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World Pharma Today, in its advent to be the standalone ready-reckoner in the pharma domain, is proud to present expert predictions for 2025 from leading voices in the pharmaceutical industry. From groundbreaking advancements in bioconjugates and cell and gene therapies to the integration of digital solutions and innovative device technologies, these insights reveal the trends shaping the future of pharma and healthcare. Key themes include supply chain efficiency, patient-centric solutions, platform standardization, and leveraging data-driven approaches for accelerated drug development. Stay informed with thought leadership from industry pioneers like Abzena, TrakCel, Recipharm, Renaissance Lakewood and Simbec-Orion as we explore the evolving landscape of pharma innovation.
We begin with Abzena, which talks about going beyond the regular antibody-drug conjugations (ADCs). Then we move to a piece from TrakCel that lays focus on increased productivity and efficiency across advanced therapy supply chains. Recipharm then shows the significance of digital solutions so as to pass through the intricacies of drug development. Renaissance Lakewood, thereafter, gives a brief on the advancement in the nasal spray device tech. Finally, we put the spotlight on Simbec-Orion that talks specifically on Project Optimus designed due to the rising number of molecularly targeted oncology therapies which are in development.
Essentially, we talk of what all these 5 companies saw as the biggest trend in their respective domains and if they foresee this to continue in 2025 as well, thereby not just aligning to their respective goals but also witnessing immense promise throughout each of them.
Abzena
Author: Campbell Bunce, Chief Scientific Officer
2024 marked the shift to complex modalities with bi and tri-specific antibodies being conjugated to a wide variety of payloads from cytotoxics to nucleotides. With innovative options for more precise targeting and different payloads, there’s been an explosion in thinking of where and how these new bespoke conjugated molecules can be applied. Pharma has moved past simple Antibody-drug conjugations (ADCs), which have proven the approach but have surfaced some issues with clinical safety and complex manufacturing controls (CMC).
As we move into 2025 and developers apply more learnings from the first phase of bioconjugates, upfront de-risking of development and manufacturing is a must to support both early scientific and longer-term commercial success. By taking a toolbox of proven conjugation technologies, well understood biology and chemistry simplified with a platform approach, along with complementary analytical capabilities, will allow focus of expertise and resources on the novel value-add areas.
I believe 2025 will also see a burgeoning demand for standalone analytical capabilities as the impacts of the Biosecure Act and import tariffs on industry-wide complex supply chains play out. A holistic approach for development, characterization and commercial manufacturing will be vital to achieve the full therapeutic potential of these new technically challenging modalities.
TrakCel
Author: Dr. Fiona Withey, CEO
The pace of advancement of cell and gene therapies (CGTs) has been interesting to watch as they grow as a viable treatment option for hard-to-treat diseases. 2024 was a record year for CGT approvals, a trend we expect to continue in 2025 with the continued acceleration of the CGT Industry. We expect to see an increased focus on patient accessibility through increased productivity and efficiency across advanced therapy supply chains.
The sensitive nature of the data used in CGTs, often involving personalized treatments and handling of genetic material and information, combined with the large number of parties handling this data, will increase the need to focus on patient privacy and data security.
The continued proliferation of software platforms to manage the CGT supply chain is leading to management inefficiencies and frustration among healthcare professionals. This situation will likely be exacerbated as more advanced therapies become available commercially. In 2025, we expect to see a continued push from healthcare providers for platform standardization to deliver a consistent user experience and ease the management burden for all.
Recipharm
Author: Uwe Hanenberg, Head of Product Implementation at Recipharm
In 2024, the pharma industry demonstrated a growing reliance on digital solutions to navigate the complexities of drug development. This trend was driven by the need for more efficient, data-driven approaches to early drug development, formulation and process development, and manufacturing.
By harnessing the power of advanced analytics and data science, companies are gaining a deeper understanding of the interplay between material attributes, process parameters, and drug product quality. This enables more informed decision-making, optimised resource allocation, and accelerated development timelines.
This shift towards digital solutions is evident in the increasing adoption of platforms that leverage data science in modelling and simulation to streamline processes. These platforms, including Recipharm’s ReciPredict, are enabling pharma companies to optimise active pharmaceutical ingredient (API) consumption,de-risk technology transfers and fulfill the expectations of authorities
As the industry continues its digital transformation, we anticipate this trend to accelerate in 2025, leading to more efficient and predictable drug development outcomes. The integration of advanced technologies and data-driven approaches will be crucial for meeting evolving demands and ensuring the efficient delivery of high-quality therapies to patients.
Renaissance Lakewood
Author: Eric Kaneps, Vice President, Sales & Marketing
The main trend I saw in 2024 was the emergence of new and innovative nasal spray device technologies offering improved usability, dose accuracy and portability. This is a trend that will continue into 2025 and beyond.
Advancements in nasal spray devices with a focus on improving user experience and providing clear dosing instructions can help to minimize discomfort and empower patients to take control of their treatment. These advancements can significantly improve patient compliance, particularly for patients with chronic conditions or complex dosing regimens, ultimately leading to improved outcomes.
However, to achieve these patient benefits, developers must carefully consider nasal spray device selection as this can impact the performance of the final product and the overall patient experience. Companies can leverage contract development and manufacturing organizations (CDMOs) with nasal spray development expertise to help with product performance by optimizing device design and formulation characteristics.
Moving into 2025, it will become increasingly important to partner with a CDMO that not only provides nasal spray expertise but also brings together all R&D studies and activities under one roof. By helping avoid any potential delays and ensuring the needs of the project are met, this streamlined approach accelerates the delivery of crucial nasal spray therapies to the patients who need them.
Simbec-Orion
Author: Romillie Cruz, M.D., Vice President Medical & Scientific Services
In clinical-stage drug development, 2024 saw a continued push towards trial designs prioritizing both patient safety and enhanced therapeutic efficacy. A good example is the implementation of Project Optimus, an initiative from the FDA’s Oncology Center of Excellence targeting oncology drug development.
Project Optimus has been designed in response to the increasing number of molecularly targeted oncology therapies in development. Moving away from maximum tolerated dose clinical trial designs originally developed for cytotoxic chemotherapies, the initiative focuses on selecting doses that minimise toxicity but maximise efficacy and tolerability. By adopting more advanced clinical trial designs, oncology drug developers can help ensure that doses are neither too high and unnecessarily toxic nor too low and not beneficial to patients.
With the prevalence of cancer rising globally and the continued development of targeted therapies, the uptake of more advanced clinical trial designs is expected to continue into 2025 and beyond. Although this complex issue will require proactive measures and a comprehensive approach to clinical trial design and early-phase drug development, oncology developers aiming to reform the current dose optimisation and selection paradigm can ultimately help improve patient outcomes.
Going forward, 2025 looks exciting and also pretty inviting too, when we consider these trends taking shape of robust possibilities. This is, indeed just a drop in the ocean, considering that there are massive possibilities which await across numerous other sub-domains as well.
