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Last Updated: March 27, 2025

Ipilimumab - Biologic Drug Details


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Summary for ipilimumab
Recent Clinical Trials for ipilimumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Jun Zhang, MD, PhDPhase 2
AstraZenecaPhase 3
Neonc Technologies, Inc.Phase 1/Phase 2

See all ipilimumab clinical trials

Recent Litigation for ipilimumab

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Bristol-Myers Squibb Co. v. AstraZeneca Pharmaceuticals LP2023-01-23
Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.2022-03-17

See all ipilimumab litigation

PTAB Litigation
PetitionerDate
Amgen Inc. et al.2025-02-28
Replimune Limited et al.2022-11-02

See all ipilimumab litigation

Pharmacology for ipilimumab
Mechanism of ActionCTLA-4-directed Antibody Interactions
Physiological EffectIncreased T Lymphocyte Activation
Established Pharmacologic ClassCTLA-4-directed Blocking Antibody
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 ipilimumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Ipilimumab

Introduction to Ipilimumab

Ipilimumab, marketed under the brand name Yervoy, is a groundbreaking biologic drug that belongs to the class of immune checkpoint inhibitors. It targets the T cell-surface protein CTLA-4, enabling the immune system to recognize and eliminate cancer cells more effectively. Approved by the FDA for the treatment of metastatic melanoma, ipilimumab has revolutionized the field of oncology[1][2][4].

Market Overview

The ipilimumab market is poised for significant growth driven by several key factors:

  • High Melanoma Incidence Rates: The increasing prevalence of melanoma, a type of skin cancer, is a major driver. Melanoma cases are rising globally, creating a higher demand for effective treatments like ipilimumab[1][4].
  • Sophisticated Healthcare Infrastructure: Regions with advanced healthcare systems, such as North America and Europe, are seeing increased adoption of ipilimumab due to better access to cutting-edge treatments and favorable reimbursement policies[1][4].
  • Advancements in Immunotherapy: Continuous research and development in immunotherapy are expanding the indications for ipilimumab, making it a versatile treatment option for various types of cancer[1][4].

Market Growth Projections

The ipilimumab market is expected to grow at a compound annual growth rate (CAGR) of a significant percentage from 2024 to 2034. By the end of this period, the market is projected to reach a substantial value in USD million. In 2024, the market was valued at USD xx million, indicating a strong growth trajectory[1].

Regional Analysis

North America

North America dominates the ipilimumab market, accounting for more than 46% of the global share. This dominance is attributed to high melanoma incidence rates, a sophisticated healthcare infrastructure, and advantageous reimbursement policies. Robust R&D efforts and strong industry-academia linkages further fuel the market growth in this region[1].

Europe

Europe is the second-largest region in the ipilimumab market. The increasing adoption of immunotherapy in melanoma treatment, supported by a conducive regulatory environment and rising incidence rates, drives demand. Well-established healthcare systems and clinical expertise in key European countries contribute to the market's growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Factors such as improved healthcare infrastructure, rising disposable incomes, and growing awareness among patients and healthcare providers about cancer treatment alternatives are driving this growth. Countries like China and India, with large populations and increasing cancer incidence rates, are key contributors to this regional growth[1].

Key Market Players

The ipilimumab market is dominated by a few large pharmaceutical companies:

  • Bristol-Myers Squibb Company: As the original developer and marketer of Yervoy (ipilimumab), Bristol-Myers Squibb has seen significant financial success with this drug. In 2014, Yervoy generated $1.3 billion in global sales, demonstrating strong demand in both community and institutional settings[2].
  • AstraZeneca: Although primarily known for other drugs, AstraZeneca's involvement in the broader immunotherapy market positions it as a significant player.
  • Merck & Co., Inc.: Merck's presence in the oncology market, particularly with its own immunotherapy products, makes it a relevant competitor in the ipilimumab market[1].

Market Drivers

Growing Prevalence of Cancer

The rising number of cancer cases globally, especially melanoma, is a primary driver for the ipilimumab market. This trend is expected to continue, providing multiple growth opportunities through the forecast period[4].

Improvements in Immunotherapy

Continuous advancements in immunotherapy are expanding the indications for ipilimumab. Clinical studies investigating its effectiveness in different cancer types and treatment contexts are driving market growth[1][4].

FDA Approvals and Broader Indications

Ipilimumab's FDA approval and subsequent broader indications have made it a mainstay in the treatment of advanced melanoma. This regulatory support enhances its market position and adoption rates among oncologists[1].

Investment in Healthcare

Increased investment in healthcare, along with awareness campaigns and educational programs, is fueling demand for ipilimumab. These initiatives raise patient and healthcare provider awareness of the benefits of immunotherapy[1].

Market Challenges

Patent Exclusivity and Manufacturer Strategies

The market dynamics are influenced by patent exclusivity and the strategies of manufacturers for market expansion. These factors can impact pricing and market share distribution among key players[1].

COVID-19 Impact

The COVID-19 pandemic had a minimal negative impact on the ipilimumab market, primarily due to disruptions in the supply chain. However, the market has since recovered, and businesses are returning to normalcy, which is expected to support continued growth[4].

Financial Performance

Ipilimumab has been a financially successful drug since its introduction. In 2014, it generated $1.3 billion in global sales, with strong financial performance across all geographies. This success is attributed to its effectiveness in treating metastatic melanoma and its adoption in both community and institutional settings[2].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of ipilimumab, particularly when compared to other treatments, is a critical factor in its market dynamics. For instance, a study comparing nivolumab-ipilimumab with pembrolizumab-axitinib highlighted the significant costs associated with these treatments. However, ipilimumab's ability to provide long-term survival benefits makes it a valuable, albeit costly, treatment option[5].

Future Outlook

The future of the ipilimumab market looks promising, driven by ongoing research and development, expanding indications, and increasing adoption in various regions. As healthcare infrastructure improves and awareness about immunotherapy grows, the demand for ipilimumab is expected to rise, solidifying its position as a key treatment in oncology.

Key Takeaways

  • Growing Demand: The ipilimumab market is driven by the rising prevalence of melanoma and other cancers.
  • Regional Dominance: North America leads the market, followed by Europe and the rapidly growing Asia Pacific region.
  • Key Players: Bristol-Myers Squibb, AstraZeneca, and Merck & Co., Inc. are major players.
  • Market Drivers: Improvements in immunotherapy, FDA approvals, and increased healthcare investment are key drivers.
  • Financial Success: Ipilimumab has been financially successful since its introduction.
  • Future Growth: The market is expected to grow significantly due to ongoing R&D and expanding indications.

Frequently Asked Questions

What is ipilimumab, and how does it work?

Ipilimumab is an immune checkpoint inhibitor that targets the T cell-surface protein CTLA-4, enabling the immune system to recognize and eliminate cancer cells more effectively.

Which regions dominate the ipilimumab market?

North America dominates the ipilimumab market, followed by Europe and the Asia Pacific region.

What are the key drivers of the ipilimumab market?

The key drivers include the growing prevalence of cancer, improvements in immunotherapy, FDA approvals, and increased investment in healthcare.

How has the COVID-19 pandemic affected the ipilimumab market?

The COVID-19 pandemic had a minimal negative impact on the ipilimumab market, primarily due to supply chain disruptions, but the market has since recovered.

What is the financial outlook for the ipilimumab market?

The ipilimumab market is expected to grow significantly, driven by ongoing R&D, expanding indications, and increasing adoption in various regions.

Cited Sources

  1. We Market Research: Ipilimumab Market Size, Share, Trends and future projections.
  2. Bristol Myers Squibb: 2014 Annual Report.
  3. MarketsandMarkets: Biosimilars Market Key Growth Drivers and Trends Forecast.
  4. BioSpace: Ipilimumab Market: Growing prevalence of cancer around the world ...
  5. JAMA Network Open: Cost-effectiveness of Pembrolizumab Plus Axitinib vs Nivolumab ...

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