Number of pages: 100 | Report Format: PDF | Published date: March 29, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 561.2 million |
Revenue Forecast in 2031 |
US$ 745.1 million |
CAGR |
3.2% |
Base Year for Estimation |
2022 |
Forecast Period |
2023-2031 |
Historical Year |
2021 |
Segments Covered |
Drug Type, Indication, Distribution Channel, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global filgrastim market was valued at US$ 561.2 million in 2022 and is expected to register a revenue CAGR of 3.2% to reach US$ 745.1 million by 2031.
Filgrastim Market Fundamentals
Filgrastim is a drug used to treat neutropenia in patients with myelosuppression following chemotherapy or radiation, which raises the risk of infection and associated complications. The first short-acting recombinant methionyl human granulocyte colony-stimulating factor (G-CSF), filgrastim, was authorized in the U.S. in 1991. Since the original product’s release, long-acting variants such as pegfilgrastim and biosimilars with comparable indications have continued to be produced. As of 2018, the U.S. FDA has given filgrastim approval primarily for six indications: (1) decreasing the risk of infection and preventing febrile neutropenia in cancer patients receiving mesenchymal stem cells; (2) speeding up the recovery of neutrophils and shortening the duration of fever in patients with acute myeloid leukemia; (3) lessening the duration of neutropenia and neutropenia-related clinical sequelae in patients with non-myeloid malignancies receiving myeloablative chemotherapy followed by bone marrow transplantation; (4) mobilizing autologous hematopoietic progenitor cells into the peripheral blood for leukapheresis collection; (5) decreasing incidence and duration of severe neutropenia sequelae in symptomatic severe chronic neutropenia patients; and (6) enhancing the survival of patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). Since the patent for filgrastim has expired in recent years, various biosimilar filgrastim (Bio-F) products were developed, including Zarxio®, Granix®, and Nivestym®. These Bio-Filgrastims were developed to be clinically equivalent to their reference drug in terms of quality, safety, and efficacy.
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Filgrastim Market Dynamics
Cancer incidence has climbed globally, surpassing cardiovascular diseases as the second greatest cause of death. This phenomenon is caused by environmental variables such as cigarette use, altered dietary habits, urbanization, and prolonged post-reproductive lifetime. For instance, according to World Cancer Research Fund International, in 2020, there were estimated 18.1 million new cancer cases worldwide. About 9.3 million of these instances involved men, while 8.8 million involved women. For different cancers, chemotherapy is the first line of treatment. The number of cancer cases has risen, resulting in a significant increase in the use of chemotherapy as a treatment. Specific cancers and cancer treatments, such as chemotherapy, may increase the risk of infection. The reason for this is that they cause a reduction in the amount of white blood cells, which are crucial for combating sickness. There are times during chemotherapy when the patient is more susceptible to infection due to a particularly low level of white blood cells. Stress, poor diet, and insufficient sleep can all deteriorate the immune system, increasing the likelihood of infection. Therefore, the increased chemotherapy rates propelled the need for filgrastim.
The global industry is expected to benefit from the population’s growing cancer awareness. The rate of advancement in cancer treatment is accelerating. Emerging from the research and development pipeline are numerous novel treatments frequently combined with other brand-new or current medications. Numerous pharmaceutical companies are funding these revolutionary medication development projects to treat cancer. For instance, Pfizer purchased Array BioPharma in June 2019 to expand its oncology footprint and pipeline, starting with a melanoma combination medication that has been licensed and is currently testing for metastatic colorectal cancer. This is expected to accelerate market expansion, along with growing consumer desire for biosimilar and biologic products.
Biosimilars are a popular option for treating numerous chronic and uncommon diseases worldwide due to their affordability. Cost-effectiveness is, therefore, a key element driving up product demand in this market. A recent study claims that worldwide sales of follow-on biologics with indications for treating various malignancies, such as trastuzumab, rituximab, and bevacizumab, have been rising rapidly. The company also predicted that the adoption of these medications would result in global savings of about US$ 100 billion over the following 10 years. Another factor that supports the expansion of the filgrastim market is the loss of protection incidents that occur with respect to the original drug brands in the next years.
However, the revenue growth of the filgrastim market is likely to be constrained by stringent regulations imposed on biosimilar approvals. Different regions have varying regulations about the development and usage of biologics and biosimilars. Additionally, biosimilars manufacturers are prevented from commercializing legally sanctioned biosimilars due to problems like patent infringement or contract disputes. In contrast to Europe, where the European Medicines Agency approves biosimilars as interchangeable products for biologics, the U.S. Food and Drug Administration (FDA) restricts using biosimilars as interchangeable pharmaceuticals for biologics.
Filgrastim Market Ecosystem
The global filgrastim market is analyzed from four perspectives: drug type, indication, distribution channel, and region.
Filgrastim Market by Drug Type
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Based on the drug type, the global filgrastim market is segmented into biologic and biosimilar.
The biosimilar segment accounted for the largest revenue share of the global filgrastim market in 2022. Filgrastim biosimilars are biological substitutes designed to treat patients with bone marrow damage due to extremely high radiation doses in the same way that it aids cancer patients by encouraging the creation of white blood cells, making patients less susceptible to infections. Filgrastim biosimilars are a less expensive alternative to the original medicine, which is especially essential for patients in low- and middle-income countries who may not be able to afford pricey treatments. However, before being used, biosimilars must undergo rigorous testing and clinical studies to confirm their safety and efficacy. In the coming years, the market for filgrastim biosimilars is anticipated to be driven by government initiatives to develop biosimilars. Governments all over the world are concentrating on the development of biosimilars due to their affordability. The U.S. FDA introduced the Biosimilar Action Plan to expand therapeutic alternatives. The Australian Government is dedicated to the Biosimilar Awareness Initiative, and they strengthened their dedication by providing an AU$ 5 million grant to the Generic and Biosimilar Medicines Association to accept increased general biosimilar education and activities that support the appropriate prescribing, dispensing, and usage of biosimilar medicines. Thus, government incentives for biosimilar development contribute to increased production and awareness, which in turn helps to support the expansion of the market for filgrastim biosimilars.
Filgrastim Market by Indication
Based on the indication, the global filgrastim market is segmented into neutropenia, oncology, chronic and autoimmune diseases, blood disorders, infectious diseases, and others.
The neutropenia segment accounted for the largest revenue share of the global filgrastim market in 2022. This can be ascribed to the usage of filgrastim to treat neutropenia in patients undergoing chemotherapy or radiation therapy. These cancer treatments can cause a decrease in the production of white blood cells, including neutrophils, which can leave patients vulnerable to infections. Filgrastim works by stimulating the production of neutrophils in the bone marrow, which can help to prevent infections and reduce the risk of complications associated with chemotherapy or radiation therapy. As a result, filgrastim is an essential medication for cancer patients undergoing these treatments.
Filgrastim Market by Distribution Channel
Based on the distribution channel, the global filgrastim market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
The hospital pharmacies segment accounted for the largest revenue share of the global filgrastim market in 2022. Hospital pharmacies play a key role in cancer treatment and are important contributors to the revenue growth of the global market. Hospital pharmacies can provide patients with a greater range of medications, including biologics, that may not be available in other settings. This can help ensure that patients receive the best possible treatment for their conditions. Additionally, hospital pharmacies can work closely with other healthcare professionals to provide coordinated and tailored care for neutropenia patients. This can result in better treatment outcomes and patient satisfaction. These pharmacies may guide patients about their medications and how to properly take them, boosting medication adherence and minimizing the risk of poor effects. In addition, the hospital pharmacy may monitor patient medications and assist with side effects and other problems that may arise throughout therapy. This can help to ensure that patients receive the best care available and that treatment outcomes improve. Hospitals can also participate in clinical trials and other cancer-related research activities. This can aid in developing new drugs and therapies for the ailment, benefiting patients and boosting market revenue growth.
Filgrastim Market by Region
Based on the region, the global filgrastim market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for the largest revenue share of the global filgrastim market in 2022. Compared to global epidemiology, the incidence is higher in the U.S., where 2.4 to 15.4 instances per million people are reported annually. Moreover, the presence of industry titans, along with the newly launched advanced tools, a well-developed healthcare infrastructure, and payment coverage, are considered to drive the market’s high demand for sophisticated healthcare services in the area. Higher investments in drug discovery R&D, significant firms with established research infrastructure, and technical improvements can all be linked to the regional market’s revenue growth. Since outsourcing is no longer just about cutting costs, a growing need for effectiveness, quality, and innovation is anticipated to support industry expansion. The Asia Pacific region is projected to demonstrate the fastest CAGR during the forecast period. Due to the availability of skilled professionals, cheaper costs, a good regulatory environment, and high-quality data, the region is becoming a hotspot for outsourcing drug discovery activities.
Filgrastim Market Competitive Landscape
The introduction of novel therapeutics, obtaining approval for those products, and participating in other activities like awareness programs are some key development strategies that many organizations emphasize. Additionally, the market classified partnerships, acquisitions, and other collaborations as improved revenue growth strategies. Given the rising global market demand for filgrastim, these steps have increased the likelihood of having profitable revenue growth prospects in the future.
Notable market participants include:
Strategic Developments
Filgrastim is a recombinant version of the naturally occurring G-CSF that stimulates neutrophil production.
The rising awareness and new product launches are responsible for driving the global market.
Stringent regulations for product approval are the most important factor to restrict global market revenue growth.
Key companies operating the global filgrastim market are Abbott Laboratories, Amgen Inc., Apotex Inc., Cadila Pharmaceuticals, and Dr. Reddy’s Laboratories.
The global filgrastim market is expected to register growth at a revenue CAGR of 3.2% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain