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Last Updated: February 12, 2025

Durvalumab - Biologic Drug Details


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Summary for durvalumab
Recent Clinical Trials for durvalumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Indiana UniversityPhase 2
TheraOpPhase 2
Boehringer IngelheimPhase 1

See all durvalumab clinical trials

Recent Litigation for durvalumab

Identify key patents and potential future biosimilar entrants

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

See all durvalumab litigation

Pharmacology for durvalumab
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 durvalumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Durvalumab

Market Overview

Durvalumab, a PD-L1 inhibitor, has emerged as a significant player in the immunotherapy market, particularly for the treatment of non-small cell lung cancer (NSCLC) and urothelial carcinoma. This biologic drug works by enhancing the immune system's ability to identify and eliminate cancer cells, making it a crucial component in modern oncology treatment protocols[1][4].

Market Size and Forecast

The global Durvalumab market is anticipated to experience substantial growth, driven by its efficacy and expanding indications. The market is projected to record a compound annual growth rate (CAGR) of XX.X% from 2024 to 2031, with the market size expected to reach USD xx Billion by 2034[1][4].

Regional Analysis

North America

North America, particularly the United States and Canada, dominates the Durvalumab market with a significant share. This region benefits from a robust economy, advanced healthcare infrastructure, and early adoption of innovative therapies. Extensive insurance coverage and efficient regulatory processes by the U.S. FDA also facilitate rapid market entry and adoption[1][4].

Europe

Europe is another major region, driven by a rising cancer burden and an aging population. The well-established healthcare systems and the presence of leading pharmaceutical companies in countries like the UK, Germany, France, and Italy support market growth. However, varying reimbursement policies across countries can impact market access and expansion[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing segment during the forecast period. Economic development, rising healthcare spending, and improvements in healthcare infrastructure in countries such as China, Japan, and India are driving this growth. The increasing incidence of cancer and evolving regulatory frameworks further enhance market opportunities[1][4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa present both opportunities and challenges. Economic fluctuations and political instability in some countries can impact market dynamics, but countries like Brazil, Mexico, and Argentina are key players in these regions[1].

Market Drivers

Rising Prevalence of Cancer

The increasing prevalence of cancers such as NSCLC and urothelial carcinoma is a primary driver of the Durvalumab market. This rise in cancer cases necessitates the development and adoption of effective therapies, making Durvalumab a vital treatment option[1][4].

Advances in Immunotherapy

Advancements in immunotherapy and positive clinical trials have significantly boosted the market for Durvalumab. The drug's efficacy in enhancing the immune system's response to cancer cells has made it a cornerstone in oncology treatment protocols[1][4].

Regulatory Approvals and R&D

Continuous research and development (R&D) expenditures and regulatory approvals for extended uses are crucial drivers. Ongoing clinical trials exploring new indications for Durvalumab further expand its application potential[1][4].

Increased Healthcare Spending

Increased healthcare spending and growing awareness among patients and healthcare providers about advanced treatments also fuel the market growth. This increased spending enables greater access to innovative therapies like Durvalumab[1][4].

Market Challenges

High Treatment Costs

One of the significant challenges facing the Durvalumab market is the high cost of treatment. Despite financial assistance programs that can reduce the cost to as little as $0 per infusion, the overall expense remains a barrier for many patients[5].

Regulatory Hurdles

Regulatory hurdles, although less pronounced in regions like North America and Europe, can still impact market access and expansion in other regions. Varying reimbursement policies and regulatory frameworks can complicate the market dynamics[1][4].

Financial Performance

Revenue Growth

The financial performance of Durvalumab is closely tied to the overall growth of AstraZeneca, its primary manufacturer. In 2022, AstraZeneca reported strong revenue growth, with oncology product sales increasing by 19%. This growth is expected to continue, driven by the success of Durvalumab and other oncology treatments[2].

Market Share

The Durvalumab market is dominated by Medimmune (AstraZeneca), with North America holding the largest market share. The market's financial trajectory is influenced by the company's investment in R&D, market development activities, and the success of partnered medicines[4].

Key Market Players

The Durvalumab market is primarily dominated by AstraZeneca through its subsidiary Medimmune. Other key players involved in the broader immunotherapy and oncology market include companies like Genentech, NeoImmuneTech, and Takeda, which are also developing drugs for various cancer indications[3][4].

Clinical Trials and Pipeline

Ongoing clinical trials are a critical component of the Durvalumab market's growth. These trials are exploring new indications and enhancing the drug's application potential. Positive outcomes from these trials further solidify Durvalumab's position in the oncology treatment landscape[1][4].

Patient Access and Financial Support

To address the high treatment costs, various financial assistance programs are available. For example, patients can receive financial support that reduces the cost of Durvalumab infusions to as little as $0, helping to improve access to this critical treatment[5].

Key Takeaways

  • Market Growth: The Durvalumab market is expected to grow significantly, driven by its efficacy in treating NSCLC and urothelial carcinoma.
  • Regional Dominance: North America and Europe are major regions, with Asia-Pacific expected to be the fastest-growing segment.
  • Market Drivers: Rising cancer prevalence, advances in immunotherapy, regulatory approvals, and increased healthcare spending are key drivers.
  • Challenges: High treatment costs and regulatory hurdles are significant challenges.
  • Financial Performance: Strong revenue growth is anticipated, driven by AstraZeneca's oncology portfolio.
  • Market Players: Medimmune (AstraZeneca) dominates the market, with other key players involved in broader oncology treatments.

FAQs

What is Durvalumab and how does it work?

Durvalumab is a PD-L1 inhibitor that works by enhancing the immune system's ability to identify and eliminate cancer cells. It is used to treat various malignancies, including NSCLC and urothelial carcinoma.

Which regions dominate the Durvalumab market?

North America and Europe are the dominant regions, with Asia-Pacific expected to be the fastest-growing segment during the forecast period.

What are the primary drivers of the Durvalumab market?

The primary drivers include the rising prevalence of cancer, advances in immunotherapy, regulatory approvals, and increased healthcare spending.

What are the main challenges facing the Durvalumab market?

High treatment costs and regulatory hurdles are the main challenges.

How is patient access to Durvalumab supported financially?

Financial assistance programs are available to reduce the cost of Durvalumab infusions, making the treatment more accessible to patients.

Which company is the primary manufacturer of Durvalumab?

AstraZeneca, through its subsidiary Medimmune, is the primary manufacturer of Durvalumab.

Sources

  1. OpenPR: Durvalumab Market Size and Forecast[1].
  2. AstraZeneca: Full year and Q4 2022 results[2].
  3. PR Newswire: The Evolving Market Dynamics of B-cell Lymphomas[3].
  4. We Market Research: Durvalumab Market Size, Share, Trends, Growth, & Analysis[4].
  5. IMFINZI: Financial Assistance for Stage 4 NSCLC – IMFINZI® (durvalumab)[5].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.