Healthcare continues to change at breakneck speed. Some of that change is clearly linked to effects of the COVID-19 pandemic, but other factors — politics, the courts, research, regulatory decisions, supply chain issues, a looming recession — are poised to have an outsized influence on an industry that has already undergone a radical transformation. What’s in store for healthcare and health policy in 2023? We took a look at a few critical areas.
Reproductive rights – communicating through uncertainty
In December 2021, we predicted a sea change coming for women’s reproductive rights, as the U.S. Supreme Count was poised to rule on abortion. With its decision in Dobbs v. Jackson, the Court overturned Roe v. Wade, and nearly 50 years of established law, giving states the ability to restrict access to abortion services and even levy criminal penalties against women who sought them and physicians who provide these services.
In 2023, the impacts of this ruling will take full shape, and from what we’re seeing, the issue goes much further than access to abortion services. Since the Supreme Court’s ruling, it’s clear that many elements of the healthcare industry are likely to be impacted. These areas include contraception (where some states have already targeted banning or restricting access to IUDs and other forms of birth control), in-vitro fertilization (which has been targeted as some states are seeking policies granting “personhood” rights to frozen embryos), and there have already been stories of restricted access to certain drugs, such as a medication for arthritis, that can be used off-label to help end a patient’s pregnancy. And on and on.
These are not insignificant industries: The U.S. fertility industry market alone is $25 billion (projected to reach $45 billion by 2027); the contraceptives market is valued at $8.3 billion and is expected to reach $12 billion by 2030; and the pregnancy testing market is estimated to reach nearly $2 billion by 2030. The impact on these industries from the Dobbs decision and resulting state laws is yet unknown.
Putting the politics aside, which is challenging for an issue this polarized, we believe that the issue of women’s reproductive rights will be in constant flux in the coming year. Companies in these areas of healthcare will need strong IR and PR plans, as the coming years will be contentious and there are potentially billions of dollars in market value up for grabs. Or, perhaps, companies will be able to successfully navigate growing market share during this tumultuous time. Are there new opportunities afforded by Dobbs and the shifting state law landscape? Forward-looking companies will quickly determine the answer to that question. The recent mid-term elections resulting in a divided Congress makes further federal legislation unlikely, but state-led regulations are still in play. Hold on tight.
Neuroscience – momentum and uncertainty
After many decades of frustratingly slow progress in neuroscience, including treatments for diseases like Alzheimer’s, ALS and Parkinson’s – where millions of patients are waiting for effective treatments – interesting recent developments point to 2023 being a pivotal year of progress in neuroscience drug development. The FDA’s controversial approval of Biogen’s Adulhelm (aducanumab) treatment for Alzheimer’s Disease and the Centers for Medicare and Medicaid Services’ (CMS) subsequent decision to largely not cover the drug for Medicare beneficiaries, set the stage for some deep soul-searching in biopharma about appropriate regulatory and payor strategies. Regardless of the Adulhelm decision, there’s a renewed sense of hope for finally developing safe and effective treatments for perplexing neurodegenerative diseases. And not a minute too soon, as an aging American population continues to battle more and more from these illnesses.
Other biopharma companies have announced positive data read outs in the Alzheimer’s space, including Eisai/Biogen’s lecanemab, and the FDA recently approved a promising new (although controversial) treatment for ALS. It appears there’s a renewed interest in neuroscience — including mental illness — areas that, save for a few companies, have been previously deprioritized over the past decade. Companies in neuroscience can ride the wave of increased investor, physician and patient interest in their areas of expertise. Clinical data will be king in 2023, as too many therapies that initially looked promising ended up failing in late clinical trials. Watch this space, as biopharma could have some breakthroughs in 2023, which should spur additional investment in neuroscience and mental health.
COVID’s next chapter – addressing mutating diseases
While the COVID-19 pandemic has been declared “over,” the impact of this disease is still very much front and center for tens of millions of Americans who are immunocompromised or who are suffering from long COVID. Experts predict that new variants will cause another spike in cases this winter in the U.S. Masking and social distancing policies have been dropped across the country, and there are ongoing policy conversations about an appropriate vaccine strategy (annual boosters, etc.)— COVID won’t be done with us anytime soon.
One emerging issue that is beginning to grab the spotlight is the U.S. government’s funding strategy around COVID therapeutics. The government invested heavily in monoclonal antibodies (mAbs). However, one mAb after another has either failed or is waning in efficacy as the virus mutates. The question we need to ask is whether leaning so heavily into mAbs will ever lead to an effective, long-lasting therapeutic for COVID or any other disease characterized by mutations that lead to new variants. Each new mAb developed over the past two years was developed specifically for a particular variant. But, as the virus continues to mutate, mAb treatments appear to become less effective, if effective at all. Some antivirals have shown promise, although emerging research indicates the virus is poised to develop resistance to these drugs.
Biopharma needs to develop new answers for COVID therapeutics, in addition to a host of other diseases that feature multiple mutations, such as seasonal and pandemic influenza (flu). Solving this challenge will be a watershed moment in medical science, and may also provide answers for future pandemics, such as a virulent flu strain. Biopharma companies and the federal government will likely shift funding to companies that can address mutation, making this a high-stakes game where success will be rewarded.
Our experts delve further into what policy, investor relations, and strategic communications may look like next year in the ICR 2023 trends series.