As advanced technologies begin to replace outdated systems and the demand for specialized medicines increases, the pharmaceutical industry is perfectly positioned to embrace the next generation of manufacturing. In 2024, we can expect to see business model changes led by the rise of patient-specific therapies and a deepening reliance on modern, digital manufacturing systems to improve operational efficiency and increase ROI. Cloud-based systems and real-world data fueled by artificial intelligence (AI) will remain driving factors that shape the industry’s future, while regulatory guidance from the FDA fuels the interest in innovative systems that can digitize and modernize processes while safeguarding quality. While innovation soars for pharma in 2024, organizations will also invest time and resources into building out robust security measures to protect their growing data sets. Despite the many scientific and technological advancements, the industry has forecasted slimmer budgets and the need for shorter manufacturing timelines in 2024. Truly successful teams will map their innovation paths to their use cases and adopt solutions that fit their goals and spend.
In the sections below we’ll explore these industry trends and others and in greater detail. Below we provide a top 10 impactful trends that pharmaceutical leaders should consider.
1) The Specialized Drug Market will Expand
In 2022, 34 percent of all newly approved drugs were labeled as personalized therapies, which uses an individual’s unique genetic profile to guide medical decisions around the diagnosis, prevention and treatment of a specific disease. This unique treatment process can identify patients who are most likely to respond to a particular treatment, while sustaining the lowest level of adverse effects. Due to its potential to revolutionize disease treatment and improve overall patient outcomes, this unique drug modality is expected to see continued expansion well into 2024.
According to the Alliance for Regenerative Medicine, there were six regulatory approvals of a cell or gene therapy between the U.S. and the EU as of August, 2023. Nine additional therapies were scheduled for approval the same year – matching the number of approvals by the FDA in the previous five years combined.
In December of 2023, the FDA announced the first set of approved cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. One of these therapies includes the first FDA-approved treatment to utilize a novel genome editing technology, marking a major innovative milestone for gene therapy.
In 2024 stakeholders will continue to invest in differentiated advanced therapies such as cell and gene therapies, and regenerative medicines. The improvement of biomedical science, paired with greater access to purpose-built, intelligent pharmaceutical technology will be a driving force for this sector.
“If doctors know your genes, they can predict drug response and incorporate this information into the medical decisions they make.”
Dr. Rochelle Long, a pharmacogenomics expert at NIH
2) Leaner Business Models
While the pharmaceutical industry is expected to operate on leaner budgets heading into 2024, big investments in emerging markets, biologics and speciality therapies will take over portfolios. As drug discovery, development, and even delivery become highly precise and individualized processes under advanced therapies, organizations will have to work harder to ensure that treatment plans for a targeted therapy are highly accurate for the individual patient. New drug modalities will compete against traditional drugs in both R&D and commercial sales. As treatments advance through development pipelines they hold immense potential for the early biopharmaceutical teams that actively pursue them.
“To date, annual sales for new modalities (excluding mRNA) have reached approximately $20 billion, boosting the overall market cap for biopharma companies by more than $300 billion.”
- Boston Consulting Group
New drug discovery has changed the traditional pharma portfolio, making way for niche drug therapies and making generic blockbuster drugs a thing of the past. Historically, a drug company could release a treatment, market it and grow it into a billion dollar franchise, but that landscape has changed. In 2024, we can expect to see the rise of biotech startups, in addition to non-traditional, tech-focused companies stepping into the biopharma industry. Mergers and acquisitions should also see an increase after a steady decline, pending interest rate movement.
Most significantly, data will become invaluable as part of the entire drug lifecycle, making it a key area of investment for businesses. Speciality therapies will rely heavily on real world data and evidence to support their findings. As a result, new investments in real world data management, collection, and generation will be made, as companies look to demonstrate economical value in treatment options.
3) Big Data and Analytics will Drive Efficiency
We are at an inflection point as new technology trends accelerate and change the pharmaceutical market. In manufacturing, integrating big data from R&D and various manufacturing units can reduce time to market and improve quality. This allows for more accurate, real-time data performance, which enables leaders to make better decisions around inventory, processes, and quality that impact the next generation of manufactured products.
In a 2023 NewVantage survey, 83.9 percent of executives indicated that their organizations would increase investment in data and analytics, in spite of potential economic uncertainty. Key interests for stakeholders in 2024 will include Data Modernization, Data Quality and AI according to respondents.
