Industry Outlook

The oncology biosimilars market stood at US$ 3520.9 Mn in 2021 and projected to exhibit a double-digit compound annual growth rate (CAGR) of 28.3% during the forecast period from 2023 to 2030. According to U.S. Food and Drug Administration, biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic, commonly referred to as the reference product. Sandoz’s Zarxio (filgrastim-sndz) and Cephalon’s Granix (tbo-filgrastim) were the first biosimilars to be approved in the U.S. and Europe for cancer supportive care. However, 2017 turned out to be the pivotal year in oncology biosimilars as Amgen’s Mvasi (bevacizumab-awwb) and Mylan’s Ogivri (trastuzumab-dkst), biosimilars to Genentech’s Avastin and Herceptin respectively received approval in United States. Mvasi is approved for the treatment of lung, colorectal, kidney, brain and cervical cancers; whereas Orivri is approved for treating breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).  Moreover, Sandoz and Celltrion Healthcare also received European Commission approval for Rixathon (rituximab) and Truxima (rituximab) for treatment of certain types of blood cancers. Strong oncology biosimilar pipeline is further anticipated to drive the market growth during the forecast period. Europe dominated the global oncology biosimilars market on account of presence of more approved biosimilars in the region compared to other regions. Moreover, organized regulatory bodies to monitor oncology biosimilar approvals are further driving the market in Europe. North America expected to grow at the fastest growth rate during the forecast period due to recent approvals of major breakthrough biosimilars, patent expirations and robust pipeline candidates anticipated to enter the market during the forecast period.

"Robust Pipeline of Monoclonal Antibodies to Drive the Market Growth"

In 2021, Granulocyte Colony-Stimulating Factor (G-CSF) lead the market by drug class segment; however, monoclonal antibodies class will continue to rise post approval showcasing excellent growth during the forecast period. Currently, approximately 30 percent of all the biosimilars in the pipeline that await FDA approval are monoclonal antibodies. This highlights the potential of monoclonal antibodies in treatment of chronic diseases in terms of efficacy and improved patient access and affordability especially for a disease like cancer. Currently there are only three biosimilar monoclonal antibodies approved for treating cancer. However, experts predict that the number will surge in the near future driven by continuous efforts for reducing healthcare costs, strong pipeline and biologics that are on the verge of losing their patent exclusivity globally by 2020.

"Constant Rise of Cancer Prevalence to Showcase Double Digit CAGR for Oncology Biosimilars during the Forecast Period"

Cancer accounts for one in six deaths globally, claiming more lives than AIDS, tuberculosis and malaria combined. According to International Agency of Research on Cancer (IARC), there were 14.8 million new cases of cancer and 8.8 million cancer deaths in 2015, worldwide. This number projected to grow to 21.7 million new cases and 13 million deaths due to cancer by 2030 owing to growing geriatric population. Breast cancer is anticipated to witness tremendous growth during the forecast period, as it is the most common type of cancer in women, globally. Approximately, 1 in 8 women (i.e 12.4%) are at a risk of developing breast cancer in United States. In 2018, over 266,120 new cases of invasive breast cancer are expected to be diagnosed in the United States. China has also observed surge in the breast cancer incidence rate in last decade. For instance, an analysis from China’s national cancer registry reveals that breast cancer rate has increased around 3.5% per year from 2000 to 2014. Thus, high prevalence coupled with biosimilar approvals for breast cancer treatment would drive the oncology biosimilars market.

"Increasing Approvals in North America to set the stage for swift growth during the forecast period"

In 2021, Europe occupied largest share of the global market share for oncology biosimilars. The key factors responsible for the Europe market growth are availability of more oncology biosimilars in the region, organized approval and regulatory scenarios and high cancer prevalence. However, North America projected to surge at highest growth rate owing to approvals of biosimilars for treatment of wide range of cancers. Moreover, more than 12 products await FDA approval for market entry in North America, which would set a stage of rapidgrowth of the region. Rising prevalence of cancer, enhanced funding by the pharmaceutical companies in the R&D segment, rising awareness towards biosimilars and curbing healthcare cost would result in market growth.

Market is studied in order to understand the current and future market trends in the oncology biosimilars market. The market is estimated by providing the compounded annual growth rate (CAGR) and data forecast from 2023 to 2030. Product portfolio provided in the report gives information of the approved biosimilars prescribed for the treatment of cancer. Strategic acquisition, merger and collaboration among the key players for developing innovative product pipeline mentioned in the business strategy section. The key players currently engaged in the oncology biosimilars market are Samsung Bioepis Co. Ltd., Celltrion Inc., Biocon, Dr. Reddy’s Laboratories Ltd., Intas Pharmaceuticals Ltd., STADA Arzneimittel AG, Pfizer Inc., Sandoz, Inc., Teva Pharmaceutical Industries Ltd., Apotex Inc., and BIOCAD.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Oncology Biosimilars market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Oncology Biosimilars market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Oncology Biosimilars market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2032.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Oncology Biosimilars market?
• Which is the largest regional market for Oncology Biosimilars market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Oncology Biosimilars market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Oncology Biosimilars market worldwide?