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US Biologic Therapy Market Research Report By Therapy Type (Monoclonal Antibodies, Vaccines, Cell Therapy, Gene Therapy), By Application (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases), By Route of Administration (Intravenous, Subcutaneous, Intramuscular) and By End User (Hospitals, Clinics, Home Healthcare) - Forecast to 2035


ID: MRFR/Pharma/18320-HCR | 100 Pages | Author: Garvit Vyas| December 2023

US Biologic Therapy Market Overview


Key US Biologic Therapy Market Trends Highlighted


The US Biologic Therapy Market is seeing several important trends that are shaping its future. A significant driver of this market is the increasing prevalence of chronic diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. As the population ages and lifestyle-related illnesses rise, more individuals are seeking effective treatment options, driving the demand for biologic therapies.


Additionally, advancements in biotechnology have made it possible to develop more targeted and personalized therapies, catering to individual patient needs and improving treatment outcomes. The US healthcare system is also shifting towards value-based care, prompting healthcare providers to focus on treatments that offer not only effectiveness but also cost-effectiveness.


Opportunities abound in the US Biologic Therapy Market, particularly for companies that are able to innovate and bring new therapies to market. With a robust pipeline of biologics in development, including monoclonal antibodies and cell and gene therapies, there is potential for significant growth in this sector.


Moreover, as reimbursement policies evolve, companies that can navigate these changes will find new avenues for market entry and expansion. In recent times, there has been a notable trend towards biosimilars, which are biologic products highly similar to already approved reference products.


This provides a cost-effective alternative to original biologics, making treatments more accessible to patients. The US FDA has been promoting the development of biosimilars to encourage competition and lower costs in the biologic therapy landscape. Overall, the US Biologic Therapy Market is on a trajectory of growth, characterized by innovation, increasing accessibility, and a focus on patient-centered care.


US Cancer Biologic Therapy Market size

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


US Biologic Therapy Market Drivers


Increase in Prevalence of Chronic Diseases


The US Biologic Therapy Market Industry is witnessing significant growth due to the rising prevalence of chronic diseases such as diabetes, arthritis, and cancer. According to the Centers for Disease Control and Prevention (CDC), chronic diseases are responsible for 7 out of 10 deaths each year in the United States, with nearly half of all adults living with at least one chronic condition.


The American Cancer Society has reported that there were approximately 1.9 million new cancer cases diagnosed in the US in 2021 alone. This thus depicts a steady demand for biologic therapies, as these treatments are specifically designed to target complex diseases. Established organizations like Amgen and AbbVie are at the forefront of developing innovative biologic therapies, contributing to substantial advancements and care options in this area.


Advancements in Biotechnology and Research


The US Biologic Therapy Market Industry is being propelled by rapid advancements in biotechnology and Research and Development (R&D) within the healthcare sector. According to the National Institutes of Health (NIH), biomedical research funding has increased significantly, with over $42 billion allocated to R&D, leading to the development of novel biologics and therapies.


Such funding supports continuous innovation in manufacturing processes and new therapeutic approaches. Institutions like the Massachusetts Institute of Technology (MIT) and Stanford University are heavily involved in pioneering biotechnological research, providing a robust foundation for the expansion of the biologic therapy market in the US.


Growing Demand for Personalized Medicine


There is a growing trend towards personalized medicine, which significantly impacts the US Biologic Therapy Market Industry. As per the Personalized Medicine Coalition (PMC), the personalized medicine market is expected to double by 2025, indicating a shift in focus towards therapies that are tailored to individual patient profiles.


This is further enhanced by advancements in genetic testing technologies, which enable healthcare providers to offer targeted treatments. Major companies like Genentech are leveraging these innovations, providing biologic therapies that are customized for specific genetic markers, thus driving market growth in the US.


Regulatory Support for Biologics


Regulatory support from agencies such as the Food and Drug Administration (FDA) is a significant driver in the US Biologic Therapy Market Industry. The FDA's Biologics Control Act of 1902 established a framework for safety and efficacy of biological products, thus fostering a conducive environment for the approval of new biologic therapies.


Recent initiatives to expedite the approval process for life-saving biologics through programs like the Breakthrough Therapy designation have led to quicker access to essential treatments for patients. This supportive regulatory landscape encourages investment and development in the biologics sector, with companies like Pfizer and Merck benefiting from a streamlined pathway to introduce new products in the market.


US Biologic Therapy Market Segment Insights


Biologic Therapy Market Therapy Type Insights


The US Biologic Therapy Market is experiencing significant transformation, particularly within the Therapy Type segment which includes Monoclonal Antibodies, Vaccines, Cell Therapy, and Gene Therapy. Monoclonal Antibodies have established themselves as a critical component in treating various ailments including cancers and autoimmune disorders due to their ability to specifically target and neutralize pathological cells.



  • Their usage is widespread, which underscores the growing emphasis on targeted therapies in modern medicine.


Meanwhile, Vaccines continue to play a vital role, especially highlighted during the recent pandemic. The swift development and deployment of vaccines have underscored the potential of biologic therapies to combat infectious diseases effectively and rapidly, creating an urgent need for innovative vaccine technologies and delivery mechanisms.



  • Cell Therapy stands out as an evolving frontier in regenerative medicine, where the ability to regenerate damaged tissues and organs presents profound implications for treating chronic conditions, such as heart disease and diabetes.

  • By harnessing the body’s own cells, Cell Therapy presents a natural approach with the possibility of long-lasting solutions to several health issues.


Gene Therapy has emerged as a groundbreaking field that holds the potential to address genetic disorders by correcting faulty genes at the source. This segment is attracting vast amounts of investment and research efforts, showcasing the promise of curing previously untreatable conditions. Collectively, these Therapy Types signify a shift towards more personalized and efficient healthcare solutions, addressing unmet medical needs and advancing patient outcomes.


The US Biologic Therapy Market continues to witness robust innovation, driven by advancements in technology and a deepening understanding of disease mechanisms, further reinforcing the significance of each Therapy Type in the landscape of modern medicine. As the market grows, understanding the specific contributions and potential of each therapy will be crucial in navigating the future landscape of the US Biologic Therapy Market.


US Cancer Biologic Therapy Market segment


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Biologic Therapy Market Application Insights


The Application segment of the US Biologic Therapy Market is critical, addressing various serious health conditions that significantly impact the population. Within this segment, Oncology represents a substantial area of focus due to the increasing prevalence of cancer, necessitating advanced therapies that can improve patient outcomes.



  • Autoimmune Diseases also demand attention, as conditions like rheumatoid arthritis and lupus have seen rising diagnoses, highlighting the need for effective biologic treatments.

  • Additionally, in the context of Infectious Diseases, biologics have become integral in managing complex infections, particularly in a post-pandemic world.

  • Cardiovascular Diseases, another vital area, continue to be a leading cause of mortality in the US, driving demand for innovative biologic therapies designed to target various heart conditions.


Each of these areas not only reflects significant health challenges but also showcases the potential for growth and development in the US Biologic Therapy Market, supported by increasing research initiatives and favorable regulatory environments that encourage the advancement of biologic solutions. The emphasis on optimizing patient care drives ongoing investments and innovations in this market, contributing to improved health outcomes across these crucial applications.


Biologic Therapy Market Route of Administration Insights


The Route of Administration segment in the US Biologic Therapy Market is a critical area shaping the delivery and effectiveness of biologic therapies. This segment encompasses various methods such as Intravenous, Subcutaneous, and Intramuscular administration.



  • Intravenous delivery, known for its rapid onset of action, is often used in acute care settings, allowing for high bioavailability and immediate therapeutic effects, making it vital for patients requiring quick intervention.

  • Meanwhile, Subcutaneous administration, which is minimally invasive and can be self-administered, is gaining traction due to its convenience and decreasing healthcare costs, appealing to both patients and healthcare providers alike.

