Controlled Substance Market To Attain Revenue USD 142.11 Bn By 2032

The global controlled substance market size was evaluated at USD 84.44 billion in 2022 and is expected to attain around USD 142.11 billion by 2032, growing at a CAGR of 5.34% from 2023 to 2032. Increasing prevalence of ADHD to boost the demand for controlled substances in the market.

Controlled Substance Market Size and Growth Rate From 2023 To 2032

Market Overview:

Controlled substances are drugs or chemicals widely used to treat sleep disorders, ADHD, depression and other neurobiological disorders. Governments and governmental bodies tightly control such drugs. Access or distribution of controlled substances without a license is illegal across the globe. The global controlled substances market is anticipated to grow with increased spending on drug discovery worldwide during the forecast period. Improved mental health awareness has boosted the demand for controlled substances to provide quality healthcare to patients. The pain management segment of the application of controlled substances will show significant growth owing to the increased demand for opioids in the pain-relieving process for cancer patients.

Report Highlights:

  • North America acquires the highest revenue share in the market of the global controlled substance. Latin America and Europe are expected to show significant growth in the market during the forecast period.
  • Pain management is a leading segment in the market of global controlled substances.
  • Increasing demand for relief drugs for chronic diseases is likely to boost the market's growth.
  • Retail pharmacy is the fastest-growing global controlled substances market distributor segment. 

Controlled Substance Market Report Scope:

Report Coverage Details
Market Revenue in 2023 USD 88.95 Billion
Projected Forecast Revenue in 2032 USD 142.11 Billion
Growth Rate from 2023 to 2032 CAGR of 5.34%
Largest Market North America
Base Year 2022
Forecast Period 2023 to 2032
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Regional Snapshot:

North America dominates the market of global controlled substance, and the region will maintain growth during the forecast period of 2023-2032. Increasing patients of chronic diseases, neurobiological issues and sleep disorders have boosted the demand for controlled drugs in the region. The overall development in the pharmaceutical sector and rapid approvals for controlled drugs in the treatment of ADHD and depression are fueling the growth of the controlled substance market in the U.S. and Canada. Canopy Growth Corporation, Tilray, Aphria Incorporation, Medical Marijuana Inc., Thermo Fisher Scientific and Insys Therapeutics are headquartered in the U.S. and Canada.

The presence of these key players makes these countries the most significant contributor to North America's market growth. Product development, partnerships and targeting emerging markets are a few major driving factors that have propelled the demand for the controlled substance market in North America.

Europe acquires the second-largest revenue share in the market of global controlled substance after North America. The rising adoption of e-prescriptions in Europe of controlled substances has provided convenience to patients by reducing the overall workload from the healthcare sector. The European market has the potential to grow during the forecast period owing to the increased awareness of controlled substances. However, the current shortage of opioids from November 2022 has hampered the economic growth of the market of a controlled substances in Europe. Germany is considered a significant contributor to the development of the market. Increasing cases of sleep disorders and depression among youth and the prevalence of chronic diseases among the geriatric population have boosted the demand for controlled drugs in the market. The presence of major key players such as G.W. Pharmaceuticals, Consort Medical and Johnson Matthey has contributed to the growth of the controlled substance market in Europe.

Latin America is considered the fastest-growing region in the market of the global controlled substance. The increased demand for medical marijuana in Columbia has fueled the region's market growth. Moreover, boosting healthcare infrastructure and increased focus on treating chronic diseases have propelled the market of controlled substances in Asia.

Market Dynamics:


Increasing prevalence of ADHD across the globe

Attention deficit hyperactivity disorder (ADHD) cases have increased in recent years. Especially children below 9 are likely to suffer from ADHD, which causes chronic attention difficulties and hyperactivity. The neurological issue requires the dosage of controlled drugs as a part of therapy. Stimulant-controlled drugs such as Adderall, Vyvanse or Ritalin are prescribed to treat ADHD. The U.S. Food & Drug Administration (FDA) and other drug administrative bodies across the globe are focused on fast-track approvals for the usage of controlled substances in the treatment of ADHD, which has boosted the number of R&D activities in the global market. It has also provided lucrative opportunities for the overall pharma industry to strengthen. Considering these factors, the increasing prevalence of ADHD in kids is a major driving factor for the growth of the market of the global controlled substance.


Side effects caused by the controlled substances

Controlled substances may lead to prolonged severe side effects and potential complications. The risk of side effects due to controlled substances is a major restraining factor for the growth of the global market. Side effects such as failure of specific organs, memory loss, memory disturbances, behavioural issues, continuous headache, diarrhoea, and dizziness are life-threatening. Some side effects of controlled drugs last for 10-12 hours, while others can last for extended periods. Considering the prolonged risks associated with controlled drugs, governments and drug administration bodies across the globe have imposed stringent regulations on the usage of controlled medicines.


Increased research and development (R&D) activities in the market of the global controlled substance

Increased research and development (R&D) activities have fueled the chances of new controlled drug discovery. Research & development activities not only discovered drugs but also improved the population's health. R&D activities are considered a boon for investors in the market as they allow increased market participation for critical investors. With a growing demand for controlled drugs owing to the rising neurobiological disorders, research and development activities are expected to provide more efficient ways of treatment in the market of controlled substances. Thus, increased research and development (R&D) activities for controlled substances bring lucrative opportunities for investors, manufacturers, and pharmacies and fuel the overall controlled substances market growth.


Shortage of controlled drugs

Drug shortage is a global issue that creates an obstacle to the growth of the market of a controlled substances. Drugs involved in the market of the controlled substance are liable to the shortage, which affects the stakeholders, healthcare providers and patients. Manufacturing issues cause drug shortages, unavailability of raw materials, logistic or transportation problems demand, and regulatory issues. The significant impact of drug shortage is on clinical operations. Shortage of drugs results in delayed or denied treatment, which can hamper patients' health. For instance, the opioid shortage in the global market since November 2022 has created challenges for the market of a controlled substances. The ongoing crisis of opioids has restricted physicians and pharmacists from prescribing and dispensing drugs to treat ADHD.

Recent Developments:

  • In December, a leading global clinical-stage biopharmaceutical company, Vistagen, announced that the U.S. Food & Drug Administration had granted fast-track designation to the company for the production PH10. PH10 will be used for the treatment of major depressive disorders.
  • In December 2022, The Harold Rogers Prescription Drug Monitoring Program (PDMP) granted $1.4 million in funding to support PDMP EHR integration in New Jersey to address the opioid crisis.
  • In November 2022, J.B. Chemicals Company Ltd. announced that the company had received an abbreviated new drug application (ANDA) from the U.S. Food & Drug Administration (FDA) for a new drug to help treat panic disorder and anxiety disorders.
  • In October 2022, the Medicine and Healthcare Products Regulatory Agency, U.K., approved oral treatment for treating insomnia in children and ADHD in adolescents.
  • In January 2022, the U.S. Drug Enforcement Administration (DEA) issued a proposal to address the transfer of electronically prescribed controlled substances. The proposal aims to amend a new policy for pharmacies to prescribe controlled substances. The amendment allows the transfer of electronically prescribed controlled substances between Drug Enforcement Administration-registered retail pharmacies.

Major Key Players:

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

Market Segmentation:

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

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