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Alzheimer's Disease: Pipeline Review, Developer Landscape and Competitive Insights

NEW YORK, Jan. 13, 2020 /PRNewswire/ --

INTRODUCTION
Alzheimer's disease is a neurodegenerative condition characterized by progressive memory loss, cognitive dysfunction and dementia. Currently, it is the most commonly reported neurodegenerative disorder across the world, and the sixth leading cause of death in the US. , It was estimated that, in 2018, nearly 5.7 million Americans (considering all age groups) were living with Alzheimer's disease. During the same year, Alzheimer's disease and other dementias were projected to be responsible for a healthcare burden amounting to USD 277 billion, in the US. Considering that only a limited range of diagnosis, treatment and disease management solutions are presently available, this segment of the healthcare industry is presently faced with a pressing need for accurate diagnostic (predictive) tests, and efficient treatment options that have the capability to slow the progression of the condition.

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Despite extensive research aimed at comprehending the etiopathogenesis of Alzheimer's disease, only six drugs have been approved since 1996 for treatment. The rate of failure of drugs being developed for treating Alzheimer's disease is alarming (~99.6%) and is even higher than that reported for cancer (~81%). , Most of the existing therapeutic options have proven inadequate in arresting the progression of the disease and long term management of associated symptoms. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to develop various types of disease modifying interventions and drug / therapy candidates that offer symptomatic relief. In fact, multiple initiatives by start-ups are being backed by venture capital and other strategic investors. In the coming years, the market is anticipated to grow at a significant pace as more novel solutions clear clinical evaluation and get commercialized.

SCOPE OF THE REPORT
The "Alzheimer's 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 Alzheimer's disease.

Amongst 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), type of treatment (disease modifying agents or drugs offering symptomatic relief), target stage of the disease (early, mid and late stages), type of therapy (monotherapy or combination therapy), path to clinic (dedicated, and repositioned / repurposed), mechanism of action, and route of administration of the drugs / therapies being developed for the treatment of the condition.
 An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a representation, highlighting the distribution of the marketed and development stage molecules based on the mechanism of action, [B] a 2X2 grid analysis, representing the distribution of drug candidates across type of therapy, path to clinic 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 analysis highlighting the key unmet needs across Alzheimer's disease, featuring insights generated through data captured from 5000+ social media posts, 250+ recent scientific publications, 100+ patient blogs and the views of key opinion leaders expressed by both patients and industry experts.
 A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinuations, year of discontinuation, phase of discontinuation, mechanism of action of the terminated drug, target stage of disease and the reason(s) for discontinuation.
 A detailed publication analysis of close to 300 articles, highlighting the therapeutic areas of focus within the industry. The analysis also highlights the key trends observed across the publications, including information on popular biological targets being investigated, study type (review article, research article and meta-analysis), year of publication, and the most popular journals (in terms of number of articles published within our dataset) within this domain.
 An analysis of the partnerships that have been established till 2019 (February), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, manufacturing agreements, and other relevant deals.
 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 discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company name):
 Kenneth Moch (President and Chief Executive Officer, Cognition Therapeutics)
 Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International)

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.

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 2030, the report also provides our independent view on various non-commercial 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 Alzheimer's disease market in the long term.

Chapter 3 provides a brief introduction to Alzheimer's disease, and its associated symptoms. It also features a detailed discussion on the causes of the condition (based on various existing hypotheses), stages of disease progression, factors influencing the onset and progression of the disease, and the different pharmacological and non-pharmacological interventions that are presently indicated for the treatment of this condition. The chapter includes a discussion on the epidemiology of the disease and highlights the diverse initiatives / programs led by the National Institutes of Health (NIH) to support scientific discovery and help in disease management.

Chapter 4 includes information on over 200 molecules that are currently approved / under development for the treatment of Alzheimer's disease. It features a comprehensive analysis of pipeline molecules, highlighting the 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), target stage of disease (early, mid or late stage), type of therapy (monotherapy or combination therapy), path to clinics (dedicated, repositioned or repurposed), and mechanism of action and route of administration of the drugs being developed for the treatment of the disease. In addition, the chapter provides information on drug developer(s), highlighting year of their establishment, location of headquarters and employee strength. In addition, it presents certain key insights derived from the study, which includes a representation highlighting the distribution of the marketed and pipeline molecules based on various mechanisms of action. The chapter includes a comprehensive 2X2 grid analysis, representing the distribution of the clinical drug candidates across type of therapy, path to clinic and stage 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 highlights the key unmet needs associated with the management and treatment of Alzheimer's disease. The chapter provides detailed analysis of the various challenges and areas of concern, which were identified from views expressed by patients / experts across different platforms, such as social media posts, recent scientific publications and patient blogs, and the inputs of key opinion leaders at conferences / symposiums. The chapter presents an insightful word cloud analysis, summarizing the opinions expressed across public online portals.

Chapter 6 features a detailed assessment of over 70 discontinued drugs, providing information on the reason(s) for discontinuation, year of discontinuation, mechanism of action of the terminated drugs, phase of discontinuation and the target stage of disease. In addition, the chapter presents over 180 terminated clinical trials highlighting the year of termination and the key geographies where these trials were being conducted.

