Oncology Biosimilars Market

The oncology biosimilars market was valued at US$ 10.67 billion in 2024 and is expected to grow to US$ 24.71 billion by 2031, with a projected CAGR of 12.8% from 2025 to 2031.

Market Insights and Analyst View:

Biosimilars are biopharmaceutical products that closely mimic existing reference biologic drugs in terms of safety, efficacy, and quality, though they are not identical. Available biosimilars include monoclonal antibodies and supportive agents like filgrastim, pegfilgrastim, epoetin α, and epoetin ζ, which are used to treat various cancers. The market is driven by factors such as an increase in cancer incidence, the cost-effectiveness of biosimilar drugs, and a rise in oncology biosimilar approvals. Furthermore, collaborations among manufacturers for biosimilars and clinical trials are expected to introduce new trends in the oncology biosimilars market in the coming years. However, high manufacturing costs and complexities in producing biosimilars pose challenges to market growth.

Oncology Biosimilars Market Size and Share - Market Drivers:

According to the World Health Organization (WHO), approximately 20 million new cancer cases and 9.7 million cancer-related deaths were reported globally in 2022. The latest estimates from WHO’s Global Cancer Observatory indicate that 10 different types of cancer accounted for about two-thirds of new cases and deaths worldwide in 2022. Lung cancer was the most prevalent, with 2.5 million new cases, representing 12.4% of the total. Female breast cancer followed with 2.3 million cases (11.6%), and colorectal cancer accounted for 9.6% of new cases. Prostate cancer and stomach cancer ranked fourth and fifth, with 1.5 million and 970,000 cases, respectively. The introduction of more affordable oncology biosimilars can alleviate healthcare costs and enhance access to effective cancer treatments due to their proven safety and efficacy in real-world settings, supported by clinical evidence and physicochemical quality data. For example, a study published by the Multidisciplinary Digital Publishing Institute (MDPI) in July 2023 compared the safety profiles of biosimilar monoclonal antibodies (mAbs) used in cancer with their reference counterparts, concluding that there were no significant differences in safety between biosimilars like bevacizumab, trastuzumab, and rituximab and their originators. This supports the use of biosimilars as viable alternatives to biologic originators. Consequently, the increasing cancer burden and rising mortality rates necessitate affordable treatment options, thereby driving the growth of the oncology biosimilars market.

Strategic Insights

Segmentation and Scope:

The Oncology Biosimilars Market Analysis and Forecast to 2030 is a detailed study focusing on global market dynamics to identify key drivers, future trends, and lucrative opportunities that can help pinpoint major revenue pockets. The report provides an overview of the market with detailed segmentation based on drug class, cancer type, and distribution channel. It also includes a thorough analysis of leading market players and their strategic developments. The scope of the oncology biosimilars market report encompasses an assessment of market performance across North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa.

Segmental Assessment:

The market is segmented by drug class into monoclonal antibodies, granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs). In 2023, the monoclonal antibodies segment held the largest share of the oncology biosimilars market and is expected to register the highest CAGR from 2023 to 2031. Monoclonal antibodies can eliminate cancer cells through various mechanisms, including blocking ligand-receptor growth and survival pathways. Key mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and complement-mediated cytotoxicity. Rituximab, Trastuzumab, and Bevacizumab are examples of biosimilar monoclonal antibodies approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for cancer treatment as of December 2019.

The market is categorized by cancer type into colorectal cancer, cervical cancer, breast cancer, supportive care, lymphoma, and others. The supportive care segment held the largest market share in 2023, while colorectal cancer is projected to experience the highest CAGR from 2023 to 2031. According to WHO, cancer is a significant health issue and the leading cause of death globally. With the rising prevalence of cancer, many oncology biosimilar manufacturers are focused on developing and launching new products. For instance, CT-P16 by Celltrion, 163 HD204 by Prestige Biopharma, CBT124 by Cipla Biotech, and MIL60 by Beijing Mabworks Biotech are potential biosimilars of bevacizumab currently in phase 3 studies, being evaluated for safety and efficacy in treating patients with non-small cell lung cancer.

The market is segmented by distribution channel into hospital pharmacy, retail pharmacy, and online pharmacy. In 2022, the hospital pharmacy segment held the largest market share, while the online pharmacy segment is expected to register the highest CAGR from 2023 to 2031. Hospital pharmacies serve as the primary platform for patients to purchase prescription drugs, including biosimilars.

Regional Analysis:

In terms of revenue, North America accounted for a significant share of the oncology biosimilars market in 2023, followed by Europe. The increasing incidence of cancer, growing approvals of biosimilars for cancer treatment, and advanced healthcare infrastructure are expected to drive the oncology biosimilars market in North America during the forecast period.

The rising cancer cases, increasing approvals of biosimilars for cancer treatment, and advanced healthcare infrastructure are anticipated to propel the oncology biosimilars market in North America. Biologics are among the most expensive medications in the US, and biosimilars are expected to be more cost-effective than their reference products. A cost comparison published in an article by PubMed Central in October 2022 analyzed the average wholesale price (AWP) per unit of biologics and biosimilars based on US drug prices as of June 2021, indicating that biosimilars could provide savings of 15-23% for bevacizumab. Among bevacizumab biosimilars, Zirbes offers significantly higher savings compared to the originator product, Avastin. Biosimilars for supportive cancer care agents, such as Filgrastim biosimilars, offer savings ranging from 17.3% to 34% compared to their reference products, while pegfilgrastim biosimilars provide savings from 33% to 37%. Additionally, Epogen biosimilars offer savings of 33.5%. According to the Cardinal Health Biosimilars Report published in 2022, the FDA has approved 33 biosimilars in the US, with 21 commercially available, 17 of which are used for cancer treatments. The same report estimates that biosimilars could reduce US drug expenditure by US$ 133 billion by 2025. Thus, biosimilars have significant potential to lower the costs of biologic medicines in the US, making care more accessible to patients and fostering innovations and scientific advancements, thereby driving the oncology biosimilars market in this region.

Oncology Biosimilars Market Report Scope

Industry Developments and Future Opportunities:

The oncology biosimilars market forecast can assist stakeholders in planning their growth strategies. Below are some key developments and initiatives undertaken by major players in the oncology biosimilars market:

1. In November 2022, Organon launched AYBINTIO, a biosimilar of Avastin, in Canada, aimed at patients with certain aggressive cancers, including metastatic colorectal cancer (mCRC), metastatic lung cancer, and glioblastoma, expanding the company's biosimilar portfolio.
2. In May 2022, Biocon Biologics and Viatris launched Abemy, a biosimilar to Roche’s Avastin (Bevacizumab), which has been approved by Health Canada for four types of cancers.
3. In April 2020, Pfizer received approval from the European Commission (EC) for RUXIENCE, a monoclonal antibody biosimilar to Mather (rituximab), for treating certain cancers.
4. In January 2020, Chorus Biosciences entered into a licensing agreement with Innocents Biologics Co., Ltd. for the development and commercialization of a bevacizumab (Avastin) biosimilar in the US and Canada.

Competitive Landscape and Key Companies:

Top players in the oncology biosimilars market include CELLTRION, Inc.; Teva Pharmaceutical Industries Ltd; Pfizer Inc; Sandoz Group AG; Biocon; Amgen Inc; Samsung Bioepis; Coherus BioSciences; BIOCAD; and Lilly. These companies focus on introducing new high-tech products, advancing existing technologies, and expanding geographically to meet the growing global consumer demand.