Global Biologic Therapeutics Market Growth, Share, Size, Trends and Forecast (2022 - 2028)

Antibody therapeutics, particularly monoclonal antibodies (mAbs), have revolutionized treatment in various disease areas. These biologic drugs are designed to target specific antigens on cells or proteins involved in diseases like cancer, autoimmune disorders, and infectious diseases. They work by either directly attacking diseased cells or modulating immune responses to restore health. The market for antibody therapeutics continues to grow due to their high specificity, efficacy, and potential for personalized treatment strategies.

Vaccines are critical in preventing infectious diseases by inducing an immune response against pathogens. Biologic vaccines are developed using antigens derived from viruses, bacteria, or other microorganisms, which stimulate the body's immune system to produce protective antibodies. They play a vital role in public health by reducing disease transmission, morbidity, and mortality globally. Advances in vaccine technology, such as recombinant DNA techniques and adjuvant formulations, have enhanced vaccine efficacy and safety profiles, driving continued innovation in this segment.

Cell therapy involves the use of living cells to treat diseases or repair damaged tissues. This includes therapies such as CAR-T cell therapy for cancer, where a patient's own T cells are genetically modified to recognize and attack cancer cells. Cell therapies offer promising outcomes for patients with otherwise challenging-to-treat conditions, fostering research into improving cell manufacturing processes, enhancing therapeutic efficacy, and expanding applications across different disease types.

Gene therapy aims to treat or prevent diseases by altering the genetic makeup of cells. This is achieved by delivering therapeutic genes into patient cells to correct genetic mutations, restore normal function, or enhance resistance to diseases. Recent advancements in gene editing tools like CRISPR-Cas9 have accelerated the development of gene therapies, offering potential cures for genetic disorders, cancer, and infectious diseases. The market for gene therapy is poised for growth as technologies evolve and clinical successes validate their therapeutic potential.

Biologic therapies have transformed cancer treatment by targeting specific molecules involved in tumor growth and immune evasion. Antibody therapeutics, such as checkpoint inhibitors and targeted therapies like HER2 inhibitors, are key in oncology for improving survival outcomes and reducing side effects compared to traditional chemotherapy. Cell therapies like CAR-T cells show promise in treating hematologic malignancies and solid tumors, reflecting a paradigm shift towards personalized and targeted cancer therapies.

Biologic therapies play a pivotal role in managing autoimmune diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. Antibody therapeutics, including TNF inhibitors and interleukin-targeted therapies, suppress inflammatory responses and modulate immune activity to alleviate symptoms and prevent disease progression. Continued research focuses on identifying new targets and optimizing biologic therapies to enhance efficacy and safety profiles in these chronic conditions.

Biologic therapies in hematology primarily include monoclonal antibodies and cell therapies for treating blood cancers like leukemia, lymphoma, and multiple myeloma. Antibody-drug conjugates and bispecific antibodies are increasingly used to selectively deliver cytotoxic agents to cancer cells, minimizing damage to healthy tissues. Cell therapies, such as CAR-T cells, offer curative potential in relapsed or refractory hematologic malignancies, demonstrating significant advancements in precision medicine for blood disorders.

Biologic therapies are also utilized in various other applications, such as infectious diseases (e.g., vaccines for viral infections), metabolic disorders (e.g., enzyme replacement therapies for lysosomal storage disorders), and neurological disorders (e.g., gene therapies for neurodegenerative diseases). These therapies address diverse medical needs and represent ongoing areas of innovation and therapeutic advancement in biotechnology and pharmaceutical research.

Global Biologic Therapeutics Segment Analysis

In this report, the Global Biologic Therapeutics Market has been segmented by Source, Disease Category, Product, Application and Geography.

Global Biologic Therapeutics Market, Segmentation by Source

The Global Biologic Therapeutics Market has been segmented by Source into Microbial, and Mammalian.

The Global Biologic Therapeutics Market is divided into two primary categories based on the source of production: microbial and mammalian. Microbial sources include bacteria and yeast, which are commonly used for the production of biologic therapeutics. These sources are often favored due to their ability to grow quickly, their cost-effectiveness, and their ability to produce high yields of biologic products. The use of microbial systems is typically seen in the production of monoclonal antibodies, recombinant proteins, and vaccines.

