According to a recent report by Grand View Research, Monoclonal Antibodies Market Size, Share & Trends Analysis By Source Type (Chimeric, Murine, Humanized, Human), By Production Type (In Vivo, In Vitro), By Application, By End-use, By Region, And Segment Forecasts, 2022 – 2030, the global monoclonal antibodies market size was valued at $185.5 billion in 2021 and is projected to have a compound annual growth rate (CAGR) of 11.3% from 2022 to 2030. 
 
Monoclonal antibodies (mAbs) are manufactured proteins designed to function like human antibodies in the immune system. Some monoclonal antibodies (mAbs) are a type of immunotherapy that work by triggering the immune system to attack cancer cells. While more targeted mAbs can work to block signals that tell cancer cells to divide or attach themselves to cancer cells, making it easier for the immune system to find them. mAbs can be produced and identified four ways: Human, Humanized, Murine and Chimeric.
 
Human are fully human proteins and the therapies end in -umab; Humanized are made from parts of mouse proteins attached to human proteins and the therapies end in -zumab; Murine are made from mouse proteins and the therapies end in -omab; Chimeric are part mouse and part human combination and the therapies end in -ximab.¹ 
 
Examples of mAbs that attach themselves to cancer cells include: Roche’s MabThera/Rituxan (rituximab), to treat chronic lymphocytic leukaemia (CLL) and certain types of non-Hodgkin lymphoma. Lilly’s Erbitux (cetuximab) to treat advanced bowel cancer and head and neck cancer, and Genentech’s Herceptin (trastuzumab) to treat breast cancer and stomach cancer.
 
Other mAbs, such as immunotherapies called checkpoint inhibitors, work by acting on cells of the immune system, blocking proteins that stop the immune system from attacking cancer cells.²
 
Several examples of checkpoint inhibitors include: Bristol Myers Squibb’s Opdivo (nivolumab), which is used to treat numerous types of cancer including lung cancer, melanoma, kidney and liver cancer, among others, and Yervoy (ipilimumab) to treat advanced melanoma; and Merck’s Keytruda (pembrolizumab), also used to treat numerous cancers such as lung, breast, kidney, and lymphoma.
 
Production Process
The typical production process for mAbs commonly starts with generation of mAb-producing cells by fusing myeloma cells with selected antibody-producing splenocytes, such as B cells. The B cells are usually sourced from animals, namely mice. After cell fusion, large numbers of clones are screened and selected based on antigen specificity and immunoglobulin class.³ Once candidate hybridoma cell lines are identified, each “hit” is confirmed, validated, and characterized using downstream functional assays. Once complete, the clones are scaled up where additional downstream bioprocesses occur.³
 
There are four steps to produce monoclonal antibodies: animal immunization, fusion and selection, antibody purification and Quality Control. The following details the production process:
 
Immunization of mice and isolation of splenocytes 
Mice are immunized with an antigen then their blood is screened for antibody production. The antibody-producing splenocytes are then isolated for in vitro hybridoma production.³
 
Preparation of myeloma cells 
Myeloma cells, once fused with spleen cells, can result in hybridoma capable of unlimited growth. Myeloma cells are prepared for fusion.³
 
Fusion 
Myeloma cells and isolated splenocytes are fused together to form hybridomas in the presence of polyehthylene glycol (PEG), which causes cell membranes to fuse.³
 
Clone screening and picking 
Clones are screened and selected based on antigen specificity and immunoglobulin class.
 
Functional characterization 
Confirm, validate and characterize each potentially high-producing colony.
 
Scale up and wean 
Scale up clones producing desired antibodies and wean off selection agents.
 
Expansion 
Expand clones producing desired antibodies using bioreactors or large flasks.
 
Market
A key factor driving the mAbs market, according to the Grand View Research report, is the rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and others, along with increasing demand for biologics. Also, increasing applications of mAb therapies for targeted therapies and rising awareness about such therapies is expected to significantly contribute to market growth. According to the Grand View report, the mAbs market size in 2022 will be $210 billion and forecast revenue in 2030 to be $494.5 billion.
 
The COVID-19 pandemic has also increased market expansion prospects with the development of mAbs directed against the SARS-CoV-2 virus. In February 2022, the U.S. FDA granted emergency use authorization (EUA) for Lilly’s bebtelovimab for the treatment of COVID-19 patients that are at risk of developing severe disease or hospitalization. 
 
mAb therapies offer some advantages over previous therapies in terms of specificity, effectiveness, and ease of delivery. Currently more than 100 mAbs have been approved by the U.S. FDA and the scope of therapeutic mAb applications is expected to grow.
 
According to the Grand View report, North America recorded the largest market share of 46.2% in 2021 due to the presence of a highly developed healthcare infrastructure, high patient awareness, and growth in cancer research prospects, among other factors. Key players such as Pfizer, Amgen, and Merck, among others, are expected to boost the market growth.⁴
 
References:
1.     https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/monoclonal-antibodies.html
 
2.     https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/monoclonal-antibodies
 
3.     https://www.moleculardevices.com/applications/monoclonal-antibody-production#gref
 
4.     https://www.grandviewresearch.com/industry-analysis/monoclonal-antibodies-market