Controlled Substance Market
Number of pages: 100 | Report Format: PDF | Published date: June 21, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 85.50 billion |
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Revenue Forecast in 2031 |
US$ 134.92 billion |
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CAGR |
5.2% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
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Segments Covered |
Drugs, Application, Distribution Channel, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global controlled substance market was valued at US$ 85.50 billion in 2022 and is expected to register a revenue CAGR of 5.2% to reach US$ 134.92 billion by 2031.
Controlled Substance Market Fundamentals
A controlled substance refers to a drug or chemical compound that is regulated by the government due to its potential for abuse, addiction, and negative health consequences. These substances are classified and categorized into different schedules or classes based on their level of control and medical utility. Controlled substances are subject to legal restrictions and regulations regarding their manufacture, distribution, possession, and use. The regulations aim to prevent illicit drug trade, reduce substance abuse, protect public health and safety, and ensure appropriate medical use. The specific criteria for categorizing substances as controlled can vary between countries, but they generally consider factors such as the potential for abuse, addictive properties, recognized medical uses, and the overall risk to individuals and society.
Controlled Substance Market Dynamics
Controlled substances, particularly opioids, are commonly prescribed for managing acute and chronic pain. The demand for these medications is driven by the need to alleviate pain in patients undergoing surgeries, recovering from injuries, or living with chronic pain conditions. According to the CDC, Between 2019 and 2021, the prevalence of chronic pain among U.S. adults ranged from 20.5% to 21.8%, with high-impact chronic pain prevalence ranging from 6.9% to 7.8%. An estimated 51.6 million the U.S. people (20.9%) suffered chronic pain in 2021, with 17.1 million (6.9%) experiencing high-impact chronic pain. Controlled substances play a crucial role in palliative care, where the focus is on providing relief from pain and symptoms for patients with serious illnesses. Medications like opioids help improve the quality of life for patients in palliative care settings, which is increasing the controlled substance market demand. Controlled substances are used for treating various medical conditions, such as attention deficit hyperactivity disorder (ADHD), narcolepsy, anxiety disorders, epilepsy, and severe insomnia. These medications are prescribed to manage symptoms and improve the functioning of patients with these conditions. According to the WHO, around 50 million people worldwide have epilepsy, and nearly 80% of them live in low and middle-income countries. Controlled substances are also utilized in the treatment of substance use disorders. Medications like methadone, buprenorphine, and naltrexone are prescribed as part of medication-assisted treatment (MAT) programs to help individuals recover from opioid addiction and reduce the risk of relapse. Ongoing research and development efforts in the pharmaceutical industry drive the development of new controlled substances or improved formulations. This includes the creation of abuse-deterrent formulations that aim to reduce the potential for abuse or tampering, which is also expected to boost the controlled substance market growth.
However, strict regulatory requirements and compliance obligations pose challenges for healthcare providers, including prescribing practices, record-keeping, reporting, and adherence to controlled substance regulations. The complexity of these regulations is restricting the controlled substance market growth. The stigma surrounding controlled substances and substance use disorders can act as a barrier to effective healthcare delivery. Misconceptions and societal biases may prevent patients from seeking appropriate treatment or hinder healthcare providers from addressing substance abuse issues openly and effectively, thus hindering the controlled substance market growth.
Controlled Substance Market Ecosystem
The global controlled substance market is analyzed from four perspectives: drugs, application, distribution channel, and region.
Controlled Substance Market by Drugs
Based on the drug, the global controlled substance market is segmented into opioids, stimulants, depressants, cannabinoids, and others.
The opioids segment accounted for the largest controlled substance market share in 2022. Opioids are potent analgesics commonly prescribed for managing moderate to severe pain. They are highly effective in providing relief from acute pain resulting from surgeries, injuries, or medical conditions like cancer. The prevalence of pain-related conditions and the need for effective pain management contribute to the widespread use of opioids. According to the National Center for Biotechnology Information, over 310 million major procedures are performed worldwide every year, approximately 40 to 50 million in the United States and 20 million in Europe. Opioids have well-established medical uses and are recognized as essential medications for pain management in various clinical settings. Their efficacy in relieving pain has led to their widespread acceptance and incorporation into treatment guidelines. While efforts are being made to develop non-opioid pain management strategies, opioids still play a critical role due to limited alternatives in certain situations. Patients with severe, refractory pain may not respond adequately to non-opioid options, and opioids remain an important option for effective pain relief. Opioids have been widely used for decades, and pharmaceutical companies have invested heavily in these medications' research, development, and marketing. This has resulted in a well-established market presence and familiarity among healthcare providers, contributing to the growth of the opioids segment.
