Controlled Substance Market at a CAGR of ~7% during the forecast period of 2022 to 2030

Stimulant Drugs Prove Useful for Children with ADHD and Tourette Syndrome

Stimulant medications are increasingly gaining credibility for being a safe and effective option for ADHD (Attention Deficit Hyperactivity Disorder) treatment as far as children are concerned. Improved formulations of stimulants have benefitted children in letting them focus their thoughts better and ignore distractions. Companies in the controlled substance market are teaming up with doctors and healthcare providers to combine the treatment of stimulant medications with behavior therapy to treat children suffering from ADHD. This developmental aspect has helped children pay more attention to routine activities and control their behavior.

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The application of stimulants in the treatment of ADHD is estimated to increase in the coming years. ADHD accounts for the second-highest revenue amongst all applications in the controlled substance market, with a projected value of ~US$ 25 billion by the end of 2027. Due to these favorable aspects, it has been found that, the right medication of stimulants amongst ADHD patients has shown positive improvements in their behavioral patterns. Two forms of stimulants, namely, immediate release (short-acting) medications and extended release (immediate-acting and long-acting) medications are lately being talked about in the controlled substance market. The former is gaining increased popularity, since the medication is less expensive as compared to other stimulant drugs.

Stimulant drugs are even proving useful for patients with Tourette syndrome. Medications such as atomoxetine or guanfacine are safe and recommended for children to reduce conditions associated with frequent tics and unusual vocal sounds.

Pain Management Increases Scope of Opioid Treatment for Advanced Cancer Patients

Pain management is a necessary aspect for patients associated with advanced cancer. Thus, opioids are highly recommended for cancer patients to reduce the discomfort caused due to a diverse group of pain syndromes. Pain management is estimated to account for the highest revenue amongst all applications in the controlled substance market, with an estimated value of ~US$ 43 billion by the end of 2027. Thus, the increased prescription of opioid for advanced cancer patients is one of the major reasons for the exponential growth of pain management in the controlled substance market.

Although opioids help reduce the severity of pain syndromes, certain drawbacks of the medication are leading to resistance in its adoption amongst advanced cancer patients. Cognitive impairment and delirium are some of the few side effects caused due to the consumption of opioids. To overcome these drawbacks, healthcare companies in the controlled substance market are increasing awareness about screening in the early stages of delirium. Mini Mental State Examination and the Memorial Delirium-Assessment Scale are some of the credible tools that aid the screening procedure to assess the severity of cognitive impairment and delirium in patients.

In order to encourage advanced cancer patients to adopt opioids, companies in the controlled substance market are educating doctors and healthcare providers to thoroughly examine the complex and multi-faceted nature of pain management amongst patients.

Judicious Prescription of Tramadol to Reduce Incidence of Morbidity and Mortality

The controlled substance market is projected to grow at a healthy CAGR of ~7% during the forecast period. However, on the other hand, the limitations and adverse effects of certain drugs may hamper the growth of the controlled substance market. For instance, tramadol is an effective drug for pain relief, but confounding reasons of patients have led to instances of increased morbidity and mortality.

Tramadol has the potential for abuse and addiction. Although tramadol is being utilized and accepted in medical care, it is tightly regulated. Confounding reasons present ambiguity for the effectiveness of tramadol. Although tramadol is classified as a Schedule IV drug, lack of appropriate prescription for the drug has caused high rates of death in the controlled substance landscape. To overcome these challenges, manufacturers in the controlled substance market are increasing awareness about the judicious prescription of tramadol. They are increasing research & development to help educate doctors and patients about the potential risks of tramadol treatment.

In order to make medical research studies more authentic, companies in the controlled substance market should assess confounders to enhance the credibility of research outcomes. Healthcare companies are increasing the availability of tramadol amongst patients suffering from osteoarthritis and other painful conditions.

Analysts’ Viewpoint

Opioids are efficacious pain-reducing medications. However, strict laws and regulations dictate the prescription of opioids, since these medications are found to cause serious harm to patients, owing to their side effects. As such, healthcare companies need to work in collaboration with health commissions such as the FDA to improve enforcement on the illicit marketing of unapproved opioids, and offer access to improved treatment alternatives for patients suffering from acute and chronic pain.

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Manufacturers should strengthen their distribution networks through retail and online pharmacies, as these two sectors are projected for high growth in the controlled substance market. Likewise, there is scope for increased market growth in Europe and Asia Pacific, owing to improvements in the healthcare infrastructure in both these regions.

Global Controlled Substance Market: Description

Controlled substances are drugs or chemicals that are controlled under the Controlled Substance Act (CSA). The manufacture, possession, or use of these drugs is regulated by a government. These are illegal drugs that can have a detrimental effect on a person’s health and welfare. As a result, federal and state governments have regulated these substances. However, if someone has properly prescribed and lawfully purchased one of these substances, they are exempted from prosecution.

These substances are used for assistance in the treatment of several types of neurological disorders, as well as in drug research.

The demand for controlled substances has been increasing due to the rise in the number of people suffering from various ailments, such as chronic pain. Drugs such as opioids are the most effective analgesics for severe pain, and the mainstay of acute and terminal cancer pain treatments. The development of existing controlled substance molecules in different dosages is boosting their demand in the prescription market. For instance, amphetamine chewable tablets in various formulations create the demand for controlled substances to treat diseases such as ADHD, which affects millions of children across the world.

The global controlled substance market was valued at ~US$ 64 Bn in 2018, and is projected to reach a value of ~US$ 115 Bn by 2027, expanding at a CAGR of ~7% during the forecast period of 2019 to 2027.

Controlled Substance Market: Drivers

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.

Overall growth of the controlled substance market can be ascribed to rise in the prevalence of diseases which need controlled substances to treat them. Hence, overall increase in the patient pool has led to growth of the global controlled substance market.

New product approvals such as cocaine-based, C-Topical solutions or upcoming launches such as intranasal fentanyl sprays for cancer pain are some of the evolving trends in this industry, and can be growing factors for the overall controlled substance market.

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Global Controlled Substance Market: Prominent Segments

Rise in attention deficit hyperactivity disorder prevalence and recently launched products in this category are some of the major factors expected to drive the ADHD segment in the global controlled substance market in terms of application.

Based on distribution channel, the retail pharmacies segment is likely to be a highly lucrative segment during the forecast period, owing to a rise in the number of retail pharmacies, especially in the Asia Pacific region.

Global Controlled Substance Market: Competition Landscape

Key players analyzed in this report on the global controlled substance market are –

  • F. Hoffmann-La Roche AG
  • AbbVie, Inc.
  • Mallinckrodt plc
  • Pfizer, Inc.
  • Sun Pharmaceuticals Ltd.
  • Ampac Fine Chemicals
  • GW Pharmaceuticals plc
  • Merck & Co., Inc.
  • Lannett
  • Teva Pharmaceutical Ltd.

Key Questions Answered in the Controlled Substance Market Report

  • What is the sales/revenue generated by each drug across all regions in the controlled substance market during the forecast period?
  • What are the opportunities in the global controlled substance market?
  • What are the major drivers, restraints, opportunities, and threats in the controlled substance market?
  • Which region is likely to expand at the fastest CAGR in the global controlled substance market during the forecast period?
  • Which controlled substance drug and application segments are expected to generate the highest revenue, globally, in 2027? Which segment is projected to expand at the highest CAGR during the forecast period?
  • What was the market share or position of different companies operating in the global controlled substance market in 2018?

Global Controlled Substance Market – Segmentation


  • Opioids
  • Stimulants
  • Depressants
  • Cannabinoids


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

Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies


  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa


1. Preface

1.1. Market Definition and Scope

1.2. Market Segmentation

1.3. Key Research Objectives

1.4. Research Highlights

2. Assumptions and Research Methodology

3. Executive Summary : Global Controlled Substance Market

4. Market Overview

4.1. Introduction

4.1.1. Class Definition

4.1.2. Industry Evolution / Developments

4.2. Overview

4.3. Market Dynamics

4.3.1. Drivers

4.3.2. Restraints

4.3.3. Opportunities

4.4. Global Controlled Substance Market Analysis and Forecasts, 2017–2030

4.4.1. Market Revenue Projections (US$ Mn)

5. Market Outlook

5.1. Pipeline Analysis

5.2. Key Merger & Acquisition

5.3. Regulatory Scenario

6. Global Controlled Substance Market Analysis and Forecasts, by Drug, 2017-2030 

6.1. Introduction & Definition

6.2. Key Findings / Developments

6.3. Market Value Forecast, by Drug, 2017–2030

6.3.1. Opioids Codeine Morphine Fentanyl Hydrocodone Tramadol Oxycodone Others

6.3.2. Stimulants Amphetamine Methylphenidate Dextroamphetamine Methamphetamine Modafinil Others

6.3.3. Depressants Barbiturates Benzodiazepines

6.3.4. Cannabinoids

6.4.  Market Attractiveness, by Drug

7. Global Controlled Substance Market Analysis and Forecasts, by Application, 2017-2030 

7.1. Introduction & Definition

7.2. Key Findings / Developments

7.3. Market Value Forecast, by Application, 2017–2030

7.3.1. ADHD

7.3.2. Pain Management

7.3.3. Depression

7.3.4. Sleep Disorder

7.3.5. Cough Suppression

7.3.6. Anxiety

7.3.7. Seizure

7.3.8. Others

7.4.  Market Attractiveness, by Application

8. Global Controlled Substance Market Analysis and Forecasts, by Distribution Channel

8.1. Introduction & Definition

8.2. Key Findings / Developments

8.3. Market Value Forecast, by Distribution Channel, 2017–2030

8.3.1. Hospital Pharmacies

8.3.2. Retail Pharmacies

8.3.3. Online Pharmacies

8.4. Market Attractiveness, by Application

9. Global Controlled Substance Market Analysis and Forecasts, by Region, 2017-2030

9.1. Key Findings

9.2. Market Value Forecast, by Region

9.2.1. North America

9.2.2. Europe

9.2.3. Asia Pacific

9.2.4. Latin America

9.2.5. Middle East & Africa

9.3. Market Attractiveness, by Region

10. North America Controlled Substance Market Analysis and Forecast, 2017-2030


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