세계의 단일클론항체 치료제 시장(2023-2030년)

Market Overview

The Global Monoclonal Antibody Therapeutics Market reached US$ 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 531,314.6 million by 2030. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2023-2030).

Monoclonal antibody therapeutics (mAbs) are generated from identical antibodies (or simply antibody fragments) in a homogeneous manner. The antigen recognition site, biological interactions, affinity and downstream biologic consequences of every antibody molecule in the product are identical. This sets mAbs apart from polyclonal antibodies, which have a diverse range of protein sequences and epitope recognition

The global market for monoclonal antibody therapeutics is expanding as a result of factors including the increasing prevalence of autoimmune disorders, the growing size of the therapeutic pipeline, investment by biopharmaceutical companies and their upcoming medical approvals across countries are also creating a positive outlook for the monoclonal antibody therapeutics market growth.

Market Dynamics

Increasing Regulatory Approvals and Launch of Therapies Drive the Growth of the Monoclonal Antibody Therapeutics Market

The growing number of regulatory approvals by various regulatory bodies for different monoclonal antibodies therapeutics utilized for cancer or autoimmune diseases, the growing clinical trials by major biopharmaceutical companies, an increase in the population with cancer, and new, innovative, technologically sophisticated therapies are all contributing to the growth of the global market for monoclonal antibody therapeutics.

Furthermore, on January 5, 2023, Nirsevimab's Biologics License Application (BLA) was approved by the U.S. FDA, Center for Drug Evaluation and Research for the treatment of children up to 24 months old who are still susceptible to developing severe respiratory syncytial virus (RSV) disease throughout the second RSV season as well as for infants and newborns entering or already experiencing their first RSV season. Hence, the growing number of novel therapies launched by biopharmaceutical companies is driving the monoclonal antibody therapeutics market.

The Growing Investments in Research and Development by Biotechnology Companies Create Lucrative Opportunities for Manufacturers

Due to increasing spending or investments in research and development capabilities by key players or biotechnology businesses for unique technological breakthroughs, there is a growing market opportunity for monoclonal antibody therapeutics. Another trend driving the monoclonal antibody therapies market is the increasing occurrence of respiratory diseases.

Furthermore, in April 2023, early experiments conducted by researchers at Janssen Biotech, Inc. and NYU Grossman School of Medicine demonstrated that a bioengineered medication candidate can prevent infection with the bacterium species Staphylococcus aureus.

It details the preliminary evaluation of mAbtyrins, a combination molecule derived from an engineered human monoclonal antibody (mAb), a kind of protein that adheres to and identifies S. aureus for uptake and eradication by immune cells. Centyrins, tiny proteins that are attached to the mAb, stop these germs from drilling holes in the human immune cells where they hide.

Higher Costs and Strict Regulatory Measures will Hamper the Growth of the Market.

However, biotherapeutics, including monoclonal antibodies and recombinant proteins, which have grown into the foundation of contemporary medicine, are still largely beyond reach for populations in middle- and low-income countries, in part due to their high costs, despite often providing clinical benefits over the standard of care is a restraint for monoclonal antibody therapeutics market.

The average yearly cost of a mAb was $96,731, and for 34 mAb-indication combos, it exceeded $100,000. Despite making up 40% of the approved mAb-indication combinations, hematology and oncology mAbs accounted for over 85 percent of those with a price tag of $100,000 or higher. Hence these above mentioned factors are limiting the monoclonal antibody therapeutics market's growth.

COVID-19 Impact Analysis

The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.

These therapeutic monoclonal antibodies were also used to control COVID-19. For instance, on February 11, 2022, Eli Lilly and Company announced that Bebtelovimab, an antibody that exhibits neutralization against the Omicron variant, received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global monoclonal antibody therapeutics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global monoclonal antibody therapeutics market growth over the forecast period.

Segment Analysis

The global monoclonal antibody therapeutics market is segmented based on product type, application, production source, distribution channel and region.

