North America Monoclonal Antibodies Market Analysis, Segments, Key Players, Drivers, Trends by Forecast 2022 to 2028

The North America monoclonal antibodies market is expected to reach US$ 1,20,713.2 million by 2028 from US$ 54,629.4 million in 2021. The market is estimated to grow at a CAGR of 12.0% from 2021-2028.

North America Monoclonal Antibodies Market According to the International AIDS Vaccine Initiative (IAVI) report, the development of mABs is one of the fastest-growing segments of biomedical research. For records, more than 50 mABs were licensed in the last six years, and in 2019, seven of the ten best-selling novel drugs for cancer and autoimmune diseases were mABs. Further, with the growing number of non-communicable and infectious diseases, for which mABs are or might prove effective treatment, there is certainly an accelerating demand for such products. For example, mABs sales are predominant in the US. North America Monoclonal Antibodies Market As the percentage of mABs in the development pipeline increases, more and more mABs will enter the market, and the disparity in access between high-income countries and the rest of the world will worsen. Furthermore, a few combinations of mABs are also being developed to address many diseases, including chronic infections and cancer. North America Monoclonal Antibodies Market On the other hand, several counties are taking strong initiatives to shorten the regulatory process for mABs effective for treating chronic diseases. For records, in early 2019, the CFDA approved three mABs from domestic developers and ten mABs from multinational pharmaceutical companies. Such factors are stimulating the uptake of mABs, aiding the market significantly.

North America Monoclonal Antibodies Market Favorable government regulations in North America regional market authorizes monoclonal antibodies during the onset of the pandemic. For instance, in December 2021, North America Monoclonal Antibodies Market The US Food and Drug Administration (FDA) announced Emergency Use Authorization (EUA) for AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab and administered together) intended for pre-exposure prophylaxis of COVID-19 for certain adults and pediatric individuals. As monoclonal antibodies are laboratory manufactured proteins involved in mimicking the immune system's ability to fight off harmful pathogens such as viruses. Therefore, "Tixagevimab" and "cilgavimab" are long-acting monoclonal antibodies particularly directed for spike protein of SARS-CoV-2. North America Monoclonal Antibodies Market Apart from that, favorable funding for development of biologics further enhanced the market growth for monoclonal antibodies during the onset of pandemic in North America regional market. For example, the US International Development Finance Corporation (DFC) announced furnishing of US$50 million to Biological E Limited for increasing COVID-19 vaccine manufacturing capacity. Also, favorable policy relating to product approvals for biologics by the FDA positively impacts the market growth.

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Segments Covered

By Source

Human
Humanized
Chimeric
Murine
By Production Method

In-Vitro
In-Vivo
By Indication

Cancer
Autoimmune Diseases
Infectious Diseases
Inflammatory Diseases
Microbial Diseases
By Application

Therapeutic Applications
Diagnostic Applications
Research Applications
By End-User
Hospitals
Research Institutes

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The List of Companies

Novartis AG

Pfizer Inc.

GlaxoSmithKline plc.

Amgen Inc

DAIICHI SANKYO COMPANY, LIMITED

Hoffmann-La Roche Ltd.
AstraZeneca

Eli Lilly and Company

Bayer AG

Bristol-Myers Squibb Company

North America Monoclonal Antibodies Market

The monoclonal antibodies (mAbs) market in North America has witnessed substantial growth in recent years, driven by advances in biotechnology, an aging population, and an increased prevalence of chronic diseases. North America Monoclonal Antibodies Market As monoclonal antibodies (mAbs) continue to revolutionize medical treatments across a broad spectrum of diseases such as cancer, autoimmune disorders, and infectious diseases, North America, particularly the United States and Canada, remains one of the most lucrative and rapidly expanding regions for the mAb industry. This article provides an in-depth analysis of the North American monoclonal antibodies market, highlighting key trends, drivers, challenges, and future outlooks.

Overview of Monoclonal Antibodies

North America Monoclonal Antibodies Market Monoclonal antibodies are laboratory-made molecules that act as substitutes for natural antibodies. They are designed to target specific antigens found on pathogens, cancer cells, or other disease-causing agents in the body. North America Monoclonal Antibodies Market By binding to these antigens, mAbs can help to neutralize harmful invaders, mark them for destruction by the immune system, or block certain biological pathways that contribute to disease progression.

North America Monoclonal Antibodies Market Since their first approval in the 1980s, monoclonal antibodies have become one of the most powerful tools in modern medicine. North America Monoclonal Antibodies Market They are currently used in the treatment of various conditions, ranging from cancer (e.g., trastuzumab for HER2-positive breast cancer) to autoimmune diseases (e.g., adalimumab for rheumatoid arthritis) and infectious diseases (e.g., palivizumab for respiratory syncytial virus).

Canada Market Insights:
Regulatory Environment:

In Canada, Health Canada oversees the approval of mABs, and the regulatory processes are similar to those of the FDA, though the speed of approval may vary. Health Canada has been increasingly receptive to accelerated approvals for critical treatments, particularly in oncology and infectious diseases, to address public health needs.
Healthcare System: Canada's single-payer, publicly funded healthcare system affects the market dynamics for mABs. The cost-effectiveness of new treatments is a significant factor for mAB approval and reimbursement. Companies may need to adjust pricing strategies to comply with Canadian provincial health plans

Economic and Market Conditions:
Canada's smaller population compared to the U.S. means a smaller overall market for mABs. However, Canada still represents a lucrative market, particularly in high-demand areas like oncology, autoimmune diseases, and inflammatory conditions.

Government Funding: Canada offers significant government investment in healthcare and pharmaceutical development, which can provide opportunities for companies to secure funding for mAB research and development or commercialization.

Market Access and Affordability:
Biosimilars: Similar to the U.S., the Canadian market for mABs is expected to grow with the entry of biosimilars, especially for blockbuster mABs like Herceptin and Humira. Canadian regulators have been proactive in approving biosimilars, providing a more cost-effective treatment option for patients.
Patient Access Programs: Companies may consider developing patient assistance programs or cost-sharing initiatives to improve access to expensive mAB therapies in Canada, particularly for underserved communities or in more remote regions.

Geographic Hotspots for mABs:
Major metropolitan areas such as Toronto, Vancouver, and Montreal are key markets for mABs due to their large populations and strong healthcare infrastructure. These cities are also hubs for medical research and development, which can provide partnerships and collaboration opportunities for companies entering the Canadian market.
Mexico Market Insights (for North American Region):
Although smaller compared to the U.S. and Canada, Mexico is part of the broader North American monoclonal antibody market and presents opportunities for growth.

Regulatory Environment:
COFEPRIS, Mexico's Federal Commission for the Protection against Sanitary Risk, regulates the approval of biologics like mABs. The regulatory process in Mexico can be more time-consuming compared to the U.S. and Canada, but recent reforms are intended to streamline approvals, especially for essential biologics.

Market Access:
Mexico's healthcare system combines public and private sectors, with a growing need for more affordable biologics. There is increasing demand for mABs in the treatment of cancer, autoimmune diseases, and infectious diseases.
Cost Sensitivity: Given the lower healthcare spending compared to the U.S. and Canada, there is a higher emphasis on cost-effective solutions. Companies entering the Mexican market should consider partnering with local distributors and optimizing the pricing of mABs to cater to the local population's affordability levels.

Opportunities for Market Expansion:
As Mexico's middle class expands, so does the demand for advanced healthcare treatments, including monoclonal antibodies. Urban areas like Mexico City and Monterrey are expected to see the highest demand for mABs, driven by increasing awareness and access to cutting-edge treatments.

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