Pegfilgrastim Biosimilars Market Size, Share, Trends & Forecast 2032

Pegfilgrastim Biosimilars Market Outlook

The rising prevalence of leukaemia has been driving the demand for Pegfilgrastim biosimilars. The number of leukaemia cases was 0.58 million in 2023. 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 2024-2032.

Pegfilgrastim Biosimilars: Introduction

Pegfilgrastim biosimilars are biologic medical products highly similar to the reference drug pegfilgrastim, used primarily to reduce the risk of infection in patients undergoing chemotherapy. Pegfilgrastim, a pegylated form of filgrastim, stimulates the production of white blood cells, enhancing the immune system's ability to combat infections. Biosimilars offer a cost-effective alternative to the original biologic, making this crucial therapy more accessible. As the market for pegfilgrastim biosimilars grows, it plays a significant role in oncology care, driven by increasing cancer incidences, the patent expiry of the reference product, and supportive regulatory environments fostering the development and adoption of biosimilars.

Key Trends in the Global Pegfilgrastim Biosimilars Market

The pegfilgrastim biosimilars market is witnessing dynamic growth, driven by several key trends that are reshaping the landscape of oncology treatments. As a cost-effective alternative to the reference biologic, pegfilgrastim biosimilars are becoming increasingly important in cancer care.

• Increasing Cancer Incidence: The rising global incidence of cancer is a primary driver for the demand for pegfilgrastim biosimilars. With chemotherapy being a common treatment, the need for supportive care medications like pegfilgrastim to manage neutropenia is growing significantly.
• Patent Expiries: The expiration of patents for original pegfilgrastim products has opened the market for biosimilars. This has led to increased competition among manufacturers, driving down prices and making treatments more affordable for patients.
• Regulatory Support and Approvals: Regulatory bodies worldwide, such as the FDA and EMA, are increasingly approving pegfilgrastim biosimilars, ensuring they meet stringent safety and efficacy standards. This regulatory support is facilitating the entry of new biosimilars into the market, enhancing their availability.
• Cost-effectiveness and Healthcare Savings: Pegfilgrastim biosimilars offer substantial cost savings compared to the reference product. This cost-effectiveness is crucial for healthcare systems aiming to reduce expenditure while maintaining high-quality care. Biosimilars help alleviate the financial burden on both patients and healthcare providers.
• Advancements in Biotechnology: Continuous advancements in biotechnology are improving the production and development processes of biosimilars. Enhanced manufacturing techniques are leading to higher quality biosimilars, ensuring they are as effective and safe as the original biologics.
• Strategic Collaborations and Partnerships: Pharmaceutical companies are increasingly engaging in strategic collaborations and partnerships to develop and market pegfilgrastim biosimilars. These alliances are accelerating the research and development process, leading to quicker market entry and broader distribution networks.
• Rising Awareness and Acceptance: There is growing awareness and acceptance of biosimilars among healthcare professionals and patients. Education campaigns and positive clinical experiences are enhancing confidence in the use of biosimilars, contributing to their increased adoption in clinical practice.
• These trends collectively highlight the evolving dynamics of the pegfilgrastim biosimilars market, underscoring its critical role in modern oncology care.

Pegfilgrastim Biosimilars Market Segmentation

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 Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

Pegfilgrastim Biosimilars Market Overview

The pegfilgrastim biosimilars market is poised for significant growth, driven by the increasing prevalence of cancer, the need for cost-effective treatment options, and advancements in biotechnology. Pegfilgrastim biosimilars, which are highly similar to the reference biologic pegfilgrastim, play a crucial role in managing chemotherapy-induced neutropenia, thereby reducing the risk of infections in cancer patients.

In North America, the pegfilgrastim biosimilars market is expanding rapidly due to the high incidence of cancer and the expiration of patents for original biologics. The United States, in particular, is witnessing a surge in the adoption of biosimilars, fueled by favorable regulatory policies from the FDA, which has approved several pegfilgrastim biosimilars. Additionally, the high healthcare expenditure in the region supports the adoption of cost-effective alternatives, further propelling market growth.

Europe also represents a significant market for pegfilgrastim biosimilars, driven by strong regulatory support and the presence of a well-established healthcare system. The European Medicines Agency (EMA) has been proactive in approving biosimilars, ensuring they meet stringent safety and efficacy standards. Countries like Germany, France, and the United Kingdom are leading the way in biosimilar adoption, driven by initiatives to reduce healthcare costs and improve patient access to essential medications.

