Oncology Biosimilars Market Research Report Information By Drug (G-CSF, Monoclonal Antibody and Hematopoietic Agents), By Disease Indication (Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Neutropenia, Blood Cancer, Leukemia (Myeloid Leukemia, Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma) and Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy and Online Pharmacy), And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2032

Global Oncology Biosimilars Market Overview

Oncology Biosimilars Market Size was valued at USD 4.2 Billion in 2022. The Oncology Biosimilars market industry is projected to grow from USD 4.6 Billion in 2023 to USD 9.3 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9.20% during the forecast period (2024 - 2032). The rising prevalence of cancer worldwide is the key market driver enhancing the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Oncology Biosimilars Market Trends

• Increasing cancer burden is driving the market growth

Market CAGR for Oncology Biosimilars is being driven by the increasing cancer burden. With cancer incidence on the rise, there is a growing demand for effective and affordable treatment options. Oncology biosimilars offer a cost-effective alternative to originator biologics, providing patients with access to essential cancer therapies at lower costs. As healthcare systems face the challenge of providing quality care while managing escalating healthcare costs, the adoption of biosimilars becomes increasingly attractive. Biosimilars enable healthcare providers to expand patient access to cancer treatment, potentially improving outcomes and reducing the economic burden of cancer care. As a result, the increasing cancer burden fuels the demand for oncology biosimilars, driving market growth and expanding the availability of affordable cancer treatments worldwide.

Growing acceptance among physicians and patients is a key driver of the Oncology Biosimilars Market. As physicians become more familiar with biosimilars and gain confidence in their safety, efficacy, and quality, they are more likely to prescribe them as alternatives to originator biologics. Additionally, patients are increasingly open to using biosimilars based on their physicians' recommendations and positive experiences reported by other patients. This acceptance is further fueled by clinical data demonstrating the comparable efficacy and safety profiles of biosimilars to their reference biologics. As trust in biosimilars grows, physicians and patients are more inclined to consider biosimilars as viable treatment options for cancer, leading to increased adoption and utilization of oncology biosimilars in clinical practice, thereby driving market growth.

A supportive regulatory environment plays a crucial role in driving the Oncology Biosimilars Market. Regulatory agencies, such as the FDA in the United States and the EMA in Europe, have established pathways for the approval of biosimilars, providing clear guidelines and requirements for their development, evaluation, and approval. This regulatory framework ensures that biosimilars meet rigorous standards of safety, efficacy, and quality, instilling confidence in healthcare professionals and patients. Furthermore, expedited approval pathways, such as the FDA's Biosimilar Action Plan and the EMA's biosimilar approval process, streamline the regulatory review process for biosimilars, facilitating market entry and adoption. A supportive regulatory environment fosters competition, encourages innovation, and promotes the availability of affordable oncology biosimilars, ultimately driving market revenue growth and expanding patient access to cancer treatments.

For instance, Samsung Bioepis and Biogen disclosed that the Food and Drug Administration (FDA) greenlit BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for addressing neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Notably, BYOOVIZ marked the initial approval of an ophthalmology biosimilar in the United States.

Oncology Biosimilars Market Segment Insights

Oncology Biosimilars Drug Insights

The Oncology Biosimilars Market segmentation, based on Drug, includes G-CSF, Monoclonal Antibody and Hematopoietic Agents. In 2023, the G-CSF segment dominated the market, accounting for 35% of market revenue. They are widely used in cancer treatment to prevent chemotherapy-induced neutropenia, making them essential supportive care medications. Secondly, the expiration of patents for originator G-CSF biologics has led to the introduction of biosimilar alternatives, driving competition and market penetration. Lastly, favorable regulatory pathways and established clinical experience with G-CSF biosimilars contribute to their widespread acceptance and adoption in oncology practice.

Monoclonal antibody drugs are experiencing the highest Compound Annual Growth Rate (CAGR) in the Oncology Biosimilars Market due to several key factors. Firstly, monoclonal antibodies play a crucial role in cancer therapy, targeting specific molecules involved in tumor growth and progression. Secondly, the expiration of patents for originator monoclonal antibody biologics has led to the development and introduction of biosimilar alternatives, driving market growth. Lastly, increasing acceptance and adoption of monoclonal antibody biosimilars by healthcare providers and patients contribute to their rapid expansion in the oncology biosimilars market.

