Sargramostim - Biologic Drug Details

Summary for sargramostim

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

Recent Clinical Trials for sargramostim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Partner Therapeutics, Inc.	Phase 1
Children's Hospital Los Angeles	Phase 4
United Therapeutics	Phase 4

See all sargramostim clinical trials

Recent Litigation for sargramostim

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Allergan USA, Inc. v. MSN Laboratories Private Ltd.	2023-10-18
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
ModernaTX, Inc. v. Pfizer Inc.	2022-08-26

See all sargramostim litigation

Pharmacology for sargramostim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage Colony-Stimulating Factor

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 sargramostim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Sargramostim

Introduction

Sargramostim, known by its tradename Leukine, is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that plays a crucial role in immunostimulation and the treatment of various medical conditions. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Size and Growth

The global Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) market, which includes sargramostim, was valued at USD 1.83 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 10.7% through the forecast period of 2024-2030, reaching USD 3.74 billion by 2030[1].

Drivers of Growth

Several factors drive the growth of the GM-CSF market, including sargramostim:

Increasing Demand for Prophylaxis

The increasing demand for prophylaxis with granulocyte colony-stimulating factor (G-CSF) and GM-CSF is a significant driver. These factors reduce the incidence of febrile neutropenia (FN) and allow patients to receive and stay on myelosuppressive chemotherapy. For instance, prophylaxis with G-CSF is expected to reduce incidents of febrile neutropenia by 3.3 million and cases of chemotherapy reduced dosage intensity by less than 85% over the next 10 years[1].

Clinical Success and Research

Strong research and development activities, particularly the increasing success rates in clinical trials, are also driving the market. Market leaders are continuously striving to make breakthroughs in the form of new and effective drugs, which includes strategic collaborations to enhance product innovation[1].

Challenges and Restraints

Despite the growth drivers, there are several challenges and restraints affecting the market:

High Cost

The high cost of GM-CSF treatments is a significant restraint. For example, primary prophylactic (PP) G-CSF administration in the first chemotherapy cycle was associated with a 57% increase in total Medicare costs, despite a reduction in medical costs for neutropenia. This increase is largely attributed to the rise in chemotherapy costs[1].

Adverse Reactions

Historically, sargramostim has faced issues related to adverse reactions. The liquid formulation of sargramostim was withdrawn from the market in 2008 due to an increase in spontaneous reports of adverse reactions, including syncope, following a change in the formulation. However, the original liquid formulation without edetate disodium (EDTA) was later reintroduced[4].

Regional Insights

The market for GM-CSF, including sargramostim, varies significantly by region:

North America

North America is expected to witness significant growth due to advancements in cancer research, access to cancer treatment, and clinical practices in the USA. According to the National Cancer Institute (NCI), approximately 1,735,350 new cases of cancer were diagnosed in the US, contributing to the growth of the GM-CSF market in this region[1].

Europe

Europe holds the second-largest share in the GM-CSF market, driven by the growing use of bone and blood marrow transplantation to treat blood diseases[1].

Middle East and Africa

This region holds the least market share due to poor health spending, low income, and economically diverse nations[1].

Applications and End Users

Sargramostim is used across various applications and by different end users:

Applications

• Solid Tumors: Sargramostim is used to support patients undergoing chemotherapy for solid tumors.
• Lymphoma: It is used in the treatment of lymphoma to stimulate the production of white blood cells.
• Kidney Cancer: Sargramostim can be used to support patients with kidney cancer undergoing chemotherapy.
• Lung Disease: It is also used in the treatment of certain lung diseases[1].

End Users

• Hospitals and Clinics: These are the primary end users, where sargramostim is administered to patients.
• Surgical Centers: Some surgical centers also use sargramostim for post-surgical care.
• Diagnostic Centers: Diagnostic centers may use sargramostim as part of their treatment protocols.
• Research Centers: Research centers are involved in clinical trials and studies related to sargramostim[1].

Economic Evaluation

Economic evaluations highlight the cost-effectiveness of different GM-CSF regimens:

Cost Comparison

Studies have shown that filgrastim alone and sequential sargramostim and filgrastim are less costly and therapeutically more beneficial compared to sargramostim alone. For instance, total costs were higher for patients receiving sargramostim alone than for those in other treatment arms[2].

Regulatory Approvals and Safety

Sargramostim has undergone significant regulatory scrutiny:

FDA Approvals

In March 2018, the FDA extended the label for sargramostim to include its use as a countermeasure for acute radiation syndrome. The FDA has concluded that Leukine (sargramostim) can be safely used without restrictions on distribution or use, subject to postmarketing studies to evaluate its safety and efficacy in specific settings[4][5].

Market Outlook

The biologics market, which includes GM-CSF, is expected to grow significantly:

Biologics Market Growth

The biologics market size reached USD 349.6 billion in 2023 and is projected to reach USD 699.5 billion by 2032, with a CAGR of 7.8% during 2024-2032. This growth is driven by the rising prevalence of chronic diseases, technological advancements, and the growing adoption of biosimilars[3].

Key Takeaways

• The GM-CSF market, including sargramostim, is expected to grow at a CAGR of 10.7% from 2024 to 2030.
• The market is driven by increasing demand for prophylaxis and strong research and development activities.
• High costs and adverse reactions are significant restraints.
• North America is expected to hold the highest market share.
• Sargramostim is used across various applications, including solid tumors, lymphoma, and kidney cancer.
• Economic evaluations highlight the cost-effectiveness of different GM-CSF regimens.

FAQs

What is the forecasted market size of the GM-CSF market by 2030?

The market size of the GM-CSF market is expected to reach USD 3.74 billion by 2030[1].

Which region is expected to hold the highest share in the GM-CSF market?

North America is expected to hold the highest share in the GM-CSF market[1].

What are the main applications of sargramostim?

Sargramostim is used in the treatment of solid tumors, lymphoma, kidney cancer, and certain lung diseases[1].

What are the significant restraints to the growth of the GM-CSF market?

The high cost of GM-CSF treatments and adverse reactions are significant restraints to the market growth[1][4].

What is the new indication approved for sargramostim by the FDA?

The FDA approved a new indication for sargramostim to increase survival in adult and pediatric patients acutely exposed to radiation, as a countermeasure for acute radiation syndrome[4][5].

Sources

1. Maximize Market Research: Granulocyte Macrophage Colony Stimulating Factor Market - 2030
2. PubMed: Economic evaluation of filgrastim, sargramostim, and sequential ...
3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled ...
4. Wikipedia: Sargramostim
5. FDA: Approval Package for: LEUKINE (sargramostim)