The Total Addressable Market (TAM) for Monoclonal Antibodies was valued at USD 162.47 billion in 2021. It is projected to reach USD 390.58 billion by 2030, growing at a CAGR of 10.2% during the forecast period (2022-2030). Monoclonal antibodies (mAb) are the antibodies that are developed in a laboratory from a clone of a single B-cell. These antibodies identify and cling to a particular receptor found on the surface of cells. The monoclonal antibodies are comparable and identical immunoglobulins (Ig). Additionally, these are used as diagnostic indicators to detect various disease agents. Autoimmune illnesses, inflammatory diseases, viral diseases, and other diseases are treated with monoclonal antibodies. The rise in the incidence of cancer and other chronic diseases increased government funding for cancer research and technology development, and the rapid uptake of humanized monoclonal antibodies (mAbs) in the treatment of various diseases, including inflammatory, cancerous, and autoimmune diseases, are the main factors driving the growth of the monoclonal antibodies market.
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Rising Prevalence of Various Types of Cancer
With an expected 2.3 million new cases (11.7%), female breast cancer has surpassed lung cancer as the most often diagnosed cancer. Lung cancer (11.4%), colorectal cancer (10.0%), prostate cancer (7.3%), and stomach cancer (5.6%) are the following most frequently diagnosed cancers. Additionally, it is predicted that there will be 28.4 million new instances of cancer worldwide in 2040. Since many of these nations lack the necessary healthcare infrastructure to treat cancer symptoms successfully, the burden is disproportionately heavy in low and middle-income nations. Most recent research has been directed at creating effective therapies for the five most common cancer types: lung, breast, colorectal, prostate, and stomach. The market for monoclonal antibodies is expanding as more people choose various cancer treatments due to increased cancer prevalence.
Increasing Demand for Cost-Efficient Biosimilar Monoclonal Antibodies
Pharmaceutical medicines known as "biosimilars" are created to have features similar to those of a biologic drug that has already received approval. The immune system uses the vast, complex proteins known as biosimilar monoclonal antibodies to recognize and neutralize invading substances like germs and viruses. The cost of the biosimilar monoclonal antibodies is about 20%–25% less than that of the original biologic medication. The goal of biosimilar monoclonal antibodies is to reduce the rise in healthcare costs and manage economic pressure from governments and patient groups to lower medicine costs and broaden access to care. For instance, the Central Drugs Standard Control Organization's (CSDCO) Guidelines on Similar Biologics, a biosimilar policy in India, is expected to improve the country's biosimilar medication business significantly.
Poor Demand in Underdeveloped Countries
In developing nations like Asia and Africa, factors such as a lack of financial resources, low income, a shortage of biotechnology firms, and a lack of sophisticated production methods restrain the growth of the monoclonal antibodies market. Additionally, inadequate government support for the use of monoclonal antibodies products and a lack of qualified specialists restrain the growth of the monoclonal antibodies market in developing nations like Ethiopia, Afghanistan, and Guinea.
Growth Opportunities in Emerging Markets
The availability of improved healthcare industry infrastructure, the expansion of the pharmaceutical and biotechnology industries, and the rise in the demand for monoclonal antibody products are all expected to contribute to the growth of the monoclonal antibodies market. These untapped, emerging markets will also present opportunities for the market. Due to the increased demand for improved sophisticated manufacturing systems and significant government investments to upgrade healthcare infrastructure, the healthcare business is growing rapidly in emerging nations.
Additionally, due to patent expiration and a growth in demand for individualized treatments, pharmaceutical and biotechnology industries are concentrating on expansions in developing nations like India, China, and Japan. One of the most important pharmaceutical markets is in the United States, and among the BRIC countries, China dominates the market, followed by Brazil, Russia, and India. Pharmaceutics research has advanced in Asian nations due to increased clinical study activity and resource availability.
The global monoclonal antibodies market is segmented by source, indication, and end-users.
Based on the source, the global market is bifurcated into murine, chimeric, humanized, and human.
