Analysts’ Viewpoint on U.S. Controlled Substance Market Scenario
High incidence rate of chronic pain among the geriatric population, introduction of controlled substance or controlled drug products, and rise in target population of attention deficit hyperactivity disorder are main factors that are expected to boost the U.S. controlled substance market. The market is estimated to grow at around 5% of CAGR from 2022 to 2031. These controlled substances are illicit drugs; hence, controlled drugs used in medical preparations require proper prescription from a licensed medical professional. Opioids offer the best results in the treatment of certain disorders. Consequently, several clinical trials are being conducted in the past few years by key players in the industry. Moreover, the COVID-19 pandemic impacted harshly the manufacturing and export of drugs, which has led to a negative impact on production rate of controlled substances.
Controlled substances are basically controlled drugs or prescribed medications, which are designated by the law and their production & use are regulated by the government. These controlled substances or controlled prescribed medications are used in treatment of several types of neurological disorders as well as in drug research. Various product types of controlled substances are, opioids, stimulants, depressants, and cannabinoids drugs.
The U.S. controlled substance market is likely to grow at a steady pace during the forecast period, owing to the increasing demand for controlled substances as drugs on chronic pain.
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Chronic pain persists for a longer duration, and the number of patients suffering from chronic pain is increasing. According to data provided by the Centers for Disease Control and Prevention, in 2019, an estimated 20.4% adults in the U.S. had chronic pain, and 7.4% adults had high-impact chronic pain.
Moreover, increase in geriatric population that is more prone to chronic pain, due to reduced mobility and lack of activity, is projected to propel to demand for controlled substance. The WHO stated that the growth rate of the geriatric population would be higher in developed countries, especially in countries such as the U.S. According to the U.S. Census Bureau, around 89 million people are expected to be aged over 65 years in the U.S. by 2050.
The launch of new products is estimated to boost the market, as this would provide more options for effective treatment. Controlled drugs for depression, or other drugs such as amphetamine, which are available in the market in different forms can be easily abused, primarily by adolescents. Several pharmaceutical companies are taking interest or initiatives to introduce some new products or capsule control drugs in the market in order to provide better treatment to people suffering from chronic diseases. For instance, in 2020, Trevena, Inc., a biopharmaceutical company, received the U.S. FDA approval for its brand OLINVYK (oliceridine) injection for the management of acute pain in adults. In addition, the FDA recently approved cocaine-based products, such as C-Topical in topical form, to provide anesthetic support during procedures.
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Opioid is basically used to treat moderate to severe pain. The growth of the opioid segment can be attributed to the consistent rise in population that suffers from pain, and an opioid is used as a component in the management of pain. Awareness about the advantages of these drugs to treat different types of pain and availability through different distribution channels, such as online mode prescribed by specialists, have increased considerably. Therefore, a rise in the demand for opioids for use in pain management is one of the major reasons that boosts the market.
In terms of revenue, the opioid product type segment accounted for a dominant share of the market in 2021. The segment is anticipated to expand at a high CAGR rate from 2022 to 2031.
The pain management segment is projected to account for a notable share of the global market. Pain can lead to severe complications if proper care or treatment is not provided for a longer time. Unattained pain results in many health issues such as vein thrombosis, reduced patient mobility, and pulmonary embolism. Therefore, doctors usually prescribe analgesics in the initial stage of pain. If the patient remains unresponsive for the initial medications then, these controlled drugs are used for further treatment. Thus, this increase in use of controlled drugs is estimated to fuel the demand for controlled substances.
Geriatric individuals and people suffering from chronic pain caused by cancer and other diseases can be effectively treated with controlled substance drugs; hence, an increase in usage of controlled substances is estimated to propel the market significantly during the forecast period.
Based on distribution channel, the U.S. controlled substance market has been segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The retail pharmacies segment accounted for a dominant market share of the market, in terms of revenue, in 2021. The segment is anticipated to grow at a high CAGR during the forecast period.
Medicines for various neurological disorders, pain management, etc., are prescribed for a long period, which prompts patients to prefer retail stores instead of visiting hospitals. A rise in the number of retail pharmacies, owing to the growth of international pharmacy corporates in the U.S., and initiatives taken by key players in strengthening their distribution networks are also expected to boost the segment.
The U.S. controlled substance market is a consolidated with a limited number of distributers. Key players operating in the market are AbbVie, Inc., Pfizer, Inc., Merck & Co., Inc., Mallinckrodt plc, F. Hoffmann-La Roche AG, Janssen Pharmaceuticals, Inc., and Teva Pharmaceutical Industries Ltd. Each of these players has been profiled in the U.S. controlled substance market report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments.
Attribute |
Detail |
Market Size Value in 2021 |
US$ 44.5 Bn |
Market Forecast Value in 2031 |
US$ 74.3 Bn |
Growth Rate (CAGR) |
5.2% |
Forecast Period |
2022–2031 |
Historical Data Available for |
2017–2020 |
Quantitative Units |
US$ Bn for Value |
Market Analysis |
It includes cross segment analysis at global as well as regional level. Furthermore, qualitative analysis includes drivers, restraints, opportunities, key trends, Porter’s Five Forces analysis, value chain analysis, and key trend analysis. |
Competition Landscape |
|
Format |
Electronic (PDF) + Excel |
Market Segmentation |
|
Companies Profiled |
|
Customization Scope |
Available upon request |
Pricing |
Available upon request |
The U.S. controlled substance market was valued at US$ 44.5 Bn in 2021 and expected to reach US$ 74.3 Bn by 2031.
The U.S. controlled substance market is anticipated to grow at a CAGR of 5.2% during the forecast period.
High incidence rate of chronic pain among geriatric population Introduction of new controlled substance products Rise in target population of attention deficit hyperactivity disorder (ADHD).
The opioid product type segment is likely to account for the largest share, in terms of revenue, in 2031.
AbbVie, Inc., Pfizer, Inc., Merck & Co., Inc., Mallinckrodt plc, Hoffmann-La Roche AG, and Janssen Pharmaceuticals, Inc. are the prominent players in the U.S. controlled substance market.
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: U.S. Controlled Substance Market
4. Market Overview
4.1. Introduction
4.2. Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. U.S. Controlled Substance Market Analysis and Forecast, 2017–2031
4.4.1. Market Revenue Projections (US$ Mn)
5. Key Insights
5.1. Total Number of Prescriptions, by Product Type (2020)
5.2. Regulatory Scenario of Controlled Substance in the U.S.
5.3. Key Industry Events (Mergers, Acquisitions, Partnerships, Collaborations, etc.)
5.4. COVID-19 Pandemic Impact on Industry (Value Chain and Short-/ Mid-/Long-Term Impact)
6. U.S. Controlled Substance Market Analysis and Forecast, by Product Type
6.1. Introduction & Definition
6.2. Key Findings / Developments
6.3. Market Value Forecast, by Product Type, 2017–2031
6.3.1. Opioids
6.3.1.1. Codeine
6.3.1.2. Morphine
6.3.1.3. Fentanyl
6.3.1.4. Others
6.3.2. Stimulants
6.3.3. Depressants
6.3.4. Cannabinoids
6.4. Market Attractiveness, by Product Type
7. U.S. Controlled Substance Market Analysis and Forecast, by Distribution Channel
7.1. Introduction & Definition
7.2. Key Findings / Developments
7.3. Market Value Forecast, by Distribution Channel, 2017–2031
7.3.1. Hospitals Pharmacies
7.3.2. Retail Pharmacies
7.3.3. Online Pharmacies
7.4. Market Attractiveness, by Distribution Channel
8. U.S. Controlled Substance Market Analysis and Forecast, by Indication
8.1. Introduction & Definition
8.2. Key Findings / Developments
8.3. Market Value Forecast, by Indication, 2017–2031
8.3.1. Pain Management
8.3.2. Sleep Disorder
8.3.3. Anxiety
8.3.4. Seizure
8.3.5. Others
8.4. Market Attractiveness, by Indication
9. Competition Landscape
9.1. Market Player Competition Matrix
9.2. Company Profiles
9.2.1. AbbVie, Inc.
9.2.1.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.1.2. Product Portfolio
9.2.1.3. SWOT Analysis
9.2.1.4. Strategic Overview
9.2.2. Pfizer, Inc.
9.2.2.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.2.2. Product Portfolio
9.2.2.3. SWOT Analysis
9.2.2.4. Strategic Overview
9.2.3. Merck & Co., Inc.
9.2.3.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.3.2. Product Portfolio
9.2.3.3. SWOT Analysis
9.2.3.4. Strategic Overview
9.2.4. Mallinckrodt plc
9.2.4.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.4.2. Product Portfolio
9.2.4.3. SWOT Analysis
9.2.4.4. Strategic Overview
9.2.5. F. Hoffmann-La Roche AG
9.2.5.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.5.2. Product Portfolio
9.2.5.3. SWOT Analysis
9.2.5.4. Strategic Overview
9.2.6. Janssen Pharmaceuticals, Inc.
9.2.6.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.6.2. Product Portfolio
9.2.6.3. SWOT Analysis
9.2.6.4. Strategic Overview
9.2.7. Purdue Pharma L.P.
9.2.7.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.7.2. Product Portfolio
9.2.7.3. SWOT Analysis
9.2.7.4. Strategic Overview
9.2.8. Teva Pharmaceutical Industries Ltd.
9.2.8.1. Company Overview (HQ, Business Segments, Employee Strength)
9.2.8.2. Product Portfolio
9.2.8.3. SWOT Analysis
9.2.8.4. Strategic Overview
List of Tables
Table 01: U.S. Controlled Substance Market Value (US$ Bn) Forecast, by Product Type, 2017–2031
Table 02: U.S. Controlled Substance Market Value (US$ Bn) Forecast, by Opioids, 2017–2031
Table 03: U.S. Controlled Substance Market Value (US$ Bn) Forecast, by Indication, 2017–2031
Table 04: U.S. Controlled Substance Market Value (US$ Bn) Forecast, by Distribution Channel, 2017–2031
List of Figures
Figure 01: U.S. Controlled Substance Market Value (US$ Bn) Forecast, 2017–2031
Figure 02: U.S. Controlled Substance Market Value Share, by Product Type, 2021
Figure 03: U.S. Controlled Substance Market Value Share, Indication, 2021
Figure 04: U.S. Controlled Substance Market Value Share, Distribution Channel, 2021
Figure 05: U.S. Controlled Substance Market Attractiveness Analysis, by Product Type, 2022–2031
Figure 06: U.S. Controlled Substance Market Attractiveness Analysis, by Product Type, 2022–2031
Figure 07: U.S. Controlled Substance Market Value (US$ Bn), by Opioids, 2017–2031
Figure 08: U.S. Controlled Substance Market Value (US$ Bn), by Stimulants, 2017–2031
Figure 09: U.S. Controlled Substance Market Value (US$ Bn), by Depressants, 2017–2031
Figure 10: U.S. Controlled Substance Market Value (US$ Bn), by Cannabinoids, 2017–2031
Figure 11: U.S. Controlled Substance Market Attractiveness Analysis, by Indication, 2022–2031
Figure 12: U.S. Controlled Substance Market Value (US$ Bn), by Pain Management, 2017–2031
Figure 13: U.S. Controlled Substance Market Value (US$ Bn), by Sleep Disorder, 2017–2031
Figure 14: U.S. Controlled Substance Market Value (US$ Bn), by Anxiety, 2017–2031
Figure 15: U.S. Controlled Substance Market Value (US$ Bn), by Seizure, 2017–2031
Figure 16: U.S. Controlled Substance Market Value (US$ Bn), by Others, 2017–2031
Figure 17: U.S. Controlled Substance Market Attractiveness Analysis, by Indication, 2022–2031
Figure 18: U.S. Controlled Substance Market Attractiveness Analysis, by Distribution Channel, 2022–2031
Figure 19: U.S. Controlled Substance Market Value (US$ Bn), by Hospital Pharmacies, 2017–2031
Figure 20: U.S. Controlled Substance Market Value (US$ Bn), by Retail Pharmacies, 2017–2031
Figure 21: U.S. Controlled Substance Market Value (US$ Bn), by Online Pharmacies, 2017–2031
Figure 22: U.S. Controlled Substance Market Attractiveness Analysis, by Distribution Channel, 2022–2031