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Non-Opioid Drugs for Chronic Pain and Pain Management Devices Market, 2018-2025

Non-Opioid Drugs for Chronic Pain and Pain Management Devices Market, 2018-2025

  • August 2018
  • 340 pages
  • ID: 5563048
  • Format: PDF
  • Roots Analysis Private Ltd.

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INTRODUCTION
Chronic pain refers to the psychophysiological response to an underlying clinical condition, which is observed to persist for a duration greater than six months and is generally unresponsive to multiple treatment regimens. It is estimated that more than 1.5 billion individuals across the world suffer from this type of pain. Some of the most common physiological conditions that are characterized by a chronic sensation of pain include migraine, lower back pain, pain associated with cancer, arthritis-related pain and neurogenic pain. Owing to the rapid onset of their medicinal effect, which offers immediate relief with high efficacy, opioids are still considered to be one of the most widely used pharmacological interventions for the management of moderate to severe forms of pain. However, these drugs are known to induce a euphoric state upon intake, often causing patients to abuse them; increased recreational use of opioids has also been shown to lead to drug addiction. The over-prescription of such medicinal products, which promotes their misuse, is considered as one of the root causes of the opioid crisis. In a recent article, published in 2017, 11.5 million individuals were reported to have been caught misusing prescription opioids, while over 42,000 died from opioid overdose, in the US alone. Moreover, opioid abuse was estimated to have been responsible for over USD 500 billion worth of economic deficit (in the US) due to loss of productivity and healthcare costs.

The opioid crisis has prompted drug manufacturers to develop non-addictive, non-narcotic-based therapeutics / analgesics for the management of pain. Unlike opioids, non-opioid drugs do not affect receptors present in the brain and, thus, are not addictive. These drugs work directly on injured / diseased body tissues and generally block the production of prostaglandins by inhibiting the cyclooxygenase (COX) enzyme at the site of injury / infection, thereby, decreasing the generation of pain mediators within the peripheral nervous system. Additionally, there are various pain management devices that have been reported to significantly reduce or eliminate the need for pharmacological interventions. Such devices are increasingly being used to treat a variety of clinical conditions that are characterized by chronic pain and offer the convenience of being used in the homecare setting as well. However, it is imperative for patients to consult qualified healthcare professionals, who have the required understanding of such therapeutic options, prior to using such devices.

SCOPE OF THE REPORT
The “Non-Opioid Drugs for Chronic Pain and Pain Management Devices Market, 2018-2025” report provides an extensive study on the marketed, clinical and preclinical products / product candidates for management of chronic pain. The report also features a detailed overview of the devices that are used for the treatment / management of pain associated with chronic clinical conditions. Amongst other elements, the report includes:
• A detailed assessment of the current market landscape of drugs being developed for the treatment of chronic pain, providing information on their respective developer(s), phase of development (clinical, and preclinical / discovery), type of molecule (small molecule and biologic), indication (nociceptive and neuropathic), mechanism of action (channel blockers, receptor antagonists, protein pathway modulators and others) and route of administration (intra-articular, intravenous, intranasal, intranasal, intrathecal, oral, subcutaneous, topical and transdermal).
• An in-depth analysis of the product pipeline and developer companies, featuring [A] a mirror analysis highlighting the relative popularity of different disease indications based on the number of molecules available / under development for each indication and the number of companies involved, [B] a logo landscape of the various industry players involved in this domain, distributed on the basis of location of headquarters and company size (small-sized, mid-sized and large), [C] a heptagon representation highlighting the distribution of marketed and pipeline molecules based on their respective mechanisms of action, and [D] a funnel analysis highlighting the distribution of molecules on the basis of stage of development, route of administration and treatment type.
• An analysis highlighting the key unmet needs across chronic pain, featuring insights generated from data sourced from patient blogs, recent scientific publications, social media posts and the views of key opinion leaders expressed on various online platforms.
• An elaborate discussion on lifecycle management strategies, describing how different companies are using various methods to prolong patent age and, thereby, expand marketing exclusivity in order to exploit the revenue generation potential of their proprietary products. The section also includes detailed case studies elaborating on diverse lifecycle management strategies of marketed drugs that are nearing patent expiry.
• Comprehensive profiles of drugs that are in phase III of clinical development, with information on developer companies (including location of headquarters and year of establishment), type of molecule, mechanism of action, current status of development, route of administration, information on clinical trials and key developments (if available).
• A detailed assessment of the current market landscape of various devices that are being developed for chronic pain management, highlighting information on developer (size of company and location of headquarters), mechanism of action (electrical stimulation, electromagnetic pulse, heat therapy, light therapy, radiofrequency stimulation and others), site of application on the body (head, arm, knees and other areas), modality of the device (invasive and non-invasive), and treatment requirements (at home and at hospitals / outpatient clinics), and type of device (wearable, hand-held and implants).
• An insightful 2X2 competitive analysis for the various devices, highlighting the most important products based on the modality of device, treatment requirement, type of device, and supplier power (based on size of employee base of the company). The chapter also includes profiles of devices that emerged as relatively superior (based on the analysis); each profile features details on the developer (location of headquarters and year of establishment), approval year, mechanism of action, key features and key developments.
• An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements (related to both technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements and others
• An analysis of investments made at various stages of product development; these include seed financing, venture capital financing, debt financing and grants / awards, received by companies that are operating in this domain.

