Oncology Biosimilars Market By Drug Class (Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor), By Disease Condition (Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer, Neutropenia, Others) - Growth, Share, Opportunities & Competitive Analysis, 2018 – 2026
Industry Outlook
The oncology biosimilars market stood at US$ 1,651.5 Mn in 2017 and projected to exhibit a double-digit compound annual growth rate (CAGR) of 28.3% during the forecast period from 2018 to 2026. 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 2017, 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 2017, 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.
Historical & Forecast Period
This research report presents the analysis of each segment from 2016 to 2026 considering 2017 as the base year for the research. Compounded annual growth rate (CAGR) for each respective segments calculated for the forecast period from 2018 to 2026.
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 2018 to 2026. 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.
Key questions answered in this report
- How the global oncology biosimilars market will perform during the forecast period from 2018 to 2026?
- What are the latest trends in the oncology biosimilars market and valuable opportunities for key players?
- Who are the leading players in the global oncology biosimilars market?
- Which is the leading/and fastest region in the global oncology biosimilars market?
- Currently, what are the approval guidelines for the oncology biosimilars?
- What impact would the pipeline drugs have on the global oncology biosimilars market?
- What are drivers and restrains governing the global oncology biosimilars market?
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
Note :
Modification in the list of company profiles or scope of the study can be incorporated on request.
* OB - Oncology Biosimilars
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)
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)
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