Two major studies looking at the barriers to commercial innovation and development of stem cell treatments in the UK have concluded that the industry will not succeed unless substantial changes to NHS culture and structure take place.

Stem cell therapy as a commercial enterprise is attracting a lot of interest, with nearly 200 companies now developing primary and secondary cell therapies, with another 180 running cord blood banks.

Total sales worldwide are now thought to exceed 1 billion US dollars a year and a number of products are now in late stage clinical trials.

But researchers concluded that the chances of routine treatments appearing in the short term are small and the whole stem cell industry in the UK is at serious risk of “market failure”.

A key problem appears to be a high turnover of companies in this leading edge biotech sector, which means it is dominated by lots of small young companies that don’t have enough resources to bring products to market and those that do can’t sell enough.

One of them is Dr Paul Martin, an expert in the sociology of emerging medical technologies, from the Institute of Science and Society at the University of Nottingham, who said:

“While the government has identified regenerative medicine as a national priority and the US has lifted its ban on stem cell therapy, urgent public policy action is needed if it is to become a reality.”

He said that although stem cell therapy is now an important branch of medicine, in the UK marketplace firms that specialize in it struggle to survive, and the market may well collapse in the short term.

“Unless the situation changes the industry will contract and the progress needed to develop important cell therapies will be adversely affected,” said Martin.

The researchers looked at what happens between discovery and commercialization of innovation in stem cell technology, and in particular how the knowledge is passed on. They found that the people at the commercial end of the process need to work more closely with the people at the clinical end, and more money is needed for clinical studies. They also said the regulations surrounding what can and can’t be done with stem cells need to be clearer, as should the rules about claiming some of the commercial investment back.

Another clear barrier is the lack of enabling technologies to translate what is proved in the lab to what can be producted on the shop floor of the manufacturer so as to lower the cost of manufacturing.

Martin said there were also “major structural barriers within the NHS that make it difficult to translate new scientific knowledge of stem cells into improved patient care”.

Each stem cell therapy has to meet a number of very strict criteria before a doctor can use it on a patient, he said, and the therapies are also expensive and show little evidence of proven clinical outcomes.

The two studies are the result of two years work looking into the UK’s regenerative medicine sector. The research was funded by the Engineering and Physical Sciences Research Council (EPSRC), and was led by researchers at Nottingham University.

The findings are being presented at the second National Stem Cell Network‘s Annual Scientific Conference which is being held this week from 6 to 8 April at Oxford University.

Sources: University of Nottingham.

Written by: Catharine Paddock, PhD