • Technological Advancements: Continuous improvements in insulin delivery systems and the development of more targeted therapies contribute to market growth.
  • Government Initiatives: Programs aimed at reducing insulin prices, such as the Medicare pilot program in the U.S., can boost market growth by making these drugs more accessible[4].

Challenges

  • Pricing Pressures: The decline in Humalog's revenue is partly due to pricing pressures and increased competition from other insulin products.
  • Regulatory Changes: Changes in regulatory environments, such as price controls or increased scrutiny on pharmaceutical pricing, can impact revenue.
  • Competition: The short-acting insulin market is competitive, with other products like Novolog and Humulin vying for market share[1][4].

Competitive Landscape

Key Competitors

The short-acting insulin market is dominated by a few key players:

  • Novo Nordisk AS: Known for its Novolog product, which currently holds the largest market share.
  • Eli Lilly and Company: The manufacturer of Humalog.
  • Sanofi: Another major player in the insulin market with its Humulin product[1].

Market Segmentation

The market is segmented by drug type (Novolog, Humalog, Humulin) and by region (North America, Asia-Pacific, Europe, Middle-East & Africa). This segmentation helps in understanding the specific market dynamics and competitive landscape in different regions[1].

Future Outlook

Despite the projected decline in Humalog's market value, the overall short-acting insulin market is expected to grow. The increasing burden of chronic diseases, technological advancements, and favorable reimbursement policies are expected to drive this growth.

Strategic Initiatives

To maintain market share, Eli Lilly & Company is likely to focus on:

  • Innovation: Continuing to invest in research and development to improve insulin delivery systems and therapies.
  • Market Expansion: Expanding into new regions and increasing market penetration in existing ones.
  • Price Management: Managing pricing strategies to remain competitive in a market with increasing price pressures[1][4].

Key Takeaways

  • Market Growth: The global short-acting insulin market is expected to grow, albeit at a modest CAGR.
  • Humalog's Decline: Despite its significant market share, Humalog's revenue is projected to decline due to pricing pressures and competition.
  • Regional Importance: The U.S. remains a critical market for Humalog, driven by a large diabetic population and lack of price regulations.
  • Investment and Innovation: Eli Lilly & Company's investments in production capacity and research are crucial for maintaining market competitiveness.

FAQs

Q: What is the projected market value of the global short-acting insulin market by 2030?

A: The global short-acting insulin market is projected to reach USD 10,287.9 million by 2030[1].

Q: Why is Humalog's revenue declining?

A: Humalog's revenue is declining due to pricing pressures and increased competition from other insulin products, resulting in a projected CAGR of -2.47% from 2021 to 2030[1].

Q: Which region accounts for the highest sales of Humalog?

A: The United States accounts for the highest sales of Humalog, with over 56% of the global market share in 2021[4].

Q: What initiatives is Eli Lilly & Company taking to support Humalog production?

A: Eli Lilly & Company has announced a $400 million investment to expand its production capacity, aimed at supporting the demand for Humalog and other insulin products[1].

Q: How does the competitive landscape affect Humalog's market share?

A: The competitive landscape, with key players like Novo Nordisk AS and Sanofi, contributes to the decline in Humalog's market share. Novolog, in particular, dominates the market with a larger share[1].

Sources

  1. Spherical Insights: "Short-Acting Insulin Market Size, Share | Statistics 2030"
  2. Eli Lilly & Company: "Lilly Reports Strong Fourth-Quarter 2023 Financial Results and"
  3. BioSpace: "Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems"
  4. Mordor Intelligence: "Short-acting Insulin Market - Share, Size & Industry Analysis"
  5. Eli Lilly & Company: "Lilly reports Q3 2024 financial results highlighted by strong volume"

More… ↓

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