Life Sciences in 2020: Industry Insiders' Predictions
We predict which new technologies, emerging therapeutics and regulatory changes are going to have the biggest impact on life sciences in 2020.
Life Sciences in 2020
The changes industry insiders expect to see
Life Sciences in 2020: Industry Insiders' Views
With new technologies, emerging therapeutics, regulatory changes and an increasingly volatile political landscape in much of the world, the life sciences industries face an important year ahead. Marking the start of a new decade, 2020 could see big developments in industries that traditionally move slowly
Over the course of 2019 we have surveyed almost 2000 industry insiders on the hottest topics in areas that cover the breadth of life sciences. From emerging therapies such as peptides and oligonucleotides, antibody engineering, cell and gene therapies, and microbiome therapeutics; to clinical trials; to medtech and pharmaceutical regulatory affairs and law; to crop protection and nutrition. Furthermore, we have spoken to dozens of experts on the key areas of innovation.
What all this adds up to is an unparalleled insight into how professionals representing hundreds of different companies and organizations around the world expect life sciences to change in 2020. In this report, we have gathered all this data and analysis together in one place to offer a snapshot of industry opinion and predictions for the year ahead.
Explore this interactive flipbook or click 'Contents' in the top left to download it as an offline PDF.
What will have the biggest impact on life sciences in 2020?
- New technologies
- Regulatory changes
- The political landscape
- Something else
In August 2019, 187 industry professionals responded to our survey on Analytics, Manufacturing & Supply Chain in cell and gene therapies. Dan Stanton, Editor of BioProcess Insider, analysed the results:
“When asked where the next big success and/or approval will lie in the cell and gene therapy industry, 47% ticked the “gene therapy” box. This may be slightly misleading as several gene therapies have already been commercialized, the latest being AveXis/Novartis’ Zolgensma (onasemnogene abeparvovec) priced at $2.1 million, and while we are still in the early days of the industry.
A quarter checked Solid Tumor treatment, which makes more sense as the CAR-Ts available and about to breakthrough are all focusing blood cancers. But more interesting is the written responses, with several stating allogeneic immunotherapies will be the next big thing in cell therapies.”
Download the Cell and Gene Therapy Supply Chain, Analytics and Manufacturing Report.
Oligonucleotide, Peptide, mRNA and CRISPR Therapeutics
In June 2019, we asked 124 professionals working in peptides and oligonucleotides where they saw the industry going in the future in our State of the Industry survey. A large part of the survey focused on new technologies, which hold promising ways to innovate the discovery and delivery of these advanced medicines. CRISPR was seen as the technology with the biggest potential to transform drug development in this field in the next three years, followed by nanotechnology.
Liquid chromatography-mass spectrometry (LC-MS) and mRNA made up the rest of the top four technologies.
Respondents were asked about the major advancements they expected to see in the next five years in each of the different areas. As the chart to the right shows, responses were varied, though common themes began to emerge. Delivery is a particularly important challenge facing those working on oligos, peptides and therapeutics, and one that the industry clearly hopes and expects to be improved on in 2020.
The efficiency of delivery is the biggest challenge facing the development of new peptides, oligos and mRNA therapies. The clearest finding in the burgeoning space is that R&D efforts are being hindered by delivery issues of these therapies.
Dan Stanton, Editor, BioProcess Insider
Download the full State of Oligo, Peptide, mRNA and CRISPR Therapeutics Report here.
Antibody Engineering and Therapeutics
Emerging technologies such as Artificial Intelligence, next generation sequencing and display systems are changing the way antibodies are being engineered at a rapid rate. At the same time, novel approaches to identifying targets and delivering antibodies are improving therapeutic effectiveness.
In August 2019 we conducted a survey of industry professionals on how they are working with these emerging technologies today and how that will change in 2020. 211 professionals responded, representing pharma and biotech (52%), academia (28%), CDMOs, and CROs (9%), and service providers and consultancies (6%) from North America (46%), Europe (34%) and Asia (14%).
When asked on a scale of 1-10 how likely it is that their company will increase its use of either bioinformatics and computational tools or AI and machine learning in the next two years, the most common response for both was 10 (as the chart left shows).
Taking an average score out of 10 for each of the different technologies, bioinformatics and computational tools was the more popular, averaging 7.44 / 10, compared to 5.64 / 10 for AI and machine learning. However, with both relatively high, it is clear that technology is likely to play a central role in antibody engineering in the immediate future.
Download the full Emerging Technologies and Novel Approaches in Antibody Engineering and Therapeutics report here.
Human Microbiome Therapeutics
As with any new field of research, there is a lot of excitement around the potential of human microbiome therapeutics, but also a lot of uncertainty. In June 2019 we conducted a survey of microbiome therapeutics professionals around the world, revealing unique insights into how the future landscape looks around emerging technologies, manufacturing and commercialization.
The future of microbiome therapeutics is exciting yet still unclear. Everyone in the industry has different views on where the research will begin to focus and where the next advances will come. Indeed, when asked about where the next major advancement in microbiome therapeutics would be, respondents were split between diseases beyond the gut (42%) and understanding the mechanism of action (42%).
Digging deeper into diseases beyond the gut, the areas that respondents saw the most potential for growth away from gastrointestinal (26%), were autoimmune disorders (28%).
The balance of excitement and uncertainty around the area was reflected perfectly when respondents were asked how likely it was that in the next two years their company will submit a marketing application for a microbiome therapeutic product currently in their pipeline. Answers were split, with 42% saying it was ‘Unlikely’ or ‘Very Unlikely’ and 44% saying it was ‘Likely’ or ‘Very Likely’.
No microbiome therapeutic has achieved marketing approval yet, and respondents were split in what they think the first one will be. The most common prediction was a probiotic, followed by a Fecal Micobiota Transplant (FMT), c. difficile treatment and an acne product.
Whatever the first approval turns out to be, 2020 is set to be an important year for the field of human microbiome therapeutics.
Download The Future Landscape of Microbiome Therapeutics report here.
Pharma regulatory landscape in 2020
The MedTech industry is going through a period of unprecedented change with the EU MDR implementation deadline in 2020 and IVDR in 2022. But how well really is the industry prepared for the changes ahead?
Are Competent Authorities ready? Do Notified Bodies have the resource and capacity? Do manufacturers have the tools and processes in place to ensure compliance? What are the key issues beyond compliance? Will the MDR and IVDR be fit for purpose? Will they facilitate innovation and ultimately, will they improve patient outcomes?
In February 2019, we asked MedTech professionals these questions and based on 291 responses created a State of the Industry Report that offered insights into the biggest challenges and how industry insiders are tackling them going into 2020.
The changes that the EU MDR/IVDR will have on the industry is one of the biggest concerns going into the new decade with much uncertainty. Indeed,when asked how innovation will be impacted, 58% of respondents thought it would have a 'Moderate' or 'Major' negative impact.
However, in contrast, respondents were more optimistic about how the new regulations would impact patient outcomes; 56% predicting a positive change.
Global Pharmaceutical Regulatory Affairs
2020 should be a fascinating year for global pharma regulatory affairs. Market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where pharmaceutical sales are forecast to expand at double digit rates.
Meanwhile, updates on global eSubmissions, plans for implementing eCTD within National Procedures, and SPOR are now taking hold. For those in regulatory information management, there are numerous challenges ahead for publishing and operations professionals as they plan their regulatory strategy.
However, one thing in particular is likely to impact the field more than any other - especially in the UK and Europe; Brexit. As these graphics show, the majority of the 217 respondents to our February 2019 survey thought Brexit would have a negative impact on their daily work, for a huge variety of different reasons.
The pharmaceutical industry is facing an unprecedented level of disruption and the role of legal professionals in the industry is rapidly evolving to keep pace with the changing needs of the businesses they support. Rapidly advancing science is being counterbalanced with stricter regulations and challenges to the very core of how innovation is incentivised and funded. Legal professionals sit at the axis of these changes, increasingly tasked with being strategic partners and business enablers in the face of change.
