慢性腰痛（CLBP） - 市場の洞察、疫学および2028年までの予測
Chronic Lower Back Pain (CLBP) - Market Insights, Epidemiology and Market Forecast-2028
|発行||DelveInsight Business Research LLP||商品コード||888159|
|出版日||ページ情報||英文 301 Pages
|慢性腰痛（CLBP） - 市場の洞察、疫学および2028年までの予測 Chronic Lower Back Pain (CLBP) - Market Insights, Epidemiology and Market Forecast-2028|
|出版日: 2019年07月01日||ページ情報: 英文 301 Pages||
DelveInsight's 'Chronic Lower Back Pain (CLBP)- Market Insights, Epidemiology and Market Forecast-2028 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology as well as the market trends of CLBP in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The report provides the current treatment practices, emerging drugs, market share of the individual therapies, the current and forecasted market size of CLBP from 2017 to 2028 segmented by the seven major markets. The report also covers current treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate best of the opportunities and assess the underlying potential of the market.
Study Period: 2017-2028
Chronic low back pain (CLBP) is defined as pain that persists for 12 weeks or longer, even after an initial injury or underlying cause of acute low back pain has been treated. Low back pain is very common and at one point everyone may have faced this problem. The exact cause of lower back pain is unknown. Lower back pain that is long-term (for more than 3 months) is called chronic low back pain, this condition might originate from an injury, disease, or stress on different structures of the body, and pain may vary significantly and may be felt as bone pain, nerve pain, or muscle pain.
When assessing CLBP, clinicians should inquire about pain onset, severity, chronicity, and other factors such as painful experience. Pain severity may form a bi-dimensional or a one-dimensional scale depending on the specific instruments tested. High inter-correlations between pain-intensity measures and pain-related disability measures support the concept of using them as a unitary construct of pain severity. Various scales are used by experts in order to assess the severity of pain in CLBP patients, two of the most widely used are Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS).
The DelveInsight's CLBP market report gives a thorough understanding of the CLBP by including details such as disease definition, classification, symptoms, etiology, pathophysiology, diagnostic trends. It also provides treatment algorithms and treatment guidelines for CLBP in the US, Europe, and Japan.
The CLBP epidemiology division provides insights about historical and current patient pool and forecasted trend for every 7 major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight's report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology [segmented by Total Prevalent Population, Gender-Specific Prevalent Population, Age-Specific Prevalent Population, Severity-Specific Prevalent Population, Number of CLBP Patients on Prescription Medications by different Class and Number of CLBP Patients on Opioids by low dose, high dose, and overdose] scenario of CLBP in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2028.
As per DelveInsight's analysis, a higher percentage of diagnosed prevalence was observed for females, in comparison to males, in all the 7MM countries, except Japan, wherein males occupy a larger patient pool than females. According to DelveInsight's estimations, the total prevalent population of CLBP in the 7MM was observed to be 73,802,461 in 2017, which is expected to increase during the study period i.e. 2017-2028. Furthermore, the total diagnosed prevalent population of CLBP in the 7MM was assessed to be 44,281,476 in 2017.
The estimates show the highest diagnosed prevalence of CLBP in the United States with more than 20 million cases in 2017. Among the European 5 countries, the United Kingdom had the highest diagnosed prevalent population of CLBP, followed by Germany and France. On the other hand, Spain had the lowest diagnosed prevalent population. Additionally, Japan was observed with 8,865,879 diagnosed prevalent cases for CLBP in 2017. According to DelveInsight's analysis, it has been observed that CLBP is mostly diagnosed in the age group of 40-69. Moreover, we have observed that moderate to severe are the majorly diagnosed CLBP patients.
This segment of the CLBP report encloses the detailed analysis of marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
NKTR-181 (Nektar Therapeutics), a long-lasting opioids analgesic, acts as a selective mu-opioid receptor (MOR) agonist, is aimed to provide potent drug relief without the inherently high levels of euphoria. Phase III trial has been completed and another phase III trial currently under evaluation. NKTR-181 has been granted Fast Track designation by the US FDA and new drug application (NDA) has been filed for this drug by the company. NKTR-181 is the first analgesic opioid molecule to exhibit a reduction in specific CNS-mediated side effects, like euphoria, through the strategic alteration of brain-entry kinetics.
Buprenorphine (CAM2038: Braeburn Pharmaceuticals/Camurus) acts as a partial agonist at the mu opioid receptor and also exhibits antagonistic effects at the kappa opioid receptor. This drug is being evaluated in Phase III clinical trials Opioid Use Disorder; Chronic Pain, and Chronic Lower Back Pain. The company is expecting long-term efficacy and results of pivotal Phase III studies by the first half of 2019. The drug has an advantage in the administration as it is weekly/monthly SC depot, which avoids the healthcare professional requirement. If approved, CAM2038 offers an HCP-administered dosing regimen that will allow patients to transition from daily oral opioids to manage chronic pain, while potentially minimizing the risks of abuse, misuse, and diversion.
