The global biosimilars market size is evaluated at USD 40.36 billion in 2025 and is expected to hit approximately USD 175.99 billion by 2034, representing a healthy CAGR of 17.78% between 2025 and 2034.
In terms of revenue, the worldwide market for biosimilars was calculated at USD 34.43 billion in 2024 and is projected to reach approximately USD 148.85 billion by 2033. The Europe biosimilars market is estimated at USD 15.37 billion in 2024 and is accelerating a solid CAGR of 17.34% during the forecast period. The market size and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.
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Biosimilars Market Key Points
• Europe dominated the market with the largest market share of 38.23% in 2024.
• Asia Pacific is expected to expand at the fastest CAGR of 28.91% during the forecast period.
• By product, the monoclonal antibodies segment has captured around 41.32% of revenue share in 2024.
• By product, the insulin segment is projected to grow at a double-digit CAGR of 18.00% during the forecast period.
• By application, the oncology segment has contributed the largest market share of 24.58% in 2024.
• By application, the chronic and autoimmune disorders segment is growing at a CAGR of 18.10% during the forecast period.
• By manufacturer, the in-house segment accounted for the biggest market share of 84.62% in 2024.
• By manufacturer, the contract research and manufacturing services segment is poised to grow at a remarkable CAGR of 18.10% during the forecast period.
Biosimilars Market Revenue Analysis:
Biosimilars Market Revenue, by Application, 2022-2024 (USD Million)
|
Application |
2022 |
2023 |
2024 |
|
Oncology |
6,102.66 |
7,183.57 |
8,463.88 |
|
Growth Hormonal Deficiency |
3,471.72 |
4,066.32 |
4,767.24 |
|
Blood Disorders |
4,386.88 |
5,122.82 |
5,987.84 |
|
Chronic & Autoimmune Disorders |
5,287.81 |
6,205.83 |
7,290.07 |
|
Infectious Diseases |
2,537.22 |
2,953.96 |
3,442.38 |
|
Others |
3,339.07 |
3,866.68 |
4,480.91 |
Biosimilars Market Revenue, by Manufacturer, 2022-2024 (USD Million) Manufacturer 2022 2023 2024 Contract
Research and Manufacturing Services 3,842.00 4,509.02 5,296.80 In-House 21,283.36 24,890.17 29,135.53 Market Overview and Industry Potential Biosimilars
are biological medicines that are similar to standard biologics in terms of
safety, efficacy, quality, effectiveness, immunologics, and regulatory
standards. They are approved by the European Medicines Agency (EMA) and
are available for marketing in the European Union (EU). The main
therapeutic areas are diabetes, cancer, and rheumatoid arthritis which are
treated in a precise manner. The risk management plan, comparative clinical and
non-clinical studies, pharmaceutical quality studies, etc. ensure the approvals
of biosimilars only after the patent expiration of the original biologics
medicine. The
major contribution of the EMA in performing R&D testing for biosimilars
drives their promising approvals for marketing in the EU and for
patient-treatment without compromising standard therapeutic effects of the
reference medicines. The potential offerings in terms of interchangeability
usage find ways to use biosimilars instead of reference medicines or other
biosimilars with same reference products. The expansive use of monoclonal
antibodies, proteins, or coagulation factors as the active substances
accelerates their therapeutic effects. The robust production of these
biological medicines by using cutting-edge technologies is contributing to a
remarkable pharmaceutical success. Role of Artificial Intelligence in the Biosimilars Market Artificial intelligence has tremendous potential
to enhance the development of biosimilars, ensure safety and quality, and
improve the manufacturing efficiency. With the help of machine learning and spectroscopy, the AI modelling methods
can analyze patterns in biosimilar use. The integration of AI and the internet of things (IoT) transformed the
biosimilar drug development process by analyzing vast biological data,
optimizing trial designs, and predicting molecular behaviors. AI models can
compare the outcomes of biosimilars with their originator products. Set up a meeting at your convenience
to get more insights instantly! https://www.precedenceresearch.com/schedule-meeting Major Trends in the Biosimilars Market Therapeutic Preparations of Biosimilars: They
