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U.S. Biosimilars Market

U.S. Biosimilars Market Charting Growth Trajectories: Analysis and Forecasts 2025-2033

U.S. Biosimilars Market by Drug Class (Filgrastim & Pegfilgrastim, Monoclonal Antibodies, Others), by Disease Indication (Cancer, Autoimmune Diseases {Arthritis, Psoriasis, Neutropenia, Others}, Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), by Forecast 2026-2034

Jul 27 2025

Base Year: 2025

180 Pages

U.S. Biosimilars Market Charting Growth Trajectories: Analysis and Forecasts 2025-2033

Key Insights

The U.S. Biosimilars Marketsize was valued at USD 6.73 USD billion in 2023 and is projected to reach USD 25.85 USD billion by 2032, exhibiting a CAGR of 21.2 % during the forecast period. Biosimilars are biologic medical products highly similar to already approved reference biologics, with no significant differences in safety, purity, or potency. Types include monoclonal antibodies, growth factors, hormones, and therapeutic proteins. Key features encompass rigorous comparability testing to ensure efficacy and safety, potential for cost reduction in healthcare, and regulatory approval through pathways like the EMA or FDA. Applications span various therapeutic areas, including oncology, autoimmune diseases, and chronic conditions like diabetes. By offering more affordable alternatives to expensive biologics, biosimilars enhance patient access to essential treatments, potentially improving health outcomes and contributing to more sustainable healthcare systems.

U.S. Biosimilars Trends

U.S. Biosimilars Market Market Size and Forecast (2024-2030) — U.S. Biosimilars Market Company Market Share

Shift towards biosimilar use: Biosimilars are increasingly being adopted as healthcare providers and patients become aware of their safety and efficacy.
Competitive pricing: Biosimilars offer significant cost savings compared to branded biologics, creating competitive pressure in the market.

Driving Forces: What's Propelling the U.S. Biosimilars Market

Patent Cliffs & Market Entry Opportunities: The expiration of patents on numerous blockbuster biologics creates a significant influx of market opportunities for biosimilar manufacturers. This wave of patent expirations is a primary driver of market growth.
Supportive Regulatory Landscape & Policy Initiatives: Legislative efforts such as the Biologics Price Competition and Innovation Act (BPCIA) of 2009 and the CREATES Act of 2019 have fostered a more favorable regulatory environment for biosimilar development and approval, encouraging market entry and competition.
Cost Reduction & Improved Healthcare Access: Biosimilars provide a cost-effective alternative to branded biologics, offering substantial savings to healthcare systems and increasing access to potentially life-saving treatments for a wider patient population. This cost advantage is a key driver of adoption.
Increased Physician & Patient Acceptance: Growing awareness and understanding of biosimilars' safety and efficacy profiles, coupled with positive clinical trial results and successful market launches, contribute to greater acceptance among both healthcare professionals and patients.

Challenges and Restraints in U.S. Biosimilars Market

Complex & Stringent Regulatory Pathway: The rigorous regulatory pathway for biosimilar approval, including extensive testing and demonstrating biosimilarity, presents a significant hurdle for manufacturers, increasing development costs and timelines.
Addressing Misconceptions & Building Confidence: Overcoming persistent misconceptions and concerns regarding the safety and efficacy of biosimilars remains a crucial challenge. Effective communication strategies are essential to build patient and physician confidence.
Intense Competition & Brand Loyalty: Competition from established branded biologics, often supported by extensive marketing and physician preference, presents a significant barrier to biosimilar market penetration. Strategies to overcome brand loyalty are critical for success.
Reimbursement Policies & Access Issues: While reimbursement coverage is improving, inconsistencies and complexities in insurance coverage can hinder patient access to biosimilars, limiting market expansion.

Emerging Trends in U.S. Biosimilars

Expansion of therapeutic areas: Biosimilar development is expanding into new therapeutic areas, including oncology and immunology.
Increased use of biosimilar combinations: Combinations of biosimilars are being used to treat complex diseases, offering greater efficacy and convenience.
Entry of new players: Several new biosimilar manufacturers are entering the U.S. market, intensifying competition and driving innovation.