The Asia Pacific region is emerging as a lucrative market for pegfilgrastim biosimilars, with countries like China, India, and Japan at the forefront. The increasing cancer burden in this region, coupled with the growing awareness and acceptance of biosimilars, is driving market growth. Additionally, government initiatives to promote the use of biosimilars and the presence of a large patient pool are significant factors contributing to the market expansion. The competitive landscape in the Asia Pacific is also marked by the presence of numerous local and international players investing in biosimilar development and manufacturing.

In Latin America, the pegfilgrastim biosimilars market is gaining momentum, driven by the rising incidence of cancer and the need for affordable treatment options. Countries like Brazil and Mexico are leading the region's market growth, supported by government policies aimed at reducing healthcare costs and improving access to essential medications. The market is also benefiting from the increasing presence of global pharmaceutical companies, which are expanding their biosimilar portfolios in the region.

The Middle East and Africa region presents a growing opportunity for the pegfilgrastim biosimilars market. The increasing prevalence of cancer and the need for cost-effective treatments are driving demand. Countries in the Gulf Cooperation Council (GCC), such as Saudi Arabia and the United Arab Emirates, are witnessing growing investments in healthcare infrastructure, which is facilitating the adoption of biosimilars. In Africa, the market is gradually expanding, with South Africa being a key market due to its relatively advanced healthcare system and regulatory framework.

Pegfilgrastim Biosimilars Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

·  Merck & Co., Inc.: Established in 1891, Merck & Co., Inc. is headquartered in Kenilworth, New Jersey, USA. It is a leading global biopharmaceutical company known for its extensive portfolio of innovative medicines, vaccines, biologic therapies, and animal health products. Merck's key products include cancer treatments such as Keytruda, vaccines like Gardasil, and diabetes medications like Januvia. The company is committed to research and development, driving advancements in various therapeutic areas including oncology, infectious diseases, and cardiometabolic disorders. Merck's dedication to improving health and well-being is reflected in its robust pipeline and strategic collaborations.

·  Zydus Lifesciences Limited: Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, was established in 1952 and is headquartered in Ahmedabad, India. It is one of India's leading pharmaceutical companies with a diverse portfolio spanning generics, specialty pharmaceuticals, biosimilars, and vaccines. Key products include Lipaglyn, the world’s first drug for treating diabetic dyslipidemia, and Exemptia, a biosimilar of Adalimumab. Zydus is known for its strong emphasis on research and development, with multiple state-of-the-art facilities and a robust pipeline focused on areas like cardiology, gastroenterology, and oncology.

·  Ratiopharm GmbH: Established in 1974, Ratiopharm GmbH is headquartered in Ulm, Germany. It is a leading European pharmaceutical company specializing in the production of high-quality generic medicines. Ratiopharm's portfolio includes a wide range of generics covering therapeutic areas such as pain management, cardiovascular health, and respiratory diseases. The company is part of the Teva Pharmaceutical Industries group, benefiting from a global network and extensive research capabilities. Ratiopharm is committed to making healthcare more accessible and affordable through its cost-effective and reliable generic drugs.

·  Jiangsu Hengrui Pharmaceuticals Co. Ltd: Established in 1970, Jiangsu Hengrui Pharmaceuticals Co., Ltd. is headquartered in Lianyungang, China. It is one of China's largest and most innovative pharmaceutical companies, known for its comprehensive portfolio that includes oncology, anesthesia, cardiovascular, and anti-infective drugs. Key products include Camrelizumab, a PD-1 inhibitor, and Apatinib, a targeted cancer therapy. Jiangsu Hengrui places a strong emphasis on research and development, with a focus on discovering and developing novel therapeutics. The company is expanding its global presence through strategic partnerships and an increasing pipeline of innovative drugs.

·  Biocon Limited: Founded in 1978, Biocon Limited is headquartered in Bangalore, India. It is a leading global biopharmaceutical company known for its innovative and affordable biologics, biosimilars, and generic formulations. Biocon's key products include biosimilars such as Trastuzumab, Pegfilgrastim, and Insulin Glargine. The company is dedicated to high-quality research and development, with a strong focus on chronic disease areas like diabetes, oncology, and autoimmune conditions. Biocon's mission is to make healthcare more accessible through innovation and cost-effective solutions, with a significant presence in both developed and emerging markets.

Other key players in the market include Dr. Reddy's Laboratories Ltd, Pfizer Inc., Emcure Pharmaceuticals Limited, USV Private Limited, Apotex Pty Ltd, Kyowa Kirin Co., Ltd., Lupin Limited