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Last Updated: April 26, 2025

Nivolumab - Biologic Drug Details


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Summary for nivolumab
Recent Clinical Trials for nivolumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Targovax ASAPhase 2
Arcus Biosciences, Inc.Phase 1/Phase 2
AVEO Pharmaceuticals, Inc.Phase 2

See all nivolumab clinical trials

Recent Litigation for nivolumab

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.2022-03-17

See all nivolumab litigation

PTAB Litigation
PetitionerDate
Amgen Inc. et al.2025-02-28
Replimune Limited et al.2022-11-02
Genome & Company2018-10-02

See all nivolumab litigation

Pharmacology for nivolumab
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 nivolumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Nivolumab

Introduction to Nivolumab

Nivolumab, marketed under the brand name Opdivo, is a biologic drug that has revolutionized the field of oncology through its immunotherapeutic approach. It works by inhibiting the PD-1 receptor, allowing the immune system to recognize and attack cancer cells more effectively.

Historical Growth and Drivers

The nivolumab market has experienced rapid expansion in recent years. In 2023, the market size was $1.47 billion, and this growth is attributed to several key factors:

  • Advancements in Immunotherapy: The evolution of immunotherapy has been a significant driver, as it has opened up new avenues for cancer treatment.
  • Increase in Cancer Cases: The rising incidence of cancer globally has increased the demand for effective treatments like nivolumab.
  • Success of Clinical Trials: Positive outcomes from clinical trials have bolstered the credibility and adoption of nivolumab.
  • Regulatory Approvals: Favorable regulatory decisions have facilitated the widespread use of nivolumab[1][4].

Current Market Size and Projected Growth

As of 2024, the nivolumab market is projected to reach $1.69 billion, with a Compound Annual Growth Rate (CAGR) of 15.1%. Looking ahead, the market is expected to grow to $2.81 billion by 2028, maintaining a CAGR of 13.6%[1][4].

Key Trends Shaping the Future

Several trends are anticipated to influence the nivolumab market in the forecast period:

  • Biomarker-Driven Treatment Approaches: Personalized medicine is becoming increasingly important, with treatments tailored to individual patient profiles.
  • Neoantigen Vaccines: The development of neoantigen vaccines is expected to enhance immunotherapy regimens.
  • Enhanced Immunotherapy Regimens: Continuous advancements in combination therapies will play a crucial role.
  • Long-Term Follow-Up Studies: There will be an emphasis on long-term follow-up studies to assess treatment efficacy[1][4].

Segmentation of the Nivolumab Market

The nivolumab market can be segmented in several ways:

  • By Type: Injection 4mL and Injection 10mL.
  • By Route of Administration: Intravenous and other routes.
  • By Application: Melanoma, Non-small Cell Lung Cancer (NSCLC), Malignant Pleural Mesothelioma, Classical Hodgkin Lymphoma (CHL), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Renal Cell Carcinoma (RCC), and other applications.
  • By End-User: Clinics, hospitals, and other end-users[4].

Geographical Landscape

North America has been the leading region in the nivolumab market as of 2023. However, the Asia-Pacific region is expected to emerge as the fastest-growing region in the forecast period due to increasing access to cancer care and growing healthcare infrastructure[1].

Financial Performance and Revenue Streams

The financial performance of nivolumab is robust, with significant revenue generated from its sales. For instance, Opdivo sales increased by 1.4 billion yen to 46.8 billion yen in a recent fiscal year, reflecting a volume increase of around 20% despite price revisions[5].

Impact of Cancer Incidence

The rising prevalence of cancer, particularly non-small cell lung cancer (NSCLC), is a major driver for the nivolumab market. In 2023, the American Cancer Society projected 1.9 million new cancer cases in the US, and NSCLC accounted for 81% of all lung cancer cases, further propelling the demand for nivolumab[4].

Competitive Landscape

The nivolumab market is competitive, with various pharmaceutical companies and healthcare providers involved. The market report from The Business Research Company provides insights into the market positioning of major competitors, their revenues, and market shares, which are crucial for stakeholders making informed decisions[1][4].

Challenges and Restraints

Despite the growth, the nivolumab market faces several challenges:

  • High Inflation: Economic instability can affect the affordability and accessibility of the drug.
  • Global Conflicts: Events like the Ukraine-Russia war can impact supply chains and market dynamics.
  • COVID-19 Impact: The pandemic has had a mixed impact on the healthcare sector, including delays in clinical trials and changes in patient treatment patterns[4].

Research and Development

Continuous investment in research and development is vital for the growth of the nivolumab market. Companies are planning significant R&D expenses, such as Ono Pharmaceutical's plan to spend 72.0 billion yen over the full fiscal year, to drive innovation and improve treatment outcomes[5].

Conclusion

The nivolumab market is poised for significant growth driven by advancements in immunotherapy, increasing cancer incidence, and personalized medicine. With a projected market size of $2.81 billion by 2028, stakeholders including pharmaceutical companies, healthcare professionals, and investors are keenly watching the trends and opportunities in this sector.

Key Takeaways

  • Rapid Market Growth: The nivolumab market is growing rapidly, driven by immunotherapy advancements and rising cancer cases.
  • Projected Market Size: The market is expected to reach $2.81 billion by 2028.
  • Key Trends: Biomarker-driven treatments, neoantigen vaccines, and enhanced immunotherapy regimens are key trends.
  • Geographical Expansion: Asia-Pacific is expected to be the fastest-growing region.
  • Financial Performance: Significant revenue is generated from nivolumab sales, with continuous investment in R&D.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the nivolumab market? A: As of 2024, the nivolumab market size is projected to be $1.69 billion[1].

Q: What are the main drivers of the nivolumab market growth? A: The main drivers include advancements in immunotherapy, increasing cancer incidence, successful clinical trials, and regulatory approvals[1][4].

Q: Which region is expected to be the fastest-growing in the nivolumab market? A: The Asia-Pacific region is expected to be the fastest-growing region in the forecast period[1].

Q: How does the rising prevalence of cancer impact the nivolumab market? A: The rising prevalence of cancer, especially non-small cell lung cancer, significantly drives the demand for nivolumab[4].

Q: What are some of the challenges facing the nivolumab market? A: Challenges include high inflation, global conflicts, and the impact of COVID-19 on the healthcare sector[4].

Cited Sources

  1. The Business Research Company. Nivolumab Market Overview 2024-2028: Global Expansion Driven By Immunotherapy Advancements And Rising Cancer Incidence As Per The Business Research Company's Nivolumab Global Market Report 2024. GlobeNewswire, January 18, 2024.
  2. Immunocore. Immunocore reports first quarter financial results and provides a business update. Immunocore, May 8, 2024.
  3. AJMC. Samsung Bioepis Reports 2024 Biosimilar Market Growth Trends. AJMC, October 15, 2024.
  4. The Business Research Company. Nivolumab Market Report 2024. The Business Research Company.
  5. Ono Pharmaceutical Co., Ltd. Financial Results. Ono Pharmaceutical Co., Ltd., November 11, 2019.

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