Article
May 06, 2025
The Rise of Targeted Modalities in Pharmaceutical Development
Targeted modalities represent a significant evolution in drug development, reports Anshul Gupte, Vice President of Pharmaceutical Development at PCI Pharma Services. They distinguish themselves from traditional small molecules and biologics by focusing on precise mechanisms of action.
These therapies are designed to bind specifically to receptors or biological targets, thereby ensuring a more directed and effective treatment while reducing systemic exposure and unintended side-effects. Two of the leading targeted modalities, antibody drug conjugates (ADCs) and targeted protein degraders (TPDs), are poised to experience significant market growth in the future. The ADC market, for instance, is projected to increase from $7.6 billion in 2022 to $19.8 billion by 2028, growing at a CAGR of 15.2% during that period.1 Similarly, the global TPD market was valued at approximately $541.98 million in 2024 and is expected to reach $3.55 billion by 2034, growing at a CAGR of 20.7% during the forecast period.2 Although targeted modalities are most commonly associated with oncology, their application is expanding into other disease states where specific pathways can be leveraged for therapeutic intervention.
The growing importance of targeted modalities
The increasing relevance of targeted modalities can be attributed to several key factors. First, advancements in genetic research have deepened our understanding of how individual genetic make-up influences disease susceptibility and treatment response.
By tailoring therapies to target specific genetic markers, drug development is moving toward precision medicine and offering highly effective solutions for distinct patient populations.
Second, improvements in drug discovery methodologies have enhanced our ability to design treatments that deliver active pharmaceutical ingredients (APIs) directly to their intended targets. Unlike traditional therapies that distribute broadly within the body, targeted modalities minimise unnecessary exposure, thereby reducing toxicity and enhancing therapeutic efficacy.
Beyond genetic targeting, advances in molecular engineering and computational drug design have enabled the development of highly specific therapies. The use of ADCs and other precision-based approaches has drastically improved treatment outcomes for patients with conditions that were previously deemed to be untreatable.
Overcoming challenges in development
Despite their promise, targeted therapies present unique challenges during development and production. Many of these compounds are highly potent and sensitive to environmental factors such as heat, light and oxygen. Additionally, these therapies could require the use of specialised solubility and/or stability enhancement technologies. As a result, they often require optimised formulations to ensure stability and efficacy during extended periods. Lyophilisation or freeze-drying is a common approach used to improve the shelf-life and stability of these therapies for parenteral administration.
The high potency of these compounds necessitates stringent containment measures during manufacturing to protect operators from exposure. Conversely, maintaining the integrity of the drug product itself is equally critical, particularly for parenteral formulations that are administered intravenously, intramuscularly or subcutaneously. Any contamination could compromise the safety and efficacy of the therapy. “With targeted therapies, we must protect both the operators from exposure and the therapy itself from external contamination,” says Gupte. “It’s a two-way street.”
Another major hurdle is scalability. Supporting targeted therapies through preclinical and early clinical trials and then translating the processes to a larger scale could be complex. Ensuring reproducibility and maintaining the same level of precision at commercial volumes requires meticulous planning and robust quality control processes.
Analytical considerations in targeted drug development
Targeted therapies require specialised analytical techniques to ensure quality and efficacy. Given their low concentrations – often at the nanogram level or even lower – highly sensitive assays are necessary to detect and accurately quantify active compounds. For complex molecules such as ADCs, analytical methods must not only assess the presence of the therapeutic agent but also its biological activity.
Regulatory agencies emphasise the importance of building quality into the product rather than merely testing for it at the end of development. Analytical methods serve as the foundation to maintain quality throughout the drug development process, ensuring that formulations remain stable and biologically active from production to patient administration.
“The active molecule might be present in a formulation, but is it still biologically active? That’s the key question we need to answer with targeted therapies,” notes Gupte. This underscores the necessity of rigorous bioassays and functional testing in addition to standard chemical characterisation.
Scaling-up manufacturing for targeted therapies
Scaling-up the production of targeted modalities presents distinct challenges. Unlike traditional pharmaceuticals produced in large batches, these therapies often require smaller, more flexible manufacturing processes. Facilities must be equipped to handle variable batch sizes while maintaining the necessary environmental controls to preserve drug stability and potency.
Moreover, the manufacturing process must be adaptable to different formulation needs. Some targeted therapies begin as parenteral formulations owing to stability concerns but may later transition to oral dosage forms. Contract development and manufacturing organisations(CDMOs) that offer both oral solid dose (OSD) and injectable capabilities provide valuable flexibility to drug developers by ensuring seamless transitions between formulation types as needed.
The role of CDMOs in targeted modalities
CDMOs play an increasingly vital role in terms of bringing targeted therapies to market. Many pharmaceutical companies, particularly small biotech firms, lack the specialised facilities and expertise required to develop and manufacture these complex treatments. CDMOs provide critical support by offering experience with high-potency compounds, advanced analytical capabilities and flexible manufacturing solutions.
An effective CDMO must prioritise three key components: facility adaptability, cutting-edge equipment and expert talent. By maintaining a network of specialised partners, CDMOs can address gaps in capability, ensuring a streamlined pathway from drug discovery to commercialisation.
According to Gupte: “The best CDMO is one that remains technology agnostic by choosing the right solution for the molecule rather than fitting the molecule into pre-existing technology. It’s about flexibility and adaptability.” CDMOs must also balance their expertise in both small- molecule and biologic drug production. As targeted modalities could involve hybrid approaches – such as ADCs, which combine a biologic (antibody) with a cytotoxic small-molecule drug – an integrated skillset is crucial.
The future of targeted drug development
The next decade promises significant advancements in targeted modalities. Although oncology remains the primary focus, emerging applications in neurology, autoimmune disorders and rare diseases are gaining traction. Personalised therapies – potentially tailored to individual patients – represent the ultimate goal, with artificial intelligence (AI) playing an instrumental role in optimising drug design and development.
AI-driven insights are already accelerating drug discovery by identifying optimal targets and refining molecular structures. Although AI’s role in drug product development remains in its early stages, its influence is expected to grow as more data becomes available to streamline both formulation and manufacturing processes.
Additionally, the regulatory landscape is evolving to accommodate the rapid advancements in targeted modalities. With many of these therapies being classified as breakthrough treatments, agencies such as the US FDA and EMA are working to establish streamlined approval pathways that balance speed with safety. “Targeted modalities push the boundaries of science. They demand smarter, faster and more adaptable solutions from both regulators and manufacturers alike,” says Gupte.
Final thoughts
Targeted modalities are at the forefront of pharmaceutical innovation, pushing the boundaries of technology and therapeutic effectiveness. Their potential to transform patient care is immense, but success depends on leveraging the right expertise, technologies and partnerships. As the field evolves, CDMOs will continue to play a crucial role by enabling pharmaceutical companies to develop and deliver life-changing therapies with greater speed and precision. As Gupte puts it: “Targeted modalities are the tip of the spear – the most advanced tools we have to fight diseases. They push the boundaries of science, requiring us to be smarter, faster and more adaptable than ever before.”
References
1. www.marketsandmarkets.com/Market-Reports/antibody-drug-conjugates-market-122857391.html.
2. www.polarismarketresearch.com/industry-analysis/targeted-protein-degradation-market.
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