• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor

    US Insulin Biosimilars Market

    ID: MRFR/Pharma/18133-HCR
    100 Pages
    Garvit Vyas
    September 2025

    US Insulin Biosimilars Market Research Report By Type (Rapid-acting biosimilars, Long-acting biosimilars, Premixed biosimilars) and By Indication (TYPE I DIABETES, TYPE II DIABETES) - Forecast to 2035

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    US Insulin Biosimilars Market Infographic
    Purchase Options
    $ 4,950.0
    $ 5,950.0
    $ 7,250.0

    US Insulin Biosimilars Market Summary

    The US Insulin Biosimilars market is poised for substantial growth, projected to reach 531.0 USD Million by 2035.

    Key Market Trends & Highlights

    US Insulin Biosimilars Key Trends and Highlights

    • The market valuation is expected to increase from 125.7 USD Million in 2024 to 531.0 USD Million by 2035.
    • A compound annual growth rate (CAGR) of 13.99% is anticipated from 2025 to 2035.
    • The rising prevalence of diabetes in the United States is likely to drive demand for insulin biosimilars.
    • Growing adoption of biosimilar therapies due to cost-effectiveness is a major market driver.

    Market Size & Forecast

    2024 Market Size 125.7 (USD Million)
    2035 Market Size 531.0 (USD Million)
    CAGR (2025-2035) 13.99%

    Major Players

    Novartis, Merck, Eli Lilly, Biocon, Sandoz, CG Bio, Boehringer Ingelheim, Fresenius Kabi, Pfizer, Teva, Amgen, AbbVie, Roche, Sanofi, Mylan

    US Insulin Biosimilars Market Trends

    The US Insulin Biosimilars Market is experiencing significant growth driven by increasing healthcare costs, a rising prevalence of diabetes, and the demand for affordable treatment options. Insulin biosimilars present an opportunity for cost savings compared to their originator counterparts, making them appealing to patients and healthcare providers alike. The introduction of new biosimilars into the market is also a response to the ongoing push for more affordable medications, which aligns with the broader healthcare reforms initiated by the US government.

    Market Segment Insights

    Insulin Biosimilars Market Type Insights

    The US Insulin Biosimilars Market is rapidly evolving, with Type serving as a pivotal segment that includes various formulations tailored to meet diverse patient needs. Within this segment, Rapid-acting biosimilars are particularly significant as they offer a quick onset of action, making them essential for postprandial glucose control. These products allow for flexibility in meal timing, critical for individuals managing their diabetes effectively. Long-acting biosimilars also play a crucial role by providing steady insulin levels over an extended period, which is beneficial for maintaining basal insulin needs and reducing the frequency of injections required throughout the day.

    The importance of Long-acting biosimilars is underscored by their ability to improve adherence to treatment regimens, thus potentially lowering the long-term complications associated with diabetes. Premixed biosimilars, on the other hand, combine both rapid and long-acting insulins, making them a convenient option for patients who prefer a simplified management approach without having to measure various insulins separately. This ease of use enhances patient compliance and offers a practical solution for glycemic control.

    Overall, the segmentation of the US Insulin Biosimilars Market by Type reveals a landscape characterized by innovation and the continuous introduction of products designed to enhance patient outcomes, supported by a growing demand for cost-effective treatment alternatives in the diabetes management arena.

    Factors such as the rising prevalence of diabetes in the United States, increasing healthcare costs, and the push for biosimilars as a viable alternative to branded insulins fuel the demand further. This indicates a robust future for the Type segment, reflecting a market transition towards more accessible insulin therapies that can accommodate the diverse needs of patients across the country. The US Insulin Biosimilars Market segmentation not only highlights competitive aspects but also aligns with the ongoing trends of personalized medicine and patient-centered care, which are becoming increasingly important in the healthcare landscape.

    Each component within the Type segment presents unique advantages that contribute significantly to patient management strategies while addressing broader healthcare challenges, including affordability and access to necessary treatments.

    Insulin Biosimilars Market Indication Insights

    The US Insulin Biosimilars Market focuses on various indications, with Type I and Type II diabetes being the principal categories that drive the market dynamic. Type I diabetes, often diagnosed in childhood, progresses lifelong and requires constant insulin management, fostering a significant demand for biosimilars that can offer cost-effective alternatives to legacy products. Conversely, Type II diabetes has been on the rise, driven by factors such as obesity and sedentary lifestyles, thus increasing the overall market growth potential for biosimilars as more patients enter into treatment regimens.

    The growing emphasis on accessible and affordable treatment options underpins the rising significance of biosimilars in both indications, as they serve to improve patient outcomes while managing healthcare expenditures. Moreover, the regulatory landscape in the US, which supports the approval of biosimilars, further enhances the speed-to-market for these alternatives, positioning them as an essential option for both Type I and Type II diabetes management. As these indications encompass a vast portion of the diabetes population in the US, the insights surrounding their treatment options reflect the overarching trend towards innovation and efficacy in diabetes care.

    Get more detailed insights about US Insulin Biosimilars Market

    Key Players and Competitive Insights

    The US Insulin Biosimilars Market has been experiencing significant growth driven by the increasing prevalence of diabetes and the rising need for cost-effective treatment options. The integration of biosimilars into the insulin segment is reshaping the competitive landscape, allowing for more affordable therapeutic alternatives that can potentially enhance patient access to necessary medications. As healthcare systems look for ways to reduce expenses without compromising the quality of care, the introduction of insulin biosimilars has become a focal point. This transition is characterized by innovation in drug development and regulatory frameworks that support the entry of biosimilars into the market.

    Companies are working tirelessly to establish their presence and differentiate their products in this increasingly competitive environment.

    Novartis

    Novartis has carved out a significant niche within the US Insulin Biosimilars Market by leveraging its strong research and development capabilities. The company's depth of expertise in the biopharmaceutical sector enables it to effectively navigate the complexities associated with the development and commercialization of biosimilars. Novartis has focused on delivering high-quality products that not only meet regulatory standards but also address patient needs for affordable insulin options. With a strong brand reputation and a commitment to innovation, Novartis is well-positioned in the market.

    The company utilizes robust marketing strategies and collaborations with healthcare providers to streamline adoption and ensure its biosimilars gain traction in a competitive space, enhancing its market presence more rapidly.

    Merck

    Merck has also made notable strides in the US Insulin Biosimilars Market, showcasing a diverse portfolio of products that cater to different patient needs. The company's strength lies in its comprehensive understanding of the diabetes landscape, alongside its ongoing investments in biosimilar research and development. Key products have reflected Merck’s emphasis on quality and efficacy, driving a strong presence in the market. With a commitment to innovation, Merck continually seeks opportunities for mergers and acquisitions that can bolster its competitive edge and expand its capabilities within the biosimilars segment.

    The company focuses on leveraging its established distribution networks and partnerships with healthcare institutions to ensure its products reach patients effectively, ultimately contributing to enhanced patient outcomes and affordability in the US insulin treatment arena.

    Key Companies in the US Insulin Biosimilars Market market include

    Industry Developments

    Recent developments in the US Insulin Biosimilars Market indicate a growing focus on increasing accessibility to insulin products. In August 2023, Eli Lilly announced the launch of a new biosimilar insulin product, which is aimed at improving affordability for patients. Merck has also been making strides in the market, reflecting a competitive atmosphere as companies strive to innovate and capture market share. Furthermore, Novartis has been actively engaging in partnerships and collaborations to enhance its biosimilar portfolio, signifying an evolving landscape. The market's growth is evident, with valuations surging due to heightened demand for cost-effective diabetes treatments.

    In March 2022, the FDA's approval of multiple biosimilar insulin products marked a significant achievement, contributing to increased competition among major players such as Biocon, Sandoz, and Teva.

    Additionally, in September 2022, Boehringer Ingelheim and Fresenius Kabi announced a strategic partnership focusing on insulin biosimilars, thereby solidifying their positions in the market. Overall, the competitive dynamics and recent developments reflect a robust evolution of the US Insulin Biosimilars Market, emphasizing innovation and patient-centered approaches.

    Market Segmentation

    Insulin Biosimilars Market Type Outlook

    • Rapid-acting biosimilars
    • Long-acting biosimilars
    • Premixed biosimilars

    Insulin Biosimilars Market Indication Outlook

    • TYPE I DIABETES
    • TYPE II DIABETES

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 109.69(USD Million)
    MARKET SIZE 2024 125.71(USD Million)
    MARKET SIZE 2035 530.99(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 13.995% (2025 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    MARKET FORECAST PERIOD 2025 - 2035
    HISTORICAL DATA 2019 - 2024
    MARKET FORECAST UNITS USD Million
    KEY COMPANIES PROFILED Novartis, Merck, Eli Lilly, Biocon, Sandoz, CG Bio, Boehringer Ingelheim, Fresenius Kabi, Pfizer, Teva, Amgen, AbbVie, Roche, Sanofi, Mylan
    SEGMENTS COVERED Type, Indication
    KEY MARKET OPPORTUNITIES Rising diabetes prevalence, Cost-effective treatment options, Expanding reimbursement policies, Increasing patient awareness, Market entry of new players
    KEY MARKET DYNAMICS regulatory approval processes, pricing pressures, increasing diabetes prevalence, competition from generics, physician adoption rates
    COUNTRIES COVERED US

    FAQs

    What is the expected market size of the US Insulin Biosimilars Market in 2024?

    The US Insulin Biosimilars Market is expected to be valued at 125.71 million USD in 2024.

    What is the projected market size of the US Insulin Biosimilars Market by 2035?

    By 2035, the US Insulin Biosimilars Market is projected to reach a value of 530.99 million USD.

    What is the expected CAGR for the US Insulin Biosimilars Market from 2025 to 2035?

    The expected CAGR for the US Insulin Biosimilars Market during the period from 2025 to 2035 is 13.995 percent.

    Which segment is projected to have the largest market size in 2035 for rapid-acting biosimilars?

    The rapid-acting biosimilars segment is anticipated to be valued at 178.91 million USD by 2035.

    How much is the long-acting biosimilars segment expected to be worth in 2035?

    The long-acting biosimilars segment is expected to reach a value of 215.75 million USD in 2035.

    What is the expected market value for premixed biosimilars in 2035?

    The premixed biosimilars segment is anticipated to be valued at 136.33 million USD in 2035.

    Who are the major players in the US Insulin Biosimilars Market?

    Key players in the US Insulin Biosimilars Market include Novartis, Merck, Eli Lilly, and Biocon among others.

    What is the market size for rapid-acting biosimilars in 2024?

    In 2024, the market size for rapid-acting biosimilars is valued at 40.0 million USD.

    What are the growth drivers for the US Insulin Biosimilars Market?

    Growth drivers for the US Insulin Biosimilars Market include increasing diabetes prevalence and growing awareness about biosimilars.

    Which factors could present challenges to the US Insulin Biosimilars Market growth?

    Challenges to the US Insulin Biosimilars Market growth may include regulatory hurdles and market competition.

    Report Infographic
    Free Sample Request

    Kindly complete the form below to receive a free sample of this Report

    Customer Strories

    “I am very pleased with how market segments have been defined in a relevant way for my purposes (such as "Portable Freezers & refrigerators" and "last-mile"). In general the report is well structured. Thanks very much for your efforts.”

    Victoria Milne Founder
    Case Study

    Chemicals and Materials