Mammalian sources, on the other hand, include cell lines derived from animals, such as Chinese hamster ovary (CHO) cells, which are widely used in the production of therapeutic proteins and monoclonal antibodies. Mammalian cell cultures offer the advantage of producing biologic products that are more similar to human proteins, ensuring better stability and activity. These products often have higher therapeutic efficacy and fewer immune reactions when administered to patients. However, the production process for mammalian-derived biologics tends to be more complex and expensive compared to microbial sources.

Both microbial and mammalian sources contribute significantly to the overall growth of the biologic therapeutics market, but they serve different needs and therapeutic areas. The choice of source often depends on the nature of the product being developed, the required scale of production, and the intended patient population. Microbial sources are typically chosen for more straightforward biologic products, while mammalian sources are preferred for more complex biologics, especially those targeting chronic diseases and cancer.

Global Biologic Therapeutics Market, Segmentation by Disease Category

The Global Biologic Therapeutics Market has been segmented by Disease Category into Oncology (MABs, Vaccines, Recombinant Proteins, Antisense & RNAi Therapeutics, Others), Infectious Diseases (Vaccines, MABs, Antisense & RNAi Therapeutics, Recombinant Proteins, Others), Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, Others.

The Global Biologic Therapeutics Market has been segmented by disease category into several therapeutic areas, each addressing different types of medical conditions. Oncology remains one of the largest segments, with biologic therapies such as monoclonal antibodies (MABs), vaccines, recombinant proteins, and antisense & RNAi therapeutics playing a significant role in cancer treatment. These therapies are crucial in targeting specific molecules involved in cancer cell growth, thereby offering targeted and effective treatment options. Additionally, the use of MABs and vaccines in oncology continues to expand, with ongoing research enhancing their effectiveness in treating various cancer types.

Infectious diseases is another major segment within the biologic therapeutics market, with biologic treatments focusing on vaccines, MABs, and recombinant proteins. These therapies aim to treat and prevent infections caused by bacteria, viruses, and other pathogens. The rise of new and resistant strains of infections has increased the demand for innovative biologics, particularly vaccines and advanced MABs, which are designed to boost immunity and target pathogens more effectively. The segment also includes antisense & RNAi therapeutics, which are being explored for their potential in combating viral infections through the silencing of specific genes.

Other significant disease categories in the biologic therapeutics market include immunological disorders, cardiovascular disorders, and hematological disorders. Immunological therapies are being developed to treat conditions like autoimmune diseases and allergies, often through biologics that modulate the immune system. Cardiovascular and hematological disorders, including conditions like heart failure, blood clotting disorders, and anemia, benefit from biologics such as monoclonal antibodies, recombinant proteins, and novel therapies targeting specific biomarkers. The segment also includes treatments for other diseases, indicating the broadening applications of biologic therapeutics across diverse medical conditions.

Global Biologic Therapeutics Market, Segmentation by Product

The Global Biologic Therapeutics Market has been segmented by Product into Antibody therapeutics, Vaccines, Cell therapy, Gene therapy and Other therapies.

Antibody Therapeutics constitute a significant portion of the biologic therapeutics market. Monoclonal antibodies (mAbs) are engineered proteins designed to target specific antigens or receptors involved in diseases such as cancer, autoimmune disorders, and infectious diseases. These therapies work by either blocking harmful signaling pathways, enhancing immune responses, or delivering cytotoxic agents directly to diseased cells. Key examples include drugs like rituximab for non-Hodgkin lymphoma and adalimumab for rheumatoid arthritis, illustrating their efficacy and therapeutic breadth across different indications.

Vaccines are another essential segment, crucial for preventing infectious diseases through the stimulation of the immune system. Biologic vaccines utilize weakened or killed pathogens, their toxins, or protein subunits to induce protective immune responses. They play a pivotal role in public health by reducing the spread and impact of communicable diseases such as influenza, hepatitis, and COVID-19. Advances in vaccine technology continue to enhance their safety, efficacy, and scalability, driving market growth and global immunization efforts.

Cell Therapy represents an innovative approach using living cells to treat diseases. This includes therapies like CAR-T cell therapy, where a patient's T cells are genetically modified to target and destroy cancer cells expressing specific antigens. Cell therapies offer promising outcomes for hematologic malignancies and solid tumors, providing personalized treatment options for patients with refractory or relapsed cancers. The market for cell therapies is expanding as research progresses into optimizing manufacturing processes and broadening therapeutic applications.

Gene Therapy involves the delivery of therapeutic genes to replace or correct faulty genes in patient cells, offering potential cures for genetic disorders, cancer, and infectious diseases. Gene editing technologies like CRISPR-Cas9 have revolutionized the field by enabling precise modifications to the genome, opening new avenues for personalized medicine and disease prevention. As clinical successes and regulatory approvals increase, gene therapy holds promise for addressing rare genetic conditions and advancing treatment paradigms across various therapeutic areas.

Global Biologic Therapeutics Market, Segmentation by Application

The Global Biologic Therapeutics Market has been segmented by Application into Oncology, Autoimmune and Inflammatory Diseases, Hematology and Other Applications.

Oncology represents a significant and rapidly growing segment within the biologic therapeutics market. Biologic therapies have revolutionized cancer treatment by targeting specific molecules involved in tumor growth and immune evasion. Monoclonal antibodies (mAbs) such as trastuzumab for HER2-positive breast cancer and rituximab for non-Hodgkin lymphoma exemplify targeted therapies that improve survival rates and reduce side effects compared to traditional chemotherapy. Additionally, innovative approaches like CAR-T cell therapy are gaining prominence for their ability to reprogram a patient's immune cells to recognize and destroy cancer cells, showing promise in hematologic malignancies and solid tumors.

Autoimmune and Inflammatory Diseases constitute another key application area for biologic therapeutics. These conditions, including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases, involve dysregulated immune responses leading to chronic inflammation and tissue damage. Biologics such as TNF inhibitors (e.g., adalimumab) and interleukin-targeted therapies (e.g., ustekinumab) modulate immune activity to alleviate symptoms and prevent disease progression effectively. Their targeted mechanisms reduce systemic side effects compared to conventional immunosuppressive therapies, offering improved quality of life for patients.

Hematology encompasses biologic therapies used in the treatment of blood disorders, including leukemia, lymphoma, and multiple myeloma. Monoclonal antibodies, such as rituximab and daratumumab, are integral to the treatment of hematologic malignancies by targeting specific antigens on cancerous cells and enhancing immune-mediated destruction. Moreover, cell therapies like CAR-T cells have demonstrated remarkable success in treating refractory or relapsed hematologic cancers, highlighting their potential as curative therapies and paving the way for personalized treatment approaches in hematology.

Global Biologic Therapeutics Market, Segmentation by Geography

In this report, the Global Biologic Therapeutics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Biologic Therapeutics Market Share (%), by Geographical Region, 2021

Europe represents another significant market for biologic therapeutics, characterized by stringent regulatory frameworks, strong healthcare infrastructure, and a growing emphasis on personalized medicine. Countries such as Germany, France, and the United Kingdom are key hubs for biotechnology innovation and clinical research, driving advancements in monoclonal antibodies, vaccines, and cell therapies. The European Medicines Agency (EMA) oversees drug approvals and market access across EU member states, fostering a competitive landscape for biologic therapies.

Asia-Pacific is witnessing rapid growth in the biologic therapeutics market, fueled by increasing healthcare expenditure, expanding biopharmaceutical industries, and rising prevalence of chronic diseases. Countries like China, Japan, and India are emerging as pivotal markets for biologic drugs, supported by government initiatives to enhance healthcare infrastructure and promote innovation in biotechnology. Regulatory harmonization efforts and partnerships with global pharmaceutical companies are driving market expansion and improving patient access to advanced biologic therapies.

The segmentation of the global biologic therapeutics market by geography highlights diverse regional landscapes characterized by varying levels of healthcare development, regulatory complexities, and market opportunities. Continued innovation, strategic partnerships, and regulatory advancements are expected to shape the future growth trajectory of biologic therapies worldwide, addressing unmet medical needs and improving patient outcomes across different regions.

This report provides an in depth analysis of various factors that impact the dynamics of Global Biologic Therapeutics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers:

• Increasing prevalence of chronic diseases
• Advancements in biotechnology and genetic engineering
• Growing demand for personalized medicine

• Rising investments in research and development - Rising investments in research and development (R&D) within the biologic therapeutics sector are pivotal to driving innovation, advancing medical science, and addressing unmet medical needs globally. This trend reflects a growing recognition of the potential of biologic drugs to revolutionize treatment paradigms across various disease areas.

  Increased R&D investments are fueling advancements in biotechnology and genetic engineering, which are essential for developing novel biologic therapies. Biologics, such as monoclonal antibodies, vaccines, and cell therapies, leverage sophisticated biotechnological processes to target specific disease mechanisms with high precision and efficacy. These therapies offer advantages over traditional small-molecule drugs by providing more targeted treatments with potentially fewer side effects.

  The complexity of biologic drugs necessitates substantial investment in research to optimize manufacturing processes, enhance product quality, and ensure consistency in therapeutic outcomes. Innovations in bioprocessing technologies, such as continuous manufacturing and single-use systems, are improving scalability and reducing production costs, thereby expanding patient access to biologic therapies worldwide.

  In oncology, for instance, R&D investments are driving the development of next-generation antibody-drug conjugates (ADCs) and personalized cancer vaccines that can target specific mutations in tumors, potentially improving survival rates and patient quality of life. Similarly, in autoimmune diseases and inflammatory disorders, ongoing research is focused on identifying new therapeutic targets and developing biologics that modulate immune responses more effectively.

Restraints:

• High production costs
• Complex manufacturing processes
• Stringent regulatory requirements

• Competition from biosimilars - Competition from biosimilars represents a significant challenge in the biologic therapeutics market, impacting both originator biologic drugs and the overall dynamics of healthcare access and affordability.

  Biosimilars are highly similar versions of approved biologic drugs, developed to be comparable in terms of safety, efficacy, and quality to their reference products. Unlike generic versions of small-molecule drugs, which are identical copies, biosimilars are structurally similar but not identical due to the inherent complexity of biologics and variability in manufacturing processes.

  One of the primary drivers of biosimilar competition is cost. Biosimilars typically enter the market at lower prices compared to originator biologics, offering potential cost savings for healthcare systems, insurers, and patients. This competitive pricing can lead to reduced healthcare expenditures and broader patient access to essential biologic therapies, particularly in regions where healthcare budgets are constrained.

  While biosimilars offer potential benefits such as cost savings and increased patient access to biologic therapies, competition from biosimilars poses complex challenges related to regulatory pathways, market acceptance, intellectual property, manufacturing standards, and healthcare system integration. Continued efforts to address these challenges through regulatory alignment, education, and strategic market access initiatives are essential for realizing the full potential of biosimilars in improving healthcare affordability and sustainability globally.

Opportunities:

• Expansion into emerging markets
• Advances in personalized medicine
• Development of novel biologic therapies

• Strategic partnerships and collaborations - Strategic partnerships and collaborations play a crucial role in the biologic therapeutics market, driving innovation, expanding market reach, and enhancing competitiveness among industry stakeholders. These partnerships bring together complementary expertise, resources, and capabilities to address complex challenges and capitalize on emerging opportunities in drug development, manufacturing, and commercialization.

  Biopharmaceutical companies often collaborate with academic institutions, research organizations, and biotechnology firms to advance scientific knowledge and accelerate the discovery of novel biologic therapies. These collaborations enable access to specialized expertise, cutting-edge technologies, and research infrastructure, facilitating the translation of basic research into clinically relevant therapies. By pooling resources and sharing risks, partners can expedite R&D timelines, mitigate development costs, and expand their pipeline of innovative biologics.

  Strategic partnerships involve licensing agreements where a biopharmaceutical company grants rights to develop, manufacture, and commercialize its biologic drug to another entity in exchange for upfront payments, milestone payments, and royalties. Co-development agreements leverage the strengths of multiple partners to advance promising drug candidates through clinical trials and regulatory approvals. These collaborations enable partners to leverage complementary capabilities in clinical development, regulatory affairs, and global market access, enhancing the probability of successful product launches and market penetration.

  Biologic drug manufacturing requires specialized facilities, expertise in bioprocessing technologies, and stringent quality control measures. Strategic partnerships between biopharmaceutical companies and contract manufacturing organizations (CMOs) facilitate efficient scale-up production, reduce manufacturing costs, and ensure consistent supply of biologic therapies to global markets. Additionally, collaborations with logistics providers optimize distribution networks, ensuring timely delivery and adherence to regulatory requirements across diverse geographic regions.

Key players in Global Biologic Therapeutics Market include:

• AbbVie Inc.
• AstraZeneca Plc
• Bristol-Myers Squibb Co.
• F. Hoffmann-La Roche Ltd.
• GlaxoSmithKline Plc
• Johnson & Johnson
• Merck & Co. Inc.
• Novartis AG
• Pfizer Inc.
• Sanofi

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis