By: Phil Nadeau, Steve Scala, Joseph Thome, Tyler Van Buren, Rick Weissenstein, Erin McCallister
Apr. 17, 2025 - 5 minutes
Overview:
- The market for pain relief is large; approximately 1 in 5 people globally suffer chronic pain, and there's a total addressable market (TAM) of more than US$12.4 billion for brand drugs in the U.S. alone.
- More than 15 novel programs are currently in development with clinical data pending across acute, neuropathic and osteoarthritis conditions. Key opinion leaders (KOLs) find the targets sensible for pain.
- Recent medical breakthroughs driving the sector include the first new non-opioids to treat acute pain in over two decades.
- New Washington legislation may also incentivize the adoption of non-opioid alternatives.
The TD Cowen Insight
These novel mechanisms from top pharmaceutical companies provide reason for optimism, and policies in D.C. could help brand drugs gain traction over generic opioids, satisfying an unmet need in the pain market.
Driving Growth of Non-Opioid Market
We believe that the pain treatment landscape could represent a new and underappreciated opportunity for investors. After years of failed attempts to move away from opioid-based pain options, combined with the more recent concern about the opioid public health crises, our analyses of the acute and chronic pain pipeline provides reason for optimism.
Medical Breakthroughs
The approval of the first non-opioid to treat acute pain in more than two decades, a burgeoning pipeline of potential new drug candidates backed by sound scientific rationale and some early clinical proof of concept gives us confidence that the pain market could flourish over the coming decade.
A key linchpin to this scientific revolution of sorts, is whether clinicians will use them and whether payors will reimburse these newer options ahead of much cheaper, but more addictive, opioids. Our KOLs suggest that they will reach for the newer options so long as payors also put them on par (at the same formulary tier) as opioids. The price differential of the new drugs isn't to be taken lightly but put up against the cost of opioid addiction and abuse. It may be able to tip the scale.
Potential Legislation Changes
Legislation passed by Congress in 2022 could also start to help in 2025. Another bill has been proposed that could further incentivize the use of new non-opioid alternatives. We remain confident that non-opioid alternatives will be preferred – or at the very least not discouraged – by the new administration.
Overall, our research finds that physicians' expectations for the use of a non-opioid in acute pain implies penetration that is far greater than consensus (and our estimates), suggesting a desire among physicians to adopt non-opioid options that is much stronger than investors assume. This report also introduces a deep pain pipeline of potential new agents that we believe could be surprising (in a positive vein) for investors who may not be paying attention. The number of novel pain mechanisms in clinical development, and the potential that they could meaningfully change the pain treatment paradigm, would seem to be much greater than investors appreciate.
What Is Proprietary?
This multi-analyst report provides an in-depth look at the commercial outlook for the newest non-opioid pain medicine as well as a sweeping overview of the clinical pipeline and scientific rationale for the myriad targets under investigation. Our findings are supported by expansive Key Opinion Leader (KOL) diligence including discussions with seven scientists and clinicians, two regulatory experts and surveys of 25 physicians and 15 payors. Analyses of clinical pipelines, literature reviews and assessments of U.S. regulatory and legislative landscape buttress the report.
Billion-Dollar Growth Expected in Pain Management Category
We expect the demand for pain management products, branded and generics, to continue to grow due to the following:
- favorable demographics,
- increasing incidence of chronic pain conditions,
- increasing physician recognition of the benefits of pain management, and
- a steady stream of new pain products, including opioid alternatives recently approved and in late stages of development.
In addition to the first new drug in two decades, pipelines at pharma companies and some innovative biotech companies are starting to advance novel candidates with a range of mechanisms.
Our KOLs believe the novel targets make sense mechanistically though clinical efficacy and safety in patients need to bear out.
Nonetheless, the global pain market is sizeable, offering significant market opportunity if even one of these agents is successful. Globally, 1 in 5 people experience chronic pain. In the U.S. more than 17 million Americans experience high intensity chronic pain. For acute pain, it is estimated that there are approximately 1.5 billion painkilling days per year. Even if brand products priced at a nominal $8 per day were to penetrate just 20% of this heavily generic market, we estimate that the pain market for brand products could be at least $12.4 billion in the U.S. alone. In the near term, we project that the pain management category could grow from approximately $1.7 billion in 2023 to $4.1 billion worldwide by 2030.
What To Watch
Numerous early- and late-stage pain programs targeting novel mechanisms are expecting data and trial starts over the next 18-plus months. There are also a handful of policy and legislative milestones that are on our radar, including a scheduled May Food and Drug Administration (FDA) Advisory Committee meeting that could give us the first glimpse of the new administration's perspective on opioids and potentially non-opioid pain alternatives.
Subscribing clients can read the full report, Breaking Through Pain: New Targets & Opportunities - Ahead Of The Curve, on the TD One Portal