As per MRFR analysis, the US Biologics Market Size was estimated at 111.33 (USD Billion) in 2023. The US Biologics Market Industry is expected to grow from 129.41(USD Billion) in 2024 to 350.0 (USD Billion) by 2035. The US Biologics Market CAGR (growth rate) is expected to be around 9.466% during the forecast period (2025 - 2035).
The US Biologics Market has Substantial activity owing to the shifts in biotechnology and the increased spending on research and development activities. An important factor that is propelling the market is the increasing incidence of chronic diseases that require effective treatments. Furthermore, the demand for biologics is being driven by the aging population because the elderly need treatment for cancer, autoimmune diseases, diabetes, and many other diseases. It is easy to find prospects in the US Biologics Market, especially now, with the increasing adoption of personalized medicine.
The American population is becoming far more commonplace to treat with tactics that aim to boost processes to increase efficiency and effectiveness while minimizing the side effects. The adoption of artificial intelligence and machine learning technology in the drug discovery cycle offers another growth opportunity by allowing companies to reduce spending on research and efficiently commercialize new products. In addition, biosimilars are projected to have a significant impact as they can broaden the market to essential therapies and biologics, thus enabling the public to have access to these more affordable alternatives. There is a noticeable shift toward more supportive trends for the biologics which had neglected the supports; for example, the FDA started to enact measures for accelerating the introduction of new treatments to the market.
The US Pharma industry is internally collaborative in order to balance patient safety and foster innovations. This, along with increased cooperation between pharmaceutical companies and academic institutions, will increase the efficiency of biologics development over the years. Continuous progress in these areas indicates a vibrant upcoming landscape within the biologics market driven by enhanced commitment toward patient care and fresh opportunities to innovate.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The increasing prevalence of chronic diseases such as diabetes, cancer, and autoimmune disorders significantly drives the US Biologics Market Industry. According to the Centers for Disease Control and Prevention (CDC), around 6 in 10 adults in the US have a chronic disease, and 4 in 10 have two or more. This rising tide of chronic ailments necessitates effective treatment options, thereby fueling the demand for biologic therapies. The American Cancer Society has noted a staggering increase in cancer cases, projecting approximately 1.9 million new cases of cancer in the US in 2021, and expects this trend to continue with a 10% increase over the next decade.
Such statistics underscore the importance of biologics in managing these conditions effectively, propelling the growth of the US Biologics Market.
Technological advancements in the development of biologics represent a powerful driver for the US Biologics Market Industry. The FDA has been approving an increasing number of biologic drugs, with over 50 biologic drugs gaining approval in 2021 alone. This technological evolution includes the introduction of monoclonal antibodies, gene therapy, and CAR-T cell therapy, which show promising results in treating previously hard-to-manage health conditions.
As more organizations like the National Institutes of Health (NIH) invest in research and development, the expanded availability of advanced therapeutics reinforces the momentum of biologic treatments, potentially elevating market growth significantly.
The acceleration of the biopharmaceutical industry within the US serves as a vital market driver for the US Biologics Market Industry. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceuticals represent 40% of the total pharmaceutical sales, highlighting their critical role in the market. The organization anticipates substantial investments in biologic research and development to continue growing, fueled by the US government's recent incentives for life sciences innovation.
These investments enhance the potential for novel biologics, further establishing a robust framework for long-term market success within the biopharmaceutical landscape.
The US Biologics Market is experiencing significant growth, especially within the Product Service segment, driven by an increasing demand for advanced therapeutics and precision medicine. This segment encompasses various areas such as Monoclonal Antibodies, Interleukins, Vaccines, Growth Factors, Gene Therapy, and others. Monoclonal Antibodies have gained immense popularity due to their efficacy in targeting specific pathogens and diseases, making them essential tools in the treatment of conditions like cancer and autoimmune disorders. Their capacity to provide personalized medicine is positioning these therapeutic agents at the forefront of medical innovation.
Similarly, Interleukins play a crucial role in enhancing immune responses, facilitating advances in treating chronic inflammatory diseases, and providing new avenues for cancer immunotherapy. Vaccines remain prominent, particularly given the recent global health challenges, with a renewed focus on ensuring widespread access and the development of next-generation vaccines that offer enhanced efficacy and safety profiles. Growth Factors are vital in regenerative medicine, driving advancements in cellular therapies and tissue engineering. Their importance is underscored by their potential in treating degenerative diseases and injuries.
Gene Therapy is expanding rapidly, allowing for innovative approaches to correct genetic disorders at their root cause, making profound societal impacts by potentially eradicating hereditary diseases. Collectively, these areas represent significant opportunities for growth in the US Biologics Market. Each of these segments contributes to an evolving landscape of biopharmaceuticals, addressing complex health challenges faced by the population and reflecting the shift towards more targeted and personalized treatment options. The US continues to be a hub for innovation in these fields, bolstered by robust R initiatives conducted by leading biopharmaceutical companies and supported by favorable regulatory environments.
As a result, the importance of the Product Service segment within the overall US Biologics Market cannot be overstated, as it continuously adapts and responds to the changing needs of patients and healthcare systems across the nation.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The Disease Indication segment of the US Biologics Market showcases significant diversity and demand across various therapeutic areas. Notably, Rheumatoid Arthritis and Psoriasis/Psoriatic Arthritis represent critical areas, given their prevalence and the chronic nature of these diseases, significantly impacting patient quality of life. Cancer therapies also play a pivotal role in driving advances within the market, reflecting the increasing investment in innovative biologics to target specific malignancies and improve survival rates. Furthermore, as the incidence of diabetes continues to rise, related biologics are crucial for management and treatment, addressing the pressing health challenge faced by the US population.
Market trends also reveal a shift toward personalized medicine, fostering growth driven by the development of novel therapies tailored to individual patient profiles. Simultaneously, challenges include regulatory complexities and high R costs that impact market entry. Overall, the US Biologics Market segmentation in Disease Indication reflects a robust landscape poised for continued evolution and growth, addressing critical healthcare challenges with innovative solutions.
The US Biologics Market is a highly dynamic and competitive landscape characterized by rapid advancements in biotechnology and a surge in demand for innovative therapeutics. The biologics sector encompasses a wide range of products, including monoclonal antibodies, vaccines, and therapeutic proteins, all of which address various medical conditions.
The market is shaped by factors such as the growing prevalence of chronic diseases, expanding healthcare expenditure, and an increasing focus on personalized medicine. As a result, companies operating in this space must continuously innovate while navigating a complex regulatory environment, intense competition from both established firms and emerging biotech companies, as well as ongoing pricing pressures from payers and healthcare providers.
AbbVie holds a prominent position in the US Biologics Market, exhibiting strong capabilities in the development and commercialization of biologics. The company is recognized for its robust portfolio of immunology and oncology products, which have been instrumental in addressing patient needs across various therapeutic areas. AbbVie's investment in research and development has led to breakthrough treatments that enhance patient outcomes and solidify its reputation as a leader in the biotech field. Additionally, AbbVie benefits from successful collaborations, partnerships, and a commitment to advancing science, which further strengthens its foothold in the US market. The company relies on its expertise and resources to maintain competitive advantages, ensuring sustained growth and market presence.
Johnson and Johnson has established itself as a significant player in the US Biologics Market, with a diverse range of key products and services that cater to several therapeutic areas, including immunology, oncology, and infectious diseases. The company’s commitment to innovation is evident through its continuous investments in research and development aimed at delivering transformative therapies to patients. Johnson and Johnson's strengths lie in its extensive market presence,
global reach, and value-driven approach, which leverage synergies between its pharmaceutical and consumer divisions. The company's history of successful mergers and acquisitions has further bolstered its biologics portfolio and allowed it to capitalize on emerging market trends. By strategically positioning itself within the US market, Johnson and Johnson remains resilient against competitive pressures, showcasing its capability to adapt and excel in the ever-evolving landscape of biologics.
The US Biologics Market has seen significant developments recently, particularly with prominent companies like AbbVie, Johnson Johnson, Genentech, and Bristol-Myers Squibb leading the way. In September 2023, Regeneron Pharmaceuticals announced a strategic collaboration with AstraZeneca aimed at advancing oncology treatments, which is set to enhance both companies' portfolios in biologics. Moreover, Biogen and Eli Lilly showcased promising data regarding their respective Alzheimer's therapies, highlighting the ongoing focus on neurological conditions.
The market valuation for biologics in the US continues to grow, driven by increased investment and innovation. Products that target chronic diseases and personalized medicine are expanding rapidly, with Gilead Sciences making strides in HIV treatment advancements. Notably, the acquisition trend remains active, with Amgen acquiring Five Prime Therapeutics in April 2021 to bolster its oncology pipeline, enhancing its market position. Over the past two years, the US biologics sector has witnessed substantial investment, resulting in a robust pipeline of new therapies, reflecting a noteworthy shift towards biologics as primary treatment modalities in various disease categories.
| Report Attribute/Metric | Details |
| Market Size 2023 | 111.33(USD Billion) |
| Market Size 2024 | 129.41(USD Billion) |
| Market Size 2035 | 350.0(USD Billion) |
| Compound Annual Growth Rate (CAGR) | 9.466% (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 | AbbVie, Johnson and Johnson, Genentech, Biogen, Bristol-Myers Squibb, Amgen, Eli Lilly and Company, Merck and Co, Gilead Sciences, Pfizer, Sanofi, Novartis, Vertex Pharmaceuticals, AstraZeneca, Regeneron Pharmaceuticals |
| Segments Covered | Product Service, Disease Indication |
| Key Market Opportunities | Personalized medicine advancements, Biosimilars market growth, Expanding gene therapy applications, Immunotherapy innovation and demand, Increased R investment in biologics |
| Key Market Dynamics | Aging population, Increasing chronic diseases, Advancements in biotechnology, Rising healthcare expenditure, Favorable regulatory environment |
| Countries Covered | US |
Frequently Asked Questions (FAQ) :
The US Biologics Market is expected to be valued at approximately 129.41 USD Billion in 2024.
By 2035, the US Biologics Market is projected to reach around 350.0 USD Billion.
The expected CAGR for the US Biologics Market from 2025 to 2035 is 9.466%.
In 2024, the Monoclonal Antibody segment is expected to dominate the market, valued at 50.0 USD Billion.
The Interleukins segment is projected to be valued at around 55.0 USD Billion by 2035.
Major players in the US Biologics Market include AbbVie, Johnson and Johnson, Genentech, Biogen, and Bristol-Myers Squibb among others.
The Vaccines segment is expected to be valued at approximately 30.0 USD Billion in 2024.
The Gene Therapy segment is anticipated to grow to a market value of around 45.0 USD Billion by 2035.
Factors driving growth include increasing demand for innovative therapies and advancements in biotechnology.
Challenges may include regulatory hurdles and high costs associated with biologics development and production.
The US Biologics Market is expected to be valued at 135.0 USD Billion in 2024.
By 2035, the US Biologics Market is projected to reach 750.0 USD Billion.
The expected CAGR for the US Biologics Market from 2025 to 2035 is 16.87%.
The Monoclonal Antibody segment is expected to dominate with a valuation of 350.0 USD Billion in 2035.
The Interleukins segment is valued at 15.0 USD Billion in 2024.
Monoclonal Antibodies are a key application driving significant growth in the US Biologics Market.
The Vaccines segment is projected to reach a value of 180.0 USD Billion by 2035.
Major players include Merck and Co, Biogen, Novartis, and Gilead Sciences among others.
The Growth Factors segment is expected to reach a valuation of 70.0 USD Billion by 2035.
Gene Therapy is anticipated to be valued at 60.0 USD Billion by 2035.
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Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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