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[Research Report] The biosimilars market size is expected to grow from US$ 18,435.89 million in 2021 to US$ 1,36,069.53 million in 2028; it is estimated to register a CAGR of 34.8% from 2022 to 2028.
Analyst Perspective
The major factors driving the growth of the biosimilars market are the growing incidence of chronic diseases, such as cancers, along. The growing burden of cancer and increasing deaths due to it creates the need for affordable treatment and thus boosts the growth of the biosimilars market. The key market players also anticipated market growth over the forecast period through various strategic activities, such as product launches, mergers, and acquisitions. An increase in the prevalence of autoimmune diseases such as ankylosing spondylitis and rheumatoid arthritis drives the growth of the Biosimilars Market Size. For instance, according to a paper published in “Scandinavian Journal of Rheumatology,” in 2020, titled ‘Prevalence of ankylosing spondylitis in Spain,’ about 7.3% population showed positive screening for ankylosing spondylitis. Biosimilars, such as infliximab-axxq (Avsola), infliximab-qbtx (Ixifi), infliximab-dyyb (Inflectra), and infliximab-abda (Renflexis) are used for the treatment of chronic pain in arthritis.
Market Overview
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines.Biosimilars are safe and effective treatment options for many illnesses, such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease, and colitis), arthritis, kidney conditions, and cancer. Biosimilars increase access to lifesaving medications at potentially lower costs. The primary drivers of the biosimilars market are increasing incidence of chronic diseases.
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Biosimilars Market: Strategic Insights
Market Size Value in US$ 18,435.89 million in 2021 Market Size Value by US$ 1,36,069.53 million in 2028 Growth rate CAGR of 34.8% from 2022 to 2028 Forecast Period 2022-2028 Base Year 2021
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Biosimilars Market: Strategic Insights
Market Size Value in | US$ 18,435.89 million in 2021 |
Market Size Value by | US$ 1,36,069.53 million in 2028 |
Growth rate | CAGR of 34.8% from 2022 to 2028 |
Forecast Period | 2022-2028 |
Base Year | 2021 |
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Rising Approvals of Biosimilars to Drive Global Biosimilars Market Growth
The Food and Drug Administration (FDA) approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve patient care by increasing the number of medication options at potentially lower costs.
A few recent approvals of biosimilar products are mentioned in the following table.
Biosimilars Name | Approval Date | Reference Product |
Alymsys (bevacizumab-maly) | April 2022 | Avastin (bevacizumab) |
Cimerli (ranibizumab-eqrn) | August 2022 | Lucentis (ranibizumab) |
Fylnetra (pegfilgrastim-pbbk) | May 2022 | Neulasta (pegfilgrastim) |
Stimufend (pegfilgrastim-fpgk) | September 2022 | Neulasta (pegfilgrastim) |
Vegzelma (bevacizumab-adcd) | September 2022 | Avastin (bevacizumab) |
Idacio (adalimumab-aacf) | December 2022 | Humira (adalimumab) |
Byooviz (ranibizumab-nuna) | September 2021 | Lucentis (ranibizumab) |
Rezvoglar (insulin glargine-aglr) | December 2021 | Lantus (insulin glargine) |
Semglee (Insulin glargine-yfgn) | July 2021 | Lantus (Insulin glargine) |
Yusimry (adalimumab-aqvh) | December 2021 | Humira (adalimumab) |
Hulio (adalimumab-fkjp) | July 2020 | Humira (adalimumab) |
Riabni (rituximab-arrx) | December 2020 | Rituxan (rituximab) |
Nyvepria (pegfilgrastim-apgf) | June 2020 | Neulasta (pegfilgrastim) |
Thus, the rising approvals of biosimilars are propelling the biosimilars market growth.
Segmental Analysis
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Based on disease indication, the biosimilars market is segmented into cancer, diabetes, autoimmune disease, and other disease indication. The cancer segment held the largest market share in 2021 and autoimmune disease is anticipated to register the highest CAGR of 36.1% during the forecast period (2022–2028). Based on drug class, the biosimilars market is segmented as granulocyte colony-stimulating factors, human growth hormone, insulin, TNF blockers and monoclonal antibodies, and others (osteoporosis, etc). The granulocyte colony-stimulating factors drug class segment held the largest share of the market in 2021. Moreover, the other drug class segment is expected to grow at the highest CAGR during the forecast period. Based on application, the global biosimilars market is divided into intravenous, subcutaneous, and other applications. The intravenous segment held the largest share of the market in 2021 and is expected to grow at the highest CAGR during the forecast period. The biosimilars market, by end-user, is segmented into hospitals, specialty clinics, homecare, and other end users. The hospitals segment held the largest share of the market in 2021 and homecare segment is anticipated to register the highest CAGR of 36.6% in the market during the forecast period (2022–2028).
Biosimilars Market, by Disease Indication – 2021 and 2028
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Regional Analysis
The North America biosimilars market was valued at US$ 5,479.84 million in 2021 and is projected to reach US$ 47,746.80 million by 2028; it is expected to grow at a CAGR of 37.3% during the forecast period. The North America biosimilars market is segmented into the US, Canada, and Mexico. The US held the largest share of the North American biosimilars market in 2019. increasing incidence of diabetes, infertility as well as rising product development in biosimilars market. According to NIH Autoimmune Diseases Coordinating Committee, in 2019, more than 24 million Americans suffer from autoimmune diseases. Eight million people have auto-antibodies, blood molecules that indicate a person's risk of developing autoimmune diseases. For unknown reasons, autoimmune diseases are affecting more people. According to the Clinical Research Branch at the National Institute of Environmental Health Sciences (NIEHS), in 2020, there is a significant increase in the prevalence of antinuclear antibodies (ANA), the most common biomarker of autoimmunity in the US. The study is the first to evaluate ANA changes in a representative sampling of the US population over time. It includes males, non-Hispanic whites, adults over 50, and adolescents. In the US, biosimilars are used to treat patients with cancers, kidney diseases, diabetes, and other autoimmune diseases such as rheumatoid arthritis and Crohn's disease. According to Cardinal Health, a total of 33 biosimilars have been approved by the FDA in the US and 21 are commercially available. Of the 21 biosimilars on the market, 17 are used for treatments associated with cancers, three are used to treat autoimmune conditions and one is used to treat diabetes.
Biologics are the most expensive medicines in the US with costs totaling tens of thousands of dollars each year per patient. Biosimilars are expected to be priced 15% to 30% lower than their reference product. In 2020 alone, biosimilars saved US$ 7.9 billion, with savings expected to grow significantly in the next few years as more biosimilars enter the market. According to Cardinal Health, it is expected that biosimilars are expected to reduce US drug expenditure by US$ 133 billion by 2025. Thus, in the US, biosimilars have immense potential, for lowering the costs of biologic medicine and making care more accessible to patients, and for creating new innovations and scientific breakthroughs, thereby driving the biosimilars market growth in this region
Key Player Analysis
The biosimilars market analysis consists of players, such as Amgen Inc, Celltrion Inc, Sanofi SA, Biocon Ltd, Pfizer Inc, Samsung Bioepis Co Ltd, Coherus BioSciences Inc, Eli Lilly and Co, Sandoz AG, Teva Pharmaceutical Industries Ltd, and Dr. Reddy's Laboratories Ltd. Among the players in the biosimilars market, Pfizer Inc. and Novartis, Inc are the top two players owing to the diversified product portfolio offered.
Recent Developments
Inorganic and organic strategies such as mergers and acquisitions, product launches are highly adopted by companies in the biosimilars market. A few recent key market developments are listed below:
- In January 2022, Biocon Biologics a subsidiary of Biocon Ltd. Completed Acquisition of Viatris’ Global Biosimilars Business. The acquisition provides Biocon Biologics with direct commercial capabilities and supporting infrastructure in the advanced markets and several emerging markets, bringing it closer to patients, customers, and payors. With this acquisition Biocon Biologics emerges as a world leading biosimilars player with eight commercialized products.
- In October 2022, Biocon Biologics Out-Licenses Two Biosimilar Assets to Yoshindo for Commercialization in Japan. Under the terms of this deal, Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics, for an addressable market opportunity of US$ 700 million.
- In December 2022, Celltrion USA announced submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to FDA. A subcutaneous formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.
- In September 2022, Celltrion USA received U.S. FDA approval for its oncology biosimilar Vegzelma for the treatment of six types of cancer such as metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Vegzelma is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA.
- In May 2022, Biocon Biologics and Viatris Launch Abevmy. Biocon Biologics Ltd., a subsidiary of Biocon Ltd., and Viatris Inc. announced that Abevmy (bBevacizumab) is available in Canada. Abevmy, co-developed by Biocon Biologics and Viatris, is a biosimilar to Roche’s Avastin (Bevacizumab) and has been approved by Health Canada across four oncology indications.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Disease Indication, Drug Class, Route of Administration, and End User
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
France, Germany, Italy, Spain, United Kingdom
Frequently Asked Questions
The Biosimilars market majorly consists of the players, such as Biocon Ltd, Sanofi-Aventis, Celltrion Inc., Amgen Inc., Pfizer Inc., Samsung Bioepis, Sanofi SA, Coherus BioSciences Inc, Dr. Reddy’s Laboratories Ltd, Eli Lilly and Co, Sandoz AG, and Teva Pharmaceutical Industries Ltd.
The insulin segment held the largest share of the market in 2022. Also, the same segment is estimated to register the highest CAGR in the market during the forecast period.
The factors that are driving the growth of the biosimilars market are the increasing aging population, changing social behavior, and the rising adoption of a sedentary lifestyle by people with accelerating urbanization boost the prevalence of obesity and various chronic diseases, such as diabetes. Also,twin studies have long established that genes can cause chronic conditions such as cardiovascular disease (CVDs), diabetes, obesity, Alzheimer's disease (AD), and depression. These are some of the major factors contributing to the growth of the biosimilars industry.
The CAGR value of the biosimilars market during the forecasted period of 2022-2028 is 34.8%.
The Asia Pacific is expected to be the fastest-growing region in the Biosimilars market over the forecast period due to the increasing prevalence of chronic diseases and the cost-effectiveness of biosimilars drugs.
The Biosimilars market is estimated to be valued at US$ 22,676.15 million in 2022.
The Biosimilars market is expected to be valued at US$ 1,36,069.53 million in 2028.
Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDAâ€approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
The List of Companies - Biosimilar Market
- Biocon Ltd
- Sanofi-Aventis
- Celltrion Inc.
- Amgen Inc.
- Pfizer Inc.
- Samsung Bioepis
- Sanofi SA
- Coherus BioSciences Inc
- Dr. Reddy’s Laboratories Ltd
- Eli Lilly and Co
- Sandoz AG
- Teva Pharmaceutical Industries Ltd.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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