Big data investments will continue to increase as software capabilities evolve to catch up with complex modalities and the industry begins to derive business value from data collection and analytics. 2024 shows immense promise for harnessing data to drive and expedite clinical research and drug development in particular. The true measure of this trend’s success will lie in whether or not a business can realize value at every single stage of the business function, or if results will be isolated.
“The increased availability and use of big data and large language models to make data-informed decisions is ushering in a new era of possibilities.”
– Jessica N. Berrellez, Executive Officer, Food and Drug Administration
4) Digital Transformation Becomes a Must Have
Paper is a thing of the past and cloud-native technology has become standard. Aside from its high cost, paper can’t prevent human error or make it easier to record and search documentation. This leaves teams vulnerable to deviations incurred during tech transfers or batch production, which directly impacts drug quality and a company’s bottom line. With budgetary constraints already plaguing the industry, organizations have no room for error and no time to waste on outdated processes.
Notably, small and medium-sized pharma companies (SMBs) stand to gain the most from this shift toward the cloud and digital innovation, as they look to gain new opportunities for more informed decision making, better data management, and cost-cutting in 2024. With new tech platforms offering everything from an entry-level digital kickstart program, to a revamped end-to-end product lifecycle digitization plan, or an enterprise-wide digital initiative that connects and optimizes processes across sites and teams, system modernization continues to be a must.
16 out of the top 20 pharma companies leverage cloud technology. [Source: McKinsey]
The FDA continues to push pharma organizations to modernize operations in order to foster innovation, increase quality and improve supply dependability. Organizations that kickstart their digital initiatives early can expect to see a major reduction in batch release time, batch review, data entry and deviations, not to mention the significant cost savings attributed to each.
“By 2027, 80% of manufacturing operations management solutions will be cloud-native and edge-driven, closing the IT/OT convergence gap.”
5) AI will Accelerate Drug Lifecycles
AI is undoubtedly shaping the future of critical industries, with immense potential for accelerating drug discovery and development, delivering new cures to patients around the world. The continued digitization of therapeutics will increase the velocity of drug discovery and development for AI treatments, resulting in even more clinical trials and cures.
AI-powered tools can identify new drug targets, predict clinical outcomes, and improve personalized treatments. In 2023, the first AI-generated drug entered clinical trials for human patients. Industry leaders will likely continue to incorporate AI and analytics into early-stage drug discovery and clinical development in an effort to shorten go-to market timelines.
The entire drug lifecycle is expected to pick up pace, as AI is leveraged for optimizing manufacturing processes, eliminating extensive scale up times and helping organizations stimulate growth despite budget constraints. AI tools will help executives gain deeper insights, identify areas of improvement, make data-driven decisions, and bolster overall productivity.
In fact, the global data analytics market is projected to surpass around USD 393.35 billion by 2032. That’s a big investment in technology that made big headlines in the second half of 2023. While the industry may still struggle in the early part of 2024 for clear ways to apply AI to existing processes without disrupting compliance protocols, this technology has the potential to accelerate and streamline drug manufacturing in a meaningful way.
6) Privacy and Security Beef Up
As the pharma industry advances their digital innovation programs and shifts toward a data-driven culture, more robust privacy and security frameworks will be needed. In 2024 we’ll see the emergence of teams responsible for developing more robust security models responsible for safeguarding pharmaceutical innovation. As excitement builds around greater introduction of AI it’s important that security measures advance alongside the technology. Overall, organizations should be looking to create an ecosystem in which data collection and analysis are conducted in a secure, vigilant environment.
The Zero Trust cybersecurity model has emerged as the gold standard for not only promoting software assurance within highly regulated industries like pharma, but for safeguarding digital networks that leverage intelligent, emerging technologies. The Zero Trust approach – an approach implemented by the U.S. Department of Defense (DoD) and encouraged by the U.S. FDA – is a highly effective and comprehensive practice that assumes no user or device is trustworthy.
In addition, we will see AI tools and machine learning technology used for cyber detection to improve response capabilities. The industry will see greater resources invested in addressing evolving cyber threats, identifying vulnerabilities, and establishing ways to mitigate risks to its infrastructure and proprietary data.
7) Outsourcing Expands with a Digital-First Approach
Contract manufacturing has seen a marked uptick in expansion throughout 2023 as a flood of new therapies continue to enter the market. In particular, digital drug companies using AI to discover thousands of new drugs will rely entirely on CDMOs for their manufacturing.
