Sung Joo (SJ) Lee, Ph.D., Founder and President, Orum Therapeutics
We believe the next major wave in biologics will come from hybrid modalities — platforms that merge the precision of biologics with the catalytic potential of small molecules to unlock entirely new mechanisms of action. One example of this is DACs (degrader–antibody conjugates), which combine the proven targeting of antibodies with the power of targeted protein degradation.
This kind of innovation is being driven by several converging factors: growing interest in degrading previously “undruggable” targets, the need for more selective and less toxic therapies, and the industry’s experience with ADCs, which has paved the way for new payload classes like TPDs. At Orum, we see DACs as an evolution beyond conventional antibody–drug conjugates (ADCs), especially with the generation of new degrader payloads. Instead of relying on cytotoxic payloads that damage DNA or microtubules, Orum is creating new catalytic, non-genotoxic approaches that can be tuned for greater tissue specificity and therapeutic breadth.
As more companies explore these new combinations of biologics and small molecules, we expect to see continued momentum toward customizable, modular platforms like ours that can scale across disease areas and enable smarter drug design.
Normand Blais, Chief Science Officer, BIOVECTRA
The next big modality in biologics is likely to be cell and gene therapies, including CAR-T therapy, synthetic mRNAs, and gene editing tools like CRISPR. Advancements in gene editing, personalized medicine, and the successful application in cancer and vaccines are driving this growth.
Biologic innovation holds immense promise for addressing unmet medical needs. While mature biologics, such as monoclonal antibodies, peptides, and recombinant proteins, continue to grow, newer modalities like ADCs, bispecifics, and nucleic acids are now delivering returns. These platforms are reshaping therapeutic possibilities across oncology and rare and infectious diseases.
The future looks bright for regenerative cell-based therapies. An mRNA-based CRISPR/Cas9 system offers a promising tool for cell reprogramming and differentiation. Progress in manufacturing is being achieved through platform technologies, modular facilities, and automated and AI-enabled process control. This shift supports faster scale-up and more agile CMC strategies.
At BIOVECTRA, we offer pDNA for viral vector applications and end-to-end GMP manufacturing for mRNA products and gene editing tools including proteins, pDNA, mRNA, and LNPs, supporting innovators from milligram to commercial scales.
With advances in sequencing, AI, and microfluidics, personalized mRNA-based medicine will soon complement CAR T-cell therapy and immunotherapy. Innovative delivery systems and formulations will be essential to combine nucleic acid components and treat complex diseases. BIOVECTRA is investing in technologies that will power this next wave of biologic innovation.
Joseph Jeong, Ph.D., Vice President, Head of ADC Development, Samsung Biologics
Since the COVID-19 pandemic, the emergence of new modality drugs has been facilitating the development of innovative medicines by shifting the frame from traditional biologics to targeted therapies. Among the most advanced, ADCs have demonstrated the greatest potential in targeted therapies, particularly in oncology, for the following reasons.
When it comes to treating cancer, chemotherapy, consisting of small molecule chemical compounds, is typically used as the first-line treatment. Chemotherapy often targets rapidly dividing cells, as cancer cells usually proliferate within 24 hours. However, there is no specific way to distinguish between the cancerous and normal cells when chemicals are administered, which will eventually end up damaging normal cells too. ADCs’ mode of action (MoA) minimizes the unwanted attacks on healthy cells by utilizing monoclonal antibodies (mAbs) that recognize the antigen expressed only on the surface of specific cancer cells. The best example is PADCEV®, recently approved as a form of first-line treatment for bladder cancer. It has unlocked the possibility for ADCs to replace existing chemical compound–based first-line chemotherapy.
Another advantage of ADCs is tailored therapy to address unique features of tumor cells by combining various types of linkers and payloads into antibodies through numerous conjugation methods. One of the most challenging aspects of cancer treatments is tumor resistance due to the heterogeneous feature of tumor cells with diverse levels of antigen expression. By taking advantage of their high membrane permeability, released payloads from the initial target of antigen-expressing tumor cells can also target neighboring antigen-low and antigen-negative tumor cells. This is referred to as the bystander effect of ADCs. One of the blockbuster ADCs, Trastuzumab deruxtecan, also known as Enhertu from Daiichi Sankyo, makes use of this bystander effect by combining the cleavable linker and highly membrane-permeable payload, extending the cytotoxic effect to neighboring HER2– cells.
As the prospective new modality drug, ADCs have shown potential to precisely target heterogeneous tumor cells and the tumor microenvironment by modulating the payload and linker through their innovative MoA, which was not feasible with conventional mAbs. Samsung Biologics is poised to support ADC developers in overcoming such challenges, with the launch of ADC services this year, as well as a sequence of preemptive investments in the latest technologies and platform developments for meeting current and future needs of the growing ADC market.
Chris Chen, Ph.D., Chief Executive Officer, WuXi Biologics
While mAbs have reached a mature stage of development and commercialization after decades of progress, the persistent challenge of improving safety and efficacy continues to propel innovation across the biopharmaceutical industry.
About ten years ago, we anticipated the growth potential of bispecific antibodies (BsAbs) and ADCs. Today, the proliferation of global partnerships (including co-development agreements, licensing deals, and M&A activities) and active R&D pipelines has validated these insights. We remain confident that BsAbs and ADCs will continue to drive biologics innovation over the next 5–10 years, addressing critical unmet medical needs.
Currently, WuXi Biologics is supporting 817 integrated projects, representing one of the industry's largest portfolios of complex biologics. This includes 328 mAbs, 151 BsAbs /multispecific antibodies, 194 ADCs, 80 fusion proteins, and 24 vaccines. Notably, BsAbs and ADCs now constitute over 40% of the total portfolio — a remarkable increase from 14% in 2018, demonstrating accelerated growth of new modalities.
The advancement of these modalities is enabled by our state-of-the-art technology platforms, including WuXiBodyTM (universal bispecific/multispecific antibody discovery platform) and WuXiDARx™ (drug-to-antibody ratio technology platform). It is further expedited by our end-to-end solutions. We anticipate that an increasing number of new therapies will soon gain approval from regulatory authorities, ultimately benefiting patients worldwide.
Gordon Bates, Member of the Executive Committee and Head of Integrated Biologics, Lonza
Across the industry, we see a clear need from drug developers for more personalized, precise, and effective therapies — particularly for complex diseases like cancer, autoimmune disorders, and rare conditions. As science advances, next-generation biologics are stepping in to meet that need.
One of the most exciting next-generation modalities is bispecific antibodies. These innovative molecules engage two distinct targets simultaneously, unlocking enhanced therapeutic mechanisms such as dual inhibition, immune cell redirection, and precise payload delivery. This capability offers the potential for more effective, targeted treatments — especially for complex diseases like cancer and rare conditions where traditional approaches may have been less effective.
Additional factors driving momentum for advancement in bispecific antibodies are protein engineering and computational design. This aids in overcoming development hurdles like mispairing, immunogenicity, and low yields. Novel pairing technologies and in silico screening tools also enable faster development and clinical supply timelines. Meanwhile, AI-enabled analytics and high-throughput platforms are making it easier to scale production and bring these therapies to market faster, while intensified manufacturing processes will help address the cost of goods.
Today, 11 bispecifics have been approved by the FDA, nine of them in oncology. Bispecifics also continue to show strong potential for autoimmune and neurological indications. At Lonza, we’re investing in the infrastructure and expertise required to accelerate the development and commercialization of bispecifics. This momentum signals a broader shift in biologics — one that’s rooted in smarter design, deeper disease understanding, and a relentless drive to improve patient outcomes.
Steve Barr, Ph.D., Head of Small Molecules, SK pharmteco
The next big modality in biologics is likely to be ADCs and other targeted protein therapeutics, such as multispecific antibodies and radiopharmaceuticals.
Several factors are driving innovation in this space. First, the success of earlier-generation ADCs has validated the concept of delivering potent cytotoxic payloads directly to cancer cells, minimizing systemic toxicity. Second, antibody engineering advancements yield more stable, target-specific antibodies with improved pharmacokinetic profiles. Third, the development of novel linkers and payloads with enhanced efficacy and tolerability is expanding the therapeutic window of ADCs.
Similarly, multispecific antibodies, capable of binding two targets, show promise in redirecting immune cells to tumors or blocking multiple signaling pathways simultaneously. Radiopharmaceuticals, which deliver radioactive isotopes directly to cancer cells, are also gaining traction due to their targeted action. The increasing understanding of tumor biology and the urgent need for more effective and less toxic cancer therapies are key drivers propelling innovation in these next-generation biologics.
