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レポート概要
| 本調査資料では、世界のバイオシミラー市場について調査し、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、製品クラス別（モノクローナル抗体、組換えホルモン、免疫調節薬、抗炎症薬、その他）分析、用途別（血液疾患、成長ホルモン欠乏症、慢性・自己免疫疾患、腫瘍、その他）分析、地域別分析、競争状況、市場機会/将来の見通しなどを掲載しています。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・世界のバイオシミラー市場規模：製品クラス別（モノクローナル抗体、組換えホルモン、免疫調節薬、抗炎症薬、その他） ・世界のバイオシミラー市場規模：用途別（血液疾患、成長ホルモン欠乏症、慢性・自己免疫疾患、腫瘍、その他） ・世界のバイオシミラー市場規模：地域別 ・競争状況 ・市場機会/将来の見通し |
The Biosimilars Market is valued at approximately USD 28,235 million in 2020 and is expected to witness a revenue of USD 103,638 million in 2026, with a CAGR of 24.2% over the forecast period.
The impact of COVID-19 on the Biosimilars market may be significant and has imposed a great challenge to the pharmaceutical companies, focused on biosimilar development.The reduction in the FDA approval of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, thereby hindering market growth. Also, as most of the clinical trials have been postponed to combat the COVID-19 situation and to minimize the infection among participants, most of the pipeline products are exhibiting a slow pace of research and development activities. Also, due to the lockdown and travel restrictions across the globe, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, because of the above-mentioned factors, COVID-19 has a great impact on th studied market.
Several blockbuster biologic drugs of major pharmaceuticals companies, such asTruvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs are expected to lose US exclusivity in 2020. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. Besides, factors, such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders with the need for diversification in technology and business models, growing prevelence of chronic diseases are expected to drive the global biosimilar market. At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus impeding the growth of the market studied.
Key Market Trends
Oncology Segment Holds the Major Share in Global Biosimilars Market
The oncology segment is expected to hold the major market in Biosimilars Market and the high incidence of cancers worldwide is the major factor driving the growth of the studied market over the forecast period. According to the Globocan 2020, the incidence of new cancer cases was estimated to be 19,292,789 in 2020, with nearly 9,958,133 deaths due to cancers. Additionally, the new cancer incidence is estimated to reach 30.2 million by 2040 as per International Agency for Research on Cancer (IARC).
In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including precautionary measures, lack of personal protective equipment, and staff shortage as per the research article published in the JCO Global Oncology, 2020. Additionally, this impact was more pronounced in low-income countries. Therefore, COVID-19 is expected to hinder the number of cancer therapies offered to cancer patients, which indirectly is expected to impact the studied segment.
Additionally, the increasing research and development activities by key players focused on oncology along with rising in FDA approvals is expected to drive the studied market growth. For instance, in Dec 2020, Amgen received US FDA approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Thus, because of the aforementioned factors, the Biosimilars Market on Oncology segment is anticipated to witness significant growth over the forecast period.
North America Holds the Major Share and is Expected to Dominate the Biosimilars Market Over the Forecast Period
North America is anticipated to observe a significant CAGR over the forecast period in Biosimilars Market. The major factors driving the growth of the studied market in the region include high incidence of chronic diseases such as cancers, along with the increased investment on research and development activities by the major players. According to the GLOBOCON 2020, the new cancer cases diagnosed were 2,281,658 in the United States in 2020, with 612,390 deaths. Among all cancers, breast cancer had the highest incidence with 253,465 cases, followed by lung (227,875), Prostate(209,512) and colon(101,809) new cancer cases in 2020 in United States.
Also, according to the research article published in Biosimilar Development, 2020, most of the Biosimilars products are injectables and require a physician to administer those products to patients. However, most of the hospitals and clinics in the United States have restricted physical consultations, owing to the high rate of SARS-CoV2 viral transmission. This factor is expected to impede the studied market growth in the region during the pandemic
Also, North America is the hub for a large number of key players of the studied market such as Pfizer, Inc, Mylan NV, Amgen, Inc and Coherus Biosciences, Inc among others. The increasing pipeline of products and new product launches surges the market growth in the region. For instance, in June 2020, Pfizer, Inc., received FDA approval for its pegfilgrastim biosimilar Nyvepria, indicated for use in lowering the incidence of infection as manifested by febrile neutropenia. Thus, in view of the high incidence of chronic diseases such as cancers and increasing R & D activities, the studied market is expected to propel significantly over the forecast period in North America.
