바이오시밀러 시장 : 규모, 점유율, 동향 분석, 약제 클래스별, 적응증별, 최종 용도별, 지역별, 부문 예측(2025-2033년)

Biosimilars Market Summary

The global biosimilars market size was estimated at USD 33.92 million in 2024 and is projected to reach USD 151.58 million by 2033, growing at a CAGR of 18.27% from 2025 to 2033. The cost-effectiveness of biosimilar drugs and the prevalence of chronic disorders globally are major factors contributing to market growth.

In addition, these drugs are comparatively easy to produce since they require less investment in research and development while providing similar results. This can help cut down expenditures on health. Moreover, the reduction in production costs and increasing demand can encourage producers to shift to biosimilars due to increased profits, which can give a further boost to this market. Biosimilars may contain slightly different substances and combinations of medical ingredients, but they are considered similar to their reference biologics in terms of effectiveness and safety.

Several regulations are in place to assess the compatibility and safety of biosimilar drugs. For instance, the FDA's Abbreviated New Drug Application Process requires applicants to scientifically prove that the performance of their product is similar to the reference biologics. It can be demonstrated by proving that their product takes a similar time to reach the bloodstream as the original product. Such regulations can help build trust in these drugs and expand their market share.

Moreover, the increasing prevalence of chronic or non-communicable diseases across the globe is also expected to drive the market. According to statistics released by the World Health Organization in November 2023, non-communicable diseases, such as cancer, diabetes, and heart diseases, cause 41 million deaths every year, out of which 77% of fatalities belong to low- and middle-income countries.

The U.S. FDA approved three cancer-related biosimilars in 2022, which are expected to hit the market in 2023. These growing opportunities in this market are also encouraging key players to increase their investment in the research and development of biosimilars. For instance, according to an article published in Business Today in April 2022, Biocon Biologics planned to increase its R&D expenses by 10% to 15% to advance its pipeline of biosimilar molecules. The step is expected to help strengthen its future position in the market. There is a boom in the pharmaceutical industry in the development of biosimilar medications.

Global Biosimilars Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biosimilars market report based on drug class, indication, end use and region:

• Drug Class Outlook (Revenue, USD Billion, 2021 - 2033)
• Monoclonal Antibodies (mAbs)
• Growth Factors & Hematopoietic Agents
• Insulin & Analogues
• Osteoporosis / Bone Metabolism Agents
• Others
• Indication Outlook (Revenue, USD Billion, 2021 - 2033)
• Autoimmune Disorders (RA, IBD, Psoriasis, Ankylosing Spondylitis)
• Oncology (Breast, Colorectal, Lymphoma, Lung, Gastric)
• Diabetes Mellitus (Type 1 & Type 2)
• Ophthalmic Disorders (Wet AMD, DME, RVO)
• Hematologic / Rare Blood Disorders
• Others
• End Use Outlook (Revenue, USD Billion, 2021 - 2033)
• Hospitals
• Specialty Pharmacies
• Online & Retail Channels
• Regional Outlook (Revenue, USD Billion, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwaita

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Drug Class
  • 1.2.2. Indication
  • 1.2.3. End Use
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Biosimilars Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
  • 3.3.3. Pipeline Analysis

Chapter 4. Biosimilars Market: Drug Class Business Analysis

• 4.1. Drug Class Market Share, 2024 & 2033
• 4.2. Drug Class Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Drug Class, 2021 to 2033 (USD Billion)
• 4.4. Monoclonal Antibodies (mAbs)
  • 4.4.1. Monoclonal Antibodies (mAbs) Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.5. Growth Factors & Hematopoietic Agents
  • 4.5.1. Growth Factors & Hematopoietic Agents Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.6. Insulin & Analogues
  • 4.6.1. Insulin & Analogues Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.7. Osteoporosis / Bone Metabolism Agents
  • 4.7.1. Osteoporosis / Bone Metabolism Agents Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.8. Others
  • 4.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 5. Biosimilars Market: Indication Business Analysis

