U.S. Biosimilars MarketU.S. Biosimilars Market Charting Growth Trajectories: Analysis and Forecasts 2024-2032
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 2024-2032
Base Year: 2023
180 Pages
U.S. Biosimilars Market Charting Growth Trajectories: Analysis and Forecasts 2024-2032
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
- 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 expiries: A significant number of blockbuster biologics are facing patent expiration in the near future, opening up opportunities for biosimilar manufacturers to enter the market.
- Government initiatives: The U.S. government has taken several steps to encourage biosimilar development and adoption, including the Biologics Price Competition and Innovation Act (BPCIA) of 2009 and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019.
- Rising healthcare costs: Biosimilars offer a cost-effective alternative to branded biologics, potentially reducing healthcare expenditure and improving access to affordable treatments.
Challenges and Restraints in U.S. Biosimilars Market
- Regulatory hurdles: The development and approval process for biosimilars is complex and time-consuming, posing challenges for manufacturers.
- Lack of awareness: Misconceptions and uncertainties about biosimilar safety and efficacy can hinder their adoption.
- Competition from branded biologics: Branded drug manufacturers may engage in strategies to maintain market share by offering discounts or rebate programs.
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: Ongoing research and development is improving the safety and efficacy of biosimilars, making them more attractive to patients.
- Favorable reimbursement policies: Insurance companies are increasingly covering biosimilars, making them more affordable for patients.
- Increasing adoption in retail pharmacies: Biosimilars are gaining popularity in retail pharmacies, expanding accessibility for patients.
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
- 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.)
- Biocon Ltd. (India)
- Mylan N.V. (U.S.)
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:
- Market size and growth projections
- SWOT analysis
- Competitive landscape
- Regulatory environment
- Growth drivers and challenges
- Future outlook
U.S. Biosimilars Market REPORT HIGHLIGHTS
| Aspects | Details |
|---|---|
| Study Period | 2018-2032 |
| Base Year | 2023 |
| Estimated Year | 2024 |
| Forecast Period | 2024-2032 |
| Historical Period | 2018-2023 |
| Growth Rate | CAGR of 21.2% from 2018-2032 |
| Segmentation |
|
Frequently Asked Questions
Table Of Content
- 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, 2018-2030
- 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.
- 5.1. Market Analysis, Insights and Forecast - by Drug Class
- 6. Northeast U.S. Biosimilars Market Analysis, Insights and Forecast, 2018-2030
- 6.1. Market Analysis, Insights and Forecast - By Drug Class
- 6.1.1 Filgrastim & Pegfilgrastim
- 6.1.2 Monoclonal Antibodies
- 6.1.3 and Others
- 6.2. Market Analysis, Insights and Forecast - By Disease Indication
- 6.2.1 Cancer
- 6.2.2 Autoimmune Diseases {Arthritis
- 6.2.3 Psoriasis
- 6.2.4 Neutropenia
- 6.2.5 and Others}
- 6.2.6 and Others
- 6.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 6.3.1 Hospital Pharmacies
- 6.3.2 Retail Pharmacies
- 6.3.3 and Online Pharmacies
- 7. Southeast U.S. Biosimilars Market Analysis, Insights and Forecast, 2018-2030
- 7.1. Market Analysis, Insights and Forecast - By Drug Class
