Controlled Substance Global Market Report 2024

The controlled substance market size has grown strongly in recent years. It will grow from $89.78 billion in 2023 to $95.98 billion in 2024 at a compound annual growth rate (CAGR) of 6.9%. The expansion observed during the historic period can be attributed to several factors, including medical advancements, the establishment of regulatory frameworks, an increase in the incidence of chronic diseases, the growth of the pharmaceutical industry, and enhanced international trade and collaboration. These elements collectively contributed to the growth and development of the controlled substances sector during that timeframe.

The controlled substance market size is expected to see strong growth in the next few years. It will grow to $125.96 billion in 2028 at a compound annual growth rate (CAGR) of 7.0%. The anticipated growth in the forecast period can be attributed to the emphasis on precision medicine, the expansion of telemedicine and remote healthcare, the pursuit of opioid alternatives, ongoing regulatory updates, and an increased focus on mental health. Major trends expected during this period encompass changes in regulations and compliance standards, a growing emphasis on drug safety and abuse prevention, advancements in drug delivery technologies, the emergence of biosimilars and generic versions, and the integration of digital health solutions. These factors are poised to shape and influence the trajectory of the controlled substances sector in the upcoming forecast period.

The rising demand for medically prescribed medications is set to drive the growth of the controlled substance market. Medically prescribed drugs are those intended for treatment, cure, prevention, or management of illnesses and are often classified as controlled substances. These drugs play a pivotal role in the controlled substance market by improving patient outcomes and curbing unnecessary expenditures. For example, as per a report released by the Centers for Medicare and Medicaid Services (CMS) in February 2023, the spending on prescription drugs surged by 7.8% to $378.0 billion in 2021. Hence, the escalating demand for medically prescribed drugs is a catalyst for 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 2021, ANI Pharmaceuticals Inc., a pharmaceutical company based in the United States, completed the acquisition of Novitium Pharma for $163.5 million. Through this strategic acquisition, ANI Pharmaceuticals Inc. aims to fortify its research and development capabilities, expand its generics portfolio, bolster its contract development and manufacturing organization (CDMO) division, and establish a fully compliant production facility in the United States. Novitium Pharma, a US-based pharmaceutical company, specializes as a bulk manufacturer of certain controlled substance classes.

Major companies operating in the controlled substance market report are Merck & Co. Inc., Johnson and Johnson Services Inc., Orbis Biosciences Inc., GW Pharmaceuticals plc, Corium Inc., Pfizer Inc., Aradigm Corporation, Alkermes plc, Sun Pharmaceutical Ltd., F. Hoffmann-La Roche Ltd., AbbVie Inc., Mallinckrodt plc, 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 2023. 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.

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 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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