The biologics market size reached USD 436.63 billion in 2024 and is expected to attain USD 845.78 billion by 2033, expanding at a compound annual growth rate (CAGR) of 7.6% between 2025 and 2034.
The growth of the biologics market is driven by the advancements in biotechnology and the increased burden of chronic diseases worldwide. Furthermore, the increasing production of novel drugs contributes to market expansion.
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An Overview and Growth Potential of the Market
Biologics are therapeutic products that are derived from living organisms or their components, like proteins, cells, or nucleic acids. These products differ from traditional drugs, which are mostly chemically synthesized. Biologics are complex as well as large molecules that are produced with the help of advanced technology like genetic engineering. The complex nature of these biologics helps them closely mimic natural substances. Biologics have a range of applications across healthcare, pharmaceutical, biotechnology, and biopharmaceutical industries.
The primary reason for the exponential growth of the biologics market is the increasing utilization of biologics in cancer treatments. Biologics such as monoclonal antibodies are used to enhance the effectiveness of cancer treatments because they selectively target the cancer cells while sparing healthy cells. Advancements in biotechnology have improved various techniques and processes for manufacturing biologics. This has further helped boost the innovation of novel and more effective biologics. In addition, the rising investments in research and development activities contribute to market expansion.
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Major Trends in the Biologics Market
Rising Investments in R&D and Regulatory Support:
Funding for R&D programs plays a crucial role in advancing any field. Governments around the world and pharmaceutical companies are investing heavily in research and development activities to discover and develop new biologics. These investments allow researchers to invest in advanced technologies, bringing innovations to the market. Moreover, regulatory agencies are increasingly providing pathways to accelerate the approvals of biologics, contributing to the growth of the market. The FDA regulates the manufacturing and marketing of small molecule and biological drugs.
Increasing Prevalence of Chronic Diseases:
The prevalence of chronic diseases, such as autoimmune disorders, diabetes, and cancer, is increasing at an unprecedented level worldwide. According to the World Health Organization (WHO), cancer is the leading cause of global mortality, taking about one in six people’s lives. There were an estimated 20 million new cases of cancer and 9.7 million deaths from cancer worldwide in 2022. The cancer burden is expected to increase by about 77% by 2050. This highlights the need for biological therapies. Biologics interact with specific biological pathways in the body that help manage chronic diseases. Moreover, the demand for cell therapies is increasing with the growing instances of chronic diseases, contributing to market expansion. Biologics are essential for promoting the growth of cells used in cell therapies.
Advancements in Biotechnology:
Advancements in biotechnology create lucrative growth opportunities in the market. Innovations in biotechnology enable the development of new biologics, such as monoclonal antibodies and gene therapies. These advancements further pave the way for the development of personalized medicines. The availability of targeted therapies is increasing with improvement in techniques as well as technologies utilized for diagnosis, drug development, and research. Biologics are used to enhance the targeted delivery of therapeutic cells.
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Regional Insights
North America’s Dominance in the Market
North America led the market in 2024. There are several reasons for the region's stronghold on this market. The presence of numerous leading biotechnology, biopharmaceutical, and pharmaceutical companies in the region is a major factor supporting market growth. The reimbursement policies offered by governments and insurance agencies help patients opt for novel drugs and treatments for various health issues. With the significant rise in the prevalence of chronic diseases, investments in research and development activities have increased over the years.
The U.S. plays an important role in the North American biologics market. The presence of a large number of key players, along with a strong pharmaceutical manufacturing infrastructure, boosts market growth. The U.S. government is investing heavily in R&D activities to accelerate the development of novel therapies. In addition, the rising approvals for biologics drive the country's market. For instance, in 2024, the U.S. FDA approved 50 new small molecules, biologics, and oligonucleotides.
Exploring the Asia Pacific’s Role in the Market
Asia Pacific is projected to observe the fastest growth in the next few years. The number of people being affected with chronic diseases like diabetes, cardiovascular diseases, and cancer is steadily rising in the region. This highlights the need for novel drugs and therapeutics, significantly boosting the demand for biologics. The growing geriatric population is further solidifying the need for novel treatments and drugs. Many regional players are making efforts to fulfill the rising demand for biologics. They are also investing heavily to expand the availability of biological products. Moreover, the increase in healthcare expenditure and rapid expansion of the biotechnology and biopharmaceutical industries are contributing to regional market growth.
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Market Segmentation
Product Insights
The blood and blood products segment dominated the biologics market with the largest share in 2024 due to their increased demand. Blood and blood products play a crucial role in various treatments. This versatility contributes to segmental dominance.
Application Insights
The oncology segment registered dominance in the market in 2024. This is mainly due to the rise in incidences of cancer across the world. The emergence of biological medications, specifically monoclonal antibodies and immunotherapies has contributed significantly to better outcomes of cancer treatments. These therapies help reduce side effects and increase survival rates in patients, making them a popular choice for cancer treatments.
Competitive Landscape
The biologics market continues to evolve rapidly. Key players competing in the market include Amgen, Merck & Co., F. Hoffmann-La Roche Ltd., Bristol-Myers Squibb, Sanofi, Bayer AG, AstraZeneca, GlaxoSmithKline Plc., Novartis AG, and Eli Lilly and Company. These companies are focusing on business development strategies, such as partnerships, mergers, and acquisitions, to expand their footprints worldwide.
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Recent Developments
- In January 2025, Cytovance Biologics and PolyPeptide entered into a collaboration to develop microbial and mammalian-expressed peptide drugs.
- In December 2024, CuraTeQ Biologics s.r.o., a step-down subsidiary of Aurobindo Pharma, announced that it received marketing authorization from the UK’s Medicine and Healthcare Products Regulatory Agency for the Bevqolva. This is a bevacizumab biosimilar version used for the treatment of various cancers.
- In December 2024, Biocon Biologics received the U.S. FDA approval to launch the biosimilar of Janssen's Stelara by February 2025, targeting autoimmune conditions like Crohn's disease and plaque psoriasis.
Segments Covered in the Report
By Product
• Blood and Blood Products
• Cellular and Gene Therapy Products
• Tissue and Tissue Products
• Vaccines
• Others Types
By Indication
• Oncology
• Immunology
• Infectiuos Disease
• Other Indications
By Application
• Diagnosis
• Treatment
By Manufacturing Facility
• Outsourced
• In-house
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
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