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    Biologics Market

    ID: MRFR/HC/0831-CR
    138 Pages
    Rahul Gotadki
    December 2018

    Biologics Market Research Report By Product Type (Monoclonal Antibodies, Vaccines, Cell and Gene Therapy, Recombinant Proteins, Hormones), By Application (Oncology, Infectious Diseases, Autoimmune Disorders, Cardiovascular Diseases, Neurological Disorders), By End User (Hospitals, Pharmaceutical Companies, Research Institutes, Diagnostics Laboratories), By Source (Microbial, Mammalian, Plant, Transgenic Animals) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa)- Forecast to 2035

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    Biologics Market Summary

    As per Market Research Future Analysis, the Biologics Market was valued at 374.57 USD Billion in 2024 and is projected to grow to 610.0 USD Billion by 2035, with a CAGR of 4.54% from 2025 to 2035. The market is driven by the rising prevalence of chronic diseases, advancements in biotechnology, and increasing demand for biologic drugs.

    Key Market Trends & Highlights

    The Global Biologics Market is characterized by significant trends driven by healthcare demands and technological advancements.

    • Rising prevalence of chronic diseases, accounting for approximately 70% of global deaths, is driving demand for biologics.
    • Monoclonal Antibodies are projected to grow from 150.0 USD Billion in 2024 to 250.0 USD Billion by 2035.
    • Vaccines are expected to increase from 90.0 USD Billion in 2024 to 140.0 USD Billion by 2035.
    • North America is expected to lead the market with a valuation of 159.05 USD Billion in 2024, rising to 257.27 USD Billion by 2035.

    Market Size & Forecast

    2023 Market Size USD 358.3 Billion
    2024 Market Size USD 374.57 Billion
    2035 Market Size USD 610.0Billion
    CAGR (2025-2035) 4.54%

    Major Players

    Key players include Genentech, Pfizer, AbbVie, Roche, Gilead Sciences, Johnson and Johnson, Bristol Myers Squibb, Eli Lilly, Biogen, Celgene, Novartis, Merck, Regeneron, and Amgen.

    Biologics Market Trends

    The Global Biologics Market is currently characterized by a number of substantial trends that are being driven by the growing demand for healthcare and the advancements in biotechnology. The global increase in the prevalence of chronic diseases is a significant market driver, as it stimulates the demand for innovative therapeutic solutions. 

    The transition to personalized medicine is revolutionizing the development of treatments, resulting in the creation of biologic products that are specifically designed to address the unique requirements and conditions of each patient.

    In addition, the market is seeing a rise in the number of biosimilars, which provide cost-effective alternatives to originator biologics, thereby allowing for greater access to essential therapies. The market offers a plethora of opportunities for stakeholders to investigate. 

    The potential for considerable growth is presented by the ongoing research and development endeavors to develop innovative biologic therapies, particularly in the context of autoimmune diseases and cancer. The adoption of advanced technologies, including gene editing and cell therapies, is also gathering momentum, which is facilitating the development of new treatment options.

    The environment for biologics development is being further enhanced by governments worldwide investing in biotech infrastructures and providing support for research initiatives. Regulatory frameworks that are adapting to the complexities of biologics are becoming increasingly important, as evidenced by recent trends. The introduction of new products into the market can be accelerated by the efforts of global regulatory bodies to streamline processes to ensure timely approvals.

    Moreover, the growing collaboration between pharmaceutical companies and academic institutions is fostering innovation, leading to enhanced research capabilities and new therapeutic developments. Overall, the Global Biologics Market is evolving rapidly, driven by innovation and the pressing need for effective healthcare solutions.

     

    The Global Biologics Market is poised for transformative growth, driven by advancements in biotechnology and an increasing demand for innovative therapies that address complex diseases.

    U.S. Food and Drug Administration (FDA)

    Biologics Market Drivers

    Global Aging Population

    The aging global population is a critical driver of the Global Biologics Market Industry. As individuals age, the incidence of age-related diseases such as cancer, diabetes, and autoimmune disorders rises, creating a heightened demand for effective biologic therapies. This demographic shift necessitates innovative treatment solutions, positioning biologics as a vital component of modern healthcare. The market's growth is indicative of this trend, with a valuation of 374.6 USD Billion in 2024, and projections suggest it could reach 610 USD Billion by 2035, reflecting the increasing reliance on biologics to manage chronic health conditions.

    Rising Demand for Biologics

    The Global Biologics Market Industry is experiencing a notable increase in demand for biologics, driven by the growing prevalence of chronic diseases and genetic disorders. As healthcare systems worldwide shift towards personalized medicine, biologics are becoming essential in treatment protocols. In 2024, the market is valued at approximately 374.6 USD Billion, reflecting a robust growth trajectory. This demand is expected to escalate as more biologics receive regulatory approvals, enhancing treatment options for patients. The industry's focus on innovative therapies suggests that the market could reach 610 USD Billion by 2035, indicating a significant opportunity for stakeholders.

    Advancements in Biotechnology

    Technological advancements in biotechnology are propelling the Global Biologics Market Industry forward. Innovations such as CRISPR gene editing and monoclonal antibody development are revolutionizing the way diseases are treated. These advancements not only enhance the efficacy of biologics but also reduce production costs, making therapies more accessible. The integration of artificial intelligence in drug discovery processes further streamlines development timelines. As a result, the market is projected to grow at a CAGR of 4.53% from 2025 to 2035, highlighting the potential for continued innovation and expansion within the industry.

    Regulatory Support and Approvals

    Regulatory bodies worldwide are increasingly supportive of biologics, which is a key driver for the Global Biologics Market Industry. Streamlined approval processes and incentives for biosimilars are encouraging pharmaceutical companies to invest in biologic research and development. For instance, the U.S. Food and Drug Administration has implemented initiatives to expedite the review of biologic applications, thereby fostering a conducive environment for market growth. This regulatory support is likely to enhance the number of biologics available in the market, contributing to the projected market value of 610 USD Billion by 2035.

    Increasing Investment in Biologics Research

    Investment in biologics research is surging, significantly impacting the Global Biologics Market Industry. Governments and private entities are allocating substantial funds towards the development of novel biologics, recognizing their potential to address unmet medical needs. This influx of capital is facilitating advanced research initiatives, clinical trials, and collaborations between academia and industry. As a result, the market is expected to witness a steady growth trajectory, with a valuation of 374.6 USD Billion in 2024 and a projected increase to 610 USD Billion by 2035, underscoring the importance of sustained investment in this sector.

    Market Segment Insights

    Biologics Market Product Type Insights

    The Global Biologics Market has experienced significant growth, particularly in the Product Type segment, where various categories cater to diverse therapeutic needs. In 2024, the overall valuation of the Global Biologics Market is expected to reach 374.57 USD Billion, with prominent contributors such as Monoclonal Antibodies, Vaccines, Cell and Gene Therapy, Recombinant Proteins, and Hormones. 

    Monoclonal Antibodies hold a substantial market share, valued at 150.0 USD Billion in 2024 and projected to rise to 250.0 USD Billion by 2035, highlighting their critical role in treating various diseases, including cancers and autoimmune conditions.

    Vaccines are also a vital component, anticipated to be valued at 90.0 USD Billion in 2024 and increasing to 140.0 USD Billion by 2035, reflecting their importance in public health initiatives and disease prevention across the global population. Cell and Gene Therapy are gaining attention as revolutionary treatment options, with a value estimated at 40.0 USD Billion in 2024 and an expected rise to 80.0 USD Billion by 2035, as advancements in genetic engineering and personalized medicine hold promise for curing previously untreatable conditions. 

    Biologics Market Application Insights

    The Global Biologics Market primarily reflects a robust application focus, with an overall valuation reaching 374.57 USD Billion in 2024. The market data reveals significant segmentation within various therapeutic areas, with Oncology taking a prominent role due to the increasing incidence of cancer globally, which drives innovation and investment in biological therapies. 

    Infectious Diseases also command attention, particularly with the need for advanced treatments spurred by the rise of antibiotic-resistant strains. Autoimmune Disorders have emerged as critical, necessitating biologics that target specific immune responses, giving rise to tailored treatment approaches.

    Cardiovascular Diseases remain a major concern, promoting investment in biologic drugs that aim to reduce events of heart attacks and strokes. Neurological Disorders exhibit a growing demand for biologic therapies aimed at conditions like Alzheimer’s and Multiple Sclerosis, reflecting ongoing challenges in treating these complex diseases. Market statistics indicate that the continued research and development activities in these segments will support growth and innovation, driving the overall expansion of the Global Biologics Market in the coming years.

    Biologics Market End User Insights

    The Global Biologics Market revenue is expected to reach 374.57 USD Billion by 2024, indicating significant growth driven by diverse End Users such as Hospitals, Pharmaceutical Companies, Research Institutes, and Diagnostics Laboratories. Hospitals play a crucial role as they integrate biologics into patient care, enhancing treatment options and improving outcomes. 

    Pharmaceutical Companies are vital in developing innovative biological drugs, leveraging advanced technology for thorough research and trials. Research Institutes contribute significantly through studies that propel knowledge and application of biologics, often pushing the boundaries of existing therapies.

    Diagnostics Laboratories increasingly rely on biologics for advanced testing and diagnostics, ensuring accurate identification of diseases, which is essential in personalized medicine. Overall, the Global Biologics Market segmentation clearly highlights the interconnectedness of these End Users and their collective drive towards advancements in healthcare, making this industry essential for addressing various health challenges on a global scale.

    Biologics Market Source Insights

    The Source segment of the Global Biologics Market plays a crucial role in defining the overall industry landscape. By 2024, the market is expected to be valued at USD 374.57 billion, reflecting a robust growth trajectory driven by increasing healthcare expenditure and advancements in biotechnology. Within this segment, the principal sources include Microbial, Mammalian, Plant, and Transgenic Animals, each contributing unique advantages. Microbial sources, known for their rapid production capabilities, are significant for generating therapeutic proteins and vaccines.

    Meanwhile, Mammalian sources offer a crucial platform for complex biologics, such as monoclonal antibodies, which are essential in the treatment of various diseases. The use of Plant sources is emerging, providing a sustainable alternative for biological production with reduced contaminants. 

    Transgenic Animals, although less common, serve niche markets where unique biologics or complex protein synthesis is needed. The diverse functionalities of these sources not only enhance the Global Biologics Market segmentation but also reflect the ongoing innovation trends that cater to evolving healthcare demands.

    Get more detailed insights about Biologics Market Research Report - Forecast to 2035

    Regional Insights

    The Global Biologics Market is demonstrating robust growth across various regions, with North America leading the charge with a notable valuation of 159.05 USD Billion in 2024, expected to rise to 257.27 USD Billion by 2035. This region is primarily recognized for its advanced healthcare infrastructure and substantial investment in Research and Development, positioning it as a dominant force in the Global Biologics Market. 

    Europe follows closely, valued at 109.12 USD Billion in 2024 and projected to reach 173.61 USD Billion by 2035, supported by an increasing focus on biologics in therapeutic applications.

    The APAC region, valued at 70.78 USD Billion in 2024 and anticipated to grow to 114.03 USD Billion by 2035, is emerging due to a rising patient population and enhanced access to healthcare, showcasing significant market potential. In South America, the market is valued at 20.67 USD Billion in 2024 and aims to reach 30.45 USD Billion by 2035, driven by improvements in healthcare infrastructure. 

    The Middle East and Africa (MEA) market, valued at 15.95 USD Billion in 2024 and expected to ascend to 34.64 USD Billion by 2035, reflects a growing commitment to healthcare advancements despite facing various challenges.

    Overall, the Global Biologics Market is characterized by its varied regional performances, each contributing unique strengths and opportunities for growth.

    Biologics Market Region

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The Global Biologics Market is characterized by a dynamic competitive landscape where innovation, emerging technologies, and strategic collaborations play a pivotal role. Biologics, which include a range of products such as vaccines, blood components, and monoclonal antibodies, are increasingly integral to modern therapeutics. The market sees constant evolution driven by factors such as regulatory changes, advances in biotechnology, and the growing emphasis on personalized medicine.

    These trends have prompted companies to strategically position themselves, enhancing their research and development capabilities while optimizing their product offerings to cater to a broader range of medical needs. As companies vie for market share, their insights into competitive strategies, such as pipeline development and partnerships, become critical for sustaining growth in the rapidly expanding biologics sector.

    Genentech possesses a robust presence in the Global Biologics Market, primarily recognized for its pioneering contributions to biotechnology and innovative therapeutics. Known for a strong commitment to research and development, Genentech has built a portfolio of biologics that are fundamental in addressing various therapeutic areas such as oncology and immunology. The company's strengths lie in its advanced product development capabilities and its ability to collaborate on groundbreaking scientific developments.

    Such collaborations enhance its pipeline and allow for rapid advancements in treatment options. Additionally, Genentech's strategic alliances further bolster its market position, enabling access to cutting-edge technologies and expanding its reach in the global market.

    Pfizer is a significant player in the Global Biologics Market, driven by its extensive pipeline and a portfolio that includes some of the most sought-after biologics, particularly in areas such as immunology, oncology, and rare diseases. The company's strengths are derived from its strong research capability, vast resources, and experience in commercialization, which allow it to maintain a competitive edge. 

    Pfizer's robust market presence is amplified through strategic mergers and acquisitions that enhance its product offerings and market reach. With an emphasis on developing biosimilars and novel monoclonal antibodies, Pfizer continues to diversify its biologics landscape. Recent collaborations and partnerships aimed at advancing technologies further solidify Pfizer's position, demonstrating the company’s commitment to innovation in the global biologics sector and ensuring it meets diverse patient needs across various regions.

    Key Companies in the Biologics Market market include

    Industry Developments

    • Q3 2025: Eli Lilly to Acquire Morphic Holding for $3.2 Billion to Expand Biologics Pipeline Eli Lilly announced a definitive agreement to acquire Morphic Holding, a biotechnology company focused on oral integrin therapies, for $3.2 billion in cash, strengthening Lilly’s biologics and immunology portfolio.
    • Q2 2025: Sanofi Opens New Biologics Manufacturing Facility in France Sanofi inaugurated a state-of-the-art biologics manufacturing plant in Vitry-sur-Seine, France, aimed at increasing production capacity for monoclonal antibodies and other biologic drugs.
    • Q2 2025: Amgen Receives FDA Approval for BLINCYTO® (blinatumomab) for Additional Indication Amgen announced that the U.S. FDA approved BLINCYTO® for the treatment of adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia, expanding the drug’s approved uses.
    • Q2 2025: Samsung Biologics Signs $1 Billion Manufacturing Contract with AstraZeneca Samsung Biologics secured a $1 billion contract to manufacture biologic drugs for AstraZeneca, further cementing its role as a leading contract development and manufacturing organization (CDMO) in the biologics sector.
    • Q1 2025: Roche Appoints New Head of Biologics Division Roche announced the appointment of Dr. Maria Fernandez as the new Head of its Biologics Division, effective March 2025, to drive innovation and growth in its biologics business.
    • Q1 2025: Regeneron and Intellia Therapeutics Announce Strategic Collaboration for CRISPR-based Biologics Regeneron and Intellia Therapeutics entered a multi-year collaboration to develop CRISPR-based biologic therapies for genetic diseases, combining Regeneron’s biologics expertise with Intellia’s gene editing technology.
    • Q4 2024: Pfizer Launches New Biosimilar for Oncology in the U.S. Pfizer announced the U.S. launch of a new biosimilar to treat certain types of cancer, expanding its biologics portfolio and increasing competition in the oncology biosimilars market.
    • Q4 2024: Bristol Myers Squibb Receives EMA Approval for New Biologic Therapy for Multiple Sclerosis Bristol Myers Squibb received European Medicines Agency (EMA) approval for its new biologic therapy targeting relapsing forms of multiple sclerosis, marking a significant regulatory milestone.
    • Q4 2024: Novo Nordisk to Invest $2.3 Billion in New Biologics Plant in Denmark Novo Nordisk announced a $2.3 billion investment to build a new biologics manufacturing facility in Denmark, aimed at meeting growing global demand for its diabetes and obesity biologics.
    • Q3 2024: AbbVie and Genmab Announce FDA Approval of Epkinly™ for Diffuse Large B-cell Lymphoma AbbVie and Genmab received FDA approval for Epkinly™, a new biologic therapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma, expanding treatment options for patients.
    • Q3 2024: GSK Acquires Biotech Startup Affinivax for $2.1 Billion to Boost Vaccine Biologics Portfolio GSK completed the acquisition of Affinivax, a biotech company specializing in next-generation vaccine biologics, for $2.1 billion, strengthening its pipeline in infectious disease prevention.
    • Q2 2024: Moderna Announces $500 Million Investment in New mRNA Biologics Facility in Canada Moderna revealed plans to invest $500 million in a new mRNA biologics manufacturing facility in Quebec, Canada, to support the production of vaccines and therapeutics for global markets.

    Future Outlook

    Biologics Market Future Outlook

    The Global Biologics Market is projected to grow at a 4.53% CAGR from 2024 to 2035, driven by advancements in biotechnology, increasing demand for personalized medicine, and regulatory support.

    New opportunities lie in:

    • Invest in biosimilars to capture market share from expiring patents. Leverage AI for drug discovery to enhance R&D efficiency. Expand into emerging markets to tap into growing healthcare needs.

    By 2035, the Global Biologics Market is poised for robust growth, reflecting a dynamic and evolving landscape.

    Market Segmentation

    Biologics Market Source Outlook

    • Microbial
    • Mammalian
    • Plant
    • Transgenic Animals

    Biologics Market End User Outlook

    • Hospitals
    • Pharmaceutical Companies
    • Research Institutes
    • Diagnostics Laboratories

    Biologics Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Biologics Market Application Outlook

    • Oncology
    • Infectious Diseases
    • Autoimmune Disorders
    • Cardiovascular Diseases
    • Neurological Disorders

    Biologics Market Product Type Outlook

    • Monoclonal Antibodies
    • Vaccines
    • Cell and Gene Therapy
    • Recombinant Proteins
    • Hormones

    Report Scope

    Report Attribute/Metric Source:Details
    MARKET SIZE 2023358.3(USD Billion)
    MARKET SIZE 2024374.57(USD Billion)
    MARKET SIZE 2035610.0(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)4.54% (2025 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    MARKET FORECAST PERIOD2025 - 2035
    HISTORICAL DATA2019 - 2023
    MARKET FORECAST UNITSUSD Billion
    KEY COMPANIES PROFILEDGenentech, Pfizer, AbbVie, Roche, Gilead Sciences, Johnson and Johnson, Bristol Myers Squibb, Eli Lilly, Biogen, Celgene, Novartis, Merck, Regeneron, Amgen, Sanofi
    SEGMENTS COVEREDProduct Type, Application, End User, Source, Regional
    KEY MARKET OPPORTUNITIESExpanding personalized medicine approaches, Increasing demand for monoclonal antibodies, Growth in biosimilars adoption, Advancements in gene therapies, Rising prevalence of chronic diseases
    KEY MARKET DYNAMICSgrowing aging population , increasing chronic diseases , advancements in biotechnology , rising healthcare expenditure , favorable government policies
    COUNTRIES COVEREDNorth America, Europe, APAC, South America, MEA

    Market Highlights

    Author
    Rahul Gotadki
    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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    FAQs

    What is the projected market size of the Global Biologics Market in 2024?

    The Global Biologics Market is expected to be valued at 374.57 USD Billion in 2024.

    What is the expected value of the Global Biologics Market by 2035?

    By 2035, the Global Biologics Market is anticipated to reach 610.0 USD Billion.

    What is the expected compound annual growth rate (CAGR) for the Global Biologics Market from 2025 to 2035?

    The Global Biologics Market is projected to grow at a CAGR of 4.54% from 2025 to 2035.

    What is the largest market segment by product type in the Global Biologics Market for 2024?

    Monoclonal Antibodies represent the largest segment, valued at 150.0 USD Billion in 2024.

    How does the North American market contribute to the Global Biologics Market in 2024?

    In 2024, the North American region is expected to be valued at 159.05 USD Billion, dominating the market.

    What is the expected market size of the Vaccines segment by 2035?

    The Vaccines segment is projected to reach 140.0 USD Billion by 2035.

    What is the projected growth of the APAC region in the Global Biologics Market from 2024 to 2035?

    The APAC region is expected to grow from 70.78 USD Billion in 2024 to 114.03 USD Billion by 2035.

    Who are the key players in the Global Biologics Market?

    Key players include Genentech, Pfizer, AbbVie, Roche, and Gilead Sciences among others.

    What will the market size of the Cell and Gene Therapy segment be in 2024?

    The Cell and Gene Therapy segment is expected to be valued at 40.0 USD Billion in 2024.

    What challenges are currently facing the Global Biologics Market?

    Challenges include regulatory hurdles and market entry barriers for new players.

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