Egalet-002 (Egalet Corporation), is pure opioid which acts as opioid mu and kappa agonist; opioid delta agonists. The US FDA has granted Fast Track Designation for this drug. Eaglet Corporation has filed the NDA for this drug candidate. Egalet Corporation initially anticipated the NDA submission of Egalet-002 in 2019. Although the company completed phase III studies for Egalet-002 with proven efficacy, it has determined to delay indefinitely the previously-announced anticipated 2019 filing date for the Egalet-002 NDA, unless the availability of a partner to share the cost. The company is actively seeking partners for Egalet-002 as well as other product candidates.
Tanezumab (Pfizer/Eli Lilly and Company) is the first-in-class, non-opioids treatment which acts by selectively targeting, binding to and inhibiting nerve growth factor (NGF). The drug is being evaluated in Phase III clinical trials for CLBP. The US FDA has granted Fast Track designation for Tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and CLBP. But a lower dose of the drug, tanezumab, failed to alleviate pain when compared with a placebo, the companies said in a statement.
Rexlemestrocel-L (MPC-06-ID; Mesoblast) is an allogeneic mesenchymal precursor cell (MPC) product candidate and Phase III trials are being conducted for this potent drug candidate. This drug works as "Cell Replacement: Proteoglycan & collagen stimulant".
The CLBP market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted trend of the market by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.
This segment gives a thorough detail of market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market, and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
A number of medications have proven to be effective in chronic pain disorders and their use individually or in combination should improve the management of chronic pain. Especially for neuropathic pain, the medications recommended as first-line treatments include TCAs, SNRIs, calcium channel α2-δ ligands, and lidocaine patch. Opioid analgesics and tramadol are recommended as second-line treatments that can be considered for first-line use in selected clinical circumstances.
A thorough understanding of pain mechanisms and good communication between physicians and patients are required to improve patient outcomes. Avoiding ineffective treatments and maximizing the treatments that have been proven beneficial in clinical trials (i.e., evidence-based treatments) are likely to produce better outcomes than have often been experienced by clinicians and patients in the management of chronic pain. Additionally, identifying and co-managing pain that is comorbid with psychiatric disorders have promise for improving both the physical and psychological outcomes.
Furthermore, the multimodality treatment of chronic pain incorporates not only this approach to pharmacological treatment, but also non-pharmacological strategies such as interventional pain management, physiotherapy, psychotherapy, and pain rehabilitation.
The market size of CLBP in the 7MM is expected to grow at a CAGR of 4.84% for the study period (2017-2028). The current market size of CLBP is entirely dependent on supportive treatment regimens, along with the drugs that have been approved to treat comorbidities associated with CLBP, and those that are in general approved for chronic pain. The supportive therapies are either prescribed as monotherapy or are given in combination. The prescription of these therapies varies greatly among the 7MM countries, i.e. while opioids remain the mainstay of treatment in the United States, NSAIDs are more commonly prescribed in the EU-5 countries.
With the launch of the effective branded targeted therapies, the market is going to rise which will introduce another USD 623.19 million in 2022, to the overall therapies market. Of the emerging therapies, Braeburn Pharmaceuticals/Camurus, Pfizer/Eli Lilly and Company, Mesoblast, Nektar Therapeutics, Egalet Corporation are expected to enter the treatment market, with their respective products, during the forecast period [2019-2028]. The current opioid prescription market is expected to decline in the coming years. This may be attributed to the fact that in the coming years, patients with CLBP will switch from currently prescribed opioids to emerging opioid therapies, such as, NKTR-181 (Nektar Therapeutics), Buprenorphine (CAM2038; Braeburn Pharmaceuticals/Camurus), and Egalet-002 (Egalet Corporation), which have proven safety and efficacy in CLBP patients.
This section focusses on the rate of uptake of the potential drugs recently launched in the market or will get launched in the market during the study period from 2017 to 2028. The analysis covers market uptake by drugs; patient uptake by therapies, and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The dynamics of Chronic Lower Back Pain (CLBP) market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the diseases, incremental healthcare spending across the world and expected the launch of emerging therapies during the forecast period of 2019-2028. Companies across the globe are thoroughly working toward the development of new treatment therapies for CLBP.
More than a dozen companies have shifted their focus towards this therapeutic area. To name a few: Braeburn Pharmaceuticals, Camurus, Regeneron Pharmaceuticals, Teva Pharmaceutical, Pfizer, Eli Lilly and Company, Mesoblast, Nektar Therapeutics, Egalet Corporation, Axsome Therapeutics, Allodynic Therapeutics, Astellas Pharma, Grunenthal GmbH, Frontier Biotechnologies, DiscGenics, Yuhan Corporation, Semnur Pharmaceuticals, Sollis Therapeutics, SpineThera, Stayble Therapeutics, AnGes MG, and others. While some of these are in the early stage of development, yet others have reached the NDA filling stage in the development process.