Oncology Biosimilars Market

Market Insights

The oncology biosimilars market was valued at $1,651.5 million in 2017 and was expected to grow at a double-digit compound annual growth rate (CAGR) of 28.3% from 2018 to 2026. According to the 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-send) and Cephalon’s Granix (to-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-aww) and Mylan’s Ogivri (trastuzumab-dust), biosimilars to Genentech’s Avastin and Herceptin, respectively, received approval in the 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 the treatment of certain types of blood cancer.

Strong oncology biosimilar pipelines are further anticipated to drive market growth during the forecast period. Europe dominated the global oncology biosimilars market on account of the 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 is expected to grow at the fastest 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.

Market Synopsis

A Strong Monoclonal Antibody Pipeline to Drive Market Growth

In 2017, Granulocyte Colony-Stimulating Factor (G-CSF) led the market by drug class segment; however, monoclonal antibodies 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 the treatment of chronic diseases in terms of efficacy, 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 to reduce healthcare costs, a strong pipeline, and biologics that are on the verge of losing their patent exclusivity globally by 2020.

During the forecast period, the rising cancer prevalence will drive a double-digit CAGR for oncology biosimilars.

Cancer accounts for one in six deaths globally, claiming more lives than AIDS, tuberculosis, and malaria combined. According to the International Agency for Research on Cancer (IARC), there were 14.8 million new cases of cancer and 8.8 million cancer deaths in 2015 worldwide. This number is projected to grow to 21.7 million new cases and 13 million deaths due to cancer by 2030, owing to the 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 risk of developing breast cancer in the United States. In 2018, over 266,120 new cases of invasive breast cancer were expected to be diagnosed in the United States. China has also observed a surge in the breast cancer incidence rate in the last decade. For instance, analysis from China’s national cancer registry reveals that the breast cancer rate has increased by around 3.5% per year from 2000 to 2014. Thus, high prevalence coupled with biosimilar approvals for breast cancer treatment would drive the oncology biosimilar market.

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

In 2017, Europe accounted for the majority of the global market for oncology biosimilars. The key factors responsible for the Europe market’s growth are the availability of more oncology biosimilars in the region, organized approval and regulatory scenarios, and high cancer prevalence. However, North America is projected to surge at the highest growth rate owing to the approval of biosimilars for the treatment of a wide range of cancers. Moreover, more than 12 products await FDA approval for market entry in North America, which would set the stage for rapid growth in the region. Rising cancer prevalence, increased R&D funding by pharmaceutical companies, increased awareness of biosimilars, and lower healthcare costs would all result in market growth.

Periods of History and Forecast

This research report presents the analysis of each segment from 2016 to 2026,considering 2017as the base year for the research. The compound annual growth rate (CAGR) for each of the respective segments was calculated for the forecast period from 2018 to 2026.

Report Scope by Segments

The oncology biosimilars market report furnishes quantitative analysis along with its latest market trends. The market is segmented based on drug classes, disease conditions, and geography.

The 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 a data forecast from 2018 to 2026. The product portfolio provided in the report gives information on the approved biosimilars prescribed for the treatment of cancer.

The strategic acquisition, merger, and collaboration among the key players for developing an innovative product pipeline are 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.

Chapter 1. Preface
1.1. Report Description
1.1.1. Study Purpose
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I – Secondary Research
1.3.2. Phase II – Primary Research
1.3.3. Phase III – Expert Panel Review
1.3.4. Assumptions
1.4. Market Segmentation

Chapter 2. Executive Summary
2.1. Global OB Market Portraiture
2.2. Global OB Market, by Drug Class, 2017 (US$ Mn)
2.3. Global OB Market, by Disease Condition, 2017 (US$ Mn)
2.4. Global OB Market Share, by Geography, 2017 (US$ Mn)

