DDW’s Megan Thomas takes a wide-angle look at the sector and speaks to experts and thought leaders about their predictions for therapeutic antibodies in 2025.

Clinical advancements

Marcelo Freire, Vice President of Global Medical Affairs, Therapeutic Area Head of Gastroenterology at Takeda, comments on monoclonal antibodies (mAbs) from a gastro perspective. He says: “The advent of advanced therapies such as monoclonal antibodies (e.g. integrin-blocking biologics), have led to precision approaches and substantial improvements in the treatment of diseases like Crohn’s disease and ulcerative colitis. However, unmet medical needs remain for many patients, including the need for better control of clinical symptoms, achieving mucosal healing, and reducing long-term complications.”

He notes that inflammatory bowel disease (IBD) poses significant physical and mental health challenges and impacts over 6.8 million people worldwide, with ever increasing prevalence. Building on the substantial progress already made, Freire believes even more can be done for patients. He concludes: “By ensuring timely initiation of biologic therapy; by identifying which patients can benefit most from specific advanced therapies; and by exploring dual advanced therapies, aiming to redefine the treatment paradigm by breaking the efficacy ceiling of current monotherapies.”

Antibody technology

Stefano Gullà, CSO of Kling Biotherapeutics, says that understanding how the immune system reacts to disease is still an important frontier for drug development and that one way of discovering the new disease relevant antigens and antibodies is by screening B-cells, a key technology use in the sector. He says: “It’s possible to capture an individual’s B-cell repertoire from human or animal sources into immortalised B cell libraries. These can be screened multiple times to generate valuable datasets of antibodies and targets with desired binding and functional properties. This approach can identify novel targets that are applicable to cancer as well as infectious diseases. Immortalised B cell libraries of ‘exceptional responders’ can be used to generate insights for discovery of new therapies and for the creation of extensive patient databases that can lead to a more profound understanding of a functional immune response.”

He also notes that antibody-based therapies have been playing an increasingly important role since the turn of the century and that they are now becoming standard of care in many forms of cancer and other diseases. He said: “There’s an opportunity to build on this with first-in-class or best-in-class antibodies with greater safety and efficacy than their predecessors. We have made great advances in validating new mechanisms of action (eg. TCEs, ADCs) but we now need more relevant and completely novel antigen targets. New approaches to antigen and antibody discovery will progressively take centre stage.”

According to BCC Research, the global market for antibody drugs is expected to grow from $242.6 billion in 2024 and projected to reach $412.1 billion by the end of 2029¹. Commenting on the market, Gulla concludes: “While the market is set to grow, many important drugs are set to go off patent. Patients will be asking for better therapies with significant improvements in safety and efficacy. We continue to face threats from Covid and other emerging pandemics which require a fast response more than ever before. We see multiple opportunities for anti-infective antibodies to follow on the success of Beyfortus and in leveraging new targets for oncology that can synergise to produce transformative benefits for patients.”

Meanwhile, Heidelberg Pharma’s CEO, Andreas Pahl, highlights the many established targets for ADCs, which he believes leave the industry in a good position to further refine the cancer-killing “payload”. Heidelberg Pharma’s approach uses amanitin, which in nature is found as the deadly poison in the death cap mushroom. Pahl says: “When combined with Heidelberg Pharma’s ADC delivery platform, this potent toxin can be delivered to very specific cancer cell targets and has the potential to kill all types of cancer, including those resistant to other treatments. Amanitin is unique in cancer research in that it targets the transcription process at the heart of all eukaryotic cells, where information stored in DNA is converted into messenger RNA (mRNA) that codes for the proteins that are essential for a cell’s functioning and survival.”

Market predictors

In terms of the market, Pahl also thinks that the rise of ADCs as a priority for big pharma companies can be attributed to several factors. “Firstly, the success of recent ADC approvals and their demonstrated clinical benefits have validated the potential of this therapeutic modality. ADCs offer a targeted approach to cancer treatment, combining the specificity of antibodies with the potency of cytotoxic drugs, which has shown promise in improving patient outcomes. Additionally, advancements in ADC technology, such as better linkers and more effective payloads, have addressed some of the earlier limitations, making ADCs more attractive for development.”

