Biologics Market

Global Biologics Market:

The global biologics market size reached USD 377.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 769.7 Billion by 2033, exhibiting a growth rate (CAGR) of 7.38% during 2025-2033. The rising prevalence of chronic diseases, which necessitate more effective treatment options, continuous technological advancements facilitating the development of increasingly targeted therapies, and the emergence of advanced drug delivery systems represent some of the factors that are propelling the market.

Biologics Market Analysis:

• Major Market Drivers: The global biologics market is primarily being driven by the rising prevalence of chronic diseases and the development of increasingly targeted therapies. Moreover, the expanding healthcare budgets across countries are resulting in a sustained biologics industry demand for advanced therapeutic options, which is acting as another significant growth-inducing factor.
• Key Market Trends: The advent of new-age targeted therapies that enhance treatment effectiveness while minimizing any side effects is among the key biologics market trends. Furthermore, the development of advanced drug delivery systems and the emerging trend of regulatory changes and harmonization across the globe are also bolstering the biologics market growth.
• Competitive Landscape: Some of the major market players in the biologics market include AbbVie Inc., Amgen Inc., AstraZeneca plc, F. Hoffmann-La Roche Ltd, GlaxoSmithKline plc, Johnson & Johnson, Merck KGaA, Novartis AG, Pfizer Inc., and Sanofi, among many others.
• Geographical Trends: North America currently dominates the global biologics market, primarily owing to the presence of well-established healthcare infrastructures and significant investments in biopharmaceutical research. Moreover, the region is home to several leading biopharmaceutical companies and research institutions, which drive innovations.
• Challenges and Opportunities: The high production costs, stringent regulatory requirements, and the elevating need for cold chain logistics for storage and transportation, which adds to the costs, are the key market challenges. Moreover, the extensive requirements for sophisticated clinical trials to ensure safety and efficacy also pose substantial barriers to entry and expansion in the biologics market. Meanwhile, the escalating incidences of chronic diseases, the increasing number of patents that are getting expired, and the continuous advancements in targeted therapies are the major opportunities positively influencing the biologics industry’s future scope.
   

Biologics Market Trends:

Continuous Innovations in Targeted Therapies

A significant driver in the market for complex molecules is the continuous innovation in targeted therapies. These are therapies designed to specifically act on certain cells or molecules responsible for disease, thus increasing treatment effectiveness while minimizing side effects. Given the critical nature of diseases like cancer and autoimmune disorders, targeted therapies offer a novel and effective avenue for treatment. For example, in March 2024, Caltech researchers developed an ultrasound-activated drug-delivery system aimed at cancer treatment, which promised targeted therapy with minimal side effects. This technique combines gas vesicles and mechanophores in order to precisely activate drugs, thereby reducing harm to healthy tissues. Similarly, a report published in Nature Medicine in March 2024 presented the initial results of recurrent glioblastoma (rGBM) patients who were treated with intrathecally administered, autologous, bivalent chimeric antigen receptor (CAR) T-cells targeting two proteins (epidermal growth factor receptor (EGFR) and interleukin-13 receptor alpha 2 (IL13Rα2)) to combat aggressive brain tumor growth. Extensive scientific research has enabled the understanding of disease mechanisms at the molecular level, paving the way for specialized treatments that are more effective and less toxic than traditional approaches. With increasing investments in research and development, coupled with a heightened focus on personalized medicine, these targeted therapies are poised to become mainstream. Their introduction and subsequent success can substantially elevate the demand for complex molecules, thus serving as a pivotal driver for the market.

The Emergence of Advanced Drug Delivery Systems

Drug delivery systems play an increasingly crucial role in healthcare, often determining the effectiveness and patient compliance for complex molecular treatments. Innovation in this sector comes in various forms, from controlled-release mechanisms to nanotechnology-based delivery systems. For instance, in January 2024, University of North Carolina researchers introduced a wireless drug delivery system named the Spatiotemporal On-Demand Patch (SOP). This technology, which resembles a band-aid, has the capability to receive wireless commands from computers or smartphones, enabling precise scheduling and triggering of drug release via microneedles. Such advancements make it easier for patients to adhere to their treatment regimens, thereby improving clinical outcomes. Newer delivery systems might replace daily injections with weekly or even monthly doses, substantially enhancing patient convenience and willingness to continue treatment. Significant investments are flowing into the research and development of these technologies, with the aim to maximize the therapeutic effectiveness of complex molecules. These advances in drug delivery systems are contributing immensely to the market's resilience and growth potential, fulfilling a demand for more efficient and patient-friendly therapeutic options.

Regulatory Changes and Harmonization

Navigating through the labyrinthine regulatory environments has long been a daunting challenge for companies in the healthcare sector. However, the current trend toward regulatory harmonization is simplifying this complex landscape. For example, the US Food and Drug Administration (FDA) released a draft guidance titled “Good Clinical Practice (GCP) E6(R3)” in July 2023 in collaboration with the International Council for Harmonisation (ICH) to “provide a unified standard to facilitate the mutual acceptance of clinical data for ICH member countries and regions” to help encourage more innovative and efficient trial designs. With unified or mutually recognized approval processes across different countries, market entry barriers are substantially reduced. This means that new and existing products can reach a wider patient base much faster than before. The implications are manifold: not only is there an accelerated pace at which these innovative therapies are made available to patients, but there is also a significant expansion in the geographic reach of these products. This favorable alignment of regulatory practices, by expediting approvals and broadening market access, is driving substantial and sustained growth in the global market for complex biologics molecules.

Biologics Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global biologics market research report, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on source, product, disease, and manufacturing.

Breakup by Source:

• Microbial
• Mammalian
• Others
   

Microbial accounts for the majority of the biologics market share

The report has provided a detailed breakup and analysis of the market based on the source. This includes microbial, mammalian, and others. According to the report, microbial represented the largest segment.

The microbial segment in the global market is mainly driven by its cost-effectiveness and shorter production times compared to mammalian cell cultures. The ability of microbial systems to produce large quantities of proteins makes them an attractive option for the mass production of vaccines and insulin. Moreover, advancements in microbial fermentation technologies are making it easier to produce complex proteins. For instance, Samsung Biologics selected Rapid Micro Biosystems’ Growth Direct platform in January 2024 to automate its critical microbiology quality control testing in order to deliver increased efficiency, more data integrity, as well as scalable quality control operations. Furthermore, a wide range of approved microbial-based products and a robust pipeline of microbial-based therapies are contributing to the growth of this segment.

Breakup by Product:

• Monoclonal Antibodies
• Vaccines
• Recombinant Proteins
• Antisense, RNAi and Molecular Therapy
• Others
   

Monoclonal antibodies represent the largest market segment

The report has provided a detailed breakup and analysis of the market based on the product. This includes monoclonal antibodies, vaccines, recombinant proteins, antisense, RNAi and molecular therapy, and others. According to the report, monoclonal antibodies represented the largest segment, leading the biologics industry statistics.

The monoclonal antibodies (mAbs) segment is increasingly prominent due to their specificity in targeting a wide array of diseases including cancers, autoimmune disorders, and infections. Technological advancements in antibody engineering and hybridoma technologies have allowed for the development of highly specific and potent mAbs. Additionally, the growing number of FDA approvals for monoclonal antibodies further fuels this segment. The capacity for personalized treatment options using monoclonal antibodies also adds to its robust market potential.

Breakup by Disease:

• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Hematological Disorders
• Others
   

Oncology accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the disease. This includes oncology, immunological disorders, cardiovascular disorders, hematological disorders, and others. According to the report, oncology represented the largest segment.

The oncology segment in the global market is driven by the high prevalence of cancer worldwide and an aging population more susceptible to this disease. Advancements in genomics have facilitated the development of targeted therapies for various types of cancer. The growing awareness about personalized medicine and targeted therapy in cancer treatment is also propelling this segment forward. Moreover, a strong pipeline of oncology biologics in clinical trials indicates future market growth.

Breakup by Manufacturing:

• Outsourced
• In-House
   

In-house represents the largest market segment

The report has provided a detailed breakup and analysis of the market based on the manufacturing. This includes outsourced and in-house. According to the report, in-house represented the largest segment.

The in-house segment benefits from complete control over the research, development, and manufacturing processes. Organizations are increasingly preferring in-house production to protect intellectual property rights and proprietary technologies. In-house facilities also allow for quicker adaptations to market changes and more effective implementation of quality controls. The capacity for more integrated and streamlined operations contributes to the growth of the in-house segment in the global biologics market.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America exhibits a clear dominance, accounting for the largest biologics market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America dominates the global biologics market, primarily due to the presence of a well-established healthcare infrastructure and significant investments in biopharmaceutical research. The region is home to numerous leading biopharmaceutical companies and research institutions that drive innovation, which is creating a positive outlook for the market. In addition to this, favorable regulatory support in the form of fast-track approvals for biologics and various financial incentives for extensive research and development (R&D) activities are also contributing to the market growth. Moreover, rising patient awareness and willingness to adopt new therapies are further fueling the biologics market demand in North America. Furthermore, the U.S. is the largest market within the region, which is majorly buoyed by high healthcare spending, broad insurance coverage, and an increase in chronic and lifestyle-related diseases.

Competitive Landscape:

Key players in the global biologics market are aggressively focusing on innovation and research & development (R&D) activities. They are continually expanding their product pipelines to include advanced therapies in oncology, immunology, and other therapeutic areas. To meet stringent regulatory requirements, companies are investing significantly in state-of-the-art manufacturing facilities that adhere to good manufacturing practices. Collaborative agreements with academic institutions are being initiated for acquiring novel technologies. Through mergers and acquisitions, these organizations are consolidating their market presence. Strategic partnerships with smaller biotech companies are enabling the leveraging of unique skill sets and technologies. Furthermore, market leaders are engaging in patient access programs to facilitate the affordability of biologics.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• AbbVie Inc.
• Amgen Inc.
• AstraZeneca plc
• F. Hoffmann-La Roche Ltd
• GlaxoSmithKline plc
• Johnson & Johnson
• Merck KGaA
• Novartis AG
• Pfizer Inc.
• Sanofi
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Biologics Market News:

• March 2024: A Swiss contract drug manufacturer, Lonza, announced that it would buy one of the world's largest manufacturing sites for biologic drugs in California from drugmaker Roche for US$ 1.2 Billion.
• March 2024: Pearl Bio, a synthetic biology company, announced that it had entered a license, collaboration and option agreement with Merck to discover biologic therapies comprising non-standard amino acids.
• March 2024: Eris Lifesciences announced the acquisition of Biocon Biologics’ branded formulation business. As part of this deal, Eris also signed a 10-year supply agreement with Biocon Biologics.
• September 2023: Amgen announced that it had reached a consent order agreement with the Federal Trade Commission, resolving a pending lawsuit and paving the way for its acquisition of Horizon Therapeutics. The companies anticipate finalizing the acquisition in early Q4 2023, focusing on serving patients with rare diseases.
• August 2023: AbbVie Inc. announced that the European Commission has approved AQUIPTA (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval makes AQUIPTA the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the European Union for the preventive treatment of both chronic and episodic migraine.
• August 2023: AstraZeneca plc announced that Japan's Ministry of Health, Labour and Welfare had approved the expanded use of Soliris (eculizumab) for treating pediatric patients with generalized myasthenia gravis who are resistant to other therapies. The approval follows positive outcomes from a Phase III trial, making Soliris the first targeted therapy for this condition in children and adolescents in Japan.

Biologics Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the biologics market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global biologics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the biologics industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.