If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the life sciences. The development and widespread adoption of new technologies is key to revolutionizing the way we diagnose, prevent, treat and manage disease.
Here is a look at some life science trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.
The RNA Revolution: From mRNA Vaccines to RNA Editing
The age of RNA is officially here, and it’s here to stay as more than a passing life science trend.
RNA, and its protein-generating form messenger RNA (mRNA) discovered in 1961, has quickly transitioned from being an obscure, finicky molecule that is difficult to work with, to becoming a significant cornerstone of therapeutic innovation in pharma and biotech. The power of its real-world application was demonstrated by the resounding success of the mRNA COVID-19 vaccines.
The mRNA COVID-19 vaccines have showcased the speed, versatility, scalability and flexibility that mRNA-based interventions offer. They can be developed and adapted quickly. Formulas can be generated in days and clinical-grade manufacturing can be accomplished in weeks. This is why creating variant-specific boosters to battle emerging new variants of SARS-CoV-2 like Delta and Omicron will not be problematic for mRNA-based vaccine makers.
The market for mRNA-based vaccines and therapeutics is projected to grow from $46.7 billion in 2021, a figure that has already been overtaken by the two leading mRNA COVID-19 vaccines alone, to $101.3 billion by 2026 at a compound annual growth rate (CAGR) of 16.8 percent, according to a report by BCC Research.
RNA technology is not new nor has its potential been surprising.
RNA in the Making
So why did this perceived RNA ‘revolution’ take so long? RNA is an unstable molecule because it is single-stranded and susceptible to RNA degrading enzymes found ubiquitously in the environment. That’s why it requires careful handing at the lab bench and storage at double digit sub-zero temperatures. It is also prone to quick destruction by the body’s immune system before it can be translated into protein in cells.
In attempts to mask RNA from immune attack, researchers Drew Weissman and Katalin Karikó at the University of Pennsylvania switched out uridine, which is one of the four bases of the RNA code, for pseudouridine. This did the trick and set the stage for the development of viable mRNA-based therapeutics. To address delivery issues, Robert Malone, a graduate student at the Salk Institute for Biological Studies in California, showed in 1987 that lipid droplets could be combined with mRNA to help get it into cells.
Fast forward to more recent times, companies like Moderna as well as Pfizer’s COVID-19 vaccine partner BioNTech had been working on mRNA-based therapeutics, including vaccines, for just over a decade. While BioNTech was focused on developing mRNA vaccines for cancers, Moderna was dedicated to RNA therapeutics in addition to vaccines.
After the success of its first commercial vaccine product, Moderna has developed an mRNA-based vaccine against influenza, for which it recently released early positive safety and efficacy data. It is also working to create an all-in-one influenza, COVID-19 and RSV vaccine as well.
Apart from smaller biotechs and start-ups, big pharma is also starting up and/or expanding their in-house mRNA tech programs or striking development partnerships. In February, Gilead Sciences announced it is teaming up with biotech Gritstone bio to develop an mRNA-based vaccine for HIV. At the beginning of the year, Genentech, a member of the Roche Group, struck a deal with Ribometrix to leverage its discovery platform to discover, develop and commercialize small molecule drug candidates against RNA targets. The deal could bring the North Carolina-based RNA-based small molecule therapeutics developer more than $1 billion.
RNA therapeutics hold promise as powerful treatments for diseases, including those that are genetic-based. It’s, therefore, no surprise that the development of RNA-based therapies will be among the major life science trends over the next several years.
RNA-based treatments include RNA interference (RNAi) with double-stranded RNA molecules, or small interfering RNA (siRNA) involving single-stranded antisense oligonucleotides (ASOs). Double-stranded RNA is flagged by cells as foreign, triggering the cell’s RNA interference machinery to dice it up and destroy it.
The gene-editing tool CRISPR edits DNA using specialized strands of guide RNA and endogenous cellular mechanisms of RNA interference. We talked about the emergence of dozens of CRISPR biotechs last year and the growing number of CRISPR-based therapies in clinical trials for conditions ranging from Duchenne muscular dystrophy (DMD) and sickle cell disease (SCD).
