BLINCYTO Drug Profile

Summary for Tradename: BLINCYTO

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BLINCYTO

Recent Clinical Trials for BLINCYTO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ho Joon Im	Phase 2
Goethe University	Phase 1/Phase 2
University Hospital Schleswig-Holstein	Phase 1/Phase 2

See all BLINCYTO clinical trials

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 BLINCYTO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2024-11-26	Company disclosures
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2032-04-30	Company disclosures
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2018-04-21	Company disclosures

3) Low Certainty: US Patents for BLINCYTO 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
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2033-02-08	Patent claims search
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2035-05-04	Patent claims search
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2032-02-15	Patent claims search

International Patents for BLINCYTO

Country	Patent Number	Estimated Expiration
Russian Federation	2008129080
Cyprus	1116874
South Korea	20120099647

Supplementary Protection Certificates for BLINCYTO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016/021	Ireland		PRODUCT NAME: BLINATUMOMAB; REGISTRATION NO/DATE: EU/1/15/1047 20151123
93067	Luxembourg		PRODUCT NAME: BLINATUMOMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BLINCYTO); FIRST REGISTRATION DATE: 20151125
132016000051579	Italy		PRODUCT NAME: POLIPEPTIDE (DENOMINATO BLINATUMOMAB) COMPRENDENTE DUE SITI DI LEGAME ANTIGENICI, IN CUI UN SITO DI LEGAME SI LEGA ALL'ANTIGENE UMANO CD19 E L'ALTRO SITO DI LEGAME SI LEGA ALL'ANTIGENE UMANO CD3(BLINCYTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1047, 20151125

Market Dynamics and Financial Trajectory for the Biologic Drug: BLINCYTO

Introduction to BLINCYTO

BLINCYTO (blinatumomab) is a biologic drug developed by Amgen, primarily used for the treatment of acute lymphoblastic leukemia (ALL). It is a bispecific T-cell engager (BiTE) antibody that targets both CD19 on the cancer cells and CD3 on T cells, facilitating the destruction of cancer cells.

Market Size and Forecast

The BLINCYTO market has been experiencing significant growth. As of 2023, the market size was valued at USD 826 million and is projected to reach USD 1,374 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period 2024-2031[1].

Another forecast indicates that the global market for BLINCYTO was estimated to be worth USD 512 million in 2023 and is forecasted to reach USD 820.8 million by 2030, with a CAGR of 7.3% during the forecast period 2024-2030[3].

Key Drivers of Market Growth

Increasing Incidence of Leukemia

The rising incidence of acute lymphoblastic leukemia (ALL) globally is a significant driver for the BLINCYTO market. The steady increase in diagnosed cases, particularly in pediatric populations, has led to a growing demand for effective treatment options. Health organizations report a consistent rise in ALL cases due to genetic factors and environmental influences, making BLINCYTO an appealing solution[1].

Advancements in Biopharmaceuticals

Technological innovations in biopharmaceuticals, including monoclonal antibody development and cell therapy techniques, have enhanced the efficacy and safety profiles of biologic drugs like BLINCYTO. These advancements enable healthcare providers to offer tailored therapies, improving overall outcomes and reducing adverse effects. The focus on next-generation therapies and the lucrative potential of the biopharmaceutical market draw significant investments, benefiting BLINCYTO's market presence[1].

Rise in Research Funding

Increased research funding for cancer treatments, specifically for ALL, has positively impacted the BLINCYTO market. Governments, private investors, and nonprofit organizations are allocating substantial resources to innovative cancer therapies, validating the efficacy of BLINCYTO through clinical trials and enhancing its market credibility[1].

Financial Performance of BLINCYTO

Sales Growth

BLINCYTO has shown robust sales growth. In the first quarter of 2024, BLINCYTO sales increased by 26% year-over-year to $244 million, driven by broad prescribing across academic and community settings[2].

In the third quarter of 2024, BLINCYTO sales increased by 49% year-over-year to $327 million, primarily driven by volume growth[4].

