The healthcare landscape is constantly evolving, with new treatments and therapeutic alternatives emerging to meet the needs of patients worldwide. Among these advancements, the rise of biosimilars—biological products that are highly similar to already-approved reference biologics—has become a crucial component of expanding access to life-saving treatments. Pegfilgrastim, a critical biologic used to treat neutropenia (low white blood cell count), primarily in leukaemia patients, is one such biologic for which biosimilars are gaining significant attention.
Pegfilgrastim biosimilars offer an affordable alternative to the original branded product, Neulasta, manufactured by Amgen. These biosimilars are poised to make a meaningful impact on global healthcare systems, especially as the prevalence of leukaemia continues to rise, driving the demand for affordable treatment options.
In this blog, we will explore the growing demand for Pegfilgrastim biosimilars, key players in the market, and the competitive landscape, while also providing an outlook on the market’s future growth prospects.
The Prevalence of Leukaemia and the Demand for Pegfilgrastim Biosimilars
Leukaemia, a type of cancer that affects the blood and bone marrow, is one of the most common forms of cancer diagnosed globally. According to the World Health Organization (WHO), there were approximately 0.58 million new cases of leukaemia worldwide in 2023. This growing number of diagnoses is straining healthcare systems, particularly in regions with limited access to advanced cancer treatments.
A significant side effect of many chemotherapy treatments used for leukaemia is neutropenia, a condition in which the number of white blood cells is reduced, leaving patients vulnerable to infections. Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) that helps stimulate the production of neutrophils, thus reducing the risk of infection during chemotherapy.
As leukaemia cases increase globally, so does the need for Pegfilgrastim. However, the high cost of branded biologic drugs like Neulasta presents a barrier to access for many patients, particularly in lower-income regions. This is where biosimilars come in. Pegfilgrastim biosimilars, which offer comparable efficacy and safety profiles at a fraction of the cost, are emerging as a crucial solution to this problem.
Market Growth Drivers and Dynamics
1. Increasing Leukaemia Incidence
The rising number of leukaemia cases worldwide is a significant driver for the growing demand for Pegfilgrastim biosimilars. As the global population ages, the incidence of leukaemia, particularly in elderly patients, is expected to continue increasing. This demographic shift is directly contributing to the surge in demand for drugs like Pegfilgrastim.
2. Patent Expirations and Cost Savings
The expiration of patents for branded biologics like Neulasta is opening the door for biosimilars. As the market for the original drug becomes more competitive, biosimilar manufacturers can step in with lower-cost alternatives. The affordability of biosimilars is crucial for expanding access to life-saving treatments, especially in emerging markets.
3. Regulatory Support
Governments and regulatory bodies around the world are increasingly supporting the development and approval of biosimilars, recognising their potential to reduce healthcare costs and improve access to essential therapies. In the United States, for example, the FDA has streamlined the approval process for biosimilars, which has led to more rapid market entry for these products.
4. Healthcare Cost Pressure
With the rising cost of healthcare, especially in developed countries, there is an urgent need to reduce spending on expensive biologic treatments. Pegfilgrastim biosimilars provide an economically viable solution to this challenge, offering patients the same clinical benefits at a significantly lower price point.
Competitive Landscape: Key Players in the Pegfilgrastim Biosimilars Market
Several pharmaceutical companies are vying for market share in the Pegfilgrastim biosimilars space. The key players in this market include both established pharmaceutical giants and emerging biosimilar developers. Below are some of the leading companies involved in the production and distribution of Pegfilgrastim biosimilars:
1. Merck & Co., Inc.
Merck is a global leader in pharmaceuticals, and its biosimilar division has been expanding rapidly. The company’s involvement in the Pegfilgrastim biosimilars market is part of its broader strategy to enhance its oncology portfolio and address the growing need for affordable cancer treatments.
2. Zydus Lifesciences Limited
India-based Zydus Lifesciences is a significant player in the global biosimilars market. With a focus on affordable and accessible therapies, Zydus has developed multiple biosimilars, including Pegfilgrastim. The company is leveraging its strong manufacturing capabilities and international presence to strengthen its position in the market.
3. Ratiopharm GmbH
A subsidiary of Teva Pharmaceutical Industries, Ratiopharm is a well-established name in the biosimilars market. Its Pegfilgrastim biosimilar is part of its broad portfolio of high-quality, cost-effective alternatives to branded biologics.
4. Jiangsu Hengrui Pharmaceuticals Co., Ltd.
A leading Chinese pharmaceutical company, Hengrui Pharmaceuticals has made significant strides in biosimilars, particularly in oncology. The company’s Pegfilgrastim biosimilar is gaining traction in markets across Asia and other regions.
5. Biocon Limited
Biocon is one of India’s largest biopharmaceutical companies and a key player in the global biosimilars market. The company’s expertise in biosimilars, including Pegfilgrastim, has made it a prominent player in both developed and emerging markets.
6. Dr. Reddy’s Laboratories Ltd.
India-based Dr. Reddy’s Laboratories has a robust portfolio of biosimilars, including Pegfilgrastim. The company’s competitive pricing and strategic partnerships have enabled it to gain a significant foothold in international markets.
7. Pfizer Inc.
As a major player in the global pharmaceutical industry, Pfizer has made significant investments in biosimilars, with Pegfilgrastim being a key part of its oncology biosimilars portfolio. The company is leveraging its global distribution network to expand the reach of its products.
8. Emcure Pharmaceuticals Limited
Emcure Pharmaceuticals, based in India, has been a prominent player in the global biosimilars market, offering affordable treatments for a range of diseases, including cancer. Its Pegfilgrastim biosimilar is well-regarded in several international markets.
9. USV Private Limited
USV Private Limited, another Indian pharmaceutical company, has ventured into the biosimilars market with Pegfilgrastim as one of its key products. The company is focused on bringing affordable, high-quality biosimilars to market.
10. Apotex Pty Ltd
Apotex is a global leader in generic pharmaceuticals, and its biosimilars division is growing rapidly. The company’s Pegfilgrastim biosimilar is gaining approval in various international markets, providing cost-effective treatment options to cancer patients.
11. Kyowa Kirin Co., Ltd.
Japan-based Kyowa Kirin is a leader in biologics and biosimilars, with a focus on oncology. The company’s Pegfilgrastim biosimilar is an important part of its biosimilar portfolio.
12. Lupin Limited
Lupin, another leading Indian pharmaceutical company, has a growing biosimilars portfolio. The company’s focus on oncology biosimilars, including Pegfilgrastim, positions it for success in the global market.
Market Outlook: Forecast 2024-2032
The Pegfilgrastim biosimilars market is expected to grow at a compound annual growth rate (CAGR) of 7% between 2024 and 2032. This growth is driven by the factors mentioned above, including the rising incidence of leukaemia, patent expirations, and increasing healthcare cost pressures.
Regions like North America, Europe, and Asia-Pacific are expected to witness significant growth due to both the high demand for affordable cancer treatments and the regulatory push for biosimilars. Emerging markets in Latin America and Africa will also play a crucial role in the expansion of Pegfilgrastim biosimilars, as more governments and healthcare systems recognise the value of biosimilars in addressing treatment gaps.
