Monoclonal Antibody Therapeutics Market: By Source Type By Application, By End User and Region Forecast 2020-2031

Monoclonal Antibody Therapeutics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Source Type (Murine, Chimeric, Humanized, and Human) By Application (Oncology, Autoimmune Diseases, Infectious Diseases, Neurological Diseases, and Others), By End User (Hospitals, Specialty Centers, and Others) and Region Forecast 2020-2031

Monoclonal Antibody Therapeutics Market size was valued at US$ 254.88 billion in 2024 and is expected to reach US$ 657.61 billion by 2031, growing at a significant CAGR of 14.5% from 2025-2031. The monoclonal antibody therapeutics industry seeks to develop and sell monoclonal antibodies (mAbs) as therapeutic agents against diseases, including cancer, autoimmune disorders, and infectious diseases. The market is driven by technological advancements in biotechnology, increasing incidence of chronic diseases, and drug development investments, enabling highly targeted treatments with greater efficacy. Restrictions to market expansion are high development expenses, rigorous regulatory approval, and biosimilar competition for established products. Though these limitations cause the market to retreat, developments in manufacturing technologies and expanding usage of personalized medicine will result in further growth in the market.

Facts & Figures:

  • Oncology is still the largest area of application, where monoclonal antibodies are applied widely to treat cancer, e.g., checkpoint inhibitors against PD-1 and PD-L1.
  • The U.S. FDA has approved more than 100 monoclonal antibody products, with existing breakthroughs in antibody fragments and bispecific antibodies.
  • Expansion of biosimilars is transforming the monoclonal antibody market, with biosimilar adoption to increase at a CAGR of over 15%, increasing competition as well as the affordability of prices.
  • The aging population is contributing towards market growth, with over 24% of the American population expected to be 65 years or older by 2060.
  • In 2020, cancer alone accounted for an estimated 10 million deaths worldwide.

Key Developments:

  • In January 2024, UCB Inc. received FDA approval for RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG).
  • In November 2023, Almirall S.A.'s EBGLYSS (lebrikizumab) received an approval from the European Commission (EC). The medication is utilized in the therapy of moderate-to-severe atopic dermatitis (AD).
  • In August 2023, Regeneron Pharmaceuticals, Inc. was approved by the FDA for Veopoz (pozelimab-bbfg) for CHAPLE disease.
  • In March 2023, BioNTech SE and OncoC4, Inc. formed a strategic collaboration for co-development of monoclonal antibody candidate.

Monoclonal Antibody Therapeutics Market Segmentation:

Based on the source type:

  • Murine
  • Chimeric
  • Humanized
  • Human

The human source type dominated the largest proportion. Human mAbs provide effective modulation in effector functions and are less immunogenic than chimeric or humanized mAbs. These kinds of antibodies may be generated by application of phage display and hybridoma technologies to transgenic mice. Consequently, owing to recent technological advancements in genetic engineering, the manufacture of fully human mAbs is expected to gain momentum in the near future.

Based on the application:

  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Neurological Diseases
  • Others

Oncology segment accounted for the highest share in the applications market for mAbs. This is due to the fact that a high rate of regulatory approvals for the treatment of cancer using mAbs has occurred. Cancer prevalence is one of the major drivers that are expected to drive mAbs therapeutics growth since they may have zero or minimal side effects as compared to other drugs and chemotherapy. Some of the mAb therapies used now are non-small cell lung, brain tumor, ovarian, breast, gastric, melanoma, colorectal, Hodgkin's lymphoma, etc.

Based on the end user:

  • Hospitals
  • Specialty Centers
  • Others

The hospitals segment accounted for the maximum market share because of the rising use of mAbs in cancer treatment at hospitals. Increased healthcare spending worldwide, patient awareness levels rising, and ready availability of sophisticated hospital infrastructure in developed nations are the drivers set to lead the segment to hold dominance in the forecast period.

Monoclonal Antibody Therapeutics Market Summary

Study Period

2025-2031

Base Year

2024

CAGR

14.5%

Largest Market

North-America

Fastest Growing Market

Asia-Pacific

Monoclonal Antibody Therapeutics Market Dynamics

Drivers

Genetic engineering technology and biotechnology are driving market expansion for monoclonal antibody therapeutics by enabling the creation of extremely targeted drugs with greater effectiveness. Increasing rates of chronic conditions such as cancer, autoimmune diseases, and infectious diseases are driving demand for monoclonal antibody therapy. Support from government authorities and expedited approval procedures are propelling market growth by putting new treatments into the hands of patients sooner. In addition to that, enormous R&D investments are expanding monoclonal antibody therapeutic applications and further promoting the market.

Restraints

Monoclonal antibody treatments market is faced with several limitations, including expensive treatment and production costs, that limit access, particularly in poor nations. Strict regulatory controls and lengthy delay times in approvals stifle innovation and market access. Biosimilar entry brings competitive pressure, which could influence prices and market share for established monoclonal antibody treatments. Additionally, manufacturing complexities in mass scale and supply chain could limit availability and affordability.

Opportunities

The market offers numerous opportunities for development and expansion. Development is becoming more efficient, lowering the cost and speeding up clinical trials, with increasing growth in the use of AI-based drug discovery, which is improving the efficiency of monoclonal antibody development. Bispecific and multispecific antibody development is widening the number of therapeutic applications, especially in oncology and autoimmune diseases. Asia-Pacific and Latin American emerging economies are highly profitable with greater investment in healthcare and greater accessibility of biologic drugs. Increased focus on targeted therapies through monoclonal antibodies is fueling the market for improved and targeted therapy. Increased opportunities through biosimilars are also making space for cheap alternatives, hence making them easily available to patients across the globe.

Trends

Monoclonal antibody drug market is transforming with a few major trends shaping its evolution. Fusion of drug discovery with AI is accelerating monoclonal antibody R&D, making it more effective and economical. Bispecific and multispecific antibody technologies are expanding therapeutic use spaces, primarily in cancer and autoimmune diseases. Rise in biosimilars is fueling competition and spurring access to affordable therapies. Targeted treatment with monoclonal antibodies is being driven by personalized medicine, which allows for targeted and more effective treatment. Besides this, the developing markets of the Asia-Pacific nations are driven by rising health care expenditures and growing access to biologic drugs.

Monoclonal Antibody Therapeutics Market Segmentation Analysis

Report Benchmarks

Details

Report Study Period

2025-2031

Market Size in 2024

US$ 254.88 billion

Market Size in 2031

US$ 657.61 billion

Market CAGR

14.5%

By Source Type

  • Murine
  • Chimeric
  • Humanized
  • Human

By Application

  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Neurological Diseases
  • Others

By End User

  • Hospitals
  • Specialty Centers
  • Others

By Region

  • North America (U.S., Canada)
  • Europe (Germany, U.K., France, Italy, Russia, Spain, Rest of Europe)
  • Asia-Pacific (China, India, Japan, Australia, Southeast Asia, Rest of Asia Pacific)
  • Latin America (Mexico, Brazil, Argentina, Columbia, Rest of Latin America)
  • Middle East & Africa (GCC, Egypt, Nigeria, South Africa, Rest of Middle East and Africa)

Analyst Review

According to PBI Analyst, monoclonal antibody drugs are continuing to make their swift growth, driven by technological innovation in biotechnology, increasing prevalence of chronic disease, and increased spending on drug development. Oncology remains the single most important area of application, with monoclonal antibodies being used widely to treat cancer, including checkpoint inhibitors against PD-1 and PD-L1. The industry is also expanding very strongly in applications involving autoimmune and infectious diseases. Biosimilar adoption is transforming market dynamics, with biosimilar adoption and enhancing access and affordability.

An aging population is fueling market growth, with more than 24 percent of the U.S. population being above 65 years in 2060. In addition, markets such as Asia-Pacific and Latin America are calling out to investments with growing healthcare expenditures and enhanced access to biologic medicines.

Key Features of the Report

  • The monoclonal antibody therapeutics market report provides granular level information about the market size, regional market share, historic market (2020-2024), and forecast (2025-2031)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porter's Five Force Analysis 

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Frequently Asked Questions

The monoclonal antibody therapeutics market size was valued at US$ 254.88 billion in 2024 and is projected to grow at a CAGR of 14.5% from 2025-2031

Biosimilars are increasing competition, improving affordability, and expanding patient access to monoclonal antibody therapies, reshaping the market landscape.

Asia-Pacific and Latin America are attracting investments due to rising healthcare expenditures, increasing disease prevalence, and improved access to biologic therapies.

High production costs, complex supply chains, and stringent regulatory requirements pose challenges in scaling monoclonal antibody manufacturing.

Monoclonal antibodies offer higher specificity and reduced off-target effects compared to small-molecule drugs, making them ideal for precision medicine applications.

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sanofi, Takeda Pharmaceuticals

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Author

Muni Kumar Meravath

Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....

