단일클론항체 치료제(mABs) 시장

The market for monoclonal antibody therapeutics (mABs) is anticipated to expand from US$ 249.14 million in 2024 to US$ 619.6 million by 2031, reflecting a projected CAGR of 13.9% from 2025 to 2031.

Market Insights and Analyst Perspective:Intensive research and development efforts, along with a rising incidence of chronic diseases, are expected to significantly influence the forecast for the monoclonal antibody therapeutics (mABs) market in the upcoming years.

A monoclonal antibody (mAbs) is a uniform collection of antibodies that specifically target designated antigens. The manufacturing of therapeutic mAbs necessitates a mammalian expression system that provides the cellular machinery required for glycosylation, proper folding, orientation, and covalent binding of antibody peptide chains to create complete and biologically active molecules. Innovative antibody modalities, such as bispecific and trispecific antibodies, can recognize multiple epitopes on a single antigen, while single-domain antibodies can more easily penetrate tissues. These advanced antibody types can improve the efficacy of antibody therapeutics, thereby broadening their application areas. Additionally, these antibodies can form antibody-drug conjugates to enhance the targeting efficiency of chemotherapy agents towards specific cell types. The production of mAB-based drugs for various diseases is driving market growth. Strategic product launches by manufacturers present lucrative opportunities in the market. Moreover, the trend of combination drugs that include mABs is gaining traction in the mAbs therapeutic market.

Market Driver

Growth in Production of mAB-Based Drugs for Various Diseases

Monoclonal antibody therapeutics (mABs) are utilized to treat a diverse array of diseases, including cancer, autoimmune disorders, and metabolic conditions. These drugs, developed by biopharmaceutical companies and research institutions, have garnered significant attention in the global market due to their high specificity, effective targeting capabilities, and minimal toxicity and side effects. Consequently, an increase in the production capacity of mAB therapeutics is expected to propel the growth of the monoclonal antibody therapeutics (mABs) market.

Market Opportunity

Innovative Product Launches Through Strategic Developments by Manufacturers

Organic growth through product launches by manufacturers of therapeutic mABs is likely to enhance the monoclonal antibody therapeutics (mABs) market in the near future. In March 2022, Adagio Therapeutics, Inc. announced the launch of ADG20 (ADINTREVIMAB), the first monoclonal antibody to achieve primary endpoints with statistical significance for both pre-and post-exposure prophylaxis and treatment of COVID-19, seeking US Emergency Use Authorization (EUA).

Additionally, inorganic growth through mergers and acquisitions is expected to lead to the introduction of new therapeutic mABs. For example, in July 2023, Eli Lilly announced the acquisition of Versanis, a private clinical-stage biopharmaceutical company focused on treating cardiometabolic diseases. This acquisition allows Eli Lilly to access Versanis's core product portfolio, which includes a monoclonal antibody product named bimagrumab, currently being evaluated in the "BELIEVE Phase 2b study" as a standalone treatment and in combination with semaglutide for its potential to reduce fat mass, preserve muscle mass, and improve outcomes for individuals with obesity and related complications. These factors are anticipated to significantly contribute to the growth of the monoclonal antibody therapeutics (mABs) market in the coming years.

Monoclonal Antibody Therapeutics (mABs) Market Trends

Combination Drugs Featuring Monoclonal Antibodies (mABs)As per the National Institute of Health (NIH) 2021 report, Roche and Regeneron (pharmaceutical companies) initiated a phase 2/3 clinical trial to assess combination monoclonal antibodies for patients with mild to moderate COVID-19. They are evaluating "REGN-COV2," a cocktail drug that combines two monoclonal antibodies-casirivimab and imdevimab-for COVID-19 treatment. These companies anticipate that this combination mAB drug could reduce hospitalization by 70% and be particularly effective for children over 12 years old (weighing more than 40 kg). Researchers are actively exploring more therapeutic combinations of monoclonal antibodies. For instance, bamlanivimab and etesevimab developed by Eli Lilly demonstrated positive clinical outcomes for COVID-19 in 2022. Therefore, the trend of combination drugs utilizing monoclonal antibodies for various diseases is expected to gain significant traction in the monoclonal antibody therapeutics (mABs) market in the coming years.

Strategic Insights

Report Segmentation and Scope:The analysis of the monoclonal antibody therapeutics (mABs) market has been conducted by considering the following segments: product, application, and distribution channel.

The market is categorized by product into recombinant mABs, antibody-drug conjugates, bispecific and multispecific mABs, biosimilars, and others. By application, the monoclonal antibody therapeutics (mABs) market is segmented into oncology, autoimmune diseases, and others. The autoimmune diseases segment is further divided into rheumatoid arthritis, psoriasis, ulcerative colitis, and others. The distribution channel segmentation includes hospital pharmacies, retail pharmacies, and others.

In terms of product, the recombinant mABs segment held the largest share of the monoclonal antibody therapeutics (mABs) market in 2022. The antibody-drug conjugates segment is projected to exhibit the fastest CAGR of 18.5% during the forecast period. According to a report by ACS Publications, therapeutic recombinant monoclonal antibodies represent cutting-edge biomedical research aimed at developing effective strategies to treat a wide range of diseases for which no effective treatments currently exist. Tocilizumab is an example of a recombinant mAB used to treat arthritis, idiopathic arthritis, and rheumatoid arthritis (RA). Furthermore, recombinant mABs can also be utilized for treating autoimmune diseases and cancer. Bevacizumab is a recombinant mAB currently employed in the treatment of breast, lung, and colorectal cancers, as well as HIV-1, bacterial toxin infections/reactions, and infections from SARS-CoV-2 and the Ebola virus.

Antibody-drug conjugates (ADCs) are a rapidly emerging class of therapeutic agents that combine chemotherapy and immunotherapy. According to a NIH report, ADCs are primarily based on immunoglobulin G (IgG), with 13 ADCs having received approval from the US Food and Drug Administration (FDA) to date. Additionally, over 90 ADCs are currently in clinical development or trials.

Thus, the regulatory approvals of ADCs and ongoing clinical trials for treatment strategies targeting rare diseases are expected to drive the growth of the monoclonal antibody therapeutics (mABs) market, particularly in the antibody-drug conjugates segment during the forecast period.

Regional Analysis:Geographically, the Monoclonal Antibody Therapeutics (mABs) market report encompasses North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. In 2022, North America held the largest share of the global monoclonal antibody therapeutics (mABs) market. The Asia Pacific region is projected to experience the highest CAGR from 2022 to 2030. Within North America, the US represents the largest market share, benefiting from expedited product approval processes for mAB therapeutics. As of December 2019, 79 therapeutic mABs had been approved by the US FDA, according to a study published in the BioMed Central journal. Among these, 30 are intended for cancer treatment. In May 2021, the FDA granted EUA for a new therapeutic mAB-Sotrovimab-designed for outpatient use in treating individuals with severe COVID-19. In February 2022, the FDA issued EUA for bebtelovimab, developed by Eli Lilly and Company, targeting the Omicron variant. Additionally, etesevimab is another example of therapeutic mABs approved by the US FDA.

Monoclonal Antibody Therapeutics (mABs) Market Report Scope: Industry Developments and Future Opportunities:Several strategic initiatives by leading players in the monoclonal antibody therapeutics (mABs) market are outlined below:

In January 2023, AstraZeneca received approval for Evusheld in the European Union (EU). Evusheld is a combination of two long-acting antibodies-tixagevimab (AZD8895) and cilgavimab (AZD1061). The US government supported the development of this product through federal funding from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.

In August 2023, Regeneron Pharmaceuticals, Inc. entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to facilitate clinical development, manufacturing, and regulatory licensure for next-generation monoclonal antibody therapy against COVID-19. Under this agreement, Regeneron aims to collaborate with BARDA to evaluate, further develop, and manufacture this therapy, as well as conduct regulatory activities.

Competitive Landscape and Key Companies:Prominent companies in the monoclonal antibody therapeutics (mABs) market include GlaxoSmithKline, F. Hoffmann-La Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KGaA, and AstraZeneca. The monoclonal antibody therapeutics (mABs) market report includes an analysis of company positioning and concentration to assess the performance of key players in the market.

Table Of Contents

1. Introduction

• 1.1 Scope of the Study
• 1.2 Market Definition, Assumptions and Limitations
• 1.3 Market Segmentation

2. Executive Summary

• 2.1 Key Insights
• 2.2 Market Attractiveness Analysis

3. Research Methodology

4. Monoclonal Antibody Therapeutics Market Landscape

• 4.1 Overview
• 4.2 PEST Analysis
• 4.3 Ecosystem Analysis
  • 4.3.1 List of Vendors in the Value Chain

5. Monoclonal Antibody Therapeutics Market - Key Market Dynamics

• 5.1 Key Market Drivers
• 5.2 Key Market Restraints
• 5.3 Key Market Opportunities
• 5.4 Future Trends
• 5.5 Impact Analysis of Drivers and Restraints

