Monoclonal Antibodies Market - Forecasts from 2022 to 2027

The monoclonal antibodies market is projected to grow at a CAGR of 7.99% to reach US$223.885 billion by 2027, from US$130.758 billion in 2020.

The immune system naturally produces antibodies in response to an infection. A monoclonal antibody is a molecule is designed to enhance the body’s natural immune system response against an invader, such as cancer or an infection. It is developed in a laboratory and hence comes under man-made drugs. Monoclonal antibodies are created to specifically target an essential part of the infectious process, and therefore they have an advantage over other types of treatment for infections. It is created by exposing a white blood cell to a particular viral protein. It is then cloned to mass-produce antibodies, which target that virus. The monoclonal antibodies are developed to treat several viral infections, such as Ebola and rabies. They were widely used during the COVID-19 pandemic, as the clinical trials proved that the antibodies are effective in reducing the symptom severity.

Increased demand for monoclonal antibodies

According to the World Health Organization, around 10 million people died due to cancer worldwide in 2020. For cancer treatment monoclonal antibodies are significantly helpful, therefore, there is an increasing need for affordable cancer therapies. Moreover, during the COVID-19 pandemic, a large number of monoclonal antibodies’ clinical trials took place in order to develop novel drug therapy as well a wide range of product approvals were made for emergency use in COVID-19 treatment.

With its growing demand, the market players have a strong focus on the development as well as the discovery of monoclonal antibodies therapeutics. The step has been taken to offer highly specific treatment for complex and severe diseases. Furthermore, it will stimulate the monoclonal antibodies market growth potential.

Key Developments

• In April 2020, Merck announced the launch of the biosimilar to trastuzumab (Herceptin), which is widely recommended for the treatment of metastatic breast cancer and metastatic gastric cancer. The trastuzumab biosimilar is known as trastuzumab-dttb (Ontruzant), in the United States. The doses are available in both 150-mg single-dose vials and 420-mg multiple-dose vials. In January 2019, the FDA approved Trastuzumab-dttb. Moreover, in March 2020, FDA subsequently approved a 420-mg multi-dose of trastuzumab-bttb. The US launch was made as a part of a development and commercialization agreement with Samsung Bioepis.
• In May 2022, Swiss multinational Roche Pharma announced the launch of the world’s first fixed dose combination of two monoclonal antibodies, PHESGO, in oncology for the treatment of HER-2-positive breast cancer in India. The company combined the injections of Perjeta (pertuzumab) and Herceptin (trastuzumab). The dose will be used as intravenous (IV) chemotherapy. They will be useful in the treatment of early and metastatic HER2-positive breast cancer. The dose combination has been approved in over 100 countries worldwide. The company has quoted the drug’s price as 20% less than individual meditations.
• In February 2019, China National Medical Products Administration (NMPA) approved Henlius’s first product, HLX01 (rituximab injection). The dose will be used for the treatment of adult patients in three indications such as- i) relapsed or refractory, follicle lymphoma, ii) previously untreated stages III-IV follicular, non-Hodgkin’s lymphoma, and iii) CD20-positive. HLX01 was China’s first approved product which was the first independently researched and developed mAb drug in China.

North America is expected to hold a significant share during the anticipated period

North American countries have well-developed healthcare infrastructure. However, the high intake of alcohol and junk/fast food culture in this region is leading to obesity and also putting the population at a high risk of being infected with cancer. According to a study by American Cancer Society researchers in 2019, there were at least 42% of newly diagnosed cancers in the US - about 740,000 cases in 2019 were potentially avoidable. The study also said that out of the newly diagnosed cancer patient 19% of all cancers are caused by smoking and 18% are caused due to lack of physical activity, excess alcohol, and junk food consumption, which leads to excess body weight and poor nutrition. Furthermore, new vaccines/drugs are being developed to help in the treatment of cancer patients. For example, in October 2022, Amneal Pharmaceuticals announced the launch of bevacizumab-maly (Alymsys) in the United States. The drug is a biosimilar reference of bevacizumab (Avastin, Genentech). Bevacizumab-maly is developed by mAbxience. The drug will be useful in the treatment of metastatic colorectal cancer, first-line non-squamous non-small cell lung cancer, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

COVID 19 Insights

During the pandemic, when there wasn’t a specific treatment for COVID-19, monoclonal antibodies were widely used in the treatment of COVID-19 patients. Monoclonal antibodies therapy prevented hospitalization, reduced viral loads, and lessened symptom severity of the virus. FDA granted several monoclonal antibody therapies Emergency Use Authorization (EUA) for the treatment of COVID-19. Moreover, in 2021, the potential application of monoclonal antibody therapy was extended by FDA for the preventive use for those who were at risk due to a confirmed exposure to the virus. The decision was based on the basis of a large clinical trial that found that monoclonal antibodies prevented the symptoms during the interaction of COVID positive family members with the other household members. Monoclonal antibody therapy was done through intravenous (IV) infusion during the pandemic.

Market Segmentation:

• By Indication
• Inflammatory Disease
• Cancer
• Microbial Disease
• Others
• By Source
• Humanized
• Human
• Chimeric
• Murine
• By Application
• Diagnostic
• Therapeutic
• Others
• By End-User
• Hospitals & Clinics
• Research Laboratories
• By Geography
• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Others
• Asia Pacific
• China
• Japan
• South Korea
• India
• Thailand
• Taiwan
• Others