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), By End-user (Hospitals, Clinics, Home Healthcare), and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

Global Biologic Therapy Market Overview

As per MRFR analysis, the Biologic Therapy Market Size was estimated at 298.24 (USD Billion) in 2023. The Biologic Therapy Market is expected to grow from 308.65 (USD Billion) in 2024 to 450 (USD Billion) by 2035. The Biologic Therapy Market CAGR (growth rate) is expected to be around 3.49% during the forecast period (2025 - 2035).

Key Biologic Therapy Market Trends Highlighted

Due to a number of factors, the Biologic Therapy Market is expanding significantly. The rising incidence of chronic illnesses including diabetes, cancer, and autoimmune disorders is one of the main factors driving the industry and driving the need for more specialized and efficient treatment choices.

Furthermore, developments in genetic research and biotechnology are improving the creation of biologic medicines and increasing their accessibility for patients. Because biologic medicines may be customized to each patient's unique profile, enhancing treatment results, the move toward personalized medicine is also very important.

As businesses concentrate on growing their product lines and breaking into developing regions, opportunities in the Biologic Therapy Market are growing. As more and more cutting-edge biologics hit the market, regulatory bodies are likewise implementing quicker procedures to get these novel therapies to patients.

There will probably be more biopharmaceutical discoveries as a result of the growing cooperation between pharmaceutical corporations and research universities. Recent patterns show that biosimilars, which provide an affordable substitute for conventional biologic medicines, are becoming more and more popular.

This change not only facilitates accessibility but also fosters manufacturer competition, which might result in more reasonably priced treatment alternatives for people everywhere. With the integration of digital health technologies into biologic medicines for improved patient monitoring and adherence, technology has also emerged as a revolutionary element.

Additionally, the worldwide COVID-19 pandemic has increased attention to biologic medicines, especially in the development of vaccines, underscoring their significance in global health systems. All things considered, the Biologic Therapy Market is expanding and is probably going to keep doing so with further innovation, research, and government backing.

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

Biologic Therapy Market Drivers

Increasing Incidence of Chronic Diseases

The Biologic Therapy Market is experiencing significant growth due to the increasing incidence of chronic diseases such as cancer, diabetes, and autoimmune disorders. The World Health Organization (WHO) has indicated a significant rise in the global cancer burden, estimating that by 2040, there will be 27.5 million new cancer cases globally each year, a 47% increase compared to 2020 levels.

This increasing prevalence of chronic conditions drives the demand for advanced biologic therapies that offer more effective and targeted treatment options. Established organizations such as the American Cancer Society and the European Society for Medical Oncology are actively promoting research and awareness about biologic therapies, further contributing to market growth.

The push for innovative treatments in various regions, compounded by rising healthcare expenditure, is expected to create favorable conditions for the Biologic Therapy Market as it meets the growing patient needs.

Advancements in Technology and Research

Technological advancements in the development of biologic therapies significantly contribute to the growth of the Biologic Therapy Market. Innovations in genetic engineering, molecular biology, and personalized medicine are leading to the discovery of highly targeted therapies with improved efficacy and safety profiles.

For instance, the increasing number of patents filed related to monoclonal antibodies and gene therapy demonstrates the ongoing investment in Research and Development (R&D) within the sector.

The U.S. Food and Drug Administration (FDA) has accelerated approval processes for promising biologics, with a record 53 novel drug approvals in 2021 alone. This trend signifies the commitment of established organizations towards enhancing treatment options, indicating a robust environment for further market expansion.

Growing Geriatric Population

The global population is aging rapidly, which plays a crucial role in expanding the Biologic Therapy Market. According to the United Nations, the global population aged 60 and over is projected to reach 2.1 billion by 2050, doubling from 1 billion in 2020. Older adults are more susceptible to chronic illnesses, which escalates the demand for effective biologic treatments tailored for age-related conditions.

