Published: 2019 April 09
Updated : 2022 December 15

Monoclonal Antibody Therapeutics Market

SKU : BT12
180 pages
Report Summary
Table of Contents
List of Tables & Figures

Monoclonal Antibody Therapeutics Market is segmented By Product Type (Naked, Fusion Protein, Antibody fragment, Conjugate, Multi-specific), By Application (Cancer, Autoimmune Diseases, Infectious Diseases, Others), By Production Source (Human, Humanized, Chimeric, Others), By End User, Hospitals, Private Clinics, Research Institutes), By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029

[150 Pages Report] Monoclonal Antibody Therapeutics Market is expected to grow at a CAGR of 14.1% during the forecasting period 2022-2029. Monoclonal Antibody therapy is a form of immunotherapy that uses monoclonal antibodies (mAb) to bind mono specifically to specific cells or proteins. Therapeutic monoclonal antibodies harness the highly evolved specificity of adaptive immunity to fight disease. Monoclonal antibodies are being used to treat severe and chronic conditions.

Market Growth Dynamics

The rising incidence of cancer is expected to increase demand for infusion therapies, thereby contributing to the significant growth of the monoclonal antibodies market.

The rising incidence of cancer and other chronic diseases drives the market growth

The global market for the Monoclonal Antibody Therapeutics Market is primarily driven by the rising incidence of cancer and other chronic diseases coupled with the rise in R&D activities in genomics. According to the World Health Organization, The global cancer burden has risen to 18.1 million new cases and 9.6 million deaths in 2018. Additionally, the increasing drug approvals and launches of novel monoclonal antibodies for various diseases treatments such as cancer, robust research, and development of monoclonal antibodies for multiple diseases, and technologies such as the advent of mammalian cell culture, process, and formulation technology is expected to be significant market opportunities. As of 2017, 47 monoclonal antibody products have been approved in the US and Europe to treat a variety of diseases. Continuing at the current approval rate of nearly four new products per year, around 70 monoclonal antibody products will be on the market by 2020, with combined global sales of almost USD 125 billion.

Increasing regulatory approvals and the launch of therapies are driving the market growth  

The rise in approval of monoclonal antibodies by regulatory offices favors the launch of innovative therapeutics, which is expected to drive the market's growth over the forecast period. For instance, in 2018, Chugai Pharmaceutical Co., Ltd. (part of Roche Holding AG) announced that it received Breakthrough Therapy Designation from the U.S. FDA for its product, Satralizumab. In May 2018, Johnson & Johnson received the U.S. Food and Drug Administration's approval for its monoclonal antibody, Darzalex (daratumumab), in combination with Velcade (bortezomib), melphalan, and prednisone, for the treatment of patients with newly diagnosed multiple myeloma, not eligible for autologous stem cell transplant (ASCT).

Higher costs and strict regulatory measures are likely to hamper the market growth

However, higher costs and strict regulatory measures resulting in lengthy approval procedures may restrict the market growth. Drugs formed from mAbs is that they are very distinct and have restricted targets. This is because they associate with cells and do not penetrate them. This, to some degree, has hampered the global monoclonal antibodies market. Another problem in using mAbs is that they require to be injected, unlike small molecule drugs.

Monoclonal Antibody Therapeutics Market Scope



Market CAGR


Segments Covered

By Product Type, By Production Source, By Application, By End User, and By Region

Report Insights Covered

Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights.

Fastest Growing Region

Asia Pacific

Largest Market Share 

North America

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COVID-19 Impact Analysis

The COVID 19 pandemic and lockdown in various countries across the globe have affected the financial status of businesses in all sectors. In addition, the lockdown in various countries due to the pandemic has placed an economic burden on the healthcare sector. Therefore, the guidelines issued by the U.S. Food and Drug Administration (FDA) include general considerations to assist sponsors and researchers, which ensure the safety of trial participants, compliance with good clinical practice (GCP), and minimize risks to trial integrity for the duration of the COVID-19 public health emergency. In addition, the appendix of the guidelines also provides answers to some general questions, that the U.S. Food and Drug Administration (FDA) had received from various sponsors and researchers about conducting clinical trials during the COVID-19 public health emergency.

Segment Analysis

The cancer segment is expected to grow at the fastest CAGR during the forecast period (2021-2028)   

Cancer has the dominating market share owing to the surge in cancer incidents and the extensive use of monoclonal antibody therapeutics in cancer treatment. According to the World Health Organization, one in 5 men and one in 6 women worldwide develop cancer during their lifetime, and one in 8 men and one in 11 women die from the disease.

Worldwide, the total number of alive within five years of a cancer diagnosis, called the 5-year prevalence, is estimated to be 43.8 million. Moreover, due to minimizing adverse effects associated with monoclonal antibody therapeutics use, they have proven to be an excellent alternative treatment for cancer compared to drugs and chemotherapy. Additionally, the growing drug pipeline coupled with treatment approvals and clinical trials is anticipated to provide future growth opportunities for the market.

For instance, Keytruda (Pembrolizumab), a monoclonal antibody used for the treatment of different types of cancer, costs about US$ 2,250 for a vial of 50 mg. In addition, the loss of patents is also expected to hinder the market growth over the forecast period. For instance, the Rituximab (Rituxan) product of Genentech, Inc. (Roche) failed its patent in the U.S. and Europe.

Geographical Analysis

The North American region holds the largest market share in the global monoclonal antibody therapeutics market

North America is the dominant share in the global monoclonal antibody therapeutics market and can be attributed to the presence of a well-established healthcare infrastructure. Moreover, its broad base of the patient population, well-established reimbursement policies, high awareness regarding diseases, government support in infection control & management, rising incidence of lifestyle-associated diseases, and higher investment in R&D activities by the government for cancer contribute to the growth of North America's share. Domestically, the US drug industry spends approximately $45 billion annually on R&D. According to the Centers for Disease Control and Prevention (CDC), 6 in 10 adults in the US have a chronic disease, of which 4 in 10 Adults have two or more.

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services in the USA regulating the monoclonal antibodies and pharmaceutical drugs market. Increasing product launches and regulatory support for the treatment of rare diseases by USFDA is expected to support the region's monoclonal antibody therapeutics market growth.

For instance, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.), a human monoclonal antibody, for the treatment of a rare disease metastatic Merkel cell carcinoma (MCC). Similarly, the U.S FDA granted accelerated approval to immunotherapy product- TECENTRIQ (atezolizumab), a humanized, engineered monoclonal antibody, to treat people with locally advanced or metastatic urothelial carcinoma.

Competitive Landscape

The monoclonal antibody therapeutics market is moderately competitive with the presence of local as well as global companies.  Some of the key players which are contributing to the growth of the market include Pfizer Inc., Novartis AG, Bayer AG, Sanofi S.A., CASI Pharmaceuticals, Eli Lilly and Co., Merck & Co., Inc., Changchun Zhongyingfeng Science And Technology Co., Ltd, Hangzhou Immuno Biotech Co. Ltd, Nantong Egens Biotechnology Co. Ltd among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the monoclonal antibody therapeutics market globally.    

Monoclonal Antibody Therapeutics Market Key Companies to Watch

CASI Pharmaceuticals

Overview: CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on the acquisition, development, and commercialization of therapeutics addressing cancer and other unmet medical needs in China, Taiwan, Hong Kong, and Macau.

Product Portfolio: The Company develops and commercializes oncology drugs and drug candidates. CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin’s Lymphoma Patients.

Key Development: In April 2019, CASI Pharmaceuticals, announced the signing of a license agreement for exclusive worldwide rights to the investigational anti-CD38 monoclonal antibody (Mab) TSK011010 program from Black Belt Therapeutics Limited. Under the contract, CASI will be responsible for all development and commercialization activities of the TSK011010 program.

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  1. What is the study period of this market?

A.The Monoclonal Antibody Therapeutics Market market is studied from 2022 - 2029.

2.  What is the growth rate of Monoclonal Antibody Therapeutics Market?

A.The Monoclonal Antibody Therapeutics Market is growing at a CAGR of 14.1% over the next 5 years.

3.  Who are the key players in Monoclonal Antibody Therapeutics Market?

A. Daiichi Sankyo Company Limited, Johnson & Johnson, Abbvie Inc, UCB Inc, Amgen Inc are the major companies operating in Monoclonal Antibody Therapeutics Market.

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