Global Pegfilgrastim Biosimilars Market Share, Size, Analysis, Forecast: By Indication Type: Neutropenia, Hematopoietic Subsyndrome, Others; By Product Type: MK-6302, PEG – GCSF, PEG Neutrogena, Grasustek, LA-EP2006, R-TPR-029, Filgrastim, Others; By Application; Market Dynamics; Regional Analysis; Supplier Landscape; 2023-2031

Global Pegfilgrastim Biosimilars Outlook

The rising prevalence of leukaemia has been driving the demand for Pegfilgrastim biosimilars. The number of leukaemia cases was 0.54 million in 2022. With the alarming rise in the leukaemia cases, the global Pegfilgrastim biosimilars market is likely to grow at a CAGR of 7% during the forecast period of 2023-2031.

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Pegfilgrastim Biosimilars: Insights, Mechanism of Action, and Uses

Pegfilgrastim biosimilar is the PEGlyated form of filgrastim, a recombinant human granulocyte stimulating factor (GSF). It is mainly used to increase the production of neutrophils or white blood cells. Amgen originally developed this medication under the brand name Neulasta. It stimulates the bone marrow to make more neutrophils, which will help fight infections in patients suffering from immune systems attacking disorders.

Pegfilgrastim has been approved in the United States, United Kingdom, and Australia since 2002. There are a significant number of Pegfilgrastim biosimilars approved by the regulatory authorities. Biosimilars have become an effective treatment option due to their reasonable costs and effective clinical management parameters.

Fulphila, Pelmeg, Pegex, and Nyvepria are some of the approved biosimilars for the Pegfilgrastim drug. With the advent of extensive research and studies, the new biosimilars are expected to enter the market and facilitate the market growth.

The drug also has some adverse effects, including dizziness, vomiting, joint discomfort, hair loss, and chest pain. The World Health Organization has also included Pegfilgrastim under the Emergency Medicines list and considered it safe and effective.

According to the Pegfilgrastim biosimilars market research report, the market can be categorised into the following segments:

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Market Breakup by Indication Type

• Neutropenia

• Hematopoietic Subsyndrome

• Others

Market Breakup by Product Type

• MK-6302

• Peg G-CSF

• PEG Neutrogena

• Grasustek

• LA-EP2006

• R-TPR-029

• Filgrastim

• PEG-GCSF

• Others

Market Breakup by Application

• Chemotherapy Induced Neutropenia

• Transplantation

• Others

Market Breakup by Distribution Channel

• Hospital Based Pharmacies

• Online Pharmacies

• Retail Pharmacies

Market Breakup by Region

• North America
  • United States of America
  • Canada
• Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Others
• Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

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Increasing Prevalence of Cancer to be Leading Driver for the Pegfilgrastim Biosimilars Market

The emerging Pegfilgrastim biosimilars seem promising in commercial aspects. Key market leaders will be the biosimilars companies that will provide fast and effective treatment for debilitating diseases. 

Increasing Prevalence of Cancer

The growth of the Pegfilgrastim biosimilars market is driven by the increasing prevalence of the immune weakening disorders, like cancer and AIDS, among others. According to the International Agency for Research on Cancer, 1 out of 5 people is diagnosed with cancer in their lifetime all over the world.

The incidence of cancer increases with age, and hence, with the rising geriatric population, the demand for the product also increases.

More Expenditure in the R&D Sector

The research and developmental activities have tremendously increased in the biosimilars sector. The key players are investing in research and development to get a market breakthrough by discovering novel Pegfilgrastim biosimilars. This will propel the expansion of the market further. For example, a biosimilar drug being developed by Fresenius Kabi, if approved, is expected to generate massive revenue for the company.

Additional factors, such as the low cost of biosimilars, greater awareness, and increased healthcare expenditure, are projected to drive the market growth forward.

Hospital-based pharmacies are expected to hold a significant share of the Pegfilgrastim biosimilars market. This is due to the drug's application in chronic disorders requiring hospital admissions.

North America and Europe to be the Fastest Growing Regions

North America is anticipated to demonstrate growth at the highest rate, while Europe’s regional market is projected to have the largest share in the global market. This is due to the rise in cancer prevalence and developed healthcare facilities in the region. The rapid increase in the number of cancer cases is likely to facilitate the demand the drug in the coming years across the globe.

Therapeutic Landscape

Pegfilgrastim biosimilar is used for the management of autoimmune or immune weakening disorders. This medication alters the body’s mechanism by increasing the concentration of neutrophils. This boosts immunity and helps to fight foreign agents.

This medication also plays an essential role in reducing the chances of infection in people who have cancer or those receiving chemotherapy medications. Thus, the cancer segment is projected to witness a substantial market share in the Pegfilgrastim biosimilars.

Pegfilgrastim is also recommended for saving patients exposed to myelosuppressive radiations, which can cause life-threatening damage to bone marrow. Neulasta also decreases the incidence of neutropenia and non-myeloid malignancies.

The biosimilar is eliminated from the body through renal clearance and neutrophil-mediated clearance. However, pegylation of filgrastim makes renal clearance insignificant. Pegfilgrastim biosimilar exhibits non-linear pharmacokinetics, that is, with the increase in dose, the clearance of Pegfilgrastim biosimilar decreases.

With extensive research and development, novel biosimilars are also being discovered for various therapeutic indications. Hence, incorporating these biosimilars in novel therapeutic areas will add to the Pegfilgrastim biosimilars market size.

Clinical Trial Landscape

The expiry of the patent of the original Pegfilgrastim raised concerns about the discovery of new biosimilars. Scientists and researchers initiated clinical trials for new drug products that can be used to discover Pegfilgrastim biosimilars. 

In clinical trials, the biosimilars are compared with the standard European Pegfilgrastim, United States Pegfilgrastim, or both. The pharmacodynamic and pharmacokinetic studies are compared to assess the clinical efficacy of the discovered products.

Novel Approved Pegfilgrastim Biosimilars

In 2022, the FDA approved a new biosimilar, Fylnetra, with the same clinical indications as Neulasta. In clinical trials, the common adverse effects were reported under the excepted criteria and are still under post-marketing surveillance.

In 2018, the FDA approved Udencya, a Pegfilgrastim biosimilar, for the management of neutropenia. During clinical trials, it demonstrated efficient results with minimal adverse effects.

The invention and development of novel biosimilars are essential to delivering a potent and cost-effective therapy. Thus, these economic benefits will help augment the better accessibility of healthcare services. The new targeted Pegfilgrastim biosimilar therapies will push the development of the market during the forecast period.

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the Pegfilgrastim biosimilars market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:

• Merck & Co., Inc.

• Zydus Lifesciences Limited

• Ratiopharm GmbH

• Jiangsu Hengrui Pharmaceuticals Co. Ltd

• Biocon Limited

• Dr. Reddy's Laboratories Ltd

• Pfizer Inc.

• Emcure Pharmaceuticals Limited

• USV Private Limited

• Apotex Pty Ltd

• Kyowa Kirin Co., Ltd.

• Lupin Limited

Key Highlights of the Report

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.