Monoclonal Antibodies Market by Source (Murine, Chimeric, Humanized, and Human), Indication (Cancer, Autoimmune Diseases, Neurological Diseases, Infectious Diseases, and Others), End-user (Hospitals, Research Institutes, and Others), and Region (North America, Asia Pacific, Europe, Latin America, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2023 – 2031
Monoclonal Antibodies Market Outlook
The global monoclonal antibodies market size was estimated at USD 168.69 Bn in 2022 and is anticipated to reach USD 494.78 Bn by 2031, expanding at a CAGR of 12.7% during the forecast period 2023-2031. The market growth is attributed to the increasing use of monoclonal antibodies to cure cancer and infectious diseases.
Monoclonal antibodies are proteins made of B lymphocytes, which bind to certain targets in the body, such as antigens, and neutralize the effect of the foreign particles. These antibodies bind to only one specific antigen and help the body fight against diseases. Monoclonal antibodies are used alone or to carry drugs, toxins, and radioactive substances directly to oncogenic cells in the body. Monoclonal antibodies are identical in various properties such as binding affinity for their targets, protein sequence, and antigen-binding site.
Monoclonal Antibodies Market Macro-economic Factors
Government Regulations
Government regulations play an integral role in the approval and branding of monoclonal antibodies for the consumption and treatment of patients. The FDA had granted Emergency Use Approvals (EUAs) for several mAb treatments, including REGEN-COV (casirivimab and imdevimab), etesevimab and bamlanivimab (BAM/ETE), and sotrovimab, during the COVID-19 pandemic.
Presently, the US has not authorized the use of BAM/ETE and REGEN-COV, as these mAbs are not effective against omicron variants. Government regulations are stringent. Monoclonal antibodies are approved when GMP (Good Manufacturing Practices) is followed and every minute detail is provided during the trials, including reliable host cells. Details of host cells include the origin, source, and history.
Prevalence of Diseases
The prevalence of diseases is one of the major factors that affect the monoclonal antibodies market positively. Monoclonal antibodies are used for the treatment of various diseases such as cancer, autoimmune diseases, infectious diseases, neurological diseases, asthma, natural and synthetic toxins, and others. For instance, Cytomegalovirus (CMV) causes retinitis and gastroenteritis in HIV-infected patients. Approximately 40,000 cases of CMV are reported annually and 25% of the patients suffer from mental retardation and hearing loss. The rising number of cases is contributing to the growth of the monoclonal antibodies market.
Production & Consumption
Production & consumption of monoclonal antibodies go hand in hand, as maintenance of storage facilities is quite expensive. The storage of monoclonal antibodies requires a temperature of at least 2-8oC to maintain functional viability for about a year. Monoclonal antibodies sustain for many years if the antibodies are stored at -20°C in 50% glycerol. If the storage conditions are disrupted, monoclonal antibodies are subject to physicochemical transformations and post-translational modifications.
R&D Activities
Monoclonal antibodies are emerging as a significant class of therapeutic agents for the treatment of various human diseases. The treatments available for the diseases are the outcome of previous R&D activities in the field of monoclonal antibodies. The R&D activities include various steps and perspectives consisting of participants, development phases, citations of related patents, and therapeutic indications with potentially valuable insights for pharmaceutical investors, researchers, and policymakers. R&D activities are a major factor affecting the overall monoclonal antibodies market.
Monoclonal Antibodies Market Dynamics
The global monoclonal antibodies market report has up-to-date insights that help in formulating a strategic roadmap about the estimated market scenario and performance during 2023 to 2031.
Drivers
Increasing Prevalence of Chronic Diseases such as Cancer and Autoimmune Diseases
Chronic diseases such as neurological degeneration, cancer, and autoimmune diseases are rising among the population. Monoclonal antibodies are one of the most adopted and well-accepted medications for the treatment of these diseases. Monoclonal antibodies specifically interact with the antigens to minimize their effect and do not pose major side effects to the health of the patient. Monoclonal antibody therapy is cost-effective as compared with traditional chemotherapy in the treatment of chronic diseases, which is expected to drive the monoclonal antibodies market.
Employment of Advanced Genetic Engineering Technology
One of the significant advantages of using monoclonal antibodies as therapeutic agents is that the production of monoclonal antibodies is enhanced using genetic engineering. Genetic engineering is a process that uses laboratory technologies to alter genetic material. This process is utilized to enhance and speed up the production process as per the requirement. Presently, genetic engineering technology is used for the production process, and this technology proves to be beneficial in terms of cost and down-steaming process.