- 7.1.1 Filgrastim & Pegfilgrastim
- 7.1.2 Monoclonal Antibodies
- 7.1.3 and Others
- 7.2. Market Analysis, Insights and Forecast - By Disease Indication
- 7.2.1 Cancer
- 7.2.2 Autoimmune Diseases {Arthritis
- 7.2.3 Psoriasis
- 7.2.4 Neutropenia
- 7.2.5 and Others}
- 7.2.6 and Others
- 7.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 7.3.1 Hospital Pharmacies
- 7.3.2 Retail Pharmacies
- 7.3.3 and Online Pharmacies
- 8. Midwest U.S. Biosimilars Market Analysis, Insights and Forecast, 2018-2030
- 8.1. Market Analysis, Insights and Forecast - By Drug Class
- 8.1.1 Filgrastim & Pegfilgrastim
- 8.1.2 Monoclonal Antibodies
- 8.1.3 and Others
- 8.2. Market Analysis, Insights and Forecast - By Disease Indication
- 8.2.1 Cancer
- 8.2.2 Autoimmune Diseases {Arthritis
- 8.2.3 Psoriasis
- 8.2.4 Neutropenia
- 8.2.5 and Others}
- 8.2.6 and Others
- 8.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 8.3.1 Hospital Pharmacies
- 8.3.2 Retail Pharmacies
- 8.3.3 and Online Pharmacies
- 9. Southwest U.S. Biosimilars Market Analysis, Insights and Forecast, 2018-2030
- 9.1. Market Analysis, Insights and Forecast - By Drug Class
- 9.1.1 Filgrastim & Pegfilgrastim
- 9.1.2 Monoclonal Antibodies
- 9.1.3 and Others
- 9.2. Market Analysis, Insights and Forecast - By Disease Indication
- 9.2.1 Cancer
- 9.2.2 Autoimmune Diseases {Arthritis
- 9.2.3 Psoriasis
- 9.2.4 Neutropenia
- 9.2.5 and Others}
- 9.2.6 and Others
- 9.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 9.3.1 Hospital Pharmacies
- 9.3.2 Retail Pharmacies
- 9.3.3 and Online Pharmacies
- 10. West U.S. Biosimilars Market Analysis, Insights and Forecast, 2018-2030
- 10.1. Market Analysis, Insights and Forecast - By Drug Class
- 10.1.1 Filgrastim & Pegfilgrastim
- 10.1.2 Monoclonal Antibodies
- 10.1.3 and Others
- 10.2. Market Analysis, Insights and Forecast - By Disease Indication
- 10.2.1 Cancer
- 10.2.2 Autoimmune Diseases {Arthritis
- 10.2.3 Psoriasis
- 10.2.4 Neutropenia
- 10.2.5 and Others}
- 10.2.6 and Others
- 10.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 10.3.1 Hospital Pharmacies
- 10.3.2 Retail Pharmacies
- 10.3.3 and Online Pharmacies
- 11. Competitive Analysis
- 11.1. Market Share Analysis 2023
- 11.2. Company Profiles
- 11.2.1 Pfizer Inc. (U.S.)
- 11.2.1.1. Overview
- 11.2.1.2. Products
- 11.2.1.3. SWOT Analysis
- 11.2.1.4. Recent Developments
- 11.2.1.5. Financials (Based on Availability)
- 11.2.2 Amgen Inc. (U.S.)
- 11.2.2.1. Overview
- 11.2.2.2. Products
- 11.2.2.3. SWOT Analysis
- 11.2.2.4. Recent Developments
- 11.2.2.5. Financials (Based on Availability)
- 11.2.3 Samsung Bioepis (South Korea)
- 11.2.3.1. Overview
- 11.2.3.2. Products
- 11.2.3.3. SWOT Analysis
- 11.2.3.4. Recent Developments
- 11.2.3.5. Financials (Based on Availability)
- 11.2.4 Novartis AG (Switzerland)
- 11.2.4.1. Overview
- 11.2.4.2. Products
- 11.2.4.3. SWOT Analysis
- 11.2.4.4. Recent Developments
- 11.2.4.5. Financials (Based on Availability)
- 11.2.5 Celltrion Inc. (South Korea)
- 11.2.5.1. Overview
- 11.2.5.2. Products
- 11.2.5.3. SWOT Analysis
- 11.2.5.4. Recent Developments
- 11.2.5.5. Financials (Based on Availability)
- 11.2.6 Viatris Inc. (U.S.)
- 11.2.6.1. Overview
- 11.2.6.2. Products
- 11.2.6.3. SWOT Analysis
- 11.2.6.4. Recent Developments
- 11.2.6.5. Financials (Based on Availability)
- 11.2.7 Coherus BioSciences (U.S.)
- 11.2.7.1. Overview
- 11.2.7.2. Products
- 11.2.7.3. SWOT Analysis
- 11.2.7.4. Recent Developments
- 11.2.7.5. Financials (Based on Availability)
- 11.2.1 Pfizer Inc. (U.S.)