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 parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term, for the period 2018-2025. The report includes a detailed market segmentation on the basis of indication (chronic back pain, lumbar radiculopathy, migraine, osteoarthritis and neuropathic pain), type of molecule (small molecule and biologic), mechanism of action (CGRP inhibitors, COX/ NGF inhibitors, TRPV1 receptor antagonists, channel blockers and others) and geography (North America, Europe, Asia Pacific and rest of the World). In addition, the report features an opportunity analysis for the chronic pain management devices market. The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Ryan Jeffcoat (Director of Clinical Affairs & New Markets, AVACEN Medical), Lisa Robin (Chief Advocacy Officer, Federation of State Medical Boards), Nelson Hendler (Chief Executive Officer, Mensana Clinic Diagnostics) and Mark Wiederhold (Chief Executive Officer, Virtual Reality Medical Center). All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views
While the focus has been on forecasting the market till 2025, the report also provides our independent view on various trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the non-opioid drugs and pain management devices market, in the mid-long term.

Chapter 3 provides an introduction to chronic pain and associated disease indications. It features a detailed discussion on the classification of pain, and affiliated symptoms and causes. The section also highlights the available therapeutic options for the treatment / management of this clinical condition. In addition, it summarizes the reasons for the opioid crisis, and the steps being taken within healthcare domain to develop and introduce alternative, non-opioid-based therapeutic strategies.

Chapter 4 highlights the key unmet needs associated with the management and treatment of chronic pain. The chapter provides a detailed analysis of such needs as identified from views expressed by patients / industry experts across different platforms, such as patient blogs, recent scientific publications, social media posts and as discussed by key opinion leaders at various conferences / symposiums. The chapter also presents an insightful sentiment analysis and word cloud analyses, summarizing the diverse opinions expressed across the aforementioned public portals.

Chapter 5 includes information on over 160 non-opioid molecules that are currently approved / under development for therapeutic use. It features a comprehensive analysis of marketed and pipeline molecules, highlighting the phase of development (clinical and preclinical / discovery stage) of product candidates, type of molecule (small molecule and biologic), sub-indication (nociceptive and neuropathic) mechanism of action, route of administration and information on the developer companies (including location of headquarters and year of establishment). In addition, it presents a set of key insights derived from a mirror analysis, highlighting the relative popularity of the different indications based on the number of molecules available / under development for each indication and the number of companies involved. The chapter also features a heptagon representation highlighting the distribution of the marketed and pipeline molecules based on different mechanisms of action and a logo landscape of the various industry players involved in this market, distributed on the basis of location of headquarters and company size (small-sized, mid-sized and large). Additionally, the chapter features a funnel analysis highlighting the distribution of molecules on the basis of stage of development, route of administration and treatment type.

Chapter 6 includes a detailed discussion on product life cycle management strategies that are being considered by developers of already approved / marketed drugs. It focuses on specific strategies, which are used by drug developers in this domain, to expand patent protection and retain the revenue generation potential of their proprietary products without having to contend with the competition that is likely to be generated by generic versions.

Chapter 7 contains detailed profiles of drugs that are in phase III of clinical development. Each profile features an overview of the developer, information on the route of administration, type of molecule, mechanism of action, current status of development, key clinical trials and key recent developments (wherever available).

Chapter 8 includes information on close to 120 devices that are currently approved / under investigation for the treatment / management of chronic pain. It also features a comprehensive analysis of the information on developer (size of company and location of headquarters), mechanism of action, site of application on the body (head, arm, knees and other areas), modality of the device (invasive and non-invasive), treatment requirement (at home and at hospitals / outpatient clinics), type of device (wearable, hand-held and implants) and mechanism of action of device (electrical stimulation, radiofrequency stimulation, heat therapy and others) .