Restrains
Monoclonal antibodies are popular in developed countries as a treatment method for various chronic diseases. However, it is not adopted in underdeveloped countries, due to a lack of awareness, low disposable income of people, and lack of money for the treatment of diseases. Major part of the global population resides in countries such as China and India; however, the primary consumption of monoclonal antibodies is in North America and Europe. A lack of awareness regarding monoclonal antibodies is expected to affect the growth of the monoclonal antibodies market.
Opportunities
Chemotherapy delivers drugs to the entire body. It aims to target the area of the body with cancerous cells while minimizing the number of healthy cells affected during treatment. The treatment has a negative impact on the healthy cells that surround the cancer cells. Autoimmune diseases do not have a defined treatment, which resulted in high R&D activities regarding these diseases.
R&D of the medication for autoimmune disease diagnostics is expected to create opportunities in the monoclonal antibodies market. According to the National Institutes of Health (NIH), up to 23.5 Million Americans (~7% of the population) suffered from an autoimmune disease in 2017, and the prevalence is rising.
Scope of Monoclonal Antibodies Market Report
The report on the global monoclonal antibodies market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes |
Details |
Report Title |
Monoclonal Antibodies Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast |
Base Year |
2021 |
Historic Data |
2016 and 2021 |
Forecast Period |
2023–2031 |
Segmentation |
Source (Murine, Chimeric, Humanized, Human), Indication (Cancer, Autoimmune Diseases, Neurological Diseases, Infectious Diseases, Others), and End-user (Hospitals, Research Institutes, Others) |
Regional Scope |
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
Report Coverage |
Company Share, Monoclonal Antibodies Market Size and Analysis, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast |
Key Players Covered |
AbbVie Inc., Janssen Biotech, Inc., Amgen Inc., AstraZeneca, Lilly, Merck & Co., Inc., Abbott, Novartis AG, Pfizer Inc., and Takeda Pharmaceutical Company Limited |
Monoclonal Antibodies Market Segmental Outlook
What Key Factors Contribute to the Rapid Expansion of the Source Segment?
Based on the source, the monoclonal antibodies market is segmented into murine, chimeric, humanized, and human. The human segment is projected to account for a substantial share of the monoclonal antibodies market during the forecast period. The human-type monoclonal antibody is made of human protein and does not induce immunogenicity. When the murine type of monoclonal antibodies is given to a patient, the immune system of the patient is triggered; hence the focus is shifting toward the humanized and human-type monoclonal antibodies.
Which Major Factors influence the Significant Growth of the Indication Segment?
On the basis of indication, the market is fragmented into cancer, autoimmune diseases, neurological diseases, infectious diseases, and others. The cancer segment is projected to hold a significant share of the market during the forecast period, as the prevalence of cancer is extremely high. Monoclonal antibodies are used to ease the patient's condition due to their minimum side effects compared to chemotherapy.
The infectious diseases segment is anticipated to register a considerable CAGR owing to the increasing use of monoclonal antibodies to treat infectious diseases across the globe. Due to the COVID-19 pandemic, the use of rise of drug-resistant bacteria, and the rapid development of neutralizing monoclonal antibodies (mAbs) to treat infectious diseases was needed, and the increasing usage of monoclonal antibodies to treat other infectious diseases can further boost the global market.
What are the Main Aspects for Boosting the End-user Segment?
Based on the end-user, the market is categorized into hospitals, research institutes, and others. The hospital segment is expected to hold a major share of the market during the forecast period, as hospitals are a common treatment spot for the treatment of various diseases as compared with specialty centers. However, the research institute segment is expected to register a considerable CAGR during the forecast period as monoclonal antibodies are used for clinical trials to research additional applications of monoclonal antibodies across diverse branches of science.
Why is North America dominating Global Monoclonal Antibodies Market?
The market is divided into five regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is projected to account for a significant share of the monoclonal antibodies market during the forecast period, owing to the high number of FDA approvals for monoclonal antibodies and high awareness about monoclonal antibody therapy.
Europe is expected to hold a substantial market share during the forecast period, owing to increasing R&D activities for patients with complicated and untreated diseases. The market in Asia Pacific is anticipated to expand at a high CAGR during the forecast period, as underdeveloped countries are adopting the monoclonal antibody therapy method for treating life-threatening diseases. The significant rise in the incidence of cancer and autoimmune diseases is expected to boost the market.