In addition, deeper R&D investments, patient expirations, and active pharmaceutical ingredient (API) complexity will remain key drivers for CDMO growth, allowing their customers to easily expand their geographical presence, decrease resource costs, and enhance on-demand services.
In turn, contract manufacturers will turn to digital, agile technology platforms that can help them continuously enhance both efficiency and capacity in order to keep up with the growing demand for their services. Ideal CDMO partners for digital-first sponsors will follow the same innovative approach, leveraging reliable, collaborative manufacturing systems that can easily facilitate tech transfers, share master data, and ensure quality.
8) Manufacturing Siloes will Come Together
The pharma industry has become more siloed and segmented than ever before. Multiple sites, teams and outsourced partners are now a part of manufacturing of a single drug product. As manufacturing systems advance and collaboration emerges as a key element in connecting distributed internal and external teams, we’ll see the rise of end-to-end digital platforms that can bridge the gap between siloed teams.
Systems that can leverage enterprise-wide recipe templates, perform seamless tech transfers, and securely manage product life-cycle data across all networks, will prove invaluable to stakeholders looking to accelerate manufacturing capabilities. Organizations will be able to shorten their product lifecycle stage, cut down training time, consolidate point solutions and gain greater operational visibility overall.
9) The Workforce Gap will Widen
Recent research from the Alliance for Regenerative Medicine (ARM) highlights a growing workforce gap in skills needed for employees working within the key areas of the industry, such as development and manufacturing. If left unaddressed, this trend could threaten the industry’s ability to maintain its path toward digital maturity and deep innovation. Some key concerns include: the growing number of clinical trial programs misaligned with hiring motions, all-time high turnover, and the greater need for trained talent. Even the FDA is admittedly backlogged due to understaffing, leading to a diminished capacity to review the influx of submissions.
Heading into 2024, Organizations should look to establish a connected workforce with strategies that accelerate digital skills across all areas of the organization. Onboarding leaders should continue to prioritize time to competency and create a cross-functional program with leaders from IT, HR, sales, customer service and supply chain. In order to increase appeal, organizations will want to incorporate intelligent technology into their processes, and use platforms that offer workflow recommendations to help users accomplish what would otherwise be impossible within existing constraints. Systems with built-in automation and AI will also enable teams to manage more complex issues, creating greater overall efficiency and workforce satisfaction
10) Greater Investment in Sustainability
Rounding out our top 10 is a deepening commitment to sustainability. Technologies that drive greater sustainability, reduce the reliance on paper and can lessen unnecessary material waste will continue to rise in popularity as teams look to get greener in 2024.
Cloud-based systems eliminate the need for heavy server systems that take up more space and require more power and maintenance while digital tracking can help ensure that ingredients and resources are managed properly before their expiration.
From raw material cultivation to drug disposal, the pharma industry’s carbon footprint is considerable. The need for sustainability has become more apparent in recent years as global concerns about climate change continue to grow. Pharma systems with collaboration and remote support embedded in the platform have emerged as a solution for greatly reducing the need for travel. Partners, stakeholders, subject matter experts and equipment vendors can all connect, problem solve and effectively plan across one shared system.
“The pharmaceutical sector is accountable for 4.4% of worldwide emissions — and if no action is taken — its carbon dioxide emissions are predicted to triple by 2050.”
-Health Care Without Harm
Practices such as green chemistry, which aims at reducing the amount of excess by products and hazardous chemicals generated during manufacturing, is another approach that organizations may continue to consider in the future. By using safer chemicals, organizations can reduce the risk of harm to human health and the environment.
Despite economic pressures, the pharmaceutical industry is poised for massive innovation and steady growth across R&D, Development and Manufacturing heading into 2024. New drug modalities and the rise of smaller firms will continue to shape the future of the industry and the technology it adopts in order to keep up with demand. Companies that can adapt to changing market conditions and understand the impact that modern, agile systems can have on efficiency and quality stand to have the most potential for success.
As talk of modernization sweeps the industry, innovation leaders at leading organizations will continue to turn to qualified vendors for a digital maturity roadmap that matches their use cases and budget.
Looking for a modern, end-to-end, manufacturing system with capabilities that can help you achieve the quality, efficiency, and results you need? Click here.
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