The coming year will be characterized by seismic shifts, a consequence of 2023's historic highs as well as its economic lows. From the groundbreaking FDA approval of the first CRISPR-based gene therapy for sickle cell disease to the impact of the Inflation Reduction Act on drug pricing negotiations, the industry now stands at the intersection of innovation and adaptation.
Each year, we ask industry leaders to share their predictions with us. This article delves into the anticipated trends for 2024, from the transformative role of AI in drug development to regulatory shifts to watch.
Therapeutic advances
Pharma must address new CGT challenges
“2023 will be remembered as a historic year for CRISPR, with the U.S. FDA’s approval of the first commercially available CRISPR-based gene therapy for the treatment of sickle cell disease. In the U.S., the FDA anticipates it could approve around 10 to 20 cell and gene therapy products a year starting in 2025, based on the current pipeline. As a result, 2024 will be a critical year to address challenges associated with the rise of CGTs, including manufacturing capacity and the translation of research quickly into the clinic. Industry will continue its focus on industrializing the processes that go into their development to streamline and reduce costs. This will be particularly critical for early-stage therapeutic developers who will want end-to-end solutions to quickly progress from lab to clinic. We also expect to see an increased focus on off-target editing analysis as part of this transition to the clinic, in a drive to make these therapies as safe as possible.”
— Sandy Ottensmann, Vice President, Global Services and Business Unit Leader, IDT
“The approval of the first CRISPR-based therapy in the UK and the U.S. resulted in even more interest on integrating CRISPR-Cas in various fields, with discussion on changes in regulations, reflecting the increasing acceptance of this technology worldwide. However, some challenges still persist in maintaining consistent manufacturing processes for therapeutic applications, emphasizing the need for more reliability to advance CRISPR-Cas for broader clinical use. Also, overall more refined delivery methods in combination with efficient CRISPR-Cas tools is crucial for precise gene editing. Besides the technical hurdles, affordability and accessibility concerns also exist for CRISPR-based therapies, necessitating solutions to ensure widespread adoption. Despite these obstacles, the development of CRISPR-Cas continues to progress, offering diverse tools for novel applications. In 2024, focus on CRISPR-derived technologies like base and prime editing is expected to increase, aiming for accurate and lower off-target editing results. The year promises more advancements, shaping the landscape of genetics further.”
— Karolina Makovskyte, Vice President, Business Development, Caszyme
“Cell and gene therapies represent the next frontier in medicine. Despite high patient demand, relatively few eligible patients have received currently approved CGTs. While the industry is working to overcome the barriers that keep these critical therapies from reaching patients, there is still significant work ahead. Manufacturing cell and gene therapies is a significant barrier-with complex, highly manual and expensive processes that do not scale. Reliance on these processes often result in extensive waitlists, with clinicians and patients hoping for manufacturing slots to open in time. In 2024, we expect a continued shift toward therapy developers prioritizing manufacturing alongside scientific innovation earlier, in the preclinical or early clinical phases, rather than waiting until phase 3 which is usually too late.”
— Jason Foster, Chief Executive Officer, Ori Biotech
“Implementation efficiency must be a focus area in 2024. With licensed products in multiple categories, the challenge is to make products available more efficiently. Areas of critical importance are in manufacturing, donor engagement, and change management. In 2016, CAR-T manufacturing capacity was the industry bottleneck; today it is product logistics. The logistics have now outstripped the scientific and regulatory concerns as barriers to patient access so that treatment is sharply limited to a small number of facilities. In 2024, distributed manufacturing operations — whether fully at bedside or in a sequence of facilities from hospital to critical manufacturer — will be a big area of development. With allogeneic therapies emerging in late-stage development, the donor for those materials must become a bigger focus — how to target, engage, and select, those donors will be critical to the next wave of development. These are the questions we must tackle in 2024.”
— Becky Cap, Senior Vice President, Biotherapies, Vitalant
“Cell and gene therapies continue to generate excitement, and we will see more enter the clinic in 2024 — particularly for solid cancer indications, making use of innovative technologies and cell types including macrophages and NK cells. We will also see more iPSC-derived products reach the clinic for non-cancer indications such as eye diseases. This activity in part reflects positive changes in the US funding environment for CGTs. However, large-scale manufacturing of cell therapies remains difficult and costly, particularly across geographic locations. Despite the desire for regulatory harmonization, discrepancies between geographical authorities add complexity and cost, slowing development and limiting commercial potential. Transatlantic manufacturing partnerships can streamline shared processes, offering expertise on local regulations to accelerate trials run in both the U.S. and Europe.”
— Angela Osborne, Chief Executive Officer and Founder, eXmoor Pharma
"In 2023, we will likely see the first year of over $5B in global sales of cell and gene therapy products. While this represents a significant milestone for maturity of the field, manufacturing costs remain a major barrier to more widespread adoption of CGT products. We are seeing increased momentum towards a variety of orthogonal approaches to this problem, including (to name just a few) automated manufacturing systems, allogeneic approaches, in vivo CAR-Ts, stable cell lines, non-viral delivery, and capsid engineering for improved tropism. Given the breadth and depth of innovation represented by these approaches, I have no doubt that the field will find solutions to drive down costs and enable broader adoption of CGT products in the not-too-distant future.”
— Katy Spink, Ph.D., Chief Operating Officer and Managing Partner, Dark Horse Consulting Group
CAR-T will grow
“The compound annual growth rate for CAR-T therapies in 2024 is predicted to be around 19%. It is worth highlighting that there will be an increase on their use for solid tumours treatments, In vivo use of CAR-Ts and also for other applications such as lupus and other immune diseases. Moreover, several gene therapies are currently in their pivotal stages, and we expect regulatory decisions for them to be reached in the coming year. If, as predicted, these therapies are approved, non-oncology applications will gain relevance, reaching a much larger population. Finally, there will be an increase in the use of lentiviral vectors for in vivo applications, for the delivery of gene editing tools, for in vivo CAR-Ts and for vaccination, due to their capacity to induce long-lasting humoral immunity and high efficiency to transduce dendritic cells among others.“
— Natalia Elizalde, Chief Business Development Officer, VIVEbiotech
2024 will be the year of precision medicine for obesity
"We’re in the middle of an obesity drug gold rush, and the momentum is set to (escalate) continue into 2024 and beyond with an influx of pharmaceutical companies working to add a weight-loss drug to their development arsenal. This surge goes beyond the appetite-suppressing GLP-1s, as companies explore alternative mechanisms. As the race continues and more drugs are introduced, the need to apply precision medicine only grows. 2024 will be the year of precision medicine for obesity, to eliminate the trial-and-error approach and fundamentally transform the way we treat this pervasive disease."
— Mark Bagnall, Chief Executive Officer, Phenomix Sciences
Small molecules will shine
“Autoimmunity may reach epidemic proportions. This new awareness gives full importance to the treatment of these pathologies. Urgent action is needed. The efficacy of non-steroidal anti-inflammatory drugs and corticosteroids is compromised by the metabolic effects of long-term treatment. Therefore, small molecules which are active at very low doses and act on multiple intracellular pathways, have a bright future. The route of administration is critical and topical galenics, dermal, oral, buccal, transdermal, nasal, inhalation and subcutaneous can make a difference. The development of new drug delivery systems or advanced therapy medicinal products will enable the safe transport of small drugs to the target site. In 2024, some DDS and ATMPs, including carriers such as liposomes, degradable polymer carriers, cell carriers such as red blood cells, and exosomes, will receive regulatory approval, paving the way for personalized advanced therapies based on small molecules.”
— Carole Nicco, Chief Science Officer, BioSenic
Cough drugs will improve with the use of AI
“2024 will be the year of cough. Amidst the heightened presence of Covid and other upper respiratory infections, as well as other common diseases like COPD, cough is now being eyed as a vital that should be monitored the way we monitor blood pressure or temperature. Leveraging the power of AI, we’ve gained an understanding of the patterns of cough over time and the critical role of continuous monitoring. This year, we will see AI playing a major role in cough monitoring for pharma to measure cough drugs’ effectiveness for the first time.”— Peter Small, Chief Medical Officer, Hyfe AI
The mRNA field will expand
mRNA is currently one of the most versatile ways to address both infectious and noninfectious diseases. It’s no surprise that so many programs in phases two and three of clinical development are poised to hit the market in 2024. In the coming year, we’ll continue to learn about the effectiveness of these products across a vast range of disease indications. The data so far are compelling, so it's likely the year to come will set the field up for a great 2024, 2025, and beyond.
— Drew Burch, President, Nucleic Acid Production, TriLink Biotechnologies
RNA quality will be key to success of new modalities
“In the RNA field, people will now realize that quality comes before quantity. As new horizons open up, it is becoming clear that the quality of the RNA, from the design of the open reading frames, through the use of optimized untranslated regions to the intrinsic quality and purity of the produced RNA are key for the potential success of the new modalities. However, such quality is not achieved overnight and having access to parties that have been working in the field for multiple years makes a real difference, while also remembering that everything needs to be scalable and be suited for GMP manufacturing at a GMP certified partner.”
— Bernard Sagaert, Chief Executive Officer, etherna
Drugs will shift from injectables to oral/nasal platforms
“In 2024, a shift in the development pipeline will move from injectable vaccines to more accessible oral/nasal platforms. This transition aims to empower consumers by enabling at-home vaccination in a less invasive, welcoming environment. The move seeks to enhance adoption rates, eliminating injection-related fears and discomfort, improving compliance for vaccination programs. Oral platforms offer convenience, less invasiveness, and can be self-administered without medical supervision, particularly benefiting vulnerable populations. Developing oral vaccines is complex, and smaller biotech companies are well-positioned to lead. Medicated feeds will be a focus in 2024 for livestock vaccine research and development. Oral vaccines in animal feed offer efficiency, are less labor-intensive, and animal-friendly, preventing large-scale culling and curbing disease spread. The economic gains and ethical/environmental considerations make oral vaccines essential. Though funding challenges may initially hinder smaller companies, the urgency of this issue will likely drive a shift in opportunity cost, leading to innovation in healthcare by smaller biotech firms.”
— Kyle Flanigan, Chief Executive Officer and Co-founder, US Specialty Formulations (USSF)
Antibody-drug conjugates will keep making headlines
"Antibody-drug conjugates has been one of the most sought-after technology platforms in oncology. ADCs bring together a deadly combination of the highly specific targeting ability of monoclonal antibodies and high potent killing of cytotoxic agents. Big pharma M&A in ADCs have been on hyper-drive of late. Pfizer acquiring Seagen for $43B and Merck’s ADC partnership with Daiichi Sankyo for $22 Bn were two of the biggest deals of 2023. Chinese biotech companies have been the hotbed of ADC M&A activity, many big pharma companies have looked up to them for boosting their ADC capability. Few key deals include Bristol Myers Squibb partnering with SystImmune, BioNTech partnering with MediLink, GSK partnering with Hansoh, Merck partnered with Kelun Biotech. It is expected that ADCs would continue to be a very attractive space going into 2024 as well.
— Dinakaran Balasubramanian, Head Commercial Strategy & Insights, Biologics, Dr. Reddy's Laboratories
Manufacturing technology
Pharma will reimagine pharmacovigilance with tech
"In 2024, traditional challenges will persist in pharmacovigilance as case volumes grow without a corresponding increase in workforce. The broken PV model prompts companies to evaluate automation's role in operational improvement, though there's hesitancy towards technologies like generative artificial intelligence and machine learning. Companies must assess their processes holistically before integrating advanced automation, as adding it to inadequate processes provides short-term relief but jeopardizes long-term operations. The PV space, resistant to change, faces the dilemma of prolonged system validation. However, proactive shifts are essential, or change will be enforced. The upcoming year brings new market expansions and regulatory updates, complicating the balance between monitoring adjustments and handling case volume growth. Without fixing current PV models, the cycle of market complexity and hasty automation integration into insufficient processes will impede operations, necessitating organizations to reimagine their models."
— Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA
“Pharmacovigilance will shift to operate as a strategic partner in the coming year. A significant part of this shift will be thanks to automation and analytics, especially as adverse event data volume continues to grow with the increasing popularity of real-world data for signal detection. Targeted automation will be key in scaling operations without increasing costs or sacrificing data quality – especially for smaller, emerging biotechs with lean teams. Safety teams have traditionally garnered a reputation as an essential but often overlooked business function. As automation becomes the norm for safety activities like case intake and processing, we expect to see pharmacovigilance teams leaping out of the background and shifting away from their sole focus on compliance. Safety will take its seat at the table and increasingly partner with clinical, quality, and commercial teams to execute strategic initiatives like protocol design and product labeling. The time has come for pharmacovigilance to shine.”
— John Lawrie, Vice President, Veeva Vault Safety Strategy
“In the upcoming year, organizations will attempt widespread integration of generative AI in pharmaceutical safety processes. Full implementation in 2024 is unlikely, but organizations will gain profound knowledge of its capabilities for future pharmacovigilance enhancement. While automation, including generative AI, holds disruptive potential, there's a need for a deeper understanding of its impact and changes. Safety departments seek trust in technology accuracy, yet potential biases and inaccuracies pose significant barriers. The transformative use of generative AI in pharmacovigilance is imminent but not immediate. In 2024, organizations grapple with data inaccuracies in safety databases despite quality checks. The surge in cases requiring manual review prompts a reevaluation of the flawed human model filled with incorrect data, posing potential patient risks. Increasingly, organizations turn to technological solutions to reduce errors, cut costs, and shift pharmacovigilance focus from transactional data activities to risk management.”
— Michael De Jong, Vice President, Global Head, Professional Services for Pharmacovigilance and Regulatory Solutions, IQVIA
NGS will offer new levels of drug safety and quality
“Next-generation sequencing (NGS) stands poised to disrupt traditional virus contamination testing methodologies for biopharmaceuticals by offering a more comprehensive, sensitive and efficient approach. Unlike conventional methods that rely on targeted assays to detect specific viruses, NGS enables unbiased, high-throughput sequencing of nucleic acids, providing an unprecedented ability to detect a broad spectrum of viral contaminants in a single analysis. NGS allows for the detection of a wide range of viruses, including known and novel strains, without the need for prior knowledge or assay redesign. This flexibility is particularly valuable in an ever-evolving landscape of viral threats. NGS also offers the advantage of replacing traditional animal tests used in viral testing. Those tests are less sensitive, which is critical for ensuring the safety and quality of drug products, as even trace amounts of viral contaminants can have significant implications for patient safety. This disruptive technology has the potential to revolutionize how the industry safeguards the integrity of biopharmaceutical products, offering a powerful tool to identify and address viral contaminants with unprecedented precision.”
— Olaf Stamm, Ph.D., Senior Business Development Specialist, Charles River Laboratories
Tech will help break down CGT silos
“Cell and gene therapy technologies, indications served, and regulatory approvals continue to grow, with over 1,500 clinical trials in progress. However, developers still struggle to affordably make enough doses. In 2024, we expect an increased focus on getting the most from blood, the starting source for manufacturing these life-saving drugs. Progress this year will result from standardization to improve efficiencies at every stage between blood product collection and finished therapeutic dose. Leveraging data gleaned from our devices during apheresis, cell expansion and fill-and-finish, we partner with academics and drugmakers to develop and optimize methodologies for each therapeutic purpose and share the results. More and more, the CGT industry has embraced this effort of breaking down silos, and collaboration will be crucial going forward. We owe it to the donors who donate a part of themselves to generate these therapies, and to the patient's awaiting treatment.”
—Veerle d’Haenens, General Manager, Global Therapeutic Systems and Cell Therapy Technologies, Terumo Blood and Cell Technologies
Plants will focus on automation, digital solutions and connectivity
"While interest and adoption of artificial intelligence and machine learning will continue to grow, this year we’ll see biomanufacturers taking more concrete steps to enable the best outcomes. We know it’s coming so how do we prepare? That’s by placing a strategic focus on data management. There is no AI/ML without data that is good, accessible and actionable. Organizations need to ask themselves: ‘How do we optimize our systems? How do we automate and centralize our processes?’ This year, the focus will be on the connectivity and interoperability of systems so that data is automatically collected, uploaded, and compiled centrally for AI/ML to have beneficial outputs. Overall, this industry has been the most reluctant to adopt automated technology for a host of reasons, so you won’t suddenly see a switch. Each plant will be starting at different points. Total adoption will take time."
— Nicolas Pivet, Automation, Controls, Digital & Learning Solutions Leader, Cytiva
“In 2024, the pharma market will continue shifting towards high-value drugs, particularly those meeting the growing demand for obesity and weight management. Concurrently, the rise in biologics is poised to lead the market. Each of these products necessitates the use of syringes, cartridges, vials, or devices, demanding accuracy in assembly and quick inspection for quality assurance. We are in front of a very diversified scenario. Vaccines and blockbuster drugs are produced in large batch sizes, while biologics, biotech drugs, gene therapies, and mRNAs are high-value products made in smaller batches. This dynamic demands a flexible manufacturing strategy to control the variables influencing the processes. Automation and digitalization are increasingly emerging as key trends in manufacturing, helping pharma companies reach higher product quality, enhanced performance, increased customization, and time savings. These advancements can improve inspection accuracy, boosting detection rates while minimizing false rejection rates.”
— Alessandro Zannini, U.S. Sales Director, Stevanato Group
“The pharmaceutical industry has been lagging in its adoption of Industry 4.0, while manufacturing in general is already in the process of adopting Industry 5.0. Initiatives such as Process Analytical Technology (PAT) gained considerable attention from the pharmaceutical industry when they were launched about two decades ago but have yet to see broad adoption. However, the advent of continuous manufacturing (particularly in biomanufacturing) is fueling renewed interest in PAT. In 2024, I would expect a significant increase in PAT implementation in commercial pharma manufacturing. Another worthwhile trend will be adoption of artificial intelligence/machine learning-based tools in biomanufacturing for process modelling, data analytics, and process control. It is time that the industry figures out how to glean process knowledge from the hordes of data generated in modern-day manufacturing facilities. To quote mathematician Clive Humby, ‘data is the new oil.’”
— Anurag S. Rathore, Ph.D., Editor-in-Chief, The AAPS Journal
“We see companies making great progress toward achieving a ‘digital plant.’ Development of digital manufacturing strategies leveraging new technologies like cloud, artificial intelligence, and advanced analytics will create new capabilities to help deliver required business outcomes. As companies progress, their success will require strong collaboration to connect technology, people, and processes across the value chain."
— Kristel Biehler, Vice President, Life Sciences, Emerson
“Though all the media buzz centers around AI the challenge for biomanufacturers has been how to securely collect and transmit plant floor data to powerful enough systems for analysis (the cloud), while remaining compliant with regulatory requirements. Major advances in connectivity and cloud computing power enable us to collect, process and analyze all this connected data from our plants. ‘Smart’ devices and the Internet of Things are smaller technological contributors. AI can now leverage this data for deep-dive insights to enhance efficiencies like never before. Along with regulatory compliance and data integrity, an additional challenge for biopharma is the culture change necessary for data-driven decision making. Legacy paper documentation compliance methods left behind slow-moving processes for efficiency and quality improvements. Biopharma leadership must implement these digitalization solutions to improve productivity and meet regulatory requirements, and continuously evaluate the role of data in future optimization or innovation.”
— John Fisher, Director, Global Engineering, Avantor
“We will see digitalization with AI capabilities solve real production headaches for pharmaceutical manufacturers in 2024. Because AI is a game-changer in the way humans interact with data, it empowers pharma manufacturing organizations to produce more efficiently. Today’s pharma manufacturers benefit from a huge amount of data, and thanks to cloud approaches, data is available at all levels of the organization but remains siloed and rarely used by frontline workers. AI will reshape how seamlessly front-line workers use data, even unstructured text. User interfaces provide functions such as smart searches that utilize natural language processing to lift decades of knowledge within seconds. This allows shop floor workers to prevent non-conformities before they occur and find the right solution to improve continuously. AI unleashes the full potential of humans in an Industry 5.0 concept—fully informed to reduce risks, ensure patient safety, and increase production.”
— Andreas Eschbach, Chief Executive Officer and Founder, eschbach
Biopharmas reimagining big data will leap ahead of the crowd in personalized medicine
"Life sciences has been waiting a long time for big data to significantly change the commercial viability of personalized medicine. With automation maturing, research and development teams can seize the opportunity — but only if their big data is clean, standardized, interoperable and secure. This year, organizations will focus on making big data (ranging from raw trial and site-specific data to IT data points, such as cycle times) more usable by addressing common challenges around cleaning data, who owns it, and standard approaches to managing it. The outcome will lead to study data volumes increasing exponentially. This will require a transparent data model with strict user access controls to address data privacy and cybersecurity concerns. Automation will help industry leaders make hundreds of marginal and incremental efficiency gains across the development life cycle, whether deep querying protocols, detecting patterns during medical imaging analysis, or verifying the origin of chemical components. A growing industry impetus will lead to more direct data APIs between sponsors, health institutes and regulatory authorities so that 'big (clean) data' becomes a reality, creating the right conditions for commercially viable, personalized medicines to reach patients in need.”
–Stephan Ohnmacht, Vice President, Veeva R&D Business Consulting, Europe
All pharma stakeholders will leverage tech
"2024 will bring more approvals of CGT products, potentially for indications such as solid tumor cancers and autoimmune conditions with larger patient populations. To assist CGT developers scaling-out these therapies, 2024 must be transformative for partners who support the supply chain. To serve much larger patient populations, every efficiency available must be leveraged. Expect the adoption of cutting-edge technologies such as machine learning, AI and automated manufacturing processes, to increase, particularly around manufacturing, scheduling, and patient engagement. This year is going to be a year for innovation and development for those supporting CGT scale-up across multiple territories and product types.”
— Akshay Peer, Senior Vice President Product, TrakCel
Plant floor digitalization will mature
“Manufacturing facilities will increase the pace of digitalization as they look to adopt advanced technologies like predictive analytics and artificial intelligence. The implementation of robotic automation in more areas, including distribution, will improve cost to produce and delivery times. Smaller, finely-tuned, vertical-specific large language models will make the use of generative AI in manufacturing a reality. With greater digitalization, access to real-time data for the supply chain, manufacturing hangups and non-compliant processes, pharma manufacturers can improve their efficiency by 50% or more in 2024. AI is expected to revolutionize the industry by making it faster, more efficient, and more cost-effective to analyze and action the data. The final consideration is around IIoT. The industry will finally begin to see the fruits of standardization rather than continue in a state of disparity that hampers the digital revolution that needs to occur in manufacturing.”
— Matt Lowe, Chief Strategy Officer, MasterControl
Pharma will look to digital condition monitoring to proactively spot issues
“When it comes to managing industrial processes, the industrial internet of things environment continues to be a game-changer. It enables operations to closely monitor equipment performance and analyze data that affects the process results. One of the crucial aspects of ensuring smooth functioning of chemical and pharmaceutical vacuum systems is digital condition monitoring. This process uses various sensors and software tools to detect abnormalities in the system. By identifying potential issues before they become major problems, these tools can help reduce downtime, maintenance costs, and total cost of ownership. This is critical for success in 2024 and the future.”
— Alex Hintsman, Business Development Manager, Chemical and Pharmaceutical, Busch Vacuum Solutions
“The pharma industry will want OT (operational technology) for their distributed control system and IT for their manufacturing execution system which we call smart factory (note, previously you had one or the other; OT or an IT connection). Condition monitoring tells manufacturers that there is a risk of process(es) going out of control. This information is now simultaneously available on the network to both OT and IT systems to act early before mistakes enter the production stream. Trends in manufacturing include increased use of OPC UA in production and the development of products that produce more relevant production data. Additionally, there is a rise in the use of industrial Ethernet to replace analog sensor signals for more data and condition monitoring, as well as an increased focus on security functions in manufacturing.”
— Jeff Holcomb, Industrial Automation Market Manager, Mettler Toledo
Manufacturing platforms will help drugmakers meet demands
“Platforms and modular devices to automate labor-intensive processes will become increasingly important for manufacturing multiple batches in parallel. Devices reducing manual labor and come with integrated sensors for online monitoring of process parameters will play a crucial role in meeting the rising demand for small and even personalized batches. CROs and CDMOs will need to work together to choose manufacturing platforms at early developmental stages. Developers of devices will start to collaborate to create standardized interfaces for hardware and software.
— Joel Eichmann, Co-founder and Managing Director, Green Elephant Biotech
“In 2023 many cell and gene therapy companies were exposed for CGT manufacturing inefficiencies that wasted investor money and contributed to many CGT business failures. The primary cause for CGT manufacturing inefficiencies is reliance on overly complicated technology to deliver oxygen and nutrients to cells and a lack of high throughput manufacturing experience. If CGT manufacturing follows historic trends of well-established drug products, a reckoning is coming where the CGT industry will galvanize around the simplest and most repeatable manufacturing platform technology.”
—Josh Ludwig, Global Commercial Director, ScaleReady
“Despite recent funding obstacles, the biologics and sterile injectables markets continue to experience strong tailwinds and have demonstrated resilience during a challenging period. For more traditional biologics, like recombinant protein and antibodies, bispecific mAbs and fusion protein will continue to make progress, and the traditional mAb platform will continue to produce more productive expression systems and more intensified processes that produce higher yields. These advances allow us to do more with less — specifically, being able to manufacture in single-use bioreactors at a smaller scale. In CGT, we’ve seen a maturation of the space as more cell and gene therapies advance through the clinic to later stages and commercialize to address unmet patient need in larger patient populations (ex. sickle cell, hemophilia, type 1 diabetes). Similar to proteins, the improvement of platform processes should help ensure that innovators can efficiently develop and scale their processes for clinical and, ultimately, commercial supply.”
— Victor Vinci, Ph.D., Global Vice President, Product Development, Catalent Cell, Gene & Protein Therapies
Each year, we ask industry leaders to share their predictions with us. This article delves into the anticipated trends for 2024, from the transformative role of AI in drug development to regulatory shifts to watch. Read part 2.
