|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
Need a report that reflects how COVID-19 has impacted this market and its growth?
The biosimilars market is expected to grow at a registered CAGR of 24.2% over the forecast period, 2022-2027.
The impact of COVID-19 on the biosimilars market may be significant, and it has imposed a great challenge on 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, 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 pipeline products exhibit a slow pace of research and development activities. Also, due to the global lockdown and travel restrictions, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, COVID-19 greatly impacts the market because of the factors above.
Several blockbuster biologic drugs of major pharmaceuticals companies, such as Truvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs, lost 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 the growing prevalence of chronic diseases are expected to drive the global biosimilar market. According to Globocan 2020, the estimated incidence of cancer cases in the United States accounted for 2,281,658, with 612,390 deaths, in 2020. The high incidence of cancer surges the demand for effective therapeutics and thus, drives the studied market.
Additionally, the key market players anticipated the market growth over the forecast period by various strategic activities, such as product launches, mergers, and acquisitions. For instance, in July 2021, the Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine)
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 market report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the value (USD million) for the above segments.
|By Product Class|
|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 International Agency for Research on Cancer 2020, the estimated number of new leukemia cases in 2020 was 474,519 globally. According to the same source, the disease also had significantly high mortality, with total global deaths of 311,594.
In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including preventive 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, indirectly impacting the studied segment.
Additionally, the increasing research and development activities by key players focused on oncology, along with rising FDA approvals, are expected to drive the studied market’s growth. For instance, in December 2020, Amgen received the United States Food and Drug Administration (USFDA) 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 factors above, 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 the 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 biosimilars products are injectables and require a physician to administer those products to patients. However, most 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 many 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 FDA approval for its pegfilgrastim biosimilar, Nyvepria, indicated for lowering infection incidence. Thus, the market is expected to propel significantly over the forecast period in North America due to the high incidence of chronic diseases, such as cancers, and increasing R&D activities.
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The biosimilars market is highly competitive, with many key players dominating the market. The major players in 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 market players are adopting various growth strategies, such as acquisitions, partnerships, and new product launches, securing their position in the global market. For instance, in February 2021, Coherus BioSciences, Inc. reported that the United States Food and Drug Administration (“FDA”) has accepted for review the 351(k) Biologics License Application (“BLA”) for CHS-1420, a Humira (adalimumab) biosimilar product candidate,
- In December 2021, the Food and Drug Administration (FDA) approved Eli Lilly’s Rezvoglar (insulin-glargine-aglr), a biosimilar to LANTUS (insulin glargine). Rezvoglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
- In September 2021, Samsung Bioepis and Biogen announced that the Food and Drug Administration (FDA) had approved BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ was the first ophthalmology biosimilar approved in the United States.
Table of Contents
1.1 Study Assumptions and Market Definition
1.2 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 (Market Size by Value – USD million)
5.1 By 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 By Application
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
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.3.4 Middle-East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle-East and Africa
5.3.5 South America
184.108.40.206 Rest of South America
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 Viatris Inc. (Mylan)
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.
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 2019 - 2027.
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 2021.
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.