Chapter 3. Oncology Biosimilars (OB): Market Dynamics and Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Attractive Investment Proposition, by Geography, 2017
3.6. Competitive Analysis: Global OB Market, by Key Players, 2017

Chapter 4. Global Oncology Biosimilars (OB) Market, by Drug Class, 2016-2026 (US$ Mn)
4.1. Overview
4.2. Monoclonal Antibodies
4.3. Granulocyte Colony-Stimulating Factor (G-CSF)
4.4. Pipeline Analysis
4.4.1. Phase III Drug Analysis
4.4.1.1. Rituximab Biosimilar
4.4.1.2. Trastuzumab Biosimilar
4.4.1.3. Filgrastim Biosimilar
4.4.1.4. Bevacizumab Biosimilar
4.4.2. Tabular Representation of Phase I and Phase II Drugs

Chapter 5. Global Oncology Biosimilars (OB) Market, by Disease Condition, 2016-2026 (US$ Mn)
5.1. Overview
5.2. Breast Cancer
5.3. Lung Cancer
5.4. Colorectal Cancer
5.5. Cervical Cancer
5.6. Blood Cancer
5.7. Neutropenia
5.8. Others (Brain Cancer, Stomach Cancer, etc.)

Chapter 6. Global Oncology Biosimilars (OB) Market, by Geography, 2016 – 2026 (US$ Mn)
6.1. Overview
6.1.1. North America OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
6.1.2. North America OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
6.1.3. North America OB Market, by Country, 2016 – 2026 (US$ Mn)
6.1.3.1. U.S.
6.1.3.2. Canada
6.2. Europe OB Market Analysis, 2016 – 2026
6.2.1. Europe OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
6.2.2. Europe OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
6.2.3. Europe OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
6.2.3.1. U.K.
6.2.3.2. Germany
6.2.3.3. Rest of Europe
6.3. Asia Pacific OB Market Analysis, 2016 – 2026
6.3.1. Asia Pacific OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
6.3.2. Asia Pacific OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
6.3.3. Asia Pacific OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
6.3.3.1. China
6.3.3.2. Japan
6.3.3.3. Rest of Asia Pacific
6.4. Latin America OB Market Analysis, 2016 – 2026
6.4.1. Latin America OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
6.4.2. Latin America OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
6.4.3. Latin America OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
6.4.3.1. Brazil
6.4.3.2. Mexico
6.4.3.3. Rest of Latin America
6.5. Middle East & Africa OB Market, 2016 – 2026
6.5.1. Middle East & Africa OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
6.5.2. Middle East &Africa OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
6.5.3. Middle East & Africa OB Market Analysis, by Region, 2016 – 2026 (US$ Mn)
6.5.3.1. GCC
6.5.3.2. Rest of Middle East & Africa

Chapter 7. Company Profiles
7.1. Amgen, Inc.
7.1.1. Business Description
7.1.2. Financial Information (Subject to Data Availability)
7.1.3. Product Portfolio
7.1.4. News Coverage
7.2. Mylan N.V.
7.3. Samsung Bioepis Co. Ltd.
7.4. Teva Pharmaceutical Industries Ltd.
7.5. Pfizer, Inc.
7.6. Celltrion Healthcare
7.7. Novartis International AG
7.8. Biocon Limited
7.9. Biogen Idec
7.10. Sandoz
7.11. Dr. Reddy’s Laboratory
7.12. Merck & Co.
7.13. Shanghai Henlius Biotech, Inc.
7.14. Biocad

