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Last Updated: March 25, 2025

ACTEMRA Drug Profile


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Recent Clinical Trials for ACTEMRA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 1
Christine RyanPhase 2
Emory UniversityPhase 1

See all ACTEMRA clinical trials

Recent Litigation for ACTEMRA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Hetero USA, Inc.2024-08-08
AbbVie Inc. v. Hetero USA, Inc.2023-11-20
Genentech, Inc. v. Biogen MA Inc.2023-07-13

See all ACTEMRA litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA, LLC2022-06-07
Celltrion, Inc. et al.2022-02-21
Fresenius Kabi USA, LLC2021-11-24

See all ACTEMRA litigation

Pharmacology for ACTEMRA
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 ACTEMRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for the Biologic Drug: ACTEMRA

Market Overview

The Actemra (tocilizumab) drug market is a significant segment within the biologics industry, driven by several key factors. As of 2024, the Actemra drug market is valued at USD 3.796 billion and is projected to reach USD 6.7 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.5% from 2024 to 2031[1].

Market Drivers

Increased Prevalence of Autoimmune Diseases

The primary driver of the Actemra market is the increasing prevalence of autoimmune diseases, particularly rheumatoid arthritis, globally. Rheumatoid arthritis affects around 1% of the general population worldwide, with rising incidence and prevalence rates, especially in countries undergoing rapid modernization and urbanization such as China, India, and Brazil[1].

Strong Efficacy and Expanded Indications

Actemra's strong efficacy results have made it a preferred first-line treatment option for many physicians. The drug has been approved for treating various conditions, including rheumatoid arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome associated with CAR-T cell therapy. These expanded indications have broadened the patient population eligible for Actemra treatment, further driving market growth[1][4].

Emerging Markets

The potential for expansion into emerging markets is a significant opportunity for the Actemra drug market. Economic growth and the development of healthcare systems in these regions have led to a rising middle-class population that can afford advanced medical therapies. Partnering with local drug makers for manufacturing and distribution, and targeting public and private insurance coverage, can help pharmaceutical companies capture new patient volumes and drive future revenue growth[1].

Market Challenges

High Cost of Biologic Treatments

One of the major challenges facing the Actemra market is the high cost of biologic treatments. This can limit access to the drug, especially in regions where healthcare budgets are constrained. Pharmaceutical companies need to balance pricing strategies to make their products more affordable in emerging markets while maintaining profitability[1].

Regulatory Approval Processes

Stringent regulatory approval processes also pose a challenge. The need for rigorous clinical trials and regulatory clearances can delay market entry and increase costs. Companies must navigate these regulatory hurdles efficiently to ensure timely market access[1].

Route of Administration

Intravenous Administration

The intravenous route of administration remains the preferred mode for Actemra due to its greater convenience and effectiveness. This method ensures higher bioavailability and rapid delivery of the drug into the bloodstream, which is crucial for achieving the desired therapeutic effects. Hospitals, with their specialized infrastructure and capacity for handling high volumes of infusion treatments, are the major consumers within the Actemra drug market[1].

Competitive Landscape

Major Players

The Actemra drug market is dominated by several major pharmaceutical companies, including Hoffmann-La Roche, Genentech, Novartis, Biogen, Sanofi, Boehringer Ingelheim, and AbbVie. Roche, in particular, has maintained a high market share through strategies such as expanding indications, aggressive promotion, life-cycle management innovations, and strategic partnerships[1].

Biosimilar Readiness

Despite the entry of biosimilars into the market since 2018, none have captured more than 15% of the market share. Roche's strategies have made the branded Actemra product less financially attractive for biosimilar makers, helping to maintain its market dominance[1].

Financial Performance

Revenue Growth

Actemra has been a significant contributor to Roche's pharmaceutical division. In 2022, despite a decline in sales due to lower demand from COVID-19 patients, Actemra continued to drive revenue growth. The drug's sales were CHF 2.7 billion in 2022, although this represented a 22% decline at constant exchange rates compared to the previous year[2].

Operating Profit

The Pharmaceuticals Division of Roche saw a 5% increase in core operating profit in 2022, partly driven by the performance of Actemra and other key products like Alecensa, Gazyva/Gazyvaro, and Perjeta. However, the overall IFRS operating profit decreased due to higher intangible assets impairment[2].

Global Sales Impact

Excluding the impact of COVID-19 restrictions in China, sales in the international region increased by 6% in 2022, driven by higher demand for key products including Actemra. This growth underscores the drug's global market potential and the resilience of the biologics segment despite pandemic-related challenges[2].

Regional Trends

Latin America

The biologics market in Latin America, including drugs like Actemra, is expected to see significant growth. The region's biosimilars market was valued at $517 million in 2018 and is projected to increase to $3.9 billion by 2025. This growth is driven by increasing healthcare expenditure, expanding healthcare infrastructure, and government initiatives aimed at improving healthcare access and affordability[3].

Emerging Markets Expansion

Actemra's expansion into emerging markets is crucial for its long-term growth. By tailoring products to local market incomes and partnering with local drug makers, pharmaceutical companies can capture new patient volumes and drive revenue growth in these regions[1].

Key Takeaways

  • The Actemra drug market is valued at USD 3.796 billion in 2024 and is expected to reach USD 6.7 billion by 2031, growing at a CAGR of 8.5%.
  • The increased prevalence of autoimmune diseases and strong efficacy results are major drivers of the market.
  • Intravenous administration remains the preferred route due to its convenience and effectiveness.
  • Major players like Roche have maintained market dominance through strategic partnerships and life-cycle management.
  • Emerging markets offer significant growth opportunities, but high costs and regulatory challenges need to be addressed.

FAQs

What is the current market size and projected growth of the Actemra drug market?

The Actemra drug market is valued at USD 3.796 billion in 2024 and is expected to reach USD 6.7 billion by 2031, growing at a CAGR of 8.5% from 2024 to 2031[1].

What are the primary drivers of the Actemra market growth?

The primary drivers include the increased prevalence of autoimmune diseases like rheumatoid arthritis globally and the strong efficacy results of Actemra, making it a preferred first-line treatment option[1].

Which route of administration is most preferred for Actemra?

The intravenous route of administration is the most preferred due to its greater convenience and effectiveness, ensuring higher bioavailability and rapid delivery of the drug into the bloodstream[1].

Who are the major players in the Actemra drug market?

Major players include Hoffmann-La Roche, Genentech, Novartis, Biogen, Sanofi, Boehringer Ingelheim, and AbbVie[1].

How has the COVID-19 pandemic impacted Actemra sales?

The COVID-19 pandemic led to a decline in Actemra sales in 2022 due to lower demand from hospitalized patients, but the drug continues to drive revenue growth in other segments[2].

What are the challenges facing the Actemra market?

The high cost of biologic treatments and stringent regulatory approval processes are the major challenges facing the Actemra market[1].

Sources

  1. CoherentMI: Actemra Drug Market Report, Trends, Share & Insights.
  2. Roche: Finance Report 2022.
  3. Cambridge University Press: The Pharmaceutical Market for Biological Products in Latin America.
  4. Market Statsville Group: Tocilizumab Market Size, Share and Trends Analysis by 2033.
  5. Roche: Finance Report 2023.

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