North America Biopharmaceuticals Market Outlook

The North America biopharmaceuticals market was valued at US$ 151.22 billion in 2022 and is projected to reach US$ 315.74 billion by 2028, growing at a CAGR of 13.1% from 2022 to 2028.

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Rare Disease Treatment Drives Market Growth

The growing potential of biopharmaceuticals to treat rare diseases is a key factor fueling market expansion. According to the National Institutes of Health (NIH), 30 million Americans—approximately 10% of the population—suffer from one of the ~7,000 known rare diseases. Despite scientific and operational challenges, North American researchers have made significant strides in developing novel therapies for these conditions.

In the past decade, the US FDA has approved over 350 orphan drugs, many of which address diseases with limited or no treatment options. For example, Transthyretin amyloid cardiomyopathy (ATTR-CM) is a rare and fatal cardiovascular disorder with a median life expectancy of only 2.5–3.5 years if left untreated.

Companies such as Ultragenyx Pharmaceutical Inc. are advancing therapies for ultra-rare diseases. In December 2021, the company began clinical trials for UX053, an mRNA-based therapy for Glycogen Storage Disease (GSD) type 3. UX053 is designed to deliver large genes to targeted cells and ensure uniform protein expression. Ultragenyx aims to personalize mRNA therapy by adjusting dosage levels and frequency based on patient needs. Such innovations are accelerating the market’s growth trajectory.

Regional Overview

The North America biopharmaceuticals market spans the US, Canada, and Mexico. Market growth is driven by:

• Rising incidence of chronic diseases such as cancer, Alzheimer’s, and heart disease.
• Rapid technological advancements in drug development.
• Increased investments in research and development, particularly in the US.

The US leads globally in R&D investment and innovation. As of 2020, US-based biopharmaceutical companies had more than 3,400 drugs in clinical development, nearly half of the estimated 8,000 worldwide. Of these, over 1,100 drugs target various forms of cancer.

Beyond healthcare, the industry significantly contributes to the US economy. In 2018:

• Pharmaceutical and medical manufacturing accounted for 0.95% of private-sector value added.
• Biotech R&D contributed an additional 0.23%.

According to CDC data (July 2022):

• 20.1 million adults aged 20+ in the US have coronary artery disease—the most common heart condition.
• A heart attack occurs every 40 seconds, affecting approximately 805,000 people annually.

These statistics underscore the urgent need for innovative therapies, further propelling the biopharmaceuticals market in North America.

North America Biopharmaceuticals Strategic Insights

Strategic insights for the North America Biopharmaceuticals 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.

key company profiles

  AbbVie Inc

  AGC Biologics AS

  Amgen Inc

  Boehringer Ingelheim International GmbH

  Bristol-Myers Squibb Co

  Eli Lilly and Co

  Johnson & Johnson

  Lonza Group AG

  Thermo Fisher Scientific Inc

  WuXi Biologics Inc

North America Biopharmaceuticals Regional Insights

The geographic scope of the North America Biopharmaceuticals 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.

North America Biopharmaceuticals Market Segmentation

The North America biopharmaceuticals market is categorized based on product type, application, and country.

By Product Type:

The market is segmented into the following categories:

• Monoclonal Antibodies (held the largest market share in 2022)
• Recombinant Vaccines, further divided into:
• Cancer Vaccine
• Malaria Vaccine
• Ebola Vaccine
• Hepatitis-B Vaccine
• Tetanus Vaccine
• Diphtheria Vaccine
• Cholera Vaccine
• Others
• Conventional Vaccines, further divided into:
• Polio Vaccine
• Pox Vaccine
• Others
• Recombinant Growth Factors, including:
• Erythropoietin
• Granulocyte Colony Stimulating Factor
• Purified Proteins, including:
• Leukemia Inhibitory Factor (LIF)
• P53 Protein
• P38 Protein
• Others
• Recombinant Proteins, including:
• Serum Albumin
• Amyloid Protein
• Defensin
• Transferrin
• Recombinant Hormones, including:
• Recombinant Human Growth Hormones
• Recombinant Insulin
• Other Recombinant Hormones
• Recombinant Enzymes, including:
• Enterokinase
• Cyclase
• Caspase
• Cathepsin
• Cell & Gene Therapies, segmented into:
• Allogenic Products
• Autologous Products
• Acellular Products
• Cytokines/Interferons/Interleukins
• Others

By Application:

The market is segmented into:

• Oncology (accounted for the largest market share in 2022)
• Inflammatory & Infectious Diseases
• Autoimmune Disorders
• Metabolic Disorders
• Hormonal Disorders & Growth Failure
• Cardiovascular Diseases
• Neurological Diseases
• Others

By Country:

• United States (dominated the regional market in 2022)
• Canada
• Mexico

Key Market Players:

Leading companies in the North America biopharmaceuticals market include:

• AbbVie Inc.
• AGC Biologics AS
• Amgen Inc.
• Boehringer Ingelheim International GmbH
• Bristol-Myers Squibb Co.
• Eli Lilly and Co.
• Johnson & Johnson
• Lonza Group AG
• Thermo Fisher Scientific Inc.
• WuXi Biologics Inc.

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Author's Bio
Akshay
Senior Market Research Expert at Business Market Insights