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Last Updated: February 7, 2025

Tocilizumab-bavi - Biologic Drug Details


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Summary for tocilizumab-bavi
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Pharmacology for tocilizumab-bavi
Mechanism of ActionInterleukin 6 Receptor Antagonists
Established Pharmacologic ClassInterleukin-6 Receptor Antagonist
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 tocilizumab-bavi Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tocilizumab-bavi Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tocilizumab-bavi Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Tocilizumab-Bavi

Introduction

Tocilizumab, a monoclonal antibody, has been a cornerstone in the treatment of various autoimmune diseases and, more recently, severe COVID-19 cases. The emergence of biosimilars, such as tocilizumab-bavi, is transforming the market landscape, offering cost-effective alternatives and expanding patient access. Here, we delve into the market dynamics and financial trajectory of tocilizumab-bavi.

Global Tocilizumab Market Overview

The global tocilizumab market is experiencing significant growth, driven by its expanding indications for autoimmune diseases and its role in treating COVID-19. As of 2023, the market size was valued at USD 81.19 million and is projected to grow at a CAGR of 12.20% to reach USD 203.93 million by 2031[1].

Expanding Indications for Autoimmune Diseases

Tocilizumab's market growth is substantially driven by its approval for various autoimmune conditions. Recent approvals, such as for systemic sclerosis, have opened new avenues in regions like North America and Europe, where these conditions are prevalent. This broader application enhances the drug's market potential and addresses unmet needs in autoimmune disease management[1].

Increased Use in COVID-19 Treatment

The drug's efficacy in treating severe COVID-19 cases by addressing cytokine storms has further expanded its market potential. This increased use has contributed significantly to the growth of the global tocilizumab market[1].

Emergence of Biosimilars

The approval of biosimilars like TOFIDENCE (tocilizumab-bavi) by the FDA marks a significant milestone. TOFIDENCE is the first tocilizumab biosimilar approved in the United States, offering equivalent efficacy and comparable safety to the reference product, ACTEMRA. Biosimilars provide cost savings and promote expanded and sustainable access to therapies, which is expected to drive significant market growth[2][5].

Benefits of Biosimilars

Biosimilars like TOFIDENCE offer several benefits:

  • Cost Savings: Biosimilars are generally more affordable than the original biologic drugs, making them more accessible to a wider patient population.
  • Increased Patient Access: With lower prices, biosimilars can increase patient adoption, as seen in other markets where biosimilar competition has led to over 150 million days of patient therapy[2][5].
  • Physician Choice: The availability of biosimilars provides physicians with more treatment options, enhancing patient care and outcomes.

Market Growth Opportunities

Regional Market Dynamics

  • North America: Dominates the market due to advanced healthcare infrastructure, high prevalence of autoimmune diseases, and favorable reimbursement policies. The United States is a significant market, with extensive use of tocilizumab in both approved indications and off-label uses[1].
  • Europe: Strong market presence driven by high awareness of autoimmune diseases and robust healthcare systems. Countries like Germany, France, and the United Kingdom are key contributors[1].
  • Asia-Pacific: Emerging as a fast-growing region, driven by increasing healthcare investments and rising incidence of autoimmune disorders. Japan and China are leading this growth[1].
  • Latin America: Brazil is a key player, driven by its expanding healthcare sector and increasing adoption of biologic therapies[1].

Regulatory Environment

Challenges and Opportunities

While the emergence of biosimilars presents significant opportunities, the regulatory environment can pose challenges:

  • Stringent Approval Processes: Complex compliance requirements can delay market entry and limit the availability of tocilizumab in certain regions. For example, in Brazil, ANVISA requires trials to be conducted within the country to assess the drug's safety and efficacy specifically in the Brazilian population[1].
  • Patent Expirations: As patents for tocilizumab expire, biosimilars are poised to broaden the drug's reach, making it more accessible to a larger patient population and driving market growth[1].

Financial Trajectory

Market Size and Growth

The global tocilizumab market is projected to grow from USD 81.19 million in 2023 to USD 203.93 million by 2031, at a CAGR of 12.20%. This growth is driven by the expanding indications, increased use in COVID-19 treatment, and the emergence of biosimilars[1].

Cost Savings and Market Impact

Biosimilars are expected to significantly reduce healthcare costs. For instance, in the rituximab market, the average ASP of biosimilars is 72% lower than the reference product, indicating substantial cost savings potential for tocilizumab biosimilars as well[4].

Revenue Projections

With the approval of TOFIDENCE and other biosimilars, the revenue from tocilizumab is expected to increase due to expanded patient access and increased adoption. The cost-effectiveness of biosimilars will play a crucial role in driving this revenue growth.

Key Players and Market Share

Major players in the tocilizumab market include Roche (the original manufacturer of ACTEMRA) and biosimilar manufacturers like Biogen (TOFIDENCE) and Amgen (Trazimera). The market share of biosimilars is expected to increase as more products gain approval and enter the market[1][2].

Conclusion

The market dynamics for tocilizumab-bavi are characterized by strong growth drivers, including expanding indications for autoimmune diseases, increased use in COVID-19 treatment, and the emergence of biosimilars. These factors are expected to drive the global tocilizumab market to significant growth, with a projected market size of USD 203.93 million by 2031.

Key Takeaways

  • Expanding Indications: Tocilizumab's approval for various autoimmune conditions is a major growth driver.
  • COVID-19 Treatment: The drug's efficacy in treating severe COVID-19 cases has expanded its market potential.
  • Biosimilars: The approval of biosimilars like TOFIDENCE offers cost savings and increased patient access.
  • Regional Growth: North America, Europe, Asia-Pacific, and Latin America are key regions driving market growth.
  • Regulatory Challenges: Stringent approval processes and patent expirations are critical factors influencing market dynamics.

FAQs

What is the current market size of the global tocilizumab market?

The global tocilizumab market size in 2023 is USD 81.19 million[1].

What is the projected CAGR for the global tocilizumab market?

The global tocilizumab market is projected to grow at a CAGR of 12.20% from 2024 to 2031[1].

What are the key growth drivers for the tocilizumab market?

Key growth drivers include expanding indications for autoimmune diseases, increased use in COVID-19 treatment, and the emergence of biosimilars[1][2].

Which regions are driving the growth of the tocilizumab market?

North America, Europe, Asia-Pacific, and Latin America are the key regions driving market growth[1].

What is the significance of the FDA approval of TOFIDENCE?

The FDA approval of TOFIDENCE marks the first tocilizumab biosimilar approved in the United States, offering cost savings and expanded patient access to therapies[2][5].

Sources

  1. Databridge Market Research - Global Tocilizumab Market Industry Overview and Forecast to 2031
  2. Biospace - FDA Approves Biogen's TOFIDENCEā„¢ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA
  3. Biospace - Rheumatic Diseases Market Estimated to Reach USD 29.0 Billion by 2034
  4. Samsung Bioepis - Biosimilar Market Dynamics
  5. Biopharma Boardroom - FDA Approves Biogen's TOFIDENCEā„¢ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA

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