Monoclonal Antibodies in Modern Medicine

Monoclonal antibodies (mAbs) provide targeted treatments for cancer, immune-related disorders, infectious diseases, and hematological conditions. Since the approval of the first therapeutic mAb, muromonab-CD3 (OKT3), in 1986, the field has expanded significantly. As of June 2022, a total of 162 mAbs have received regulatory approval worldwide, reflecting both the scientific advancements and the increasing commercial investment in antibody-based therapeutics.

Among the major regulatory agencies, the U.S. Food and Drug Administration (FDA) leads with 122 approvals, followed closely by the European Medicines Agency (EMA) with 114. Japan and China, while historically behind, have rapidly expanded their presence, with 82 and 73 approvals, respectively. The growing contributions from China and Japan highlight a global shift in biopharmaceutical innovation, where new markets are increasingly contributing to the development of novel antibody therapies.¹

Related: HTP Recombinant Antibody Production

Advances in Antibody Formats and Engineering

The development of mAbs has evolved significantly beyond the conventional full-length immunoglobulin G (IgG) molecules. The 162 approved antibodies as of 2022 include:

• 115 canonical antibodies

• 14 antibody-drug conjugates (ADCs)

• 7 bispecific antibodies

• 8 antibody fragments

• 3 radiolabeled antibodies

• 1 antibody-conjugate immunotoxin

• 2 immunoconjugates

• 12 Fc-fusion proteins

Among these, ADCs and bispecific antibodies represent a growing segment of antibody therapeutics. ADCs, which consist of a cytotoxic drug linked to an antibody, enhance targeted delivery of chemotherapy to cancer cells. Bispecific antibodies, which can simultaneously bind two different antigens, have been particularly useful in immuno-oncology and autoimmune disease treatments.

Advances in antibody engineering have also improved pharmacokinetics, efficacy, and safety. Humanization techniques, such as complementary-determining region (CDR) grafting, have minimized immunogenicity, while glycoengineering has optimized antibody effector functions. A key example of glycoengineering is the development of afucosylated antibodies, which enhance antibody-dependent cellular cytotoxicity (ADCC) by increasing Fcγ receptor binding.

Related: Bispecific Antibody Production

Key Targets and Therapeutic Areas

Antibody therapies have been developed against 91 unique targets, with the most frequently targeted being PD-1, a critical immune checkpoint receptor. PD-1 inhibitors, such as pembrolizumab and nivolumab, have revolutionized cancer treatment by restoring T-cell activity against tumors. Other high-priority targets include:

• CD20 – Targeted by rituximab for B-cell malignancies

• HER2 – Targeted by trastuzumab for breast cancer

• TNF-alpha – Targeted by infliximab for autoimmune disorders

• IL-6R – Targeted by tocilizumab for inflammatory diseases

• VEGF – Targeted by bevacizumab for anti-angiogenic cancer therapy

The distribution of approved mAbs across different disease areas reveals the dominance of oncology and immune-related disorders. Nearly 43% of approved mAbs target cancer, followed by 37% for immune diseases, 11% for infectious diseases, and 7% for hematological disorders. The increasing interest in central nervous system (CNS) disorders, particularly migraine and neuroinflammation, is reflected in the approvals of anti-CGRP antibodies such as fremanezumab and galcanezumab.¹

Market Growth and Competitive Landscape

The global antibody therapy market has experienced significant growth, rising from $0.3 billion in 1997 to $186 billion in 2021. With ongoing clinical trials and regulatory approvals, the market is expected to reach $445 billion by 2028, with a compound annual growth rate (CAGR) of 13.2%.

The U.S. remains the dominant player in mAb development, housing the majority of companies with approved antibodies. Leading companies in antibody therapeutics include Roche, Bristol Myers Squibb, Johnson & Johnson, AstraZeneca, and Regeneron, each with a strong pipeline in oncology and immune-related diseases. However, China has witnessed rapid growth in the number of local companies developing mAbs, with recent approvals such as Cadonilimab, a first-in-class bispecific PD-1/CTLA-4 antibody for metastatic cervical cancer.

The Future of Monoclonal Antibodies

The field of antibody therapeutics is expanding beyond traditional modalities. Emerging technologies such as mRNA, cell therapies, and gene editing, are expected to drive the next wave of innovation. Notably, chimeric antigen receptor T-cell (CAR-T) therapies, which use engineered T cells with antibody-derived receptors, have gained traction for hematological malignancies, with five FDA-approved CAR-T therapies currently on the market.

mRNA-encoded antibodies represent a promising direction, allowing for in vivo expression of therapeutic antibodies without the need for large-scale protein production. The rapid development of neutralizing antibodies during the COVID-19 pandemic showcased the potential of combining next-generation sequencing (NGS), artificial intelligence, and single B-cell characterization for accelerated antibody discovery.

As the field advances, antibody therapeutics will continue to shape the future of precision medicine, offering targeted, effective, and safer treatments for a broad range of diseases.

At Biointron, we are dedicated to accelerating antibody discovery, optimization, and production. Our team of experts can provide customized solutions that meet your specific research needs, including HTP Recombinant Antibody Production, Bispecific Antibody Production, Large Scale Antibody Production, and Afucosylated Antibody Expression. Contact us to learn more about our services and how we can help accelerate your research and drug development projects.

References:

1. Lyu, X., Zhao, Q., Hui, J., Wang, T., Lin, M., Wang, K., Zhang, J., Shentu, J., Dalby, P. A., Zhang, H., & Liu, B. (2022). The global landscape of approved antibody therapies. Antibody Therapeutics, 5(4), 233-257. https://doi.org/10.1093/abt/tbac021