According to Statifacts, the U.S. biosimilars market size is calculated at 22.59 billion in 2025 and is projected to surpass USD 93.52 billion by 2034 with a CAGR of 17.1% from 2025 to 2034.
U.S. Biosimilars Market Report Highlights
• Based on product, the recombinant non-glycosylated proteins segment accounted for the largest revenue share for the U.S. biosimilars market in 2025.
• The recombinant glycosylated proteins segment is expected to grow significantly during the forecast period.
• The chronic and autoimmune disorders segment accounted for the largest revenue share for the U.S. biosimilars market in 2025.
• The oncology application segment is estimated to grow at the fastest CAGR over the forecast period.
The Patent expirations of biologics have driven the growth of the U.S. biosimilars market over the forecast period. Many blockbuster biologic drugs (e.g., Humira, Enbrel, and Remicade) have lost or are losing patent protection, allowing biosimilar competition to enter the market. Cost savings and healthcare spending pressure have driven the growth of the U.S. biosimilars market in the near future. Biosimilars are typically priced 15-30% lower than reference biologics, making them attractive for insurers, hospitals, and patients seeking lower-cost alternatives. The U.S. government and private payers are pushing for biosimilar adoption to reduce overall healthcare expenditures.
The expansion of biosimilars into oncology and autoimmune diseases has driven the growth of the U.S. biosimilars market in the near future. Oncology biosimilars (e.g., Herceptin, Avastin, and Rituxan) are gaining traction due to high treatment costs and payer-driven demand. Immunology biosimilars (e.g., Humira, Enbrel, and Remicade) are experiencing rapid adoption as more alternatives enter the market. More biosimilars entering the market increase competition, leading to lower prices for biologic drugs. This makes treatments more affordable, boosting overall patient access and increasing biosimilar market penetration. Historically, biosimilars have been concentrated in oncology and immunology. Expansion into diabetes (insulin biosimilars), ophthalmology (Lucentis, Eylea), and neurology (Aimovig, Botox biosimilars) will significantly broaden the market. New approvals in these areas will expand the patient base and increase overall biosimilar usage.
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Biosimilars were initially hospital-administered, but the introduction of self-injectable and retail pharmacy biosimilars (e.g., insulin and Humira biosimilars) is expanding accessibility. This shift will increase adoption rates, particularly for chronic disease patients who rely on pharmacies. More biosimilars are receiving FDA interchangeability status, allowing automatic substitution at the pharmacy. This reduces reliance on physician-driven switching, making it easier for patients to transition to biosimilars. Pharmaceutical collaborations (e.g., Amgen, Biocon, Viatris, Samsung Bioepis) are accelerating biosimilar development and market penetration. CDMOs (Contract Development & Manufacturing Organizations) are expanding production capacity and reducing supply constraints.
For instance, by February 2025, Biocon Biologics Limited plans to introduce a biosimilar of Janssen's Stelara, which targets autoimmune diseases such as plaque psoriasis and Cohn's disease, with USFDA approval. This launch is expected to greatly increase Biocon's revenue and profitability, especially in the face of competition from five other biosimilars.
Pharmaceutical collaborations (e.g., Amgen, Biocon, Viatris, Samsung Bioepis) are accelerating biosimilar development and market penetration. CDMOs (Contract Development & Manufacturing Organizations) are expanding production capacity and reducing supply constraints.
Furthermore, in February 2024, a licensing and settlement deal was signed with Johnson & Johnson and Jansen Biotech Inc. to market the Bmab 1200 in the US. Expansion beyond hospital settings is estimated to drive the growth of the U.S. biosimilar market in the near future. Initially, biosimilars were mainly used in hospital settings. Now, retail pharmacy availability (especially for insulin biosimilars like Semglee) is opening up direct-to-consumer markets.
Employer and payer demand for cost savings treatments has been estimated to drive the growth of the U.S. biosimilars market. Large employers and health insurers are pushing biosimilar adoption in formulary design to lower specialty drug spending. Biosimilar adoption incentives from PBMs (Pharmacy Benefit Managers) are increasing. Policy and regulatory tailwinds have been estimated to create opportunities to grow the market. The Inflation Reduction Act (IRA) includes provisions that encourage biosimilar use in Medicare. State-led substitution laws for interchangeable biosimilars are increasing market penetration.
