Controlled Substance Market (By Drug: Opioids, Stimulant, Depressants, Cannabinoids; By Application: ADHD, Pain management, Depression, Sleep disorder, Cough suppression, Anxiety, Seizures, Others; By Distribution: Hospital pharmacy, Retail pharmacy, Online Pharmacy)- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global controlled substance market size was exhibited at USD 84.49 billion in 2022 and is projected to hit around USD 142.28 billion by 2032, growing at a CAGR of 5.35% during the forecast period 2023 to 2032.

Controlled Substance Market Size, 2023 to 2032

Key Pointers:

  • By geography, The North America region leading the market.
  • By drug, the opioid segment dominates the market.
  • By application, the ADHD segment leading the market.
  • By distribution, the retail pharmacy segment is predicted to the fastest-growing market from 2023 to 2032.

Controlled Substance Market Report Scope

Report Coverage


Market Size in 2023

USD 89.01 Billion

Market Size by 2032

USD 142.28 Billion

Growth Rate from 2023 to 2032

CAGR of 5.35%

Base year


Forecast period

2023 to 2032

Segments covered

By Drug, By Application and By Distribution

Regional scope

North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa

Key companies profiled

Merck & Co. Inc, Johnson & Johnson, Orbis Biosciences, Aradigm Corporation, Corium International, G.W. Pharmaceuticals, Lannett


The high incidence rate of chronic pain among the geriatric population across the globe is one of the factors that increases the demand for the use of controlled substances. Several categories of pain medications are available; opioid analgesics are FDA-approved for moderate to severe pain, and effectively work in pain management.

The high rate of attention deficit hyperactivity disorder (ADHD) among children is putting more pressure for new drug formulations based on controlled substances. This is creating growth opportunities for controlled drugs, such as opioids and stimulants, in the controlled substance market.

The introduction of new products would expand the controlled substance market, while providing more options for effective treatment. Drugs such as amphetamine, in high concentration, that are available in the market in different forms, can be easily addictive if taken for a long time, especially by adolescents. Several pharmaceutical companies are taking efforts to push in new products based on controlled substances in the market, to provide better treatment options with low concentration to people who suffer from diseases such as sleep disorder and ADHD. For instance, in 2016, Neos Therapeutics Inc. launched a new candy-flavored amphetamine chewable tablet in the controlled substance market to treat ADHD patients.

Oxycodone exhibits better analgesic efficacy than fentanyl, and comparable efficacy to morphine. In terms of patient satisfaction, higher satisfaction levels were observed with oxycodone in different studies, which has resulted in increased sales across the globe.

Amphetamine IR and ER formulation development is one major trend observed, which shows promising growth in the next few years due to a number of upcoming launches by several players for specific indications.

Segments Insight: 

Drug Insights:

Based on a drug, the global controlled substance market is segmented into opioids, stimulants, depressants and cannabinoids. Among all, the opioid segment dominates the global controlled substance market. Opioids are pain-relieving drugs that are widely used in the treatment of cancer. The increasing prevalence of cancer across the globe has been a major driving factor for the growth of the opioids segment. Despite multiple benefits, many healthcare providers are focused on reducing the use of opioids. The step is to prevent patients from getting addicted to opioid drugs.  

Application Insights:

Based on application, the global controlled substance market is segmented into ADHD, pain management, depression, sleep disorder, cough suppression, anxiety, seizures and others. The rising prevalence of attention deficit hyperactivity disorder (ADHD) and the newest drug discovery have made ADHD a leading segment of the global controlled substance market. 

ADHD envelops impulsivity, due to which behavior is affected. The cause of ADHD is still indistinct. Growing awareness about mental illness and increased research and development activities in the neuroscience field has fueled the segment's growth. 

Furthermore, the pain management segment is expected to show noticeable growth during the forecast period. Controlled substances in the pain management segment are widely used to treat cancer to reduce discomfort. The increasing number of cancer cases globally has boosted the number of opioid prescriptions, considered a primary cause that aids the growth of the pain management segment in the controlled substance market. 

Controlled substances/drugs such as Benzodiazepines treat sleep disorders and insomnia. Rising cases of such illnesses have boosted the demand for controlled substances. The increased demand makes the sleep disorder segment the fastest-growing global controlled substances market.

Distribution Insights:

Based on distribution, the global controlled substance market is segmented into hospital pharmacies, retail pharmacy & online pharmacies. The retail pharmacy segment is the fastest-growing global controlled substance market segment. Retail pharmacies are licensed and provide patients with medications at retail prices. The ease of access to the retail pharmacy has boosted the segment's growth. Many governments worldwide have allowed retail pharmacies to access and prescribe controlled drugs. 

However, the hospital pharmacy segment is maintaining growth as hospital pharmacies hold a separate unit/department for ordering, dispensing, transporting and prescribing controlled pharmaceuticals. Hospital pharmacies are still the most preferred distributors of controlled drugs that aid the growth of the segment in the global market. 

Regional Insights:

Geographically, North America is a leading region in the controlled substance market. Increased numbers of patients and developing healthcare infrastructure have boosted the demand for controlled substances in North America. The rising investments in research and development (R&D) activities, majorly in the U.S. and Canada, have surged the market's growth in North America. Europe is expected to witness significant growth in the upcoming years. 

The presence of major key players and relaxation in the prescription policies by several governments and governmental bodies are driving factors for the growth of the controlled substance market in Europe. However, the high-cost medications for treating ADHD, depression and other disorders are likely to hamper the European controlled substance market. 

Asia Pacific is considered the fastest-growing region in the controlled substance market. Favoring government policies for the development of controlled drugs has propelled the market's growth in Asia Pacific. Along with this, Latin America is also expected to witness growth in the controlled substance market due to the increased demand for medically prescribed drugs in Colombia. The controlled substance market in developing countries of the Middle East and Africa is showing steady growth. The market will significantly boost in Latin America and MEA during the forecast period of 2023-2032. 

Recent Developments:

  • In December 2022, a leading biotech company in the U.S., AbbVie, announced that the company received approval from the U.S. Food & Drug Administration (FDA) for its Cariprazine (Vraylar) as an adjunctive therapy for major depressive disorders in adults.
  • In December, the government of Yukon, a Canadian territory, announced the expansion of pharma services. Pharmacists in Yukon can now access and prescribe controlled substance medicines for travel-related disorders.
  • In December 2022, Spark Biomedical announced a strategic partnership with AcuityMD. The partnership aims to promote Spark’s noninvasive therapeutic to treat withdrawal symptoms caused due to opioid disorder. Spark’s therapy offers a controlled tool that sends mild impulses to the brain to help alleviate opiate symptoms.
  • In December 2022, The New Zealand government amended the Misuse of Drugs Regulations 1997. The amendments will allow prescribers to issue signature-exempt prescriptions for controlled drug medicines. The controlled medication for ADHD will be covered by a single e-script which will be helpful for patients that have to visit G.P. for regular prescriptions from rural areas.
  • In June 2022, Bicycle Health, a virtual opioid use disorder treatment startup, raised $50 million in a series B funding round led by InterAlpen Partners for virtual opioid use disorder treatment.
  • In May 2022, the U.S. Food and Drug Administration (FDA) approved Quelbree, a non-stimulant medication for ADHD in adults. Quelbree received approval from the FDA in 2021 to treat ADHD in kids under six years of age.
  • In April 2022, the government of Florida took a step towards expanding telemedicine facilities. The government decided to remove prior restrictions on prescription controlled substances in telemedicine. The new law in Florida now allows telemedicine prescriptions for controlled substances with very few and 

Some of the prominent players in the Controlled Substance Market include:

  • Merck & Co. Inc
  • Johnson & Johnson
  • Orbis Biosciences
  • Aradigm Corporation
  • Corium International
  • G.W. Pharmaceuticals
  • Lannett

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global Controlled Substance market.

By Drug

  • Opioids
  • Stimulant
  • Depressants 
  • Cannabinoids

By Application

  • ADHD
  •  Pain Management
  • Depression
  • Sleep Disorder
  • Cough Suppression
  • Anxiety
  • Seizures 
  • Others

By Distribution

  • Hospital Pharmacy
  • Retail Pharmacy 
  • Online Pharmacy

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Report Detail

  • Report Code:5998
  • No. of Pages:150+
  • Format:PDF/PPT/Excel

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