Monoclonal antibodies (mAbs) are laboratory-made proteins that are designed to mimic the immune system's ability to fight off harmful pathogens such as viruses and cancer cells. Since the approval of the first monoclonal antibody drug, Orthoclone OKT3, in 1986, monoclonal antibodies have revolutionized the treatment of various diseases, including cancer, autoimmune disorders, and infectious diseases.

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Furthermore, the surge in the prevalence of lifestyle disorders is also a major factor contributing to the increase in the prevalence of chronic diseases. For instance, as per the data provided by the Global Obesity Observatory (2021), Mexico presents a national risk of obesity development on a scale of 10 to be 8. This represents that the majority of the population in Mexico either falls in the bracket of the obese population or is highly susceptible to being obese in the coming years. Many studies have established that excess body fat increases the risk for several cancers, including colorectal, postmenopausal breast, uterine, esophageal, kidney, and pancreatic cancers. Additionally, the increase in aging population in the country is also said to contribute to cancer incidence.

The surge in the incidence of cancer has surged the demand for monoclonal antibodies owing to their targeted nature and high efficiency. According to World Health Organization, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020 globally. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. The use of monoclonal antibodies in cancer treatment has expanded significantly over the years, with drugs such as Rituxan, Herceptin, and Avastin being some of the most widely used therapies.

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Figure 1: Worldwide Cancer Incidence2020

The development of targeted therapies has been an active area of research for many years, resulting in a range of treatment options that can be used to manage and treat several chronic diseases. Some of the leading companies in the market include Roche, Amgen, Bristol Myers Squibb, AbbVie, and Johnson Johnson. These companies are investing heavily in RD to develop new and innovative therapies, as well as expanding their manufacturing capacities to meet the growing demand for monoclonal antibodies based treatments.

The encouraging response has propelled further research and development activities among pharmaceutical giants to design more efficient and targeted cancer drugs. The major companies in cancer research including Sanofi, Pfizer, Amgen, Roche, and others have actively invested in cancer research. For instance, in January 2022, HaemaLogiX Ltd (HaemaLogiX) and Lonza entered into an agreement to manufacture the next clinical batch (cGMP) of HaemaLogiXs lead multiple myeloma drug candidate, KappaMab, a monoclonal antibody that binds to a cell surface target called kappa myeloma antigen (KMA) that is only found on myeloma cancer cells and not on normal plasma cells.

Counties such as China and Japan in the Asia-Pacific region are also rapidly investing in procedure trays research. Adding to this, several companies have also adopted strategic alliances to launch liquid biopsy tests in Asia Pacific region. For instance, March 2021, Eli Lilly and Company announced a collaboration with Singapore's MerLion Pharmaceuticals to develop new monoclonal antibodies for the treatment of multidrug-resistant bacterial infections. Further in January 2021, Takeda Pharmaceutical Company entered into a partnership with Australia's CSL Behring to develop and commercialize a new monoclonal antibody for the treatment of hereditary angioedema.

Figure 2: Monoclonal antibodies approval by U.S. FDA, 2016-2021

TOP INVESTORS IN MONOCLONAL ANTIBODIES DEVELOPMENT

Over the last few years, procedure trays has witnessed a string of institutional investors and corporations, who are looking at the growing demand for liquid biopsy tests and are investing in the industry be it small or large investments. Big companies are acquiring/partnering with smaller companies or start-ups to increase their market share. Some of the prominent mergers and acquisitions/partnerships in the smart home ecosystem include:

In February 2022, Eli Lilly and Company announced that United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.\

In June 2021, Amgen entered into collaboration with Kyowa Kirin Co., Ltd. to jointly develop and commercialize KHK4083, which is Kyowa Kirin's potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.

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CONCLUSION

In conclusion, monoclonal antibodies is poised for significant growth in the coming years, driven by factors such as the increasing prevalence of chronic diseases and the growing demand for personalized medicine. The continued development of new and innovative therapies, coupled with the expansion of manufacturing capacities, is expected to further propel the growth forward. However, the market is not without challenges, including high development costs, regulatory hurdles, and the potential for biosimilar competition. Overall, the monoclonal antibodies represent a significant opportunity for pharmaceutical companies and investors alike. Contact Universal Data Solutions, a rapidly growing dynamic market research firm led by a core of dedicated professionals for further information. According to the Universal Data Solutions analysis, the development of advanced technologies would massively transform the global scenario of monoclonal antibodies and as per their Monoclonal Antibodies Market report, the global market was valued at USD 180 billion in 2021, growing at a CAGR of 9% during the forecast period from 2022 - 2028 to reach USD XX billion by 2028.