As with other RNA technologies, RNA editing also makes use of endogenous cellular components and processes. RNA editing utilizes editing ASOs, which pair with cellular RNA to form double-stranded RNA, triggering recruitment of endogenous ADAR enzymes (adenosine deaminases acting on RNA) to a target adenosine in a disease-associated RNA. ADAR reverses guanine (G) to adenosine (A) mutations by mediating conversion of A to inosine (I), which is seen as guanosine (G). This has the possibility to target the more than 20,000 G to A disease-causing mutations in humans.
To develop these novel RNA-based therapeutics, we saw a number of big pharma companies team up with smaller biotechs focused on developing RNA-based therapeutics. This included Eli Lilly’s partnership with Netherlands-based RNA biotech ProQR Therapeutics this year to develop RNA editing-based therapies for rare genetic diseases, namely blindness-causing retinal conditions, based on the company’s proprietary Axiomer RNA editing platform technology. The deal is worth $1.5 billion. Prior to this, Lilly struck an agreement worth $1.25 billion (including $25 million upfront) with UK-based MiNA Therapeutics to develop small activating RNA (saRNA) drugs for up to five targets across Lilly’s key therapeutic areas of cancer, diabetes, immunology, neurodegenerative diseases and pain. We’ll be on the lookout to see how these partnerships pan out in the development of RNA-based therapeutics.
In addition to Moderna and BioNTech, Ionis Pharmaceuticals, Alnylam Pharmaceuticals and Sarepta Therapeutics are the big, small RNA biotechs to continue watching in 2022. Sarepta Therapeutics has been focused on developing AOS for the treatment of DMD and has received FDA approvals for three of its compounds — EXONDYS 51 (eteplirsen), VYONDYS 53 (golodirsen) and AMONDYS 45 (Casimersen), which are based on exon skipping. The trio brought a significant increase of about $70 million in revenue for Sarepta during the third quarter of this year, to between $605 million and $615 million. Sarepta currently has 14 RNA programs in its pipeline of 42 programs.
A trend that spiked in 2020 and that will continue into 2022, and beyond, is digital transformation in healthcare. This has been a huge topic in healthcare, especially with the onset of the pandemic. Digital transformation is growing rapidly and is a trend that is here to stay.
Digital transformation technologies include telemedicine, remote monitoring and health wearables among others. The pandemic shuttered operations in many clinical spaces, which led to a shift to virtual visits and telemedicine. Telehealth went from being an option that not many healthcare practitioners routinely used, to a necessity during the pandemic.
Both healthcare providers and patients quickly realized that remote and virtual models of care were not only borne out of necessity during the pandemic, but they offer patients significant convenience and improve accessibility. Patients can also communicate with their providers more often from the comfort of their own home. Not having to travel to clinical sites for healthcare visits or for participation in a clinical trial can help reduce costs and time associated with transportation for patients and their caregivers.
The increasing digitalization of healthcare is being realized by digital health companies that are helping design and implement digital health technologies. According to non-profit digital health company Rock Health, throughout 2020, digital health companies in the US raised $14.1 billion in venture capital funding, which is a 72 percent increase from 2018, and the largest amount achieved since 2011.
The biggest challenge to the digitalization of healthcare is transitioning from old models to new digital models. This involves technology transfer and training staff in new digital methods.
Digital Health Tools
How is digital transformation happening and how is it achieved? The simple answer is that it’s largely about out with the old tools and in with new innovative technologies.
Digital solutions in healthcare rely on the technologies that enable them. The technological tools must be sophisticated, reliable and user friendly, particularly for patients. While telemedicine involves the use of phones, things can get more complicated with more complex devices or video-based calls. But going online to book health appointments, including COVID-19 vaccine appointments, has certainly become the new norm.
Old methods such as paper-based record keeping are now being replaced by electronic patient records, for example. And the collection, management and analysis of data is being achieved with electronic data capture (EDC) systems involving cloud technologies, which can help create centralized, accessible data systems. The application of sophisticated analytics to manage and analyze the data is helping to drive enhanced insights into diagnosis, treatment and overall patient care.
AI and Automation
The application of artificial intelligence (AI) and machine learning (ML) technologies in healthcare can help drive more efficient and effective patient care. The integration of these sophisticated tools is allowing for deeper insights to be extracted from existing and new data. For example, the application of digital approaches in pathology is allowing for more detailed insights that were not achievable in the past, as well as integration with other data forms. AI can also be used in applications like robot-guided surgery and in radiotherapy planning where they can help improve treatment delivery and outcomes.