Organizations such as the World Health Organization are prioritizing geriatric healthcare, signaling a shift in public health strategy that will further stimulate demand for biologic therapies. This demographic trend presents both challenges and opportunities for the Biologic Therapy Market as it navigates the complexities of an aging population.

Increased Regulatory Support for Biologic Therapies

Regulatory bodies are increasingly providing support for the development and approval of biologic therapies, positively impacting the Biologic Therapy Market. Initiatives by organizations such as the FDA and the European Medicines Agency (EMA) aim to streamline the approval process for biologics, fostering innovation and market entry for new therapies.

Recent modifications in regulatory frameworks, including the introduction of the Biosimilar User Fee Act, have facilitated quicker market access for biosimilars, contributing to competitive pricing and improved patient access.

In 2022, approximately 18 new biosimilar products were approved in the European Union, showcasing a conducive regulatory landscape that bolsters the growth prospects of biologic therapy companies. This supportive environment not only encourages new entrants but also enhances consumer confidence in biologic treatments.

Biologic Therapy Market Segment Insights

Biologic Therapy Market Therapy Type Insights

The Biologic Therapy Market segment focusing on Therapy Type revealed significant insights into its structure and growth potential.

Monoclonal Antibodies represented a dominant player, with a valuation of 120.0 USD Billion in 2024, projected to increase to 175.0 USD Billion by 2035. This segment was crucial due to its extensive application in treating diseases such as cancer and autoimmune disorders, representing majority holding in the market.

Vaccines followed closely behind, valued at 80.0 USD Billion in 2024, expected to rise to 115.0 USD Billion by 2035. The COVID-19 pandemic has underscored the importance of vaccines, amplifying their role in global health strategies and making this segment a significant contributor to market growth.

Cell Therapy was valued at 60.0 USD Billion in 2024 and is expected to reach 85.0 USD Billion by 2035, reflecting growing innovations in regenerative medicine and personalized therapies that target specific diseases, thereby affirming its importance.

Gene Therapy, valued at 48.65 USD Billion in 2024, is anticipated to grow to 75.0 USD Billion by 2035, serving as a pivotal segment for its potential to treat genetic disorders at the molecular level, highlighting increasing interest and investment in advanced therapeutic strategies.

The Biologic Therapy Market revenue derives its dynamics from clinical successes and advancements in Research and Development, while challenges include regulatory approvals and supply chain complexities.

Overall, the market's segmentation indicates robust opportunities for growth across varying therapy types, with continued innovation expected to drive progress in the Biologic Therapy Market.

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

Biologic Therapy Market Application Insights

Within the domain of Applications, the market is intricately segmented into various categories, including Oncology, Autoimmune Diseases, Infectious Diseases, and Cardiovascular Diseases, each playing a vital role in overall industry dynamics.

Oncology remains a critical area, driven by the rising prevalence of cancers that necessitate effective treatment options, while Autoimmune Diseases are increasingly receiving attention as awareness and diagnosis improve.

Infectious Diseases, particularly in light of global health challenges, emphasize the urgency for innovative biologic therapies. Furthermore, Cardiovascular Diseases, being a leading cause of morbidity worldwide, highlight the significance of biologic therapies in developing effective management strategies.

Collectively, these segments are expected to shape the Biologic Therapy Market landscape, reflecting changing health priorities and advancements in treatment modalities. Understanding the diverse applications is essential, as they represent major areas of investment, Research and Development, and healthcare resource allocation, ultimately driving the market forward.

Biologic Therapy Market Route of Administration Insights

The Biologic Therapy Market is experiencing notable growth, showcasing its significance in healthcare. Within this market, the Route of Administration plays a critical role in determining the effectiveness and acceptance of therapies.

Key routes, such as Intravenous, Subcutaneous, and Intramuscular, offer unique advantages that cater to specific patient needs and treatment requirements. Intravenous administration is often favored for its rapid onset and consistent delivery, making it suitable for patients requiring immediate therapeutic effects.

