provides an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of chronic kidney disease.
Chronic 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.
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.
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.
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).
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.
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 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.
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).
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.
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.
Key Topics Covered
1. Preface 1.1. Scope of the Report 1.2. Research Methodology 1.3. Chapter Outlines
2. Executive Summary
3. Introduction 3.1. Chapter Overview 3.2. An Overview of Chronic Kidney Diseases 3.2.1. Medical Conditions Associated with Chronic Kidney Diseases 188.8.131.52. Alport Syndrome 184.108.40.206. Diabetic Nephropathy 220.127.116.11. Focal Segmental Glomerulosclerosis 18.104.22.168. Glomerulonephritis 22.214.171.124. Nephrotic Syndrome 126.96.36.199. Polycystic Kidney Disease 188.8.131.52. Hypertensive Kidney Disease 184.108.40.206. Pyelonephritis 3.2.2. Stages of Chronic Kidney Disease 3.2.3. Symptoms 3.2.4. Diagnosis 3.2.5. Treatment Options 220.127.116.11. Therapeutics 18.104.22.168. Other Modalities 3.2.7. Kidney Transplant and Implications
4. Pipeline Review: Marketed And Development Drugs 4.1. Chapter Overview 4.2. Drugs for Chronic Kidney Disease: Marketed and Development Pipeline 4.3. Chronic Kidney Disease: Pipeline Analysis 4.3.1. Analysis by Phase of Development 4.3.2. Analysis by Type of Molecule 4.3.3. Analysis by Route of Administration 4.3.4. Analysis by Target Therapeutic Indication(s) 4.3.5. Analysis by Size of Developer 4.3.6. Analysis by Size and Location of the Players 4.3.7. Analysis of Leading Developers 4.3.8. Heptagon Representation: Distribution by Target Therapeutic Indication and Phase of Development 4.3.9. Grid Analysis: Distribution by Target Therapeutic Indication, Dosing Frequency and Phase of Development 4.3.10. Geographical Landscape
6. Chronic Kidney Disease: Unmet Needs Analysis 6.1. Chapter Overview 6.2. Unmet Needs Analysis in Chronic Kidney Disease 6.2.1. Unmet Needs Expressed in Patient Blogs 22.214.171.124. Methodology 126.96.36.199. Key Insights 6.2.2. Unmet Needs Reported in Published Literature 188.8.131.52. Methodology 184.108.40.206. Key Insights 6.2.3. Unmet Needs Expressed on Social Media Platforms 220.127.116.11. Methodology 18.104.22.168. Key Insights 6.2.4. Unmet Needs Highlighted by Experts 22.214.171.124. Titte Srinivas, Intermountain Medical Centre 126.96.36.199. Brian Clement, Hippocrates Health Institute 188.8.131.52. Frank Brennan, Palliative Care Physician 184.108.40.206. Sarah Brook, Renal Dietitian, Salford Royal NHS Foundation Trust 220.127.116.11. Joseph Selvanayagam, Medical Researcher, Flinders University 18.104.22.168. Vanessa Rojas-Bautista, UC Irvine Health 6.2.5. Concluding Remarks: Key Unmet Needs in Chronic Kidney Disease
7. Company Competitiveness Analysis 7.1. Chapter Overview 7.2. Methodology 7.2.1. Assumptions and Key Parameters 7.3. Company Competitiveness Analysis: Key Insights 7.3.1. Key Players: North America 7.3.2. Key Players: Europe 7.3.3. Key Players: Asia Pacific
8. KOL Analysis 8.1. Chapter Overview 8.2. Methodology 8.3. Principal Investigators Involved in Clinical Trials 8.4. Prominent Key Opinion Leaders 8.5. Most Active Key Opinion Leaders
9. Partnerships and Collaborations 9.1. Chapter Overview 9.2. Partnership Models 9.3. Novel Therapeutics for Chronic Kidney Disease: List of Partnerships and Collaborations 9.3.1. Analysis by Year of Partnerships 9.3.2. Analysis by Type of Partnership 9.3.3. Most Active Players: Analysis by Number of Partnerships 9.3.4. Regional Analysis 22.214.171.124. Intercontinental and Intracontinental Agreements
10. Funding And Investment Analysis 10.1. Chapter Overview 10.2. Types of Funding 10.3. Novel Therapeutics for Chronic Kidney Disease: Funding and Investment Analysis 10.3.1. Analysis by Number of Instances 10.3.2. Analysis by Amount Invested 10.3.3. Analysis by Type of Funding 10.3.4. Most Active Players 10.3.5. Most Active Investors 10.4. Concluding Remarks