Global Trastuzumab Biosimilar Market

Report ID : 1080 | Published : 2021-07-23 | Pages: 140 | Format: PDF/EXCEL

Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that binds to human epidermal growth factor receptor 2 (HER2). HER2 is over expressed in some types breast cancer cells hence, trastuzumab is mainly indicated for the treatment of HER2 positive breast cancer as well as it is also approved for the treatment of metastatic breast cancer and gastric cancer. It is marketed under the trade name of Herceptin by Roche. It is approved by U.S. Food and Drug Administration (FDA) in 1998 and by European Medicines Agency in 2000. Trastuzumab was Roche’s first targeted anticancer drug which accounts more than 90% of HER2 positive cancer market.
Trastuzumab is world’s second monoclonal antibody which has resulted in a better prognosis for breast cancer (HER2 positive) and improved survival rates. As a cost of Herceptin is so high therefore there is great demand for affordable medicines so that it can fulfil the need of low-income patients as well as expand its coverage. Biosimilar is defined as a type of biological products that are approved by respective regulatory bodies because of its clinical similarity to already approved biological products. Patent of Herceptin expired in Europe in 2014, in Asia in 2017, and in the U.S. in 2019. Thus many of biosimilar of trastuzumab have entered into the market. For instance, in June 2019, FDA has approved Allergan and Amgen’s biosimilar of Herceptin, for the breast cancer. Additionally, in December 2019, Biocon Ltd. and Mylan N.V. has launched the Ogivri, a biosimilar to Herceptin (trastuzumab).
The patent expiry of the key trastuzumab biologics are expiring and several companies are entering into development of biosimilar for trastuzumab biosimilar. Introduction to biosimilar in the market, increase in incidence and prevalence rate of breast and gastric cancer, rising demand for targeted therapy, and price cuts have boosted the growth of trastuzumab biosimilar market. The price of trastuzumab biosimilar is predicted to be 80% of that of Herceptin thus making it more affordable and accessible in low and medium income developing countries. However, stringent regulatory process for the approval of trastuzumab biosimilar is major restrain for the growth of the trastuzumab biosimilar market.
The Global Trastuzumab Biosimilar market is segmented into, product, indication, distribution channel, and region. Based on product, ogivri, herzuma, ontruzant, trazimera, and other pipeline products. Based on indication, the global trastuzumab biosimilar market is segmented into adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer, and further indication. Based on distribution channels the global market is segmented as hospital pharmacy, online pharmacy, and others direct distribution channels. The hospital pharmacy segment is expected to grow during the forecast period due to an increase in the number of hospital visits and hospital stays.
At the regional level, the Global Trastuzumab Biosimilar Market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. In terms of revenue, Europe is a major contributor to the global trastuzumab biosimilar market. This is partly because of a trastuzumab patent has been expired in 2014, and in Nov 2017, Samsung Bioepis launched trastuzumab biosimilar in Europe. Followed by Europe, North America is estimated to rank second in the global market owing to patent expiry of Herceptin in 2019, and launch of a biosimilar for same are expected to propel the growth of the market in the region. Additionally, strong clinical pipeline, increasing research and drug development activities propels market growth in the region. Asia Pacific is third promising revenue contributor which is expected to grow at a rapid pace in the upcoming year. Countries such as Japan, India, and China are major contributors to this market. Emerging and huge population base countries such as China and India offer tremendous market opportunities.
The Key players of this market include Amgen Inc., Pfizer Inc., Samsung Bioepis Co., Ltd., Merck & Co., Biocon Limited, Mylan Inc., BioXpress Therapeutics SA, Celltrion, EirGenix, Inc., Teva Pharmaceutical Industries Ltd., ALTEOGEN Inc., Apotex (Apobiologix), AryoGen Pharmed, BIOCAD, Prestige BioPharma (PBP), PlantForm, Outlook Therapeutics (Oncobiologics), Shanghai CP Guojian Pharmaceutical, Shanghai Henlius Biotech, and Stada Arzneimittel AG among others.

Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Trastuzumab Biosimilar Market Snapshot

Chapter 4. Global Trastuzumab Biosimilar Market Variables, Trends & Scope

4.1. Market Segmentation & Scope

4.2. Drivers

4.3. Challenges

4.4. Key Trends in the Market

4.5. Clinical Trial/Pipeline Analysis

4.6. Industry Analysis – Porter’s Five Forces Analysis

4.7. Historic Revenue of Originator Brand (Herceptin) 2011-2019

4.8. Technology Advancement and Key Funding Activities in Trastuzumab Biosimilar Market

4.9. Impact of COVID -19 on Pharmaceutical Industry

Chapter 5. Market Segmentation 1: Product Estimates & Trend Analysis

5.1. Product Type & Market Share, 2020 & 2028

5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2028 for the following Product:

