Trastuzumab Biosimilar Market is expected to grow at a 25.0 % CAGR during the forecast period for 2025-2034.
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, Route of administration, Molecule Type, 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.
In Case of the segment Route of administration, it comprises Subcutaneous, Intravenous, Parenteral, and Molecule Type. Whereas the molecule type segment includes Monoclonal antibodies, Peptide, Protein, Small molecule, and Product Type. 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.
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Report Attribute |
Specifications |
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Growth Rate CAGR |
CAGR of 25.0 % from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Million and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Product, By Indication, By Route of Administration, By Molecule Type |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
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. |
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Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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, 2024-2034
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 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, 2024-2034
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 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: Route of Administration Estimates & Trend Analysis
7.1. Indication Type Analysis & Market Share, 2024-2034
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Indication Type:
7.2.1. Subcutaneous
7.2.2. Intravenous
7.2.3. Parenteral
7.2.4. Molecule Type
Chapter 8.Trastuzumab Biosimilar Market Segmentation 4: Molecule Type Estimates & Trend Analysis
8.1. Indication Type Analysis & Market Share, 2024-2034
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Indication Type:
8.2.1. Monoclonal antibodies
8.2.2. Peptide
8.2.3. Protein
8.2.4. Small molecule
8.2.5. Product Type
Chapter 9.Trastuzumab Biosimilar Market Segmentation 5: Distribution Channel Estimates & Trend Analysis
9.1. Distribution Channel Analysis & Market Share, 2024-2034
9.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Distribution Channel:
9.2.1. Hospital Pharmacy
9.2.2. Online and Retail Pharmacy
9.2.3. Other Direct Distribution Channels
Chapter 10.Trastuzumab Biosimilar Market Segmentation 6: Regional Estimates & Trend Analysis
10.1. North America
10.1.1. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Product, 2021-2034
10.1.2. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Indication Type, 2021-2034
10.1.3. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Route of Administration, 2021-2034
10.1.4. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Molecule Type, 2021-2034
10.1.5. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2021-2034
10.1.6. North America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by country, 2021-2034
10.1.6.1.U.S.
10.1.6.2.Canada
10.2. Europe
10.2.1. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by Product, 2021-2034
10.2.2. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, 2021-2034
10.2.3. Europe Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Route of Administration, 2021-2034
10.2.4. Europe Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Molecule Type, 2021-2034
10.2.5. Europe Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2021-2034
10.2.6. Europe Trastuzumab Biosimilar Market revenue (US$ Million) by country, 2021-2034
10.2.6.1.Germany
10.2.6.2.Poland
10.2.6.3.France
10.2.6.4.Italy
10.2.6.5.Spain
10.2.6.6.UK
10.2.6.7.Rest of Europe
10.3 Asia Pacific
10.3.1. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Product, 2021-2034
10.3.2. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, 2021-2034
10.3.3. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Route of Administration, 2021-2034
10.3.4. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Molecule Type, 2021-2034
10.3.5. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2021-2034
10.3.6. Asia Pacific Trastuzumab Biosimilar Market revenue (US$ Million) by Country, 2021-2034
10.3.6.1.China
10.3.6.2.India
10.3.6.3.Japan
10.3.6.4.Australia
10.3.6.5.Rest of Asia Pacific
10.4. Latin America
10.4.1. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by product, (US$ Million)
10.4.2. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by Indication Type, (US$ Million)
10.4.3. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Route of Administration, 2021-2034
10.4.4. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Molecule Type, 2021-2034
10.4.5. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) estimates and forecasts by Distribution Channel, 2021-2034
10.4.6. Latin America Trastuzumab Biosimilar Market revenue (US$ Million) by country, (US$ Million) 2021-2034
10.4.6.1.Brazil
10.4.6.2.Rest of Latin America
10.5. MEA
10.5.1. MEA revenue Trastuzumab Biosimilar Market revenue (US$ Million) by country, (US$ Million) 2021-2034
10.5.1.1.GCC Countries
10.5.1.2.South Africa
10.5.1.3.Rest of MEA
Chapter 11. Competitive Landscape
11.1. Major Mergers and Acquisitions/Strategic Alliances
11.2. Company Profiles
11.2.1. Amgen Inc.
11.2.2. Pfizer Inc.
11.2.3. Samsung Bioepis Co., Ltd.
11.2.4. Merck & Co.
11.2.5. Biocon Limited
11.2.6. Mylan Inc.
11.2.7. BioXpress Therapeutics SA
11.2.8. Celltrion
11.2.9. EirGenix, Inc.
11.2.10.Teva Pharmaceutical Industries Ltd.
11.2.11.ALTEOGEN Inc.
11.2.12.Apotex (Apobiologix)
11.2.13.AryoGen Pharmed
11.2.14.BIOCAD
11.2.15.Prestige BioPharma (PBP)
11.2.16.PlantForm
11.2.17.Outlook Therapeutics (Oncobiologics)
11.2.18.Shanghai CP Guojian Pharmaceutical
11.2.19.Shanghai Henlius Biotech
11.2.20.Stada Arzneimittel AG
Global Trastuzumab Biosimilar Market Outlook By Product
Global Trastuzumab Biosimilar Market Outlook By Indication
Global Trastuzumab Biosimilar Market Outlook By Route of Administration
Global Trastuzumab Biosimilar Market Outlook By Molecule Type
Global Trastuzumab Biosimilar Market Outlook By Distribution Channel
Global Trastuzumab Biosimilar Market Outlook By Region
North America Trastuzumab Biosimilar Market by Country
Europe Trastuzumab Biosimilar Market by Country
Asia Pacific Trastuzumab Biosimilar Market by Country
Latin America Trastuzumab Biosimilar Market by Country
Middle East & Africa Trastuzumab Biosimilar Market by Country
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:
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:
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.
