Major players in the antibody-drug conjugates (ADCs) market are Bayer AG, Concortis Biotherapeutics, F. Hoffman-La Roche Ltd., Immunomedics Inc., and Oxford BioTherapeutics.
The global antibody drug conjugates market is expected to grow from $2.34 billion in 2020 to $2.6 billion in 2021 at a compound annual growth rate (CAGR) of 11.1%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $6.12 billion in 2025 at a CAGR of 23.9%.
The antibody-drug conjugates (ADCs) market consists of sales of antibody-drug conjugates (ADCs). Antibody-drug conjugates (ADCs) are complex engineered therapeutics consisting of monoclonal antibodies, directed toward tumor-associated antigens, to which highly potent cytotoxic agents are attached using chemical linkers.
The antibody drug conjugates market covered in this report is segmented by type into monoclonal antibodies, linker, drug/toxin, others. It is also segmented by application into blood cancer, breast cancer, ovarian cancer, lung cancer, brain tumor, others; by product into adcertis, kadcyla, others; by technology into immunogen technology, seattle genetics technology, immunomedics technology, others and by end user into hospital, clinics, others.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The challenges involved in the manufacturing of ADC’s is acting as a restraint on the antibody drug conjugates market.ADC manufacturing facilities require high capital investment and extensive specialized training for operators.
ADC process development is complicated as it requires optimization of additional process steps that are not present in conventional monoclonal antibodies manufacturing such as the antibody-drug conjugation reaction and subsequent drug substance purification. Also, antibody drug conjugates must be manufactured in aseptic environments and operating personnel should be protected from the highly toxic drug compounds, thereby presenting operational difficulties.
Manufacturers of antibody drug conjugates are increasingly collaborating or partnering with other companies to share technology, resources, product knowledge and expand business.For instance, in March 2019, Astrazeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo Company for the proprietary antibody drug conjugate trastuzumab deruxtecan (DS-8201).
In April 2019, Shanghai Miracogen entered into an agreement with Netherlands based Synaffix to use its tools for building antibody drug conjugates. According to the deal, Miracogen is licensing two platforms from Synaffix which is expected to boost its product pipeline.
The antibody drug conjugates market is being driven by rising incidences of cancer globally.The major causes for most cancers include obesity, smoking, alcohol, improper eating habits.
The Cancer Research UK predicts that there will be 27.5 million new cases of cancer each year by 2040. The rising incidences of cancer are expected to increase the demand for antibody drug conjugates driving market growth.
Manufacturers of antibody drug conjugates are monitored by various regulatory bodies such as the Food and Drug Administration in the USA.In the USA, there is no specific regulatory guidance to industry on ADC development and the FDA follows existing guidelines for small drugs and monoclonal antibodies to regulate ADC.
The product quality offices at FDA such as the Office of Biotechnology Products (OBP)/Office of Pharmaceutical Quality primarily focus on the manufacturing of the antibody component of the ADC and the control strategy for the antibody intermediate, as well as for the drug substance (DS) and drug product (DP). Small molecule review groups in the Office of Pharmaceutical Quality bear primary responsibility for review of the adequacy of the payload and linker, conjugation reaction and aspects of the control strategy.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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