On the other hand, Subcutaneous administration provides the benefits of self-administration, improving patient compliance and comfort, which is becoming increasingly important in chronic disease management. Intramuscular administration, while less commonly used, still holds its ground for vaccines and certain therapeutic agents.

This segmentation within the Biologic Therapy Market is crucial, as it reflects evolving healthcare protocols and patient preferences, presenting opportunities for companies to innovate and tailor their strategies effectively.

As healthcare dynamics change, understanding the Biologic Therapy Market statistics related to these routes will be vital for stakeholders aiming to maximize market penetration and optimize patient outcomes.

Biologic Therapy Market End-user Insights

The Biologic Therapy Market has shown considerable potential across various End-user categories, notably in Hospitals, Clinics, and Home Healthcare settings. Hospitals are significant due to their extensive infrastructure and capacity to handle complex biologic treatments, which results in a substantial proportion of market demand.

Clinics also contribute significantly, often providing outpatient services and specialized treatments, thereby enhancing access to biologic therapies for a wider population. Home Healthcare has emerged as a vital sector, addressing the increasing preference for patient-centric care in comfortable environments, underlining the shift towards more personalized treatment options.

This trend is driven by advancements in technology and an emphasis on managing chronic conditions effectively at home. Additionally, the Biologic Therapy Market statistics reflect a steady growth fueled by the rising prevalence of chronic diseases, increased availability of new biologics, and a growing elderly population.

As the market evolves, these End-users are positioned to shape the future of biologic therapies globally through innovation and improved patient outcomes.

Biologic Therapy Market Regional Insights

In the Biologic Therapy Market, the regional segment showcased substantial market dynamics. By 2024, the North America region held a significant valuation of 130.0 USD Billion, leading the market and reflecting its advanced healthcare infrastructure and research capabilities.

Europe followed closely with a valuation of 81.0 USD Billion, notable for its strong regulatory framework and innovative biotech initiatives. The Asia Pacific region, valued at 58.0 USD Billion, was marked by rapid growth in emerging markets and increasing healthcare spending, which positioned it as a rapidly expanding sector.

South America, valued at 23.0 USD Billion, and the Middle East and Africa, with a valuation of 16.65 USD Billion, faced unique challenges such as regulatory hurdles but are gradually advancing in biologic adoption due to evolving healthcare frameworks.

Each region contributed to the Biologic Therapy Market statistics, with North America showing majority holding that dominated due to the prevalence of chronic diseases and greater access to biologic therapies, while Europe stood out by driving stringent standards and collaborations.

Overall, these regional valuations emphasized the significant role each played in shaping market growth and dynamics through unique offerings and challenges.

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

Biologic Therapy Market Key Players and Competitive Insights

The Biologic Therapy Market has seen considerable growth over recent years, driven by the increasing prevalence of chronic diseases and a rising demand for innovative treatment options.

This market is characterized by the development of biopharmaceuticals, which are derived from living organisms and have proven highly effective in treating a variety of conditions, including autoimmune diseases, cancers, and infectious diseases.

As the industry evolves, competition has intensified, with numerous pharmaceutical companies investing heavily in research and development to create new biologic therapies. The landscape includes a mix of established players and emerging biotech firms, all aiming to capture market share through innovative product offerings, strategic partnerships, and extensive clinical trials.

Companies in this sector are focused on improving patient outcomes, enhancing treatment accessibility, and addressing unmet medical needs, which further fuels competitive dynamics within the market.

Merck & Co. has established itself as a significant player in the Biologic Therapy Market, leveraging its strong pipeline of innovative therapies and a well-developed distribution network. The company has a robust portfolio of biologic medications that cater to various therapeutic areas, showcasing its commitment to advancing healthcare.

Its strengths lie not only in the efficacy and safety of its products but also in its considerable investments in research and development, which have propelled the company to the forefront of biologic innovation. Merck & Co.'s strategic collaborations with academic institutions and other biopharma companies further enhance its market presence, allowing the company to stay ahead in the highly competitive landscape.

