Monoclonal Antibody Market Set to Triple by 2033, Revolutionizing Disease Treatment

By Dr. Chinta SidharthanReviewed by Lily Ramsey, LLMOct 28 2024

With the invention of hybridoma technology in 1975, monoclonal antibodies (mABs) have undergone significant advancements and evolved from murine-based to humanized versions, reducing the risk of immune reactions. Furthermore, their ability to target specific proteins has made them more effective than pharmaceutical drugs for various diseases.

In a recent review published in Molecular Biomedicine,  researchers highlighted the advancements in antibody engineering. They discussed the various ways in which mAbs could revolutionize disease treatment by addressing the current medical needs and overcoming existing challenges.

​​​​​​​Study: Monoclonal antibodies: From magic bullet to precision weapon. Image Credit: paulista/Shutterstock.com

Monoclonal Antibodies

Antibodies are the body’s chief defense mechanism and are produced in response to the detection of harmful substances such as viruses, bacteria, and toxins. Monoclonal antibodies are engineered to precisely target specific antigens or proteins, making them valuable in treating cardiovascular disease, autoimmune disease, and cancer.

Despite their success in the treatment of non-infectious diseases, the development of mAbs for use against viral and bacterial infections has been challenging due to the complex and variable nature of infections, as well as high production costs.

However, rapid technological advancements during recent events, such as the coronavirus disease 2019 (COVID-19) pandemic, have renewed interest in mAbs as a safer and more effective treatment alternative.

Evolution of mAbs

Monoclonal antibodies are lab-engineered proteins designed to specifically target disease-related molecules. The technology has evolved significantly over the years, and the review presented a detailed overview of this evolution.

The earliest mAbs were derived from murine models, which triggered adverse immune reactions in humans. Therefore, to improve the compatibility of mAbs in humans, scientists developed ‘humanized’ mAbs through complementarity determining region (CDR) grafting where the murine components are minimized, and only the essential binding regions from the mice are retailed. At the same time, the rest are replaced with human components.

Furthermore, various bioinformatic tools have also been developed to create mAbs with human-like properties, which enhance their safety and effectiveness.

Humanized mAbs such as trastuzumab, which is used in cancer treatment, now constitute half of the therapeutic mAbs in use, and their applications are being expanded to treat other chronic conditions besides cancer.

The production methods for mAbs have also undergone substantial advances. In vitro displays such as ribosome, phage, mammalian, and yeast displays have allowed rapid discovery of mAbs. Plant-based and transgenic animal methods have also offered cost-effective and scalable options for monoclonal antibody production.

Furthermore, newer technologies involving ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) to encode mAbs have also enabled quicker in vivo synthesis without the need for extensive purification. This diversity of monoclonal antibody production methods is providing safer and more effective treatments across a wide range of medical conditions.

Additionally, affinity maturation is a process that occurs in therapeutic settings, enhancing the binding affinity of mAbs for specific targets. The use of yeast and phage displays has allowed scientists to screen and select mAbs with the highest binding affinity that can effectively neutralize pathogens.

Recent innovations have also focused on developing next-generation antibodies, such as bispecific antibodies that can recognize and bind to two separate targets, improving the precision of the treatment and enhancing the immune responses.

Ongoing research is also invested in developing tri-specific antibodies that can target multiple pathways simultaneously, as well as catalytic antibodies that have enzymatic functions that can be useful in treating infections.

Current and Future Applications of Monoclonal Antibody Therapies

The ability of mAbs to target specific proteins and cellular receptors has revolutionized the treatment options for respiratory, cardiovascular, autoimmune, and various infectious diseases.

The review included a comprehensive discussion of the existing therapeutic mAbs for various non-communicable diseases and discussed some of the ongoing research for developing monoclonal antibody therapies for infectious or communicable diseases.

This section covered the use of mAbs in a wide range of non-communicable diseases such as cardiovascular disease, respiratory diseases such as asthma, autoimmune disorders such as rheumatoid arthritis, as well as cancer and type 1 diabetes.

The researchers also discussed ongoing research on mAbs against a range of viral, bacterial, fungal, and parasitic pathogens.

Challenges, Limitations, and Potential Advances

Although mAbs are a promising alternative for the treatment of numerous non-communicable and infectious diseases, they come with several challenges and limitations.

The administration of mAbs requires optimized doses, while stability, durability of therapeutic effects, and interactions with other therapies and biological molecules require better understanding.

Furthermore, the production of mAbs continues to be expensive and time-consuming, requiring sophisticated cell lines and purification mechanisms. Additionally, despite the development of humanized mAbs, the issues related to adverse reactions such as allergies, cytokine storms, and autoimmunity continue to be significant challenges.

Although the use of emerging artificial intelligence (AI) and machine learning models and tools could help optimize mAB design, current models lack the large amounts of experimental data required for accurate predictions.

The researchers believe that the aim of future mAB research should be to enhance the safety profiles, tailor mAB therapy for individuals, and explore new mechanisms of mAB delivery for broader treatment options.

Conclusions

Overall, the review highlighted the importance of mABs as a promising targeted approach to treating various non-infectious and infectious diseases, including antibiotic-resistant infections and cancers.

However, despite the substantial advantages of mABs, the high production costs, limited targets, and accessibility issues present various challenges. The researchers believe that future research must focus on improving the design of mABs, enhancing delivery methods, and using AI models to accelerate the development process.