List of Figures

FIG 1. Oncology Biosimilars (OB) Market: Research Methodology
FIG 2. OB: Market Segmentation
FIG 3. Global OB Market, by Drug Class, 2017 (US$ Mn)
FIG 4. Global OB Market, by Disease Condition, 2017 (US$ Mn)
FIG 5. Global OB Market, by Geography, 2017 (US$ Mn)
FIG 6. Attractive Investment Proposition, by Geography, 2017
FIG 7. Competitive Analysis: Global OB Market, by Key Players, 2017
FIG 8. Global Monoclonal Antibodies Market in OB, 2016-2026(US$ Mn)
FIG 9. Global Granulocyte Colony-Stimulating Factor (G-CSF) Market in OB, 2016-2026 (US$ Mn)
FIG 10. Global Rituximab Biosimilar Market in OB, 2016-2026(US$ Mn)
FIG 11. Global Trastuzumab Biosimilar Market in OB, 2016-2026 (US$ Mn)
FIG 12. Global Filgrastim Biosimilar Market in OB, 2016-2026(US$ Mn)
FIG 13. Global Bevacizumab Biosimilar Market in OB, 2016-2026 (US$ Mn)
FIG 14. Global Breast Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 15. Global Lung Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 16. Global Colorectal Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 17. Global Cervical Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 18. Global Blood Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 19. Global Neutropenia Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 20. Global Others Cancer Treatment in OB Market, 2016-2026 (US$ Mn)
FIG 21. U.S. OB Market, 2016-2026 (US$ Mn)
FIG 22. Canada OB Market, 2016-2026 (US$ Mn)
FIG 23. U.K. OB Market, 2016-2026 (US$ Mn)
FIG 24. Germany OB Market, 2016-2026 (US$ Mn)
FIG 25. Rest of Europe OB Market, 2016-2026 (US$ Mn)
FIG 26. China OB Market, 2016-2026 (US$ Mn)
FIG 27. Japan OB Market, 2016-2026 (US$ Mn)
FIG 28. Rest of Asia Pacific OB Market, 2016-2026 (US$ Mn)
FIG 29. Brazil OB Market, 2016-2026 (US$ Mn)
FIG 30. Mexico OB Market, 2016-2026 (US$ Mn)
FIG 31. Rest of Latin America OB Market, 2016-2026 (US$ Mn)
FIG 32. GCC OB Market, 2016-2026 (US$ Mn)
FIG 33. Rest of Middle East & Africa OB Market, 2016-2026 (US$ Mn)

List of Tables

TABLE 1 Global Oncology Biosimilars (OB) Market Portraiture
TABLE 2 Global OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
TABLE 3 Pipeline Analysis: Phase I and Phase II Drugs
TABLE 4 Global OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
TABLE 5 Global OB Market, by Geography, 2016 – 2026 (US$ Mn)
TABLE 6 North America OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
TABLE 7 North America OB Market, by Disease Condition, 2016 – 2026 (US$ Mn
TABLE 8 North America OB Market, by Country, 2016 – 2026 (US$ Mn)
TABLE 9 Europe OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
TABLE 10 Europe OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
TABLE 11 Europe OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 12 Asia Pacific OB Market, by Drug Condition, 2016 – 2026 (US$ Mn)
TABLE 13 Asia Pacific OB Market, by Disease Type, 2016 – 2026 (US$ Mn)
TABLE 14 Asia Pacific OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 15 Latin America OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
TABLE 16 Latin America OB Market, by Disease Condition, 2016 – 2026 (US$ Mn
TABLE 17 Latin America OB Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 18 Middle East & Africa OB Market, by Drug Class, 2016 – 2026 (US$ Mn)
TABLE 19 Middle East & Africa OB Market, by Disease Condition, 2016 – 2026 (US$ Mn)
TABLE 20 Middle East & Africa OB Market, by Region, 2016 – 2026 (US$ Mn)
TABLE 21 Amgen, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 22 Mylan N.V.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 23 Samsung Bioepis Co. Ltd.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 24 Teva Pharmaceutical Industries Ltd.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 25 Pfizer, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 26 Celltrion Healthcare: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 27 Novartis International AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 28 Biocon Limited: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 29 Biogen Idec: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 30 Dr. Reddy’s Laboratory: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 31 Merck & Co.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 32 Shanghai Henlius Biotech, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 33 Biocad: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)