Complete 2015-16 Induced Pluripotent Stem Cell (iPSC) Industry Report

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Bharat Book Bureau

16 Mar, 2015, 16:00 IST

MUMBAI, March 16, 2015 /PRNewswire/ --

Recent months have seen the first iPSC clinical trial in humans, creation of the world's largest iPSC biobank, major funding awards, a historic challenge to the "Yamanaka Patent", a Supreme Court ruling affecting industry patent rights, announcement of an iPSC cellular therapy clinic scheduled to open in 2019, and much more. Furthermore, iPSC patent dominance continues to cluster in specific geographic regions, while clinical trial and scientific publication trends give clear indicators of what may happen in the industry in 2015 and beyond.

Is it worth it to you to get informed about rapidly-evolving market conditions and identify key industry trends that will give you an advantage over your competition?

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REPORT APPLICATIONS 

This global strategic report is produced for: 

  • Management of Stem Cell Product Companies
  • Management of Stem Cell Therapy Companies
  • Stem Cell Industry Investors

It is designed to increase your efficiency and effectiveness in: 

1. Commercializing iPSC products, technologies, and therapies

2. Making intelligent investment decisions

3. Launching high-demand products

4. Selling effectively to your client base

5. Increasing revenue

6. Taking market share from your competition

OVERVIEW 

1. In 2007, a series of follow-up experiments was done at Kyoto University in which human adult cells were transformed into iPSC cells.

2. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.

3. Continued research and experimentation have resulted in numerous advances over the last few years. For example, several independent research groups have announced that they have derived human cardiomyocytes from iPSCs. These cells could be used in a laboratory context to test drugs that treat arrhythmia and other cardiac conditions, and in a clinical context they could potentially be implanted into patients with heart disorders.

4. Preliminary results are indicating positive results for the participants in this iPSC clinical trial. Interestingly, Ocata Therapeutics (previously ACT) is conducting similar research, but the company has moved away from its initial focus on iPSCs and has instead chosen to focus on human embryonic stem cells (hESCs). It is currently conducting clinical trials using retinal pigmented epithelial cells produced from hESCs for purposes of treating several types of macular degeneration. The company reported positive preliminary results, which were published in the Lancet in October 2014.

5. Also of great significance, Kyoto University Hospital in Kobe, Japan announced in February of 2015 that it will be opening an iPSC therapy center in 2019, for purposes of conducting clinical studies on iPSC therapies. The announcement has further positioned Japan as the leading nation committed to bringing iPSC therapies to clinic. Officials for Kyoto Hospital said it will open a 30-bed ward to test the efficacy and safety of the therapies on volunteer patients, with the hospital aiming to initiate construction at the site in February of 2016 and complete construction by September 2019.

6. Current research with iPSCs underway at Kyoto University includes differentiation of iPSCs into dopamine-releasing neurons for transplantation into patients who are afflicted with Parkinson's disease. University researchers are also working on generating a formulation of platelets that will assist with blood clotting. Dr. Shinya Yamanaka, who is credited with discovering iPSCs in 2006 and who shared the 2012 Nobel Prize in Medicine for the discovery, leads the existing iPSC research center at Kyoto University.

7. And in 2007, performed follow-up experiments in which his team transformed human adult cells into iPSC cells.

8. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.

9. James Thomson is both the Founder and current Chief Scientific Officer of Cellular Dynamics International (CDI), a leading supplier of human iPSC lines for purposes that include drug discovery, safety, stem cell banking, cellular safety, and more.

Landmark Events Create Market Opportunities 

In 2009 ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University, was the first to make iPSC product commercially available with the launch of human iPSC-derived cardiomyocytes, which it called "ReproCario."

10. Other stem cell derived cardiomyocytes are now available commercially from Cellular Dynamics International, GE Healthcare, Cellectis, and others. ReproCELL's innovation in the area of iPSC commercialization has been driven in part by joint research relationships it established in 2003 with Tokyo University and in 2004 with Kyoto University, the eventual site of iPSC discovery in 2006.

11. Since 2009, ReproCELL has expanded its line of iPSC reagents and iPSC-derived cell lines to include heart, liver, and nerve cells.

12. The company primarily sells these products as research tools, although they also have the potential for use in toxicology and drug discovery applications. Currently, ReproCELL offers the following iPSC products:

  • Research reagents optimized for human iPSC culture
  • Human iPSC-derived cardiomyocytes, which launched in April of 2009 (the first iPSC product to be sold commercially)
  • Human iPSC-derived neurons, launched in October of 2010
  • Human iPSC-derived hepatocytes, launched in May of 2012
  • Disease model cell generation using human iPS cell technologies

Four Primary Areas of Commercialization 

There are currently four major areas of commercialization for induced pluripotent stem cells, as described below: 

1. Drug Development & Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.

2. Cellular Therapy: iPSCs can be used for cellular therapy applications, including autologous transplantation and potentially gene therapy. The purpose of cellular therapy is to reverse injury or disease.