Controlled Substance Market by Application
Based on the application, the global controlled substance market is segmented into pain management, ADHD, depression, sleep disorder, cough suppression, anxiety, seizures, and others.
The ADHD segment accounted for the prominent revenue share of the controlled substance market. ADHD is one of the most common neurodevelopmental disorders affecting children and adults. The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity. The high prevalence of ADHD contributes to a large patient population requiring treatment, thereby driving the demand for controlled substances. According to the National Center for Biotechnology Information, In 2020, the prevalence of persistent adult ADHD was 2.58%, and symptomatic adult ADHD was 6.76%, corresponding to 139.84 million and 366.33 million affected adults worldwide. Stimulant medications have been widely studied and incorporated into treatment guidelines for ADHD. Healthcare providers often follow established protocols and guidelines, which recommend the use of stimulant medications as a first-line treatment option for managing ADHD symptoms. ADHD is a chronic condition that often requires long-term treatment. Stimulant medications are typically prescribed for extended periods to manage ongoing symptoms and improve daily functioning. Stimulant medications effectively target the core symptoms of ADHD, including inattention, hyperactivity, and impulsivity. By addressing these symptoms, these medications help individuals with ADHD improve their focus, attention span, and impulse control, enhancing their overall functioning and quality of life. Pharmaceutical companies have invested in researching and developing new formulations and delivery methods for ADHD medications. This ongoing innovation contributes to the availability of a variety of stimulant medications, catering to individual preferences and treatment needs. Healthcare providers, particularly psychiatrists and pediatricians, are often familiar with diagnosing and managing ADHD. They have experience in prescribing controlled substances for ADHD treatment, contributing to the growth of this segment in the market.
Controlled Substance Market by Distribution Channel
Based on the distribution channel, the global controlled substance market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
The online pharmacies segment is anticipated to register a lucrative growth rate during the forecast period from 2023 to 2031. Online pharmacies offer convenience and accessibility to consumers, allowing them to purchase medications, including controlled substances, from the comfort of their homes. This eliminates the need for physical visits to brick-and-mortar pharmacies, making it particularly appealing to individuals with limited mobility, transportation challenges, or those living in remote areas. The overall growth of the e-commerce industry has provided a conducive environment for the growth of online pharmacies. As more consumers embrace online shopping for various products, including medications, the demand for online pharmacies has increased. The expansion of telehealth services, including online consultations with healthcare providers, has further facilitated the growth of online pharmacies. Telehealth platforms often include online pharmacy services, allowing patients to receive prescriptions electronically and conveniently order their medications, including controlled substances, online.
Controlled Substance Market by Region
Geographically, the global controlled substance market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest controlled substance market size in terms of revenue generation accounting for around 34.2% share of the market. North America has a high prevalence of chronic conditions such as arthritis, cancer, and neurological disorders, which often necessitate the use of controlled substances for effective management of pain and other symptoms. According to the CDC, around in 4 U.S. adults (23.7%), or about 58.5 million people, have doctor-diagnosed arthritis. The aging population in North America contributes to an increased demand for healthcare services, including medications. As individuals age, they are more likely to develop chronic conditions that require controlled substances for pain management, symptom relief, and other therapeutic purposes. Mental health disorders, including depression, anxiety, and attention-deficit/hyperactivity disorder (ADHD), are prevalent in North America. Controlled substances, such as antidepressants and stimulant medications, play a vital role in managing these conditions, driving the demand for these medications. According to the Anxiety and Depression Association of America, ADAA, GAD affects 6.8 million adults, or 3.1% of the U.S. population, yet only 43.2% are receiving treatment. The opioid crisis has sparked a greater focus on addiction treatment services in North America. Efforts to expand access to medication-assisted treatment (MAT) programs, counseling services, and harm reduction initiatives are driving the demand for controlled substances used in addiction treatment.
Controlled Substance Market Competitive Landscape
The prominent players operating in the global controlled substance market are:
Controlled Substance Market Strategic Developments
A controlled substance refers to a drug or chemical compound that is regulated by the government due to its potential for abuse, addiction, and negative health consequences. These substances are classified and categorized into different schedules or classes based on their level of control and medical utility.
Asia Pacific can be considered the key growth region due to the surge in controlled substance industry trends in China, Japan, and the Indian subcontinent.
The prominent players operating in the global controlled substance market are F. Hoffmann-La Roche Ltd., Merck & Co. Inc, AbbVie, Inc., Pfizer, Inc., and Mallinckrodt plc.
The global controlled substance market growth is estimated to grow at a revenue CAGR of 5.2% during the forecast period from 2023 to 2031.
The estimated size of the global controlled substance market in 2031 is US$ 134.92 billion.
*Insights on financial performance are subject to the availability of information in the public domain