Obinutuzumab - Biologic Drug Details

Summary for obinutuzumab

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

Recent Clinical Trials for obinutuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
The University of Queensland	Phase 3
University of Adelaide	Phase 3
City of Hope Medical Center	Phase 2

See all obinutuzumab clinical trials

Recent Litigation for obinutuzumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Acerta Pharma B.V. v. Cipla Limited	2024-05-16
Acerta Pharma B.V. v. Sandoz Inc.	2022-02-04
Acerta Pharma B.V. v. Cipla Limited	2022-02-03

See all obinutuzumab litigation

PTAB Litigation

Petitioner	Date
Sandoz Inc.	2023-02-03
Dr. Reddy's Laboratories, Inc. et al.	2022-10-14
Dr. Reddy's Laboratories, Inc. et al.	2022-02-03

See all obinutuzumab litigation

Pharmacology for obinutuzumab

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic Antibody

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 obinutuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Obinutuzumab

Market Overview

Obinutuzumab, a monoclonal antibody targeted at the CD20 protein on B lymphocytes, is a crucial treatment for chronic lymphocytic leukemia (CLL) and certain non-Hodgkin lymphomas. The global market for obinutuzumab is poised for significant growth, driven by several key factors.

Rising Prevalence of Hematologic Diseases

The increasing incidence of hematologic diseases such as CLL and non-Hodgkin lymphoma is a primary driver of the obinutuzumab market. As the global population ages and the prevalence of these diseases rises, the demand for targeted therapies like obinutuzumab is expected to increase[1].

Advances in Cancer Treatment

Advances in cancer treatment and the positive outcomes from clinical trials have solidified obinutuzumab's position in the market. The drug's ability to enhance therapeutic effects when used in conjunction with other medications, such as chlorambucil, further supports its adoption[1].

Regulatory Clearances

Regulatory approvals from bodies like the FDA and EMA have been instrumental in expanding the market for obinutuzumab. These clearances validate the drug's safety and efficacy, boosting confidence among healthcare providers and patients[1].

Regional Market Dynamics

North America

North America dominates the obinutuzumab market, accounting for more than 49% of the global revenue. The region's advanced healthcare systems, significant investment in cancer research, and strong pharmaceutical sectors in the U.S. and Canada contribute to this dominance. Comprehensive reimbursement policies and high healthcare expenditure also support the robust growth in this region[1].

Europe

Europe's market is driven by well-established healthcare systems and a high incidence of cancer. The European Medicines Agency (EMA) provides regulatory oversight, facilitating market growth. Countries like Germany, France, and the UK are key contributors due to their strong healthcare infrastructure. However, variations in healthcare policies and reimbursement practices across different European nations influence market dynamics and adoption rates[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. This growth is attributed to the large population base, increasing cancer prevalence, and economic development. Improving healthcare infrastructure in emerging markets like China and India, along with Japan's advanced healthcare system, supports the region's expanding healthcare access and rising awareness of cancer treatments[1].

Financial Trajectory

Cost-Effectiveness Analysis

The financial trajectory of obinutuzumab is influenced by its cost-effectiveness compared to other treatments. Studies have shown that obinutuzumab plus chemotherapy is cost-effective when compared to rituximab plus chemotherapy, with an incremental cost-effectiveness ratio (ICER) of approximately $2,300 per quality-adjusted life-year (QALY) in the U.S.[4].

Administration Costs

The administration method of obinutuzumab also impacts its financial trajectory. Short Duration Infusion (SDI) of obinutuzumab has been shown to be more cost-effective than the Regular Infusion Rate (RIR), with a cost-saving of €1,007 (2.6%) per patient from the societal perspective. This is due to the shorter administration time and reduced healthcare professional (HCP) time required for SDI[2].

Drug and Administration Costs

The cost of obinutuzumab itself is a significant factor. Each 1,000mg vial costs approximately $5,275.50. When combined with chlorambucil, the total treatment cost is substantial, with estimates ranging between $29,240 and $29,958 for the extra cost of obinutuzumab plus chlorambucil compared to rituximab plus chlorambucil[3].

