One 2021 trend – the rapid launch of numerous COVID-19 vaccines making their way from the bench and into billions of arms around the world – cast a shadow over everything else in the industry.
The Delta and omicron variants, as well as breakthrough cases, have demonstrated that COVID-19 is not yet in the rearview mirror. Nonetheless, throughout this rollercoaster of a year, the life sciences showed incredible growth and persistence. So, what can we expect in 2022?
Many of the industry anticipated trends for 2022 are a direct result of the pandemic. But other trend-dictating factors haven’t gone away – our aging population continues to age, and the prevalence of chronic disease continues to rise.
Here are the five trends we’re monitoring in 2022.
- Orally Disintegrating Tablets. We anticipate the industry’s increasing interest in orally disintegrating tablets (ODTs) will continue in 2022 (and beyond). As we discussed in December, ODTs offer some distinct advantages over other dosage forms, including increased bioavailability, faster pregastric absorption rates and higher levels of patient compliance. Many reasons lead to patient non-compliance, but the top complaints usually relate to taste, trouble swallowing, gagging—all challenges that ODTs can overcome. Pharma companies are eager to solve these challenges, as dosage non-compliance is a significant cause of revenue loss.
Hygiene is another reason we anticipate ODTs will become a preferred dosage form for many pharma companies. More than ever in the wake of COVID-19, both healthcare workers and patients are aware of hygiene. Pills, liquids, and pastes are much more susceptible to germs than ODTs, whereas the individual blister packaging of ODTs keeps the medication sterile – providing peace of mind to patients. While adoption of the ODT dosage form is still evolving, we don’t see it slowing down.
- Monoclonal Antibodies. Another trend certain to continue increasing in 2022 is the growth of the monoclonal antibodies (MAbs) market. More than 100 MAbs are approved and on the market – and a stunning 1,200+ candidates are in development. The MAb market now accounts for more than one-fifth of drugs approved by the FDA each year, and over the past five years they have been the fastest-growing biopharmaceutical product class worldwide.
The FDA approved the first monoclonal antibody in 1985, but it wasn’t until 2010 that the rate of approvals started to rapidly escalate. The significant growth of monoclonal antibodies is partially a result of the rise in chronic illnesses, such as autoimmune disease, infectious diseases and cancers, and – you guessed it – the emergence of COVID-19.As these diagnoses increase worldwide, we are seeing more companies developing monoclonal antibodies to treat them, leading to a ripple effect.The more MAb drugs there are in the pipeline, the more approvals can happen – which in turn leads to more funding, research, and advancements in MAb technologies. Janice Reichert, PhD, executive director of the Antibody Society and editor-in-chief of MAbs predicts that the number of approvals will not drop anytime soon.
- The growth of monoclonal antibodies is indicative of a larger trend in pharma—namely biopharma. If you’ve been following any sort of pharma news over the last decade, you know that biologics have taken a substantial portion of drug approvals – accounting for about 25% of all NMEs over the last 5 years. In addition to monoclonal antibodies, this category of drug includes recombinant proteins/hormones, vaccines, and cell and gene therapy.
Key players in the industry continue to invest in the development of biologics and biosimilars (generic biologics). At the same time, the COVID-19 pandemic is all but ensuring the biologics market will not slow down as companies race to find more treatments. In fact, a record-high $5.9 billion was invested during the third quarter of 2020 in biopharma-related industries, dominated by $3.9 billion in 104 deals invested in biotech alone.
But the biologics train was moving fast well before COVID-19. Biologics have done what many small molecules cannot do: target niche populations to solve unmet medical needs. As our population ages and chronic illnesses continue to rise, the demand for personalized medicine and biologics will continue. The growth in biologics has also been driven by investors who continue to show interest in hot technologies like gene therapy and CRISPR.
And as the first wave of biologicals approaches the patent cliff, there will be a substantive rise in biosimilars.
- Vaccine adjuvants. Another trend we’ll be monitoring in 2022 is vaccine adjuvants. Vaccine adjuvants are components of a vaccine that enhance the body’s response to the target (the disease). Not all vaccines need adjuvants, but the ones that do are significantly improved.
The industry’s emphasis on vaccine adjuvants is partially related to COVID-19. However, it’s also directly related to other trends we’ve mentioned above, like the world’s aging population, the surge in infectious diseases, and increased interest from pharma companies.
Vaccine adjuvants have been around for 90 years, but in the last twenty years scientists have gained a greater understanding of how adjuvants work, which has led to more developments in the field. Adjuvants can help improve efficacy in situations where scientists have run against challenges. For example, certain populations don’t respond as well to vaccines. These populations include elderly patients, immunocompromised patients, chronic disease sufferers and infants.
Adjuvants can help improve the immune response in these populations.
In the 21st century, we are dealing with highly sophisticated and persistent pathogens that evade human immune responses, a key reason for the growing focus on adjuvants. These pathogens have caused huge challenges and are why infectious diseases remain very much an issue worldwide. However, modern adjuvants appear poised to overcome these challenges. Recognizing that the area of adjuvants is constantly evolving, investors and key industry players have turned their attention to its potential.
- Track & Trace and Serialization. The final trend we are following is the implementation of track & trace procedures and serialization. The deadline to comply with the FDA’s The Drug Quality and Security Act (DQSA) is coming up in 2023, so any company that has yet to implement “an electronic, interoperable system to identify and trace certain prescription drugs” will be focusing on that in 2022. This act aims to help the FDA curb counterfeit, stolen, or tampered drugs, and it will allow the agency to remove potentially harmful drugs from the supply chain swiftly.
The first step is serialization or assigning a serial number on products to be tracked and traced throughout their journey. Tracking is understanding where the product is along the supply chain, while tracing identifies anything that comes in contact with the product. Track & trace technology is constantly advancing, and now allows companies to monitor their products’ journey in real-time. As technology continues to improve rapidly, the global track and trace solutions market is projected to reach USD 7.3 billion by 2026 from USD 4.1 billion in 2021.Serialization and track & trace procedures aren’t just beneficial for the FDA and the patients. They also benefit the pharma companies. With these processes in place, companies can better protect their brand and curb revenue lost from stolen products along the supply chain. They also offer more transparency to patients (another hot button issue that will remain a focus next year and beyond).
What’s Driving the Trends? Geriatric, Chronic Disease and COVID Populations.
The common thread among most of these trends is a response to rising patient populations – primarily geriatric and chronic disease patients. As these populations increase, the burdens on our healthcare systems will increase as well.
The other driver is, of course, COVID-19. As we move into the third year of this pandemic, we aren’t just addressing new cases but also those with prolonged COVID-19 effects. The industry continues to work to address these issues – and anticipate future COVID-related challenges – a key reason we don’t see most of the trends listed above slowing down any time soon.