Monoclonal Antibody Therapeutics Market by Source, End User, Application

Description

List of Tables

[187 Pages Report] The Monoclonal Antibody Therapeutics Market size was estimated at USD 153.35 billion in 2023 and expected to reach USD 169.87 billion in 2024, at a CAGR 11.34% to reach USD 325.37 billion by 2030.

Monoclonal antibody (mAb) therapeutics involves the use of antibodies engineered in the laboratory to mimic the immune system's ability to target and destroy harmful pathogens such as viruses and bacteria. Monoclonal antibodies are designed to target and neutralize specific pathogens, making them highly effective in the treatment of a variety of diseases, including cancer, autoimmune diseases, infectious diseases, and cardiovascular disorders. The growing incidence of chronic diseases worldwide, such as cancer and autoimmune disorders, significantly drives the need for monoclonal antibody therapeutics due to their specificity and efficacy in treatment. Numerous government programs and funding opportunities for research and development in biopharmaceuticals have positively impacted the monoclonal antibody therapeutics market. However, transitioning from small-scale laboratory production to large-scale commercial production presents challenges, including maintaining product quality and consistency. The potential of monoclonal antibodies to trigger immune responses in patients and other performance limitations affects efficacy and safety profiles. Key players are enhancing the therapeutic efficacy of monoclonal antibodies by conjugating them with potent cytotoxic to improve the treatment of cancers and other severe diseases. Innovations in bioprocessing, such as continuous manufacturing and single-use technologies, can address current production and scalability challenges, reducing costs and improving accessibility. Moreover, the shift towards personalized medicine and the incorporation of antibody-drug conjugates for the treatment of various diseases has further created new avenues of opportunities for monoclonal antibody therapeutics.

KEY MARKET STATISTICS
Base Year [2023]	USD 153.35 billion
Estimated Year [2024]	USD 169.87 billion
Forecast Year [2030]	USD 325.37 billion
CAGR (%)	11.34%

Source: Rising prevalence of human monoclonal antibodies due to their lower immunogenicity

Chimeric monoclonal antibodies are engineered antibodies where the majority of the antibody molecule is derived from human sources, with a minor portion being sourced from non-human species, typically mice. This combination reduces immunogenicity compared to fully murine monoclonal antibodies while retaining the desired antigen specificity. Human monoclonal antibodies are sourced from human genes and proteins. This approach significantly decreases the potential for immunogenic reactions, making these antibodies more compatible with human immune systems. They are produced using techniques such as phage display or transgenic mice engineered to produce human antibodies, offering high specificity and safety in therapeutic applications. Humanized monoclonal antibodies are created by grafting the non-human antibody's complementarity-determining regions (the specific parts that bind to the antigen) onto a human antibody framework. This method maintains the antibody's specificity towards its target while significantly reducing its immunogenicity. Humanized antibodies balance retaining the desired activity of non-human antibodies and minimizing potential immune responses against them.

End User: Increasing adoption in hospitals necessity for precise diagnostic oversight and administration typically involving intravenous infusion

In hospitals, monoclonal antibody therapeutics are used to manage and treat chronic illnesses such as cancer, autoimmune diseases, and infectious diseases. This utilization stems from their ability to specifically target diseased cells or pathogens without affecting surrounding healthy tissues, thus limiting side effects and promoting rapid patient recovery. In private clinics, these therapeutics find application primarily in treating patients with conditions that require personalized care protocols, including rheumatoid arthritis, psoriasis, and other autoimmune disorders. The precision of monoclonal antibodies allows for tailored treatments, enhancing the effectiveness of therapy and improving patient outcomes. Research institutes leverage monoclonal antibody therapeutics as pivotal tools in advancing medical science. They are crucial for the development of new treatment modalities and the understanding of disease mechanisms. These institutes focus on innovating and improving monoclonal antibody technologies, thus paving the way for the next generation of therapies in various fields of medicine.