U.S. Biosimilars Market Trends
• Increased Adoption of Biosimilars: Firms such as Humira Biosimilars are following a notable shift. Major pharmacy benefit managers (PBMs) like CVS Caremark and Optum Rx have excluded Humira from their formularies in favor of more cost-effective biosimilar alternatives. The oncology sector is witnessing a surge in biosimilar entries, enhancing treatment accessibility and affordability for cancer patients.
• Strategic Partnerships and Private-Label Biosimilars: PBMs are forming alliances with drug manufacturers to develop private-label biosimilars. Notable collaborations include CVS Caremark with Cordavis, Optum with Nuvaila, and Express Scripts with Quallent Pharmaceuticals. These partnerships aim to streamline the introduction of biosimilars, offering more affordable alternatives to high-cost biologics.
• Expansion into New Therapeutic Areas: Upcoming biosimilars in the U.S. biosimilar market are preparing for the launch of biosimilars targeting drugs like ustekinumab (Stelara), signaling a new phase in biosimilar development. Regulatory and competitive dynamics, especially rules instated by the Food and Drug Administration continues to approve new biosimilars, increasing competition and potentially leading to lower prices.
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U.S. Biosimilars Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2026 |
USD 26.45 billion |
|
Revenue forecast in 2034 |
USD 93.52 billion |
|
Growth rate |
CAGR of 17.1% from 2023 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD billion and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Drug Class, Disease Indication, Distribution Channel, Manufacturer |
|
Key companies profiled |
Amgen Inc.; FHoffman-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories; Teva Pharmaceutical Industries Ltd; Pfizer Inc.; Samsung Biopis; Biocon; Viatris Inc.; Celltrion Healthcare Co.,Ltd; AbbVie Inc. |
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Databook (Price USD1550) https://www.statifacts.com/order-report/7827 How are
biosimilars approved? • Biosimilars are approved by the FDA
after studies show that they are as safe and effective as the original
biologic. • Biosimilars
are made from the same types of sources as the original biologic. • Biosimilars
are given at the same strength and dosage as the original biologic. • Biosimilars
are not expected to cause new or worsening side effects. Benefits of
biosimilars • Biosimilars can be more affordable than
the original biologic. • Biosimilars
can help patients live a longer and better quality of life. • Biosimilars
can help reduce health inequality. Artificial
intelligence Role of U.S. Biosimilars Market AI-driven drug
design can analyze biological structures to develop biosimilars faster and with
greater precision, leading to a significant boost in the U.S. biosimilars
market. Machine learning (ML) models can optimize cell line development and
bioprocessing, improving yield and reducing costs. Predictive analytics can
help manufacturers anticipate supply chain disruptions and ensure steady
production. AI-powered predictive models can reduce the need for extensive clinical trials by simulating how biosimilars interact
with the human body, saving time and cost. Natural language processing (NLP)
can automate regulatory paperwork, making FDA submission processes more
efficient. Artificial intelligence can also identify optimal patient
groups for biosimilar trials, improving recruitment and success rates. AI-driven
real-world evidence (RWE) can demonstrate biosimilar efficacy and safety to
regulators, payers, and physicians, increasing adoption. AI can optimize
pricing models; ensuring biosimilars remain cost-competitive while maximizing
reimbursement opportunities. AI-powered forecasting tools help manufacturers
predict biosimilar uptake and demand trends more accurately. AI-based chatbots
and digital assistants can educate physicians and patients about biosimilar
safety, benefits, and switching options. AI-driven personalized patient
engagement platforms can monitor adherence, flag concerns, and improve
biosimilar retention rates. Predictive analytics can identify which patients
and healthcare providers are most likely to adopt biosimilars, enabling
targeted outreach. AI can analyze real-world patient data, electronic health
records (EHRs), and social media to detect adverse events faster. Automated
systems improve drug safety monitoring and regulatory reporting, ensuring
continued patient trust in biosimilars. AI-driven logistics and demand
forecasting can prevent biosimilar shortages and optimize distribution
networks. Blockchain-integrated AI can ensure transparency in the biosimilar
supply chain, reducing fraud and inefficiencies. In May 2023,
Sandoz partnered with Just–-Evotec Biologics to develop and manufacture
multiple biosimilars. This collaboration leverages an AI-driven technology
platform to deliver fully integrated drug substance development and continuous
manufacturing, supporting the expansion of Sandoz’s pipeline to 24 biosimilar
assets. Companies like Insilico Medicine are pioneering the use of AI in drug
discovery, biomarker development, and aging research. Their AI-driven platforms
integrate deep learning, reinforcement learning, and generative models to
identify novel drug targets and design new drug candidates, accelerating the
development of biologics and biosimilars. U.S.
