Amazon Omics: A new age of clinical research is rising
Discover the latest clinical research trends in Amazon Omics, and explore how the phenomenon revolutionizes data analysis and precision/personalized medicine.
Future of pharma
& life sciences:
What to expect
The pharma industry and life sciences sector are facing skyrocketing operational complexity and ever-increasing pressure to innovate.
Although the pharmaceutical industry and life sciences sector have undergone seismic transformations over the past decade, new long-term challenges are looming on the horizon. As the 2022 McKinsey Life Sciences Resilience Survey highlights, the current macroeconomic situation poses a major concern for 70 — 80% of life sciences company executives. However, navigating such a complex landscape does not imply a gloomy outlook. An overwhelming 80% of the survey’s respondents also believe that their organizations will be positioned to thrive in the near future. So, what will happen next? This article provides a comprehensive 2023 pharmaceutical industry analysis and discusses the key trends, challenges, and opportunities that will shape the market this year.
As one of the key trends in the pharmaceutical industry, quantum computing is rapidly emerging as a powerful tool for drug discovery, by offering the potential to revolutionize its processes and accelerate the development of new treatments. By harnessing the power of the quantum phenomena such as superposition and entanglement, quantum computers can solve complex problems that otherwise are intractable. Recently, QuEra Computing, a startup created by scientists from Harvard and MIT, has developed a quantum processor of 256 qubits, which surpasses its last 127 qubits version. And, there’s much more to come. As ambitions for quantum computer development continue to rise, Google announced its intentions to create a machine with 1 million qubits by 2029. With the stakes being so high, no wonder global pharma spending on quantum computing in Research & Development (R&D) is predicted to reach billions of dollars by 2030, according to McKinsey.
Quantum computers have the capacity to dramatically reduce the time and cost of drug discovery. By examining vast amounts of data at unprecedented rates, they would quickly identify promising drug candidates and accurately simulate the effects of potential drugs on biological systems. This approach would enable researchers to swiftly identify molecules with the ability to treat diseases, significantly accelerating drug discovery. In addition, quantum computing could also enhance the safety of drugs as it would make more accurate predictions of the imaginable adverse effects. Accurately simulating the interaction of potential drugs with the body’s biological system, researchers can identify the probable side effects before conducting clinical trials, making drugs safer for the patients. Although it could take years to make quantum computing viable, it would be a major boon for the pharmaceutical industry and a major breakthrough in the fight against disease.
Traditionally, the pharmaceutical and life sciences industry has been highly siloed, with different functions such as research and development, manufacturing, and sales which operate in isolation from each other. The status quo has become increasingly inadequate in the face of complex and rapidly evolving challenges. To address these dilemmas, companies are forming strategic alliances to access and share data, allowing them to better understand the customer’s needs and develop personalized treatments. This approach allows them to pool their resources and knowledge in order to tackle complex problems and develop innovative solutions.
Partnerships further cooperation across various areas of the pharma and life sciences. Organizations are switching their operational models so as to build a more comprehensive ecosystem of collaboration with other industry players. For instance, Pfizer and BioNTech have embarked on a journey of mRNA technology discovery, forming a strategic partnership that helps protect individuals against influenza and COVID-19. Similarly, AstraZeneca and Huma are collaborating to expand digital health innovation. Meanwhile, aside from traditional partnerships, a new breed of collaborations are appearing – academia and the industry are joining forces in fields such as quantum computing.
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The emergence of new technologies and advancements in the life sciences and pharmaceutical industry have opened up the possibilities of adaptable transformation within biotech companies. This transformation is happening across all sectors of the industry, from drug development to clinical research and beyond. It involves implementing Agile working principles, such as flexible and collaborative working practices, rapid prototyping, and regular customer feedback.
Agile methodologies, which prioritize flexibility and rapid iteration, have already proven successful in software development and are now making inroads into the biotech sector. Here, an Agile transformation has the potential to disrupt traditional business models and drive significant changes in the way companies operate, becoming one of the major pharma trends of the future. As Harvard Business Review highlights, the Agile principle of rapid iterations makes it possible for organizations to increase their R&D productivity by 20%.
One key aspect of the Agile transformation is the ability to rapidly prototype and test new products and ideas, allowing biotech firms to move more quickly from concept to market. It is particularly valuable in the highly competitive and rapidly evolving biotech industry, where the ability to bring new treatments and therapies to market quickly can provide a significant competitive advantage. Another key aspect of the Agile transformation lies in the focus on collaboration and cross-functional teamwork. In biotech companies, this approach can facilitate better communication and coordination between R&D, manufacturing, and commercial teams, leading to more efficient and effective product development. In addition, by adopting the Agile principles and practices, biotech companies can streamline their compliance processes and become more adaptable and responsive to changing regulatory requirements.
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Pharmaceutical technical development, also known as CMC (chemistry, manufacturing, and controls), is a highly complex and multifaceted discipline that plays a critical role in the successful production of medications. Although CMC may not have the same level of recognition as clinical development, it is a vital force in advancing the pharmaceutical industry. It enables companies to accelerate drug development, pioneer new forms of drug delivery, and increase patient adherence.
These technological advancements will bring a welcoming transformation for CMC in 2023. As biopharmaceutical companies expand in terms of the size and complexity of their operations, the need for efficient and reliable processes and procedures will become greater. In an attempt to live up to these technology-related pharma trends, companies will increasingly look to modernize their CMC functions, with a focus on streamlining processes and maximizing resources. In response to this development, the U.S. Food and Drug Administration (FDA) will launch a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program for organizations striving to expedite their CMC development activities.
The year 2023 will likely bring an increased emphasis on technological advancement, automation, and data-driven decision-making. In particular, cloud computing, Artificial Intelligence (AI), Machine Learning (ML), and predictive modeling will become essential elements of the CMC modernization process. Automation will help ensure the accuracy and consistency of CMC operations and reduce reliance on manual labor. Data-driven decision-making will further aid in streamlining processes and enable a more effective use of resources. As a result, biopharmaceutical companies will be better equipped to develop, manufacture and regulate the quality of their products.
The rapid development of cell and gene therapies over the course of the current decade will have significant implications for trends in the pharmaceutical industry in 2023. This shift is likely to be driven by the emergence of personalized treatments and targeted gene therapies, which allow physicians to tailor therapies to specific patient characteristics. In addition, advances in genetic screening and analysis techniques promise to enable physicians to identify patients suitable for gene and cell therapies, as well as predict outcomes and develop treatments accordingly. For example, there were 12 clinical trials examining the potential of AAV-based gene therapies to treat hemophilia A and B as of December 2022, according to Nature. Yearly, these rare but deadly conditions are diagnosed in roughly 400 babies in the US alone.
The use of cell and gene therapy techniques is also likely to reduce the cost of many treatments. With the success of new technologies, such as CRISPR/Cas9, it has become possible to produce and manipulate large groups of cells quickly, reducing the need for expensive manufacturing processes. This could enable much cheaper treatments to be developed, potentially leading to greater access and improved outcomes for many patients. Furthermore, cell and gene therapy treatments could bring about a shift in drug development models, with a greater emphasis on R&D carried out by biopharmaceutical firms. This transformation could also add a new layer of complexity to the regulatory environment. Ultimately, cell and gene therapies are set to have a major impact on the future landscape of pharma and life sciences in 2023, and it is likely that these treatments will contribute to significant disruptions in the industry.
High-throughput screening (HTS) is set to transform biomedical R&D in 2023, with its global market being forecasted to reach $18.09 billion USD by 2030, as per Growth Plus Reports. By leveraging automation and miniaturization techniques, HTS offers the potential to rapidly and accurately evaluate the efficacy of compounds and biological agents in a wide array of biological systems. As HTS technology becomes increasingly accessible, it is anticipated that the biomedical research industry will benefit from advances in drug discovery, development, and delivery. The ability to rapidly evaluate biological agents across large datasets without compromising on accuracy or efficiency will lead to savings in both time and finances in the long term. Furthermore, HTS is expected to facilitate deeper insights into cellular pathways and mechanisms of action, greatly expanding the possibilities for interventions with improved efficacy and reduced side effects.
All this will enable a new paradigm of R&D, one in which researchers can rapidly identify promising therapeutic candidates and quickly progress them through the preclinical testing process. HTS also offers the potential to reduce the costs associated with drug development, as the need for costly animal models and extensive laboratory testing can be minimized. By enabling the rapid, efficient, and cost-effective evaluation of compounds and agents, HTS will provide a much-needed impetus to biomedical R&D, transforming the way in which new drugs and treatments are developed.
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In 2023, vaccine ecosystems will be required to further operational alignment and efficiency in the wake of the potential emergence and spread of new infectious diseases. This will entail an emphasis on risk management, mitigation strategies, and contingency plans to ensure that vaccine productions can withstand any potential hiccups. Vaccine ecosystems will further focus on maintaining supply chain resilience so as to handle the complexity of both the production and distribution of vaccines. In addition, vaccine manufacturers will need to refine their contingency models to better anticipate disruption events, and develop enhanced processes and systems in order to react quickly to changes and ensure timely vaccine supply. Through the improvement of predictive analytics and anticipatory planning, vaccine manufacturers will seek to respond effectively to future pandemics or health crises with agility and stability.
Moreover, production readiness will be further enhanced through investments in automated systems. AI-enabled track and trace technology, automated testing and inspection systems, and integrated digital operations will be widely adopted to gain operational efficiencies and ensure supply continuity. Additionally, given the rise in demand for biologics, vaccine manufacturers will leverage continuous manufacturing and biomanufacturing technologies to reduce costs and timelines. Evidently, resilience will continue to serve as a baseline for vaccine manufacturing in 2023, providing both novice and established vaccine manufacturers with new opportunities to efficiently navigate the unpredictable environment.
It is anticipated that patient-centricity will become increasingly embedded in the operations and indicators of success for pharmaceutical and life sciences companies, with improved patient experience and outcomes expected to be major factors in the growth of pharmaceutical and life sciences companies. To achieve this, they are likely to focus on greater collaboration with patient organizations, have a higher technology adoption, and enhance data collection and analysis techniques all in order to create tailored and personalized treatments for individuals.
In 2023, patients will continuously become more informed and involved in their care through better access to medical information and the ability to leverage new technologies. As such, pharma and life sciences will continue shifting from its historically provider-centered approach to a much more comprehensive and patient-centered model that is far more collaborative and proactive rather than just responsive. This is very likely to involve new policy initiatives, changes to industry practices, and increased opportunities for patient engagement, all of which should lead to enhanced healthcare outcomes.
A greater emphasis on patient-generated data will become paramount, as this data will offer invaluable insights for healthcare providers and pharma manufacturers. A number of opportunities could include patient registries, which track patient data over time, and patient-reported outcomes surveys, which provide real-time data about a patient’s experience with a given therapy. Moreover, pharma and life sciences companies may focus more on consumer-centric practices such as patient assistance programs and patient advocacy initiatives.
The digital age has pushed pharmaceutical and life science companies to the brink of unprecedented and long-term challenges, which is clearly reflected in the 2023 pharma trends. Increasing complexity and risk, advances in digital technology, growing governance expectations, and supply chain disruptions are all part of the changing landscape that bring major implications for organizations operating in these industries. Given the numerous forces at play, how are they going to navigate this defining fork in the road? This year will surely tell.
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