1.Executive Summary
2.Global Monoclonal Antibody Therapeutics Market Introduction 
2.1.Global Monoclonal Antibody Therapeutics Market  - Taxonomy
2.2.Global Monoclonal Antibody Therapeutics Market  - Definitions
2.2.1.Source Type
2.2.2.Application
2.2.3.End User
2.2.4.Region
3.Global Monoclonal Antibody Therapeutics Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Monoclonal Antibody Therapeutics Market Analysis, 2020 - 2024 and Forecast 2025 - 2031
4.1.  Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Monoclonal Antibody Therapeutics Market  By Source Type, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
5.1. Murine
5.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Chimeric
5.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Humanized
5.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
5.4. Human
5.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.4.3. Market Opportunity Analysis 
6.Global Monoclonal Antibody Therapeutics Market  By Application, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
6.1. Oncology
6.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Autoimmune Diseases
6.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Infectious Diseases
6.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
6.4. Neurological Diseases
6.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.4.3. Market Opportunity Analysis 
6.5. Others
6.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.5.3. Market Opportunity Analysis 
7.Global Monoclonal Antibody Therapeutics Market  By End User, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
7.1. Hospitals
7.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Specialty Centers
7.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Others
7.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
8.Global Monoclonal Antibody Therapeutics Market  By Region, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
8.1. North America
8.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Europe
8.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Asia Pacific (APAC)
8.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Middle East and Africa (MEA)
8.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
8.5. Latin America
8.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.5.3. Market Opportunity Analysis 
9.North America Monoclonal Antibody Therapeutics Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
9.1. Source Type Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.Murine
9.1.2.Chimeric
9.1.3.Humanized
9.1.4.Human
9.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.Oncology
9.2.2.Autoimmune Diseases
9.2.3.Infectious Diseases
9.2.4.Neurological Diseases
9.2.5.Others
9.3.  End User Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.3.1.Hospitals
9.3.2.Specialty Centers
9.3.3.Others
9.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.4.1.United States of America (USA)
9.4.2.Canada
10.Europe Monoclonal Antibody Therapeutics Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
10.1. Source Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Murine
10.1.2.Chimeric
10.1.3.Humanized
10.1.4.Human
10.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Oncology
10.2.2.Autoimmune Diseases
10.2.3.Infectious Diseases
10.2.4.Neurological Diseases
10.2.5.Others
10.3.  End User Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Hospitals
10.3.2.Specialty Centers
10.3.3.Others
10.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Germany
10.4.2.France
10.4.3.Italy
10.4.4.United Kingdom (UK)
10.4.5.Spain
11.Asia Pacific (APAC) Monoclonal Antibody Therapeutics Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
11.1. Source Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Murine
11.1.2.Chimeric
11.1.3.Humanized
11.1.4.Human
11.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Oncology
11.2.2.Autoimmune Diseases
11.2.3.Infectious Diseases
11.2.4.Neurological Diseases
11.2.5.Others
11.3.  End User Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Hospitals
11.3.2.Specialty Centers
11.3.3.Others
11.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.China
11.4.2.India
11.4.3.Australia and New Zealand (ANZ)
11.4.4.Japan
11.4.5.Rest of APAC
12.Middle East and Africa (MEA) Monoclonal Antibody Therapeutics Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
12.1. Source Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Murine
12.1.2.Chimeric
12.1.3.Humanized
12.1.4.Human
12.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Oncology
12.2.2.Autoimmune Diseases
12.2.3.Infectious Diseases
12.2.4.Neurological Diseases
12.2.5.Others
12.3.  End User Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Hospitals
12.3.2.Specialty Centers
12.3.3.Others
12.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.GCC Countries
12.4.2.South Africa
12.4.3.Rest of MEA
13.Latin America Monoclonal Antibody Therapeutics Market ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
13.1. Source Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Murine
13.1.2.Chimeric
13.1.3.Humanized
13.1.4.Human
13.2.  Application Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Oncology
13.2.2.Autoimmune Diseases
13.2.3.Infectious Diseases
13.2.4.Neurological Diseases
13.2.5.Others
13.3.  End User Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Hospitals
13.3.2.Specialty Centers
13.3.3.Others
13.4.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Brazil
13.4.2.Mexico
13.4.3.Rest of LA
14. Competition Landscape
14.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
14.2.1.AbbVie
14.2.2.Amgen
14.2.3.AstraZeneca
14.2.4.Bristol-Myers Squibb
14.2.5.Eli Lilly
14.2.6.Genentech
14.2.7.GlaxoSmithKline
14.2.8.Johnson & Johnson
14.2.9.Merck & Co.
14.2.10.Novartis
14.2.11.Pfizer
14.2.12.Regeneron Pharmaceuticals
14.2.13.Roche
14.2.14.Sanofi
14.2.15.Takeda Pharmaceuticals
15. Research Methodology 
16. Appendix and Abbreviations 

Key Market Players

  • AbbVie
  • Amgen
  • AstraZeneca
  • Bristol-Myers Squibb
  • Eli Lilly
  • Genentech
  • GlaxoSmithKline
  • Johnson & Johnson
  • Merck & Co.
  • Novartis
  • Pfizer
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi
  • Takeda Pharmaceuticals

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