| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2019-2022 |
| Base Year |
2023 |
| Forecast Period |
2024-2032 |
| Pegfilgrastim Biosimilars Market Size 2024 |
USD 1,683 Million |
| Pegfilgrastim Biosimilars Market, CAGR |
8.7% |
| Pegfilgrastim Biosimilars Market Size 2032 |
USD 3,280.35 Million |
Market Overview:
The Pegfilgrastim Biosimilars Market is projected to grow from USD 1,683 million in 2024 to USD 3,280.35 million by 2032, with a compound annual growth rate (CAGR) of 8.7% during the forecast period. Pegfilgrastim biosimilars are biologic drugs that stimulate white blood cell production, primarily used to reduce infection risk in cancer patients undergoing chemotherapy. The increasing prevalence of cancer, rising healthcare costs, and the growing demand for cost-effective treatment options are key factors driving the market’s expansion. Additionally, the patent expiry of branded pegfilgrastim drugs has opened the market for biosimilars, further propelling market growth.
Several factors drive the growth of the Pegfilgrastim Biosimilars Market. The rising global incidence of cancer has increased the demand for effective treatments, particularly for chemotherapy-induced neutropenia, where pegfilgrastim plays a critical role. Biosimilars offer a more affordable alternative to branded biologics, enabling broader patient access, particularly in emerging markets. Regulatory support for biosimilars from agencies like the European Medicines Agency (EMA) and the U.S. FDA has also facilitated market entry and adoption. Moreover, the ongoing focus on reducing healthcare costs in developed and developing countries has encouraged the use of pegfilgrastim biosimilars in treatment protocols.
North America holds a significant share of the pegfilgrastim biosimilars market, driven by high cancer prevalence, strong regulatory support, and the presence of key players in the region. Europe follows closely, with countries like Germany and the UK adopting biosimilars as cost-effective solutions for healthcare systems. The Asia-Pacific region is expected to witness the fastest growth due to increasing cancer rates and the growing acceptance of biosimilars in countries such as China and India. Expanding healthcare infrastructure and favorable government policies in these regions further support market growth.
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Market Drivers:
Rising Incidence of Cancer:
The increasing global incidence of cancer is one of the primary drivers of the Pegfilgrastim Biosimilars Market. With more patients undergoing chemotherapy, the demand for pegfilgrastim biosimilars to treat chemotherapy-induced neutropenia is rising. For instance, according to the World Health Organization (WHO), cancer remains a leading cause of death worldwide, with approximately 19.3 million new cases and 10 million cancer-related deaths in 2020. The need for supportive care therapies like pegfilgrastim biosimilars, which help restore white blood cell counts, is therefore becoming more critical in oncology care.
Patent Expiry of Branded Pegfilgrastim:
Another significant factor driving the growth of the market is the patent expiration of branded pegfilgrastim, such as Neulasta. As patents for these drugs expire, biosimilar versions are entering the market, offering more affordable alternatives to the original biologics. For instance, Coherus BioSciences and Mylan have both launched biosimilar versions of pegfilgrastim, providing cost-effective options for patients and healthcare systems. This growing competition in the market has resulted in increased access to pegfilgrastim for patients, particularly in cost-sensitive regions.
Increasing Focus on Reducing Healthcare Costs:
The rising focus on reducing healthcare costs is a key driver for the adoption of pegfilgrastim biosimilars. Governments and healthcare providers are seeking ways to lower expenditures on expensive biologic drugs while maintaining quality of care. For instance, the European Medicines Agency (EMA) and the U.S. FDA have established regulatory pathways that support the approval of biosimilars, encouraging their use in healthcare systems. Biosimilars, including pegfilgrastim, can reduce treatment costs by 15% to 30%, making them attractive options for healthcare providers.
Growing Acceptance of Biosimilars in Emerging Markets:
Emerging markets, particularly in Asia-Pacific and Latin America, are increasingly accepting biosimilars due to their cost-effectiveness and efficacy. For example, countries like India and China have implemented supportive policies and regulatory frameworks to promote biosimilar adoption. These countries are seeing growing use of pegfilgrastim biosimilars in cancer care as healthcare infrastructure expands, further driving market growth.
Market Trends:
Increasing Approval and Launch of Biosimilars:
One of the most prominent trends in the Pegfilgrastim Biosimilars Market is the rising number of regulatory approvals and product launches. Over the past few years, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-tracked the approval of pegfilgrastim biosimilars to increase access to affordable cancer care. For instance, in 2022, Mylan and Biocon launched Fulphila, a biosimilar to Neulasta, in several countries after receiving FDA approval. This ongoing wave of biosimilar approvals reflects the growing confidence of healthcare authorities in the safety and efficacy of biosimilars.
Increased Focus on Subcutaneous Delivery:
Another emerging trend is the increasing use of subcutaneous delivery for pegfilgrastim biosimilars. With patient comfort and convenience becoming priorities, healthcare providers are opting for subcutaneous injections, which are less invasive and easier to administer. For example, companies such as Sandoz and Coherus BioSciences are developing biosimilar versions of pegfilgrastim with subcutaneous administration options, making it more convenient for patients to receive treatment at home or in outpatient settings. This trend is expected to enhance treatment adherence and overall patient satisfaction.
Adoption of Biosimilars in Oncology Supportive Care:
The use of biosimilars in oncology supportive care is on the rise, particularly as healthcare systems aim to provide cost-effective treatments for cancer patients. Biosimilars are increasingly recognized as safe and effective alternatives to expensive biologics in managing chemotherapy-induced neutropenia, with pegfilgrastim being a key therapeutic. For instance, EMA guidelines support the use of biosimilars in oncology, citing similar efficacy and safety profiles to their reference biologics. This shift is increasing the adoption of pegfilgrastim biosimilars as part of standard care protocols in cancer treatment.
Global Expansion and Strategic Partnerships:
The expansion of pegfilgrastim biosimilars is also being fueled by global partnerships between pharmaceutical companies. Collaborations between manufacturers in developed markets and local players in emerging regions are driving biosimilar availability across the globe. For example, Mylan partnered with Biocon to expand its biosimilar portfolio in Asia and Europe, capitalizing on local market expertise to increase accessibility. These strategic alliances help biosimilar manufacturers overcome regulatory hurdles and meet the growing demand for affordable cancer treatments.
Market Challenges Analysis:
High Development and Manufacturing Costs:
One of the key restraints in the Pegfilgrastim Biosimilars Market is the high cost of development and manufacturing. Biosimilars, unlike generic drugs, require extensive clinical trials to demonstrate their efficacy, safety, and similarity to the reference biologic. These trials are costly and time-consuming, leading to high development expenses. Moreover, the manufacturing of biosimilars requires advanced biotechnological processes and significant investment in state-of-the-art production facilities. As a result, despite being more affordable than biologics, biosimilars like pegfilgrastim still face considerable price pressures.
Stringent Regulatory Hurdles:
Another major challenge is navigating complex regulatory requirements in different regions. While agencies like the FDA and EMA have streamlined approval processes for biosimilars, manufacturers must meet stringent standards for demonstrating similarity to the reference biologic. This includes extensive testing for immunogenicity, efficacy, and safety, which adds time and cost to the development process. Additionally, navigating regulatory differences between regions can delay market entry and limit the availability of biosimilars in certain markets.
Market Penetration and Physician Acceptance:
Achieving widespread market penetration for pegfilgrastim biosimilars can be challenging due to physician hesitancy. Many healthcare providers remain cautious about switching patients from established biologics to newer biosimilars, particularly in oncology, where patient safety is paramount. Physicians may prefer to continue using branded biologics like Neulasta due to familiarity and confidence in long-term outcomes. Overcoming this hesitancy requires continuous education and real-world evidence demonstrating the effectiveness and safety of biosimilars.
Pricing Pressure and Competition:
Finally, the pricing pressure from both branded biologics and competing biosimilars can be intense. While biosimilars offer cost savings, they are still subject to competition from multiple manufacturers offering similar products. As more biosimilars enter the market, manufacturers face pressure to lower prices, which can impact profitability and limit their ability to recoup development costs.
Market Segmentation Analysis:
By Type
The Pegfilgrastim Biosimilars Market is segmented by type into single-dose vials and prefilled syringes/auto-injectors. Single-dose vials are traditionally used in clinical settings, where healthcare providers administer pegfilgrastim in a controlled environment. However, prefilled syringes and auto-injectors are gaining traction due to their convenience and ease of use, allowing patients to self-administer the drug at home. This shift towards patient-centric care is driving the demand for prefilled syringes, especially in developed markets where home-based treatments are becoming more common.
