단클론항체 시장 규모, 점유율, 예측 및 동향 분석 : 제품 유형, 용도, 공급원, 생산 및 최종 사용자별 - 세계 예측(-2031년)

Monoclonal Antibodies Market Size, Share, Forecast, & Trends Analysis by Type (Therapeutic, Research, Diagnostic) Application (Oncology, Immunology, Cardiology, Neurology), Source (Humanized, Murine, Human), Production, End User-Global Forecast to 2031

The global monoclonal antibodies market is projected to reach $449.8 billion by 2031 at a CAGR of 11.2% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the monoclonal antibodies market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. The growth of the monoclonal antibodies market is driven by the high burden of cancer and autoimmune diseases globally, increasing funding for clinical trials and research, growth in the biopharmaceutical industry, rising prevalence of infectious diseases, and increasing research in proteomics and genomics. However, the availability of alternative diagnostic tests and the high costs & time required for antibody development restrain the market's growth.

Furthermore, increasing R&D investments by pharmaceutical & biotech companies, expanding applications of antibodies in clinical trials and medical research, increasing research activities in developing countries, the rising need for new biomarker identification, and initiatives aimed at enhancing diagnostic testing are expected to create market growth opportunities. However, the inaccuracy of antibody tests, high manufacturing costs, concerns regarding the quality & stability of research antibodies, and complexities in the production process are some of the challenges impeding the market's growth.

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over four years (2020-2024). The key players operating in the monoclonal antibodies market are Novartis AG (Switzerland), Pfizer Inc. (U.S.), F. Hoffmann-La Roche AG (Switzerland), AbbVie Inc. (U.S.), Amgen Inc. (U.S.), Bristol-Myers Squibb (U.S.), GSK plc (U.K.), Merck KGaA (Germany), Eli Lilly and Company (U.S.), AstraZeneca plc (U.K.), Johnson & Johnson (U.S.), Takeda Pharmaceutical Company Limited (Japan), Daiichi Sankyo Company (Japan), Biogen (U.S.), and Thermo Fisher Scientific Inc. (U.S.).

Among the types covered in this report, in 2024, the therapeutic monoclonal antibodies segment is expected to account for the largest share of over 90.2% of the monoclonal antibodies market. The therapeutic monoclonal antibodies segment is further sub-segmented into oncology, autoimmune diseases, neurological diseases, infectious diseases, and other therapeutic areas. The large market share of this segment is attributed to the increasing approvals for the therapeutical monoclonal antibodies, rising demand for biosimilars, increasing prevalence of target disease, technological advancements in the formulation of antibodies, an increasing number of pipeline products, and fewer side effects of monoclonal antibodies. Additionally, with the increasing prevalence of cancer, the demand for monoclonal antibodies is also increasing for personalized cancer therapies. According to GLOBOCAN, the prevalence of cancer is expected to increase by 63.4% in 2045 from 2022.

Among the production processes covered in this report, in 2024, the in vitro process segment is expected to account for the largest share of the monoclonal antibodies market. The in vitro segment is further segmented into upstream process and downstream process. The in vitro process scales up antibody production without reliance on animal models and animal testing. It increases the production of MABs and also mitigates the ethical concerns associated with the use of animals, thus preferred over the in vivo process.

Among the sources covered in this report, in 2024, the human segment is expected to account for the largest share of the monoclonal antibodies market. Human sources are preferred for the production of monoclonal antibodies to increase treatment efficiency by reducing the risk of immunogenicity or adverse immune response. Key players are also using human sources for the development of monoclonal antibodies to improve the safety profile of MABs, production of stable human hybridomas, and ease of scaling up production.

Among the end users covered in this report, the hospitals segment is expected to account for the largest share of the monoclonal antibodies market. The large market share of this segment is attributed to the availability of MAB therapies in hospitals, the increasing number of hospitals in emerging economies, and the launch of dedicated monoclonal antibody facilities by hospitals.

An in-depth analysis of the geographical scenario of the global monoclonal antibodies market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region.

In 2024, North America is expected to account for the largest share of over 34.9% of the monoclonal antibodies market. The largest share of the regional market is attributed to the presence of key players, availability of advanced antibody engineering technology, rising number of approvals, and supportive government initiatives for the development and use of monoclonal antibodies. For instance, in September 2023, the U.S. Department of Health and Human Services announced an initiative to give underinsured and uninsured Americans access to the COVID-19 monoclonal antibody treatment bebtelovimab even after the product availability in the commercial market.

Scope of the Report:

Monoclonal Antibodies Market Assessment-by Type

• Research Monoclonal Antibodies
  • Research Area
• Oncology
• Infectious Diseases
• Cardiology
• Immunology
• Neurology
• Stem Cell Research
• Other Research Areas
  • Application
• Proteomics
• Drug Discovery & Development
• Genomics
  • Technology
• Flow Cytometry
• Immunofluorescence
• Enzyme-Linked Immunosorbent Assay
• Multiplex Immunosorbent Assay
• Western Blot
• Immunohistochemistry
• Immunoprecipitation (IP)
• Other Research Technologies
• Diagnostic Monoclonal Antibodies
  • Application
• Oncology
• Infectious Diseases
• Pregnancy Detection/Fertility Testing
• Cardiac Marker Testing
• Other Diagnostic Applications
  • Technology
• ELISA
• Lateral Flow Assay
• Immunohistochemistry (IHC)
• Immunoprecipitation (IP)
• Western Blot (WB)
• Immunocytochemistry (ICC)
• Other Diagnostic Technologies
• Therapeutic Monoclonal Antibodies
  • Therapeutic Area
• Oncology
• Autoimmune Diseases
• Neurological Diseases
• Infectious Diseases
• Other Therapeutic Areas
  • Route of Administration
• Subcutaneous
• Intravenous

Note: 1) Other Research Areas include Ophthalmology and Rare Diseases

2) Other Research Technologies include electrophoretic mobility shift assay (EMSA) and enzyme-linked immunospot (ELISPOT) assay

3) Other Diagnostic Applications include Alzheimer's, autoimmune diseases, cardiac diseases, and diabetes.

4) Other Diagnostic Technologies include Immunofluorescence, flow cytometry, in situ hybridization, dot blot, and radioimmunoassay.

5) Other Therapeutic Areas include cardiac diseases, diabetes, ophthalmology, and hematology

Monoclonal Antibodies Market Assessment-by Production Process

• In Vivo Process
• In Vitro Process
  • Upstream Process
  • Downstream Process

Monoclonal Antibodies Market Assessment-by Source

• Human
• Humanized
• Murine
• Chimeric
• Other Sources

Note: Other Sources include goat, sheep, chicken, and llama

Monoclonal Antibodies Market Assessment-by End User

• Pharmaceutical & Biotechnology Companies
• Hospitals
• Contract Research Organizations
• Other End Users

Note: Other End Users include academic & research institutes, nursing centers, and long-term care centers

Monoclonal Antibodies Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K
  • Italy
  • Spain
  • Switzerland
  • Belgium
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency and Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Process of Data Collection & Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
• 2.3. Market Sizing and Forecasting
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Drivers
  • 4.2.1. High Burden of Cancer and Autoimmune Diseases Globally
  • 4.2.2. Increasing Funding for Clinical Trials and Research
  • 4.2.3. Growth in the Biopharmaceutical Industry
  • 4.2.4. Rising Proteomics and Genomics Research Studies
  • 4.2.5. Rising Prevalence of Infectious Diseases
• 4.3. Restraints
  • 4.3.1. Availability of Alternative Diagnostic Tests
  • 4.3.2. High Costs & Time Required for Antibody Development
• 4.4. Opportunities
  • 4.4.1. Expanding Applications of Antibodies in Clinical Trials and Medical Research
  • 4.4.2 Increasing Research Activities in Developing Countries
  • 4.4.3. Increasing Need for New Biomarker Identification
  • 4.4.4. Initiatives Aimed at Enhancing Diagnostic Testing
  • 4.4.5. Increasing R&D Investments by Pharmaceutical & Biotech Companies
• 4.5. Challenges
  • 4.5.1. Inaccuracy of Antibody Tests
  • 4.5.2. High Manufacturing Costs
  • 4.5.3. Concerns Regarding the Quality & Stability of Research Antibodies
  • 4.5.4. Complexities in the Production Process
• 4.6. Factor Analysis
• 4.7. Trends
  • 4.7.1. Increasing Focus on Personalized Medicine
  • 4.7.2. Advancements in Antibody Engineering
  • 4.7.3. Integration of Artificial Intelligence in Monoclonal Antibody Production
  • 4.7.4. Use of Humanized Mouse Models
• 4.8. Regulatory Analysis
• 4.9. Pricing Analysis
• 4.10. Pipeline Analysis
• 4.11. Porter's Five Force Analysis

