The global antibodies drug market size reached USD 200.18 billion in 2022 and is expected to exceed USD 605.8 billion by 2032, expanding at a CAGR of 10.8% between 2023 and 2032. The increase in the production of monoclonal antibodies is leading to higher demand for the antibodies drugs.
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Monoclonal Antibodies (mAbs), which seem to be antibody preparations designed to bind to a single target, have shown potential in the fight against cancer as well as autoimmune diseases.
Monoclonal antibodies are protein-based therapies or drugs that are increasingly being used to treat chronic diseases. This blog examines the global market for antibody drug products and provides an update on their applications in various disease areas. The overall market for antibody drug products is divided into four major application areas: autoimmune diseases, solid tumors, lymphoma, and leukemia, as well as other diseases such as asthma, osteoporosis, and cardiovascular disease.
The FDA has approved more than 100 antibody products, and biologics account for roughly one-fifth of all new drug approvals each year. The presence of a healthy antibody therapy pipeline increases the company's chances of achieving higher market revenue. As a result of the high demand for antibody therapy, a surge in the development of new antibody products is expected to drive the antibody therapy market share.
Orthoclone OKT3 (muromonab-CD3) was the first licensed monoclonal antibody, approved in 1986 for use in preventing kidney transplant rejection.
It is a mouse monoclonal IgG2a antibody with the cognate antigen CD3. It works by binding and inhibiting the effects of CD3 on T-lymphocytes. However, due to reported side effects, its use was restricted to acute cases (e.g. human anti-mouse antibody response).
Targeted therapies are intended to attack cancer cells using antibodies and chemotherapy. They are based on the idea that cancer cells have abnormal versions of certain proteins known as receptors that exist in normal cells but not in cancer cells. Antibodies against these receptors may be used in these targeted therapies. Immunotherapy is a type of cancer treatment that employs the immune system to combat the disease. It is also known as biotherapy. This type of treatment can be used alone or in conjunction with other therapies. Immunotherapy is classified as a biological therapy. Biological therapy is a type of cancer treatment that uses compounds derived from living organisms.
Rising cancer cases around the world are expected to boost demand for antibody therapy. According to the Global Cancer Observatory (GLOBOCAN), approximately 19.3 million new cancer cases will be reported in 2020, with approximately 10 million associated deaths. according to the World Health Organization (WHO), cancer is the first/second leading cause of death in many countries, reducing life expectancy.
Cancer's increasing prevalence and high mortality rate have increased the demand for effective and targeted therapies such as antibody therapy. Recently, antibody-based treatments have advanced technologically by targeting tumor antigens and enhancing immune cells' anti-tumor capabilities. Furthermore, high product advancement and technologies for cancer treatment are expected to drive the antibody therapy market growth.
The popularity of the cost-effective bio-similar monoclonal antibodies market is rapidly increasing, which boosts monoclonal antibodies market growth. The goal of bio-similar antibodies is to control rising healthcare costs and to deal with economic pressure from patients and governments to reduce medication costs and improve treatment approaches. A bio-similar monoclonal antibody is 20%-25% less expensive than the original biologic drug. The number of clinical trials for a biosimilar is less than that of the original biologic drug, which explains why biosimilar drugs are less expensive.
The long, as well as strict regulations for approval and launch, will be a major hurdle faced by the a7ntibody-drug market. The failure to meet the stringent regulations and results had led to the withdrawal of various clinical studies by the regulatory authorities.
Certain functional disadvantages of therapeutic antibodies, such as insufficient pharmacokinetics and tissue accessibility, as well as impaired interactions with the immune system, have been identified, and these deficiencies indicate areas where more research is needed. When monoclonal antibodies were first developed, they encountered serious problems when used as therapeutics. The first monoclonal antibodies were murine molecules that were recognized as foreign when injected into patients, causing the immune system to remove them. Furthermore, in order to be effective, antibodies frequently need to interact with immune system components such as receptors on effector cells or the complement cascade.
Monoclonal antibodies are gaining popularity as a safe and effective treatment for a variety of chronic diseases. Due to the success of drugs such as Remicade, Avastin, Rituxan, and Herceptin, demand for these products is rapidly increasing. Furthermore, manufacturers are engaged in the development of new drugs and product launches, which will accelerate market growth in the near future.
The mAbs are very expensive. The low financial capabilities of the low and middle-income groups in developing and underdeveloped countries, as well as a lack of proper access to healthcare facilities, pose a significant challenge to market players and may impede the growth of the global monoclonal antibodies market.
COVID-19 had a significant impact on the global economy, including all nations, by interrupting the operations of all sectors, regardless of size. The rising prevalence of COVID-19 cases had an impact on the healthcare sector. While the impact of COVID-19 has been mostly negative across several areas, the antibody therapy sector has gained significant attention as a result of a surge in demand for COVID-19 treatment development.
Several companies accelerated their R&D for the development of COVID diagnostic and treatment tools. The FDA and other international organizations granted emergency use authorizations (EUAs) for anti-SARS-CoV-2 mAb and other antibody therapy for the treatment of moderate to severe COVID-19 infection.
Such rapid product approvals for the treatment of COVID-19 have aided the growth of the antibody therapy industry during the pandemic. As a result, COVID-19 is expected to have a positive impact on the antibody drug market.
According to the source, human antibodies will dominate the global monoclonal antibody market in 2022. The introduction of Adalimumab biosimilar is anticipated to provide significant market opportunities during the forecast period. Increased pharmaceutical company investments in human mAb research, as well as increased demand for human antibodies, are propelling the market growth. Rising technological advancements to develop a molecular understanding of diseases, a rapidly aging population, and expanding applications of monoclonal antibodies are some of the factors driving the global monoclonal antibody market growth of human antibodies.
Monoclonal antibodies are laboratory-made proteins that boost the immune system to fight against various harmful pathogens such as viruses.
Cancer will dominate the global antibody drug market in 2022, according to indications. This increase is simply due to the increased prevalence of cancer and the rising demand for monoclonal antibodies in the treatment of various cancers such as lung cancer, breast cancer, colorectal cancer, and prostate cancer. The greater efficacy of mAbs in cancer treatment with few or no side effects is a major factor driving the high demand for monoclonal antibodies among cancer patients. Rising healthcare spending and increased awareness of mAbs along with their effectiveness in cancer treatment behold their dominance in the global market.
In 2022, the hospital pharmacies segment held the largest share of the antibodies drug market segment based on the distribution channel. This is due to an increase in hospital admissions due to the rising prevalence of chronic diseases such as cancer, autoimmune diseases, and rheumatoid arthritis among the population. The increased availability of advanced healthcare facilities has resulted in increased sales revenue for hospital pharmacies in the market. The wide variety of products and drugs available in hospital pharmacies makes it a convenient location for purchasing various drugs such as mAbs.
In 2022, North America will account for 36% of total revenue. The increased prevalence of chronic diseases in North America, the presence of advanced healthcare infrastructure, a rapidly aging population, high healthcare expenditure, and increased public awareness of mAbs have resulted in increased demand for monoclonal antibodies. According to the American Cancer Society, there will be over 1.8 million new cancer cases and approximately 606,520 deaths in the United States in 2020. By 2060, the US population is expected to have approximately 24% geriatric people aged 65 or older.
According to the Centers for Medicare & Medicaid Services (CMS) National Health Accounts report, healthcare spending in the United States increased by 4.6% in 2019. Rising cancer and autoimmune disease cases in the country will drive up the demand for antibodies even more.
According to the National Stem Cell Foundation (NSCF), autoimmune diseases are the third most common cause of chronic illness in the United States. The rising prevalence of diabetes and multiple sclerosis in the country will boost the demand for antibodies.
Companies are currently funding clinical trials for over 570 mAbs. Approximately 90% of these are early-stage studies designed to assess patient populations' safety (Phase I) or safety and preliminary efficacy (Phase I/II or Phase II). The majority of mAbs in Phase I (70%) are for cancer treatment, and the proportions of mAbs in Phase II and late-stage clinical studies (pivotal Phase II, Phase II/III, or Phase III) are similar.
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Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y.Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.