Revenue and Operating Income

Amgen's financial reports indicate that the company's non-GAAP operating income increased from $3.4 billion to $4.0 billion in the third quarter of 2024, despite a decrease in non-GAAP operating margin. The company generated $3.3 billion of free cash flow in the third quarter of 2024, driven by business performance and timing of working capital items[4].

Market Constraints

High Cost of Treatment

One of the main constraints in the BLINCYTO market is the high cost of treatment. The significant financial implications for healthcare systems and patients can limit access, particularly in regions with limited insurance frameworks. High out-of-pocket expenses can deter patients from pursuing treatment, affecting market penetration and long-term sustainability[1].

Limited Patient Population

The BLINCYTO market is also constrained by its applicability to a limited patient population. While the drug is effective for certain types of ALL, its use is restricted to specific genetic profiles, limiting the number of eligible patients. This narrow focus complicates market strategies and necessitates targeted marketing efforts[1].

Competitive Landscape

Regional Market Segmentation

The BLINCYTO market is primarily segmented by geography. North America, particularly the United States, holds a significant portion of the market due to advanced healthcare infrastructures, robust research and development activities, and high investments in oncology therapies. Europe also exhibits steady growth, supported by regulatory approvals from the European Medicines Agency (EMA). The Asia-Pacific region is emerging as a significant market, driven by increasing healthcare expenditure and a heightened focus on enhancing cancer care in countries like China and India[1].

Key Players

Amgen is the main player in the BLINCYTO market, with strategic partnerships with healthcare providers playing an essential role in the drug’s market penetration[3].

Regulatory Approvals and Guidelines

Regulatory support from entities like the FDA in the United States and the EMA in Europe has been crucial for the market growth of BLINCYTO. These approvals facilitate quicker access to breakthrough therapies, enhancing the drug's market presence[1].

Future Outlook

Market Trends and Opportunities

The future outlook for BLINCYTO is promising, driven by ongoing advancements in biopharmaceuticals and increasing research funding. The growing need for personalized medicine and the rising incidence of leukemia are expected to continue driving demand for BLINCYTO.

Challenges and Restraints

Despite the positive outlook, the high cost of treatment and the limited patient population remain significant challenges. Addressing these issues through innovative pricing strategies, expanded insurance coverage, and targeted marketing will be crucial for sustained market growth.

"Health organizations report a consistent rise in ALL cases due to genetic factors and environmental influences, making BLINCYTO an appealing solution"[1].

Key Takeaways

• The BLINCYTO market is projected to grow significantly, reaching USD 1,374 million by 2031 with a CAGR of 6.2%.
• The increasing incidence of acute lymphoblastic leukemia and advancements in biopharmaceuticals are key drivers of market growth.
• High research funding and regulatory approvals are critical for the market's expansion.
• The high cost of treatment and limited patient population are significant constraints.
• Amgen is the primary player in the BLINCYTO market, with North America and Europe being key regions.

FAQs

What is BLINCYTO used for?

BLINCYTO (blinatumomab) is used primarily for the treatment of acute lymphoblastic leukemia (ALL).

What is the projected market size of BLINCYTO by 2031?

The BLINCYTO market is projected to reach USD 1,374 million by 2031[1].

What are the key drivers of the BLINCYTO market?

Key drivers include the increasing incidence of leukemia, advancements in biopharmaceuticals, and increased research funding[1].

Who is the main player in the BLINCYTO market?

Amgen is the main player in the BLINCYTO market[3].

What are the major constraints in the BLINCYTO market?

The high cost of treatment and the limited patient population are significant constraints[1].

Sources

1. Verified Market Research: Blincyto Market Size, Scope, Growth, Trends and Forecast.
2. PR Newswire: AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS.
3. Valuates Reports: Blincyto - Market, Report Size, Worth, Revenue, Growth, Industry.
4. Amgen Investors: AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS.
5. Cognitive Market Research: Blincyto Market Report 2024 (Global Edition).

Last updated: 2024-12-17