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The biosimilars market was valued at approximately USD 28,235 million in 2020, and it 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 it 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 the market growth. Also, as most of the clinical trials have been postponed to combat the COVID-19 situation and 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 world, 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 the market.
Several blockbuster biologic drugs of major pharmaceuticals companies, such as Truvada, Chantix, Forteo, Ciprodex, and Afinitor, and many other drugs lost the 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, and Orencia, 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, and growing prevalence 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.
Scope of the Report
A biosimilar is a biologic that is “similar” to another biologic medicine (known as a reference product), which is already licensed by the US Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity, and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity, or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure. The biosimilars market is segmented by product class (monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes), application (blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.
|Other Product Classes|
|Growth Hormonal Deficiency|
|Chronic and Autoimmune Disorders|
Key Market Trends
The Oncology Segment Holds the Major Share in the Global Biosimilars Market
The oncology segment is expected to hold the major share in the 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 the 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, are expected to drive the studied market’s growth. For instance, in December 2020, Amgen received the 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 is anticipated to witness significant growth over the forecast period.
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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 the 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 in research and development activities by the major players. According to the Globocon 2020, the number of new cancer cases diagnosed was 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).
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 market growth in the region during the pandemic.
Also, North America is the hub for a large number of key players in the market, such as Pfizer Inc., Mylan NV, Amgen Inc., and Coherus Biosciences Inc., among others. The increasing pipeline of products and new product launches increases the market growth in the region. For instance, in June 2020, Pfizer Inc. received the FDA approval for its pegfilgrastim biosimilar, Nyvepria, indicated for use in lowering the incidence of infection. Thus, in view of the high incidence of chronic diseases, such as cancers, and increasing R&D activities, the market is expected to propel significantly over the forecast period in North America.
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The biosimilars market is highly competitive, with many key players dominating the market. The major players of the studied market comprise 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, and new product launches, to secure the position in the global market. For instance, in December 2020, Coherus filed FDA 351(K) application for its CHS-1420, a biosimilar of adalimumab, and the regulatory decision is expected by Q4 of 2021.
- In July 2020, the FDA approved the adalimumab biosimilar, Hulio, developed by Fujifilm Kyowa Kirin Biologics, which is indicated for the subcutaneous treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
- In May 2020, Fresenius Kabi received the acceptance of the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.
Table of Contents
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 Forces 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 Product Class
5.1.1 Monoclonal Antibodies
5.1.2 Recombinant Hormones
5.1.4 Anti-Inflammatory Agents
5.1.5 Other Product Classes
5.2.1 Blood Disorders
5.2.2 Growth Hormonal Deficiency
5.2.3 Chronic and Autoimmune Disorders
5.2.5 Other Applications
5.3.1 North America
126.96.36.199 United States (By Product Class and By Application)
188.8.131.52 Canada (By Product Class and By Application)
184.108.40.206 Mexico (By Product Class and By Application)
220.127.116.11 Germany (By Product Class and By Application)
18.104.22.168 United Kingdom (By Product Class and By Application)
22.214.171.124 France (By Product Class and By Application)
126.96.36.199 Italy (By Product Class and By Application)
188.8.131.52 Spain (By Product Class and By Application)
184.108.40.206 Rest of Europe (By Product Class and By Application)
220.127.116.11 China (By Product Class and By Application)
18.104.22.168 Japan (By Product Class and By Application)
22.214.171.124 India (By Product Class and By Application)
126.96.36.199 Australia (By Product Class and By Application)
188.8.131.52 South Korea (By Product Class and By Application)
184.108.40.206 Rest of Asia-Pacific (By Product Class and By Application)
5.3.4 Middle-East and Africa
220.127.116.11 GCC (By Product Class and By Application)
18.104.22.168 South Africa (By Product Class and By Application)
22.214.171.124 Rest of Middle-East and Africa (By Product Class and By Application)
5.3.5 South America
126.96.36.199 Brazil (By Product Class and By Application)
188.8.131.52 Argentina (By Product Class and By Application)
184.108.40.206 Rest of South America (By Product Class and By Application)
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
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.
6.1.13 Dr. Reddy's Laboratories
6.1.14 Coherus Biosciences Inc.
6.1.16 Amega Biotech
6.1.17 Probiomed SA de CV
6.1.18 Boehringer Ingelheim GmbH
6.1.19 Apotex Inc.
6.1.20 Frezenius Kabi (Frezenius SE & Co. KGaA)
6.1.21 Gedeon Richter PLC
6.1.22 Mabxience SA
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Biosimilars Market market is studied from 2018 - 2026.
What is the growth rate of Global Biosimilars Market?
The Global Biosimilars Market is growing at a CAGR of 24.2% over the next 5 years.
Which region has highest growth rate in Global Biosimilars Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Biosimilars Market?
North America holds highest share in 2020.
Who are the key players in Global Biosimilars Market?
- Pfizer Inc
- Novartis AG
- Samsung Bioepies Co., Ltd
- Coherus Biosciences, Inc.
- Amgen Inc
Are the major companies operating in Global Biosimilars Market.