Having an interconnected ecosystem is also a key part of the new digital landscape in healthcare. Having connected devices allows for centralization and holistic approaches to delivering patient care. This includes efficient data collection, management and analysis to inform that care. It also enables greater accessibility to both stored and real-time data, as well as data sharing between providers and multiple centers. This can reduce time and monetary costs associated with physical visits and document deliveries.
Therefore, while the pandemic accelerated the adoption of digital healthcare, its success and new innovations will continue to help drive it forward.
Medical Device Innovations
The medical device space will see continued innovations in 2022, particularly in the growing adoption of non- or minimally invasive devices and wearable devices. Personalization of care has been a key life science trend and it is being exhibited in new-age medical devices such as at-home wearables for both health monitoring and delivery of treatment.
The global wearable medical devices market is projected to burgeon to a whopping $195.57 billion by 2027, reflecting a CAGR of 26.4 percent from 2020.
The wearable device arena was first spearheaded by the likes of Fitbit fitness trackers that record your physical activity and exercise goals. Later, smart health watches came on the scene that could monitor health indicators like heart rate, pulse, breathing and sleep patterns among others. What started as a trend several years ago has now turned into a lucrative industry. And it will continue to be lucrative as demand for health apps and associated wearable devices continues among consumers. It is estimated that just over 20 percent of Americans will use a smart wearable device in 2022 with this life science trend rising upwards over the next couple of years. Part of this owes to people wanting to take better charge of their health to look and feel better. This may have increased during the pandemic as people might have become more conscious of their health and wellness.
Wearables for health monitoring are also increasing in popularity and continue to be among the top in life science trends. With the greater adoption of virtual models of healthcare, healthcare providers can monitor patients remotely through wearable devices that are connected to the cloud. This allows for real-time data collection and some devices even have sophisticated AI-based algorithms being built into them to allow for data analytics.
Devices like wearable blood pressure monitors from companies like Omron Platinum, Withing BPM Connect and LifeSource are expected to increase in popularity. Similarly, wearable ECG monitors that assess heart rates and rhythms could also offer patients a way to monitor the activity and health of their heart more periodically than an occasional visit to the doctor’s office.
Wearable biosensors may be the next generation of wearables. Biosensors are analytical devices that detect changes in chemical substances as readouts for biological events. From patches that measure biochemical markers in fluids like saliva, tears, sweat and interstitial fluid. They can provide continuous real-time monitoring of metabolites, bacteria, hormones, glucose and other elements in these fluids. This can offer people an easy and convenient way to monitor physiological changes in real-time, over time.
Minimally Invasive Devices
Non-invasive or minimally invasive medical devices that can diagnose, monitor and treat disease is entering a promising era, and will be a key life science trend next year. In 2021, we saw a number of innovations in fields like neuromodulation, with several neurostimulation devices having received FDA approvals. These included devices to treat conditions like depression and chronic pain.
These devices are placed externally and deliver therapeutic activity in the form of electrical or magnetic signals, or in the case of virtual reality, it is in the form of imagery based on principles of cognitive behavioral therapy.
The global minimally invasive devices market is expected to grow in the coming years, with key companies including Precision for Medicine Inc, Zimmer Biomet Holdings Inc, Olympus Corp and Fortimedix Surgical BV leading the way.
Minimally invasive devices also include those that may require a one-time surgical implantation and then are controlled from the exterior. For example, the world’s first approved smart knee implant from Zimmer Biomet has gait tracking sensor technology that records metrics like range of motion, walking speed and step count. This information is then wirelessly transmitted to a cloud-based data-tracking platform that surgeons can access to monitor post-surgery recovery in real-time. This offers better post-op evaluations than self-reporting of progress.
Implants to measure eye health such as contact lenses that can monitor glucose levels in the eye are just some of the exciting innovations that we’ll continue to see in the space.
Life science trends next year will center on the individual. Empowering the patient to be an active participant in their journey towards health and wellness is a theme that has been coming to the forefront in recent years. This is why we will see more personalized strategies such as targeted therapies and customizable medical devices, inspired by, and for patients.