Controlled Substance Market Report 2025

The controlled substance market size has grown strongly in recent years. It will grow from $94.86 billion in 2024 to $101.15 billion in 2025 at a compound annual growth rate (CAGR) of 6.6%. The growth in the historic period can be attributed to medical advancements, regulatory frameworks, rising incidence of chronic diseases, expanding pharmaceutical industry, international trade, and collaboration.

The controlled substance market size is expected to see strong growth in the next few years. It will grow to $136.51 billion in 2029 at a compound annual growth rate (CAGR) of 7.8%. The growth in the forecast period can be attributed to precision medicine, telemedicine and remote healthcare, opioid alternatives, continued regulatory updates, increased mental health focus. Major trends in the forecast period include regulatory changes and compliance, increasing focus on drug safety and abuse prevention, advancements in drug delivery technologies, emergence of biosimilars and generic versions, integration of digital health solution.

The rising demand for medically prescribed drugs is anticipated to boost the growth of the controlled substance market in the future. Prescription drugs are intended for the treatment, cure, remediation, therapeutic intervention, or prevention of illness, and they are often classified as controlled substances. These drugs benefit the controlled substance market by improving patient outcomes and reducing unnecessary spending. For example, in September 2024, a report from the Centers for Medicare and Medicaid Services (CMS), a US-based federal agency, indicated that spending on prescription drugs rose by 8.4% in 2022, reaching $405.9 billion, compared to a 6.8% increase in 2021. Thus, the growing demand for medically prescribed drugs is driving the expansion of the controlled substance market.

The increasing prevalence of chronic diseases is anticipated to fuel the growth of the controlled substance market. Chronic diseases persist over an extended period and tend to worsen with time. Controlled substances are instrumental in managing symptoms associated with chronic conditions such as pain management, neuropsychiatric disorders, autoimmune ailments, cardiovascular issues, and inflammatory disorders. For instance, statistics from the National Library of Medicine in January 2023 forecast a 99.5% increase, reaching 142.66 million people aged 50 and above in the US with at least one chronic condition by 2050. Furthermore, as per the World Health Organization's (WHO) 2022 Highlights released in September 2022, 74% of global deaths, totaling 41 million annually, are attributed to noncommunicable diseases (NCDs) or chronic diseases. Hence, the mounting prevalence of chronic illnesses is a driving force behind the growth of the controlled substance market.

Product innovation stands out as a prominent trend gaining traction in the controlled substance market. Key players within this market are actively innovating new drugs and products to maintain their competitive edge. For instance, in January 2022, CMM (CareFlow Medicines Management Ltd.), a UK-based provider of medicine management solutions, collaborated with Modeus, a healthcare software provider based in Australia, to introduce the Controlled Drug Manager (CD Manager). This innovative platform for controlled drug management ensures the safe handling and monitoring of controlled drugs, including patient-owned medications. The newly launched CMM CD Manager, powered by Modeus, seamlessly integrates with CMM's medication management platform and other external systems. It's tailored for clinical staff and pharmacists in hospitals' pharmacy, wards, and theaters where controlled medications are stored. Through built-in reporting functionalities, CD Manager assists Controlled Drug Accountable Officers by monitoring controlled drug lifecycles within organizations and promptly addressing inconsistencies or potential diversions through automated alerts.

Major companies within the controlled substance market are driving innovation by introducing advanced technological products such as the e-module, aimed at securing a competitive advantage. The e-module stands as an online, interactive educational resource meticulously designed to ensure the appropriate availability of controlled substances for medical and scientific purposes. As an example, in September 2022, The International Narcotics Control Board (INCB), an independent treaty body based in Austria, unveiled the e-module. This initiative addresses barriers hindering the sufficient availability of essential narcotic and psychotropic substances crucial for medical treatments. The e-module offers self-paced training focused on estimating and evaluating controlled substances while covering the legal framework of drug control. It is available free of charge for government officials working within competent national authorities. Additionally, it's accessible in multiple languages including English, French, Portuguese, Russian, and Spanish, with translations provided in other languages as well.

In November 2023, Noramco, a US-based pharmaceutical manufacturing company, acquired Halo Pharmaceuticals for an undisclosed amount. This acquisition allows Noramco to broaden its service offerings by incorporating drug product formulation development, manufacturing, and packaging capabilities for its active pharmaceutical ingredient (API) customers. Halo Pharmaceuticals is also a US-based pharmaceutical manufacturing company that specializes in controlled substances.

Major companies operating in the controlled substance market include Merck & Co. Inc., Johnson and Johnson Services Inc., Orbis Biosciences Inc., GW Pharmaceuticals plc, Corium Inc., Aradigm Corporation, Alkermes plc, Sun Pharmaceutical Ltd., F. Hoffmann-La Roche Ltd., AbbVie Inc., Ampac Fine Chemicals, Siegfried Holding AG, Pfizer Inc., Novartis AG, GlaxoSmithKline plc, Sanofi S.A., Bristol-Myers Squibb, Eli Lilly and Company, AstraZeneca, Teva Pharmaceutical Industries, Viatris Inc., Boehringer Ingelheim, Gilead Sciences, Amgen, Regeneron Pharmaceuticals, Abbott Laboratories, Mallinckrodt Pharmaceuticals, Endo International, Catalent, Cambrex Corporation, Lonza Group, Indivior plc, Ipsen SA.

North America was the largest region in the controlled substance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the controlled substance market report during the forecast period. The regions covered in the controlled substance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the controlled substance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

A controlled substance is a drug or chemical, encompassing both illicit substances and legally prescribed pharmaceuticals, whose production, possession, or usage is regulated by the government. Controlled substance medications, whether prescribed legally or involved in illicit use, have restrictions due to their potential for causing physical and mental dependence. Despite the associated risks, these medications play a crucial role in alleviating pain and managing various symptoms, thereby enhancing the quality of life for individuals.

The primary types of controlled substances and drugs include opioids, stimulants, depressants, and cannabinoids. Opioids, for example, constitute a class of drugs utilized for the treatment of moderate to severe pain. They can be either synthesized in laboratories or derived from the opium poppy plant. These substances are distributed through various channels, including hospital pharmacies, retail pharmacies, and online platforms. Their applications span pain management, treatment for sleep disorders, addressing depression and anxiety, managing seizures, handling attention deficit hyperactivity disorder (ADHD), and more.

The controlled substances market research report is one of a series of new reports that provides controlled substances market statistics, including controlled substances industry global market size, regional shares, competitors with a controlled substances market share, detailed controlled substances market segments, market trends and opportunities, and any further data you may need to thrive in the controlled substances industry. The controlled substances market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The controlled substance market consists of sales of morphine, valium, ritalin, heroin, cannabis, diazepam, flunitrazepam, and ketamine. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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