Governments are playing a bigger role in cell and gene therapy manufacturing

Axovant announces positive results from gene therapy trials. Credit: Genome Research Limited/yourgenome.

Government institutions are becoming increasingly engaged in cell and gene therapy manufacturing across the US and UK industries, according to GlobalData’s Peter Shapiro.

Cell and gene therapy manufacturing 2019

Dr Shapiro told delegates at this year’s Clinical Trial Supply New England conference held in Boston, US, on 26 March, that Brexit confusion is also impacting the UK cell and gene manufacturing industry.

He said the British Medical Association said on March 29 that “if [the UK] leave[s] the EU on April 12 with no deal in place, this will have grave consequences for the…supply of medicines.”

Currently, the UK accounts for 16% of global cell therapy manufacturing facilities, according to GlobalData’s Contract Service Provider Database (see Figure 1).

Impact of Brexit

The UK holds the second largest share of any single country, after the US. With the prospects for a no-deal Brexit still not entirely ruled out, and the UK’s exit from the European Union being declared a “crisis” by some senior politicians — it is clear that whatever shape Brexit takes, its impact will be felt across the entire cell therapy manufacturing industry.

The Association of the British Pharmaceutical Industry (ABPI) told the BBC that it is calling for a temporary ban on drug exports from the UK in the event of a no-deal Brexit to prevent shortages. “A drop in the value of the pound would create an incentive for wholesalers to sell medicines overseas instead of to the [National Health Service],” the BBC reported on March 29.

Meanwhile, in the two largest gene therapy manufacturing regions, the UK and US, governments are increasingly engaged. This is especially the case within the UK, where due to growing industry confidence in the UK as a place to develop and manufacture cell and gene therapies, the government has provided £70 million ($92.4 million) in funding through its Industrial Strategy Challenge Fund. This has affected a rapid growth in the number of cell and gene clinical trials in the UK using gene-modified therapies, nearly doubling from 47% in 2017 to 73% in 2019, according to the GlobalData Clinical Trials Database.

Figure 1: Number of dedicated or excess capacity contract cell therapy facilities by country

Source: GlobalData, Contract Service Provider Database

GlobalData subscribers can use PharmSource’s Contract Service Provider Database to search by facilities capable of performing cell and/or gene therapy manufacturing. The results for dedicated and excess capacity facilities are displayed in Figure 1.

US outlook

Unsurprisingly, the US has the largest number of facilities, accounting for 37% of all cell therapy manufacturing. The UK is the next largest with a 16% share. The number of facilities available for this specialised form of manufacturing has increased since last year, as was predicted by the PharmSource Trend Report CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition.

Figure 2: Number of dedicated or excess capacity contract gene therapy facilities by country

Source: GlobalData, Contract Service Provider Database

As can be seen in Figure 2, it is now possible to combine information from the PharmSource Contract Service Provider Database with other GlobalData Pharma Intelligence Center databases, such as the Companies Database, to gain further insights.

Figure 2 shows the types of companies currently involved in the dedicated or excess capacity gene manufacturing industry. With this analysis, it is possible to see that the US and UK, the leaders in gene therapy manufacturing, each has nearly one-fifth of their manufacturing capacity provided by institutions rather than private or public companies. This shows the increasing role that governments are having in the development of advanced therapy medicinal products.

The Clinical Trial Supply New England conference is celebrating its 8th year of supporting clinical trial supply, trial sponsors, and offering solutions. GlobalData was present at the conference, offering trends and forecasts about the future of the manufacturing-based industry with key insights derived from Global Data’s Pharma Intelligence Center.

With the recent addition of PharmSource, GlobalData’s world-class Pharma Intelligence Center has become a far more powerful tool for manufacturing industry intelligence, offering key and insightful analysis into the contract manufacturing industry.

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