바이오시밀러 단클론항체 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 제품별, 용도별, 지역별, 경쟁별(2020-2030년)

The Global Biosimilar Monoclonal Antibodies Market was valued at USD 5.47 billion in 2024 and is projected to reach USD 10.83 billion by 2030, expanding at a CAGR of 12.03%. Biosimilar monoclonal antibodies (mAbs) represent a transformative segment in the biopharmaceutical industry due to their cost-effective nature and comparable efficacy to originator biologics. As biologic drugs become increasingly essential in treating conditions like cancer, autoimmune, and inflammatory diseases, biosimilar mAbs offer a promising alternative, especially given their affordability and accessibility. Though biosimilars are not identical to reference biologics, they are engineered to closely match in safety, efficacy, and quality. Their development through advanced recombinant DNA technology in living cells enables broader patient access and helps mitigate healthcare expenditures. As healthcare systems globally grapple with high biologic costs, biosimilar mAbs are gaining traction for their potential to alleviate economic burdens while maintaining therapeutic outcomes.

Key Market Drivers

Rising Cancer and Autoimmune Disorders

The global upsurge in cancer and autoimmune diseases has led to a growing demand for effective and affordable therapies, thereby propelling the biosimilar monoclonal antibodies (mAbs) market. Cancer, characterized by abnormal cell growth, continues to be a major cause of mortality, with the European Union reporting a 2.3% rise in new cases and a 2.4% increase in cancer-related deaths in 2022 compared to 2020. Similarly, autoimmune diseases are becoming more prevalent, heightening the necessity for targeted and cost-efficient treatments. Biosimilar mAbs have emerged as a valuable solution by providing therapeutic efficacy comparable to reference biologics at reduced costs. This market segment is increasingly crucial in balancing patient needs and healthcare affordability, driving its expansion in the global pharmaceutical landscape.

Key Market Challenges

Manufacturing Complexity

The production of biosimilar monoclonal antibodies (mAbs) is fraught with complexity due to their biological origins. These therapies are derived from living cells, introducing inherent variability in expression systems, cell lines, and culture conditions. Such variability can lead to slight differences between biosimilars and their reference biologics, complicating efforts to maintain consistent quality and biological performance. Ensuring equivalence in physicochemical properties, biological activity, and immunogenicity requires robust quality control and advanced analytical tools. Minor changes in the manufacturing process can significantly affect clinical outcomes, presenting a regulatory and developmental hurdle. This complexity results in higher development costs and prolonged timelines, emphasizing the need for substantial investments to achieve regulatory compliance and maintain product consistency.

Key Market Trends

Technological Advancements

Technological innovation is driving the evolution of biosimilar monoclonal antibodies (mAbs), transforming them into precision therapeutic tools. Advances in biotechnology and research have facilitated the development of biosimilars that closely replicate the safety and efficacy of originator biologics. These breakthroughs support the rise of personalized medicine by enabling therapies tailored to individual genetic and disease profiles. Concurrently, innovations in bioprocessing, such as enhanced cell culture methods and purification techniques, have significantly improved production efficiency and product quality. These developments not only reduce manufacturing costs but also ensure better patient outcomes. As a result, biosimilar mAbs are increasingly integrated into treatment regimens, bolstered by their improved accessibility, affordability, and alignment with modern medical strategies.

Key Market Players

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy's Laboratory

Report Scope: In this report, the Global Biosimilar Monoclonal Antibodies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biosimilar Monoclonal Antibodies Market, By Product:

• Infliximab
• Rituximab
• Abciximab
• Trastuzumab
• Adalimumab
• Bevacizumab
• Others

Biosimilar Monoclonal Antibodies Market, By Application:

• Oncology
• Chronic & Autoimmune Diseases
• Others

Biosimilar Monoclonal Antibodies Market, By Region:

• North America
• Asia-Pacific
• Europe
• Middle East & Africa
• South America

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Monoclonal Antibodies Market.

Available Customizations:

Global Biosimilar Monoclonal Antibodies Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, and Trends

4. Voice of Customer

5. Global Biosimilar Monoclonal Antibodies Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, Others)
  • 5.2.2. By Application (Oncology, Chronic & Autoimmune Diseases, Others)
  • 5.2.3. By Company (2024)
  • 5.2.4. By Region
• 5.3. Market Map

6. North America Biosimilar Monoclonal Antibodies Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Application
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Application
  • 6.3.2. Mexico Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Application
  • 6.3.3. Canada Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Application

7. Europe Biosimilar Monoclonal Antibodies Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Application
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Application
  • 7.3.2. Germany Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Application
  • 7.3.3. United Kingdom Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Application
  • 7.3.4. Italy Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Application
  • 7.3.5. Spain Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Application

8. Asia-Pacific Biosimilar Monoclonal Antibodies Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Application
  • 8.2.3. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Application
  • 8.3.2. India Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Application
  • 8.3.3. South Korea Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Application
  • 8.3.4. Japan Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Application
  • 8.3.5. Australia Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Application

9. South America Biosimilar Monoclonal Antibodies Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Application
  • 9.2.3. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Application
  • 9.3.2. Argentina Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Application
  • 9.3.3. Colombia Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Application

10. Middle East and Africa Biosimilar Monoclonal Antibodies Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Application
  • 10.2.3. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Application
  • 10.3.2. Saudi Arabia Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Application
  • 10.3.3. UAE Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Abbott
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Pfizer
• 14.3. Novartis AG
• 14.4. AbbVie, Inc.
• 14.5. Coherus BioSciences
• 14.6. Biocon Limited
• 14.7. Allergan plc.
• 14.8. Accord Healthcare limited.
• 14.9. Amgen inc.
• 14.10. Dr. Reddy's Laboratory

15. Strategic Recommendations

16. About Us & Disclaimer