Lena Jonsson, Ph.D., Product Strategy Manager, Cytiva
ADCs are an extremely interesting type of drug. Even though they have been around for some time, they are just starting to gain traction and expand beyond cytotoxic payloads. As the development of their affinity molecules continues, there are approaches using Fab fragments, bispecific antibodies, and oligos that show promising results. The increased knowledge of specific cell surface markers, combined with affinity molecule development, provides a great foundation for expanding the development of ADCs.
The ever-increasing incidence of cancer is a strong driver to constantly develop better treatments. The concept of ADCs fulfills the aspiration for a holy grail of medicine: treatment that goes only to the parts of the body that need it, leaving all other parts unaffected. Which means fewer side effects for patients while simultaneously having a higher level of success. This is due to their ability to deliver higher therapeutic doses directly to tumor cells and to a larger extent leaving healthy tissue unharmed.
There have been several significant projects showing positive early results picked up for development. This clearly highlights the high hopes that the industry has that this class of molecules will bring future success
Jeng Her, Ph.D., Founder and Chief Executive Officer, AP Biosciences
We are ushering in the Antibody 2.0 era with bispecific antibodies, but with a new innovation.
Traditional bispecifics, particularly those leveraging CD3, have shown promise but are often hindered by safety liabilities, such as cytokine release syndrome. The field is working to overcome this by engineering the next-generation bispecifics that are precisely target-dependent and mechanistically distinct, in addition to overcoming resistance and improving patient outcomes.
The new era of bispecifics will need to be designed not only for efficacy, but also for manufacturability and safety, by leveraging symmetrical structures and bivalent binding to streamline production and minimize off-target effects.
As the complexity of tumor biology deepens, the next generation of biologics must meet the moment with equally sophisticated and adaptable therapies.
Grant Boldt, Ph.D., Chief Operating Officer, CPTx
Innovation in vector technology is enabling development of a next generation of cell and gene therapies with the potential to overcome the delivery and immunogenicity challenges that have limited the use of genetic medicines. For instance, at CPTx, we are engineering single-stranded DNA to effectively deliver genetic payloads to target cells with enhanced expression efficiency. Single-stranded DNA enables precise, transient, and tissue-specific gene expression, offering the potential to minimize potential concerns of plasmid-based double-stranded DNA (dsDNA)-based approaches including unpredictable expression and the possibility of genomic integration. We believe this enhanced level of control could be especially advantageous in the context of chimeric antigen receptor T (CAR-T) cell therapy. In addition, the ability to deliver genetic material without triggering strong innate immune responses potentially expands the therapeutic potential of CAR-T therapies built with single-stranded DNA to chronic indications, such as autoimmune disorders.
At CPTx, we are also applying programmable DNA nanofabrication techniques to single-stranded DNA to design highly stable, customizable nanocarriers for precise gene delivery. These nanocarriers can be engineered to resist enzymatic degradation, extend in vivo half life and structural integrity, and minimize immune recognition. Ligand-functionalized surfaces ensure selective binding to target cells, reducing off-target effects and systemic toxicity. Their tunable architecture allows gene expression to respond to specific stimuli, enhancing therapeutic precision. Compared to viral vectors, DNA nanostructures offer improved biocompatibility, reduced immunogenicity, and the potential for safer, more effective gene therapy applications.
Andrea Como, Vice President, General Manager, Core Biologics, Catalent
Multispecific antibodies, particularly bispecific antibodies, represent the most promising next-generation modality in the biologics landscape. These advanced therapeutics target multiple epitopes simultaneously, offering enhanced efficacy and precision in addressing complex diseases where traditional monotherapies have shown limitations.
Several key factors are driving innovation in this space. First and foremost is the persistent unmet medical need across various therapeutic areas, pushing researchers to develop more sophisticated treatment approaches. The significant market potential of these multispecific platforms has attracted substantial investment, accelerating their development pipeline.
From a technological perspective, advances in cell line development have been crucial. Technologies like Catalent's GPEx® Lightning platform enable the development of high-expressing, stable cell lines capable of producing these complex biologics with the quality and consistency required for clinical and commercial manufacturing.
The collaborative ecosystem between innovator companies and experienced CDMOs has become increasingly important, particularly for emerging biotech companies. These partnerships combine specialized expertise and established infrastructure to navigate the unique challenges of multispecific antibody development, from expression and stability to regulatory compliance and scalability.
As clinical data continues to demonstrate the value of these therapeutics, I expect multispecific antibodies to capture a significant and growing share of the biologics market in the coming years.
