US Controlled Substance Market Expected to Grow $21 Billion by 2035

Driven by rising demand for pain management, attention-deficit hyperactivity disorder (ADHD), and addiction medication, the US controlled substance market is projected to surge from $31 billion to $52 billion over the next decade, according to Precedence Research.¹

“The market consists of opioids, stimulant drugs, sedatives, and addiction treatment medications provided through highly controlled pipelines,” wrote the authors of the report. “According to SAMHSA's 2024 National Survey on Drug Use and Health, approximately 48.4 million Americans aged 12 and older had a substance use disorder. Furthermore, the number of cases of persistent pain, ADHD, and substance abuse disorders is on the rise, continuing to fuel growth for the US market.”

This expansion reflects a deepening clinical reality characterized by an aging population and a significant rise in surgical procedures. Although the opioids segment held the largest market share in 2025, the stimulants category is projected to experience the fastest growth as ADHD diagnosis rates climb across the country.^1,2

For pharmacists on the front lines, this surge in volume represents a dual challenge of ensuring legitimate access for patients experiencing pain while navigating a landscape where over half of Americans over 12 have used illicit drugs at least once.^1,3

READ MORE: Opioidology: An Unbiased View of Our Opioid Crisis for Clinicians

The clinical demand is underscored by the fact that nearly 80% of emergency department visits in the US involve reports of pain, yet many providers remain hesitant to prescribe. This apprehension is mirrored in the pharmacy, where a pilot study in Texas revealed that over 60% of community pharmacists reported feeling uncomfortable when filling controlled substance prescriptions.^2,4

Such discomfort often stems from the high stakes of the opioid crisis, which has claimed over 1 million lives since 1999. Furthermore, the undertreatment of acute pain presents its own set of dangers, as poorly managed symptoms can lead to pain becoming chronic, significantly increasing long-term health care costs and diminishing patient quality of life.^2,3

The market for addiction treatment medications is also a driver of this growth, as pharmacists are increasingly recognized as the most accessible health care professionals to manage opioid use disorder (OUD). Through the use of medications like buprenorphine, methadone, and naltrexone, pharmacists help bridge the treatment gap for the 4 out of 5 adults with OUD who currently do not receive medication-assisted treatment, according to the Journal of the American College of Clinical Pharmacy.⁵

Recent regulatory shifts, such as the 2023 Mainstreaming Addiction Treatment Act, have removed previous X-waiver requirements, creating more opportunities for clinical pharmacists to collaborate with care teams and initiate these life-saving therapies.

Beyond the clinical aspects of dispensing, the financial projections underscore a staggering societal burden. The total cost of drug abuse in the US, encompassing health care, crime, and lost productivity, is estimated at $820 billion annually.³

Pharmacists play a role in mitigating these costs through harm reduction strategies, such as the distribution of naloxone and providing education on safe medication disposal.⁵

The Texas pilot study highlighted that many pharmacists were eager to provide free drug disposal envelopes to patients, yet safe disposal was infrequently addressed in standard practice before the intervention.⁴

Achieving the projected $52 billion market value will also depend on the integration of long-term recovery support services into the broader health care environment. Recovery high schools, collegiate recovery programs, and recovery community centers provide the recovery capital necessary to sustain behavior change, as stated in Alcohol Research.⁶

These services offer the environmental support that often determines the difference between a successful recovery and a relapse.

As the controlled substance market evolves over the next decade, the role of the pharmacist will likely transcend traditional dispensing, moving toward a more holistic position within a multidisciplinary team focused on managing chronic conditions, optimizing pain treatment, and supporting the long-term stabilization of patients within their communities.⁵

“Strategic developments are actively reshaping competition across controlled medication categories. In 2025, Collegium Pharmaceutical further developed its abuse-deterrent opioid products and its pain management efforts,” concluded the authors of the current report.¹ “Indivior deepened its commitment to OD treatment through ongoing innovation in addiction treatment solutions. Furthermore, the businesses are still proceeding with investments in abuse-deterrent forms, controlled release, and digital monitoring technologies to bolster market positions.”

READ MORE: Pain Management Resource Center

REFERENCES

1. Patil R. US controlled substance market size, share and trends 2026 to 2035. Precedence Research. June 22, 2026. Accessed June 23, 2026. https://www.precedenceresearch.com/us-controlled-substance-market

2. Hackworth JC, Schneider JE, Do Valle M, et al. The burden of acute pain in the U.S. in the wake of the opioid crisis. Front Pain Res (Lausanne). 2025 Oct 7;6:1642035. doi: 10.3389/fpain.2025.1642035.

3. Drug abuse statistics. National Center for Drug Abuse Statistics. Accessed June 23, 2026. https://drugabusestatistics.org/

4. Thornton JD, Smith NZY, Olateju OA, et al. Pharmacist intervention to improve controlled substance dispensing and use practices in Texas: a pilot study. JAPhA Pract Innov. 2024;1(4):100019. https://doi.org/10.1016/j.japhpi.2024.100019

5. Stranges PM, Adams KK, Alharir A, et al. Pharmacists’ contributions to the management of opioid use disorder. JACCP. 2025;8(6):500-510. https://doi.org/10.1002/jac5.70049

6. Jason LA, Salomon-Amend M, Guerrero M, et al. The emergence, role, and impact of recovery support services. Alcohol Res. 2021 Mar 25;41(1):04. doi: 10.35946/arcr.v41.1.04.