United States Biologics Market Set for Breakthrough Growth with Innovative Therapies & Expanding Applications 2025 | Top key players - Roche, Merck & Co., AbbVie.

Market Size and Growth:

The Global Biologics Market size reached US$ 472.71 billion in 2023, with a rise of US$ 512.25 billion in 2024, and is expected to reach US$ 966.98 billion by 2033, growing at a CAGR of 7.1% during the forecast period 2025-2033.

The Biologics Market report by DataM Intelligence provides insights into the latest trends and developments in the market. This report identifies the key growth opportunities in the market and provides recommendations for market participants to capitalize on these opportunities. Overall, the Biologics market report is an essential resource for market participants who are looking to gain a comprehensive understanding of the market and identify opportunities for growth.

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The Biologics Market refers to the segment of the pharmaceutical industry focused on products derived from living organisms, including proteins, monoclonal antibodies, vaccines, and cell or gene therapies. These advanced therapies are used to treat chronic diseases, cancers, autoimmune disorders, and rare conditions. The market is driven by innovation, personalized medicine, rising prevalence of complex diseases, and growing healthcare demand.

Recent Key Developments of United States (U.S):

Rise of Biosimilars and Regulatory Changes: The U.S. has seen an acceleration in biosimilar approvals and launches, particularly in immunology and oncology. The FDA has approved numerous biosimilars for blockbuster drugs, including multiple denosumab (referencing Prolia and Xgeva) and ustekinumab (referencing Stelara) biosimilars. This is leading to increased competition and lower prices for these therapies. (e.g., Bildyos and Bilprevda were approved on September 2, 2025).

Focus on Next-Generation Biologics: There is a significant trend towards more targeted and advanced biologic therapies, such as bispecific antibodies, antibody-drug conjugates (ADCs), and cell and gene therapies. The market is embracing personalized and precision medicine approaches, with new approvals for treatments tailored to specific genetic mutations or patient characteristics.

New FDA Approvals and Extended Indications: The FDA has approved several new biologics and expanded the use of existing ones. For instance, in June 2025, Enflonsia (clesrovimab-cfor) was approved to prevent RSV in infants, and Dupixent (dupilumab) received an additional indication for chronic spontaneous urticaria. Other notable approvals in the last quarter include Wayrilz (rilzabrutinib) for immune thrombocytopenia (August 29, 2025) and Dawnzera (donidalorsen) for hereditary angioedema (August 21, 2025).

Advancements in Drug Administration: Companies are developing and seeking approval for more convenient administration methods for biologics. For example, the FDA is reviewing a subcutaneous (under-the-skin) version of the cancer immunotherapy Keytruda (pembrolizumab) and a once-weekly injection of Leqembi (lecanemab) for Alzheimer's disease.

Integration of AI and Technology: The use of advanced technologies, such as artificial intelligence (AI), is growing in the biologics market. Pharmaceutical companies like Amgen are leveraging AI-driven data analytics to streamline research and development, helping to identify therapeutic candidates faster and reduce time-to-market.

Key Players:

Roche
Merck & Co.
AbbVie
Pfizer
AstraZeneca
Sanofi
Johnson & Johnson's
Bristol-Myers Squibb
Novartis
Eli Lilly.

This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

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Market Segmentation:

By Product Type: Monoclonal Antibodies (mAbs), Vaccines, Recombinant Hormones/Proteins, Cell Therapy, Gene Therapy, Antisense & RNAi Therapeutics, Others.

By Application: Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Disorders, Neurological Disorders, Metabolic Disorders, Others.

By Manufacturing: In-house Manufacturing, Outsourced/Contract Manufacturing.

By End User: Pharmaceutical and Biotechnology Companies, Hospitals, Research & Academic Institutes, Others.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Biologics market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Biologics Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Biologics market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Biologics Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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People Also Ask:

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◆ Which region is expected to dominate the industry during the forecast period?

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