Market Overview
The Global Biosimilars Market is expected to reach a value of
USD 25.5 billion in 2023, and it is further anticipated to reach a market value of
USD 100.8 billion by 2032 at a
CAGR of 16.5%. The market has seen significant growth over the past few years and is predicted to grow significantly during the forecasted period as well.
Biosimilars, also known as follow-on biologics, are nearly identical replicas of an original product, developed by different companies. These are essential medical products and are employed in the treatment of a large spectrum of chronic & acute illnesses, and are not related to recording electrical brain activity, as their primary role depends on providing treatments for several diseases & disorders.
Market Dynamic
The global market is experiencing major growth, mainly due to the increasing prevalence of chronic & acute diseases around the world, influenced by a range of internal & external factors, which is particularly fueled by a rise in patient numbers, especially in developing economies, & the rising incidence of diseases like Hodgkin's lymphoma, granulomatosis with polyangiitis, chronic lymphocytic leukemia, & microscopic polyangiitis. Further, increases in R&D investments, both in developed & developing countries, particularly in the field of medical instruments & devices, are creating lucrative opportunities for market expansion. These R&D efforts have led to developments in medical technology & enhanced healthcare quality. In addition, the growing number of screening tests for research purposes is expanding the scope for market growth, assisted by increased funding from government bodies.
However, gaining regulatory approval for biosimilars involves navigating complex & stringent regulatory pathways. Manufacturers have to demonstrate similarity to the reference biologic through vast analytical & clinical studies, which can be both time-consuming & costly, representing a major challenge to the market.
Research Scope and Analysis
By Product
The biosimilars market is categorized based on product types, into recombinant non-glycosylated proteins & glycosylated proteins. In 2023, the recombinant non-glycosylated proteins segment claims the largest share of revenue, mainly driven by the increase in regulatory approvals for biosimilars, a testament to governments' growing assistance for these products. Like, the US Food & Drug Administration gave its green light to biosimilars like Yuflyma, in May 2023 & Idacio in December 2022, respectively, for the reference drug Humira, an important treatment for Rheumatoid Arthritis (RA). In addition, the rising number of chronic diseases like diabetes is contributing to the growth of this segment.
Further, the recombinant glycosylated proteins segment is anticipated to show the fastest growth in the forecasted period. As patents for biologics, including Humira, Erythropoietin (EPO), & Neulasta, expire, various players are ready to enter the biosimilars market, providing significant growth opportunities. Furthermore, developments in technology within the recombinant glycosylated proteins segment have given growth to various therapies, like modified proteins & soluble receptors, which can further fuel the expansion of this segment by enhancing treatment options.
By Application
While considering the applications of the biosimilars market, the market is categorized into several segments, like chronic & autoimmune disorders, oncology, growth hormonal deficiency, rheumatoid arthritis, blood disorders, & more, where in 2023, chronic & autoimmune disorders drive in terms of revenue, largely owing to the growth in the number of autoimmune conditions & increased awareness surrounding these diseases. For instance, data from the National Institute of Environmental Health Sciences shows that about 24 million people in the United States suffer from autoimmune diseases, highlighting the demand for treatments in this category.
Further, oncology as an application is expected to show rapid growth in the biosimilars market, which can be attributed to the rise in global incidence of cancer cases, a major driving force behind market growth. As per the World Cancer Research Fund International, more than 18 million individuals have been battling cancer in the recent past. The development of biosimilars for cancer treatment holds promise for affordable options, mainly in low- & middle-income nations with higher cancer-related mortality rates. Enhancing access to affordable cancer treatment is anticipated to further stimulate market growth.
The Biosimilars Market Report is segmented on the basis of the following:
By Product
• Recombinant Glycosylated Proteins
• Recombinant Non-glycosylated Proteins
By Application
• Chronic & Autoimmune Disorders
• Oncology
• Blood Disorders
• Growth Hormonal Deficiency
• Rheumatoid Arthritis
• Others
Regional Analysis
North America stands out as a dominant force in the biosimilars market in 2023, accounting for the biggest revenue share at 41.6%, which is attributed to the region's strong regulatory framework for biosimilars & the presence of key industry players. Furthermore, North America benefits from relatively easy access to biosimilars. As per the US Generic Biosimilars Saving Report in the recent past, the US has taken major steps in biosimilar adoption, with 31 biosimilars approved & 20 launched, resulting in about 10 million additional days of therapy. These 20 biosimilars were priced 30% lower than their biologic counterparts, driving down costs for both biosimilars & biologics and promising further growth in the region.
Also, Asia Pacific is anticipated for rapid growth in the biosimilars market, which is fueled by the active involvement of major players like Biocon, Dr. Reddy’s Laboratories, Pfizer Inc., & more, who have played significant roles in developing & commercializing biosimilars in the region. China, in particular, has seen an increase in health expenditure as a GDP percentage, rising from about 5% in 2015 to 5.6% in 2020, highlighting the region's growing commitment to healthcare and setting the stage for substantial biosimilar market expansion.