3. Toxicology Screening: iPSCs can be used for toxicology screening, which is the use of stem cells or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.

4. Stem Cell Biobanking: The goal of stem cell biobanking is to create a repository of stem cell specimens, including source tissue from which iPSCs can be derived, differentiated cell types produced from iPSCs, and disease tissues produced from iPSCs. Large-scale stem cell repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC derived cells produced from both healthy and diseased donors. Importantly, these repositories can also greatly expand the capacity for global research and collaboration.

Key Report Findings Include: 

  • Metrics, Timelines, Tables, and Graphs for the iPSC Industry
  • Trend Rate Data for iPSC Grants, Clinical Trials, and Scientific Publications
  • Analysis of iPSC Patent Environment, including Key Patents and Patent Trends
  • Market Segmentation
  • 5-Year Market Size Projections (2015-2019)
  • Market Size Estimations, by Market Segment
  • Updates on Crucial iPSC Industry and Technology Trends
  • Analysis of iPSC Market Leaders, by Market Segment
  • Geographical Assessment of iPSC Innovation
  • SWOT Analysis for the iPSC Sector (Strengths, Weaknesses, Opportunities, Threats)
  • Preferred Species for iPSC Research
  • Influential Language for Selling to iPSC Scientists
  • Breakdown of the Marketing Methods, including Exposure and Response Rates
  • And Much More

Summary of Findings 

Induced pluripotent stem cells represent a promising tool for use in the reversal and repair of many previously incurable diseases. The cell type represents one of the most promising advances discovered within the field of stem cell research during the past decade, making this a valuable industry report for both companies and investors to claim in order to optimally position themselves to sell iPSC products. To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage of crucial iPSC trends.

Table of Content 

ABSTRACT 

BACKGROUND 

  • Definition
  • Discovery
  • Advantages & Disadvantages

TIMELINE 

  • Production of iPSCs (Key Events)
  • Full Timeline of Events

CHARACTERIZATION OF iPSC RESEARCH ADVANCES 

  • Methods of Making iPSCs - Comparison of Methods by Downstream Application
  • Summary of iPSC Derivation Methods, by Cell Type
  • Diseases in Which iSPCs Have Been Derived from Patients

MARKET EVENTS 

  • Research Advances
  • Clinical Trial Events
  • Biobanking Events
  • Patent Events
  • Other Key Industry Events

OPPORTUNITIES FOR COMMERCIALIZATION 

  • Drug Development & Discovery
  • Cellular Therapy
  • Toxicology Screening
  • Stem Cell Biobanking

COMPANIES SELLING iPSC RESEARCH PRODUCTS 

  • Complete List of Companies
  • Rate of Entrants by Year

TYPES OF iPSC RESEARCH PRODUCTS 

  • Stem Cell Product Categories
  • iPSC Market Share Breakdown, By Product Area

COMPANIES DEVELOPING iPSC THERAPIES 

  1. Commercial Entities
  2. Non-Commercial Organizations Developing iPSC Therapies

"SWOT" ANALYSIS FOR iPSC INDUSTRY 

  • Industry Strengths
  • Industry Weaknesses
  • Industry Opportunities
  • Industry Threats

STRATEGIC COLLABORATIONS FOR DEVELOPMENT OF iPSC PRODUCTS 

MARKET TREND ANALYSIS 

  1. Clinical Trial Rate Analysis
  2. Grant Rate Analysis
  3. Patent Analysis
  4. Scientific Publication Analysis
  5. Search Phrase Analysis
  6. Additional Sources of iPSC Research Funding

MARKET SIZE 

  1. Definition of "Induced Pluripotent Stem Cell (iPSC) Market"
  2. Experimental Approach
  3. iPSC Market Size
  4. iPSC Market Size, 5-Year Projections

SCIENTIST PANEL: DETAILED END-USER SURVEY 

  1. Survey Overview
  2. Characterization of Market Survey Respondents
  3. Survey Findings
  4. Terms Used in Online Product Search
  5. Breakdown of iPSC Research, By Applied Research Application

STRATEGIES FOR ACCESSING THE MARKETPLACE 

  1. iPSC Industry Influencers
  2. Commercial Influencers
  3. Top Research Institutions Performing iPSC Research
  4. Events of Interest

Input Sources 

The content and statistics contained in this report were compiled using a broad range of sources. These sources include:

  • Stem Cell Grant Funding Database (NIH database)
  • Stem Cell Patent Database (USPTO)
  • Stem Cell Clinical Trial Database (ClinicalTrials.gov)
  • Stem Cell Scientific Publication Database (PubMed)
  • Stem Cell Product Launch Announcements (Trade Journals, Google News)
  • Stem Cell Industry Events (Google News, Google Alerts)
  • Stem Cell Company News (SEC Filings, Investor Publications)
  • International Surveys (Electronically Distributed End-User Surveys)
  • And More

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