On top of all this, Brexit is looming over 2020 for the UK and Europe. Respondents to our March 2019 survey were gloomy about the effects of Brexit on their business, with 66% expecting a 'Moderately' or 'Major' negative impact. As the selected responses show, the reasons were varied.
Download the full EU Pharma Law State of the Industry Report 2019.
Technology is changing every aspect of clinical trials and although change is happening slower than many want, 2020 is still likely to see huge development and innovation.
In April 2019, we surveyed clinical trials professionals around the world on how they saw the current state of the industry and where they thought it was going in the next few years. Based on 214 responses, the final report was introduced byCiteline, picking out some of the key trends:
“Patient centric approaches are expected to reap many benefits and technologies are key to realizing these benefits. Virtual trials could increase patient participation and provide enhanced efficiencies in data monitoring/analysis. Asia and N. America are ahead of Europe in employing this approach, but virtual trials are expected to increase in the next two years across all regions. Wearables and sensors improve real-time data acquisition and, for some respondents, data quality. However, data quality remains a concern for some, which is second only to data privacy/security concerns.
Currently, AI is seldom used in trials, but increase usage is anticipated during the next two years. Robotic Process Automation (RPA), Natural Language Processing (NLP) and eHealth records offer the largest benefits, presumably for data management. For early phase studies, AI utilization may serve a more analytical role for patient identification/stratification and predictive purposes.
Study design improvements for early phase protocols aim to achieve meaningful outcomes in a shorter time. Innovative designs most commonly utilize adaptive designs, while umbrella, basket and platform designs often are employed and protocol changes for QT safety studies already are used in ~25% in early phase studies. Use of ‘real world’ evidence is increasingly important as industry addresses regulatory agencies’ post-marketing requirements and provides support for new drug applications. Cost and time savings should be realized by utilizing ‘real world’ evidence. Currently, N. America and Asia utilize this data more fully than does Europe.”
Alongside the report, we asked 10 clinical trials professionals from pharma, technology providers, patient groups and biotech for their one prediction for how clinical trials will most change in 2020:
Patricia Moenaert, Director, Portfolio Sourcing and Relationship Management (PSRM), Celgene Intl
“Sourcing/outsourcing will be supported by more automated systems by 2020 and sponsors will mainly do oversight and less micro-management since both CROs and Sponsors will join the same most common technology. This will allow sponsors to be more efficient in resourcing internally and avoid duplication of task by both CRO and sponsor. Non-core activities will be delegated to CROs who are becoming the experts, whilst science will stay core at the sponsor. Probably support from ad hoc consultancy will be part of the main business and become more efficient and cost effective including in science support.”
There will only be minimal changes as I expect the European Clinical Trial Regulation will not be fully implemented until late in 2020. Brexit and data privacy will be the main issues of focus.
Sol Yates, Associate Director, Global Regulatory Affairs, Grünenthal
Dr. Frank Berger, Head of Analytics, Global Clinical Operations, Boehringer Ingelheim
“I don’t expect revolutionary changes. The trend towards more data-driven decisions regarding inclusion/exclusion criteria, country and in particular site selections will continue, reducing the dependence on know-how and experience of individuals. I hope we get a better understanding of the impact of trial complexity, in particular protocol complexity, on our ability to execute our clinical trials according to plan. We will see more efforts towards virtual/digital trials, but this will be a slow shift.”
Bruce Hellman, CEO, uMotif - @umotif
“The change I want to see is the industry focusing on relieving the burden on patients. The good news is technology need no longer be a barrier. The next step is to better design studies around patients, rather than looking for mythical patients that fit a particular protocol.”
Jenny Royle, Patient-centricity Senior Program Leader, digitalECMT at CRUK Manchester Institute, and The Christie NHS Foundation Trust
“Trials ongoing in 2020 need to be developed now, and as such I think two of the largest changes are likely to relate to. Firstly, computer-enhanced patient identification. And secondly, an increase in the number of trials exploring drugs that also incorporate devices to optimise patient behaviour with those medications. These have potential to increase benefits of treatment, as well as monitor or mitigate some of the adverse effects, thereby rapidly improving potential patient benefit with technologies already available.”