Economic Guidance and Funding

Economic guidance panels have evaluated the cost-effectiveness of obinutuzumab, considering factors such as overall survival, adverse events, and quality of life. These evaluations help inform funding decisions and reimbursement policies, which are critical for the drug's accessibility and market growth[3].

Key Market Players and Competitive Landscape

The obinutuzumab market is characterized by the presence of major pharmaceutical companies, with Roche being a key player. The competitive landscape is influenced by the availability of biosimilars and other targeted therapies, which can impact market share and pricing strategies[1].

Market Growth Projections

The global obinutuzumab market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034. This growth is expected to result in the market reaching a significant value by 2034, driven by the increasing demand for targeted cancer therapies and the expanding healthcare infrastructure in emerging markets[1].

Challenges and Opportunities

Challenges

• Administration Time and Monitoring: The four-hour infusion time and the need for monitoring infusion-related reactions are significant challenges. However, the adoption of SDI can mitigate some of these issues[3].
• Cost and Reimbursement: The high cost of obinutuzumab and variations in reimbursement policies across different regions can affect market dynamics[3].

Opportunities

• Emerging Markets: The improving healthcare infrastructure in regions like Asia Pacific presents significant growth opportunities.
• Advancements in Administration: Innovations in administration methods, such as SDI, can enhance cost-effectiveness and patient compliance[2].

Patient and Healthcare Provider Perspectives

Patient Factors

Patients consider factors such as long remission, adverse events, and quality of life when evaluating treatments like obinutuzumab. The drug's ability to offer superior progression-free survival and overall survival compared to other treatments is a key advantage[3].

Healthcare Provider Factors

Healthcare providers emphasize the importance of flat dosing, minimal wastage, and the short number of treatments required. However, they also consider the administrative costs and the need for monitoring infusion-related reactions[3].

Key Takeaways

• Growing Demand: The obinutuzumab market is driven by the rising prevalence of hematologic diseases and advances in cancer treatment.
• Regional Dominance: North America leads the market, followed by Europe and the rapidly growing Asia Pacific region.
• Cost-Effectiveness: Obinutuzumab is cost-effective compared to other treatments, especially when administered via SDI.
• Challenges and Opportunities: High costs and administration challenges are balanced by opportunities in emerging markets and advancements in administration methods.

FAQs

Q: What is the primary indication for obinutuzumab?

A: Obinutuzumab is primarily used to treat chronic lymphocytic leukemia (CLL) and certain non-Hodgkin lymphomas.

Q: Which region dominates the obinutuzumab market?

A: North America dominates the obinutuzumab market, accounting for more than 49% of the global revenue.

Q: How does the Short Duration Infusion (SDI) of obinutuzumab compare to the Regular Infusion Rate (RIR) in terms of cost?

A: SDI is more cost-effective than RIR, with a cost-saving of €1,007 (2.6%) per patient from the societal perspective.

Q: What are the key factors influencing the cost-effectiveness of obinutuzumab?

A: The cost-effectiveness of obinutuzumab is influenced by factors such as drug costs, administration costs, supportive care, subsequent treatment costs, and adverse event costs.

Q: How does obinutuzumab compare to rituximab in terms of cost-effectiveness?

A: Obinutuzumab plus chemotherapy is cost-effective compared to rituximab plus chemotherapy, with an ICER of approximately $2,300 per QALY in the U.S.[4].

Sources

1. We Market Research, "Obinutuzumab Market Size, Share, Segmentation and Trends 2034".
2. Seed Medical Publishers, "Economic Consequences of Administering Obinutuzumab as a Short Duration Infusion".
3. pan-Canadian Oncology Drug Review, "Final Economic Guidance Report: Obinutuzumab for Chronic Lymphocytic Leukemia".
4. PubMed, "Cost-effectiveness of obinutuzumab versus rituximab biosimilars for follicular lymphoma".