are produced from biological or natural resources such as humans, animals, or
microorganisms. These are large protein-based therapeutics consisting of
nucleic acids, proteins, carbohydrates, etc. The presence of several components
such as vaccines, serums, blood antigens, antibodies, antitoxins, and
recombinant proteins makes them potentially effective. The preferences for
specific storage methods like refrigeration helps to prevent contamination and
maintain the standards. These are specialty drugs and can be directly
administered into the bloodstream. The
various biotechnological techniques including gene expression, antibody
technology, recombinant DNA technology, etc. are implemented for the
manufacturing of these therapeutics. They treated several health conditions of
patients including inflammatory bowel disease, rheumatologic diseases, dermatological
conditions, cancers, and other connective tissue disorders. They enhanced the
quality of patients’ lives by reducing disease progression, and eliminating
symptoms. Impact of Biosimilars in Cancer Care: There
are supportive cancer therapies to eliminate the side effects of cancer. The
various biosimilar development programs were organized for certain reference
medicines. These supportive measures enhanced the patient access to effective
cancer treatments with reduced costs, and favorable funds that were reallocated
to new therapies. The approvals were made by assessing the safety,
pharmacokinetics, and structure in cancer patients. Several health policies aim
to improve the population health through initiatives for reducing drug prices
and enhancing access. The
national health authorities and the countries like Poland, Denmark, Finland,
and Netherlands established national plans to promote the use of biosimilars. According
to the study of RAND Corporation, it is estimated that biosimilars showcase
substantial savings with a reduction of USD 38.4 billion in the U.S. biologics
expenditure from 2021 to 2025. Moreover, a list of essential medicines
published by the WHO showcases the importance of cost-effective medications
which include recently approved biosimilars. It also highlights their
availability in terms of affordable prices to support public health initiatives
globally. Regulatory Approvals in India: India
offers approvals and commercialization of biosimilars through their development
and launch by Indian biopharmaceutical companies. Indian biopharmaceutical
companies receive the U.S. FDA approvals for the marketing of new biologics.
Guidelines on similar biologics and regulatory requirements for marketing
authorization in India were developed by collaborative efforts of the Department
of Biotechnology (DBT) and the Central Drugs Standard Control
Organization (CDSCO). The
development and preclinical evaluation of biologics is monitored by the DBT
through the Review Committee on Genetic Manipulation (RCGM). The regulatory
entities in India such as the Drug and Cosmetic Act (1940), the Drug and
Cosmetic Rules (1945) and the Rules of Manufacture, Use, Import, Export, and
Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells
that are notified under the Environmental Protection Act (1986) regulate the
similar biologics in India. View Full Report@: https://www.precedenceresearch.com/biosimilars-market Biosimilars Market Report Coverage Report Attribute Key Statistics Market
Size in 2025 USD
40.36 Billion Market
Size by 2034 USD
175.99 Billion CAGR
from 2025 to 2034 17.78% Leading
Region Europe Fastest
Growing Region North
America Base
Year 2024 Forecast
Period 2025
to 2034 Segments
Covered Product,
Application, Region Regions
Covered North
America, Europe, Asia-Pacific, Latin America, and Middle East & Africa
For questions or customization requests, please reach out to us @ sales@precedenceresearch.com | +1 804 441 9344 Biosimilars Market Key Regions Outlook Europe Biosimilars Market Size to Reach USD 64.82 Billion by 2034, The
Europe biosimilars market size was valued at USD 13.16 billion in 2024 and is
expected to be worth around USD 64.82 billion by 2034, growing at a CAGR of
17.34% from 2025 to 2034. Europe
dominated the biosimilars market in 2023 due to the rapid adoption of
biosimilars in Europe and the favorable efforts by the regulatory authorities.
