At the centre of healthcare innovation, cell and gene therapeutics is a fast-growing area that is disrupting and shaping the pharmaceutical and biotechnology industries.
There has been a steady increase in the number of cell and gene therapies on the market, and many of the top global life sciences universities – 16 of the top 50 of which are in Europe – are shifting from a research focus to action.
As is common across biotech and pharma, CGTs are looking to decrease manufacturing costs but are also contending with a shortage of manufacturing capacity and talent.
The manufacture of CGTs is complex, and manufacturing capacity can often act as a limiting factor to treating more patients.
When combined with talent shortages, given the high level of competition with the United States for bioscientists, both talent gaps and manufacturing capacity pose significant risks to the cell and gene therapy outlook.
However, the manufacturing shortages during the height of the pandemic – shortages of raw materials, strained manufacturing capacity, clinical development and research interruptions – have also led the industry to make positive changes to adapt to these challenges.
Part of this shift has been reliant on the potential to automate processes in CGT, as many other areas of the biopharmaceutical sector have done, automating workflows and benefitting from digitalisation, and minimising human touchpoints.
As we move through 2023 and beyond, the biggest barrier to the improvement of automation in the manufacturing process will be cost.
Even though investing in automation can reduce costs in the long term, the initial costs associated with establishing these processes could prove expensive, so time will tell whether this will be considered worth the investment.
Enabling artificial intelligence (AI) and machine learning (ML) into the CGT value chain won’t happen overnight, but it’s certainly a way to work with digital advances rather than against them.
Moderna is a prime example of this, utilising digital options and analytics to boost its mRNA platform.
By digitising early, a foundation of processes is set that allows for greater degrees of automation which can optimise the research process.
Human-machine collaboration offers the ability to combine creativity and flexibility with precision and consistency, but most importantly, the ability to do so at scale and speed.
Though the limited scale of CGT will mean that progress with AI and ML in the space is limited, that’s not to say that there won’t be the potential for vast applications in the future.
As the amount of experimental data slowly expands – both public and commercial – the training of AI systems and ML approaches will increase, though again, this is likely to be costly and time-consuming in the early stages.
There are multiple reasons why the CGT market has the potential to offer significant growth opportunities, particularly in Europe, such as:
The European market is experiencing steady growth due to the increasing availability of funds from public and private institutes, and greater support from regulatory bodies for product approvals (encouraging vendors to manufacture products at a faster rate).
As with many areas of early maturity in life sciences, the true extent of the growth of CGT is entirely dependent on a number of factors that can change over time (e.g. economic stability) and how the industry adapts to these changes.
The global cell and gene therapy market is expected to grow 4x more than the current value, and the research pipeline and investor interest are only expected to expand and increase.
Beyond 2023, however, the CGT market will require strong support from regulatory bodies to commercialise products and make them more accessible to patients, which is an area currently stunting growth.
CGTs present a shift in the way that diseases can be treated, which inevitably means that embracing these changes and making them as optimal and effective as possible will take time, investment, and innovation to be successful.
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