Chapter 9 provides a comprehensive 2X2 analysis featuring a comparative overview of all the available / under development devices for chronic pain management. The analysis compares the products based on the modality of device, treatment requirement, type of device, supplier power (based on size of employee base of the company). Further, the chapter features detailed profiles of devices which appeared to be relatively superior to other products / product candidates. Each of these profiles include details on their developer (location of headquarters and year of establishment), approval year of the product, mechanism of action, key features and key developments.

Chapter 10 features an analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed the different partnership models (including product development and commercialization, R&D agreements, technology / product licensing agreements, other licensing agreements, mergers / acquisitions and clinical trial collaborations) and the most common forms of deals / agreements that have been established between 2012 to 2018.

Chapter 11 presents details on various investments received by small sized companies that are engaged in this domain. It also includes a detailed analysis of the funding instances that have taken place between January 2001 and April 2018, highlighting the growing interest of the venture capital community and other strategic investors in this domain.

Chapter 12 presents a comprehensive market forecast analysis, highlighting the future potential of non-opioid drugs in chronic pain market, till the year 2025. We have segregated the opportunity on the basis of indication (chronic back pain, lumbar radiculopathy, migraine, osteoarthritis and neuropathic pain), type of molecule (small molecule and biologic), mechanism of action (CGRP inhibitors, COX/ NGF inhibitors, TRPV1 receptor antagonists, channel blockers and others) and geography (North America, Europe, Asia Pacific and rest of the World). Future sales potential and growth opportunity were estimated based on likely adoption rates and the anticipated price of products. The report features an opportunity analysis for chronic pain management devices as well.