Regional Insights

The Americas region, particularly the U.S. and Canada, presents a highly evolved and developed landscape for monoclonal antibody therapeutics, attributed to pioneering research facilities, substantial healthcare spending, and a robust patent environment that protects innovations. Consumer needs in the U.S. are largely driven by a requirement for effective and targeted therapies for cancer, autoimmune diseases, and other chronic conditions. The U.S. Food and Drug Administration (FDA) has been proactive in approving monoclonal antibody treatments, further stimulating market growth. Recent investments mainly focus on cancer research, with biotech companies and the government funding innovative treatments. The European Union (EU) countries contribute significantly to the global monoclonal antibody therapeutics market. High-quality healthcare systems, extensive research networks, and favorable government policies support market growth in the region. Consumer needs in the EU are characterized by an increasing preference for personalized medicine and innovative treatment options. The European Medicines Agency (EMA) facilitates the approval of new therapies, with recent focus areas including oncology and immunology. Stringent regulations for the performance, safety, efficacy, and production of monoclonal antibodies provide a standardized framework for the progress of therapeutics. APAC's monoclonal antibody therapeutics market is expanding rapidly, thanks to substantial government investments in biotechnology and healthcare. The Chinese government's support for biomedical sciences and healthcare reforms has created opportunities for research and the adoption of novel therapies. As one of the leading healthcare markets in Asia, Japan demonstrates strong consumer demand for innovative monoclonal antibody therapies, particularly for aging-related diseases. India's monoclonal antibody therapeutics landscape is emerging, with growth driven by increasing healthcare awareness and improving access to healthcare. Local production and reduced treatment costs are areas of focus to meet consumer needs effectively.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Monoclonal Antibody Therapeutics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Monoclonal Antibody Therapeutics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Monoclonal Antibody Therapeutics Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Amgen Inc., Bayer AG, Biogen Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Envigo, F. Hoffmann-La Roche Ltd, GenScript, GlaxoSmithKline Plc, Johnson & Johnson, Merck Sharp & Dohme Corp.,, Novartis International AG, Pfizer Inc, and Sanofi S.A.

Market Segmentation & Coverage

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

Source
- Chimeric
- Human
- Humanized

End User
- Hospitals
- Private Clinics
- Research Institute

Application
- Autoimmune Diseases
- Cancer
- Hematological Diseases
- Infectious Diseases
- Ophthalmological Diseases

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Monoclonal Antibody Therapeutics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Monoclonal Antibody Therapeutics Market?

3. What are the technology trends and regulatory frameworks in the Monoclonal Antibody Therapeutics Market?

4. What is the market share of the leading vendors in the Monoclonal Antibody Therapeutics Market?

5. Which modes and strategic moves are suitable for entering the Monoclonal Antibody Therapeutics Market?

Product Code: MRR-4316E4E89474

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. Growing incidences of chronic and genetic diseases across the world and the need for urgent treatment strategies
  - 5.1.1.2. Favorable regulatory approvals for monoclonal antibodies
  - 5.1.1.3. Government initiatives to promote access to critical monoclonal antibody therapies for patients
- 5.1.2. Restraints
  - 5.1.2.1. Production issues and difficulties associated with storage and handling
- 5.1.3. Opportunities
  - 5.1.3.1. Ongoing advancements and R&D activities to improve the efficacy and safety of monoclonal antibody therapeutics
  - 5.1.3.2. Inclinations towards personalized medicine and incorporation of antibody-drug conjugates for treatment
- 5.1.4. Challenges
  - 5.1.4.1. Performance limitations and variability in treatment effect
5.2. Market Segmentation Analysis
- 5.2.1. Source: Rising prevalence of human monoclonal antibodies due to their lower immunogenicity
- 5.2.2. End User: Increasing adoption in hospitals necessity for precise diagnostic oversight and administration typically involving intravenous infusion
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Monoclonal Antibody Therapeutics Market, by Source

6.1. Introduction
6.2. Chimeric
6.3. Human
6.4. Humanized

7. Monoclonal Antibody Therapeutics Market, by End User

7.1. Introduction
7.2. Hospitals
7.3. Private Clinics
7.4. Research Institute

8. Monoclonal Antibody Therapeutics Market, by Application

8.1. Introduction
8.2. Autoimmune Diseases
8.3. Cancer
8.4. Hematological Diseases
8.5. Infectious Diseases
8.6. Ophthalmological Diseases

9. Americas Monoclonal Antibody Therapeutics Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Monoclonal Antibody Therapeutics Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Monoclonal Antibody Therapeutics Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. Roche Pharma India Enters into Ophthalmology with Dual-Pathway-Inhibitor Vabysmo
- 12.3.2. Partnership between AbbVie and OSE Immunotherapeutics for Chronic Inflammation Treatment
- 12.3.3. Novartis Expands Autoimmune Portfolio with Acquisition of Calypso Biotech
12.4. Strategy Analysis & Recommendation

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio