Monoclonal Antibody Therapeutics Market - Insights
Monoclonal antibodies are a type of immunotherapy, which are made in a laboratory and are several copies of a single antibody. Several monoclonal antibodies to treat inflammatory, cancer, and other diseases have been approved by the U.S. Food & Drug Administration (FDA). Depending on the source, there are four types of monoclonal antibodies: Murine, Chimeric, Humanized, and Human. Murine antibodies are entirely derived from a murine source, chimeric antibodies contain variable regions from murine origin and constant regions from human origin. Humanized antibodies are derived from a human source with a small part of a mouse or rat monoclonal antibody and human antibodies are entirely derived from a human source. Monoclonal antibodies are majorly used in cancer treatment along with certain inflammatory, infectious, and other diseases. Depending upon the functions of monoclonal antibodies (for cancer) they are further classified into subtypes such as radiolabeled antibodies, chemo labeled antibodies, and bispecific monoclonal antibodies. Commercially available monoclonal antibodies include, Iplimumab, Nivolumab, Rituximab, Blinatumomab, Proleukin, Gardasil, and Kymriah.
Increasing drug approvals and launch of novel monoclonal antibodies for treatment of various diseases such as cancer are expected to boost the market growth over the forecast period
Frequent approvals of novel monoclonal antibodies and their launches in developed economies are expected to significantly drive monoclonal antibody therapeutics market growth over the forecast period. Key players in the market have gained regulatory approvals and have launched their therapies in the market. For instance, in 2015, the U.S. FDA approved Darzalex, developed by Johnson & Johnson for multiple myeloma. Similarly, in 2017, Roche was granted accelerated approval to TECENTRIQ (atezolizumab) from the U.S FDA for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
Moreover, approvals to several combination therapies are further expected to boost the global monoclonal antibody therapeutics market growth over the forecast period. For instance, in 2017, the U.S. FDA approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients suffering from multiple myeloma. Moreover, different monoclonal antibodies with unique mechanism of actions have been approved over the past few years, which work on immune checkpoints such as CTLA-4, PD-1, and PD-L1.
The global monoclonal antibody therapeutics market was valued at US$ 95,560.5 million in 2017, and is expected to witness a robust CAGR of 6.9% over the forecast period (2018–2026).
Figure No.1: Global Monoclonal Antibody Therapeutics Market Share, By Region (%), 2018 - 2026
Source: Coherent Market Insights Analysis (2017)
Ongoing research and development of monoclonal antibodies for various diseases is expected to boost growth of the global monoclonal antibody therapeutics market
Introduction and supposed success of monoclonal antibodies and other biological products has spurred the interest of manufacturers in these therapies. Success of popular monoclonal antibodies such as Avastin, Herceptin, and Rituxan (revenues as US$ 6.8 Bn, US$ 7.1 Bn, and US$ 5.9 Bn respectively in 2017 globally) has spurred manufacturers’ interest in these therapies. Leading manufacturers have resorted to boosting pipeline through various ways such as merger and acquisitions, partnerships, and collaboration. In 2016, AbbVie acquired Stemcentrx thereby adding rovalpituzumab tesirine (Rova-T) to its product portfolio in oncology segment. Cancer treatment (various types) is at the forefront of the monoclonal antibody research as leading manufacturers are focused on development of these drugs for cancer treatment. For instance, manufacturers such as Amgen, Inc. (e.g. Tezepelumab and others) and Novartis International AG (e.g. Ofatumumab and others) have several monoclonal antibody programs in the pipeline.
However, high costs of these products is a major concern (in regions with underdeveloped reimbursement facilities) in the healthcare system and to address this problem, manufacturers have resorted to biosimilar products. Biosimilars cost much lower than the original products as the cost of development is relatively low. Majority of the available monoclonal antibody therapeutics (cancer treatments) are expected to lose patent protection by 2020 and some by 2025. For instance, drugs such as Herceptin and Avastin are expected to lose patent protection in 2019. These factors are expected to restrain the global monoclonal antibody therapeutics market growth over the forecast period.
Some of the major players operating in the global monoclonal antibody therapeutics market include, Pfizer, Inc., Novartis International AG, Amgen, Inc., Sanofi S.A., Merck & Co., Inc., GlaxoSmithKline Plc., F. Hoffmann-La Roche Ltd., AbbVie, Inc., Eily, Lilly, and Company, and Bristol-Myers Squibb Company.
Different monoclonal antibodies with unique mechanism of actions have been approved over the past few years, which work on immune checkpoints such as CTLA-4, PD-1, and PD-L1. Manufacturers are focusing on developing drugs belonging to various classes in order to treat variety of diseases ranging from cancer to rare diseases. Monoclonal antibody coupled with chemotherapy agents is becoming a viable treatment option to treat various cancers. For instance, in 2017, the U.S. Food & Drug Administration (FDA) approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients suffering from multiple myeloma, who have received two prior therapies. These factors are expected to support growth of the market over the forecast period.
Monoclonal antibody therapeutics market is driven by active research and development of novel drugs and significant number of new drug launches and approval. There are number of monoclonal antibodies in the pipeline, which are expected to receive approval over the forecast period. For instance, manufacturers such as Amgen, Inc., Novartis International AG, Merck & Co., Inc., Eily, Lilly, and Company, and others have several monoclonal antibodies in the pipeline. Moreover, efforts of manufacturers to increase number of indications (oncology) for monoclonal antibodies is further expected to boost the market growth over the forecast period. For instance, in June 2018, the U.S. Food & Drug Administration (FDA), expanded the indication of pembrolizumab (Keytruda) to include recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
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