What changes will the regulatory affairs and wider life sciences industries see in the next decade?
In March 2020, we surveyed a huge set of life sciences professionals representing every aspect of the global industry about the changes they expect to see over the next decade. With 432 responses, the results reveal unique insights into where those most central to the industry think the biggest opportunities and challenges lie in global pharma and biotech, and how they expect it to look in 2030.
Here we have filtered out the overall results to look at the 79 responses from those working in regulatory affairs.
The majority of respondents are based in Europe (57%) or North America (23%).
22% of respondents work for a consultancy or medical device company, followed by 18% at a pharmaceutical company.
Larger companies are best represented, with 52% of respondents representing organisations of 100 or more employees.
A majority of respondents work with medical devices (73%).
Of all 432 respondents surveyed, 24% work in partnering/business development, followed by 19% in drug discovery and preclinical, followed by 18% in clinical trials, commercialisation, and regulatory affairs.
"Which geographical area do you think will see the fastest growth in the life sciences industry in the next 10 years?"
“I agree that all topics raised are relevant; just one theme I am missing is manufacturing. What we see at the moment, independent of COVID, is the unavailability of hundreds of medicinal products, some of them stock-out for months or even longer, in Europe, and possibly the same or worse in other regions.
Explanations for it are
Globalization and consolidation of manufacturing especially of API’s, meaning some API’s are only produced in one region or country to supply the whole world.
Older but sometimes life-saving products are expected by health systems to be available at a very low price, which drives more and more manufacturers out, and the few who remain are not investing much into product quality, which may lead to failed health authority inspections, product defects, recalls, etc., exacerbating the strained product availability situation.”
"Which therapeutic area do you think will see the fastest growth in the next 10 years?"
"What do you think is the biggest challenge facing life sciences in the next 10 years?"
"What impact do you think each of the following technologies will have on regulatory affairs in the next 10 years?"
Click on the graph to explore the data
"In which area do you think AI will have the biggest impact in the next 10 years?"
"What is the biggest benefit you think emerging technologies will have on the industry in the next 10 years?"
"In your opinion what has been the biggest breakthrough in life sciences in the last 10 years?" Selected responses.
Drug-Device combination products
Genome/Gene sequencing
Globalization
Immuno-oncology
Oncology treatments
Patient involvement
Personalised medicines and medical devices
RNA therapeutics
Robotics and machine learning
Stem cell research
Targeted drug therapy
"How well represented do you think women and cultural/ethnic minorities are in your organisation up to the most senior positions?"
The importance put on sustainability when you and your organisation are making decisions on the future direction of the company.
There will be stricter rules.
There will be faster approvals / timelines.
There will be global harmonisation.
It will become more flexible/adapting to new drugs/medtech.
There will be advancements in tech/data handling.
There will be a shift in regulatory focus.
It will remain the same.
"For Medical devices (my experience area) not much after this year's MDR."
There will be advancements in standardisation.
There will be a more patient-centric approach.
"More patients sitting on more regulatory bodies; more patients helping industry appeal to those bodies; more patients involved in the research for new products or combinations; more trials - and different forms of trials too."
Other responses.