North America Biosimilars Market - By Product Type (Protein, Insulin, Human Growth Hormones, Granulocyte Colony-stimulating Factor (G-CSF), Interferons, Recombinant Glycosylated Proteins, Erythropoietin, Monoclonal Antibodies, Follitropin, Recombinant Peptides, Glucagon) By Technology (Mass Spectroscopy, Chromatography, Monoclonal Antibody Technology, Recombinant DNA Technology, Nuclear Magnetic resonance (NMR) technology, Electrophoresis, Bioassay) By Disease (Oncology Diseases, Blood Disorders, Growth hormone deficiencies, Chronic and autoimmune diseases, Others), and By Industry Analysis, Market Size, Share & Forecast, 2023 – 2032

MVI Statistics and Viewpoints:

• North America Biosimilars Market size exceeded USD 3.11 Billion in 2022. 
• The market is expected to showcase a CAGR of over 22.1% from 2023 to 2032. 
• By the end of the forecast period, the market is anticipated to reach a valuation of around USD 22.87 Billion.

The North American biosimilars industry presents significant growth opportunities for manufacturers willing to navigate regulatory challenges, invest in research and development, and forge strategic partnerships. As the demand for cost-effective biologics continues to rise, biosimilars are poised to play a crucial role in addressing the region's healthcare needs while providing a competitive edge in the pharmaceutical industry.

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Market Overview:

The North America Market is a dynamic landscape within the pharmaceutical industry, driven by a growing demand for cost-effective and accessible biologic medication alternatives. Biosimilars are biological products that are clinically equivalent to already approved reference biologics in terms of safety, efficacy, and quality. The primary goal of this market is to provide patients with more affordable treatment options while adhering to stringent regulatory standards. The biosimilars market in North America has gained traction as a result of factors such as the expiration of patents on several biologic drugs, rising healthcare costs, and the need to expand patient access to critical therapies. Regulatory frameworks, such as the Biologics Price Competition and Innovation Act (BPCIA) in the United States, have paved the way for the approval and adoption of biosimilars. While the market in North America is growing, it is still in its early stages when compared to other regions. The interaction of regulatory agencies, healthcare providers, and patient education will shape the North American Market, influencing healthcare accessibility and affordability.

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Drivers:

• Cost Savings and Access to Treatment: The potential for significant cost savings is one of the primary drivers of the biosimilars market. Biosimilars are a less expensive alternative to expensive reference biologics, which can result in lower healthcare costs and improved patient access to critical treatments.
   
• Patent Expirations of Biologics: Many biologic drugs in North America have reached or are about to reach the end of their patent protection. This opens the door for biosimilar manufacturers to enter the market with their versions of these biologics once the reference products' exclusivity period expires.
   
• Biosimilar Development Expertise: Leading pharmaceutical and biotechnology companies are investing in biosimilar development, leveraging their scientific knowledge and manufacturing capabilities to create high-quality biosimilars.

Restraints:

• Regulatory Complexity: Although there are regulatory frameworks in place for biosimilars, navigating the complex regulatory landscape can be difficult. Manufacturers must demonstrate biosimilarity through extensive analytical and clinical testing, which takes time and money.

By Product Type Synopsys:

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The market is classified by product type into protein, insulin, human growth hormones, granulocyte colony-stimulating factor (G-CSF), interferons, recombinant glycosylated proteins, erythropoietin, monoclonal antibodies, follitropin, recombinant peptides, glucagon. Among these segments, the monoclonal antibodies segment  is expected to hold the largest share of the North America Biosimilars Market during the study period. Monoclonal antibodies have gained popularity due to their wide range of applications in diseases such as cancer, autoimmune disorders, and inflammatory diseases. The region's increased development and adoption of biosimilar monoclonal antibodies has resulted from a growing demand for effective and affordable treatment options.

By Technology Synopsys:    

The market is classified by technology into mass spectroscopy, chromatography, monoclonal antibody technology, recombinant DNA technology, nuclear magnetic resonance (NMR) technology, electrophoresis, bioassay. Among these segments, the monoclonal antibody technology segment is expected to hold the largest share of the North America Biosimilars Market during the study period. Monoclonal antibodies are a significant class of biologic products that require sophisticated techniques such as recombinant DNA technology and hybridoma technology to develop. The growing demand for biosimilar monoclonal antibodies, driven by the need for more affordable treatment options, has resulted in significant investments and advancements in this technology, establishing it as a market leader.

By Disease Synopsys:    

The market is classified by disease into oncology diseases, blood disorders, growth hormone deficiencies, chronic and autoimmune diseases, others. Among these segments, the oncology diseases segment is expected to hold the largest share of the North America Biosimilars Market during the study period. The use of high-cost biologic therapies in cancer treatment is common, and the introduction of biosimilar versions has the potential to significantly reduce healthcare costs while ensuring effective treatment. The high prevalence of cancer, combined with the need for cost-effective therapies, has resulted in significant development and adoption of biosimilars in the oncology segment, making it a significant contributor to the region's market growth.

Top Companies Includes In The North America Biosimilars Landscape:

• Amgen Inc.
• Pfizer Inc.
• Teva Pharmaceutical Industries Ltd.
• Novartis AG
• Biocon Ltd.
• Mylan N.V.
• Celltrion Inc.
• Samsung Bioepis Co., Ltd.
• Sandoz International GmbH (a subsidiary of Novartis)
• Coherus BioSciences, Inc.
• Fresenius Kabi AG
• Apotex Inc.
• Hospira (acquired by Pfizer)
• Dr. Reddy's Laboratories Ltd.
• Momenta Pharmaceuticals, Inc.

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In-depth analysis of North America Biosimilars Market along with industry coverage and forecasting for the following segments:

Market Size, By Product Type

• Protein
• Insulin
• Human Growth Hormones
• Granulocyte Colony-stimulating Factor (G-CSF)
• Interferons
• Recombinant Glycosylated Proteins
• Erythropoietin
• Monoclonal Antibodies
• Follitropin
• Recombinant Peptides
• Glucagon

Market Size, By Technology

• Mass Spectroscopy
• Chromatography
• Monoclonal Antibody Technology
• Recombinant DNA Technology
• Nuclear Magnetic resonance (NMR) technology
• Electrophoresis
• Bioassay

Market Size, By Disease

• Oncology Diseases
• Blood Disorders
• Growth hormone deficiencies
• Chronic and autoimmune diseases
• Others