This article is part of our special report Unleashing the biotech potential in health.
The vibrant biotech sector is ready to showcase what European businesses can do when it comes to human health while waiting for more initiatives at the policy level.
Biotechnologies are embedded in industrial processes all around us, from the food we eat to the fuel that goes in our cars.
The COVID-19 pandemic emphasised the crucial contribution of biotech to the development of the next generation of medicines for human health, from virus genome sequencing to molecular diagnostics to vaccines to monoclonal antibodies.
In some therapeutic areas, there has been rapid development in genomics over the last two decades. The technologies developed in this time frame offer a significant potential to improve health outcomes and reduce the burden on healthcare systems.
For instance, antibody engineering – the modification of human monoclonal antibody sequences or structures to enhance or dampen their functions – is already been used on a clinical level for both the diagnosis and therapy of several diseases, particularly in cancer therapy.
Other applications of biotech in healthcare range from personalised medicines to biomarker testing which looks for genes, proteins, and other substances that can provide information about cancer, not to mention the Advanced Therapy Medicinal Products (ATMPs), a term that is interchangeably used as cell and gene therapies.
A flourishing sector
The biotech industry has been considered one of the fastest-growing innovative industries in Europe, with an average annual growth rate of 4.1% from 2008 to 2018, in a recent study published by the Wifor Insitute.
The study depicted biotechnology as a high-value sector for employment as well, as it pointed out that for each job in life science three jobs are created elsewhere in the European economy.
However, Europe still lags behind when it comes to patent applications filed in the biotech sector in 2018, with the United States getting the lion’s share with almost 40% of the world share.
Europe is also trying to move ahead regarding its manufacturing capabilities since these technologies are mostly manufactured in other parts of the world and predominantly in the US.
There is already some sort of ‘biotech’ ecosystem made of strong academic clusters as well as SMEs, start-ups, and global multinational companies, all with a European focus and headquarters on the continent, with some encouraging outcomes in the Mediterranean countries.
In Italy, biotech companies that deal with health-related applications account for 48% of the total, a percentage that increases to 58% for those companies dedicated to biotech R&D – which also engage 75% or more of their total research costs in biotech activities.
Next big thing: NGTs framework
The bioindustry sector has recently been affected by a number of flagship Commission policy initiatives ranging from the industrial strategy to the environmental ambition in the Green Deal.
However, the modernisation of the genetically modified organisms (GMOs) legislation – adopted more than 20 years ago – which has been repeatedly called for by the biotech sector has to wait since it has not been included in the Commission’s pipeline for the final half of the legislative term.
The next initiative on biotech that is expected to be unveiled in the second quarter of 2023 is the new legislation for plants produced by new genomic techniques (NGTs).
Although mainly devoted to crops, NGTs are employed widely in the development of medicinal products for human use.
For instance, health and medical-oriented research accounted for most of the EU research and innovation (R&I) funding for NGT-related projects under the Horizon 2020 (2014-2020) research programme, according to the European Commission.
Genome editing was predominantly used as a research tool either in cultured cells or in laboratory organisms to understand the role of genes in health and disease.
In 2021, the Commission identified NGT applications in 64 clinical trials, with cancer being the main target with 56 therapeutic applications.
A new pharmaceutical framework
As highlighted in its pharmaceutical strategy unveiled in 2021, the Commission is looking to reorient a new system of pharmaceutical incentives to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases and pediatric cancer.
As such, the forthcoming revision of the EU’s pharmaceutical framework is expected to streamline the procedures linked to the evaluation and authorisation of medicines for rare diseases, also known as orphan drugs.
This will affect the approval of gene therapies which are currently mostly used to treat and cure rare diseases. These therapies try to address the genetic cause of a disease by either replacing the malfunctioning gene or making it inactive or introducing a new gene that helps fight it.
The risk of an outdated regulatory framework to support such innovation could trigger problems in scaling up the potential impact of biotech along the whole value chain.
On the contrary, a robust regulatory framework can actually be a catalyst for growth, jobs and investments that otherwise risk going elsewhere.
Any effort to update the regulatory framework on orphan drugs has to consider the differences between standard treatments.
For instance, as the number of patients is particularly low, the world-evidence data collected once the product has been approved are smaller than the standards required for conventional medicines.
[Edited by Nathalie Weatherald]
