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Controlled Substance Market

Controlled Substance Market Size, Share, Competitive Landscape and Trend Analysis Report by Product, by Application and by Distribution Channel : Global Opportunity Analysis and Industry Forecast, 2023-2032

LS : Pharmaceuticals

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Author's: | Roshan Deshmukh
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One of the biggest challenge faced by prescriber of drugs is that every individual requires different levels of tolerance and variable opioid doses to obtain adequate pain relief. Controlled substances are medications or illicit drugs which are active in the central nervous system and can potentially cause a relative physical and mental dependence which can lead to addiction of those drugs. Furthermore, these substances can have harmful effects and health consequences when consumed high doses. These drugs have extensive implications on filling and refilling of these substances. In 1970, five specific 'Schedules' describing abuse potential, with Schedule 1 having the highest potential for abuse and each schedule thereby after that with low abuse potential were established under Controlled Substances Act. Manufacturers and dispensaries of these drugs, require a prior registration with the Drug Enforcement Agency (DEA), the organization responsible for regulating controlled substances at the federal level. Controlled substances consists of drugs like opioids, depressants, stimulants, anabolic steroids and hallucinogens. Controlled substances such as morphine, Ritalin and Valium are available only via prescription.


COVID – 19 scenario analysis:  

  • The COVID-19 pandemic has emerged as a humanitarian as well as economic crisis, creating strain on the society and affecting millions of people and businesses
  • Industry closures and people are asked to stay in their homes which has cause taken a huge toll in terms of money and economic growth
  • Over 4 million people affected globally, with 300 thousand losing their lives due to SARS-CoV-2
  • Healthcare organizations are already working in battle mode, preparing new plans to respond growing COVID-19 patients, right from sourcing rapid diagnosing kits to sufficient PPE kits for workers
  • Due to diversion of medical field towards treating COVID-19, the funding to R&D activities related to chondroitin sulfate has been reduced and this segment have to face negligence subsequently causing negative impact on controlled substances market

Top impacting factors: Market Scenario Analysis, Trends, Drivers and Impact Analysis

Growing number of prescription medicine, rising preference of physicians for prescribing controlled substances  as they offer high-therapeutic efficacy, better patient response and reduced treatment cost over the conventional drug delivery systems are expected to boost the growth. Due to highly competitive market, the pharmaceutical firms actively keep experimenting as per industry needs and fund the R&D activities to innovate solutions and better drug delivery systems would fuel the market growth. Heavy funding to R&D activities by key market players for developing highly efficient treatments and therapies for chronic such as cancer, diabetes, and hypertension is expected to surge the demand in the market for controlled substances. For example, TAR-200 (Gemcitabine) used in treatment of bladder cancer includes a controlled release drug delivery system which is a product by biomedical company Taris. 

Increasing incidences of diseases, rising geriatric population globally is among key factors contributing to the market growth. Various parameters like physical, mental and biological functions affects the medicine intake of geriatric population and also their body isn’t acquainted to withstand high doses and extreme side-effects of drugs. Hence, these challenges would create demand for controlled substances with rising number of patients. 

In comparison with the conventional delivery systems, the controlled substances are capable of imposing therapeutic effect for longer duration, target-specific drug delivery ensuring efficacy along with reduction in dose strength and dosage frequency, enhance patient response to the drug and achieve uniform drug effect. Thus, with variety of advantages and attributes possessed by controlled substances, their acceptance is expected to increase at a significant rate.

However, stringent guideline imposed by Drug Enforcement Agency (DEA) and the suspicious order monitoring (SOM) requirement that is a mandate foe registered distributors of opioids is regulated by DEA to keep check on suspicious drugs, lack of awareness of controlled substance and high prevalence of illegal controlled substances are restrains that might hamper the growth of controlled substances market. 

Pain management segment to increases use of opioids in advanced cancer treatment

Pain management segment is a prominent segment for cancer patients as opioids are used to relieve subjects suffering from cancer and reduce the discomfort caused due to pain syndromes. The increase in prescription of opioids for its utilization in cancer treatment is a major reason guiding the market growth for pain management segment. However, opioids have some side effects leading to restrain its adoption amongst advanced cancer patients. Consumption of opioids can cause certain side effects on health such as cognitive impairment and delirium. Pharmaceutical organizations are taking various initiatives to overcome these drawbacks. Educating doctors and healthcare providers about complex nature of pain management and awareness about screening in the early stages of delirium is being spread as a part of action plan in order minimize side effects. Mini Mental State Examination and the Memorial Delirium-Assessment Scale tools are used to evaluate the severity of side effects such as cognitive impairment and delirium in patients. Thus, these efforts taken in maximizing usage of opioids and reducing their side effects parallelly will lead to enormous growth of pain management segment.

North America region to dominate the market 

North America to dominate the controlled substances market. The dominance is due to factors like rise in the number of hospitals as well as patient pools due to rising burden of chronic diseases such as CVD, cancer and diabetes, growing investment in R&D activities, favoring policies by government for development on controlled drug release systems, high strain to achieve better health outputs at lower costs, and presence of leading industry players in the region is promoting adoption of the product are propelling the growth of controlled substances market in the region.

Key benefits of the report:

  • This study presents the analytical depiction of the global controlled substance industry along with the current trends and future estimations to determine the imminent investment pockets.
  • The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the global controlled substance market share.
  • The current market is quantitatively analysed to highlight the global controlled substance market growth scenario.
  • Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
  • The report provides a detailed global controlled substance market analysis based on competitive intensity and how the competition will take shape in coming years.

Questions answered in the Controlled Substance Market research report:

  • Who are the leading market players active in the controlled substance market?
  • What are the current trends that will influence the market in the next few years?
  • What are the driving factors, restraints, and opportunities in the controlled substance market?
  • What are the projections for the future that will help in taking further strategic steps?

Controlled Substance Market Report Highlights

Aspects Details
By Product
  • Opioids
  • Stimulants
  • Depressants
  • Cannabinoids
By Application
  • Pain management
  • Sleep disorders
  • Depression and anxiety
  • Seizure
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Others
By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
By Region
  • North America  (US, Canada, Mexico)
  • Europe  (France, Germany, UK, Italy, Spain, rest of Europe)
  • Asia-Pacific  (Japan, China, India, Australia, South Korea, rest of Asia-Pacific)
  • LAMEA  (Brazil, South Arabia, South Africa, rest of LAMEA)
Key Market Players

Aradigm Corporation, Alkermes plc, Corium International Inc., Depomed Inc., Merck and Co. Inc., GW Pharmaceuticals, Capsugel, Pfizer Inc, Orbis Biosciences Inc., Johnson and Johnson

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Controlled Substance Market

Global Opportunity Analysis and Industry Forecast, 2023-2032