North America Biologics Market

Historic Data: 2025-2031   |   Base Year: 2023   |   Forecast Period: 2021-2023

Analysis - by Product (Monoclonal Antibodies, Vaccine, Recombinant Hormones/Proteins, Cell and Gene Therapy, and Others), Application (Cancer, Infectious Diseases, Autoimmune Diseases, and Others), Source (Mammalian and Microbial), and Manufacturing (Outsourced and In-house)


No. of Pages: 146    |    Report Code: BMIRE00031588    |    Category: Life Sciences

North America Biologics Market
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The North America biologics market was valued at US$ 230,256.1 million in 2023 and is expected to reach US$ 888,880.0 million by 2031; it is estimated to register a CAGR of 18.4% from 2023 to 2031.

Increasing Prevalence of Chronic Diseases Fuels North America Biologics Market



According to a study titled "Chronic Disease: A Bio-Logical Approach," published in Ellerston Capital Limited, 41 million people worldwide die from chronic diseases every year, accounting for 74% of all deaths worldwide. Cancer was responsible for almost 10 million deaths in 2020, i.e., 1 in every 6 deaths. According to GLOBOCAN, 19.3 million cancer cases were registered worldwide in 2020, and the number is estimated to rise to 24.6 million by 2030. In addition, the prevalence of autoimmune diseases increases annually by 3-9%. The number of Alzheimer's disease cases is expected to reach 78 million by 2030 and 139 million by 2050. According to the World Health Organization (WHO), every year, ~17 million people across the world succumb to death due to noncommunicable diseases before the age of 70.

Biologics such as antibodies and vaccines offer more targeted treatment because they are designed to interact with the immune system in specific ways to deliver a therapeutic or prophylactic effect. Biological drugs have the promising potential to treat a few chronic autoimmune diseases by blocking the overactive components (proteins in many cases) of the immune system, which damage joints, skin, and other body parts. The treatment of cancer with biologics involves using the body's immune cells to kill cancerous cells; cytokines such as interferons, interleukins, and monoclonal antibodies (mAbs) are the most commonly used biologic therapies employed to treat cancer. Anti-amyloid mAbs have also shown promising therapeutic effects in clinical studies conducted on Alzheimer's disease patients. Chronic diseases such as ulcerative colitis and Crohn's disease include recurring episodes of inflammation of the mucosal layer of the colon. The US Food and Drug Administration has approved a few biological drugs for the treatment of Crohn's disease; these include infliximab, adalimumab, and natalizumab. Further, biological disease-modifying antirheumatic drugs are one of the major approaches to treating rheumatoid arthritis. With the shift in doctors' and patients' preference from conventional to aggressive approaches, the demand for biologics in the treatment of rheumatoid arthritis is also on the rise. Therapeutics use are partially or fully humanized proteins targeting different immune response pathways. Therefore, the increasing prevalence of chronic diseases drives the growth of the biologics market.

North America Biologics Market Overview



North America holds the largest share of the biologics market in terms of revenue. Market growth in this region is attributed to the presence of key biologics manufacturing players and the increasing spending on R and D. According to an article published in the JAMA Network, biologics R and D spending accounted for 37% of total R and D spending in the US. The number of prescriptions written for biologics and investments in the development of targeted drugs are on the rise in the country. Additionally, the approval of several novel biological drugs such as antisense, gene therapy, and RNAi therapeutics is expected to further drive the market growth. As per an article published by the National Center for Biotechnology Information (NCBI), the country recorded historically the highest percentage of biologics approvals in 2022, i.e., 40%, which indicates the stability of biologics in pharmaceutical applications. Moreover, this category of drugs accounts for 30% of the total drug approvals. In May 2024, Biocon Biologics Ltd (BBL) received FDA approval for YESAFILI (aflibercept) as the first biological alternative to Eylea. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions.

North America Biologics Market Revenue and Forecast to 2031 (US$ Million)

North America Biologics Market Revenue and Forecast to 2031 (US$ Million)
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North America Biologics Strategic Insights

Strategic insights for the North America Biologics provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

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North America Biologics Report Scope

Report Attribute Details
Market size in 2023 US$ 230,256.1 Million
Market Size by 2031 US$ 888,880.0 Million
Global CAGR (2023 - 2031) 18.4%
Historical Data 2025-2031
Forecast period 2021-2023
Segments Covered By Product
  • Monoclonal Antibodies
  • Vaccine
  • Recombinant Hormones/Proteins
  • Cell and Gene Therapy
  • Others
By Application
  • Cancer
  • Infectious Diseases
  • Autoimmune Diseases
  • Others
By Source
  • Mammalian and Microbial
By Manufacturing
  • Outsourced and In-house
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Market leaders and key company profiles
  • AbbVie Inc
  • Pfizer Inc
  • Samsung Biologics Co Ltd
  • ADMA Biologics, Inc.
  • Wuxi Biologics Inc
  • Catalent Inc
  • AGC Biologics AS
  • AstraZeneca Plc
  • Amgen Inc
  • Nitto Avecia
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    North America Biologics Regional Insights

    The geographic scope of the North America Biologics refers to the specific areas in which a business operates and competes. Understanding local distinctions, such as diverse consumer preferences (e.g., demand for specific plug types or battery backup durations), varying economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved areas or adapting their offerings to meet local demands. A clear market focus allows for more effective resource allocation, targeted marketing campaigns, and better positioning against local competitors, ultimately driving growth in those targeted areas.

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    North America Biologics Market Segmentation



    The North America biologics market is categorized into product, application, source, manufacturing, and country.

    Based on product, the North America biologics market is segmented into monoclonal antibodies, vaccine, recombinant hormones/proteins, cell and gene therapy, and others. The monoclonal antibodies segment held the largest market share in 2023.

    In terms of application, the North America biologics market is categorized into cancer, infectious diseases, autoimmune diseases, and others. The cancer segment held the largest market share in 2023.

    By source, the North America biologics market is bifurcated into mammalian and microbial. The mammalian segment held a larger market share in 2023.

    Based on manufacturing, the North America biologics market is bifurcated into outsourced and in-house. The outsourced segment held a larger market share in 2023.

    In terms of country, the North America biologics market is segmented into the US, Canada, and Mexico. The US dominated the North America biologics market share in 2023.

    AbbVie Inc, Pfizer Inc, Samsung Biologics Co Ltd, ADMA Biologics, Inc., Wuxi Biologics Inc, Catalent Inc, AGC Biologics AS, AstraZeneca Plc, Amgen Inc, Nitto Avecia, and Quality Assistance s.a. are some of the leading companies operating in the North America biologics market.

    The List of Companies - North America Biologics Market

    • AbbVie Inc
    • Pfizer Inc
    • Samsung Biologics Co Ltd
    • ADMA Biologics, Inc.
    • Wuxi Biologics Inc
    • Catalent Inc
    • AGC Biologics AS
    • AstraZeneca Plc
    • Amgen Inc
    • Nitto Avecia
    • Quality Assistance s.a.
    Frequently Asked Questions
    How big is the North America Biologics Market?

    The North America Biologics Market is valued at US$ 230,256.1 Million in 2023, it is projected to reach US$ 888,880.0 Million by 2031.

    What is the CAGR for North America Biologics Market by (2023 - 2031)?

    As per our report North America Biologics Market, the market size is valued at US$ 230,256.1 Million in 2023, projecting it to reach US$ 888,880.0 Million by 2031. This translates to a CAGR of approximately 18.4% during the forecast period.

    What segments are covered in this report?

    The North America Biologics Market report typically cover these key segments-

    • Product (Monoclonal Antibodies, Vaccine, Recombinant Hormones/Proteins, Cell and Gene Therapy, and Others)
    • Application (Cancer, Infectious Diseases, Autoimmune Diseases, and Others)
    • Source (Mammalian and Microbial)
    • Manufacturing (Outsourced and In-house)

    What is the historic period, base year, and forecast period taken for North America Biologics Market?

    The historic period, base year, and forecast period can vary slightly depending on the specific market research report. However, for the North America Biologics Market report:

  • Historic Period : 2025-2031
  • Base Year : 2023
  • Forecast Period : 2021-2023
  • Who are the major players in North America Biologics Market?

    The North America Biologics Market is populated by several key players, each contributing to its growth and innovation. Some of the major players include:

  • AbbVie Inc
  • Pfizer Inc
  • Samsung Biologics Co Ltd
  • ADMA Biologics, Inc.
  • Wuxi Biologics Inc
  • Catalent Inc
  • AGC Biologics AS
  • AstraZeneca Plc
  • Amgen Inc
  • Nitto Avecia
  • Quality Assistance s.a.
  • Who should buy this report?

    The North America Biologics Market report is valuable for diverse stakeholders, including:

    • Investors: Provides insights for investment decisions pertaining to market growth, companies, or industry insights. Helps assess market attractiveness and potential returns.
    • Industry Players: Offers competitive intelligence, market sizing, and trend analysis to inform strategic planning, product development, and sales strategies.
    • Suppliers and Manufacturers: Helps understand market demand for components, materials, and services related to concerned industry.
    • Researchers and Consultants: Provides data and analysis for academic research, consulting projects, and market studies.
    • Financial Institutions: Helps assess risks and opportunities associated with financing or investing in the concerned market.

    Essentially, anyone involved in or considering involvement in the North America Biologics Market value chain can benefit from the information contained in a comprehensive market report.

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