United States Biosimilars Market Research Report, 2030

Biologic therapies play a critical role in modern medical practice but also present challenges for payers, patients, and other stakeholders because of their high cost. Biosimilars can mitigate the cost pressures of reference biologic therapy because they are typically priced at least 25% lower, providing a means to administer cutting-edge biologic therapy while also managing cost of care. In fact, the US health care system has saved an estimated $23.6 billion from use of biosimilars. However, the market is still in a nascent phase of development, and early cost-saving successes are not guaranteed to persist unless sustainable market conditions are established. As more biosimilars are approved by the US Food and Drug Administration (FDA), the market for biosimilars in the US has been gradually expanding in recent years. The FDA has authorized 31 biosimilars for use in the US market as of April 2023, with indications ranging from autoimmune illnesses to cancer. The US biosimilar industry is still developing, with new approvals, legal issues, and policy modifications influencing the environment. It seems probable that biosimilars will keep playing a significant role in the US healthcare system as more of them are approved and made available to patients. Many biologic pharmaceuticals have reached or are about to reach the end of their patent protection, which gives biosimilar producers a chance to join the market with less expensive goods. Additionally, the high cost of biological medications has led to an increase in demand for affordable treatments. The fact that biosimilars are more reasonably priced than biologics is what is promoting their uptake. Moreover, in the US, chronic diseases including cancer and autoimmune conditions are more common. The demand for biosimilars is being fueled by the fact that they provide an affordable means of treating certain illnesses. According to the research report, “United States (US) Biosimilars Market Research Report, 2030” published by Actual Market Research, the United States Biosimilars market is projected to grow with 18.69% CAGR by 2025-30. A regulatory framework for the approval of biosimilars has been developed by the US FDA, which has made it easier for them to enter the market. Favorable governmental regulations have also been implemented. Additionally, the US has a regulatory framework in place for the approval and marketing of biosimilars according to the Biologics Price Competition and Innovation Act (BPCIA). In November 2020, the FDA approved Pfizer's biosimilar, Ruxience (rituximab-pvvr), for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. A payment strategy for biosimilars under the Medicare Part B program has been set by the Centres for Medicare and Medicaid Services (CMS). The average sales price (ASP) of the reference product + 6% of the ASP of the biosimilar is what is paid for biosimilars under this policy. By offering financial incentives to healthcare professionals, this program aims to encourage the adoption of biosimilars. The global COVID-19 pandemic has been unprecedented and staggering, with experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The market in the U.S. is considered to be fairly flat and is emerging at a slower pace with a regulatory framework being set in place. The partnerships are thus enabling the competing companies to strengthen their ability to deliver the next-generation drugs and improve the accessibility of these drugs in the U.S. Considering the ongoing litigations, the innovators are entering into agreements with biologic manufacturers. This is a factor attributed to driving the market during the forecast period.

What's Inside a Actual Market Research`s industry report?

Asia-Pacific dominates the market and is the largest and fastest-growing market in the animal growth promoters industry globally

Download Sample

The Food and Drug Administration (FDA) has since enhanced clarity on the biosimilar review process, interchangeability standards, and naming conventions, thereby fostering greater confidence among manufacturers and healthcare providers. Yet, the uptake of biosimilars has not mirrored the explosive growth seen in traditional generics, largely due to a combination of market dynamics, stakeholder incentives, and entrenched brand loyalty. For instance, originator biologic companies often deploy complex patent thickets and rebate traps that disincentivize payers from switching to biosimilars, even when they are significantly cheaper. This has sparked debates around the need for policy reforms to neutralize anti-competitive practices and improve biosimilar adoption. Market penetration has been highly variable depending on the therapeutic area, payer type, and competitive landscape. In oncology and supportive care, biosimilars have gained substantial ground, driven by aggressive pricing strategies and payer mandates. Conversely, in autoimmune disorders where biologics like Humira dominate, biosimilar entry has been slower and more contentious. However, 2023 marked a turning point with the long-anticipated launch of multiple Humira biosimilars, including offerings from Amgen, Boehringer Ingelheim, and Samsung Bioepis. These launches are being closely monitored as a litmus test for the future trajectory of the biosimilars market. Investment in biosimilar development is accelerating, driven by the convergence of technological advancements, maturing regulatory pathways, and the looming expiration of patents on many high-value biologics. U.S.-based pharmaceutical firms are increasingly partnering with international biosimilar manufacturers to combine local market expertise with global manufacturing capabilities. Additionally, the role of pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), and integrated delivery networks (IDNs) is becoming more pronounced in shaping market access strategies. As biosimilars evolve from mere cost-saving alternatives to essential components of value-based care models, their integration into clinical pathways and electronic health records will be instrumental. Moreover, the impending wave of interchangeable biosimilars those deemed substitutable at the pharmacy level could disrupt existing dynamics, especially if supported by prescriber trust and automated substitution policies. Monoclonal antibodies (mAbs) are leading the biosimilars industry in the United States due to a unique convergence of clinical significance, market opportunity, and technological maturity. These biologic therapies have become central to the treatment of numerous chronic and life-threatening conditions such as cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel disease areas where the demand for effective, targeted therapies is high and growing. The original monoclonal antibody drugs, such as Humira (adalimumab), Herceptin (trastuzumab), Rituxan (rituximab), and Remicade (infliximab), have long dominated their respective therapeutic segments, achieving blockbuster status with annual revenues reaching tens of billions of dollars. As the patents for these biologics have expired or neared expiration, they have presented an attractive opportunity for biosimilar developers to enter the market with lower-cost alternatives. Unlike simpler biologics like insulin or filgrastim, which were among the first biosimilars introduced, monoclonal antibodies represent a more complex and lucrative frontier. Their high development cost is justified by the substantial potential return on investment, particularly given the scale of patient populations and treatment durations involved. Additionally, regulatory bodies such as the FDA have developed clearer pathways and guidance specific to monoclonal antibody biosimilars, allowing manufacturers to better navigate clinical trial expectations, pharmacokinetic evaluations, and immunogenicity assessments. Clinically, mAbs offer measurable endpoints and established treatment protocols, making it easier to demonstrate biosimilarity through head-to-head studies. Moreover, the entry of biosimilar mAbs has been supported by the increasing acceptance among healthcare providers, particularly in oncology and rheumatology, where institutions are under pressure to contain costs without compromising care quality. Payers and health systems, too, have been instrumental in driving adoption through formulary placement and reimbursement incentives. The chronic and autoimmune disorders segment is experiencing a high compound annual growth rate (CAGR) in the U.S. biosimilars industry due to a combination of escalating disease prevalence, rising healthcare costs, and the growing availability of biosimilar alternatives to expensive biologic therapies. Autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis affect millions of Americans and typically require long-term or lifelong treatment with biologic drugs many of which are monoclonal antibodies like adalimumab (Humira), infliximab (Remicade), and etanercept (Enbrel). These therapies have revolutionized patient care but come with staggering price tags, making access a persistent challenge, especially for uninsured or underinsured populations. As patents for these originator biologics expire, biosimilars offer a critical solution by introducing competition that drives down prices and broadens access. The result is increased demand not only from payers and providers aiming to reduce spending, but also from patients who now have more affordable options. Moreover, healthcare policymakers and insurers in the U.S. have increasingly prioritized value-based care, encouraging the use of cost-effective treatments without compromising clinical outcomes. This policy environment is conducive to the rapid adoption of biosimilars for chronic and autoimmune diseases, where treatment regimens are standardized and outcomes well-documented. Biosimilar manufacturers, recognizing this potential, are also investing heavily in education and engagement strategies aimed at building trust among rheumatologists, gastroenterologists, and dermatologists, many of whom were initially hesitant to switch stable patients from originator biologics. Additionally, the chronic nature of autoimmune disorders means recurring treatment cycles, which amplifies the cost savings and therapeutic impact of biosimilars over time.

Make this report your own

We're excited to discuss your needs and our solutions. Let's schedule a call.

Ask an Expert

Nikita Jabrela

Business Development Manager

In-house manufacturing is leading the biosimilars industry in the United States because it offers biopharmaceutical companies greater control over production quality, cost efficiency, regulatory compliance, and intellectual property management key factors in the competitive and highly regulated biosimilars landscape. Unlike traditional small-molecule generics, biosimilars are complex biologics derived from living cells, requiring sophisticated manufacturing processes that are sensitive to even minor changes in conditions. By maintaining in-house manufacturing capabilities, companies can ensure consistency in production, adhere closely to FDA guidelines, and respond swiftly to technical or regulatory issues. This internal control is particularly crucial for building trust with clinicians and patients, as biosimilars must demonstrate high similarity to reference products in terms of safety, efficacy, and immunogenicity. Moreover, in-house production allows firms to better manage supply chains, avoid disruptions, and scale up quickly to meet market demand, which is especially important when launching biosimilars for high-volume chronic treatments. Cost is another critical advantage while the initial capital investment in biologics manufacturing facilities is high, it can lead to long-term savings by eliminating third-party margins and enabling more flexible pricing strategies. This cost efficiency not only improves competitiveness but also enhances the company’s ability to negotiate with payers and secure favorable formulary positions. Additionally, in-house capabilities empower companies to innovate and optimize processes over time, including adopting advanced technologies like single-use bioreactors and continuous manufacturing systems that improve yield and reduce environmental footprint. Large pharmaceutical firms with robust in-house infrastructure such as Amgen, Pfizer, and Samsung Bioepis (in partnership with U.S. distributors) have leveraged these advantages to dominate the U.S. biosimilars space. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

Don’t pay for what you don’t need. Save 30%

Customise your report by selecting specific countries or regions

Specify Scope Now

By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.