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The global biologics market size is worth around $411 billion in 2024 and is expected to reach $962 billion by 2035, representing a higher compounded annual growth rate (CAGR) of 8.04% during the forecast period.
Biologics refers to biological therapeutics, a class of medicines that have been isolated from living organisms and purified to treat diseases. According to the World Health Organization report, nearly 422 million people across the globe are suffering from diabetes. Moreover, nearly 41 million people die annually due to non-communicable diseases, which is equivalent to around 74% of all deaths occurring across the globe.
Based on the source, the biologics market is segmented into microbial, mammalian and others. According to our market study, microbial sources account to hold 68% of the overall market share in 2024. The highest share can be attributed to the fact that the majority of the biologics approved by the FDA are developed using microbial expression systems. Products such as recombinant insulin, platelet-derived growth factor and recombinant interferons are manufactured using microbial expression systems. In the long run, the mammalian cell culture for biologics manufacturing market segment is likely to expand at a higher CAGR during the forecast period.
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Based on the type of products, the market is distributed across monoclonal antibodies, vaccines, recombinant hormones/proteins, cellular-based therapies, antisense and RNAi therapeutics, and other products. According to our projection, currently monoclonal antibodies dominate the market by capturing 56% of the overall biologics market share. This can be attributed to the fact that monoclonal antibodies have been in great demand for targeting a broad range of diseases including cancer. Moreover, monoclonal antibodies are also used for the development of target specific therapies, which is anticipated to be a major reason for the highest share in the market.
Based on the application area, the biologics market is segmented into oncology, infectious diseases, autoimmune diseases, rare diseases, cardiovascular disorders, hematological disorders and other applications. According to our projection, use of biologics for oncology indication accounts for the largest share (40%) of the overall market in 2024. Cancer is the second leading cause of death across the globe.
Driven by the rising risk of cancer, several pharmaceutical companies are leveraging biologics such as monoclonal antibodies, immune cells, and recombinant proteins for the development of target specific therapies to eradicate cancerous cells. In the long run, hematological disorders will expand at a substantial CAGR owing to the growing research on biologics for targeting rare blood disorders such as hemophilia and sickle cell anemia.
Based on the drug classification, the market is segmented into biosimilars and originator drugs. According to our market study, originator drugs account to hold 84% of the market share in 2024. Biosimilars are likely to expand at a healthy CAGR during the forecast period.
Based on the distribution channel, the biologics market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. According to our projection, retail pharmacies hold the highest share followed by hospital pharmacies accounting to hold 37.50% of the overall revenue share in 2024.
Based on the key geographical region, the market value is distributed across North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. Currently, North America holds 60% of the overall market share. The highest growth share can be attributed to several factors such as favorable reimbursement policies, rising incidence of chronic diseases and significant investments by industry leaders as well as government organizations in R&D activities.
Europe is the second highest shareholder of the biologics industry in 2024, capturing 24% of overall revenue share. Driven by the rising prevalence of diseases including cancer, infectious disease, diabetes and age-related disorders in geriatric population, the biologics market in Asia-Pacific is anticipated to grow at a higher CAGR during the forecast period.
“Global Biologics Market Size, Trends and Future Forecast Till 2035” market report features an extensive study of the current market landscape, market size, market share, market growth, market forecast, market outlook and future opportunities in the market. Further, the market research report underlines an in-depth analysis of players engaged in offering a wide range of biologics.
The biologics industry has the presence of several small, mid-sized and large companies who hold expertise in the development of biologics. The key companies engaged in the market are emphasizing the launch of new products, R&D and strategic acquisitions, partnerships as well as collaboration to expand their product portfolio and their global reach. It is interesting to highlight here that several startup companies are proliferating in the market to develop biologics for the treatment of chronic diseases. Some notable examples of the startups are Andson Biotech (USA), Cygnal Therapeutics, Elasmogen, Entos Pharmaceuticals, metaBIX (Uruguay), MxT Biotech (South Korea), and TiumBio.
Furthermore, the established players are focusing on the launch of advanced biologics manufacturing facilities to meet growing demand for specific biopharmaceutical drugs to target diseases. In September 2024, Sanofi announced the completion of construction of its 24,000 square meter facility for production of vaccines and biologics in Neuville-sur-Saone, France. Built with an investment of $554 million, the facility is expected to begin operations by the end of 2025. In June 2024, Kyowa Kirin also announced its plans for an investment of $530 million to build a biologic manufacturing facility in North Carolina.
One of the significant factors propelling the biologics market growth is the growing prevalence of chronic diseases. According to the Centers for Disease Control and Prevention, nearly 129 million people in the United States are suffering from at least one chronic disease such as diabetes, hypertension, rheumatoid arthritis, osteoporosis, obesity and cancer. It is worth noting here that cancer and rheumatoid arthritis are affecting the population worldwide. Driven by the rising risk of diseases, several industry leaders emphasize using biologics for the development of targeted specific therapies, which is anticipated to be the major growth driver of the market.
At the same time, a number of companies are focusing their efforts on the development of biosimilars to improve the accessibility and affordability of biologic therapies in developing nations. For instance, in May 2024, Biocon Biologics (a leading biosimilar developer and manufacturing company) announced the approval of the first-to-file application for Yesafili™ (aflibercept-jbvf) by the FDA. It is an interchangeable biosimilar aflibercept (vascular endothelial growth factor inhibitor) used for the treatment of a broad range of ophthalmology conditions. Furthermore, YESAFILI is intended to utilize for the treatment of neovascular (age-related macular degeneration) and visual impairment. Even the developed nations are supporting the development and commercialization of biosimilars, driven by the need to reduce their burgeoning healthcare costs. The European Commission (EC) granted approval to Biogen’s Tofidence, a biosimilar of Roactemra in June 2024.
As the research on biologics based therapeutic drugs increases, we believe the market will grow at a steady rate during the forecast period.
Despite the growing research on biologics, the stakeholders may face several challenges that may hinder biologics market growth in the future. One of the significant factors is the high cost associated with the research, identification and development of biologics. It is important to highlight here that biologics have large molecular structure that are complex to isolate and identify. Furthermore, biologics have been developed using microbial expression systems that demand specialized controlled conditions and skilled personnels, which may enhance the overall cost of manufacturing biologics.
In addition, biologics are heat and light sensitive due to which it requires specialized controlled environment and contamination free conditions. The requirement of temperature-controlled storage and transportation equipment may further increase the cost of biologics drugs. Furthermore, the complex regulatory guidelines for approval, transportation and storage of biologics create challenges for the biologic drug development.
Biologics such as monoclonal antibodies and cell-based therapies have shown positive outcomes in the treatment of cancer and genetic diseases across the globe. For instance, In April 2024, The Biologics License Application of AstraZeneca and Daiichi Sankyo’s Datopotamab deruxtecan has been accepted by the US FDA for the treatment of patients with metastatic HR-positive, HER2-negative breast cancer. The acceptance has been provided on the basis of results from Phase III Trial on (TROPION-Breast01) in which this therapeutic drug demonstrated a significant improvement for the primary endpoint of progression-free survival in patients with metastatic HR-positive, HER2-negative breast cancer.
Considering the outcomes, various market leaders also entered strategic collaborations and made significant investments to increase their research on biologics. For instance, in March 2023, Teva made an investment of USD 1 billion in the European biologics industry. Teva decided to allocate these funds to improve technological advancements aiming to streamline biologics production. The rising investments and ongoing research in the field has brought enormous opportunities to drive innovation, which is anticipated to be a major factor of the biologics market growth.
Currently, the biologics market size is estimated to be valued at USD 411 billion in 2024 and is projected to reach USD 962 billion by 2035. The market is poised to grow at a higher CAGR of 8.04% during the projected period. This highest growth potential is likely to be the result of growing demand for target specific therapies for the treatment of chronic diseases.
Examples of the key players active in this industry (the complete list of the companies has also been included in the detailed market report) are mentioned below.
This market report includes an easily searchable excel database of all the companies developing biologics worldwide.
The market research report features an in-depth analysis of various companies that are active in this industry across various segments, as defined in the given table below.
| Key Report Attributes | Details | |
| Historical Trend | Since 2019 | |
| Base Year | 2025 | |
| Forecast Period | Till 2035 | |
| Market Size 2035 | $962 billion | |
| Market CAGR | 8.04% | |
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| By Drug Classification |
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| PowerPoint Presentation (Complimentary) |
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| Customization Scope | 15% Free Customization | |
| Excel Data Packs (Complimentary) |
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One of the key objectives of this biologics market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunities for global biologics industry players over the next decade. Based on several parameters, likely industry trends, partnerships, and through primary validation, we have provided an informed estimate on the market evolution during the forecast period 2024-2035. The market report also features the likely distribution of the current and forecasted opportunity within the biologics industry based on various relevant parameters, such as Source of Biologic (Microbial, Mammalian and Others), Type of Product (Monoclonal Antibodies, Vaccines, Recombinant Hormones/Proteins, Cellular-Based Therapies, Antisense and RNAi Therapies, and Other Products), Application Area (Cancer, Infectious Diseases, Autoimmune Diseases, Rare Diseases, Cardiovascular Disorders, Hematological Disorders and Other Applications), Drug Classification (Biosimilars, and Originator Drugs), Distribution Channel (Hospital Pharmacies, Retail Pharmacies and Online Pharmacies), Key Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America) and leading players.
In order to account for future uncertainties with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry's evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.
Several recent developments have taken place in the market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall biologics market trends that have been outlined in our analysis.