By Technology
In terms of technology, the market is divided into recombinant DNA technology and protein production technology. Recombinant DNA technology is the predominant method used to manufacture biosimilars, including pegfilgrastim, as it allows for the replication of biologic drugs at a lower cost while maintaining efficacy. Protein production technology, which focuses on optimizing the expression and stability of therapeutic proteins, is also gaining importance as manufacturers seek to improve the efficiency and consistency of biosimilar production.
By End User
The market is segmented by end user into hospitals, clinics, and homecare settings. Hospitals hold the largest share of the market, as pegfilgrastim is primarily administered in these settings to manage chemotherapy-induced neutropenia. However, homecare settings are rapidly emerging as a key segment, driven by the increasing use of prefilled syringes and the growing trend toward outpatient and self-administered treatments. This shift is expected to expand access to pegfilgrastim biosimilars, particularly in regions with advanced healthcare infrastructure.
Segmentations:
By Application:
- Chemotherapy Treatment
- Transplantation
By Distribution Channel:
- Hospital Pharmacies
- Retail Pharmacies
- Mail Order/Online Pharmacies
By Region:
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- South-east Asia
- Rest of Asia Pacific
- Latin America
- Brazil
- Argentina
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of the Middle East and Africa
Regional Analysis:
North America
North America holds the largest share of the Pegfilgrastim Biosimilars Market, accounting for approximately 40% of the global market. This dominance is primarily driven by the region’s advanced healthcare infrastructure, high cancer incidence rates, and favorable regulatory environment for biosimilars. The U.S. is the major contributor to this growth, supported by the U.S. Food and Drug Administration (FDA)‘s streamlined approval processes for biosimilars. For instance, the FDA has approved several pegfilgrastim biosimilars in recent years, including Coherus BioSciences’ Udenyca and Mylan’s Fulphila, which have been well-received by the healthcare industry. The growing focus on reducing healthcare costs and expanding patient access to affordable cancer treatments further drives biosimilar adoption in the region.
Europe
Europe accounts for approximately 30% of the market share, with countries like Germany, France, and the UK leading the region in biosimilar adoption. The European Medicines Agency (EMA) has established a robust regulatory framework that encourages the development and approval of biosimilars, including pegfilgrastim. For example, Sandoz’s Ziextenzo and Accord Healthcare’s Pelgraz have been approved and are widely used across European healthcare systems. The focus on cost-effective healthcare solutions and the growing acceptance of biosimilars among physicians and healthcare providers are key factors driving the market in Europe. Additionally, European countries have implemented incentives and reimbursement policies to promote biosimilar use, further strengthening their market position.
Asia-Pacific
The Asia-Pacific region is expected to witness the fastest growth, holding approximately 20% of the global market share. Rapidly growing cancer rates, increasing healthcare infrastructure, and the rising acceptance of biosimilars are key factors driving growth in countries such as China, India, and Japan. China and India, in particular, are seeing significant growth due to their large populations and government initiatives that support the development of biosimilars as cost-effective alternatives to branded biologics. Local companies like Dr. Reddy’s Laboratories and Biocon are emerging as key players, driving market expansion. The region’s improving regulatory landscape and the growing focus on healthcare affordability are expected to fuel continued growth.
Latin America and Middle East & Africa
Latin America and the Middle East & Africa collectively hold a smaller share of around 10% of the global market. In Latin America, countries like Brazil and Mexico are leading the adoption of pegfilgrastim biosimilars as part of broader efforts to improve access to affordable healthcare. Similarly, the Middle East is witnessing increased biosimilar adoption, particularly in Saudi Arabia and the United Arab Emirates, where governments are investing in expanding cancer care infrastructure. However, the market in these regions faces challenges related to regulatory barriers and limited healthcare infrastructure, which may slow growth compared to more developed regions.
Key Player Analysis:
Top Key Players
- Coherus BioSciences, Inc.
- Mylan N.V. (now part of Viatris)
- Biocon Limited
- Sandoz (a Novartis division)
- Reddy’s Laboratories Ltd.
- Pfizer Inc.
- Fresenius Kabi
- Amgen Inc. (reference product Neulasta)
- Apotex Inc.
- Intas Pharmaceuticals Ltd.
Competitive Analysis:
The Pegfilgrastim Biosimilars Market is highly competitive, with several key players vying for market share by offering cost-effective alternatives to branded pegfilgrastim products. Companies like Coherus BioSciences, Mylan (Viatris), and Sandoz lead the market through strategic product launches, regulatory approvals, and strong distribution networks across key regions. For example, Coherus’ Udenyca and Mylan’s Fulphila have gained significant market traction following their approval by the FDA, offering affordable options for patients undergoing chemotherapy. Biocon and Dr. Reddy’s Laboratories are also prominent players, focusing on emerging markets with growing demand for biosimilars. The competition is driven by factors such as pricing strategies, regulatory pathways, and partnerships aimed at increasing accessibility to biosimilars globally. As more biosimilars enter the market, competition is expected to intensify, with companies seeking to differentiate through pricing, patient support programs, and clinical evidence supporting the safety and efficacy of their products.
Recent Developments:
- In March 2023, Coherus BioSciences introduced a new UDENYCA® autoinjector for pegfilgrastim, expanding its portfolio to offer more convenient, patient-friendly options. The autoinjector enables self-administration and reduces the need for clinic visits, meeting the growing demand for home-based cancer care.
- In 2022 Mylan and Biocon continued to gain traction with their pegfilgrastim biosimilar, Fulphila, which was the first FDA-approved biosimilar to Neulasta. Their strategic partnership allows expanded access to more affordable cancer treatments across the U.S., Europe, and emerging markets.
- In 2023, Fresenius Kabi submitted an application to the FDA for its pegfilgrastim biosimilar. This move reflects the company’s ambition to strengthen its presence in the U.S. biosimilars market, following its success with other biosimilars in oncology.
- In December 2023, Coherus gained FDA approval for UDENYCA ONBODY™, an on-body injector for pegfilgrastim, designed to provide patients with a cutting-edge, convenient delivery system similar to the Neulasta Onpro device.
Market Concentration & Characteristics:
The Pegfilgrastim Biosimilars Market is moderately concentrated, with a few major players holding significant market share. Companies like Coherus BioSciences, Mylan (Viatris), Biocon, and Sandoz dominate the landscape through strong regulatory approvals, robust distribution networks, and strategic partnerships. These companies are actively engaged in expanding their product portfolios, including innovative delivery systems such as autoinjectors and on-body injectors, which improve patient convenience and enhance market competitiveness. The market is characterized by intense competition driven by the need for cost-effective cancer treatments, along with growing physician and patient acceptance of biosimilars as viable alternatives to biologics. As more biosimilars enter the market, smaller companies are also finding opportunities, particularly in emerging markets, where demand for affordable cancer care is rising rapidly.
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Report Coverage:
The research report offers an in-depth analysis based on Application, Distribution Channel, and Region. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook:
- The Pegfilgrastim Biosimilars Market will see increasing global adoption as biosimilars offer cost-effective alternatives to branded biologics, particularly in oncology supportive care.
- Rising cancer incidence globally will drive higher demand for pegfilgrastim biosimilars, especially as they become essential in chemotherapy-induced neutropenia management.
- Continued FDA and EMA approvals will boost market penetration, with more biosimilars being approved and launched globally.
- Innovations in delivery systems, such as autoinjectors and on-body injectors, will enhance patient convenience and support the shift toward home-based care.
- Emerging markets, particularly in Asia-Pacific and Latin America, will experience accelerated growth due to increased biosimilar accessibility and expanding healthcare infrastructure.
- Partnerships between global biosimilar manufacturers and local companies will expand market reach, particularly in cost-sensitive regions.
- Physician and patient confidence in the efficacy and safety of biosimilars will continue to improve, driving broader acceptance.
- Ongoing price competition among biosimilar manufacturers will contribute to reduced healthcare costs, making cancer treatment more affordable.
- Governments will increasingly support biosimilars through reimbursement policies and initiatives aimed at improving access to affordable cancer treatments.
- Companies will invest heavily in real-world evidence to demonstrate the long-term efficacy and safety of pegfilgrastim biosimilars, further supporting market growth.