Oncology Biosimilars Disease Indication Insights

The Oncology Biosimilars Market segmentation, based on Disease Indication, includes Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Neutropenia, Blood Cancer, Leukemia (Myeloid Leukemia, Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma) and Others. In 2023, the Breast Cancer category generated the most income. Breast cancer is one of the most prevalent cancers globally, driving significant demand for effective treatment options. Secondly, the availability of biosimilar alternatives to originator biologics used in breast cancer therapy, such as trastuzumab, has expanded treatment options and improved patient access to affordable medications. Lastly, supportive regulatory frameworks and established clinical experience with trastuzumab biosimilars contribute to their widespread acceptance and adoption in breast cancer treatment.

Non-Small Cell Lung Cancer (NSCLC) Disease Indication is experiencing the highest Compound Annual Growth Rate (CAGR) in the Oncology Biosimilars Market due to several factors. Firstly, NSCLC is one of the most prevalent types of lung cancer, driving significant demand for effective treatment options. Secondly, the emergence of biosimilar alternatives to originator biologics used in NSCLC therapy, such as bevacizumab and pembrolizumab, expands treatment options and improves patient access to affordable medications. Lastly, increasing clinical acceptance and adoption of NSCLC biosimilars contribute to their rapid expansion in the market.

Oncology Biosimilars Distribution Channel Insights

The Oncology Biosimilars Market segmentation, based on distribution channel, includes Hospital Pharmacy, Retail Pharmacy and Online Pharmacy. In 2023, the Hospital Pharmacy category generated the most income. The hospitals serve as major treatment centers for cancer patients, where biosimilars are often administered alongside other cancer therapies. Secondly, hospitals typically purchase biosimilars in bulk quantities, driving higher sales volumes through this distribution channel. Lastly, hospitals have established infrastructure and expertise in handling and administering complex biologic medications, making them key purchasers of oncology biosimilars.

Retail Pharmacy Distribution channel is experiencing the highest Compound Annual Growth Rate (CAGR) in the Oncology Biosimilars Market due to several key factors. Firstly, increasing patient preference for convenient access to medications drives demand for oncology biosimilars through retail pharmacies. Secondly, expanding availability of biosimilars in retail settings enhances patient accessibility and convenience. Thirdly, favorable regulatory policies and increasing acceptance of biosimilars among retail pharmacists contribute to their growing adoption and utilization in the retail pharmacy channel.

Figure 1: Oncology Biosimilars Market, by Distribution Channel, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Oncology Biosimilars Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and the Rest of the World. North America dominates the Oncology Biosimilars Market due to several factors. Firstly, the region boasts a robust regulatory framework and favorable reimbursement policies that facilitate market entry and adoption of biosimilars. Secondly, the presence of a large patient population, advanced healthcare infrastructure, and high healthcare expenditure contribute to significant demand for oncology biosimilars. Lastly, extensive research and development activities, coupled with strategic collaborations between pharmaceutical companies and research institutions, further drive market growth in North America.

Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: ONCOLOGY BIOSIMILARS MARKET SHARE BY REGION 2023 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe Oncology Biosimilars market accounts for the second-largest market share due to a well-established regulatory framework. Europe secures the second largest market share in the Oncology Biosimilars Market due to several factors. Firstly, the region has a well-established regulatory framework, including the European Medicines Agency's (EMA) biosimilar approval pathway, which facilitates the introduction and adoption of biosimilars. Secondly, favorable pricing and reimbursement policies encourage the use of biosimilars in European healthcare systems. Lastly, robust healthcare infrastructure and high patient awareness contribute to the significant uptake of oncology biosimilars in Europe. Further, the German Oncology Biosimilars market held the largest market share, and the UK Oncology Biosimilars market was the fastest growing market in the European region.

The Asia-Pacific Oncology Biosimilars Market is expected to grow at the fastest CAGR from 2024 to 2032. The Asia Pacific region is experiencing the highest Compound Annual Growth Rate (CAGR) in the Oncology Biosimilars Market due to several factors. Firstly, increasing cancer prevalence and healthcare spending drive demand for cost-effective treatment options like biosimilars. Secondly, supportive regulatory reforms and expedited approval pathways facilitate market entry for biosimilar manufacturers. Lastly, rising healthcare infrastructure development and growing patient awareness contribute to the rapid adoption and utilization of oncology biosimilars in the Asia Pacific region. Moreover, China’s Oncology Biosimilars market held the largest market share, and the Indian Oncology Biosimilars market was the fastest growing market in the Asia-Pacific region.