Chapter 13 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with (in alphabetical order of company name) Ryan Jeffcoat (Director of Clinical Affairs & New Markets, AVACEN Medical), Lisa Robin (Chief Advocacy Officer, Federation of State Medical Boards), Nelson Hendler (Chief Executive Officer, Mensana Clinic Diagnostics), and Mark Wiederhold (Chief Executive Officer, Virtual Reality Medical Center).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. An analysis of content presented on informal (over 200 patient blogs and over 10,000 social media posts) and formal (over 200 scientific literature studies) literary sources, and the opinions express by industry experts, confirm the existence of a significant unmet need within the chronic pain management market. Some of the unaddressed concerns highlighted on multiple portals include improper diagnosis, poor quality of life, and unavailability of non-addictive therapies to manage chronic pain.
2. Presently, over 145 non-opioid product candidates are marketed / under evaluation across various stages of development for the management of chronic pain caused due to various clinical conditions. There are eight commercialized products; of these, three drugs received approval post 2017, namely Zilretta® (2017), ZTlido™ (2018) and Aimovig™ (2018). Amongst the drugs that are in clinical development, 15% are in phase III, 30% in phase II, and 19% in phase I. Nearly 30% of the molecules are in preclinical or discovery phase.
3. It is worth noting that 31% candidates induce pain relief by inhibiting the action of receptors such as TRPV 1 and serotonin, 20% molecules act as channel blockers (primarily calcium, potassium and sodium channel blockers), while 18% of product candidates are protein inhibitors (which include COX-2 and NGF). 31% of the pipeline includes anti-inflammatory, anti-CGRP and pathway modulating molecules.
4. Majority of the drugs (54%) are being developed for management of neuropathic pain (which includes indications such as diabetic neuropathic pain, post-herpetic neuralgia, fibromyalgia, cancer-related neuropathic pain, and HIV-related neuropathic pain). It is worth mentioning that three out of the seven commercialized drugs are designed for treatment of post-herpetic neuralgia. Nearly 35% of molecules are being developed for managing nociceptive pain, of which, majority of the candidates are meant for the treatment of osteoarthritis and migraine. Rest (11%) of the drugs are being developed for managing chronic pain, for which specific indications are not known.
5. The market landscape is characterized by the presence of large (29%), mid-sized (18%) and small-sized companies (49%). Of the established pharmaceutical companies, two players have recently received approval for their non-opioid drugs for chronic pain management; namely (in alphabetical order, no selection criteria) Arbor Pharmaceuticals and Horizon Pharma. In addition, four mid-sized players, which include (in alphabetical order) Acorda Therapeutics, DepoMed, Flexion Therapeutics and Sorrento Therapeutics have also received the FDA’s approval and marketed their non-opioid candidates across various geographies. The growing unmet need for efficient non-opioid drugs for chronic pain management have spurred the establishment of many start-ups in recent years; examples include (in alphabetical order, no selection criteria) 4P Therapeutics, Acorda Therapeutics, Adynxx, Anavex, Araim Pharmaceuticals, BioHealthonomics, DermaXon, Hydra Biosciences, Levicept, Mapi Pharma, Regulonix, Saniona, Solasia Pharma and Winsantor.
6. In addition to pharmacological interventions, there are over 120 devices available for chronic pain management. Of these, 30% pf products need to be surgically placed inside the body, these include products such as (in alphabetical order, no selection criteria) Algovita®, Axium™ Neurostimulator System, Eon Mini™, Genesis, Halo CFNS System, Intellis™ System, Precision Spectra™, Proclaim™ DRG, RestoreAdvanced™ Surescan™ MRI, StimQ PNS System, SynchroMed™ II, VersaStim®, and Vivendi. Further, 25% of the products that we came across were wearable devices, such as (in alphabetical order, no selection criteria) Aleve Direct Therapy (worn at the back), ElectroMesh Garments (worn at the site of pain), Neuro-stim System (applied in the ear) and Quell Relief (wrapped around the leg). In addition, 17% of the devices pipeline featured handheld devices that can be applied at the location of pain in the body, such as (in alphabetical order, no selection criteria) BioBeam™ 940, Handy Pulse Laser, Iovera, LaserTouchOne™, MyACT®, NexWave, Sanakey and Silk’n Relif. We also observed that probes, such as such as (in alphabetical order, no selection criteria) COOLIEF, Dolphin Neurostim™, Intracept® Intraosseous Nerve Ablation System, presently constitute 7% of the total number of device based therapeutic options in the pipeline. It is also worth pointing out that a significant number of devices (21%) could not be classified under any of the aforementioned categories, these include products such as (in alphabetical order, no selection criteria) COOL! And GLOW!, NeuroCare (Digital) and Freedom (Analog), sTMS mini and The WellnessPro™ Plus.
7. The pain management devices landscape is characterized by the presence of large (8), mid-sized (13) and small sized (46) companies. Some of the noteworthy large sized device developers include (in alphabetical order, no selection criteria) Bayer, Boston Scientific, Chattem, Medtronic and St Jude Medical. Of these, St Jude Medical was observed to have the maximum pain management devices in its database. In addition, 13 mid-sized companies have developed 18 pain relief devices; notable examples of these companies include (in alphabetical order, no selection criteria) Bioness, Flownix, Gradient Medical, Mainstay Medical, Neuvectra, PainPod and Zynex. Interestingly, several small-sized companies have taken initiatives in developing the pain management devices; examples include (in alphabetical order, no selection criteria) AcuKnee, AVACEN Medical, BioElectronics. BlueWind Medical, cafaly Tecchnologies, DavaRay, ElectroCore, LightStim, Meagan Medical, Med-Ally, Prizm Medical, Renewal Technologies, Syrolight, TENS Rx, Vital Motion and Xavant Technology.
8. Stakeholders in the industry have forged several strategic partnerships in the recent past; we observed that over 26% of the agreements that have been signed between 2012 and 2018 were related to the commercialization of products. These were followed by acquisitions (23%), research and development collaborations (12%), licensing agreements (12%), product development and commercialization agreements (11%), product development agreements (8%), clinical trial collaborations (2%) and product distribution agreements (2%). Examples of recently inked deals include collaboration between Alder BioPharmaceuticals and Teva Pharmaceutical (January 2018), Grünenthal and Mundipharma (January 2018), Saniona and Proximagen (January 2018).
9. Drug development initiatives by start-ups have received financial support in terms of venture funding and research grants. In fact, more than USD 1.5 billion across 81 instances of grants, venture capital rounds and public offerings have been invested in these companies since 2000. Alta Partners, ARCH Venture Partners, Abingworth Management, Advanced Technology Ventures, Biovenutures Investors, Frazier Healthcare Partners, Lilly Ventures, Montreux Equity Partners and Walden International have emerged as some of the prominent investors, in terms of their participation in the maximum number of funding instances observed in the given time period.
10. We expect the non-opioid drugs for chronic pain management market to grow at an annualized rate of ~40% between 2018 and 2025. North America (primarily US) capture the largest market share (close to 80%), followed by Europe (France, Germany, Italy, Spain and the UK) Australia, South Korea and Japan. With three approved drugs, osteoarthritis currently captures the highest market share amongst all the indications. By 2025, in addition to osteoarthritis, the market is likely to be driven by indications such as migraine and neuropathic pain.
11. Product candidates, such as Aimovig™, fasinumab, fremanezumab, galcanezumab and tanezumab, which have received or are expected to receive approval for the treatment of migraine by late 2018 / early 2019 are most likely to achieve blockbuster status in the future. With respect to the drug class, the current market share is distributed between anti-CGRP drugs (41%) and histamine receptor antagonists (32%). By 2025, the market share is likely to be distributed amongst anti-CGRP drugs (54%), followed by NGF inhibitors (20%) and calcium / sodium channel blockers (16%).

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