  • Intramuscular administration offers an effective alternative for certain biologics that require slower absorption and sustained release into the system, contributing to its significance in the treatment landscape.


The diverse array of administration routes allows for tailored patient care, and as the frequency and complexity of biologic therapies continue to grow, this segment remains integral to ensuring optimal treatment outcomes. Trends indicate that patient-centric approaches and advancements in delivery technologies are driving growth in this area of the US Biologic Therapy Market, bolstered by increasing demand for effective therapies across various conditions.


Biologic Therapy Market End User Insights


The End User segment of the US Biologic Therapy Market plays a crucial role in the overall landscape of healthcare delivery in the region. Hospitals represent a primary setting for the administration of biologic therapies, equipped with advanced technology and specialized personnel to manage complex cases, thus contributing significantly to patient outcomes.



  • Clinics also serve as vital access points, providing outpatient services where biologics can be utilized for chronic conditions, emphasizing the importance of accessibility in effective treatment.

  • Home Healthcare has emerged as a noteworthy segment, particularly for patients requiring ongoing treatment without frequent hospital visits, reflecting evolving preferences towards at-home care and convenience.


The interaction among these End Users highlights a dynamic ecosystem, driven by growing demands for personalized healthcare, advancements in telemedicine, and patient-centric care solutions. Market trends indicate that these sectors will continue to adapt to emerging therapeutic innovations, presenting both challenges and opportunities in the delivery of biologic therapies. Overall, the segmentation into these distinct yet interconnected categories illustrates the multifaceted nature of healthcare in the US and its impact on the US Biologic Therapy Market.


US Biologic Therapy Market Key Players and Competitive Insights


The US Biologic Therapy Market is characterized by rapid growth and innovation, driven by advancements in biotechnology and the increasing prevalence of chronic diseases that require sophisticated treatment options. The market is competitive, with numerous players engaged in the development and commercialization of biologic therapies, which include a broad range of products such as monoclonal antibodies, therapeutic proteins, and vaccines.


Biologic therapies are increasingly recognized for their ability to target specific pathways involved in disease processes, offering more effective solutions to patients. As the market matures, companies are focusing on developing biologics that not only meet the regulatory requirements but also provide enhanced efficacy and safety profiles. The competitive landscape comprises both established firms with robust portfolios and emerging biotech companies that are innovating at a rapid pace.


Biogen holds a prominent position within the US Biologic Therapy Market, primarily known for its focus on neurological diseases. The company's strengths lie in its strong research and development pipeline, which has led to the introduction of several innovative therapies.


Biogen has established a strong market presence with its flagship products targeting multiple sclerosis and spinal muscular atrophy, providing substantial benefits to patients and maintaining high levels of patient retention. The company invests significantly in scientific research and collaborates with academic institutions to advance the understanding of neurologic conditions, allowing them to stay ahead of the curve in therapeutic offerings. This dedication to innovation, coupled with a robust commercialization strategy, underpins Biogen’s competitive advantage in the US market.


Celgene, operating within the US Biologic Therapy Market, is recognized for its expertise in hematology and oncology, particularly in the development of targeted treatments. The company has successfully launched key products that have transformed treatment paradigms for various blood cancers and solid tumors, contributing significantly to its market share.


Celgene's strengths include a strong emphasis on clinical trials and a commitment to discovering new therapies that address unmet medical needs. The company's strategic mergers and acquisitions have bolstered its product portfolio and expanded its market presence. Through collaborations and partnerships, Celgene has enhanced its research capabilities and access to advanced technologies, positioning itself as a formidable player in the biologic therapy landscape. The focus on innovative biologics that improve patient outcomes solidifies Celgene's role in shaping the future of treatment within the US market.


Key Companies in the US Biologic Therapy Market Include



  • Biogen

  • Celgene

  • Amgen

  • Pfizer

  • BristolMyers Squibb

  • Johnson and Johnson

  • Roche

  • Vertex Pharmaceuticals

  • AbbVie

  • Eli Lilly and Company

  • Gilead Sciences

  • Sanofi

  • Regeneron Pharmaceuticals

  • Novartis

  • Merck and Co


US Biologic Therapy Market Industry Developments


The US Biologic Therapy Market is witnessing significant developments, with various companies actively advancing their portfolios. In October 2023, Biogen announced a strategic partnership with Regeneron Pharmaceuticals to enhance the development of biologic therapies for neurodegenerative diseases, illustrating the trend of collaboration among key players.


Additionally, in September 2023, AbbVie secured FDA approval for a new biologic treatment aimed at chronic skin conditions, demonstrating a focus on expanding treatment options. The market valuation of companies like Amgen and Eli Lilly and Company has seen substantial growth, driven by increasing demand for innovative biologic therapies.


Within the last two years, notable acquisitions include Bristol Myers Squibb's purchase of Celgene in November 2020, which significantly strengthened its oncology portfolio. The US market is expected to continue its upward trajectory, influenced by advanced Research and Development initiatives and increased investment in biotechnology, aimed at addressing various chronic and rare diseases.


Companies like Gilead Sciences and Novartis are also focusing on expanding their biologics pipelines, reflecting the dynamic nature of the current market landscape.


US Biologic Therapy Market Segmentation Insights


Biologic Therapy Market Therapy Type Outlook



  • Monoclonal Antibodies

  • Vaccines

  • Cell Therapy

  • Gene Therapy


Biologic Therapy Market Application Outlook



  • Oncology

  • Autoimmune Diseases

  • Infectious Diseases

  • Cardiovascular Diseases


Biologic Therapy Market Route of Administration Outlook



  • Intravenous

  • Subcutaneous

  • Intramuscular


Biologic Therapy Market End User Outlook



  • Hospitals

  • Clinics

  • Home Healthcare

Report Attribute/Metric Source: Details
MARKET SIZE 2018 62.63(USD Billion)
MARKET SIZE 2024 64.8(USD Billion)
MARKET SIZE 2035 94.5(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 3.489% (2025 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
MARKET FORECAST PERIOD 2025 - 2035
HISTORICAL DATA 2019 - 2024
MARKET FORECAST UNITS USD Billion
KEY COMPANIES PROFILED Biogen, Celgene, Amgen, Pfizer, BristolMyers Squibb, Johnson and Johnson, Roche, Vertex Pharmaceuticals, AbbVie, Eli Lilly and Company, Gilead Sciences, Sanofi, Regeneron Pharmaceuticals, Novartis, Merck and Co
SEGMENTS COVERED Therapy Type, Application, Route of Administration, End User
KEY MARKET OPPORTUNITIES Aging population driving demand, Rising prevalence of chronic diseases, Increasing investment in biotech innovation, Growing acceptance of personalized medicine, Advancements in biosimilars development
KEY MARKET DYNAMICS Aging population, Rising chronic diseases, Increased healthcare expenditure, Advancements in biotechnology, Regulatory challenges
COUNTRIES COVERED US


Frequently Asked Questions (FAQ) :

The US Cancer Biologic Therapy Market is expected to be valued at 29.5 billion USD in 2024.

By 2035, the market is anticipated to reach a valuation of 55.3 billion USD.

The market is projected to grow at a CAGR of 5.879% from 2025 to 2035.

Monoclonal Antibodies are projected to dominate the market with a value of 11.0 billion USD in 2024.

Vaccines are expected to reach a market valuation of 14.0 billion USD by 2035.

Key players in the market include Bristol Myers Squibb, Amgen, Pfizer, Johnson and Johnson, and Roche.

Cytokines are expected to be valued at 4.5 billion USD in the market by 2024.

Gene Therapy is projected to grow significantly, with an anticipated market value of 12.3 billion USD by 2035.

Increasing prevalence of cancer and advancements in biologic therapies are key growth drivers for the market.

Regional factors such as healthcare infrastructure and regulatory policies significantly influence market growth in the U.S.

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