Growth Catalysts in U.S. Biosimilars Industry

Technological Advancements & Improved Biosimilarity: Continuous advancements in biomanufacturing technologies lead to the development of highly similar biosimilars with improved safety profiles and enhanced efficacy, bolstering confidence and driving adoption.
Expanding Reimbursement Coverage & Favorable Payer Policies: The increasing prevalence of favorable reimbursement policies and wider insurance coverage of biosimilars significantly reduces out-of-pocket costs for patients, contributing to higher market uptake.
Enhanced Distribution & Accessibility: Wider availability of biosimilars through various distribution channels, including retail pharmacies and specialty pharmacies, enhances accessibility for patients, driving market growth.
Strategic Partnerships & Market Consolidation: Strategic alliances between biosimilar manufacturers and established pharmaceutical companies can facilitate market penetration and accelerate biosimilar adoption.

Market Segmentation: U.S. Biosimilars Analysis

Drug Class:

Filgrastim & Pegfilgrastim
Monoclonal Antibodies
Others

Disease Indication:

Cancer
Autoimmune Diseases (Arthritis, Psoriasis, Neutropenia, Others)
Others

Distribution Channel:

Hospital Pharmacies
Retail Pharmacies
Online Pharmacies

Leading Players in the U.S. Biosimilars Market

Significant developments in U.S. Biosimilars Sector

FDA approves multiple new biosimilars for various diseases.
Government initiatives promote biosimilar education and awareness.
Partnerships between biosimilar companies and specialty pharmacies.
Focus on sustainable manufacturing practices in the biosimilars industry.

Comprehensive Coverage U.S. Biosimilars Market Report

This report provides a comprehensive analysis of the U.S. biosimilars market, including:

Detailed Market Sizing & Segmentation: Precise market valuation and segmentation by therapeutic area, biosimilar type, and other relevant factors.
In-depth SWOT Analysis: A comprehensive assessment of the strengths, weaknesses, opportunities, and threats impacting the U.S. biosimilars market.
Competitive Landscape & Market Share Analysis: A thorough overview of key players, their market strategies, and competitive dynamics within the U.S. biosimilars market.
Regulatory Scrutiny & Future Policy Landscape: An analysis of the current regulatory landscape and projections for future policy changes and their impact on the market.
Growth Drivers, Challenges, & Future Outlook: A detailed exploration of the factors driving market growth, potential obstacles, and future market projections.
Case Studies & Success Stories: Examples of successful biosimilar launches and market penetration strategies to illustrate key industry trends and best practices.

Geographic Coverage of U.S. Biosimilars Market

Higher Coverage

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U.S. Biosimilars Market REPORT HIGHLIGHTS

Aspects	Details
Study Period	2020-2034
Base Year	2025
Estimated Year	2026
Forecast Period	2026-2034
Historical Period	2020-2025
Growth Rate	CAGR of 21.2% from 2020-2034
Segmentation	By Drug Class Filgrastim & Pegfilgrastim Monoclonal Antibodies Others By Disease Indication Cancer Autoimmune Diseases {Arthritis Psoriasis Neutropenia Others} Others By Distribution Channel Hospital Pharmacies Retail Pharmacies Online Pharmacies By Geography

