Monoclonal Antibody Therapeutics Market Analysis | CMI

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2. MONOCLONAL ANTIBODY THERAPEUTICS MARKET ANALYSIS • Monoclonal Antibody Therapeutics Market, by Source (Human, Humanized, Chimeric, and Others), by Therapeutic Application (Oncology, Autoimmune Diseases, Infectious Diseases, Hematological Disorders, and Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, and Specialty Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026 • 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).

3. Market Drivers • 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.

4. Figure No.1: Global Monoclonal Antibody Therapeutics Market Share, By Region (%), 2018 - 2026

5. 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.

6. Market Restraints • 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.

7. Key Players • 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.

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