• 5.1. Indication Market Share, 2024 & 2033
• 5.2. Indication Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Indication, 2021 to 2033 (USD Billion)
• 5.4. Autoimmune Disorders (RA, IBD, Psoriasis, Ankylosing Spondylitis)
  • 5.4.1. Autoimmune Disorders (RA, IBD, Psoriasis, Ankylosing Spondylitis) Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.5. Oncology (Breast, Colorectal, Lymphoma, Lung, Gastric)
  • 5.5.1. Oncology (Breast, Colorectal, Lymphoma, Lung, Gastric) Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.6. Diabetes Mellitus (Type 1 & Type 2)
  • 5.6.1. Diabetes Mellitus (Type 1 & Type 2) Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.7. Ophthalmic Disorders (Wet AMD, DME, RVO)
  • 5.7.1. Ophthalmic Disorders (Wet AMD, DME, RVO) Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.8. Hematologic / Rare Blood Disorders
  • 5.8.1. Hematologic / Rare Blood Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.9. Others
  • 5.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 6. Biosimilars Market: End Use Business Analysis

• 6.1. End Use Market Share, 2024 & 2033
• 6.2. End Use Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by End Use, 2021 to 2033 (USD Billion)
• 6.4. Hospitals
  • 6.4.1. Hospitals Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 6.5. Specialty Pharmacies
  • 6.5.1. Specialty Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 6.6. Online & Retail Channels
  • 6.6.1. Online & Retail Channels Market Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 7. Biosimilars Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2033
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
• 7.4. North America
  • 7.4.1. North America Biosimilars Market Estimates and Forecasts, By Country, 2021 - 2033 (USD Billion)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Type Disease Prevalence
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Framework
    • 7.4.2.5. U.S. Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Type Disease Prevalence
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Framework
    • 7.4.3.5. Canada Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Type Disease Prevalence
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Framework
    • 7.4.4.5. Mexico Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 7.5. Europe
  • 7.5.1. Europe Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Type Disease Prevalence
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Framework
    • 7.5.2.5. UK Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Type Disease Prevalence
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Framework
    • 7.5.3.5. Germany Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Type Disease Prevalence
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. Reimbursement Framework
    • 7.5.4.5. France Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Type Disease Prevalence
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Reimbursement Framework
    • 7.5.5.5. Italy Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Type Disease Prevalence
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Reimbursement Framework
    • 7.5.6.5. Spain Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Type Disease Prevalence
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Reimbursement Framework
    • 7.5.7.5. Denmark Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Type Disease Prevalence
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Reimbursement Framework
    • 7.5.8.5. Sweden Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Type Disease Prevalence
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Reimbursement Framework
    • 7.5.9.5. Norway Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Type Disease Prevalence
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Framework
    • 7.6.2.5. Japan Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Type Disease Prevalence
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Framework
    • 7.6.3.5. China Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Type Disease Prevalence
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Framework
    • 7.6.4.5. India Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Type Disease Prevalence
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Framework
    • 7.6.5.5. Australia Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Type Disease Prevalence
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Reimbursement Framework
    • 7.6.6.5. South Korea Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Type Disease Prevalence
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Reimbursement Framework
    • 7.6.7.5. Thailand Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 7.7. Latin America
  • 7.7.1. Latin America Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Type Disease Prevalence
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Reimbursement Framework
    • 7.7.2.5. Brazil Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Type Disease Prevalence
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Reimbursement Framework
    • 7.7.3.5. Argentina Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Type Disease Prevalence
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. Reimbursement Framework
    • 7.8.2.5. South Africa Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Type Disease Prevalence
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Reimbursement Framework
    • 7.8.3.5. Saudi Arabia Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Type Disease Prevalence
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. Reimbursement Framework
    • 7.8.4.5. UAE Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Type Disease Prevalence
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Reimbursement Framework
    • 7.8.5.5. Kuwait Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. Amgen Inc.
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. F Hoffman-La Roche Ltd
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Sandoz International GmbH
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Dr. Reddy's Laboratories
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Teva Pharmaceutical Industries Ltd
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Pfizer Inc.
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. Samsung Biopis
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. Biocon
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. Viatris Inc.
    • 8.5.9.1. Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Celltrion Healthcare Co.Ltd
    • 8.5.10.1. Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives
  • 8.5.11. AbbVie Inc.
    • 8.5.11.1. Overview
    • 8.5.11.2. Financial Performance
    • 8.5.11.3. Product Benchmarking
    • 8.5.11.4. Strategic Initiatives