Biosimilars Market Segment Insights Drug Class
Insights By drug class,
the monoclonal antibodies segment registered its dominance over the U.S.
biosimilars market. Monoclonal antibodies are widely used for cancer,
autoimmune diseases, and inflammatory conditions, and they have large patient
populations. Rheumatoid arthritis, psoriasis, Crohn’s disease, and multiple
cancers drive high demand for biosimilar monoclonal antibodies. Many
best-selling monoclonal antibodies, such as Humira (adalimumab), Herceptin
(trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab), have lost patent
protection, allowing biosimilar competition. As more monoclonal antibody
biologics lose exclusivity, the biosimilar pipeline continues to expand.
Monoclonal antibody biosimilars are typically 15-40% cheaper than reference
biologics, making them attractive to payers, providers, and patients. Medicare
and private insurers favor biosimilars in formularies to control specialty drug
spending. More monoclonal antibody biosimilars are receiving FDA
interchangeability status, allowing easier substitution at the pharmacy level (e.g.,
Cyltezo for Humira). Growing real-world evidence supports the safety, efficacy,
and switching feasibility of biosimilars, increasing physician confidence. The filgrastim
& pegfilgrastim segment is expected to grow at the fastest rate in the
market during the forecast period of 2024 to 2034. Filgrastim (Neupogen) and
pegfilgrastim (Neulasta) are widely used in cancer treatment to reduce
neutropenia (low white blood cell count) caused by chemotherapy. Large oncology
patient populations drive high prescription rates, making biosimilars a
cost-effective alternative. Zarxio (filgrastim-sndz) was the first
FDA-approved biosimilar in the U.S. (2015), setting the stage for wider
acceptance of biosimilars. Fulphila, Udenyca, Ziextenzo, and Nyvepria (pegfilgrastim
biosimilars) have successfully gained market share. Pegfilgrastim biosimilars
cost 15-30% less than Neulasta, leading insurers and Medicare to prefer
biosimilars in their formularies. Competitive pricing and payer-driven
switching have increased biosimilar adoption rates. More biosimilar options
create competitive pricing pressure and increase physician and hospital
adoption. Future interchangeable biosimilar approvals could drive further
substitution without prescriber intervention. On-body pegfilgrastim delivery
devices (e.g., Neulasta Onpro) face biosimilar competition, pushing more
cost-effective options. Self-injection pegfilgrastim biosimilars make
administration easier outside hospitals, expanding patient access. Disease
Indication Insights The cancer
segment accounted for a considerable share of the U.S. biosimilars market in
2024. Many biologic drugs used in cancer treatment, such as monoclonal
antibodies (mAbs) and supportive care biologics, are extremely expensive (e.g.,
Herceptin, Avastin, Neulasta). Biosimilars offer significant cost savings
(typically 15-40% less), making them attractive for payers, hospitals, and
patients. Cancer is a leading cause of death, with rising global incidence
driving demand for effective treatments. The high number of patients needing
long-term biologic therapies increases the market potential for biosimilars.
Oncology biologics represent some of the highest revenue-generating drugs
globally. Pharma companies see oncology biosimilars as a profitable and growing
market segment. The autoimmune
diseases segment is anticipated to grow with the highest CAGR in the market
during the studied years. Autoimmune diseases such as rheumatoid
arthritis (RA), psoriasis, Crohn’s disease, and ulcerative colitis affect
millions of patients in the U.S. Chronic; long-term treatment needs make
biosimilars an attractive option for cost savings. Biologic treatments for
autoimmune diseases are extremely expensive, with some costing over US$50,000
per year. Biosimilars offer 15-50% cost reductions, leading Medicare, private
insurers, and PBMs to push for biosimilar adoption. PBMs like CVS Caremark and
Optum Rx are removing branded drugs like Humira from formularies in favor of
biosimilars. The FDA has granted interchangeability to some biosimilars (e.g.,
Cyltezo for Humira), allowing automatic substitution at pharmacies. Future
interchangeable approvals could accelerate biosimilar adoption further.
Upcoming biosimilars for Stelara (ustekinumab) in 2025 will add to the
autoimmune segment’s dominance. Future biosimilars for IL-17 and IL-23
inhibitors (e.g., Cosentyx, Skyrizi) could further expand the market. Distribution
Channel Insights The hospital
pharmacies segment led the U.S. biosimilars market. Many biosimilars,
especially monoclonal antibodies (mAbs) and supportive care biologics are
injectable or infused and require hospital or clinic administration.
