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  • Published In : Nov 2023
  • Code : CMI6201
  • Pages :175
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Global Controlled Substance Market size is expected to reach US$ 58.4 Bn by 2030, from US$ 41.8 Bn in 2023, by exhibiting a compounded annual growth rate (CAGR) of 4.9% during the forecast period. Controlled substances are drugs that are regulated by national and international drug enforcement agencies. They are accepted for medical uses but also have high potential for abuse and addiction. Controlled substances are used for pain management, anxiety, insoBnia, Attention-deficit/hyperactivity disorder (ADHD), cough suppression, and others. The key drivers include rising prevalence of chronic diseases, increasing geriatric population, and growth in prescription drug abuse.

Global controlled substance market is segmented into drug class, application, sales channel, and region. By drug class, the market is segmented into opioids, stimulants, depressants, hallucinogens, anabolic steroids and others. The opioid drugs segment is expected to account for the largest share during the forecast period due to the high use of opioids for pain management.

Global Controlled Substance Market Regional Insights

  • North America is expected to be the largest market for controlled substance market during the forecast period, which is expected to account for over 35.9% of the market share in 2023. The market growth in North America is due to the high burden of chronic diseases and increasing prevalence of prescription drug abuse in the region.
  • The Europe market is expected to be the second-largest market for controlled substance market, which is expected to account for over 28.5% of the market share in 2023. The market growth in Europe is due to the rising geriatric population and increasing use of controlled drugs.
  • The Asia Pacific market is expected to be the fastest-growing market for controlled substance market, with a CAGR of over 5.5% during the forecast period. The market growth in Asia Pacific is due to the improving healthcare infrastructure and growing awareness about controlled substances.

 Figure 1. Global Controlled Substance Market Share (%), By Region, 2023


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Analyst View of the Global Controlled Substance Market:

  • Global controlled substances market is witnessed to grow significantly in the near future. The market is primarily driven by the rising prevalence of various chronic diseases that requires treatment with controlled medications. The increasing aging population worldwide which is more susceptible to illnesses will continue boosting the demand for these pharmaceutical drugs. The growing healthcare expenditure across both developed and developing nations is another major factor for driving the market growth of the global controlled substance market. However, stringent regulations pertaining to the manufacture, distribution, and consumption of controlled substances might hamper market growth to some extent. Requirements for extensive clinical trials and regulatory approvals add to the cost of drug development. This could deter some of the market players. Non-compliance with rules might also attract heavy penalties.

Global Controlled Substance Market Drivers:

  • Increasing prevalence of chronic diseases: The rising prevalence of diseases like cancer, cardiovascular diseases, and neurological disorders is driving the demand for controlled substances for pain management. For instance, in November 2021, according to the data published by Centers for Disease Control and Prevention (CDC), in the U.S, 20.4% of adults had chronic pain and 7.4% of adults had chronic pain that limited life or work activities in 2020.
  • Growth in geriatric population: The geriatric population is more prone to chronic illnesses that require long-term use of controlled substances. According to the United Nations, the global geriatric population is expected to reach 2.1 billion by 2050.
  • Increasing healthcare expenditure: Governments across the globe are increasing their healthcare spending to improve infrastructure and access to medications. This is facilitating the uptake of controlled substances.
  • Rise in disposable incomes: The growing disposable income especially in developing regions is leading to higher healthcare expenditure and access to controlled medicines.

Controlled Substance Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 41.8 Bn
Historical Data for: 2018 to 2022 Forecast Period: 2023 - 2030
Forecast Period 2023 to 2030 CAGR: 4.9% 2030 Value Projection: US$ 58.4 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East:  GCC Countries, Israel and Rest of Middle East
  • Africa:  South Africa, North Africa, and Central Africa
Segments covered:
  • By Drug Class: Opioids, Stimulants, Depressants, Hallucinogens, Anabolic Steroids and Others
  • By Application: Pain Management, Anxiety, InsoBnia, Cough Suppression,  Attention-deficit/hyperactivity disorder (ADHD), Narcolepsy and Others
  • By Sales Channel: Hospitals & Clinics, Pharmacies and Others (Academic & Research Institutes, etc.)
Companies covered:

Johnson & Johnson Services, Inc., Pfizer Inc., Sanofi, Merck & Co., Inc., Gilead Sciences, Inc., Amgen Inc., Novartis Pharmaceuticals Corporation, AbbVie Inc., GSK Plc., AstraZeneca , Bristol-Myers Squibb Company, Eli Lilly and Company, Teva Pharmaceutical Inc., Bayer AG, Novo Nordisk A/S, Takeda Pharmaceutical Company Limited, Boehringer Ingelheim International GmbH, Aspen Holdings and Astellas Pharma Inc.

Growth Drivers:
  • Increasing prevalence of chronic diseases
  • Growth in geriatric population
  • Increasing healthcare expenditure 
  • Rise in disposable incomes
Restraints & Challenges:
  • Risk of substance abuse and addiction
  • Side effects of controlled drugs
  • Illegal trade and trafficking

 Global Controlled Substance Market Opportunities:

  • Development of abuse-deterrent formulations: Manufacturers are developing abuse-deterrent technologies to formulate controlled substances that are difficult to manipulate for abuse. This presents significant opportunities in the market.
  • Growth in emerging markets: Developing regions like China, India, and Brazil offer lucrative opportunities due to improving healthcare access and increasing prevalence of chronic diseases.
  • Rising adoption of e-prescriptions: Electronic prescriptions enhance compliance monitoring of controlled substance dispensing. This is creating prospects for the market growth.
  • Drug development for emerging applications: R&D to develop controlled substances for new therapeutic applications such as neurodegenerative disorders and ophthalmic illnesses presents new avenues.

 Global Controlled Substance Market Trends:

  • Growing use of controlled release drugs: Controlled release drugs provide longer and sustained effect thereby reducing dosing frequency. Products like OxyContin CR which is used to is used to treat moderate to severe pain, Nucynta ER are gaining wider acceptance.
  • Increasing adoption of e-pharmacies: Online pharmacies are improving access to controlled substance medications, especially in remote areas. Leading e-pharmacies like CVS pharmacy and capsule are partnering with pharmacy benefit management (PBMs).
  • Rising emphasis on medication adherence: Key market players are undertaking measures to improve patient compliance to prescribed regimens. Strategies include patient counseling, Short Message Serivcr (SMS) reminders, and online refill services.
  • Advances in drug delivery systems: Novel drug delivery technologies like transdermal patches, pre-filled syringes, and nasal sprays are enhancing safety and effectiveness of controlled substances.

Global Controlled Substance Market Restraints:

  • Risk of substance abuse and addiction: Controlled substances like opioids have a high risk of abuse and addiction which are associated with their use restrain market growth.
  • Side effects of controlled drugs: Side effects such as nausea, headaches, and dizziness with controlled substance use can negatively impact patient compliance and limit uptake.
  • Illegal trade and trafficking: Unlawful import, export, and distribution of controlled substances via illegal channels hamper the market growth of the controlled substances markets.

Counterbalances: The controlled substances should be used only after getting approval from the physician. Unlawful imports and exports also need to be taken into consideration.

Recent Developments

New product launches

  • In December 2021, Camurus AB, a pharmaceutical company, announced that its U.S. licensee Braeburn had received a complete response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its updated new drug application (NDA) for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder. CRL is a result of continued quality related deficiencies at Braeburn’s U.S. based third party manufacturer, which is identified by the U.S. FDA during a pre-approval inspection.
  • In November 2021, Sandoz International GmbH, a global leader in generic and biosimilar medicines, announced the U.S. launch of its authorized generic of Narcan (naloxone hydrochloride) Nasal Spray 4mg that is used to reverse opioid overdose. It is available to people in the U.S. via retail pharmacies and institutions including hospitals•In May 2020, Hikma Pharmaceuticals PLC., a multinational generic pharmaceutical company, launched Buprenorphine Hydrochloride Injection, 0.3mg/mL, the generic version of Buprenex [1] in the U.S. through its U.S. affiliate named Hikma Pharmaceuticals U.S.A Inc.

Acquisition and partnerships

  • In April 2021, ABneal Pharmaceuticals, Inc., a pharmaceutical company, and Kashiv Specialty Pharmaceuticals, LLC., a fully-integrated biopharmaceutical company, announced that ABneal Pharmaceuticals LLC., a subsidiary of the ABneal Pharmaceuticals LLC, had completed the acquisition of Kashiv Specialty Pharmaceuticals, LLC., a company that focuses on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs
  • In October 2020, Hikma Pharmaceuticals PLC., a multinational pharmaceutical company, and Arecor Limited, a biopharmaceutical company, announced that both the companies had entered into a new agreement to co-develop a ready-to-administer injectable medicine in the U.S., through Hikma’s affiliate Hikma Pharmaceuticals USA Inc.

Figure 2. Global Controlled Substance Market Share (%), By Sales Channel, 2023


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Top Companies in Global Controlled Substance Market

  • Johnson & Johnson Services, Inc.
  • Pfizer Inc.
  • Sanofi
  • Merck & Co., Inc.
  • Gilead Sciences, Inc.
  • Amgen Inc.
  • Novartis Pharmaceuticals Corporation
  • AbbVie Inc.
  • GSK Plc.
  • AstraZeneca
  • Bristol-Myers Squibb Company
  • Eli Lilly and Company
  • Teva Pharmaceutical Inc.
  • Bayer AG
  • Novo Nordisk A/S
  • Takeda Pharmaceutical Company Limited
  • Boehringer Ingelheim International GmbH
  • Aspen Holdings
  • Astellas Pharma Inc.

Definition: Controlled substances are drugs or chemicals whose manufacture, possession, or use are regulated by the government under the Controlled Substances Act. They are often classified into "schedules" based on their potential for abuse, risk of dependence, and accepted medical use. Schedule I substances have a high potential for abuse, no currently accepted medical use, and a lack of accepted safety for use under medical supervision. Examples include heroin, LSD, and marijuana.Schedule II substances also have a high potential for abuse which may lead to severe psychological or physical dependences.

Frequently Asked Questions

The key factors hampering the growth of the global controlled substance market are risk of substance abuse and addiction, side effects of controlled drugs, illegal trade, and trafficking.

The major factors driving the growth of the Market are increasing prevalence of chronic diseases, growth in geriatric population, increasing healthcare expenditure, and rise in disposable incomes.

The leading drug class segment in the market is the opioids.

The major players operating in the market are Johnson & Johnson Services, Inc., Pfizer Inc., Sanofi, Merck & Co., Inc., Gilead Sciences, Inc., Amgen Inc., Novartis Pharmaceuticals Corporation, AbbVie Inc., GSK Plc., AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Teva Pharmaceutical Inc., Bayer AG, Novo Nordisk A/S, Takeda Pharmaceutical Company Limited, Boehringer Ingelheim International GmbH, Aspen Holdings and Astellas Pharma Inc.

North America leads the market in terms of share.

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