Monoclonal Antibodies Market

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 2-8^oC 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

Segments

Source

• Murine
• Chimeric
• Humanized
• Human

Indication

• Cancer
• Autoimmune Diseases
• Neurological Diseases
• Infectious Diseases
• Others

End-user

• Hospitals
• Research Institutes
• Others

Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Key Market Players Profiled in the Report

• AbbVie Inc.
• Janssen Biotech, Inc.
• Amgen Inc.
• AstraZeneca
• Lilly
• Merck & Co., Inc.
• Abbott
• Novartis AG
• Pfizer Inc.
• Takeda Pharmaceutical Company Limited

Competitive Landscape

• Manufacturers operating in the global monoclonal antibodies market include AbbVie Inc., Janssen Biotech, Inc., Amgen Inc., AstraZeneca, Lilly, Merck & Co., Inc., Abbott, Novartis AG, Pfizer Inc., and Takeda Pharmaceutical Company Limited.
• Market players are pursuing key strategies such as acquisitions, collaborations, and geographic expansion, which is creating opportunities in the monoclonal antibodies market.