Antibody Therapy Market
Key Takeaways
By Type: Monoclonal antibodies have held the largest market share.
By End Use: The hospital segment captured the biggest revenue share.
By Regional Type: North America dominates the market share.
Market Overview
Therapeutic monoclonal antibodies (mAbs) represent a revolutionary advancement in medical treatment, harnessing the immune system's power to combat diseases such as cancer, infections, and autoimmune disorders. These antibodies, either derived from the body's immune system or synthesized in laboratories, target specific markers on cells or tissues, aiding in eradicating harmful agents.
A notable player in this field is AstraZeneca, whose submission to Health Canada for Evusheld, a monoclonal antibody-based treatment, underscores the growing significance of this therapeutic approach. Initiated in November 2021, this regulatory process marks a pivotal moment in the adoption of mAbs for medical use.
Monoclonal antibodies function by binding to antigens, prompting the immune system to develop tailored defenses against similar threats. This mimics the natural immune response, offering targeted treatment with fewer side effects compared to traditional therapies.
June 2023: The FDA granted approval for Genentech’s Columvi, marking the first and only bispecific antibody with a fixed-duration treatment for individuals with relapsed or refractory diffuse large B-cell lymphoma.
March 2023: BioNTech and OncoC4 announced a strategic collaboration to co-develop and commercialize a novel checkpoint antibody in multiple solid tumor indications.
The market for therapeutic antibodies has witnessed remarkable expansion, driven by the approval of new drugs catering to diverse ailments, including cancers, autoimmune disorders, metabolic conditions, and infectious diseases. Over the past 25 years, mAbs have emerged as the primary treatment modality for various illnesses, reflecting substantial advancements in discovery and development processes.
Technological innovations have notably accelerated the pace and efficiency of mAb therapies, facilitating rapid progress in research and clinical applications. As a result, therapeutic monoclonal antibodies have positioned themselves as indispensable tools in the modern medical arsenal, offering promising avenues for combating a wide array of diseases and improving patient outcomes.
February 2022: The Canadian government entered into a new agreement for COVID-19 antibody therapy.
December 2023: Bristol Myers Squibb's Abecma became the first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan.
February 2023: Pfizer Inc. received Priority Review from the FDA for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for treating patients with relapsed or refractory multiple myeloma (RRMM).
Growth Factors
Recombinant DNA Technology: The development of monoclonal antibodies through recombinant DNA technology has fueled market growth. These laboratory-produced protein molecules offer controlled manufacturing processes, enhancing their reliability and scalability.
Superior Performance: Modern antibodies demonstrate superior performance compared to polyclonal antibodies, particularly in terms of their reproducible affinity for specific target antigens. This controlled quality and specificity have significantly contributed to market expansion.
Medical Applications: Monoclonal antibodies serve not only as therapeutics but also as essential tools in various medical applications. Their routine use in hospitals for blood typing and tissue matching ensures the safety and success of critical procedures such as blood transfusions and organ transplants, further driving market growth.
Profitability and Expansion: The growth and profitability of monoclonal antibodies surpass earlier biotechnology drugs and traditional pharmaceuticals. Their rapid expansion ranks among the fastest in the global pharmaceutical landscape, attracting substantial investment and driving market expansion.
Diverse Mechanisms of Action: Monoclonal antibodies offer diverse mechanisms of action, including direct binding to target molecules to induce apoptosis, inhibit cell growth, or interfere with crucial functions. This versatility in targeting specific disease pathways fuels market growth by addressing a wide range of medical needs.
Conjugation Strategies: Leveraging the binding properties of antibodies, conjugation to cytotoxic drugs, radioisotopes, or toxins has emerged as a potent therapeutic strategy. This approach enhances the efficacy of treatments and expands the market by offering innovative solutions for challenging diseases.
Advantages of mAbs: Monoclonal antibodies offer several benefits, including fewer off-target adverse effects, reduced drug-drug interactions, higher specificity, and enhanced efficacy through targeted therapy. These advantages drive market growth by improving patient outcomes and attracting broader adoption.
Ongoing Modifications: Ongoing modifications aimed at decreasing immunogenicity and enhancing efficacy further propel market growth. Strategies such as optimizing pharmacokinetic properties and enabling oral bioavailability ensure that monoclonal antibodies remain at the forefront of medical innovation, driving continued demand and market expansion.
Market Dynamics
Drivers
Expanding Applications of Monoclonal Antibody Therapy
Advances in understanding the role of growth factors and their receptors in hematopoietic and neoplastic diseases have catalyzed the development of humanized chimeric monoclonal antibodies. These innovations offer a new perspective for treating leukemia, lymphoma, breast cancer, autoimmune diseases, and ischemic complications. Monoclonal antibodies are instrumental in cancer diagnosis and therapy, immune response modulation for autoimmune diseases and graft-versus-host disease (GVHD), and prevention of allograft rejection. Additionally, their application in treating bacterial infections and reducing tissue damage in conditions like bacterial meningitis and myocardial reperfusion injury further fuels the growth of the antibody therapy market.
January 2022: GSK and Vir Biotechnology announced a government agreement to procure an additional supply of sotrovimab, authorized for early COVID-19 treatment.
September 2022: Evusheld, a long-acting antibody combination, obtained approval in the EU for COVID-19 treatment.
Increasing Prevalence of Chronic Diseases Driving Demand for Antibody Therapy
The rising prevalence of chronic diseases has significantly contributed to the expanding use of antibody therapy. Monoclonal antibodies (mAbs) are increasingly applied in the treatment of severe, nonmalignant conditions such as atopic dermatitis, asthma, hypercholesterolemia, osteoporosis, migraine headaches, and bacterial infections. As a result, antibody drugs have become some of the most sought-after products in the pharmaceutical market. Notably, among the top 50 drugs based on sales in 2021, 22 are antibody drugs, with adalimumab (Humira) emerging as the leading antibody drug with annual sales exceeding $20 billion. This robust demand for antibody therapy, driven by the prevalence of chronic diseases, continues to propel growth in the antibody therapy market.
July 2022: Pucotenlimab, a humanized monoclonal antibody targeting PD-1, received successful approval for utilization in China.
Restraints
High Development Costs Impede Growth of Antibody Therapy Market
The formidable development costs associated with antibody therapy pose a significant obstacle to market expansion. With the average annual price of a monoclonal antibody (mAb) exceeding $96,731 and surpassing $100,000 for 34 mAb-indication combinations, affordability becomes a pressing concern for patients, healthcare providers, and payers alike. Particularly in oncology and hematology, where mAbs represent 40% of approved indications but account for over 85% of treatments priced at $100,000 or higher, the financial burden is pronounced. Adjusting for production cost factors, oncology or hematology mAbs command substantially higher annual prices compared to those used in other therapeutic areas such as cardiovascular or metabolic disorders, immunology, infectious diseases or allergy, and ophthalmology. This disparity in pricing across therapeutic categories creates barriers to access and limits the potential growth of the antibody therapy market, underscoring the need for strategies to address cost concerns and enhance affordability.
Challenges in Developing Antibodies for Complex Membrane Proteins Limit Growth of Antibody Therapy Market:
The complexities associated with developing antibodies for intricate membrane proteins like G protein-coupled receptors (GPCRs), ion channels, transporters, and membrane-bound enzymes present significant barriers to market growth in antibody therapy. Despite potential solutions such as antigen design, antibody-generation strategies, lead optimization technologies, and diverse antibody modalities, the inherent challenges persist. Therapeutic antibody discovery and development technologies are evolving, but the limitations in effectively targeting difficult membrane proteins continue to hinder progress. This restriction impedes the expansion of the antibody therapy market by limiting the development of novel treatments for diseases and conditions reliant on these intricate targets. Until these challenges are effectively addressed, the full potential of antibody-based therapies in addressing a wide range of medical needs will remain unrealized, thereby constraining market growth in this sector.
Opportunities
Advancements in Antibody Therapeutics Driving Market Growth
Antibody-based therapeutics have emerged as a cornerstone in the treatment of diverse diseases, ranging from cancers to immune disorders and infectious diseases. Recent breakthroughs in antibody discovery and development present promising opportunities for the antibody therapy market. As antibody discovery progresses to preclinical development, the consideration of biophysical properties becomes paramount in determining the drug's efficacy. Notably, advancements in computer-aided methods have led to the identification of variants demonstrating superior attributes. For instance, one variant showcased reduced aggregation propensity, increased stability, higher purification yield, lower isoelectric point (pI), enhanced affinity, and superior in vivo anti-tumor efficacy. This transformative discovery presents a promising candidate antibody for preclinical development, showcasing the potential of tailored antibodies to address unmet medical needs. Such advancements not only enhance the efficacy and safety profile of antibody therapeutics but also expand the scope of applications across various disease categories. As a result, the antibody therapy market is poised for significant growth, fueled by the continuous innovation and optimization
