Controlled Substance Market Size, Share, and Trends 2024 to 2034

The global controlled substance market size was estimated at USD 84.44 billion in 2022 and it is expected to hit around USD 142.11 billion by 2032 with a noteworthy CAGR of 5.34% from 2023 to 2032. Increased research and development (R&D) activities are expected to support the invention of a better drug delivery system; subsequently, the global controlled substance market will show significant growth.

Key Takeawayes

• 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 Overview

Controlled substances are the type of drugs that governments highly control. The restrictions associated with controlled substances are imposed on the drugs' manufacturing, sale, usage, handling, and distribution. Controlled substances can be highly addictive. Overusing such drugs can cause multiple side effects and physical and mental dependence, which are the primary reasons behind the stringent regulations imposed on the controlled substance market.

Morphine, Valium, and Ritalin are the few widely prescribed controlled substances on the market. Moreover, medications such as Xanax, Restoril, Adderall, Dexedrine, Lunesta Focalin, Concerta, Klonopin, and Ambien are controlled drugs. Controlled medications are used to treat hypertension, anxiety, insomnia, travel disorders, cognitive issues, depression, attention deficit hyperactivity disorder (ADHD), fatigue, narcolepsy, and many other problems. 

The controlled substances are prescribed by doctors/physicians after understanding patients' overall physical and mental conditions and considering all risk factors associated with controlled drugs. The primary aim of controlled medications is to reduce pain and provide quality healthcare to patients. There has been significant growth in the awareness of controlled substances as they help manage multiple issues. 

The global controlled substance market is projected to grow with increasing approvals for e-prescription for controlled substances. E-prescriptions are considered a key trend in the market. The global controlled substance market focuses on the utility and rapid adoption of electronic prescribing methods as they are convenient for both patients and healthcare providers. 

Controlled Substance Market Scope

Controlled Substance Market Dynamics

Physicians are prescribing controlled substances to provide a high-therapeutic efficacy for patients, which has boosted the global controlled substance market growth in recent years. The adoption of controlled substances in pain management during the treatment of multiple diseases over-prescription is a significant driver for the growth of the controlled substance market. 

The World Health Organization (WHO) is focused on improving the availability of controlled substances globally, along with appropriate policies and regulations. This has propelled the growth of the market. 

Increased research and development (R&D) investment to discover controlled drugs is a driving factor in the controlled substance market. The increasing prevalence of chronic diseases such as diabetes, cancer or hypertension demands controlled medications in the market, subsequently aiding the growth of the global controlled substance market. 

Controlled drugs are capable of offering treatment for an extended period. Considering the advantages of controlled drugs, the demand for opioids, stimulants, and depressants is likely to surge during the forecast period. Moreover, strengthening the distribution network owing to the development of pharmaceutical infrastructure is propelling the growth of the global controlled substance market.

On the other hand, a lack of awareness about controlled drugs is likely to hamper the global controlled substance market growth. Stringent regulations imposed by governments in different countries are major restraining factors for market growth. There are several prolonged and short-term side effects caused by controlled drugs, and the risk of side effects is likely to create an obstacle to market growth. 

Covid-19 Impacts

The spread of the deadly coronavirus led to a prolonged lockdown in 2020. The pandemic adversely affected the global controlled substance market and showed uncertainties in the market revenue during 2020-2021. The overall controlled substance market was affected during the Covid-19 pandemic due to a halt in the production cycle. All imports and exports of ingredients required to produce controlled drugs/substances were paused due to imposed restrictions on moving, halted airline travel and closed borders. This impacted the supply chain. 

Controlled substance manufacturing companies were forced to shut down in order to contain the spread of coronavirus, which led to a shortage of stock globally. Scientists/researchers focused on developing novel drugs for fighting against coronavirus; thus, the controlled substance market faced negligence. During this period, research, innovation and sales of new controlled substances were hampered. 

Controlled substances are widely used to treat ADHD, depression and sleep disorders. Patients suffering from such a disorder require immediate access to medicine/drugs. The imposed restrictions challenged the continuity of the treatment as hospital visits were reduced during the lockdown period. 

With the growing challenge of balancing the increased demand and shortage of controlled substances, the International Narcotics Control Board held a meeting on 19th March 2021 (during the pandemic phase) with competent authorities of twenty-two countries. The conference/meeting aimed to discuss the supply problems and find best practices for making controlled substances available in the market. To facilitate the availability of controlled substances, countries were advised to review their import and export authorization policies. 

Employees working in the pharmaceutical industry for the controlled substance market lost jobs during the pandemic due to the negatively impacted global economy. Due to the imposed lockdown, the global controlled substance market adopted a remote work culture. However, these impacts showed up in the initial phase of the lockdown. 

The supply chain, manufacturing units and other essential services required for the production of controlled drugs and chemicals were allowed to reopen with few relaxations due to increased demand for controlled substances needed for the treatment of ADHD, depression, cough and other disorders. 

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 narrow exceptions. 

Controlled Substance Market Companies

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

Segments Covered in the Report

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 Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa