A confluence of events in the pharma industry is converging to make 2023 a year of profound transformation in drug development and commercialization – a year that will galvanize the healthcare, medical, and pharma market insights teams that serve it.
Treatment Innovation, Yet Fewer New Drugs
Innovative new therapies are being created, commercialized, and adopted at a brisk pace, driven by demand, breakthrough advancements, acceptance of new development methods, and the need to diversify revenue channels. The emergence of transformative cell- and gene-therapies (CGTs) is a particularly exciting trend, as they require less early-stage time to develop and address a wide range of conditions including many rare diseases—diseases that are typically underfunded and under researched.
With just 37 medications approved in 2022—compared to an average of 51 over the past five years—the US Food and Drug Administration (FDA) has created pent-up demand within the pharmaceutical market. This demand contributes to growing pressure on the agency to determine better paths to assess and approve more medications, and adapt its processes to the accelerated timelines of innovative new methods. Fewer approvals also force greater focus on time-to-revenue with each drug launch, along with the imperative to access timely prescriber, patient, and stakeholder insights in ways that optimize launch planning for improved efficiency.
Acceptance of Cell- and Gene-Therapies
Though little was known or understood about these new therapies prior to Covid-19, the pandemic has served as a catalyst for awareness and acceptance of CGTs and other new, non-traditional medications. In October 2019, just three, months prior Covid-19 hitting the US, InCrowd—an Apollo commercial brand—teamed up with renowned mRNA scientist, Dr. Melissa Moore of Moderna, to share research on the Awareness of Nucleic Acid-Based Therapies among physicians. Data showed that only 56% of physicians surveyed were somewhat familiar with the CGT mechanisms covered in the survey, which included mRNA, AAV, and CRISPR, among others, and only 7% reported high familiarity with them.
Fast forward three years, more than 70% of the global population has received at least one dose of the Covid-19 vaccine, and in the US alone nearly 400 million Pfizer BioNtech and 250 million Moderna vaccinations have been administered—both mRNA-based vaccines. Awareness and acceptance of mRNA-constructed therapies (and consequently CGTs) has leapfrogged in recent years due to the education, awareness efforts, and public service campaigns required to advance Covid vaccinations. Though awareness and education efforts will need to continue to realize the promise of these therapies across multiple conditions, the demonstration of their efficacy and value in the last few years is undeniable.
Throughout the pandemic, healthcare and medical insights teams helped monitor and guide the understanding of both traditional and CGT treatments. In a healthcare environment with continued staffing shortages and physician burnout, timely healthcare professional (HCP) and patient insights will continue to play an important role in enabling changemakers to understand market challenges and address them.
The Off-Patent Drug Impact
While the world is becoming more aware of, and exposed to, CGTs, several blockbuster drugs from large manufacturers are coming off patent, creating a need for manufacturers to diversify their portfolios with propitious new therapies to fill their revenue gaps. Recent years have seen a surge in big-pharma partnerships with, and acquisitions of, innovative biotech companies to bring these new therapies along, address their own revenue gaps, and keep up with their changing markets.
Based on a robust FDA pipeline of non-traditionally developed drugs, as many as 13 new CGTs are expected to launch in 2023, with McKinsey forecasting more than 50 hitting the market in 2024. However, the potential of CGTs cannot be fully realized without significant changes in the industry, such as better ways to identify and recruit patients for clinical trials, nimbler research methods, and greater consumer awareness and access to genetic testing, among other hurdles. Insights efforts that quantify clinician stakeholder sentiments on these topics will be vital to understanding metrics on the brand health of existing therapies and framing efficient and effective launch programs for new ones.
The resources required to develop these drugs and educate healthcare professionals (HCPs), consumers, and legislators on the need for widespread genetic testing, genetic counselors and other HCP specialists, and accessibility for patients, are immense. Fortunately, some of these changes are underway. Funding through grants and investment has fueled the science behind CGT discovery over the past decade or more. The cost of genetic testing for consumers has come down significantly in recent years, while education and awareness efforts on the importance of it have gone up.
Additionally, the US Bureau of Labor Statistics anticipates an 18% growth in the need for genetic counselors in the next decade—a significantly higher growth rate than the average of all other occupations. This change is on its way and the pharma market is adapting to embrace it, teaming-up with niche pharmaceutical services firms, recruiting the most-experienced and sought-after talent, evolving their own cultures, and demanding more of their traditional vendors.
If these trends continue, 2023 will truly be a year for innovative transformers who will evolve all aspects of the industry, from clinical trial recruiting to market insights, and deliver greater patient impact along the way.