Humanoid from the Production Source Segment Accounts for 45.79% of the Market Share Owing to Rising Novel Product Launches.

A humanized antibody possesses three advantages over a native mouse mAb: it is less immunogenic (since the immune response is primarily directed against the mouse Ig constant region); it can perform human effector functions; and its serum half-life in humans is significantly longer. Researchers have extracted the mouse CDRs targeted against a relevant human antigen and assembled them in a human antibody framework to further humanize these antibodies.

A humanized IgG4 anti-PD-1 monoclonal antibody called tislelizumab is being researched as a monotherapy and in conjunction with other treatments. Treatment of inoperable recurrent metastatic or locally progressed esophageal squamous cell carcinoma (ESCC) is possible in patients who had previously received systemic therapy with the anti-PD-1 immune checkpoint inhibitor tislelizumab.

Geographical Analysis

North America Accounted for Approximately 40.2% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Manufacturers have chances to expand their operations in this region because of the rising demand for monoclonal antibody therapeutics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of monoclonal antibody therapeutics, which has increased the demand.

North America has a large number of producers and suppliers, and as a result of the swift economic development of the area, industrial production has increased, fueling the demand for monoclonal antibody therapeutics.

Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals, and novel product launches. Researchers are becoming more aware of various kinds of treatment approaches for cancer or various other disorders, leading to the expansion of the market in this region.

Competitive Landscape

The major global players in the monoclonal antibody therapeutics market include: F. Hoffmann-La Roche, Sanofi, Merck & Co. Inc., Pfizer Inc., GSK Plc, Eli Lily and Co., Regeneron Pharmaceuticals Inc., AstraZeneca, and Bayers AG among others.

Why Purchase the Report?

• To visualize the global monoclonal antibody therapeutics market segmentation based on product type, application, production source, end user and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of monoclonal antibody therapeutics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global monoclonal antibody therapeutics market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product Type
• 3.2. Snippet by Application
• 3.3. Snippet by End User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Regulatory Approvals and Launch of Therapies
    • 4.1.1.2. Rising Incidence of Cancer and Other Chronic Diseases
  • 4.1.2. Restraints
    • 4.1.2.1. Higher Costs and Strict Regulatory Measures
  • 4.1.3. Opportunity
    • 4.1.3.1. The Growing Investments in Research and Development by Biotechnology Companies
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's 5 Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID-19
  • 6.1.2. Scenario During COVID-19
  • 6.1.3. Scenario Post COVID-19
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Product Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 7.1.2. Market Attractiveness Index, By Product Type
• 7.2. Naked *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Fusion Protein
• 7.4. Antibody Fragment
• 7.5. Conjugate
• 7.6. Multi-specific

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Cancer *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Autoimmune Diseases
• 8.4. Infectious Diseases
• 8.5. Others

9. By Production Source

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 9.1.2. Market Attractiveness Index, By Production Source
• 9.2. Human *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Humanized
• 9.4. Chimeric
• 9.5. Others

10. By End User

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.1.2. Market Attractiveness Index, By End User
• 10.2. Hospital *
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Specialty Centers
• 10.4. Research Institutes

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. The U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.7.1. Germany
    • 11.3.7.2. The U.K.
    • 11.3.7.3. France
    • 11.3.7.4. Italy
    • 11.3.7.5. Spain
    • 11.3.7.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.7.1. Brazil
    • 11.4.7.2. Argentina
    • 11.4.7.3. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.7.1. China
    • 11.5.7.2. India
    • 11.5.7.3. Japan

Australia

• 11.5.7.4. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. F. Hoffmann-La Roche *
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. Novartis AG
• 13.3. Merck & Co. Inc.
• 13.4. Pfizer Inc.
• 13.5. Eli Lilly and Co. (Lilly)
• 13.6. Sanofi
• 13.7. AstraZeneca
• 13.8. Bayer AG
• 13.9. Regeneron Pharmaceuticals Inc.
• 13.10. GSK Plc

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us