Moreover, Pahl says that growing understanding of tumour biology and the identification of novel cancer-specific targets have also fuelled interest in ADCs. He continues: “ADCs have the potential to be highly effective when used in combination with other drugs, such as immune checkpoint inhibitors, kinase inhibitors, or chemotherapies. Combining ADCs with immune checkpoint inhibitors can enhance the immune system’s ability to recognise and attack cancer cells, potentially overcoming immune evasion mechanisms.”

Joseph Ferra, CEO of Elevation Oncology, comments that over the last 40 plus years, ADC technology has proven transformative in producing precision medicines antigens on the cell surface of tumours. He notes how their “elegant design” to minimise damage to healthy tissue, while simultaneously delivering therapeutic payloads directly to tumour cells, means that ADCs “capture both the specificity of antibodies and the powerful cytotoxicity of the payload to improve both efficacy and safety”. Looking forward, Ferra says: “Taking innovative approaches to harness the enormous potential of ADCs will advance promising therapeutics across numerous oncological disease states, ultimately providing substantially effective and tolerable treatments for patients living with cancer.”

Philip Jones, Vice President of Sciences and Discovery at UPMC Enterprises, the innovation, commercialisation and venture capital arm of UPMC, says that over the past 30 or so years, more than 100 antibodies and their derivatives have transformed the lives of people with autoimmune diseases and cancer. He says: “The future looks equally bright with a host of bioengineering approaches being applied to refine the pharmacokinetic properties of these antibody derivatives.”

Jones provides examples, such as enhancing the tissue penetration such as crossing the blood brain barrier; targeting unique personalised antigens with T-cell receptor (TCR) like antibodies; and multifunctional bivalent and trivalent antibodies to drive proximity-based biology bringing diverse cells together. He says: “Arming antibodies is paying dividends, too, through antibody-drug conjugates and radiotherapeutics.  Similarly, antibody derivatives are being applied as targeting vectors for cellular therapies and nanocarriers (lipid nanoparticles, exosome and extracellular vesicles).”

Moreover, Jones notes that AI and machine learning is starting to be used in antibody design with the first AI-designed mAbs entering the clinic. He concludes: “Whilst exciting, future expectations for AI-designed antibodies also must remain grounded, given the multi-parameter optimisation required to make a safe, effective medicine.”

Antibody targeting

Obi Umeh, Vice President, Franchise Global Program Leader, Rare GI & Inflammation Franchise, Takeda, adds that treatments targeting autoantibodies have transformative potential in rare autoimmune disease – offering a novel MOA that challenges the status quo and may deliver benefits for patients. He adds: “Immune thrombocytopenia (ITP) is one example where this can be applied. ITP is a rare chronic disorder characterised by the accelerated destruction of platelets, which can lead to bleeding episodes that range from bothersome to life-threatening. By selectively targeting plasma cells – the direct source of autoantibody production, therapeutic antibodies can stop the harmful destruction of platelets, addressing the root cause of the disease. This has the potential to transform the treatment paradigm.”

Miao Li, Market Development Manager, Pioneer Antibody Discovery Platform, Bio-Rad Laboratories, highlights the rapidly evolving therapeutic antibody landscape, driven by innovations that enhance targeting precision, production efficiency, and drug format diversity. She says: “An especially promising area is the targeting of G protein-coupled receptors (GPCRs), which have historically posed challenges due to their structural complexity within membranes. However, recent advancements in GPCR structure stabilisation and antibody phage display technology have made it possible to develop antibodies against these difficult targets.”

She explains that phage display technology supports animal-free antibody selection, aligning with the industry’s growing commitment to ethical and sustainable practices. She concludes: “In addition to monoclonal antibodies, bispecific antibodies – capable of engaging two targets simultaneously – are gaining momentum, particularly in oncology. These dual-targeting molecules offer the potential for greater therapeutic efficacy and reduced resistance, opening new possibilities for complex disease treatment.

“Looking ahead, therapeutic antibodies will continue to evolve with advancements in computational tools, artificial intelligence, and deeper insights into complex targets. These innovations will drive faster discovery cycles, enable more precise target selection, and open possibilities for addressing previously undruggable targets.”

References

1. https://www.bccresearch.com/market-research/biotechnology/antibody-drugs-technologies-global-markets-report.html#:~:text=Report%20Highlights,period%20of%202024%20to%202029.