Although the healthcare industry relies on the patient to take medications responsibly, in 2017, close to 18 million individuals were reported to have misused prescription drugs, in the US. In fact, data from a National Survey on Drug Use and Health conducted in the same year showed that an estimated 2 million Americans misused prescription pain relievers for the first time in the previous year. Moreover, the same study reported 1.5 million people abusing tranquilizers, over 1 million abusing prescription stimulants and more than 270,000 abusing sedatives, for the first time, in the same time period.
Owing to a rapid onset of the medicinal effect, which offers immediate relief (with high efficacy), opioids are still considered to be one of the most widely used pharmacological interventions for pain management. However, these drugs are known to induce a euphoric state upon consumption, often causing patients to abuse them; increased recreational use of opioids is known to lead to addiction. Moreover, over-prescription of such medicinal products, which promotes their misuse, is considered as one of the root causes of the opioid crisis (increasing number of deaths involving misuse and addiction to opioids), in the US. According to the Centers for Disease Control and Prevention (CDC), more than 72,000 overdose-related deaths were reported in 2017, of which close to 50,000 involved the use of an opioid. Moreover, opioid abuse was estimated to have been responsible for an economic deficit of over USD 500 billion, related to loss of productivity and healthcare costs, in the US. Other drug classes that are prone to abuse include antidepressants and central nervous system (CNS) stimulants. In 2017, close to 17,000 deaths were reported to have been the result of an overdose of prescription antidepressants. Most of these deaths (~11,500) involved the misuse of benzodiazepines, such as VALIUM® (diazepam) and XANAX® (alprazolam). CNS stimulants are usually indicated for the treatment of patients suffering from attention-deficit / hyperactivity disorder (ADHD). Among the various overdose-related deaths which took place in 2017, it is worth highlighting that over 12% involved the use of psychostimulants.
Prescription drug abuse has prompted pharmaceutical developers to devise various strategies to prevent misuse. Some of the commonly used approaches to abuse deterrence include limiting the use of opioids post-surgery, implementing stringent medicine prescribing guidelines and conducting prescription drug monitoring programs, and creating abuse-deterrent formulations (ADFs) of drugs that are likely to be misused. Drug formulations that are designed to prevent an active pharmacological substance from being abused have been identified as a viable and sustainable alternative to limiting recreational / off-prescription use of the abovementioned drug classes and its consequences. Over the years, several different types of abuse-deterrent formulation technologies have been developed; these include physical/chemical barriers that prevent drugs from being manipulated for recreational use, the addition of chemical agents that interfere with the effects of the drug upon improper use and abuse-resistant drug delivery/administration technologies. Specifically, for opioids, market experts believe that in the foreseen future, ADFs of such drugs are likely to replace conventional forms of such products. However, there are concerns regarding how this transition can be made in a responsible and economically feasible manner.
Scope of the Report
The 'Abuse-Deterrent Formulation Technologies Market, 2019-2030' report features an extensive study of the current market landscape and the future potential of industry players that are offering various abuse-deterrent formulation technologies to different pharmaceutical companies. Amongst other elements, the report features:
- A detailed assessment of the current market landscape of companies offering technologies for the development of abuse-deterrent formulations of prescription drugs that are prone to be misused, including information on key technology developers (such as year of establishment, company size, and geographical location), and their respective technologies, offering insights on current status of development (available for use and under development), target drug class (opioids, antidepressants and CNS stimulants), abuse deterrence approach (physical and chemical barriers, prodrug approach, use of agonist / antagonist, aversion, use of specific drug delivery systems, and others), disrupted route of abuse (parenteral, insufflation, covert administration, oral, and others), type of end product (tablets, capsules, transdermal patches, thin films, and others), and release characteristics (delayed / extended, controlled, immediate, and others).
- An informed competitiveness analysis of the various abuse-deterrent drug formulation technologies captured in our database, taking into consideration the supplier power (based on year of establishment) and key technology-related specifications, such as the abuse-deterrent approach, disrupted route of abuse, number of products available / under development using a particular technology and strength of intellectual property portfolio (in terms of number of affiliated patents).
- Elaborate profiles of prominent technology developers engaged in this domain, featuring an overview of the company, its financial information (if available), and a detailed description of proprietary technology/technologies. Each profile also includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future.
- An in-depth analysis of the patents that have been filed/granted related to abuse-deterrent formulation technologies, from 2000 to 2019 (till April). The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading patent assignees (in terms of the number of patents filed/granted), and patent benchmarking.
- An analysis of the partnerships that have been established in the domain in the period 2013-2019, covering product commercialization and licensing agreements, product development agreements, licensing agreements, mergers/acquisitions, service agreements, research agreements, and others.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on likely licensing deal structures and agreements that are expected to be signed between drug and technology developers in the foreseen future, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. The report features likely distribution of the current and forecasted financial opportunity across [A] target drug class (opioids, antidepressants and CNS stimulants), [B] abuse deterrence approach (physical / chemical barriers, agonist / antagonist combinations, aversion approach, prodrug approach, abuse-deterrent drug delivery systems and others), [C] type of end product (tablets, capsules, transdermal patches, thin films and others), and [D] geography (North America, Europe, Asia Pacific and the rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
- Greg Sturmer (President and Chief Executive Officer, Elysium Therapeutics)
- Aia Malik (Commercial Development Manager, Healthcare, Lucideon)
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD unless otherwise specified.
Table of Contents
Executive Summary
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution and adoption of abuse deterrent formulation technologies market in the mid to long term.
Chapter 3 is an introductory chapter that presents a general overview of the different drug classes that are prone to abuse. It features a discussion on various checkpoints that can be implemented at the clinician-, pharmacist- and patient-level to prevent the misuse of prescription drugs. Further, the chapter provides details on the various abuse deterrent drug formulation technologies that have been developed over the last several years, highlighting their respective mechanisms of action and advantages.
Chapter 4 includes information on companies offering technologies for the development of abuse deterrent formulations of prescription drugs that are prone to be misused, including information on key technology developers (such as year of establishment, company size, and geographical location), and their respective technologies, offering insights on current status of development (available for use and under development), target drug class (opioids, antidepressants and CNS stimulants), abuse deterrence approach (physical and chemical barriers, prodrug approach, use of agonist / antagonist, aversion, use of specific drug delivery systems, and others), disrupted route of abuse (parenteral, insufflation, covert administration, oral, and others), type of end product (tablets, capsules, transdermal patches, thin films, and others), and release characteristics (delayed / extended, controlled, immediate, and others).
Chapter 5 is a competitiveness analysis of the various abuse deterrent drug formulation technologies captured in our database, taking into consideration the supplier power (based on year of establishment) and key technology-related specifications, such as the abuse deterrent approach, disrupted route of abuse, number of products available / under development using a particular technology and strength of intellectual property portfolio (in terms of number of affiliated patents).
Chapter 6 includes detailed profiles of key technology developers (shortlisted based on the results of a proprietary competitiveness analysis) engaged in this domain. Each profile includes an overview of the company, its financial information (if available), and a detailed description of proprietary technology/technologies. Company profiles also include a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future.
Chapter 7 provides an in-depth analysis of the patents that have been filed/granted related to abuse deterrent formulation technologies, from 2000 to 2019 (till April). The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading patent assignees (in terms of the number of patents filed/granted), and patent benchmarking.
Chapter 8 features an elaborate discussion and analysis of the partnerships that have been established in the domain in the period 2013-2019, covering product commercialization and licensing agreements, product development agreements, licensing agreements, mergers/acquisitions, service agreements, research agreements, and others.
Chapter 9 presents a list of drug candidates, across different therapeutic classes (opioids, antidepressants, and CNS stimulants) that are eligible drugs for conversion/reformulation to ADFs in the foreseen future.
Companies Mentioned
- 4P Therapeutics (subsidiary of Nutriband)
- Acella Pharmaceuticals
- Acura Pharmaceuticals
- Adello Biologics
- Aesica Pharmaceuticals
- Alitair Pharmaceuticals
- Altus Formulation
- Aquestive Therapeutics
- Assertio Therapeutics
- Atlantic Pharmaceuticals
- Avadel Pharmaceuticals
- Bayer
- BioDelivery Sciences International
- Buzzz Pharmaceuticals
- Camargo Pharmaceutical Services
- Capsugel
- Cassava Sciences
- Catalent
- CIMA LABS (acquired by Teva)
- Coating Place
- Collegium Pharmaceutical
- Currax Pharmaceuticals
- Daiichi Sankyo
- DURECT
- Egalet
- Elite Pharmaceuticals
- Elysium Therapeutics
- Emplicure
- Encap Drug Delivery
- Endo Pharmaceuticals
- Ensysce Biosciences
- Epic Pharma
- Ethypharm
- ExxPharma Therapeutics
- Genus Lifesciences
- Glenmark Pharmaceuticals
- Grünenthal
- Indivior
- Inspirion Delivery Sciences
- Intalere
- Intellipharmaceutics
- inVentiv Health
- Janssen Pharmaceuticals
- Johnson & Johnson
- Kashiv BioSciences
- KemPharm
- KVK Tech
- Lannett
- Lonza
- Lucideon
- MainPointe Pharmaceuticals
- Mallinckrodt Pharmaceuticals
- Memorial Sloan Kettering Cancer Center
- Mundipharma
- Nektar Therapeutics
- Neos Therapeutics
- New River Pharmaceuticals
- Nutriband
- Optum (part of UnitedHealth Group)
- Orexo
- Patheon
- Pernix Therapeutics
- Pfizer
- Pop Test
- Praxis Bioresearch
- Publicis Touchpoint Solutions
- Purdue Pharma
- QRxPharma
- Quivive Pharma
- Recipharm
- Relmada Therapeutics
- Shionogi
- Shire
- Signature Therapeutics
- Skyepharma
- SPARC
- SunGen Pharma
- Tetra Bio-Pharma
- Teva Pharmaceutical
- TITAN Pharmaceuticals
- Tris Pharma
- twoXAR
- University of Nebraska Medical Center
- Zogenix
Methodology
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