Key Benefits for Industry Participants & Stakeholders
- In-depth Analysis of the Global Monoclonal Antibodies Market
- Historical, Current, and Projected Market Size in terms of Value
- Potential & Niche Segments and Regions Exhibiting Promising Growth Covered
- Industry Drivers, Restraints, and Opportunities Covered in the Study
- Recent Industry Trends and Developments
- Competitive Landscape & Strategies of Key Players
- Neutral Perspective on Global Monoclonal Antibodies Market Performance
Chapter 2 Assumptions and Acronyms Used
Chapter 3 Research Methodology
Chapter 4 Monoclonal Antibodies Market Overview
4.1 Introduction
4.1.1 Market Taxonomy
4.1.2 Market Definition
4.1.3 Macro-Economic Factors Impacting the Market Growth
4.2 Monoclonal Antibodies Market Dynamics
4.2.1 Market Drivers
4.2.2 Market Restraints
4.2.3 Market Opportunity
4.3 Monoclonal Antibodies Market - Supply Chain Analysis
4.3.1 List of Key Suppliers
4.3.2 List of Key Distributors
4.3.3 List of Key Consumers
4.4 Key Forces Shaping the Monoclonal Antibodies Market
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Buyers
4.4.3 Threat of Substitution
4.4.4 Threat of New Entrants
4.4.5 Competitive Rivalry
4.5 Global Monoclonal Antibodies Market Size & Forecast, 2015-2030
4.5.1 Monoclonal Antibodies Market Size and Y-o-Y Growth
4.5.2 Monoclonal Antibodies Market Absolute $ Opportunity
4.6 Pricing Analysis & Forecast, 2015-2030
4.7 Global Monoclonal Antibodies Market: Impact Of Key Regulations
4.8 Production and Consumption: Monoclonal Antibodies Market
4.9 Prevalence of Diseases: Monoclonal Antibodies as Therapeutic Agents
4.10 Various Mode of Action: Monoclonal Antibodies
Chapter 5 Global Monoclonal Antibodies Market Analysis and Forecast By Type
5.1 Introduction
5.1.1 Key Market Trends & Growth Opportunities By Type
5.1.2 Basis Point Share (BPS) Analysis By Type
5.1.3 Absolute $ Opportunity Assessment By Type
5.2 Monoclonal Antibodies Market Size Forecast By Type
5.2.1 Murine
5.2.2 Chimeric
5.2.3 Humanized
5.2.4 Human
5.3 Market Attractiveness Analysis By Type
Chapter 6 Global Monoclonal Antibodies Market Analysis and Forecast By Application
6.1 Introduction
6.1.1 Key Market Trends & Growth Opportunities By Application
6.1.2 Basis Point Share (BPS) Analysis By Application
6.1.3 Absolute $ Opportunity Assessment By Application
6.2 Monoclonal Antibodies Market Size Forecast By Application
6.2.1 Cancer
6.2.2 Autoimmune Diseases
6.2.3 Neurological Diseases
6.2.4 Infectious Diseases
6.2.5 Others
6.3 Market Attractiveness Analysis By Application
Chapter 7 Global Monoclonal Antibodies Market Analysis and Forecast By End-use
7.1 Introduction
7.1.1 Key Market Trends & Growth Opportunities By End-use
7.1.2 Basis Point Share (BPS) Analysis By End-use
7.1.3 Absolute $ Opportunity Assessment By End-use
7.2 Monoclonal Antibodies Market Size Forecast By End-use
7.2.1 Hospitals
7.2.2 Specialty Centers
7.2.3 Others
7.3 Market Attractiveness Analysis By End-use
Chapter 8 Global Monoclonal Antibodies Market Analysis and Forecast by Region
8.1 Introduction
8.1.1 Key Market Trends & Growth Opportunities by Region
8.1.2 Basis Point Share (BPS) Analysis by Region
8.1.3 Absolute $ Opportunity Assessment by Region
8.2 Monoclonal Antibodies Market Size Forecast by Region
8.2.1 North America
8.2.2 Europe
8.2.3 Asia Pacific
8.2.4 Latin America
8.2.5 Middle East & Africa (MEA)
8.3 Market Attractiveness Analysis by Region
Chapter 9 Coronavirus Disease (COVID-19) Impact
9.1 Introduction
9.2 Current & Future Impact Analysis
9.3 Economic Impact Analysis
9.4 Government Policies
9.5 Investment Scenario
Chapter 10 North America Monoclonal Antibodies Analysis and Forecast
10.1 Introduction
10.2 North America Monoclonal Antibodies Market Size Forecast by Country
10.2.1 U.S.
10.2.2 Canada
10.3 Basis Point Share (BPS) Analysis by Country
10.4 Absolute $ Opportunity Assessment by Country
10.5 Market Attractiveness Analysis by Country
10.6 North America Monoclonal Antibodies Market Size Forecast By Type
10.6.1 Murine
10.6.2 Chimeric
10.6.3 Humanized
10.6.4 Human
10.7 Basis Point Share (BPS) Analysis By Type
10.8 Absolute $ Opportunity Assessment By Type
10.9 Market Attractiveness Analysis By Type
10.10 North America Monoclonal Antibodies Market Size Forecast By Application
10.10.1 Cancer
10.10.2 Autoimmune Diseases
10.10.3 Neurological Diseases
10.10.4 Infectious Diseases
10.10.5 Others
10.11 Basis Point Share (BPS) Analysis By Application
10.12 Absolute $ Opportunity Assessment By Application
10.13 Market Attractiveness Analysis By Application
10.14 North America Monoclonal Antibodies Market Size Forecast By End-use
10.14.1 Hospitals
10.14.2 Specialty Centers
10.14.3 Others
10.15 Basis Point Share (BPS) Analysis By End-use
10.16 Absolute $ Opportunity Assessment By End-use
10.17 Market Attractiveness Analysis By End-use
Chapter 11 Europe Monoclonal Antibodies Analysis and Forecast
11.1 Introduction
11.2 Europe Monoclonal Antibodies Market Size Forecast by Country
11.2.1 Germany
11.2.2 France
11.2.3 Italy
11.2.4 U.K.
11.2.5 Spain
11.2.6 Russia
11.2.7 Rest of Europe
11.3 Basis Point Share (BPS) Analysis by Country
11.4 Absolute $ Opportunity Assessment by Country
11.5 Market Attractiveness Analysis by Country
11.6 Europe Monoclonal Antibodies Market Size Forecast By Type
11.6.1 Murine
11.6.2 Chimeric
11.6.3 Humanized
11.6.4 Human
11.7 Basis Point Share (BPS) Analysis By Type
11.8 Absolute $ Opportunity Assessment By Type
11.9 Market Attractiveness Analysis By Type
11.10 Europe Monoclonal Antibodies Market Size Forecast By Application
11.10.1 Cancer
11.10.2 Autoimmune Diseases
11.10.3 Neurological Diseases
11.10.4 Infectious Diseases
11.10.5 Others
11.11 Basis Point Share (BPS) Analysis By Application
11.12 Absolute $ Opportunity Assessment By Application
11.13 Market Attractiveness Analysis By Application
11.14 Europe Monoclonal Antibodies Market Size Forecast By End-use
11.14.1 Hospitals
11.14.2 Specialty Centers
11.14.3 Others
11.15 Basis Point Share (BPS) Analysis By End-use
11.16 Absolute $ Opportunity Assessment By End-use
11.17 Market Attractiveness Analysis By End-use
Chapter 12 Asia Pacific Monoclonal Antibodies Analysis and Forecast
12.1 Introduction
12.2 Asia Pacific Monoclonal Antibodies Market Size Forecast by Country
12.2.1 China
12.2.2 Japan
12.2.3 South Korea
12.2.4 India
12.2.5 Australia