The human segment is the highest contributor to the market and is expected to grow at a CAGR of 11.00% during the forecast period. Solid tumors, such as colorectal, lung, renal cell, and breast cancer, are treated with human monoclonal antibodies (mAbs) that neutralize vascular endothelial growth factor (VEGF). The neutralizing human monoclonal antibodies (mAbs) are taken into account to pick the best antibodies for further development by determining the range of neutralization, binding epitopes, and animal protection. Human monoclonal antibodies (mAbs) were first created to powerfully control their effector activities while avoiding immunogenicity, which is a problem with rodent antibodies. Furthermore, cross-reactive neuronal antibody sites in the brain have been discovered using human mAbs created from Sydenham chorea (SC) patients. AbbVie Inc., Amgen, Janssen Biotech Inc., Novartis, Janssen Biotech Inc., GlaxoSmithKline, and Bristol-Myers Squibb are a few of the major competitors in the human monoclonal antibody market.
Antibodies from non-human species that have changed their protein structures to make them more similar to naturally occurring monoclonal antibody variations in humans are known as humanized monoclonal antibodies. Humanization may be necessary when producing particular monoclonal antibodies involves using a non-human immune system, such as a mouse. The advantages of humanized monoclonal antibodies include reduced immunogenicity, human effector activities enabled by the human C region, and an extension of the mAb's serum half-life in humans. Additionally, they represent a wide variety of target antigens for treating autoimmune illnesses, such as anticancer, immunosuppressors, anti-infectives, and immunomodulators.
Based on indication, the global market is bifurcated into cancer, autoimmune diseases, inflammatory diseases, infectious diseases, microbial diseases, and others.
The cancer segment owns the highest market share and is expected to grow at a CAGR of 10.6% during the forecast period. A set of illnesses known as cancer are characterized by abnormal cell proliferation and have the potential to affect or spread to other bodily regions. Sarcomas, lymphomas, leukemia, and carcinomas are some of the more common kinds of cancer. Sarcomas develop in connective tissue, including muscle and bone. The disease's last stage, known as metastasis, is characterized by the invasion of the tumor into additional body parts. To treat different types of cancer, biological medications based on monoclonal antibodies (mAbs) have become the treatment of choice. The increase in the elderly population, the rise in cancer prevalence, the early detection of cancer, and the more significant number of R&D efforts to produce innovative monoclonal antibody therapeutics have all been major factors in the growth of this market.
The immune system attacks its body tissue due to an autoimmune disease. There are over 80 different types of autoimmune disorders, but lupus, multiple sclerosis, inflammatory bowel syndrome (IBS), type 1 diabetes, rheumatoid arthritis, psoriasis, and others are the most common ones. Due to their ability to bind to and block TNF-, the autoimmune medications adalimumab and infliximab are effective in treating rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Additionally, daclizumab and basiliximab are employed to stop acute rejection of kidney transplants. Omalizumab is also helpful for people with mild to severe allergic asthma. Due to the rise in autoimmune disease prevalence, improvements in screening and diagnosis techniques, and widespread accessibility of advanced therapeutics, it is anticipated that there will be an increase in the demand for monoclonal antibodies for the treatment of autoimmune diseases during the forecast period. Additionally, many monoclonal antibody therapeutics in development are anticipated to accelerate market expansion further.
Based on end-user, the global market is bifurcated into hospitals, research institutes, and others.
The hospital segment is the highest contributor to the market and is expected to grow at a CAGR of 10.6% during the forecast period. Hospitals are healthcare facilities with skilled nursing, medical personnel, and specialized medical gear. Due to its greater capacity for inpatients and outpatients, it is the most favored sector among the others. The hospital industry accumulated the largest share of the global monoclonal antibodies market in 2021 as a result of hospitals' increasing propensity for monoclonal antibody products. Hospitals offering novel monoclonal antibody therapy, a rise in government initiatives to ensure chronic disease prevention, and an increase in the geriatric population—a population more susceptible to chronic diseases—all contribute to the segment's growth.
Research institutes are organizations that receive funding from public or private sources to carry out studies on present or upcoming goods that may be used for diagnosing, treating, or monitoring any illness in the human body. Due to the rising burden of cancer and other chronic diseases during the predicted period, many of these organizations have improved research procedures using the funding gained to develop innovative technologies. In research facilities, monoclonal antibodies are employed to purify the target protein or detect the presence of proteins. Monoclonal antibodies are also utilized in the isolation of tissue cells by flow cytometry and the research of cell types in tissue and blood. Mice can be given injections of monoclonal antibodies to disrupt protein activity or reduce particular cell types.
The global monoclonal antibodies market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.
North America Dominates the Global Market
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North America is the most significant shareholder in the global monoclonal antibodies market and is expected to grow at a CAGR of 9.6% during the forecast period. One crucial element influencing the growth of the global market is the existence of significant critical companies in the area, such as Pfizer Inc., Merck & Co., Inc., Amgen, Inc., Abbott Laboratories, Mylan N.V., and Eli Lilly and Company. In addition, the high demand for biologics, increased R&D in genomics, the introduction of technologically cutting-edge genetic platforms like next-generation sequencing, and the rising incidence of cancer in this region all significantly contribute to the growth of the North American market. This is mainly related to a rise in patient and physician awareness of the use of monoclonal antibodies (mAb) therapy and to the increased approval of blockbuster mAbs for several applications, which foster market expansion.
Additionally, the patient base is increased by essential revenue-generating mAb medications like Avastin, Remicade, Rituxan, and Herceptin, which have received FDA approval for various diseases like cancer, ulcerative colitis, Crohn's disease, and others. Other factors that contribute to the market's expansion include the use of cutting-edge genetic engineering technology in mAb production, a well-developed healthcare infrastructure, government support for infection control and management, and an increase in the incidence of diseases linked to a sedentary lifestyle.
Europe is expected to grow at a CAGR of 10.5%, generating USD 1,44,124.70 million during the forecast period. The demand for monoclonal antibodies pharmaceuticals is expected to increase over the forecast period, and prominent companies like GLAXOSMITHKLINE PLC, NOVARTIS AG, AstraZeneca plc, Hoffmann-La Roche AG, Bayer AG, and Sanofi S.A. are expected to remain dominant in the market. Additionally, the increased use of monoclonal antibodies for the treatment of chronic illnesses as a result of the European Commission's ongoing efforts to develop strategies for the use of monoclonal antibodies in the treatment of infectious diseases has a favorable impact on the market's expansion.
For instance, a license agreement was struck between Union Chimique Belge (UCB), a biopharmaceutical company, and Roche and Genentech for the development and marketing of UCB0107, an experimental monoclonal antibody therapy. Patients with Alzheimer's disease and progressive supranuclear palsy (PSP) take this medication. Other significant development factors of the European market are the availability of qualified experts and vital infrastructure in the healthcare sector. Due to several significant players and the availability of sophisticated healthcare infrastructure with cutting-edge technology, the market for monoclonal antibodies in Germany, France, and the U.K. is predicted to rise significantly over the forecast period.
Asia-Pacific is expected to grow significantly over the forecast period. The increase in research and development efforts in genomics, the surge in demand for technologically advanced genetic platforms, and the increased patient knowledge of the uses of monoclonal antibodies (mAb) therapy are all contributing factors to the market expansion in this region. For instance, GLOBOCAN 2020 reported 5,809,431 deaths, and roughly 9,503,710 new cancer cases were recorded in Asia in 2020. Additionally, the growth of the R&D sector, the expansion of healthcare reforms, and technological developments in the production of monoclonal antibodies drive the market's expansion. The main drivers of the market's considerable growth are the demand for tailored medications, the accessibility of sophisticated healthcare systems, and the region's sharp increase in demand for advanced healthcare facilities. Additionally, a sharp increase in leading manufacturers' attention to regional expansion in developing Asia-Pacific nations to seize significant development possibilities spurs market expansion.
Due to a scarcity of clinical trial institutions with cutting-edge research facilities and a shortage of qualified medical personnel, the monoclonal antibodies industry in LAMEA is still in its infancy. LAMEA is a developing market that is anticipated to offer lucrative growth possibilities for critical players because of the rise in target populations, the increased use of monoclonal antibodies for autoimmune disorders and infectious diseases, and improvements in the healthcare system. Additionally, rising government involvement in various research institutes and an increase in the frequency of chronic diseases in LAMEA encourage people to use monoclonal antibodies, which propels the market's expansion.
The global monoclonal antibodies market’s major key players are Abbott Laboratories, Amgen Inc., AstraZeneca Plc., Bayer Ag., Eli Lily and Company., GlaxoSmithKline PLC, Johnson & Johnson, Merck & Co., Inc., Novartis Ag, and Pfizer Inc.