Several regulatory entities make efforts to obtain the approvals for safe,
high-quality, effective, and efficient biosimilar drugs for their marketing
authorization. The European Medicines Agency (EMA) is the principal
authority for giving approvals to the newly invented biosimilar drugs through
establishing regulatory guidelines and a legal framework. A
large number of approvals are given by the EMA for a variety of drug classes
such as human growth hormone, parathyroid hormone, follicle stimulating
hormone, tumor necrosis factor inhibitor, monoclonal antibody for use in the European
Union, etc. which opens doors for favorable treatment plans by healthcare
systems. EMA approved biological medicines cover a vast range of therapeutic
areas such as diabetes mellitus, breast cancer, ovarian cancer, anaemia,
chronic kidney failure, etc. EMA approved biological medicines are manufactured
by different leading companies like Eli Lilly, Mylan (Viatris), Sandoz,
Amgen, Pfizer, Samsung Bioepis, Celltrion, Hexal, Apotex, etc. which
contribute outstanding innovations. According to the Committee for Medicinal
Products for Human Use (CHMP), EMA approved products include Abasaglar,
Abevmy, Alymsys, etc. which can potentially treat different therapeutic areas. In
October 2024, EMA authorized the product named Absimky with an
active substance called Ustekinumab, manufactured by Accord Healthcare which
can treat Crohn’s disease, Paediatric psoriatic arthritis, Plaque psoriasis,
and Psoriatic arthritis and obtained a positive opinion from the CHMP. In December
2024, EMA authorized the produce named Avtozma which was
manufactured by Celltrion and contains an active substance called
tocilizumab to treat COVID-19, Cytokine release syndrome (CRS), Giant cell
arteritis (GCA), etc. • In
July 2024, STADA and Alvotech announced the launch of
first approved biosimilar named Uzpruvo across the European countries
contributing to the success of the European market.
North
America is expected to be the fastest-growing region in the biosimilars market
during the forecast period due to heavy R&D investments and the U.S. FDA
approvals for several biosimilar drugs. The major contribution of several
renowned pharmaceutical companies like Pfizer along with the U.S. FDA approvals
help to eliminate severe health incidences among the global population. These
approvals improve access to patient care by expanding the medications and
lowering the costs. Some of the FDA approved biosimilar products include
Avtozma in January 2025, Steqeyma in December 2024, Yesintek
in November 2024, Imuldosa in October 2024, and many more
such products. The
U.S. FDA provides a purple book database showcasing all FDA approved/licensed
biological products that are regulated by the Center for Drug Evaluation and
Research (CDER). This database also includes licensed biosimilars and
interchangeable products along with their reference products. The U.S. FDA also
approves products like allergenic, hematologic, cellular and gene therapy, and
vaccine products that are regulated by the Center for Biologics Evaluation
and Research (CBER). • In
August 2024, Sandoz obtained the approval from the U.S. FDA for a
biosimilar named aflibercept which can effectively treat the neovascular
age-related macular degeneration (nAMD) and eye conditions. Market Segmentation Outlook Product Outlook The
monoclonal antibodies segment dominated the biosimilars market in 2024. due to
the largest revenue share and the extensive use for treating a variety of
diseases such as rheumatoid arthritis, cancer, cardiovascular diseases, and
multiple sclerosis, etc. The potential of mAbs in targeting specific infected
cells in therapeutics and their extensive use in the treatment of cancer boosts
their expansive reach in the market. A
treatment with mAbs is a novel approach to prevent infectious diseases such as
SARS, Ebola, HIV/AIDS, influenza, etc. as they provide effective therapeutic interventions
in the treatment of these diseases. The impact of mAbs in diagnostics,
therapeutics, and targeted drug delivery systems drives their adoption in
healthcare and research. The inventions of nanobodies and intrabodies as
alternative mAbs constructs with a potential to target hematopoietic system and
nervous system disorders boost their significance in the market. The
erythropoietin segment is expected to be the fastest-growing in the biosimilars
market during the forecast period due to their potential in the rapid
production of red blood cells in the bone marrow. The extensive use in treating
anaemia effectively drives their significance. The rising incidence of kidney
related diseases and the growing need for treating them boosts the importance of
erythropoietins in research and therapeutics. The efficacy of erythropoietin as
a neuroprotective agent in treating chronic kidney disease (CKD), mild
cognitive impairment, and other neurocognitive disorders drives their expansive
reach in the healthcare market. Application Outlook The
oncology segment dominated the
biosimilars market in 2024 due to the largest revenue share and the
availability of a large number of biosimilar products at low drug prices for
treating cancer among the global population. The International Agency for
Research on Cancer reported millions of new cancer cases and related deaths
across the globe which highlights the demand for oncology research. The rising
incidence of breast cancer, ovarian cancer, color cancer, etc. needs advanced
screening, diagnosis, and treatment through R&D in oncology sectors. The
large cases of colorectal cancer, lung cancer, etc. also boost this segmental
growth in the market. The availability of several branches like medical
oncology, surgical oncology, radiation oncology, hematology oncology, etc.
