Daratumumab - Biologic Drug Details

Summary for daratumumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for daratumumab

Recent Clinical Trials for daratumumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 3
Myeloma Canada	Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 3

See all daratumumab clinical trials

Pharmacology for daratumumab

Mechanism of Action	CD38-directed Antibody Interactions
Established Pharmacologic Class	CD38-directed Cytolytic Antibody
Chemical Structure	Antibodies, Monoclonal

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 daratumumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036			Company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2027-09-26	Company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2030-09-21	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2033-02-08	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2035-05-04	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2034-06-16	Patent claims search

Market Dynamics and Financial Trajectory for Daratumumab

Introduction to Daratumumab

Daratumumab, marketed as Darzalex, is a monoclonal antibody used primarily to treat multiple myeloma, a type of blood cancer. It works by targeting the CD38 protein on the surface of myeloma cells, either directly destroying these cells or enhancing the immune system's ability to fight them[1].

Market Overview

The daratumumab market is poised for significant growth driven by several key factors:

• Increasing Prevalence of Multiple Myeloma: The global rise in multiple myeloma cases is driving the demand for targeted treatments like daratumumab[1].
• Advancements in Biotechnology: Improvements in biotechnology, particularly in the development of monoclonal antibodies, have made daratumumab a more targeted and efficient therapeutic option[1].
• Extended Approvals: Daratumumab has received approvals for treating diseases other than multiple myeloma, such as lymphoma and amyloidosis, further expanding its market[1].
• Strong Clinical Evidence: The drug's safety and efficacy, especially in combination treatments, have been well-documented, encouraging its adoption[1].

Regional Market Analysis

North America

North America dominates the daratumumab market, accounting for more than 48% of the revenue. This is due to a robust healthcare infrastructure and the early adoption of novel medicines in the United States and Canada. Major pharmaceutical companies in the region also contribute to the market's growth[1].

Europe

Europe is the second-largest region in the daratumumab market. The growth here is driven by the rising incidence of multiple myeloma and favorable reimbursement practices in countries like Germany and France. Collaborations between academic institutions and pharmaceutical companies also drive research and development in the region[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. This growth is fueled by increasing awareness of cancer treatment options and improved healthcare spending in countries like China and Japan. Major players are investing heavily to expand their market presence in developing nations such as India[1].

Financial Performance and Projections

Current Market Size and Revenue

As of 2023, the daratumumab market is valued at approximately $5.08 billion. It is projected to reach $8.36 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.42%[4].

Historical Sales

In 2020, the net trade sales of daratumumab (including the subcutaneous formulation DARZALEX FASPRO) totaled $4.19 billion, with $2.23 billion in the U.S. and $1.96 billion in the rest of the world. Genmab, the developer, receives royalties on these worldwide sales[5].

Recent Growth and Projections

Darzalex has continued to show strong sales performance. In the second quarter of 2023, it generated $2.43 billion in sales, a 22% increase from the same period in the previous year. The drug is on track to approach $10 billion in revenue for 2023, significantly exceeding initial peak sales projections made in 2017[2].

Key Market Players

The daratumumab market is dominated by a few large companies, with Janssen Pharmaceuticals being the primary player. Janssen Biotech, Inc. has an exclusive license to develop, manufacture, and commercialize daratumumab, which was granted through an agreement with Genmab A/S in August 2012[1][5].

Product Innovations and Clinical Advancements

DARZALEX FASPRO

The subcutaneous version of daratumumab, DARZALEX FASPRO, has significantly improved patient treatment times, reducing administration from hours to minutes. As of 2022, 85% of patients receiving daratumumab were using the FASPRO formulation[2].

Clinical Trials and Outcomes

Recent data from the Phase 3 PERSEUS study showed that a DARZALEX FASPRO-based quadruplet induction, consolidation, and maintenance regimen reduced the risk of progression or death by 58% compared to the standard of care regimen. This study highlighted significant clinical improvements, including unprecedented progression-free survival in transplant-eligible newly diagnosed multiple myeloma patients[3].

Market Drivers and Challenges

Market Drivers

• Increasing Healthcare Spending: Rising global healthcare spending is increasing patient access to daratumumab, promoting market growth[1].
• Strong Clinical Evidence: The drug's proven safety and efficacy, particularly in combination therapies, drive its adoption[1].
• Expanding Indications: Approvals for treating other diseases beyond multiple myeloma are expanding the market[1].

Market Challenges

• Competition: While daratumumab is a leading treatment, the multiple myeloma market is competitive, with other treatments and therapies emerging[2].
• Litigation and Regulatory Issues: Companies involved in the market, such as Johnson & Johnson, face legal challenges, including talc litigation, which can impact overall financial performance[2].

Future Outlook

The daratumumab market is expected to continue its upward trajectory, driven by increasing demand, advancements in biotechnology, and strong clinical evidence. Johnson & Johnson aims to enhance its position in the multiple myeloma market with new products like Tecvayli and Carvykti, further solidifying daratumumab's place in the treatment landscape[2].

Key Takeaways

• The daratumumab market is projected to grow significantly, driven by the increasing prevalence of multiple myeloma and advancements in biotechnology.
• North America dominates the market, followed by Europe and the rapidly growing Asia Pacific region.
• Daratumumab's strong clinical evidence and expanding indications are key drivers of its adoption.
• Janssen Pharmaceuticals is the primary player in the market, with Genmab receiving royalties on worldwide sales.
• Innovations like DARZALEX FASPRO have improved treatment times and outcomes.

FAQs

1. What is daratumumab used for?

Daratumumab is primarily used to treat multiple myeloma, a type of blood cancer, by targeting the CD38 protein on myeloma cells.

2. Which region dominates the daratumumab market?

North America dominates the daratumumab market, accounting for more than 48% of the revenue.

3. What is the projected growth rate of the daratumumab market?

The daratumumab market is expected to grow at a CAGR of 6.42% from 2023 to 2031.

4. Who are the key players in the daratumumab market?

Janssen Pharmaceuticals is the primary player, with Genmab A/S receiving royalties on worldwide sales.

5. What is DARZALEX FASPRO, and how does it differ from the original daratumumab?

DARZALEX FASPRO is a subcutaneous version of daratumumab, which reduces administration time from hours to minutes, improving patient treatment times.

Cited Sources

1. We Market Research: Daratumumab Market Report | Size, Share, Growth and Statistics.
2. FiercePharma: With Darzalex thriving, J&J increases revenue guidance for 2023.
3. Janssen: DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based quadruplet therapy regimen shows significant clinical improvement.
4. FutureWise Research: Daratumumab Market By Drug Type, By Application, By Distribution Channel.
5. Genmab: Genmab Announces 2020 Net Sales of DARZALEX® (daratumumab).