Additionally, its global reach enables Merck & Co. to adapt its strategies across different markets, ensuring that its biologic therapies meet the diverse needs of patients worldwide.

Novartis is another key competitor in the Biologic Therapy Market, recognized for its extensive product line and strong focus on research and development. The company has a diverse range of biologics aimed at treating various diseases, including oncology, immunology, and ophthalmology.

Novartis's strengths include its commitment to innovation and high-quality manufacturing standards, which are critical in the biologic sector where precision is paramount. The company has been active in strategic mergers and acquisitions to enhance its capabilities and expand its portfolio, successfully integrating new technologies and therapies that complement its existing offerings.

Notably, Novartis has made significant strides in gene therapy and cell-based treatments, positioning itself as a leader in cutting-edge therapeutic options.

The company's global presence, coupled with its adaptive marketing strategies, strengthens its competitiveness in the market, enabling it to respond effectively to the changing dynamics and growing demands of the biopharmaceutical landscape worldwide.

Key Companies in the Biologic Therapy Market Include

• Merck & Co.


• Novartis


• Regeneron Pharmaceuticals


• Teva Pharmaceutical Industries


• Pfizer


• Gilead Sciences


• Celgene


• Amgen


• AstraZeneca


• Eli Lilly


• Sanofi


• Johnson & Johnson


• Roche


• BristolMyers Squibb


• AbbVie

Biologic Therapy Market Developments

After losing Humira's exclusivity, AbbVie made a significant move into CAR-T cell and autoimmune medicines when it announced in June 30, 2025, that it would buy Capstan Therapeutics for up to $2.1 billion in cash.

Building on previous purchases, such as Gracell in late 2023, AstraZeneca agreed on March 17, 2025, to acquire EsoBiotec for up to $1 billion, including $425 million up front and $575 million in milestones, to strengthen its cancer and autoimmune cell therapy portfolio.

The incidence of chronic diseases, biotech innovation, and strategic industrial partnerships continue to be major growth drivers, according to experts' May 23, 2025, projections of the global biologics market, which are expected to expand at a rate of 10–12% through 2029.

Dr. Vinay Prasad, a well-known opponent of rapid approvals, was named director of the U.S. FDA's Center for Biologics Evaluation and Research on May 6, 2025. This appointment is expected to improve the standard of evidence for new biologic approvals globally.

The growing biosimilar landscape in immunology is further highlighted by the approval of Pyzchiva®, a ustekinumab biosimilar, by the European Commission in December 2024 and the marketing authorization of Usymro, another ustekinumab copycat, by the EMA's CHMP in June 2025.

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
  
  
  
  

• Biologic Therapy Market Regional Outlook
  
  
  
  • North America
  
  
  • Europe
  
  
  • South America
  
  
  • Asia Pacific
  
  
  • Middle East and Africa
  
  
  
  

Report Attribute/Metric	Details
Market Size 2023	298.24(USD Billion)
Market Size 2024	308.65(USD Billion)
Market Size 2035	450.0(USD Billion)
Compound Annual Growth Rate (CAGR)	3.49% (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	Merck & Co., Novartis, Regeneron Pharmaceuticals, Teva Pharmaceutical Industries, Pfizer, Gilead Sciences, Celgene, Amgen, AstraZeneca, Eli Lilly, Sanofi, Johnson & Johnson, Roche, BristolMyers Squibb, AbbVie
Segments Covered	Therapy Type, Application, Route of Administration, End-user, Regional
Key Market Opportunities	Increasing demand for personalized medicine, Expansion of biosimilars market, Advancements in drug delivery systems, Growing prevalence of chronic diseases, Rise in R&D investments.
Key Market Dynamics	Increasing prevalence of chronic diseases, Growing demand for personalized medicine, Advancements in biotechnology, High cost of treatment, Regulatory challenges and approvals
Countries Covered	North America, Europe, APAC, South America, MEA