US Biosimilar Market: Insights & Forecast with Potential Impact of COVID- 19 (2022-2026)

US Biosimilar Market: Insights & Forecast with Potential Impact of COVID- 19 (2022-2026)

The US biosimilar market is forecasted to reach US$36.16 billion in 2026, experiencing growth at a CAGR of 40.16% during the period spanning from 2022 to 2026. Growth in the US biosimilar market is supported by factors such as rising prevalence of cancer, growing geriatric population and favorable environment. However, the market growth is expected to be restrained by complexities in manufacturing, excess competition and complexities in pricing.

The US biosimilar market by drug class can be segmented as follows: monoclonal antibodies, filgrastim & pegfilgrastim and others. In 2021, the dominant share of the US biosimilar market was being held by monoclonal antibodies, followed by filgrastim & pegfilgrastim. As of 2021, there are around 90 biosimilar products in the pipeline and 33 approved biosimilar products in the US.

The US biosimilar market by product can be categorized as follows: Prolia (Denosumab), Xolair (Omalizumab), Rituxan (Rituximab), Humira (Adalimumab) and Stelara (Ustekinumab). The US Biosimilar market landscape by class can be categorized as follows: Supportive Care, Oncology, Long Acting Insulin, Rapid Acting Insulin, Ophthalmology and TNF blockers. Factors such as patent expiry Of biologics and research on new indications has been supporting the US biosimilar market.

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars. The pandemic threatened to derailed product pipelines. During the height of the outbreak, resources were diverted away from the research and development of new biosimilars and towards the fight against Covid-19.

Scope of the report:

  • The report provides a comprehensive analysis of the US biosimilar market with impact of COVID-19.
  • The market dynamics such as growth drivers, market trends and challenges are analyzed in-depth.
  • The competitive landscape of the market, along with the company profiles of leading players (Pfizer Inc., Novartis AG, Amgen Inc., Samsung Biologics Co., Ltd., Celltrion, Inc. and Viatris Inc.) are also presented in detail.
Key Target Audience:
  • Biosimilar Companies
  • Biologics Companies
  • Hospitals
  • Consumers
  • Pharmaceutical companies
  • Investment Banks
  • Government Bodies & Regulating Authorities


