Schedule a Meeting
Download Brochure
Table of Content
March 2025
With high-concentration monoclonal antibodies being essential in targeting particular disease-associated proteins, the high concentration mab products market is expanding rapidly due to the growing need for tailored therapeutics, which has become a major driver. The effectiveness and specificity of these biopharmaceuticals have been further improved by biotechnology developments, especially in antibody engineering, which has expanded their use in a variety of therapeutic domains. Additionally, monoclonal antibodies have become a popular and successful therapy option due to the rise in chronic diseases like cancer and autoimmune disorders that are occurring all over the world. These antibodies' therapeutic efficacy has been attributed in part to their capacity to target sick cells while preserving healthy ones specifically.
A variety of crippling and fatal illnesses in immunology, infectious diseases, and cancer have been effectively treated with monoclonal antibodies (mAbs), which are therapeutic proteins made from a single clone or line of cloned cells. Generally speaking, injectable monoclonal antibodies or polyclonal antibody treatments are considered high concentration antibody products (HCAPs), which have an overall product concentration of at least 100 mg/mL.
Due to their effectiveness in treating patients during the last 20 years, the global therapeutic market for monoclonal antibodies (mAbs) was estimated to be worth $115.2 billion in 2018. By the end of 2019, sales had topped $150 billion, and it is expected to reach around $300 billion by 2025. Since mAbs are now the most sold biologic, their prevalence and growth potential are further supported by the over 4,000 mAbs undergoing preclinical and clinical research.
Recent developments in antibody engineering and discovery techniques based on computational/artificial intelligence (AI) have enormous potential to speed up and enhance the production of therapeutic antibodies. Machine learning is a popular technique for creating models that forecast data with various characteristics. Protein engineering has used machine learning, which has demonstrated success in anticipating and enhancing physical characteristics. In recent years, several machine learning-based in silico prediction techniques have been created in an effort to enhance antibody design.
Applications for monoclonal antibodies may be found in many therapeutic fields. Cancer, autoimmune illnesses, viral infections, and inflammatory problems are all treated with them. The growing prevalence of chronic illnesses, the growing need for reasonably priced biologic medicines, and the expansion of regulatory approvals are all contributing factors to the worldwide market's explosive rise. Biosimilars offer a practical way for healthcare systems throughout the world to lessen the financial strain of expensive biologics, increasing access to therapy in important therapeutic areas, including immunology, ophthalmology, and cancer.
One of the main problems with high-concentration mAb preparations is the creation of reversible non-covalent aggregates through intermolecular interactions. Aggregates, both covalent and non-covalent, might negatively affect the formulation's stability throughout storage and, in turn, patient safety. Excipients, such as sugars that inhibit the development of irreversible aggregates, can be added to high-concentration mAb preparations to increase their stability.
High-concentration monoclonal antibody demand is rising, which may result in a supply scarcity and raise the total cost of treatments. It may be possible to use genetically modified plants and animals to produce novel antibodies or boost antibody output. Instead of using phage display technologies to produce less immunogenic or new antibodies or chimeric or humanized antibody production, transgenic mice could be a good option. Due to the comparatively high milk production of ruminant animals, such as sheep, goats, and cows, genetically modified animals of these species may also be utilized to generate significant amounts of therapeutic proteins, including MAbs. Therapeutic uses for recombinant antigens derived from plants are also possible.
North America dominated the high concentration mAb products market in 2024. backed by significant healthcare spending, a supportive regulatory framework, and the quick uptake of biosimilars. Faster market access has been made possible by the FDA's Biologics Price Competition and Innovation Act (BPCIA), which has streamlined the approval procedure. Strong reimbursement guidelines, government grants, and insurance support have all contributed to the increased use of biosimilars by healthcare professionals. Furthermore, the existence of significant industry participants such as Amgen Inc., Pfizer Inc., and Mylan N.V. supports market expansion. The region's biosimilar adoption in cancer, immunology, and inflammatory disorders is being driven by the rising need for reasonably priced biologics as well as the expanding acceptance of biosimilars by healthcare providers.
An estimated 129 million people in the U.S. are thought to have at least one severe chronic condition. Five of the ten leading causes of death in the U.S. are either directly related to or caused by preventable and treatable chronic diseases. Over the past 20 years, prevalence has been steadily increasing, and this trend is expected to continue. 42% of Americans have two or more chronic illnesses, and 12% have at least five. The proportion of Americans living with many chronic illnesses is increasing. In addition to its personal cost, chronic sickness has a major effect on the U.S. healthcare system. About 90% of the $4.1 trillion spent annually on health care is used to treat and manage chronic diseases and mental health conditions.
The Canadian government is making investments in a strong, resilient, and dynamic life sciences ecosystem that can handle present and upcoming medical crises. To guarantee that Canadians have access to the newest medical technology, more than $2.2 billion has been committed since March 2020 to bolster the nation's domestic biomanufacturing and life sciences capabilities. In order to boost domestic pandemic response capabilities and life science innovation, the Canadian government has funded over $2.3 billion in 41 projects in the biomanufacturing, vaccine, and pharmaceuticals ecosystem.
Asia Pacific is estimated to host the fastest-growing high concentration mAb products market during the forecast period. The main causes that are anticipated to increase the incidence of cancer and other chronic illnesses in the population are the growing prevalence of smoking, the rising consumption of processed foods, and the rising consumption of tobacco. The market for monoclonal antibodies in Asia Pacific is anticipated to rise in the future due to increased government spending in the construction of cutting-edge healthcare infrastructure and improved access to healthcare services. Additionally, the growing number of elderly people will benefit mAb sales in the future. The United Nations estimates that by 2050, there will be around 1.5 billion elderly people worldwide, with 80% of them residing in low- and middle-income nations.
As a result of legislative backing, biosimilar monoclonal antibodies (mAbs) are presently a key area of research and development in China. mAbs have emerged as essential treatments for autoimmune and cancerous conditions. As biosimilars become more competitive in China, mAbs are becoming more accessible and less expensive. The past ten years have seen a considerable increase in the Chinese copy biologicals business. The government has been aggressively pushing copy biologicals' development and application as a means of expanding access to reasonably priced medical treatment. The creation of copy biological goods is being carried out by more than 60 pharmaceutical businesses in China.
Non-communicable illnesses are responsible for 44% of disability-adjusted life years lost and 53% of all deaths in India. More than one-sixth of the world's population lives in India, which has seen significant socioeconomic growth and epidemiological transition—that is, a change from infectious to non-communicable diseases (NCDs). Through its "Chronic/Lifestyle Disease Program," the Department of Biotechnology has made significant progress over the years in advancing fundamental, clinical, translational, and multidisciplinary research in targeted regions of the nation with high illness burden.
In September 2023, SUREmAb is not only the result of our vision for the future of mAb development, but also of decades of biologics production expertise, stated Sigma Mostafa, Chief Scientific Officer at KBI. We are pleased to present a platform that may not only speed up the development process but is also high quality and economical right from the beginning, at a time where time, efficiency, and innovation all come together. SUREmAb is evidence of KBI's dedication to foreseeing market changes and developing innovative solutions that tackle tomorrow's problems now.
North America
Asia Pacific
Europe
Latin America
Middle East and Africa (MEA)
March 2025
November 2024
October 2024
October 2024