The life sciences sector continues to grow as new therapies, drugs, and products are developed. New manufacturing and business technologies are also driving change in the sector, as are ever-evolving regulations and best practice guidelines. So, where is the sector heading?
Here are nine game-changing trends in the life sciences sector to be aware of:
- Cell and gene therapies
- Mobile manufacturing
- Additive manufacturing
- Decentralised trials
- Digital twins
- Growing importance of big data and analytics
- Move away from paper documentation and manual record-keeping
- Validation for the 21st century
Let’s look at each in more detail.
Growth in Cell & Gene Therapies
The life sciences industry is increasingly focusing on treating the patient rather than the condition or illness. Cell and gene therapies (CGT) have this patient focus, with significant growth expected in CGT use over the coming years.
New CGT innovations are being developed, but these types of treatment are expensive. They are also often challenging to manufacture, as CGTs are typically customised for each patient so need to be produced in small batches. Also, production processes often need to take place much closer to the patient than is currently the case with the sector’s mass manufacturing infrastructure. This leads us to the next key trend in the life sciences sector.
Companies in the life sciences sector are digitalising workflows and processes to transform business models and develop smart manufacturing operations. The next big change on the horizon is mobile manufacturing, creating an alternative to large-scale manufacturing facilities and large-batch production runs.
Mobile manufacturing solutions won’t be required for all products, but the example of CGT therapies highlights the growing need for the sector to develop new and innovative methods of production that bring manufacturing closer to the point of care. These solutions need to be scalable, practical, compliant, and cost-effective, but progress is already being made.
Mobile manufacturing will also help to improve access to critical medicines and healthcare products, reducing the geographical and societal inequalities that currently exist around the world.
Contract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs) have been an important part of the life sciences sector for many years now. Their importance is now growing as small, medium-sized, and large life sciences sector companies continue to turn to CDMOs and CMOs, primarily for capacity, expertise, and timing reasons.
For example, large medical device companies regularly hand over elements of product development projects to a CDMO when they need specific expertise or because of insufficient internal capacity. Another example is startup companies that can bring their new product to market faster by partnering with a CMO compared to acquiring the skills, resources, technologies, and equipment that would be required to manufacture the product in-house.
3D printing technologies are already being used for prototyping in the product development process, as well as to produce prosthetics, implants, and other healthcare products. This trend is set to continue as the technologies available move beyond 3D printing to enable 4D printing.
4D printing creates 3D objects where the properties of the object can change over time in a way that is predictable. Stents are an example. Currently, stents are fixed objects with fixed properties. When 4D printing technologies become available, it will be possible to produce stents that have one shape while progressing through the body before automatically taking the required stent form when they reach the target treatment location.
Clinical trials have traditionally been centralised largely because there was no other option. One of the main problems with this approach is achieving a sufficiently diverse range of participants. It is also expensive and time-consuming. New technologies, including wearable devices, now mean decentralised clinical trials are a viable option, increasing the diversity of participants.
One model is to involve local pharmacies in clinical trials, tapping into the data they have on potential participants.
Digital twins are common in a range of situations, including production environments where digital twins can be created for individual machines or entire production lines. New technology advances are also pushing the concept of the digital twin into the field of healthcare, with many predicting there will be digital twins of people in the future.
These digital twins can be used to test drugs and medical devices, as well as to predict the outcome of various treatments. This can reduce animal testing, optimise clinical trial processes, and improve the diagnosis and treatment of patients.
Growing Importance of Big Data & Analytics
Reducing timescales while maintaining product quality, patient safety, and regulatory compliance has always been a priority for the life sciences sector. Despite this, the process to discover new drugs, develop new products, and obtain regulatory approval remains slow. The rapid development of Covid-19 vaccines showed us an alternative future, where timescales can be considerably shortened to the benefit of patients, healthcare professionals, governments, companies, and society as a whole.
Big data and analytics are crucial to shortening the lengthy timescales that exist in the life sciences sector. Here are some examples:
- Choosing clinical trial participants
- Real-time monitoring of critical quality attributes
- Accelerating drug discovery
- Improving production processes and supply chain management
- Demonstrating post-market drug safety and efficacy
Finally Moving Away from Paper Documentation and Manual Record-Keeping
The life sciences sector continues to digitalise and adopt new technologies and automation solutions. However, there are still large parts of the sector that are reliant on paper and/or manual record-keeping processes. This reliance on paper includes producing large amounts of documentation for compliance purposes.
The trend to move away from paper documentation and manual record-keeping will continue. It will also accelerate as modern technologies are adopted and processes are automated. The need for real-time data and the importance of data-driven decision-making are additional drivers for change. Furthermore, the evolving regulatory landscape is also encouraging a move away from paper, leading us to the next point.
Validation for the 21st Century
The traditional method for validating computer systems in the life sciences sector, Computer System Validation (CSV), involves manufacturers focusing heavily on the creation of documentation. The FDA has now released draft guidance on a new approach known as Computer Software Assurance (CSA).
With CSA, the FDA expects manufacturers to move away from focusing on the creation of documentation. It instead wants manufacturers to take a risk-based approach to validation with critical thinking at its core.
Staying Competitive While Pushing the Boundaries of Innovation
Some of the trends on this list are current realities, while others are emerging at the cutting edge of development. The trends also present both opportunities and challenges for companies in the life sciences sector. Understanding where the industry and technology are going can help you stay ahead of the curve.