One step forward, three steps back. That’s how the last few years have felt.
Despite significant scientific advances made throughout the pandemic, during the last months of 2021, it became increasingly difficult to hold on to the idea of a post-COVID world. Long were the days of collective hope of a swift end to the pandemic, and between variants and a breakthrough case-filled holiday season, 2022 began to sound and feel like we could be living a second round of 2020.
As pharma — and the rest of the world — embraces the new normal, how we paint a forecast of the future has become more conservative, but at the same time, not devoid of promising advances. Here’s how industry experts say that the pandemic will continue to push the limits of pharma, from drug development to plant floor manufacturing.
Therapeutic innovations
Alzheimer’s disease treatments will continue to make headlines
"Several potential blockbusters are lining up to reach the market in 2022, with Alzheimer’s disease poised to provide plenty of regulatory news. Lilly and Roche are striving to join Biogen on the market with their respective projects, although whether this happens next year depends on the FDA’s continuing support for accelerated approvals and on Roche’s willingness to file biomarker data."
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Continued focus on advanced therapies
“Biologics and cell and gene therapy manufacturing are potentially entering a hugely profitable period, but one where greater capacity will be needed....The U.S. is a long way clear of its next nearest rivals – Germany and Japan – demonstrating the country is leading the charge on advanced therapies via it's hubs in Philadelphia, Boston and California."
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Allogeneic therapy could revolutionize cell therapy research
“The potential of allogeneic T-cell therapies is becoming clearer in our field, and the development of cell product inventories that are not restricted by one-at-a-time autologous manufacturing processes may make this remarkable science accessible to more patients with cancer and autoimmune diseases like multiple sclerosis. Recent landmark studies provide compelling epidemiological and molecular data that the Epstein-Barr virus triggers the onset of MS. Cell therapies that target EBV-infected B cells and plasma cells are now in development for progressive forms of MS.”
Plant-made pharmaceuticals will hit big
“The emergence of plant-made pharmaceuticals will hit the mainstream in 2022. This long-valued platform has been around for three decades but the ability to manufacture in weeks, not months, is finally a MUST, not a nice-to-have. Our friends at Angany and Medicago announced successful vaccine trials using plants and Kentucky Bio's recent announcement have us applauding new projects and deals in the plant-made space in 2022."
A focus on targeted protein degradation
“There is a lot of mileage left with existing drug technologies that will help to temper expectations for the biotechs at the cutting edge of genetic science and provide balance in big pharma pipelines. 2022 will be big for the clinical validation of targeted protein degradation.
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Humira will stay on top
“Outside of pandemic-related products, Humira is forecast to cling on its crown as the biggest selling drug. However, 2022 will be the last year of largesse for Abbvie’s anti-rheumatic, with biosimilars due to arrive in the US in 2023.”
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RNA technologies will help combat disease with more versatile and faster-to- develop molecules
"The pandemic thrust mRNA technology into the spotlight, rapidly catalyzing years of research into life-saving vaccines. But as our survey data shows, that’s just one slender chapter in a complex story. More than one-quarter of respondents are pursuing or plan to pursue RNA therapies across a wide array of indications, from autoimmune diseases to oncology. As their pipelines mature, these companies face new questions about supply chain management, facility design and scale-up."
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Supply chain
Leading pharma organizations will make their supply chain more resilient
“Drug manufacturing is a complex, unforgiving process; making it more reliable and resilient to supply and demand shocks is essential. One area to address is empowering manufacturing with the tools to enable sites, giving them real-time data and problem-solving capabilities, to make local decisions. Manufacturing organizations must be able to measure and act on production performance in real time, to be able to shift production when needed to other sites across the globe.”
Pharma's need for verifiable cold space will continue
"Through my work in the cold storage industry, I am finding that the vast majority of facilities managers extend the rental contract long after the original commitment. There are many factors for these extensions; flexibility, efficacy, supply chain issues, continued uncertainty and realizing our clients can’t do without verifiable cold space."
Used manufacturing equipment will help meet supply chain demands
“Used manufacturing equipment can be operational in weeks instead of months or years. We have even found ourselves scouring the globe for equipment needed to scale COVID-19 vaccine production. The pandemic has shined a new light on the value of used pharmaceutical manufacturing equipment, and many companies will continue to rethink its strategic place in their procurement plans for years to come.”
Justin Kadis
Transparency into how medications are manufactured and handled will be important
“The results of our Pharmaceutical Supply Chain Vision Study found that patients expect drug manufacturers to disclose how their medications are manufactured and handled, as well as transported and stored. This shift in the industry will continue to grow this year and we can expect to see more manufacturers taking additional steps to provide assurance to consumers about their medications in order to win their trust in the supply chain.”
NFCs will help improve monitoring of medicines
“[We will see] increased popularity of providing information through Near Field Communication. This tool can inform patients about correct dosage, time spans, a reminder regarding prescription, and any further instructions. Pharma companies can use it to facilitate a patient-oriented environment and improve monitoring of currently distributed medicines.”
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Continuing supply chain disruptions will demand increased speed to value solutions
"Pharma companies will move more towards continuous manufacturing both to increase capacity and to alleviate supply chain constraints. Having battled disruptions for nearly two years, pharma manufacturers will also be eager to invest in solutions that quickly provide insight into their internal and external supply chains. Production, and the health and performance of the machines that power it, have previously been a hidden supply chain risk even though the failure of a critical machine can have a major upstream and downstream impact. Manufacturers need to know just how hard they can push their machines during demand spikes and other disruptions.”
Manufacturing technologies
Manufacturers will focus more on transforming continuous processes
“With much discussion about the benefits of moving from batch to continuous manufacturing for improved quality, throughput and yield, it is important manufacturers put the right technologies in place to optimize the latter approach. Process performance monitoring becomes a network of online models supervising desired operational indicators and key performance metrics. The models will provide automated 24x7 insights and propose adjustments for continuous processes. At the same time, batch control solutions are emerging that can predict batch results and anticipate deviations from target and automate corrective action, enabling more consistent efficient operations.”
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Continued demand for aseptic processing
"We saw strong growth in the use of advanced aseptic single-use technologies throughout the pharmaceutical space in 2021. Driven by strong global demand for sterile manufacturing capacity, we can expect this to continue into 2022. Given the arrival of the omicron variant, demand for aseptic processing shows no sign of abating in the New Year – it will be needed to support the effort to produce vaccine boosters and to provide treatments for the many patients still hospitalized by COVID-19.”
Ben Wylie
Vendors get creative with cleanroom solutions
“The Pharma Manufacturers' dilemma (build versus buy) has plagued the industry for years. In 2022, innovative solutions such as cleanroom leasing will help overcome this problem. Pharma companies will be able to respond more quickly with the development of treatments and therapies. They’ll also be able to scale their business and control costs, free from the horns of the manufacturers’ dilemma."
Engineered enzymes will make manufacturing processes greener
“The adoption of engineered enzymes for more efficient, safe, and environmentally friendlier manufacturing processes will continue to accelerate among pharmaceutical API manufacturers, and transformation efficiency is the primary reason for the growth. Process developers can skip several steps typically required when using chemical catalysts because there is no need for protective group chemistry or substrate activation. Additionally, enzymes’ extraordinary selectivity facilitates high conversion efficiency, yields and purity levels, and fewer byproducts.”
Manufacturers will bet on AI solutions to grow capacity
“This is the year in which manufacturers will have the courage to bet on data aggregation and AI solutions that help them grow their capacity, moving away from pilot mode and embedding those tools as foundational assets, which will become critical levers to support the expanded demand for drug manufacturing, especially exacerbated with the emergence of the COVID-19 pandemic.”
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Collaborations will create a more sustainable future
“This year, especially considering all the manufacturing lessons COVID taught us, we will see more biopharma companies seeking ‘team extensions’ and support models that can help them expand their capacity without adding new hires. Expertise from supplier and technology partners will bridge the gap between what’s successful in the lab to something that is technically and economically sound at production scale. These heightened collaborations will bring novel modalities to the market in a more efficient and economical way.”
— Mandar Dixit
Pharma will continue to embrace advanced manufacturing and information solutions
“The pandemic forced everyone’s attention to attaining better operational risk profiles and prompted renewed efforts to implement the digital technologies and analytical tools needed to avoid disruptions. This industrial and digital disruption is a recurring theme in pharma and a bigger picture issue – a change the industry will continue to reckon with.”
— Tom Wilson
Investments will accelerate digital transformation
“While faced with the requirement to reduce the cost of bringing products to market, clients are planning investments that will accelerate their digital transformation journey. When considering investments, clients are particularly interested in integrated, ‘full-stack’ solutions that support Manufacturing 4.0. Additionally, this global industry has been faced with supply chain issues during the pandemic, driving interest in regionalization of manufacturing capabilities – a focus that is also enabled by technology investments.”
Rapid adoption of IIoT-enabled solutions will help pharma meet quality goals
“Some pharmaceutical companies have had to address complex process challenges during the past couple of years while mass-producing an effective and safe vaccine at a historical pace. The rapid adoption of IIoT-enabled solutions — such as automated operations, simulations, and self-service data analytics — will help pharmaceutical organizations meet their operational and quality goals.”
Digital twin applications to become more commonplace
“Asset Management, Artificial Intelligence, Machine Learning, and Digital Twin applications become more commonplace, based on the additional access to all machine and process variables. Leveraging TSN technology with open-architecture industrial network solutions is key to being able to connect a multitude of disparate devices and networks into single network architecture. Pharmaceutical manufacturers will be able to analyze and transform the data from these devices into useful information that can be accessible to cloud-based applications in the IT world.”
Drug development
More R&D labs will go remote
“The pandemic forced everyone to work from home except for those who couldn't, and that included bench scientists in R&D labs. But as remote laboratory capabilities become more available and user-friendly, pharmaceutical companies and contract research organizations will look for ways to bolster scientists' ability to work from home by seeking services from cloud laboratories and other purveyors of smart technologies. This will not only improve safety, but it will also save time by enabling scientists, now free from the constraints of operating within a physical laboratory, to run experiments from anywhere at any time."
Cell therapy developers will seek more ways to “fail faster”
“It’s likely that companies will seek to speed up the failing process by adopting more sensitive and accurate molecular testing tools like digital PCR technology that deliver results in real-time. Tools like these will help researchers identify viable cell lines and screen out ones that are likely to fail in later stages of clinical development, thereby saving valuable time and money.”
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Demand for integrated drug substance and drug product services will grow
“We’re seeing a greater desire to move deeper in development toward proof-of-concept. Biotech’s want to have confidence in drug substance and drug product suitability for development, mitigating risks for commercialization and in turn driving up their valuations. This means we’re observing strong demand for integrated drug substance and drug product services — to help biotech’s accelerate development programs, anticipate downstream challenges, and improve the likelihood of clinical success.”
Oral solid dose form therapies to gain traction
“OSD has long been one of the most popular and prescribed dose forms in the industry, due to relative ease of delivery and preference by patients. Although the majority of emphasis in 2020 was on Covid-19 vaccine development, we have now seen the emergence of oral antiviral treatments for Covid 19, as well. In December of 2021, the U.S. FDA issued two emergency use authorizations for antiviral pills — Pfizer’s Paxlovid and Merck’s molnupiravir. The first OSD form, compressed sodium and potassium carbonate tablet, was invented in 1843, by William Brockedon of the UK. Since that introduction the OSD manufacturing process has greatly advanced and the compressed tablet is the most popular dosage form in use today — nearly two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets”
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The COVID-19 pandemic will have a lasting impact on clinical trials
The ongoing pandemic has stepped up the need for decentralized clinical trials. Clinical trial participation is being introduced to a broader audience for greater drug discovery with a more diverse and remote patient population. Trial conduct, data integrity, data formats, and frequency of collection are changing. High-quality technology and technical support will be necessary to continue producing exceptional clinical trials. Clinicians will embrace telemedicine and eCOA plus ePRO technology tools. Data collection, validation, and analysis methods will become key in drug development and trial evaluations. Standardization methodologies now come to the center stage to ensure that the data collection workflow from the patient and the site is streamlined, and data can be standardized irrespective of the source of the data.
Regulatory changes
AI will help meet regulatory demands
“We envision specific guidance prepared by the administrations where good AI/ML practices will support its implementation in biopharmaceuticals. We anticipate more diverse initiatives to validate AI models for biopharmaceutical applications not just in papers and guidances, but also in applications.”
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Paper-based quality systems will become obsolete
“As companies’ network of outsourcing partners, workforce working from home, and/or business unit sites have expanded, quality management systems had to be consistent across all sites and CMOs/CDMOs. To ensure that accurate quality data across business units and global sites are accessible in real-time, legacy paper-based quality systems will become obsolete, and new integrated cloud-based QMS delivery and audit management systems will be implemented to interface with all supply chain SAP platforms enabling real-time data review and observation response.
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2022 will reward interoperability and openness
“Sponsors, CROs and trial sites continue to struggle with siloed workflows and data sets. It's unrealistic for a single technology vendor to solve everything within clinical development, yet some still operate in a ‘closed’ model, which only holds the industry back. 2022 will continue to reward technology vendors that bake interoperability and openness into their platforms.”
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