Harry Yeates, Strategy Director, Langland UK
“I'm not sure, given we're already nearing the end of 2019, that we'll see a huge shift in the next 15 months. However, it's increasingly hard to ignore the transfer of wearables from the world of consumer health (where they carry disclaimers about not being medical devices) into clinical research. The recent Apple announcement of three observational trials with major US health providers, organised around its watch and Research app, attracted a lot of attention, and it seems a welcome inevitability that trial protocols will increasingly look to wearables (and other solutions) for opportunities to minimise in-person site visits.
Certainly, talk about virtual and hybrid trials is everywhere. Exactly how far that trend moves from press release to regular reality by the end of next year remains to be seen, but it's certainly happening.”
Ruby Saharan, Senior Medical Advisor- RWE, Novartis Oncology UK and Ireland
“I think we will see an increase in utilisation of wearables to supplement data that is captured formally by the physician.”
Michael Song, Senior Manager R&D, MedImmune
“We have seen the adoption of digital inhalers in clinical trials. Today’s connected device for injectables is not that user friendly, but I do see a few that are integrated, low cost and easily applied to both trials and commercial. They can help clinical trials become more robust, ensuring adherence and compliance to the treatment regimen. Key to those systems is that they are integrated and capture just the essential information. They have the capability to provide a seamless user experience and benefit all the stakeholders (patients, pharma, health insurance / payers, HCP).”
Robert Corbé, Clinical Trial Manager, Isofol Medical
“In the oncology area, new treatments are getting more and more personalized. This indicates that we need to collect and analyze various biomarkers without solid evidence that each specific biomarker is of interest for the specific indication tested. I see that more tissue samples are being taken to possibly gain knowledge of how to provide tailor made therapies, even in phase III pivotal trials. This causes increased workload for sites and study teams that needs be accounted for.”
Siobhan Southam, Strategic Engagement Leader, digitalECMT at CRUK Manchester Institute, and The Christie NHS Foundation Trust
“More devices being added to clinical trials, some of which will be useful and work and some that won’t – not necessarily because they don’t work but because patients won’t use them. The critical success factor will be patient acceptability. If the device means that they need to do more (eg taking their own samples, wearing a device) then there has to be something in it for them and for the clinical team at the sites.”
Crop protection and nutrition in 2020
Crop Protection and Nutrition
In May 2019, we conducted a survey across professionals working in the crop protection and nutrition sectors and 235 industry insiders responded. The responses provide valuable insights into the biggest challenges and opportunities facing the plant nutrition and crop protection industry and how it is changing as we go into 2020.
Luke Hutson, chief editor of New Ag International magazine explains:
“The world of crop protection and nutrition are in transition, with a growing role being played by existing and emerging biological products. Biocontrol remains a small percentage of the total crop protection market, but it has experienced a higher growth rate in recent years than its traditional counterpart. Consultancy DunhamTrimmer estimates an annual growth rate of 15% against that for conventional products of around 5%.
Biostimulants are now an established area of scientific research, with an increasing number of collaborations between academia and industry reflecting the increase in products on the market. With more products, there have been steady efforts to create regulatory frameworks for biostimulants in various regional markets.
Notably, at the end of 2018 in the USA, the Agriculture Improvement Act, also known as the Farm Bill, was signed into law and included a description of a plant biostimulant, providing the first statutory language regarding plant biostimulants in any law in the United States.
Respondents were asked to what extent they thought their organisation will develop their own technologies, such as Digital Farming and Artificial Intelligence. 41% answered positively that there was some chance in the future, giving an indication of the technologies that their company intended to develop in the near future. By no means all, the list included:
- Abiotic stress releasers; Adjuvants for formulations; Automatic imagery analysis
- Biocontrol and digital crop management tools; Development of rhizosphere in seed treatment
- Formulation of new complexes and chelates; Mating disruption and mass trapping
- Robotics and autonomous systems; Use of IOT in fertigation