PUBLISHER: DataM Intelligence | PRODUCT CODE: 1290357
PUBLISHER: DataM Intelligence | PRODUCT CODE: 1290357
The Global Monoclonal Antibody Therapeutics Market reached US$ 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 531,314.6 million by 2030. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2023-2030).
Monoclonal antibody therapeutics (mAbs) are generated from identical antibodies (or simply antibody fragments) in a homogeneous manner. The antigen recognition site, biological interactions, affinity and downstream biologic consequences of every antibody molecule in the product are identical. This sets mAbs apart from polyclonal antibodies, which have a diverse range of protein sequences and epitope recognition
The global market for monoclonal antibody therapeutics is expanding as a result of factors including the increasing prevalence of autoimmune disorders, the growing size of the therapeutic pipeline, investment by biopharmaceutical companies and their upcoming medical approvals across countries are also creating a positive outlook for the monoclonal antibody therapeutics market growth.
The growing number of regulatory approvals by various regulatory bodies for different monoclonal antibodies therapeutics utilized for cancer or autoimmune diseases, the growing clinical trials by major biopharmaceutical companies, an increase in the population with cancer, and new, innovative, technologically sophisticated therapies are all contributing to the growth of the global market for monoclonal antibody therapeutics.
Furthermore, on January 5, 2023, Nirsevimab's Biologics License Application (BLA) was approved by the U.S. FDA, Center for Drug Evaluation and Research for the treatment of children up to 24 months old who are still susceptible to developing severe respiratory syncytial virus (RSV) disease throughout the second RSV season as well as for infants and newborns entering or already experiencing their first RSV season. Hence, the growing number of novel therapies launched by biopharmaceutical companies is driving the monoclonal antibody therapeutics market.
Due to increasing spending or investments in research and development capabilities by key players or biotechnology businesses for unique technological breakthroughs, there is a growing market opportunity for monoclonal antibody therapeutics. Another trend driving the monoclonal antibody therapies market is the increasing occurrence of respiratory diseases.
Furthermore, in April 2023, early experiments conducted by researchers at Janssen Biotech, Inc. and NYU Grossman School of Medicine demonstrated that a bioengineered medication candidate can prevent infection with the bacterium species Staphylococcus aureus.
It details the preliminary evaluation of mAbtyrins, a combination molecule derived from an engineered human monoclonal antibody (mAb), a kind of protein that adheres to and identifies S. aureus for uptake and eradication by immune cells. Centyrins, tiny proteins that are attached to the mAb, stop these germs from drilling holes in the human immune cells where they hide.
However, biotherapeutics, including monoclonal antibodies and recombinant proteins, which have grown into the foundation of contemporary medicine, are still largely beyond reach for populations in middle- and low-income countries, in part due to their high costs, despite often providing clinical benefits over the standard of care is a restraint for monoclonal antibody therapeutics market.
The average yearly cost of a mAb was $96,731, and for 34 mAb-indication combos, it exceeded $100,000. Despite making up 40% of the approved mAb-indication combinations, hematology and oncology mAbs accounted for over 85 percent of those with a price tag of $100,000 or higher. Hence these above mentioned factors are limiting the monoclonal antibody therapeutics market's growth.
The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.
These therapeutic monoclonal antibodies were also used to control COVID-19. For instance, on February 11, 2022, Eli Lilly and Company announced that Bebtelovimab, an antibody that exhibits neutralization against the Omicron variant, received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
The Russia-Ukraine conflict is estimated to have a low impact on the global monoclonal antibody therapeutics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global monoclonal antibody therapeutics market growth over the forecast period.
Humanoid from the Production Source Segment Accounts for 45.79% of the Market Share Owing to Rising Novel Product Launches.
A humanized antibody possesses three advantages over a native mouse mAb: it is less immunogenic (since the immune response is primarily directed against the mouse Ig constant region); it can perform human effector functions; and its serum half-life in humans is significantly longer. Researchers have extracted the mouse CDRs targeted against a relevant human antigen and assembled them in a human antibody framework to further humanize these antibodies.
A humanized IgG4 anti-PD-1 monoclonal antibody called tislelizumab is being researched as a monotherapy and in conjunction with other treatments. Treatment of inoperable recurrent metastatic or locally progressed esophageal squamous cell carcinoma (ESCC) is possible in patients who had previously received systemic therapy with the anti-PD-1 immune checkpoint inhibitor tislelizumab.
Manufacturers have chances to expand their operations in this region because of the rising demand for monoclonal antibody therapeutics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of monoclonal antibody therapeutics, which has increased the demand.
North America has a large number of producers and suppliers, and as a result of the swift economic development of the area, industrial production has increased, fueling the demand for monoclonal antibody therapeutics.
Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals, and novel product launches. Researchers are becoming more aware of various kinds of treatment approaches for cancer or various other disorders, leading to the expansion of the market in this region.
The major global players in the monoclonal antibody therapeutics market include: F. Hoffmann-La Roche, Sanofi, Merck & Co. Inc., Pfizer Inc., GSK Plc, Eli Lily and Co., Regeneron Pharmaceuticals Inc., AstraZeneca, and Bayers AG among others.
The global monoclonal antibody therapeutics market report would provide approximately 53 tables, 54 figures and 195 Pages.
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