drives the importance for advanced R&D in this sector. The implementation
of various therapies and treatments like chemotherapy, radiation therapy,
hormone therapy, surgery, etc. accelerate the need for skilled medical
workforce and medical devices in oncology research and development. The
growth hormonal deficiency segment is expected to be the fastest-growing in the
biosimilars market over the forecast period due to the rising cases of child
malnutrition or hormonal deficiencies during pregnancy. The National
Organization for Rare Disorders reported 50% of chances of dealing with growth
hormone deficiency in a child during pregnancy which surges the need for
appropriate medical counselling and medical treatments. The
availability of different treatments like anti androgen medications, hormone
control or birth control medications, assisted reproductive technology,
metformin, etc. drives the biosimilars market as well. The growth hormone
replacement therapy offers benefits to body structure, exercise stamina,
skeletal health, cardiovascular outcomes, and quality of life. Manufacturer Outlook The
contract research and manufacturing services segment dominated the biosimilars
market in 2024 due to significant investments in R&D, manufacturing,
healthcare infrastructure, and regulatory compliance. These services offer
comprehensive solutions to reduce costs and avoid capital-intensive
investments. The
extensive knowledge of service providers, state-of-the-art facilities, and
expertise in biologics and biosimilar manufacturing augments this segmental
growth significantly. They enable biosimilar developers in avoiding the
establishment of extra infrastructure by making benefits of advanced
technologies. They offer industries with ready-made infrastructure, streamlined
processes, and well-established supply chains which enable them to bring their
products in the market in short time. These service providers situated in
emerging markets of India and China offer cost-effective solutions and improved
access to large pools of skilled workforce. Browse More Insights: 🔸Psoriasis Biosimilars
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Novartis •
Synthon Pharmaceuticals, Inc. •
Pfizer •
Amgen •
Sandoz •
Celltrion •
Accord Healthcare •
TevaPharmaceutical Industries Ltd. •
LG Life Sciences •
Celltrion •
Biocon •
Hospira •
Merck Serono •
Biogen idec, Inc. •
Genentech What is Going Around the Globe? • In January 2025, Amgen
announced the launch of the first Ustekinumab biosimilar known as Wezlana
in the U.S. market by introducing a new class of lower-cost biologics for
Americans dealing with several rheumatic and gastrointestinal conditions. • In
December 2024, the U.S. FDA approved the Ustekinumab biosimilar
known as Yesintek, manufactured by Biocon Biologics which has a great
therapeutic potential in treating inflammatory bowel disease, plaque psoriasis,
and psoriatic arthritis. Segments Covered in the Report By Product • Monoclonal
Antibodies
o Infliximab
o Trastuzumab
o Rituximab
o Adalimumab
o Other monoclonal antibodies • Insulin • Granulocyte
Colony-Stimulating Factor • Erythropoietin • Recombinant
Human Growth Hormone • Etanercept • Follitropin • Teriparatide • Interferons Anticoagulants • Other By Application •
Oncology •
Growth Hormonal Deficiency •
Blood Disorders •
Chronic & Autoimmune Disorders •
Infectious Disease •
Others By Manufacturer •
Contract Research and Manufacturing Services •
In-house By Regions •
North America •
Europe •
Asia Pacific •
Latin America •
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