Competitive Landscape
The Biosimilars market is highly competitive, with many key players dominating the market. The major players of the studied market comprise of Novartis AG, Pfizer, Inc., Amgen, Inc, Coherus Biosciences, Inc., Mylan NV (Viatris, Inc.) and Samsung Bioepis Co., Ltd among others. Most of the market players are adopting various growth strategies such as acquisitions, partnerships, new product launches to secure the position in the global market. For instance, in December 2020, Coherus has filed FDA 351(K) application for its CHS-1420, a Biosimilar of Adalimumab, and the regulatory decision is expected by Q4 of 2021.
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1 INTRODUCTION
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Several Blockbuster Biopharmaceuticals Going Off-Patent over the Next Five to Ten Years
4.2.2 Growing Burden of Chronic Diseases and Increasing R & D investments
4.2.3 Increasing Demand for Biosimilar Drugs due to Their Cost Effectiveness
4.3 Market Restraints
4.3.1 Concerns Regarding Substitutability and Interchangeability
4.3.2 Regulatory Uncertainty and Growing Competition from Biobetters
4.3.3 High Cost Involvement and Complexities in Manufacturing
4.4 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product Class
5.1.1 Monoclonal Antibodies
5.1.2 Recombinant Hormones
5.1.3 Immunomodulators
5.1.4 Anti-Inflammatory Agents
5.1.5 Others
5.2 By Applications
5.2.1 Blood Disorders
5.2.2 Growth Hormonal Deficiency
5.2.3 Chronic and Autoimmune Disorders
5.2.4 Oncology
5.2.5 Others
5.3 Geography
5.3.1 North America
5.3.1.1 United States (By Product Class, and By Application)
5.3.1.2 Canada (By Product Class, and By Application)
5.3.1.3 Mexico (By Product Class, and By Application)
5.3.2 Europe
5.3.2.1 Germany (By Product Class, and By Application)
5.3.2.2 United Kingdom (By Product Class, and By Application)
5.3.2.3 France (By Product Class, and By Application)
5.3.2.4 Italy (By Product Class, and By Application)
5.3.2.5 Spain (By Product Class, and By Application)
5.3.2.6 Rest of Europe (By Product Class, and By Application)
5.3.3 Asia-Pacific
5.3.3.1 China (By Product Class, and By Application)
5.3.3.2 Japan (By Product Class, and By Application)
5.3.3.3 India (By Product Class, and By Application)
5.3.3.4 Australia (By Product Class, and By Application)
5.3.3.5 South Korea (By Product Class, and By Application)
5.3.3.6 Rest of Asia-Pacific (By Product Class, and By Application)
5.3.4 Middle East and Africa
5.3.4.1 GCC (By Product Class, and By Application)
5.3.4.2 South Africa (By Product Class, and By Application)
5.3.4.3 Rest of Middle East and Africa (By Product Class, and By Application)
5.3.5 South America
5.3.5.1 Brazil (By Product Class, and By Application)
5.3.5.2 Argentina (By Product Class, and By Application)
5.3.5.3 Rest of South America (By Product Class, and By Application)
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Pfizer Inc
6.1.2 Eli Lilly and Company
6.1.3 Celltrion Healthcare
6.1.4 Mylan NV(Viatris, Inc)
6.1.5 Novartis AG
6.1.6 Samsung Bioepis Co. Ltd
6.1.7 Stada Arzneimittel AG
6.1.8 Teva Pharmaceutical Industries Ltd
6.1.9 Intas Pharmaceutical Ltd
6.1.10 LG Life Sciences(LG Chem)
6.1.11 Biocon Limited
6.1.12 Amgen, Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS