The industrial-scale manufacture of life-saving medicines and therapeutics has played a significant and central role in vastly improving the quality of life for billions of people worldwide. Valued at $1.6 trillion in 2023, the pharmaceutical industry is one of the largest industrial sectors in the world.
This article will examine some of the emerging trends in this sector and how they will transform pharmaceutical manufacturing and improve patient health outcomes.
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Advanced Manufacturing Technologies
Advanced manufacturing technologies have provided benefits to multiple industries, such as faster production, enhanced efficiency, improved product quality, safer work environments, reduced waste, better profitability, and more environmental friendliness.
In the pharma industry, continuous manufacturing and additive manufacturing (3D printing) have emerged as two of the most disruptive and beneficial manufacturing technologies today.
In continuous manufacturing, raw materials are constantly fed into the process at one end and continuously extracted at the other. In this production method, there is no interruption, meaning that large volumes of product can be continuously manufactured on a single, uninterrupted production line.1
Although continuous manufacturing systems can be expensive, complex, and have limited flexibility, they offer benefits such as increased efficiency, cost reduction, improved quality control, and less time-to-market. Pfizer, Novartis, and GlaxoSmithKline are investing in these technologies.1
3D printing is another emerging trend in the pharma industry, offering benefits such as vastly reduced waste, better sustainability, and unparalleled design freedom.
Customized drugs and therapeutics can be designed with novel shapes and geometric designs. Moreover, 3D printing allows new, rational designs where the active and inactive ingredients have unique spatial distributions.2
Digital Transformation
AI, IoT (Internet of Things,) machine learning (ML,) and big data are just some of the technologies involved in the digital transformation of pharmaceutical manufacturing.
Traditional challenges in pharmaceutical manufacturing, such as regulatory compliance, supply chain management, and the time-consuming and costly nature of drug discovery and R&D, are being overcome using these innovative technologies.3
Robotics, natural language processing, neural network algorithms, and computer vision are proving revolutionary in pharmaceutical manufacturing.
Digital technologies can transform data analytics, inventory management, supply chain logistics, reduced trial and error, automated inspection, expedited drug discovery, and predictive analytics and maintenance.
However, to reach their full potential, pharmaceutical manufacturing digital technologies must overcome several challenges, including ensuring data quality and security, training staff, and the potentially prohibitive start-up costs faced by small and medium-sized pharma enterprises related to their implementation.3
Learn more about Drug Discovery, Manufacturing and Development
Personalized Medicine
Personalized medicine is an emerging field in healthcare which does away with the conventional “one-size-fits-all” approach indicative of traditional pharmaceutical manufacturing.
It uses the individual’s genetic profile, lifestyle, and environment to tailor the most effective drugs and therapies to the patient.
The emergence of personalized medicine is profoundly impacting pharmaceutical manufacturing. It allows manufacturers to optimize drug development and ensure that medications are tailored to specific patient populations.
In essence, the field of personalized medicine offers improved health outcomes, patient satisfaction, and cost reduction.4
However, scalable and flexible production processes are needed to accommodate the demand for personalized medication.
A “one-size-fits-all” manufacturing approach would not work. The vast amount of different data on individual patients means that manufacturers need robust systems in place.
Recent developments in biotechnology, such as genomics and their integration into precision therapies, are transforming the world of medicine and the future of pharmaceutical manufacturing, revolutionizing how the pharma industry approaches the treatment of cancer, hereditary disease, and many other conditions and diseases.
Sustainability Initiatives
Sustainability is key to the future plans of many sectors, including the pharmaceutical industry. Green chemistry, waste-to-energy systems, renewable energy, water conservation, sustainable supply chains, and embracing the circular economy are all emerging trends in pharmaceutical manufacturing in the 21st century.
The pharma industry currently has a huge environmental impact, using large amounts of resources such as water and contributing to greenhouse gas emissions.
Several companies are leading the way in sustainable pharmaceutical manufacturing, however.
Johnson & Johnson, for example, has made water stewardship a central concern for the future of its manufacturing, with strategies such as alternative cooling tower technologies and manufacturing cycles that reuse wastewater.
Additionally, the company are working with both downstream companies and suppliers to improve the sustainability of pharmaceutical supply chains.5
Regulatory Evolution
The accelerating pace of change has led to a rapid regulatory evolution in recent years, which is likely to continue.
Recent global issues such as the COVID-19 pandemic, Brexit, and the war in Ukraine have highlighted the need for supply chain security. In recent years, sustainability, AI, data security, product quality, and a skills crisis in the industry have all been the subject of debate and regulation.
The UN’s Sustainable Development Goals, the Inflation Reduction Act, updated guidance on quality risk management (the ICH Q9 update), and a raft of new updates to pharma laws in global economies such as the UK are creating a sense of urgency in the industry that will continue for some time as it navigates a changing regulatory landscape.6
Pharma companies must comply with all relevant regulations, and staying ahead of legislative changes is vital to fostering continued growth and innovation in the sector.
Modern Challenges of Drug Discovery
Collaborative Innovation
The pharma industry is not monolithic and, indeed, contains a huge number of companies and stakeholders.
Collaboration between companies, governments, academic institutions, and patient stakeholder groups is a vital and evolving trend within the sector. Collaboration fosters innovation, accelerates R&D, reduces costs, and helps bring new products to market faster.
Workforce Development
Emerging technologies and the digital transformation of pharmaceutical manufacturing require training new and existing workforces who are competent and skilled in areas such as AI, additive manufacturing, data analytics, and green technologies.
Initiatives for training and development and significant capital investment are vital to ensure that the pharmaceutical industry has the right skills in the right places.
In Summary
The key trends in pharmaceutical manufacturing currently are emerging manufacturing technologies such as 3D printing, the digital transformation of the industry and the embracement of technologies such as AI and machine learning, sustainability, personalized medicine, the evolving regulatory landscape, collaborative innovation, and addressing the skills gap.
Embracing these areas will continue to foster innovation in pharmaceutical manufacturing, helping to accelerate the development of new, life-saving drugs and therapeutics. Thus, the industry will continue to drive forward and innovate for the benefit of patients everywhere.
References
- Popchepskiy, O (2024) Continuous Manufacturing: advantages, disadvantages and practical examples [online] Cleverence. Available at: https://www.cleverence.com/articles/business-blogs/continuous-manufacturing-advantages-disadvantages-and-practical-examples/ (Accessed on 11 July 2024)
- Jamróz, W et al. (2018) 3D Printing in Pharmaceutical and Medical Applications – Recent Achievements and Challenges Pharm. Res. 35(9) pp. 176 [online] PubMed Central. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6061505/ (Accessed on 11 July 2024)
- Praxie (2024) Unlocking Success: How AI is Transforming Pharmaceutical Manufacturing [online] Available at: https://praxie.com/ai-applications-in-pharmaceutical-manufacturing/ (Accessed on 11 July 2024)
- Parabolic Drugs Ltd. (2024) The Rise of Personalized Medicine: Implications for Drug Manufacturing [online] Available at: https://parabolicdrugs.com/the-rise-of-personalized-medicine-implications-for-drug-manufacturing/ (Accessed on 11 July 2024)
- Johnson & Johnson (2024) Position on Environmental Stewardship [online] Available at: https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-environmental-stewardship (Accessed on 11 July 2024)
- Spencer-Jolliffe, N (2024) A ‘sense of urgency’ swirls in the UK pharma regulatory landscape [online] Pharmaceutical Technology. Available at: https://www.pharmaceutical-technology.com/features/a-sense-of-urgency-swirls-in-the-uk-pharma-regulatory-landscape/ (Accessed on 11 July 2024)
Further Reading