List of Figures
- Figure 1: U.S. Biosimilars Market Revenue Breakdown (USD billion, %) by Product 2023 & 2031
- Figure 2: U.S. Biosimilars Market Value Share (%), by Drug Class 2023 & 2031
- Figure 3: U.S. Biosimilars Market Value Share (%), by Disease Indication 2023 & 2031
- Figure 4: U.S. Biosimilars Market Value Share (%), by Distribution Channel 2023 & 2031
- Figure 5: U.S. Biosimilars Market Share (%) by Company 2023
List of Tables
- Table 1: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2018 & 2031
- Table 2: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2018 & 2031
- Table 3: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2018 & 2031
- Table 4: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2018 & 2031
- Table 5: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2018 & 2031
- Table 6: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2018 & 2031
- Table 7: U.S. Biosimilars Market Revenue USD billion Forecast, by Region 2018 & 2031
- Table 8: U.S. Biosimilars Market Volume K Tons Forecast, by Region 2018 & 2031
- Table 9: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2018 & 2031
- Table 10: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2018 & 2031
- Table 11: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2018 & 2031
- Table 12: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2018 & 2031
- Table 13: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2018 & 2031
- Table 14: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2018 & 2031
- Table 15: U.S. Biosimilars Market Revenue USD billion Forecast, by Region 2018 & 2031
- Table 16: U.S. Biosimilars Market Volume K Tons Forecast, by Region 2018 & 2031
- Table 17: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2018 & 2031
- Table 18: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2018 & 2031
- Table 19: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2018 & 2031
- Table 20: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2018 & 2031
- Table 21: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2018 & 2031
- Table 22: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2018 & 2031
- Table 23: U.S. Biosimilars Market Revenue USD billion Forecast, by Country 2018 & 2031
- Table 24: U.S. Biosimilars Market Volume K Tons Forecast, by Country 2018 & 2031
- Table 25: Northeast U.S. Biosimilars Market Revenue (USD billion) Forecast, by Application 2018 & 2031
- Table 26: Northeast U.S. Biosimilars Market Volume (K Tons ) Forecast, by Application 2018 & 2031
- Table 27: Southeast U.S. Biosimilars Market Revenue (USD billion) Forecast, by Application 2018 & 2031
- Table 28: Southeast U.S. Biosimilars Market Volume (K Tons ) Forecast, by Application 2018 & 2031
- Table 29: Midwest U.S. Biosimilars Market Revenue (USD billion) Forecast, by Application 2018 & 2031
- Table 30: Midwest U.S. Biosimilars Market Volume (K Tons ) Forecast, by Application 2018 & 2031
- Table 31: Southwest U.S. Biosimilars Market Revenue (USD billion) Forecast, by Application 2018 & 2031
- Table 32: Southwest U.S. Biosimilars Market Volume (K Tons ) Forecast, by Application 2018 & 2031
- Table 33: West U.S. Biosimilars Market Revenue (USD billion) Forecast, by Application 2018 & 2031
- Table 34: West U.S. Biosimilars Market Volume (K Tons ) Forecast, by Application 2018 & 2031
- Table 35: U.S. Biosimilars Market Revenue USD billion Forecast, by Drug Class 2018 & 2031
- Table 36: U.S. Biosimilars Market Volume K Tons Forecast, by Drug Class 2018 & 2031
- Table 37: U.S. Biosimilars Market Revenue USD billion Forecast, by Disease Indication 2018 & 2031
- Table 38: U.S. Biosimilars Market Volume K Tons Forecast, by Disease Indication 2018 & 2031
- Table 39: U.S. Biosimilars Market Revenue USD billion Forecast, by Distribution Channel 2018 & 2031
- Table 40: U.S. Biosimilars Market Volume K Tons Forecast, by Distribution Channel 2018 & 2031
- Table 41: U.S. Biosimilars Market Revenue USD billion Forecast, by Country 2018 & 2031
- Table 42: U.S. Biosimilars Market Volume K Tons Forecast, by Country 2018 & 2031
| Aspects | Details |
|---|---|
| Study Period | 2018-2032 |
| Base Year | 2023 |
| Estimated Year | 2024 |
| Forecast Period | 2024-2032 |
| Historical Period | 2018-2023 |
| Growth Rate | CAGR of 21.2% from 2018-2032 |
| Segmentation |
|
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 segemnts, 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
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- 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 mix and scattered data from wide range of sources, data is triangull- ated and correlated to come up with estimated figures which are further validated through primary mediums, or industry experts, opinion leader.
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