Certolizumab pegol - Biologic Drug Details

Summary for certolizumab pegol

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

Recent Clinical Trials for certolizumab pegol

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
Janssen Research & Development, LLC	Phase 2
Al-Azhar University	Phase 2/Phase 3

See all certolizumab pegol clinical trials

Recent Litigation for certolizumab pegol

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
AbbVie Inc. v. Alvotech hf.	2021-05-28

See all certolizumab pegol litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all certolizumab pegol litigation

Pharmacology for certolizumab pegol

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 certolizumab pegol Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Certolizumab Pegol

Introduction to Certolizumab Pegol

Certolizumab pegol, marketed under the brand name CIMZIA®, is a biologic medication that belongs to the class of tumor necrosis factor (TNF) alpha inhibitors. It is designed to manage various chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and others.

Market Size and Growth Projections

The global certolizumab pegol market is poised for significant growth over the coming years. Here are some key projections:

• Global Market Size: The market is expected to grow from USD 2.3 billion in 2023 to USD 7.3 billion by 2033, at a Compound Annual Growth Rate (CAGR) of 12.3% during the forecast period from 2024 to 2033[4].
• Segmented Growth: The market is segmented by type, application, dosage form, route of administration, and distribution channels. The growth among these segments will help analyze the market dynamics and identify core market applications[1].

Key Drivers of Market Growth

Several factors are driving the growth of the certolizumab pegol market:

Rising Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease is a major driver. As these conditions become more common, the demand for effective treatments like certolizumab pegol is expected to surge[4].

Advanced Healthcare Infrastructure

Regions with advanced healthcare infrastructure, such as North America and Europe, are seeing significant market growth due to widespread patient education programs and favorable reimbursement policies. These factors enhance access to cutting-edge treatments like CIMZIA®[4].

Research and Development Activities

Ongoing research and development activities, including clinical trials and new product launches, are providing beneficial opportunities for the market. UCB, the manufacturer of CIMZIA®, is involved in multiple clinical development programs, which are expected to yield positive results in the near future[2][3].

Government Initiatives and Regulatory Support

Government initiatives aimed at improving access to high-cost medications and robust regulatory support ensure that certolizumab pegol meets stringent safety and efficacy standards. This support is crucial for the market's growth and stability[4].

Regional Analysis

The market for certolizumab pegol is geographically diverse, with different regions exhibiting varying growth patterns:

North America

North America dominates the market, accounting for over 60.5% of the market share in 2023, valued at USD 1.39 billion. This dominance is attributed to the region's advanced healthcare infrastructure and favorable reimbursement policies[4].

Europe

Europe is the second-largest market, driven by the rising prevalence of autoimmune disorders and robust healthcare systems. The region continues to see growth, particularly in countries with strong regulatory support[4].

Asia-Pacific

The Asia-Pacific region is expected to exhibit the most rapid growth in the coming years, fueled by enhancements in healthcare facilities, increased healthcare spending, and heightened awareness of autoimmune diseases. The introduction of generic versions of the drug is also expected to boost market growth in this area[4].

Latin America and Middle East & Africa

These regions are predicted to see modest growth, driven by improvements in healthcare services, government initiatives, and partnerships between local and international firms to distribute advanced treatments[4].

Financial Performance and Trajectory

Revenue and Sales

• Current Revenue: In 2023, the global sales of CIMZIA® were significant, contributing to UCB's overall revenue of € 4.87 billion. CIMZIA® itself showed stable performance, with volume growth remaining robust in the U.S. and positive in Japan, despite mandatory price cuts[2][3].
• Future Projections: The market is expected to continue growing, with the global Cimzia (certolizumab) drug market projected to reach USD 7.3 billion by 2033[4].

Profitability and EBITDA

• Adjusted EBITDA: UCB's adjusted EBITDA increased by 7% to € 1.349 billion in 2023, reflecting efficient performance and cost management despite higher operating expenses related to product launches and acquisitions[2].
• Net Financial Expenses: Net financial expenses increased due to higher interest rates and higher net debt, primarily related to the acquisition of Zogenix in 2022[2].

Challenges and Limitations

Despite the positive growth trajectory, the market faces several challenges:

High Cost and Side Effects

The high cost associated with certolizumab pegol and potential side effects such as allergic reactions, dizziness, and blood problems can hamper market growth. These factors may limit access to the medication, especially in regions with less robust healthcare systems[1].

Lack of Awareness

Lack of awareness about autoimmune diseases and the availability of treatments like certolizumab pegol can further challenge the market. Educational programs and government initiatives are crucial in addressing this issue[1].

Competitive Landscape

The certolizumab pegol market is competitive, with several key players involved:

• UCB S.A.: As the primary manufacturer of CIMZIA®, UCB plays a dominant role in the market. Other companies like LGM Pharma, ADM, BASF SE, and Cargill Incorporated are also involved, though primarily in related industries or as suppliers[1].

Key Takeaways

• Growing Market: The certolizumab pegol market is expected to grow significantly, driven by the rising prevalence of autoimmune diseases and advancements in healthcare infrastructure.
• Regional Variance: North America and Europe are current leaders, while the Asia-Pacific region is expected to show rapid growth.
• Financial Performance: Stable revenue and increasing adjusted EBITDA indicate a strong financial trajectory for UCB and the market as a whole.
• Challenges: High costs, side effects, and lack of awareness are key challenges that need to be addressed.

FAQs

What is certolizumab pegol used for?

Certolizumab pegol, marketed as CIMZIA®, is used to manage various chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and others.

What is the expected market size of certolizumab pegol by 2033?

The global Cimzia (certolizumab) drug market is expected to reach USD 7.3 billion by 2033, growing at a CAGR of 12.3% from 2024 to 2033[4].

Which regions dominate the certolizumab pegol market?

North America currently dominates the market, followed by Europe. The Asia-Pacific region is expected to show the most rapid growth in the coming years[4].

What are the key drivers of the certolizumab pegol market?

Key drivers include the rising prevalence of autoimmune diseases, advanced healthcare infrastructure, ongoing research and development activities, and government initiatives aimed at improving access to high-cost medications[4].

What challenges does the certolizumab pegol market face?

The market faces challenges such as high costs associated with the product, potential side effects, and lack of awareness about autoimmune diseases and available treatments[1].

Who are the major players in the certolizumab pegol market?

UCB S.A. is the primary manufacturer of CIMZIA®, while other companies like LGM Pharma, ADM, BASF SE, and Cargill Incorporated are also involved in related industries or as suppliers[1].

Sources

1. Data Bridge Market Research: Global Certolizumab Pegol Market Size, Share, & Industry Growth By 2029.
2. UCB: UCB on Growth Path for a Decade Plus.
3. PR Newswire: UCB on Growth Path for a Decade Plus.
4. Market.us: Cimzia (certolizumab) Drug Market Size | CAGR Of 12.3%.

Last updated: 2024-12-17