바이오시밀러 단클론항체 시장 : 부문별 예측(2025-2030년)

The Biosimilar Monoclonal Antibodies Market was valued at USD 7.69 billion in 2023, expected to reach USD 9.47 billion in 2024, and is projected to grow at a CAGR of 23.19%, to USD 33.14 billion by 2030.

Biosimilar monoclonal antibodies represent a crucial evolution in therapeutic biotechnology, defined as lab-crafted molecules designed to mimic the efficacy of original biologics, specifically monoclonal antibodies. These biosimilars offer an effective, often more cost-efficient alternative in treating conditions like cancer, autoimmune disorders, and infectious diseases, driven by the global demand for affordable healthcare solutions. The necessity of these biosimilars lies in their potential to broaden patient access to life-saving treatments, reduce healthcare expenditure, and sustain healthcare systems under financial strain. Their application spans oncology, hematology, immunology, and neurology, with targeted end-use among hospitals, specialty clinics, and research institutes. The market's ascent is fueled by factors such as the expiration of patents for original biologics, supportive governmental regulatory frameworks, and increasing acceptance from healthcare practitioners and patients.

Key growth opportunities include ongoing advancements in analytical technologies and process optimizations that enhance biosimilar development, along with growing investments in biotech startups and established pharmaceutical firms capitalizing on the lucrative biosimilar space. Meanwhile, the market faces limitations such as high R&D costs, complexities in manufacturing processes, stringent regulatory requirements, and challenges in achieving interchangeability consensus among stakeholders. To overcome these barriers, innovation in areas such as improved production processes, biosimilar antibody conjugates, and personalized therapies are promising. Businesses should focus on strategic partnerships and collaborations for clinical trials and market access. Furthermore, regional markets offering competitive manufacturing advantages, such as Asia-Pacific, present opportunities for expansion. Thorough market analysis indicates that while the biosimilar monoclonal antibody market is robust with growth potential, success hinges on innovators' ability to navigate regulatory landscapes, enhance product quality, and effectively demonstrate cost-benefit to healthcare providers. This insight underscores the dynamic nature of the market, highlighting its readiness for continued evolution and innovation-driven growth.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biosimilar Monoclonal Antibodies Market

The Biosimilar Monoclonal Antibodies Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Increasing prevalence of cost-efficient biosimilar monoclonal antibodies
  • Growth in geriatric population and rising incidence of cancer and other chronic diseases
  • Increasing healthcare expenditure in economies
• Market Restraints
  • Government regulations towards the absence of pre-analytical tests
• Market Opportunities
  • Rising number of inorganic strategies for the expansion of production facility
  • Focus on R&D to introduce innovative product pipeline
• Market Challenges
  • Complexities associated with manufacturing processes

Porter's Five Forces: A Strategic Tool for Navigating the Biosimilar Monoclonal Antibodies Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biosimilar Monoclonal Antibodies Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Biosimilar Monoclonal Antibodies Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biosimilar Monoclonal Antibodies Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Biosimilar Monoclonal Antibodies Market

A detailed market share analysis in the Biosimilar Monoclonal Antibodies Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Biosimilar Monoclonal Antibodies Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biosimilar Monoclonal Antibodies Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Biosimilar Monoclonal Antibodies Market

A strategic analysis of the Biosimilar Monoclonal Antibodies Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Biosimilar Monoclonal Antibodies Market, highlighting leading vendors and their innovative profiles. These include 3SBio Inc., AbbVie, Inc., Amgen Inc., Biocon Limited, BioXpress Therapeutics SA, C.H. Boehringer Sohn AG & Co. KG, Celltrion Healthcare Co Ltd., Coherus BioSciences, Inc., Dr. Reddy's Laboratories Ltd, Genor BioPharma Co. Ltd, Hisun Pharmaceutical, Intas Pharmaceuticals Limited, Novartis AG, Pfizer, Inc., Reliance Life Sciences, and Samsung Biologics.

Market Segmentation & Coverage

This research report categorizes the Biosimilar Monoclonal Antibodies Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Drug Class, market is studied across Abciximab, Adalimumab, Bevacizumab, Infliximab, Rituximab, and Trastuzumab.
• Based on Application, market is studied across Diagnostic, Protein Purification, and Therapeutic. The Diagnostic is further studied across MABs in Biochemical Analysis and MABs in Diagnostic Imaging. The MABs in Biochemical Analysis is further studied across Cancers, Hormonal Disorders, Infectious Diseases, and Pregnancy. The MABs in Diagnostic Imaging is further studied across Atherosclerosis, Bacterial Infections, Cancers, Cardiovascular Diseases, and Deep Vein Thrombosis. The Therapeutic is further studied across MABs as Direct Therapeutic Agents and MABs as Targeting Agents in Therapy.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Increasing prevalence of cost-efficient biosimilar monoclonal antibodies
    • 5.1.1.2. Growth in geriatric population and rising incidence of cancer and other chronic diseases
    • 5.1.1.3. Increasing healthcare expenditure in economies
  • 5.1.2. Restraints
    • 5.1.2.1. Government regulations towards the absence of pre-analytical tests
  • 5.1.3. Opportunities
    • 5.1.3.1. Rising number of inorganic strategies for the expansion of production facility
    • 5.1.3.2. Focus on R&D to introduce innovative product pipeline
  • 5.1.4. Challenges
    • 5.1.4.1. Complexities associated with manufacturing processes
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Biosimilar Monoclonal Antibodies Market, by Drug Class

• 6.1. Introduction
• 6.2. Abciximab
• 6.3. Adalimumab
• 6.4. Bevacizumab
• 6.5. Infliximab
• 6.6. Rituximab
• 6.7. Trastuzumab

7. Biosimilar Monoclonal Antibodies Market, by Application

• 7.1. Introduction
• 7.2. Diagnostic
  • 7.2.1. MABs in Biochemical Analysis
    • 7.2.1.1. Cancers
    • 7.2.1.2. Hormonal Disorders
    • 7.2.1.3. Infectious Diseases
    • 7.2.1.4. Pregnancy
  • 7.2.2. MABs in Diagnostic Imaging
    • 7.2.2.1. Atherosclerosis
    • 7.2.2.2. Bacterial Infections
    • 7.2.2.3. Cancers
    • 7.2.2.4. Cardiovascular Diseases
    • 7.2.2.5. Deep Vein Thrombosis
• 7.3. Protein Purification
• 7.4. Therapeutic
  • 7.4.1. MABs as Direct Therapeutic Agents
  • 7.4.2. MABs as Targeting Agents in Therapy

8. Americas Biosimilar Monoclonal Antibodies Market

• 8.1. Introduction
• 8.2. Argentina
• 8.3. Brazil
• 8.4. Canada
• 8.5. Mexico
• 8.6. United States

9. Asia-Pacific Biosimilar Monoclonal Antibodies Market

• 9.1. Introduction
• 9.2. Australia
• 9.3. China
• 9.4. India
• 9.5. Indonesia
• 9.6. Japan
• 9.7. Malaysia
• 9.8. Philippines
• 9.9. Singapore
• 9.10. South Korea
• 9.11. Taiwan
• 9.12. Thailand
• 9.13. Vietnam

10. Europe, Middle East & Africa Biosimilar Monoclonal Antibodies Market

• 10.1. Introduction
• 10.2. Denmark
• 10.3. Egypt
• 10.4. Finland
• 10.5. France
• 10.6. Germany
• 10.7. Israel
• 10.8. Italy
• 10.9. Netherlands
• 10.10. Nigeria
• 10.11. Norway
• 10.12. Poland
• 10.13. Qatar
• 10.14. Russia
• 10.15. Saudi Arabia
• 10.16. South Africa
• 10.17. Spain
• 10.18. Sweden
• 10.19. Switzerland
• 10.20. Turkey
• 10.21. United Arab Emirates
• 10.22. United Kingdom

11. Competitive Landscape

• 11.1. Market Share Analysis, 2023
• 11.2. FPNV Positioning Matrix, 2023
• 11.3. Competitive Scenario Analysis
• 11.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. 3SBio Inc.
• 2. AbbVie, Inc.
• 3. Amgen Inc.
• 4. Biocon Limited
• 5. BioXpress Therapeutics SA
• 6. C.H. Boehringer Sohn AG & Co. KG
• 7. Celltrion Healthcare Co Ltd.
• 8. Coherus BioSciences, Inc.
• 9. Dr. Reddy's Laboratories Ltd
• 10. Genor BioPharma Co. Ltd
• 11. Hisun Pharmaceutical
• 12. Intas Pharmaceuticals Limited
• 13. Novartis AG
• 14. Pfizer, Inc.
• 15. Reliance Life Sciences
• 16. Samsung Biologics