By Region
North America
• The U.S.
• Canada
Europe• Germany
• The U.K.
• France
• Italy
• Russia
• Spain
• Benelux
• Nordic
• Rest of Europe
Asia-Pacific
• China
• Japan
• South Korea
• India
• ANZ
• ASEAN
• Rest of Asia-Pacific
Latin America
• Brazil
• Mexico
• Argentina
• Colombia
• Rest of Latin America
Middle East & Africa
• Saudi Arabia
• UAE
• South Africa
• Israel
• Egypt
• Rest of MEA
Competitive Landscape
The biosimilars market experiences intense competition, featuring several global & local companies competing for market share. The appeal of biosimilars lies in their cost-saving potential, which draws interest among new entrants eager to boost their profits, as many of these players are dedicated to attaining regulatory nods, investing more in R&D, introducing fresh products, & expanding their geographic reach, all in an attempt to secure their position within the market.
For instance, In May 2022, Amneal Pharmaceuticals, Inc. successfully obtained approval from the US Food & Drug Administration (FDA) for a Biologics License Application (BLA) belonging to pegfilgrastim-pbbk, a biosimilar designed to be similar to Neulasta, which is set to be available under the brand name FYLNETRA.
Some of the prominent players in the Global Biosimilars Market are:
• Novartis AG
• Amgen Inc
• Pfizer Inc
• Biocon
• AbbVie Inc
• Samsung Biopis
• Viatris Inc
• Biocad
• Dr. Reddy’s Laboratories
• LG Life Sciences
• Other Key Players
COVID-19 Pandemic & Recession: Impact on the Global Biosimilars Market:
The COVID-19 pandemic and the subsequent economic recession have had mixed effects on the global biosimilars market, as the pandemic increased the need for healthcare products, like biosimilars, as it showcased the need for affordable & accessible treatments, which led to potential growth opportunities for biosimilar manufacturers. However, economic challenges & disruptions in the healthcare supply chain impacted the market's growth. Halt in regulatory approvals & limited healthcare budgets in some regions also created challenges. Overall, the impact has been a complex interplay between increased demand & economic constraints, with the long-term trajectory of the biosimilars market depending on various factors, including healthcare policies & vaccine distribution.
Report Characteristics |
Market Size (2023) |
USD 538.2 Bn |
Forecast Value (2032) |
USD 1,342.7 Bn |
CAGR (2023-2032) |
10.7% |
Historical Data |
2017 - 2022 |
Forecast Data |
2023 - 2032 |
Base Year |
2022 |
Estimate Year |
2023 |
Report Coverage |
Market Revenue Estimation, Market Dynamics, Competitive Landscape, Growth Factors and etc. |
Segments Covered |
BBy Source (Microbial, Mammalian, and Others) By
Product, Monoclonal Antibodies, Antisense & RNAi
Therapeutics, Vaccines, Recombinant Proteins, and
Others), By Disease (Oncology, Infectious Diseases,
Cardiovascular Disorders, Immunological Disorders,
Hematological Disorders, and Others), By
Manufacturing (In-house and Outsourced) |
Regional Coverage |
North America – The US and Canada; Europe – Germany, The UK, France, Russia, Spain, Italy, Benelux, Nordic, & Rest of Europe; Asia- Pacific– China, Japan, South Korea, India, ANZ, ASEAN, Rest of APAC; Latin America – Brazil, Mexico, Argentina, Colombia, Rest of Latin America; Middle East & Africa – Saudi Arabia, UAE, South Africa, Turkey, Egypt, Israel, & Rest of MEA
|
Prominent Players |
Amgen Inc., Sanofi, AbbVie Inc., Johnson & Johnson,
Samsung Biologics, Merck & Co., Pfizer Inc., Novartis
AG, Bayer AG, AstraZeneca PLC, and Other Key
Players |
Purchase Options |
We have three licenses to opt for: Single User License (Limited to 1 user), Multi-User License (Up to 5 Users), and Corporate Use License (Unlimited User) along with free report customization equivalent to 0 analyst working days, 3 analysts working days and 5 analysts working days respectively. |
Frequently Asked Questions
The Global Biosimilars Market size is estimated to have a value of USD 25.5 billion in 2023 and is
expected to reach USD 100.8 billion by the end of 2032.
North America has the largest market share for the Global Biosimilars Market with a share of about
41.6% in 2023.
Some of the major key players in the Global Biosimilars Market are Novartis AG, Pfizer Inc, Biocon, and
many others.
The market is growing at a CAGR of 16.5 % over the forecasted period.