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Biologics Market Size, Share, Growth & Industry Analysis, By Source (Microbial, Mammalian), By Product (Monoclonal Antibodies (mAbs), Vaccines, Recombinant Proteins, Gene Therapies, Cell Therapies, Others), By Application (Oncology, Infectious Diseases, Cardiovascular Diseases, Autoimmune Diseases, and Other Applications), and Regional Analysis, 2024-2031
Pages: 170 | Base Year: 2023 | Release: January 2025 | Author: Versha V.
Biologics are a class of medical products derived from living organisms, such as cells, tissues, or microorganisms, used in the prevention, treatment, or cure of various diseases. They include a wide range of products such as monoclonal antibodies, vaccines, gene therapies, and cell-based therapies.
Unlike traditional drugs, which are chemically synthesized, biologics are often produced through biological processes such as fermentation or genetic engineering.
Global biologics market size was recorded at USD 478.34 billion in 2023, which is estimated to be valued at USD 525.10 billion in 2024 and reach USD 1107.30 billion by 2031, growing at a CAGR of 11.25% from 2024 to 2031.
The market is experiencing significant growth due to technological advancements, increasing demand for innovative therapies, and strategic investments in research and development.
As global demographics shift, with aging populations there are higher incidences of chronic diseases such as heart conditions, diabetes, and arthritis are on the rise, straining healthcare systems and boosting demand for drugs, and innovative treatments.
Major companies operating in the biologics market are Eli Lilly and Company, Johnson & Johnson Services, Inc., F. Hoffmann-La Roche Ltd, Pfizer Inc., Gilead Sciences, Inc., Bristol-Myers Squibb Company, Novo Nordisk A/S, Merck KGaA, AbbVie Inc., Novartis AG, GSK plc., AstraZeneca, Regeneron Pharmaceuticals Inc., Sanofi, Takeda Pharmaceutical Company Limited, and others.
The market is experiencing robust growth driven by the success of immunotherapies in oncology and autoimmune diseases. Breakthroughs in cancer treatment, such as immune checkpoint inhibitors and CAR T-cell therapies, highlight the potential of biologics to revolutionize cancer care, leading to increased research and market growth.
Market Driver
"Expansion of Biomanufacturing Capacity and Favorable Government Incentives"
The expansion of biomanufacturing capacity is contributing significantly to the growth of the biologics market, addressing the increasing demand for biologic therapies due to rising chronic and complex diseases. Innovations such as continuous bioprocessing and single-use technologies are enhancing production efficiency and scalability, enabling faster and more cost-effective delivery of therapies.
Government incentives, such as the Orphan Drug Act, are also playing a pivotal role by offering financial and regulatory support for the development of treatments for rare diseases, thereby fosteringinvestment and innovation.
Furthermore, advancements in biologic technologies, including gene editing, CRISPR, and monoclonal antibody engineering, are enabling the development of more precise, targeted, and personalized therapies, particularly in oncology and autoimmune diseases.
Market Challenge
"Regulatory Variability and High Development Cost"
Regulatory variability across regions presents significant challenges for companies seeking biologics market access. Differing requirements for clinical trials, manufacturing, and labeling lead to delays, higher costs, and operational complexity.
In addition, the high development costs associated with biologic therapies, mainly due to extensive research, intricate manufacturing processes, and prolonged development timelines, strain profitability and limit market access, particularly for smaller firms. To address this challenge, companies can form strategic partnerships with local regulatory experts to more efficiently navigate regional differences.
Engaging early with regulators also plays a crucial role in streamlining the process, as it allows for clearer guidance on clinical trial designs and requirements, ultimately minimizing delays.
Moreover, cold chain and logistics challenges persist, as many biologics require precise temperature control throughout distribution. This increases the complexity and cost of supply chain management, particularly in underserved regions. Any disruptions can affect timely and effective delivery of products, limiting patient access and market reach.
One solution is for companies to invest in advanced cold chain technologies, such as temperature-controlled packaging, phase change materials, and real-time monitoring systems, which help maintain the required temperature range during transit and minimize the risk of spoilage.
Market Trend
"Adoption of Synthetic Biology and Precision Medicine"
The growing adoption of synthetic biology is fueling the development of customized biological systems, enhancing scalability and cost-effectiveness of biologic drug production, and accelerating advanced therapies such as gene editing and personalized treatments.
Furthermore, precision medicine is gaining significant traction as it allows for highly targeted treatments tailored to individual genetic, environmental, and lifestyle factors, thereby improving patient outcomes and reducing side effects.
Furthermore, the integration of digital twin technology in biologics manufacturing is optimizing production workflows by creating virtual replicas of physical systems. This enables real-time monitoring and predictive insights, streamlining operations, ensuring compliance, and improving product quality.
These advancements are contributing significantly to the expansion of the biologics industry, creating opportunities for personalized healthcare and more efficient, cost-effective production.
| Segmentation | Details |
| By Source | Microbial, Mammalian |
| By Product | Monoclonal Antibodies (mAbs), Vaccines, Recombinant Proteins, Gene Therapies |
| By Application | Oncology, Infectious Diseases, Cardiovascular Diseases, Autoimmune Diseases, Other Applications |
| By Region | North America: U.S., Canada, Mexico |
| Europe: France, U.K., Spain, Germany, Italy, Russia, Rest of Europe | |
| Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific | |
| Middle East & Africa: Turkey, UAE, Saudi Arabia, South Africa, Rest of Middle East & Africa | |
| South America: Brazil, Argentina, Rest of South America |
North America biologics market accounted for a substantial share of 42.41% and was valued at USD 201.91 billion in 2023. This dominance is primarily reinforced by a robust healthcare infrastructure, leading pharmaceutical companies, and continuous research advancements.
The United States leads the market, supported by government initiatives such as funding for innovative biologics and regulatory policies such as the Orphan Drug Act, which promotes the development of treatments for rare diseases.
The region further boasts a high adoption of cutting-edge biologic therapies, particularly in oncology, immunology, and autoimmune diseases, thereby propelling regional market growth. Additionally, the region's growing prevalence of chronic diseases and rising demand for personalized medicine are aiding this growth.
Asia-Pacific biologics market is expected to grow at a robust CAGR of 13.20% through the projection period. Countries like China, India, and Japan are advancing in biotechnology R&D, bolstered by government initiatives and substantial investments from both public and private sectors.
These countries are prioritizing the development of biologic therapies for cancer, autoimmune disorders, and chronic diseases, with a growing focus on precision medicine and targeted treatments.
The global biologics market is characterized by a large number of participants, including both established corporations and rising organisations. To gain a competitive edge, these companies are strengthening their positions through strategic initiatives such asg product innovations, partnerships, mergers, acquisitions, and geographic expansions.
Additionally, several firms are investing heavily in R&D to develop next-generation biologics targeting diseases such as cancer, autoimmune disorders, and rare conditions.
As the market evolves, these organizations are optimizing supply chain efficiencies and ensuring regulatory compliance. Their ongoing commitment to R&D and strategic collaborations positions them to lead in the fast-growing biologics market.
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