1. Market Overview
1.1 Biosimilar
1.1.1 Biosimilar- Introduction
1.1.2 Need for Biosimilars
1.2 Difference between Biologic, Biosimilar and Generic Drugs
Table 1: Difference between Biologics, Biosimilar and Generic Drugs
1.3 FDA-Approved Biosimilar Products
Table 2: FDA-Approved Biosimilar Products
1.4 Applications of Biosimilar
Table 3: Applications of Biosimilar
1.5 Advantages of Biosimilar
Table 4: Advantages of Biosimilar
1.6 Disadvantages of Biosimilar
Table 5: Disadvantages of Biosimilar
1.7 Biosimilar Development
Table 6: Biosimilar Development
2. Impact of COVID- 19
2.1 Impact of COVID-19 on the US Biosimilar Market
2.2 Delayed Approvals
Table 7: FDA-Approved Biosimilar Products (2020)
2.3 Inaccessibility of Healthcare Providers (HCPs)
2.4 Postponement of Inspection
2.5 Decrease in Prices
2.6 Post-COVID Scenario
3. The US Market Analysis
3.1 The US Biosimilar Market Forecast by Value
Table 8: The US Biosimilar Market Forecast by Value (2021-2026)
3.2 The US Biosimilar Market by Drug Class
Table 9: The US Biosimilar Market by Drug Class (2021)
3.3 The US Biosimilar Approvals
Table 10: The US Biosimilar Approvals (2015-2021)
3.4 The US Biosimilar Launches
Table 11: The US Biosimilar Launches (2015-2021)
3.5 The US Biosimilar in Pipeline
Table 12: The US Biosimilar in Pipeline (As of 2021)
3.6 The US Biosimilar Market by Product
3.6.1 The US Prolia (Denosumab) Biosimilar Market Forecast by Value
Table 13: The US Prolia (Denosumab) Biosimilar Market Forecast by Value (2018-2025)
3.6.2 The US Xolair (Omalizumab) Biosimilar Market Forecast by Value
Table 14: The US Xolair (Omalizumab) Biosimilar Market Forecast by Value (2018-2025)
3.6.3 The US Rituxan (Rituximab) Biosimilar Market Forecast by Value
Table 15: The US Rituxan (Rituximab) Biosimilar Market Forecast by Value (2018-2025)
3.6.4 The US Humira (Adalimumab) Biosimilar Market Forecast by Value
Table 16: The US Humira (Adalimumab) Biosimilar Market Forecast by Value (2018-2025)
3.6.5 The US Stelara (Ustekinumab) Biosimilar Market Forecast by Value
Table 17: The US Stelara (Ustekinumab) Biosimilar Market Forecast by Value (2023-2025)
3.7 The US Biosimilar Market Landscape
3.7.1 The US Supportive Care Biosimilar Market Landscape
Table 18: The US Supportive Care Biosimilar Market Landscape
3.7.2 The US Oncology Biosimilar Market Landscape
Table 19: The US Oncology Biosimilar Market Landscape
3.7.3 The US Long Acting Insulin Biosimilar Market Landscape
Table 20: The US Long Acting Insulin Biosimilar Market Landscape
3.7.4 The US Rapid Acting Insulin Biosimilar Market Landscape
Table 21: The US Rapid Acting Insulin Biosimilar Market Landscape
3.7.5 The US Ophthalmology Biosimilar Market Landscape
Table 22: The US Ophthalmology Biosimilar Market Landscape
3.7.6 The US TNF blockers Biosimilar Market Landscape
Table 23: The US TNF blockers Biosimilar Market Landscape
3.8 The US Biosimilar Pipeline Landscape
3.8.1 The US Supportive Care Biosimilar Pipeline Landscape
Table 24: The US Supportive Care Biosimilar Pipeline Landscape
3.8.2 The US Oncology Biosimilar Pipeline Landscape
Table 25: The US Oncology Biosimilar Pipeline Landscape
3.8.3 The US Insulin Biosimilar Pipeline Landscape
Table 26: The US Insulin Biosimilar Pipeline Landscape
3.8.4 The US Ophthalmology Biosimilar Pipeline Landscape
Table 27: The US Ophthalmology Biosimilar Pipeline Landscape
3.8.5 The US TNF blockers Biosimilar Pipeline Landscape
Table 28: The US TNF blockers Biosimilar Pipeline Landscape
3.8.6 The US Immunosuppressant Biosimilar Pipeline Landscape
Table 29: The US Immunosuppressant Biosimilar Pipeline Landscape
3.8.7 The US Bone Health Biosimilar Pipeline Landscape
Table 30: The US Bone Health Biosimilar Pipeline Landscape
3.8.8 The US Growth Hormone Biosimilar Pipeline Landscape
Table 31: The US Growth Hormone Biosimilar Pipeline Landscape
3.8.9 The US Infertility Biosimilar Pipeline Landscape
Table 32: The US Infertility Biosimilar Pipeline Landscape
4. Market Dynamics
4.1 Growth Drivers
4.1.1 Rising Prevalence of Cancer
Table 33: The US Estimated New Cancer Cases in (2017-2021)
4.1.2 Increasing Health Expenditure
Table 34: The US National Health Expenditure (2015-2020)
4.1.3 Growing Geriatric Population
Table 35: The US population 65 Years & Older (2020-2060)
4.1.4 Payors Favoring Biosimilars
Table 36: Share of Health Plans Preferring Biosimilars over Reference Product (2020)
4.1.5 Cost Effective
4.1.6 Favorable Environment
4.2 Key Trends & Developments
4.2.1 Patent Expiry of Biologics
Table 37: North America Unique Parenteral Biologic Molecule LoP Events (2021-2030)
4.2.2 Research on New Indications
4.3 Challenges
4.3.1 Complexities in Manufacturing
4.3.2 Excess Competition
4.3.3 Complexities in Pricing
5. Competitive Landscape
5.1 Global Market
5.1.1 Revenue Comparison- Key Players
Table 38: Key Players - Revenue Comparison (2021)
5.1.2 Market Capitalization Comparison- Key Players
Table 39: Key Players – Market Capitalization Comparison (2022)
5.1.3 FDA Approved Biosimilars- Key Players
Table 40: FDA Approved Biosimilars- Key Players
5.1.4 Forecasted Market Share - Key Players
Table 41: Key Players – Forecasted Market Share (2021- 2025)
5.1.5 Biosimilar Cancellation Cases- Key Players
Table 42: Key Players – Biosimilar Cancellation Cases
5.1.6 Avastin (Bevacizumab) Biosimilar Developers
Table 43: Avastin (Bevacizumab) Biosimilar Developers
5.1.7 Prolia (Denosumab) Biosimilar Developers
Table 44: Prolia (Denosumab) Biosimilar Developers
5.1.8 Rituxan (Rituximab) Biosimilar Developers
Table 45: Rituxan (Rituximab) Biosimilar Developers
5.1.9 Stelara (Ustekinumab) Biosimilar Developers
Table 46: Stelara (Ustekinumab) Biosimilar Developers
5.1.10 Humira (Adalimumab) Biosimilar Developers
Table 47: Humira (Adalimumab) Biosimilar Developers
5.1.11 Xolair (Omalizumab) Biosimilar Developers
Table 48: Xolair (Omalizumab) Biosimilar Developers
6. Company Profiles
6.1 Celltrion, Inc.
6.1.1 Business Overview
Table 49: Products
6.1.2 Financial Overview
Table 50: Celltrion, Inc. Sales and Net Profit (2017-2021)
6.1.3 Business Strategies
6.2 Samsung Biologics Co., Ltd.
6.2.1 Business Overview
6.2.2 Financial Overview
Table 51: Samsung Biologics Co., Ltd. Revenue and Profit (Loss) (2017-2021)
Table 52: Samsung Biologics Co., Ltd. Revenue by Region (2021)
6.2.3 Business Strategies
6.3 Amgen Inc.
6.3.1 Business Overview
6.3.2 Financial Overview
Table 53: Amgen Inc. Total Revenues and Net Income (2017-2021)
Table 54: Amgen Inc. Total Revenues by Region (2021)
6.3.3 Business Strategies
6.4 Pfizer Inc.
6.4.1 Business Overview
Table 55: Segments
6.4.2 Financial Overview
Table 56: Pfizer Inc. Revenues and Net Income (2017-2021)
Table 57: Pfizer Inc. Revenues by Segment (2021)
Table 58: Pfizer Inc. Revenues by Region (2021)
6.4.3 Business Strategies
6.5 Novartis AG
6.5.1 Business Overview
Table 59: Segments
6.5.2 Financial Overview
Table 60: Novartis AG Net Sales and Net Income (2017-2021)
Table 61: Novartis AG Net Sales by Segment (2021)
Table 62: Novartis AG Net Sales by Region (2021)
6.5.3 Business Strategies
6.6 Viatris Inc.
6.6.1 Business Overview
6.6.2 Financial Overview
Table 63: Viatris Inc. Net Sales and Net (Loss) Earnings (2018-2021)
Table 64: Viatris Inc. Net Sales by Segment (2021)
6.6.3 Business Strategies

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