5. Monoclonal Antibodies Market Assessment-by Type

• 5.1. Overview
• 5.2. Research Monoclonal Antibodies
  • 5.2.1. Research Area
    • 5.2.1.1. Oncology
    • 5.2.1.2. Infectious Diseases
    • 5.2.1.3. Cardiology
    • 5.2.1.4. Immunology
    • 5.2.1.5. Neurology
    • 5.2.1.6. Stem Cell Research
    • 5.2.1.7. Other Research Areas
  • 5.2.2. Application
    • 5.2.2.1. Proteomics
    • 5.2.2.2. Drug Discovery & Development
    • 5.2.2.3. Genomics
  • 5.2.3. Technology
    • 5.2.3.1. Flow Cytometry
    • 5.2.3.2. Immunofluorescence
    • 5.2.3.3. Enzyme-Linked Immunosorbent Assay
    • 5.2.3.4. Multiplex Immunosorbent Assay
    • 5.2.3.5. Western Blot
    • 5.2.3.6. Immunohistochemistry
    • 5.2.3.7. Immunoprecipitation (IP)
    • 5.2.3.8. Other Research Technologies
• 5.3. Diagnostic Monoclonal Antibodies
  • 5.3.1. Application
    • 5.3.1.1. Oncology
    • 5.3.1.2. Infectious Diseases
    • 5.3.1.3. Pregnancy Detection/Fertility Testing
    • 5.3.1.4. Cardiac Marker Testing
    • 5.3.1.5. Other Diagnostic Applications
  • 5.3.2. Technology
    • 5.3.2.1. ELISA
    • 5.3.2.2. Lateral Flow Assay
    • 5.3.2.3. Immunohistochemistry (IHC)
    • 5.3.2.4. Immunoprecipitation (IP)
    • 5.3.2.5. Western Blot (WB)
    • 5.3.2.6. Immunocytochemistry (ICC)
    • 5.3.2.7. Other Diagnostic Technologies
• 5.4. Therapeutic Monoclonal Antibodies
  • 5.4.1. Therapeutic Area
    • 5.4.1.1. Oncology
    • 5.4.1.2. Autoimmune Diseases
    • 5.4.1.3. Neurological Diseases
    • 5.4.1.4. Infectious Diseases
    • 5.4.1.5. Other Therapeutic Areas
  • 5.4.2. Route of Administration
    • 5.4.2.1. Subcutaneous
    • 5.4.2.2. Intravenous

6. Monoclonal Antibodies Market Assessment-by Production Process

• 6.1. Overview
• 6.2. In Vivo Process
• 6.3. In Vitro Process
  • 6.3.1. Upstream Process
  • 6.3.2. Downstream Process

7. Monoclonal Antibodies Market Assessment-by Source

• 7.1. Overview
• 7.2. Human
• 7.3. Humanized
• 7.4. Murine
• 7.5. Chimeric
• 7.6. Other Sources

8. Monoclonal Antibodies Market Assessment-by End User

• 8.1. Overview
• 8.2. Pharmaceutical & Biotechnology Companies
• 8.3. Hospitals
• 8.4. Contract Research Organizations (CROs)
• 8.5. Other End Users

9. Monoclonal Antibodies Market Assessment-by Geography

• 9.1. Overview
• 9.2. North America
  • 9.2.1. U.S.
  • 9.2.2. Canada
• 9.3. Europe
  • 9.3.1. Germany
  • 9.3.2. France
  • 9.3.3. U.K.
  • 9.3.4. Italy
  • 9.3.5. Spain
  • 9.3.6. Switzerland
  • 9.3.7. Belgium
  • 9.3.8. Rest of Europe (RoE)
• 9.4. Asia-Pacific
  • 9.4.1. Japan
  • 9.4.2. China
  • 9.4.3. India
  • 9.4.4. South Korea
  • 9.4.5. Rest of Asia-Pacific (RoAPAC)
• 9.5. Latin America
  • 9.5.1. Brazil
  • 9.5.2. Mexico
  • 9.5.3. Rest of Latin America (RoLATAM)
• 9.6. Middle East & Africa

10. Competition Analysis

• 10.1. Overview
• 10.2. Key Growth Strategies
• 10.3. Competitive Benchmarking
• 10.4. Competitive Dashboard
  • 10.4.1. Industry Leaders
  • 10.4.2. Market Differentiators
  • 10.4.3. Vanguards
  • 10.4.4. Emerging Companies
• 10.5. Market Share Analysis/Market Ranking, by Key Players (2023)

11. Company Profiles (Company Overview, Financial Overview, Product Portfolio, Strategic Developments, and SWOT Analysis)

• 11.1. Novartis AG
• 11.2. Pfizer Inc.
• 11.3. F. Hoffmann-La Roche AG
• 11.4. AbbVie Inc.
• 11.5. Amgen Inc.
• 11.6. Bristol-Myers Squibb
• 11.7. GSK plc
• 11.8. Merck KGaA
• 11.9. Eli Lilly and Company
• 11.10. AstraZeneca plc
• 11.11 Johnson & Johnson
• 11.12. Takeda Pharmaceutical Company Limited
• 11.13. Daiichi Sankyo Company
• 11.14. Biogen
• 11.15. Thermo Fisher Scientific Inc.

(Note: SWOT analysis of the top 5 companies will be provided.)

12. Appendix

• 12.1. Available Customization
• 12.2. Related Reports