Tocilizumab - Biologic Drug Details

Summary for tocilizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	3
BLAs:	4
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for tocilizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tocilizumab

Recent Clinical Trials for tocilizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 1
Christine Ryan	Phase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1

See all tocilizumab clinical trials

Recent Litigation for tocilizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
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 tocilizumab litigation

PTAB Litigation

Petitioner	Date
Fresenius Kabi USA, LLC	2022-06-07
Celltrion, Inc. et al.	2022-02-21
Fresenius Kabi USA, LLC	2021-11-24

See all tocilizumab litigation

Pharmacology for tocilizumab

Mechanism of Action	Interleukin 6 Receptor Antagonists
Established Pharmacologic Class	Interleukin-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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Tocilizumab

Introduction to Tocilizumab

Tocilizumab is a monoclonal antibody that targets interleukin-6 (IL-6) receptors, playing a crucial role in the treatment of various autoimmune diseases and conditions. Its market dynamics are influenced by several key factors, including expanding indications, technological advancements, and changing healthcare landscapes.

Market Size and Growth Projections

The global tocilizumab market is anticipated to experience significant growth over the next decade. As of 2023, the market size is estimated to be around USD 77.9 million to USD 81.19 million, depending on the source[1][4].

• By 2033, the market is projected to reach USD 181.3 million at a Compound Annual Growth Rate (CAGR) of 5.3%[1].
• Alternatively, some projections suggest a higher CAGR of 12.20%, leading to a market size of USD 203.93 million by 2031[4].

Expanding Indications for Autoimmune Diseases

One of the primary drivers of the tocilizumab market is its expanding approval for various autoimmune conditions. Tocilizumab has been approved for treating rheumatoid arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome associated with CAR-T cell therapy. Recent approvals for conditions like systemic sclerosis have further broadened its application, particularly in regions such as North America and Europe[1][4].

Increased Use in COVID-19 Treatment

The COVID-19 pandemic has significantly impacted the tocilizumab market. Tocilizumab has been used to treat severe COVID-19 cases by addressing cytokine storms, which has expanded its market potential. Studies have shown that tocilizumab can reduce mortality rates among hospitalized COVID-19 patients with elevated inflammatory markers[5].

Emergence of Biosimilars

The emergence of tocilizumab biosimilars is a transformative growth opportunity. Biosimilars like Tyenne® by Fresenius Kabi and Trazimera by Amgen offer cost-effective alternatives, enhancing accessibility and affordability for patients. As patents for tocilizumab expire, these biosimilars are poised to broaden the drug's reach, making it more accessible to a larger patient population[2][4].

Regional Market Dynamics

North America

North America dominates the tocilizumab market due to its 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][4].

Europe

Europe also has a 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, supported by widespread adoption of biologic therapies and government initiatives to support chronic disease management[4].

Asia-Pacific

The Asia-Pacific region is emerging as a fast-growing market, driven by increasing healthcare investments and a rising incidence of autoimmune disorders. Japan and China are leading this growth, with Japan's well-established pharmaceutical industry and China's expanding biosimilar market playing crucial roles[4].

Latin America

Brazil is emerging as a key player in Latin America's tocilizumab market, driven by its expanding healthcare sector and increasing adoption of biologic therapies. The country’s public healthcare system is working towards integrating biologics into its treatment protocols, which could significantly boost market growth[4].

Financial Implications and Expenditures

The financial trajectory of tocilizumab is influenced by several factors, including increased utilization, approvals for expanded indications, and the emergence of biosimilars.

• Aggregate spending on biologic disease-modifying antirheumatic drugs (DMARDs), which include tocilizumab, has shown significant growth. For instance, expenditures on biologic DMARDs increased by 45% from $166 million in 2004 to $242 million in 2013[3].

• The average cost per prescription for biologic DMARDs, including tocilizumab, remains high but relatively stable over time. For example, the cost for rituximab is approximately $5,000 per prescription fill, while other biologics like infliximab, adalimumab, and etanercept range from $2,700 to $3,800 per fill[3].

• The emergence of biosimilars is expected to reduce costs and increase accessibility. For instance, the launch of Tyenne®, a tocilizumab biosimilar by Fresenius Kabi, provides an affordable, high-quality, and safe treatment option for U.S. patients[2].

Impact of Healthcare Infrastructure and Reimbursement Policies

The demand for tocilizumab is also driven by the availability of advanced healthcare infrastructure and favorable reimbursement policies. In regions like North America, the well-developed healthcare system improves the diagnosis, treatment, and management of autoimmune disorders, increasing the demand for tocilizumab[1].

Pharmacy Benefit Managers and Cost Control Mechanisms

Pharmacy benefit managers use various control mechanisms such as benefit design modifications, step-edits, preauthorization, cost-sharing, and adherence counseling to control spending on specialty drugs like tocilizumab. These mechanisms can influence the financial trajectory by affecting the out-of-pocket costs for patients and the overall expenditure on the drug[3].

Key Takeaways

• The global tocilizumab market is expected to grow significantly due to expanding indications, increased use in COVID-19 treatment, and the emergence of biosimilars.
• North America and Europe are key markets driven by advanced healthcare infrastructure and high prevalence of autoimmune diseases.
• The Asia-Pacific region and Latin America are emerging markets with significant growth potential.
• The financial implications include high average costs per prescription, but the emergence of biosimilars is expected to reduce costs and increase accessibility.
• Healthcare infrastructure and reimbursement policies play a crucial role in the demand and financial trajectory of tocilizumab.

Frequently Asked Questions (FAQs)

What are the primary indications for tocilizumab?

Tocilizumab is primarily indicated for treating autoimmune disorders such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome associated with CAR-T cell therapy[1].

How has the COVID-19 pandemic impacted the tocilizumab market?

The COVID-19 pandemic has expanded the market potential of tocilizumab by its use in treating severe COVID-19 cases, particularly those with elevated inflammatory markers[5].

What role do biosimilars play in the tocilizumab market?

Biosimilars like Tyenne® and Trazimera offer cost-effective alternatives to the original drug, enhancing accessibility and affordability for patients, especially in price-sensitive markets[2][4].

Which regions dominate the tocilizumab market?

North America and Europe dominate the tocilizumab market due to their advanced healthcare infrastructure and high prevalence of autoimmune diseases[1][4].

How do pharmacy benefit managers influence the financial trajectory of tocilizumab?

Pharmacy benefit managers use various control mechanisms such as benefit design modifications, step-edits, preauthorization, and cost-sharing to control spending on specialty drugs like tocilizumab, affecting the out-of-pocket costs and overall expenditure[3].

Sources:

1. Market Statsville Group, "Tocilizumab Market Size, Share and Trends Analysis by 2033".
2. Fresenius, "Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®".
3. AHDB Online, "Biologic Disease-Modifying Antirheumatic Drugs in a National Privately Insured Population: Utilization, Expenditures, and Price Trends".
4. Data Bridge Market Research, "Global Tocilizumab Market Industry Overview and Forecast to 2031".
5. Oxford Academic, "Tocilizumab for the Treatment of COVID-19 Among Hospitalized Patients".

Last updated: 2024-12-17