Oncology Biosimilars Key Market Players & Competitive Insights

Leading players in the Oncology Biosimilars Market are actively engaged in strategic initiatives to maintain their competitive edge. This includes expanding their portfolio of biosimilar products for various cancer indications, such as breast cancer, lung cancer, and colorectal cancer. Additionally, these players focus on enhancing manufacturing capabilities, securing regulatory approvals, and forming strategic partnerships with healthcare providers and distributors to expand market reach and increase product accessibility. Continuous investment in research and market developments also drives innovation and differentiation among leading players in the oncology biosimilars market.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global Oncology Biosimilars industry to benefit clients and increase the market sector. In recent years, the Oncology Biosimilars industry has offered some of the most significant advantages to G-CSF. Major players in the Oncology Biosimilars market, including Amgen Inc., Pfizer Inc., Celltrion Inc., Biocon Ltd., Samsung Bioepis Co., Ltd., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd., Mylan N.V., Merck & Co., Inc., STADA Arzneimittel AG and Others, are attempting to increase market demand by investing in research and development operations.

Amgen Inc. is a global biotechnology company with a significant presence in the oncology biosimilars market. Leveraging its expertise in biologic drug development and manufacturing, Amgen has established a robust portfolio of biosimilar products targeting various cancer indications. The company's commitment to innovation and quality ensures the development of high-quality biosimilars that meet rigorous regulatory standards. With a focus on expanding patient access to affordable cancer treatments, Amgen continues to invest in research and development, manufacturing capabilities, and strategic partnerships. Through its comprehensive oncology biosimilars portfolio and global market presence, Amgen plays a pivotal role in advancing biosimilar adoption and improving patient outcomes in oncology care.

Pfizer Inc. is a leading global pharmaceutical company with a significant presence in the oncology biosimilars market. Leveraging its extensive experience in biologic drug development and manufacturing, Pfizer has established a diverse portfolio of biosimilar products targeting key cancer indications. The company's commitment to innovation, quality, and patient access drives its efforts in developing high-quality biosimilars that meet stringent regulatory requirements. Pfizer's strong global presence and strategic partnerships enable it to expand its market reach and increase the accessibility of oncology biosimilars to patients worldwide. Through ongoing investments in research and development, manufacturing capabilities, and commercialization efforts, Pfizer plays a crucial role in advancing biosimilar adoption and improving cancer care outcomes globally.

Key Companies in the Oncology Biosimilars market include

• Amgen Inc.


• Pfizer Inc.


• Celltrion Inc.


• Biocon Ltd.


• Samsung Bioepis Co., Ltd.


• Sandoz International GmbH


• Teva Pharmaceutical Industries Ltd.


• Mylan N.V.


• Merck & Co., Inc.


• STADA Arzneimittel AG

Oncology Biosimilars Industry Developments

May 2022: Amneal Pharmaceuticals, Inc. has obtained approval from the United States Food and Drug Administration ("FDA") for a Biologics License Application ("BLA") concerning pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product is set to be marketed under the proprietary name FYLNETRA.

May 2022: Berry Oncology, a firm specializing in genetic testing and early tumor screening, unveiled a HIFI system comprising HIFI-det liquid biopsy technology alongside the corresponding HIFI-cal series of algorithms.

Oncology Biosimilars Market Segmentation

Oncology Biosimilars Drug Outlook

• G-CSF


• Monoclonal Antibody


• Hematopoietic Agents

Oncology Biosimilars Disease Indication Outlook

• Breast Cancer


• Non-Small Cell Lung Cancer


• Colorectal Cancer


• Neutropenia


• Blood Cancer


• Leukemia
  
  
  
  • Myeloid Leukemia
  
  
  • Chronic Lymphocytic Leukemia
  
  
  • Non-Hodgkin Lymphoma
  
  
  
  


• Others

Oncology Biosimilars Distribution Channel Outlook

• Hospital Pharmacy


• Retail Pharmacy


• Online Pharmacy

Oncology Biosimilars Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America