Chronic Kidney Disease Market: Pipeline Review, Developer Landscape and Competitive Insights

Wednesday, March 27, 2019 General News
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NEW YORK, March 26, 2019 /PRNewswire/ -- INTRODUCTIONChronic kidney disease (CKD) is characterized by progressive

loss of kidney function over a period of time. In most patients suffering from CKD, symptoms (such as swollen ankles, blood in urine and foamy urine) are rarely observed until kidney function has declined by 75%. It is worth highlighting that over 90%
of the patients suffering from reduced kidney function are unaware of their medical condition. In the US, 15% of adults are reported to be suffering from mild or severe forms of CKD. In fact, the mean global prevalence of CKD, across all five stages of the disease, is estimated to be 13.4%. Limited availability of epidemiological data, lack of awareness, late diagnosis and inappropriate / incorrect treatment are some of the factors responsible for elevating disease incidence. It is also worth noting that developed nations spend over 2-3% of their annual healthcare budget on the treatment of end-stage renal disease (ESRD); however, the economic burden associated with milder forms of CKD is almost double the total costs incurred in the treatment of ESRD. Further, in the US, the disease has been estimated to incur combined direct and indirect costs ranging between USD 1,183 - USD 35,292 per patient, per month.Read the full report: Existing therapeutic options have already been proven to be inadequate in containing the progression of the disease and its symptoms in the long term. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to advance the development of various types of disease modifying pharmacological interventions and therapies that offer symptomatic relief. In fact, multiple initiatives by start-ups are being backed by venture capital funding in order to expedite the development of potential therapeutic options for better disease management.SCOPE OF THE REPORTThe "Chronic Kidney Disease Market: Pipeline Review, Developer Landscape and Competitive Insights" report provides an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of chronic kidney disease. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail in the document.Figure 1.1 Chronic Kidney Disease: Scope and Competitive InsightsSource: Roots AnalysisAmongst other elements, the report includes:• A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), treatment type (disease modifying agent or drugs offering symptomatic relief), mechanism of action, and route of administration of the drugs being developed for the treatment of chronic kidney disease.• An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a heptagon representation, highlighting the distribution of the marketed and development stage molecules based on the target clinical condition, [B] a 2X2 grid analysis, representing the distribution of drug candidates across various disease indications, dosing frequencies and stages of development, and [C] a diagrammatic representation of the regional landscape of industry players involved in the development of drugs in this domain, distributed based on the location of their headquarters.• An insightful market assessment summary, highlighting the clinical and commercial attractiveness of pipeline molecules (phase II and phase III), taking into consideration size of enrolled patient population (for the trial in the highest phase of development), route of administration, treatment type (disease modifying agent and drugs offering symptomatic relief) and dosing frequency (for quantifying clinical attractiveness), and target patient population, expected launch date and size of developer company (for quantifying commercial attractiveness).• An analysis highlighting the key unmet needs across chronic kidney disease, featuring insights generated from real-time data on unmet needs as identified from social media posts, recent publications, patient blogs and the views of key opinion leaders expressed on online platforms.• An insightful competitive analysis, highlighting the key players in the domain on the basis of the strength of their respective development portfolios, taking into account company size and the stage of development of lead molecules in their respective pipelines.• A detailed analysis identifying the key opinion leaders (KOLs), featuring a 2X2 analysis to assess the relative experience of certain KOLs who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field.• An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, manufacturing agreements and others• An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings.The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered from secondary sources. The opinions and insights presented in this study were influenced by inputs of several key players in this domain. 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 METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys 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 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' viewsCHAPTER OUTLINESChapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the chronic kidney disease market in the long term.Chapter 3 provides an introduction to chronic kidney disease and its associated comorbidities. It features a detailed discussion on the development, symptoms and stages of the condition, factors influencing disease progression and the various treatment regimens that are available in the market. It also includes a discussion on the epidemiology of the disease and the associated economic burden across various regions.Chapter 4 includes information on over 160 molecules that are currently approved / under development for therapeutic use. It features a comprehensive analysis of pipeline molecules, highlighting the phase of development (clinical, preclinical / discovery stage), type of molecule (small molecule or biologic), treatment type (disease modifying agent or drugs offering symptomatic relief), mechanism of action, and route of administration of the drug candidates. In addition, it presents certain key insights derived from the study, which include a heptagon representation highlighting the distribution of the marketed and pipeline molecules based on different clinical indications. The chapter includes a comprehensive 2X2 grid analysis, representing the distribution of drug candidates across various indications, dosing frequencies and stages of development. Additionally, the chapter features a regional landscape of developers engaged in this domain, distributed on the basis of the location of their headquarters.Chapter 5 features an analysis of the clinical and commercial attractiveness of the drugs designed for the treatment of CKD and its associated comorbidities. The drugs are plotted on a 2X2 matrix, with clinical attractiveness (abscissa) and commercial attractiveness (ordinate) as the two axes.The clinical attractiveness of a drug is determined by sample size of its trial (highest phase), route of administration, treatment type (disease modifying agent and drugs offering symptomatic relief) and dosage frequency. The commercial attractiveness of a drug is determined by the target population size, expected launch date and the company size.Chapter 6 highlights the key unmet needs associated with the management and treatment of chronic kidney disease. The chapter provides detailed analysis of unmet needs that were identified from views expressed by patients / experts across different platforms, such as social media posts, recent publications and patient blogs, and the inputs of key opinion leaders at conferences / symposiums. The chapter presents an insightful sentiment analysis and word cloud analysis, summarizing the opinions expressed across public portals.Chapter 7 presents an analysis of the competitive landscape of companies involved in the development of novel therapeutics for the treatment of chronic kidney disease. It is based on the number of molecules in the pipelines of different players (taking into consideration the current status of development) and company size (in terms of number of employees). In this analysis, companies across different regions (North America, Europe and Asia-Pacific) were plotted on 2X2 matrices, having company pipeline strength as the ordinate and company size as the abscissa.Chapter 8 provides an analysis of KOLs in the field of chronic kidney disease. It features a comprehensive list of principal investigators of different clinical trials, along with information related to the affiliated research institutes. The chapter features a schematic representation on a world map, highlighting the geographical locations of eminent scientists / researchers who are engaged in clinical research in this domain. It also features a comparative analysis, highlighting those KOLs who have relatively more experience in this domain.Chapter 9 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 2015 to 2018.Chapter 10 presents details on various investments received by companies that are engaged in this domain. It also includes an analysis of the funding instances that have taken place in the market, in the period between 2010 and July 2018, highlighting the growing interest of the venture capital community and other strategic investors in this market.Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures included in the report.Chapter 12 is an appendix, which contains the list of companies and organizations mentioned in the report.EXAMPLE HIGHLIGHTS1. The analysis of content presented on informal (100 patient blogs and over 3,000 social media posts) and formal (180 scientific articles) literary sources, and the opinions expressed by industry experts confirm the existence of a significant unmet need within the chronic kidney disease market. Some of the unaddressed concerns suggested across multiple portals include improved therapeutic strategies, better management of comorbidities, lack of awareness related to the conditions leading to chronic kidney disease, high economic burden, unavailability of dialysis centers and poor quality of life.2. Presently, over 160 product candidates are being evaluated across various stages of development for the management / treatment of chronic kidney disease. Of these, 24% are in the preclinical or discovery phase. Amongst the drugs that are under clinical development, 33 are in phase III / pre-registration, 47 in phase II, and 22 in phase I and phase I/II trials. Interestingly, since 2012, 22 product candidates have been commercialized; examples include JYNARQUE® (2018), Parsabiv™ (2017), RAYALDEE® (2016) and VELTASSA® (2015).3. Majority of novel drug candidates (close to 70%) are disease modifying agents, while nearly 30% designed to provide symptomatic relief only. It is worth highlighting that 75% of pipeline candidates are small molecules, and the rest are biologics. Further, most are being developed as monotherapies (close to 75%), whereas nearly 25% are currently being investigated as combination therapies.4. The market landscape is characterized by the presence of large (31), mid-sized (33) and small-sized companies (47). Examples of prominent large companies engaged in this domain include (in alphabetical order, no selection criteria) Amgen, Asahi Kasei Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Novartis Pharmaceuticals, Pfizer and Sanofi. The growing unmet need within this domain has spurred the establishment of many start-ups / small-sized companies in the recent years; examples include (in alphabetical order, no selection criteria) Algomedix, Angion Biomedica, Anthera Pharmaceuticals, Apellis Pharmaceuticals, Complexa, Ember Therapeutics, Genkyotex, Goldfinch Bio, inRegen, Kezar Life Sciences, Lanthio Pharma, Orbis Biosciences, Redx pharma, Sanifit and Serodus.5. Stakeholders in the industry have forged several strategic partnerships in the recent past; we observed that 28% of the agreements that were signed between 2015 and 2018 were related to research and development. These were followed by development and commercialization agreements (23%), licensing agreements (22%), commercialization agreements (15%), acquisitions (5%), mergers (5%), and manufacturing agreements (2%). Examples of recently inked deals include collaborations between Novo Nordisk and Evotec (August 2018), Resverlogix and Medison Pharma (January 2018), and AstraZeneca and Ionis Pharmaceuticals (February 2018).6. Drug development initiatives by start-ups have received financial support in terms of venture funding and research grants. In fact, more than USD 4.1 billion, across 118 instances of grants, venture capital rounds and public offerings, has been invested in these companies since 2010. Across all the funding rounds, the most active investors include (in terms of participation in funding rounds) Omega Funds, Flagship Pioneering, Polaris Partners, venBio Select, Oxford Finance, OrbiMed Advisors, Morningside Group, Limulus Venture Partners, Cormorant Asset Management, AJU IB Investment and Sibling Capital.7. Several prominent scientists (over 100) have made significant contributions in advancing the clinical development efforts, and therefore, have emerged as key opinion leaders in this field. Examples of prominent universities and hospitals that have been engaged in conducting breakthrough research in this domain include (in alphabetical order, no selection criteria) Icahn School of Medicine, UC San Diego School of Medicine, University of Michigan, University of Oxford and Vanderbilt University Medical Center.Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________ Contact Clare: US: (339)-368-6001 Intl: +1 339-368-6001

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