6. Monoclonal Antibody Therapeutics Market - Global Market Analysis

• 6.1 Monoclonal Antibody Therapeutics - Global Market Overview
• 6.2 Monoclonal Antibody Therapeutics - Global Market and Forecast to 2030

7. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Product, 2020-2030

• 7.1 Overview
• 7.2 Recombinant Monoclonal Antibodies (mABs)
• 7.3 Antibody-Drug Conjugates
• 7.4 Bi-Multi Specific Monoclonal Antibodies (mABs)
• 7.5 Biosimilars
• 7.6 Others

8. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Application, 2020-2030

• 8.1 Overview
• 8.2 Cancer
• 8.3 Autoimmune Diseases
  • 8.3.1 Rheumatoid Arthritis (RA)
  • 8.3.2 Psoriasis
  • 8.3.3 Ulcerative Colitis
  • 8.3.4 Others
• 8.4 Others

9. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Distribution Channel, 2020-2030

• 9.1 Overview
• 9.2 Hospital Pharmacies
• 9.3 Retail Pharmacies
• 9.4 Others

10. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million), 2020-2030 - Geographical Analysis

• 10.1 North America
  • 10.1.1 North America Monoclonal Antibody Therapeutics Market Overview
  • 10.1.2 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts to 2030
  • 10.1.3 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Product
  • 10.1.4 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Application
  • 10.1.5 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Distribution Channel
  • 10.1.6 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Countries
    • 10.1.6.1 United States Monoclonal Antibody Therapeutics Market
      • 10.1.6.1.1 United States Monoclonal Antibody Therapeutics Market, by Product
      • 10.1.6.1.2 United States Monoclonal Antibody Therapeutics Market, by Application
      • 10.1.6.1.3 United States Monoclonal Antibody Therapeutics Market, by Distribution Channel
    • 10.1.6.2 Canada Monoclonal Antibody Therapeutics Market
      • 10.1.6.2.1 Canada Monoclonal Antibody Therapeutics Market, by Product
      • 10.1.6.2.2 Canada Monoclonal Antibody Therapeutics Market, by Application
      • 10.1.6.2.3 Canada Monoclonal Antibody Therapeutics Market, by Distribution Channel
    • 10.1.6.3 Mexico Monoclonal Antibody Therapeutics Market
      • 10.1.6.3.1 Mexico Monoclonal Antibody Therapeutics Market, by Product
      • 10.1.6.3.2 Mexico Monoclonal Antibody Therapeutics Market, by Application
      • 10.1.6.3.3 Mexico Monoclonal Antibody Therapeutics Market, by Distribution Channel
• 10.2 Europe
  • 10.2.1 Germany
  • 10.2.2 France
  • 10.2.3 Italy
  • 10.2.4 Spain
  • 10.2.5 United Kingdom
  • 10.2.6 Rest of Europe
• 10.3 Asia-Pacific
  • 10.3.1 Australia
  • 10.3.2 China
  • 10.3.3 India
  • 10.3.4 Japan
  • 10.3.5 South Korea
  • 10.3.6 Rest of Asia-Pacific
• 10.4 Middle East and Africa
  • 10.4.1 South Africa
  • 10.4.2 Saudi Arabia
  • 10.4.3 U.A.E
  • 10.4.4 Rest of Middle East and Africa
• 10.5 South and Central America
  • 10.5.1 Brazil
  • 10.5.2 Argentina
  • 10.5.3 Rest of South and Central America

11. Industry Landscape

• 11.1 Mergers and Acquisitions
• 11.2 Agreements, Collaborations, Joint Ventures
• 11.3 New Product Launches
• 11.4 Expansions and Other Strategic Developments

12. Competitive Landscape

• 12.1 Heat Map Analysis by Key Players
• 12.2 Company Positioning and Concentration

13. Monoclonal Antibody Therapeutics Market - Key Company Profiles

• 13.1 F. Hoffmann-La-Roche
  • 13.1.1 Key Facts
  • 13.1.2 Business Description
  • 13.1.3 Products and Services
  • 13.1.4 Financial Overview
  • 13.1.5 SWOT Analysis
  • 13.1.6 Key Developments
• 13.2 AstraZeneca
• 13.3 Bayer AG
• 13.4 Merck KGaA
• 13.5 GlaxoSmithKline plc
• 13.6 Amgen
• 13.7 Novartis AG
• 13.8 AbbVie Inc.
• 13.9 Janssen Pharmaceuticals
• 13.10 Bristol-Myers Squibb Company

14. Appendix

• 14.1 Glossary
• 14.2 About The Insight Partners
• 14.3 Market Intelligence Cloud