Chapter 7 provides a detailed analysis of close to 300 research articles related to Alzheimer's disease, published till 2018. The analysis takes into consideration several parameters, such as biological targets being studied, study type (review article, research article, meta-analysis and clinical trials), year of publication, and the most popular journals within this domain.

Chapter 8 features an analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed different partnership models (including product development and commercialization, R&D agreements, technology / product licensing agreements, other licensing agreements, mergers / acquisitions and clinical trial agreements) that have been established till 2019 (February).

Chapter 9 presents details on various investments received by the start-ups / smaller companies that are engaged in this domain. It also includes an analysis of the funding instances that have taken place in the market, till January 2019, highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 10 provides information on the various non-pharmacological interventions, such as cognitive / emotion-oriented therapies, sensory simulation therapies and other psychological interventions, which aim to delay the loss of mental capability and help the patients retain their identity and functional autonomy. The chapter also presents a list of companies that offer such solutions, describing the devices / products and their mechanisms of action / working principles. In addition, the chapter include a list of novel diagnostic techniques, which claim to be capable of assisting in timely diagnosis.

Chapter 11 summarizes the entire report. It presents a list of key takeaways and our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of therapeutic interventions in disease area.

Chapter 12 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company name) Kenneth Moch (President and Chief Executive Officer, Cognition Therapeutics)) and Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International).

Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 14 is an appendix, which contains the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. A review of content on both informal (100 patient blogs and over 5,000 social media posts) and formal (260 scientific articles) literary sources reveal the existence of several unmet needs within the treatment landscape of Alzheimer's disease. Industry experts concur on this opinion as well, stating that one of the most pressing concerns is the need for alternative treatment options and novel therapeutic strategies that are more effective in slowing the disease progression and providing symptomatic relief.
2. Till date, six therapies have been approved for the treatment of Alzheimer's disease; these are (in order of approval year) Aricept® (1996), Exelon (2000), Razadyne (2001), Namenda (2003), Namzaric (2014) and AstroStem (2018, in Japan). Presently, more than 200 drug / therapy candidates are being evaluated across different stages of development for treating this condition and its affiliated symptoms.
3. Given the pressing need for therapeutic candidates capable of arresting disease progression and addressing the root cause of the condition, the major share of pipeline drugs (close to 60%) are disease modifying agents. On the other hand, nearly 30% of candidate therapies are designed to provide symptomatic relief only, while the rest claim to be capable of offering both the aforementioned therapeutic effects. Further, most pipeline products are being developed as monotherapies (~89%) and the rest are being evaluated in combination with other treatment options.
4. It is worth highlighting that 62% of pipeline candidates are small molecules, while the rest are biologics. Further, close to 50% of candidate drugs are currently being investigated solely for the treatment of Alzheimer's disease. 31% of the molecules under development have been repositioned after their efficacy was realized for the treatment of Alzheimer's disease. In addition, 19% of the drug candidates have been repurposed.
5. The market landscape is characterized by the presence of large (19), mid-sized (28) and small-sized companies (94). Examples of prominent large companies engaged in this domain include (in alphabetical order, no selection criteria) AbbVie, Allergan, AstraZeneca, Boehringer Ingelheim, Eisai, Eli Lilly and Company, Novartis and Roche. Moreover, 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) Actinogen Medical, AgeneBio, Anavex Life Sciences, Archer Pharmaceuticals, AZTherapies, BELLUS Health, Cognition Therapeutics, Neurim Pharmaceuticals, Neurocentria and Pain Therapeutics. Mid-sized companies that are actively contributing towards the development of Alzheimer's disease therapeutics include (in alphabetical order, no selection criteria) AB SCIENCE, AC Immune, Avanir Pharmaceuticals, Axon Neuroscience, Axovant Sciences, Intra-Cellular Therapies, Stemedica Cell Technologies and TauRx Therapeutics.
6. An analysis of around 260 peer-reviewed articles related to Alzheimer's disease, published between 2017 and 2018, highlights the increased focus on research in this field. Majority (90%) of the recent publications are research and review articles. The main objectives of more than 39% of the studies were focused on identifying and characterizing various therapeutic targets or elucidating the pathology of the disease, while 29% of the articles were based on diverse non-pharmacological interventions. Among the therapeutic targets mentioned in the aforementioned articles, amyloid beta protein, tau protein and BACE / GSK-3? appear to be the most extensively studied.
7. Stakeholders in the industry have forged several strategic partnerships in the recent past. The most popular deals inked between 2013 and 2019 were related to product development and commercialization (close to 40%), followed by research agreements and licensing agreements. Examples of recently inked deals include collaborations between Janssen Pharmaceuticals and Winterlight Labs (January 2019), Biogen and Skyhawk Therapeutics (January 2019), and Eli Lilly and AC Immune (December 2018).
8. Development efforts have been backed by various private and public investors, resulting in significant capital investments. In fact, since 2013, more than USD 2.5 billion (across 180 funding instances) has been invested in companies involved in the development of therapies for Alzheimer's disease. In 2018 alone, over 30 funding instances were reported, amounting to a total capital investment worth over USD 700 million. More than 70 investors and funding agencies have supported drug / therapy programs initiated by various small / mid-sized companies; active investors include (in terms of participation in funding rounds) the National Institutes of Health, Alzheimer's Drug Discovery Foundation, National Institute on Aging, OrbiMed Advisors, Dolby Family Ventures and Shire.

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