Biosimilars like trastuzumab (Herceptin), bevacizumab (Avastin), and infliximab
(Remicade) are often given via IV infusion, making hospital settings the
primary distribution point. In hospitals, physicians and pharmacists control
biosimilar adoption through formulary decisions, ensuring standardized use and
monitoring. Payers incentivize hospital-administered biosimilars through
reimbursement policies favoring lower-cost alternatives to reference biologics.
Oncology, rheumatology, and gastroenterology centers, often based in hospitals,
are major prescribers of biosimilars. Since biosimilars are frequently used for
cancer, autoimmune diseases, and chronic conditions, they are mainly
distributed in hospital networks. Hospitals and clinics often purchase
biosimilars in bulk under the buy-and-bill model, where they are reimbursed
after administration. This reduces direct patient costs while hospitals benefit
from lower-priced biosimilars compared to brand-name biologics. Some
biosimilars require intensive patient monitoring for potential immune
reactions, making hospital settings safer for initial doses. Pharmacovigilance
programs track biosimilar performance and side effects, which is easier in
controlled hospital environments. The retail
pharmacies segment is anticipated to grow with the highest CAGR in the market
during the studied years. The launch of self-injectable biosimilars
(e.g., Humira, Enbrel, and Stelara biosimilars) has shifted distribution from
hospitals to retail and specialty pharmacies. Unlike IV-infused biosimilars
(which require hospital administration), auto-injectors and prefilled syringes
allow for home use, making retail pharmacies a primary channel. Retail
pharmacies primarily serve patients with chronic conditions like rheumatoid
arthritis, psoriasis, and Crohn’s disease, which require long-term biologic
therapy. Biosimilars of adalimumab (Humira), etanercept (Enbrel), and ustekinumab
(Stelara) are making retail pharmacies key distribution points. Retail
pharmacies are expanding their specialty drug services, offering patient
support programs for biosimilars. Chains like CVS and Walgreens now have
specialty pharmacy divisions focusing on biosimilars. Biosimilars are 15-50%
cheaper than branded biologics, making them more attractive for patients,
insurers, and healthcare providers. Patients prefer convenience and lower
co-pays, making retail pharmacies a preferred choice over hospitals for
self-injectable biosimilars. U.S.
Biosimilars Market Top Key Companies: • Novartis • Synthon
Pharmaceuticals, Inc. •
TevaPharmaceutical Industries Ltd. • LG Life
Sciences • Celltrion • Biocon • Hospira • Merck Serono • Biogen idec,
Inc. • Genentech U.S.
Biosimilars Market Recent Developments: • In January
2025, Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries
Ltd., and Alvotech, a global biotech company that specializes in the
development and production of biosimilar medications for patients worldwide,
today announced that the FDA has accepted for review Biologics License
Applications (BLA) for AV TO5, Alvotech's proposed biosimilar to Simponi and
Simponi Aria (golimumab), which are prescribed to treat a variety of
inflammatory conditions. These are the first golimumab biosimilar candidate
submission acceptances announced by the U.S. BLA. It is projected that the FDA
will finish reviewing these applications in the fourth quarter of 2025. • In May
2024, the U.S. Food and Drug Administration approved Amgen's Bkemv
(eculizumab-aeeb) as the first biosimilar that could be used in place of
Alexion's Soliris (eculizumab). In the same dose form and strength, Bkerv is
authorized for the same indications as Soliris, namely paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). According
to a settlement that Amgen and Alexion struck in May 2020, Bkemv is scheduled
to launch in the US in March 2025. On April 19, 2023, the EU authorized Amgen's
eculizumab biosimilar under the name Bekemv. Alexion filed a case against Amgen
at the Unified Patents Court (UPC) on March 19, 2024, requesting temporary
relief in connection with a claimed infringement of EP3167888 pertaining to an
eculizumab-based PNH treatment technique. U.S.
Biosimilars Market Report Segmentation This report
forecasts revenue growth at regional, and country levels and provides an
analysis of the latest industry trends in each of the sub-segments from 2019 to
2034. For this study, Statifacts has segmented the global U.S. Biosimilars
Market By Drug Class • Filgrastim
& Peg-filgrastim • Monoclonal
Antibodies • Others By Disease
Indication • Cancer • Autoimmune
Diseases • Arthritis • Psoriasis • Others • Others By
Distribution Channel • Hospital
Pharmacies • Retail Pharmacies • Online
Pharmacies By
Manufacturer • Contract Research and Manufacturing
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