1. Introduction
- 1.1. Research Scope
- 1.2. Market Segmentation
- 1.3. Research Methodology
- 1.4. Definitions and Assumptions
2. Executive Summary
- 2.1. Introduction
3. Market Dynamics
- 3.1. Introduction
- - 3.2. Market Drivers
  - - 3.2.1. Rising Prevalence of Vitamin D Deficiency and Associated Diseases to Lead to Market Growth
- - 3.3. Market Restrains
  - - 3.3.1 Challenges with Drug Development
    - 3.3.2 Clinical Processing
    - 3.3.3 and Cost of Development to Hinder the Market Growth
- - 3.4. Market Trends
  - - 3.4.1. Increasing Number of Hospitals and ASCs Identified as Significant Market Trend
4. Market Factor Analysis
- 4.1. Porters Five Forces
- 4.2. Supply/Value Chain
- 4.3. PESTEL analysis
- 4.4. Market Entropy
- 4.5. Patent/Trademark Analysis
5. U.S. Biosimilars Market Analysis, Insights and Forecast, 2020-2032
- 5.1. Market Analysis, Insights and Forecast - by Drug Class
  - 5.1.1. Filgrastim & Pegfilgrastim
  - 5.1.2. Monoclonal Antibodies
  - 5.1.3. Others
- 5.2. Market Analysis, Insights and Forecast - by Disease Indication
  - 5.2.1. Cancer
  - 5.2.2. Autoimmune Diseases {Arthritis
  - 5.2.3. Psoriasis
  - 5.2.4. Neutropenia
  - 5.2.5. Others}
  - 5.2.6. Others
- 5.3. Market Analysis, Insights and Forecast - by Distribution Channel
  - 5.3.1. Hospital Pharmacies
  - 5.3.2. Retail Pharmacies
  - 5.3.3. Online Pharmacies
- 5.4. Market Analysis, Insights and Forecast - by Region
  - 5.4.1.
6. Competitive Analysis
- 6.1. Market Share Analysis 2025
- - 6.2. Company Profiles
  - - 6.2.1 Pfizer Inc. (U.S.)
      6.2.1.1. Overview
      6.2.1.2. Products
      6.2.1.3. SWOT Analysis
      6.2.1.4. Recent Developments
      6.2.1.5. Financials (Based on Availability)
    - 6.2.2 Amgen Inc. (U.S.)
      6.2.2.1. Overview
      6.2.2.2. Products
      6.2.2.3. SWOT Analysis
      6.2.2.4. Recent Developments
      6.2.2.5. Financials (Based on Availability)
    - 6.2.3 Samsung Bioepis (South Korea)
      6.2.3.1. Overview
      6.2.3.2. Products
      6.2.3.3. SWOT Analysis
      6.2.3.4. Recent Developments
      6.2.3.5. Financials (Based on Availability)
    - 6.2.4 Novartis AG (Switzerland)
      6.2.4.1. Overview
      6.2.4.2. Products
      6.2.4.3. SWOT Analysis
      6.2.4.4. Recent Developments
      6.2.4.5. Financials (Based on Availability)
    - 6.2.5 Celltrion Inc. (South Korea)
      6.2.5.1. Overview
      6.2.5.2. Products
      6.2.5.3. SWOT Analysis
      6.2.5.4. Recent Developments
      6.2.5.5. Financials (Based on Availability)
    - 6.2.6 Viatris Inc. (U.S.)
      6.2.6.1. Overview
      6.2.6.2. Products
      6.2.6.3. SWOT Analysis
      6.2.6.4. Recent Developments
      6.2.6.5. Financials (Based on Availability)
    - 6.2.7 Coherus BioSciences (U.S.)
      6.2.7.1. Overview
      6.2.7.2. Products
      6.2.7.3. SWOT Analysis
      6.2.7.4. Recent Developments
      6.2.7.5. Financials (Based on Availability)

List of Figures

Figure 1: U.S. Biosimilars Market Revenue Breakdown (USD billion, %) by Product 2025 & 2033
Figure 2: U.S. Biosimilars Market Share (%) by Company 2025

List of Tables

Table 1: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2020 & 2033
Table 2: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2020 & 2033
Table 3: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2020 & 2033
Table 4: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2020 & 2033
Table 5: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2020 & 2033
Table 6: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2020 & 2033
Table 7: U.S. Biosimilars Market Revenue USD billion Forecast, by Region 2020 & 2033
Table 8: U.S. Biosimilars Market Volume K Tons Forecast, by Region 2020 & 2033
Table 9: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2020 & 2033
Table 10: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2020 & 2033
Table 11: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2020 & 2033
Table 12: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2020 & 2033
Table 13: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2020 & 2033
Table 14: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2020 & 2033
Table 15: U.S. Biosimilars Market Revenue USD billion Forecast, by Country 2020 & 2033
Table 16: U.S. Biosimilars Market Volume K Tons Forecast, by Country 2020 & 2033

Methodology

Step 1 - Identification of Relevant Samples Size from Population Database

Step 2 - Approaches for Defining Global Market Size (Value, Volume* & Price*)

Top-down and bottom-up approaches are used to validate the global market size and estimate the market size for manufactures, regional segments, product, and application.

Note*: In applicable scenarios

Step 3 - Data Sources

Primary Research

Web Analytics
Survey Reports
Research Institute
Latest Research Reports
Opinion Leaders

Secondary Research

Annual Reports
White Paper
Latest Press Release
Industry Association
Paid Database
Investor Presentations

Step 4 - Data Triangulation

Involves using different sources of information in order to increase the validity of a study

These sources are likely to be stakeholders in a program - participants, other researchers, program staff, other community members, and so on.

Then we put all data in single framework & apply various statistical tools to find out the dynamic on the market.

During the analysis stage, feedback from the stakeholder groups would be compared to determine areas of agreement as well as areas of divergence

Additionally, after gathering mixed and scattered data from a wide range of sources, data is triangulated and correlated to come up with estimated figures which are further validated through primary mediums or industry experts, opinion leaders.

Frequently Asked Questions

1. What is the projected Compound Annual Growth Rate (CAGR) of the U.S. Biosimilars Market?

The projected CAGR is approximately 21.2%.

2. Which companies are prominent players in the U.S. Biosimilars Market?

Key companies in the market include Pfizer Inc. (U.S.), Amgen Inc. (U.S.), Samsung Bioepis (South Korea), Novartis AG (Switzerland), Celltrion Inc. (South Korea), Viatris Inc. (U.S.), Coherus BioSciences (U.S.).

3. What are the main segments of the U.S. Biosimilars Market?

The market segments include Drug Class, Disease Indication, Distribution Channel.

4. Can you provide details about the market size?

The market size is estimated to be USD 6.73 USD billion as of 2022.

5. What are some drivers contributing to market growth?

Rising Prevalence of Vitamin D Deficiency and Associated Diseases to Lead to Market Growth.

6. What are the notable trends driving market growth?

Increasing Number of Hospitals and ASCs Identified as Significant Market Trend.

7. Are there any restraints impacting market growth?

Challenges with Drug Development. Clinical Processing. and Cost of Development to Hinder the Market Growth.

8. Can you provide examples of recent developments in the market?

N/A

9. What pricing options are available for accessing the report?

Pricing options include single-user, multi-user, and enterprise licenses priced at USD 2850, USD 3850, and USD 4850 respectively.

10. Is the market size provided in terms of value or volume?

The market size is provided in terms of value, measured in USD billion and volume, measured in K Tons .

11. Are there any specific market keywords associated with the report?

Yes, the market keyword associated with the report is "U.S. Biosimilars Market," which aids in identifying and referencing the specific market segment covered.

12. How do I determine which pricing option suits my needs best?

The pricing options vary based on user requirements and access needs. Individual users may opt for single-user licenses, while businesses requiring broader access may choose multi-user or enterprise licenses for cost-effective access to the report.

13. Are there any additional resources or data provided in the U.S. Biosimilars Market report?

While the report offers comprehensive insights, it's advisable to review the specific contents or supplementary materials provided to ascertain if additional resources or data are available.

14. How can I stay updated on further developments or reports in the U.S. Biosimilars Market?

To stay informed about further developments, trends, and reports in the U.S. Biosimilars Market, consider subscribing to industry newsletters, following relevant companies and organizations, or regularly checking reputable industry news sources and publications.

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