5.2.1. Ogivri

5.2.2. Herzuma

5.2.3. Ontruzant

5.2.4. Trazimera

5.2.5. Other Pipeline Products

Chapter 6. Trastuzumab Biosimilar Market Segmentation 2: Indication Type Estimates & Trend Analysis

6.1. Indication Type Analysis & Market Share, 2020 & 2028

6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2028 for the following Indication Type:

6.2.1. Adjuvant Breast Cancer

6.2.2. Metastatic Breast Cancer

6.2.3. Metastatic Gastric Cancer

6.2.4. Other Indication

Chapter 7. Trastuzumab Biosimilar Market Segmentation 3: Distribution Channel Estimates & Trend Analysis

7.1. Distribution Channel Analysis & Market Share, 2020 & 2028

7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2028 for the following Distribution Channel:

7.2.1. Hospital Pharmacy

7.2.2. Online and Retail Pharmacy

7.2.3. Other Direct Distribution Channels

Chapter 8. Trastuzumab Biosimilar Market Segmentation 3: Regional Estimates & Trend Analysis

8.1. North America

8.1.1. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Product, 2020-2028

8.1.2. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Indication Type, 2020-2028

8.1.3. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2020-2028

8.1.4. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by country, 2020-2028

8.1.4.1. U.S.

8.1.4.2. Canada

8.2. Europe

8.2.1. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by Product, 2020-2028

8.2.2. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, 2020-2028

8.2.3. Europe Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2020-2028

8.2.4. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by country, 2020-2028

8.2.4.1. Germany

8.2.4.2. Poland

8.2.4.3. France

8.2.4.4. Italy

8.2.4.5. Spain

8.2.4.6. UK

8.2.4.7. Rest of Europe

8.3. Asia Pacific

8.3.1. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Product, 2020-2028

8.3.2. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, 2020-2028

8.3.3. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2020-2028

8.3.4. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Country, 2020-2028

8.3.4.1. China

8.3.4.2. India

8.3.4.3. Japan

8.3.4.4. Australia

8.3.4.5. Rest of Asia Pacific

8.4. Latin America

8.4.1. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by product, (US$ Million)

8.4.2. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, (US$ Million)

8.4.3. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2020-2028

8.4.4. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by country, (US$ Million) 2020-2028

8.4.4.1. Brazil

8.4.4.2. Rest of Latin America

8.5. MEA

8.5.1. MEA revenue Trastuzumab Biosimilar Market revenue (US$ Million) by country, (US$ Million) 2020-2028

8.5.1.1. GCC Countries

8.5.1.2. South Africa

8.5.1.3. Rest of MEA

Chapter 9. Competitive Landscape

9.1. Major Mergers and Acquisitions/Strategic Alliances

9.2. Company Profiles

9.2.1. Amgen Inc.

9.2.2. Pfizer Inc.

9.2.3. Samsung Bioepis Co., Ltd.

9.2.4. Merck & Co.

9.2.5. Biocon Limited

9.2.6. Mylan Inc.

9.2.7. BioXpress Therapeutics SA

9.2.8. Celltrion

9.2.9. EirGenix, Inc.

9.2.10. Teva Pharmaceutical Industries Ltd.

9.2.11. ALTEOGEN Inc.

9.2.12. Apotex (Apobiologix)

9.2.13. AryoGen Pharmed

9.2.14. BIOCAD

9.2.15. Prestige BioPharma (PBP)

9.2.16. PlantForm

9.2.17. Outlook Therapeutics (Oncobiologics)

9.2.18. Shanghai CP Guojian Pharmaceutical

9.2.19. Shanghai Henlius Biotech

9.2.20. Stada Arzneimittel AG

Global Trastuzumab Biosimilar Market Segmentation

Global Trastuzumab Biosimilar Market Outlook (Revenue, US$ Mn, 2019 – 2030) By Product

  • Ogivri
  • Herzuma
  • Ontruzant
  • Trazimera
  • Other Pipeline Products

Global Trastuzumab Biosimilar Market Outlook (Revenue, US$ Mn, 2019 – 2030) By Indication

  • Adjuvant Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Gastric Cancer
  • Other Indication

Global Trastuzumab Biosimilar Market Outlook (Revenue, US$ Mn, 2019 – 2030) By Distribution Channel

  • Hospital Pharmacy
  • Online Pharmacy
  • Other Direct Distribution Channels

Global Trastuzumab Biosimilar Market Outlook (Revenue, US$ Mn, 2019 – 2030) By Region

North America Trastuzumab Biosimilar Market by Country

  • U.S.
  • Canada

Europe Trastuzumab Biosimilar Market by Country

  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe

Asia Pacific Trastuzumab Biosimilar Market by Country

  • India
  • China
  • Japan
  • South Korea
  • Australia & New Zealand

Latin America Trastuzumab Biosimilar Market by Country

  • Brazil
  • Mexico
  • Rest of Latin America

Middle East & Africa Trastuzumab Biosimilar Market by Country

  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

 

 

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

To know more about the research methodology used for this study, kindly contact us/click here.

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