12.2.6 South East Asia (SEA)
12.2.7 Rest of Asia Pacific (APAC)
12.3 Basis Point Share (BPS) Analysis by Country
12.4 Absolute $ Opportunity Assessment by Country
12.5 Market Attractiveness Analysis by Country
12.6 Asia Pacific Monoclonal Antibodies Market Size Forecast By Type
12.6.1 Murine
12.6.2 Chimeric
12.6.3 Humanized
12.6.4 Human
12.7 Basis Point Share (BPS) Analysis By Type
12.8 Absolute $ Opportunity Assessment By Type
12.9 Market Attractiveness Analysis By Type
12.10 Asia Pacific Monoclonal Antibodies Market Size Forecast By Application
12.10.1 Cancer
12.10.2 Autoimmune Diseases
12.10.3 Neurological Diseases
12.10.4 Infectious Diseases
12.10.5 Others
12.11 Basis Point Share (BPS) Analysis By Application
12.12 Absolute $ Opportunity Assessment By Application
12.13 Market Attractiveness Analysis By Application
12.14 Asia Pacific Monoclonal Antibodies Market Size Forecast By End-use
12.14.1 Hospitals
12.14.2 Specialty Centers
12.14.3 Others
12.15 Basis Point Share (BPS) Analysis By End-use
12.16 Absolute $ Opportunity Assessment By End-use
12.17 Market Attractiveness Analysis By End-use
Chapter 13 Latin America Monoclonal Antibodies Analysis and Forecast
13.1 Introduction
13.2 Latin America Monoclonal Antibodies Market Size Forecast by Country
13.2.1 Brazil
13.2.2 Mexico
13.2.3 Rest of Latin America (LATAM)
13.3 Basis Point Share (BPS) Analysis by Country
13.4 Absolute $ Opportunity Assessment by Country
13.5 Market Attractiveness Analysis by Country
13.6 Latin America Monoclonal Antibodies Market Size Forecast By Type
13.6.1 Murine
13.6.2 Chimeric
13.6.3 Humanized
13.6.4 Human
13.7 Basis Point Share (BPS) Analysis By Type
13.8 Absolute $ Opportunity Assessment By Type
13.9 Market Attractiveness Analysis By Type
13.10 Latin America Monoclonal Antibodies Market Size Forecast By Application
13.10.1 Cancer
13.10.2 Autoimmune Diseases
13.10.3 Neurological Diseases
13.10.4 Infectious Diseases
13.10.5 Others
13.11 Basis Point Share (BPS) Analysis By Application
13.12 Absolute $ Opportunity Assessment By Application
13.13 Market Attractiveness Analysis By Application
13.14 Latin America Monoclonal Antibodies Market Size Forecast By End-use
13.14.1 Hospitals
13.14.2 Specialty Centers
13.14.3 Others
13.15 Basis Point Share (BPS) Analysis By End-use
13.16 Absolute $ Opportunity Assessment By End-use
13.17 Market Attractiveness Analysis By End-use
Chapter 14 Middle East & Africa (MEA) Monoclonal Antibodies Analysis and Forecast
14.1 Introduction
14.2 Middle East & Africa (MEA) Monoclonal Antibodies Market Size Forecast by Country
14.2.1 Saudi Arabia
14.2.2 South Africa
14.2.3 UAE
14.2.4 Rest of Middle East & Africa (MEA)
14.3 Basis Point Share (BPS) Analysis by Country
14.4 Absolute $ Opportunity Assessment by Country
14.5 Market Attractiveness Analysis by Country
14.6 Middle East & Africa (MEA) Monoclonal Antibodies Market Size Forecast By Type
14.6.1 Murine
14.6.2 Chimeric
14.6.3 Humanized
14.6.4 Human
14.7 Basis Point Share (BPS) Analysis By Type
14.8 Absolute $ Opportunity Assessment By Type
14.9 Market Attractiveness Analysis By Type
14.10 Middle East & Africa (MEA) Monoclonal Antibodies Market Size Forecast By Application
14.10.1 Cancer
14.10.2 Autoimmune Diseases
14.10.3 Neurological Diseases
14.10.4 Infectious Diseases
14.10.5 Others
14.11 Basis Point Share (BPS) Analysis By Application
14.12 Absolute $ Opportunity Assessment By Application
14.13 Market Attractiveness Analysis By Application
14.14 Middle East & Africa (MEA) Monoclonal Antibodies Market Size Forecast By End-use
14.14.1 Hospitals
14.14.2 Specialty Centers
14.14.3 Others
14.15 Basis Point Share (BPS) Analysis By End-use
14.16 Absolute $ Opportunity Assessment By End-use
14.17 Market Attractiveness Analysis By End-use
Chapter 15 Competition Landscape
15.1 Monoclonal Antibodies Market: Competitive Dashboard
15.2 Global Monoclonal Antibodies Market: Market Share Analysis, 2021
15.3 Company Profiles (Details – Overview, Financials, Developments, Strategy)
15.3.1 AbbVie Inc.
15.3.2 Janssen Biotech, Inc.
15.3.3 Amgen Inc.
15.3.4 AstraZeneca
15.3.5 Lilly
15.3.6 Merck & Co., Inc.
15.3.7 Abbott
15.3.8 Novartis AG
15.3.9 Pfizer Inc.
15.3.10 Takeda Pharmaceutical Company Limited