Advantages of Induced Pluripotent Stem Cells (iPSCs)
Stem cell research and experimentation has been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly. In addition, their “unspecialized” nature allows them to differentiate into a wide variety of specialized cell types. Traditionally, scientists have worked with both embryonic and adult stem cells. While the appeal of embryonic stem cells (ESCs) has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding their use. On the other hand, adult stem cells are uncontroversial, but they can have a limited differentiation capacity, creating narrowed options for use.
Therefore, induced pluripotent stem cells presented a promising combination of adult and embryonic stem cell characteristics when they broke on the stem cell scene in 2006.
Discovery of Induced Pluripotent Stem Cells (iPSCs)
Groundbreaking experimentation in 2006 led to the introduction of induced pluripotent stem cells (iPSC). These are adult cells which are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression, as well as other methods. Research and experimentation using mouse cells at Kyoto University in Japan was the first instance in which there was successful generation of the iPSC. In 2007, a series of follow-up experiments were done at Kyoto University in which human adult cells were transformed into iPSC cells.
While there has been continued excitement at the prospect of what such artificially re-manufactured cells could contribute to medical advances, there have also been issues along the way. By 2010, there were a number of private companies that were ready to capitalize on the breakthrough technology that iPSCs represent. One such company, Advanced Cell Technology (now Ocata Therapeutics) discovered several problematic issues while conducting experiments for the purpose of applying for FDA approval to use iPSCs in therapeutic applications. Concerns such as premature cell death, mutation into cancer cells, and low proliferation rates were some of the problems that surfaced.
Nonetheless, progress with iPSCs continued to accelerate within both private industry and academia, and recent years have been a time of massive change for the industry.
Accelerating Progress with Induced Pluripotent Stem Cells (iPSCs)
In one a landmark event, Cellular Dynamics International (CDI) went public in July 2013 with a offering that raised $43 million dollars for the company, securing the company’s position as the global leader in producing high-quality human iPSCs and differentiated cells in industrial quantities. Also in 2013, Celullar Dynamics International and the Coriell Institute for Medical Research announced receiving multi-million dollars grants from the California Institute for Regenerative Medicine (CIRM) for the creation of iPSC lines from 3,000 healthy and diseased donors, a result that will create the world’s largest human iPSC bank.
Furthermore, 2013 was the first year in which clinical research involving transplant of iPSCs into humans was initiated, with Masayo Takahashi of the RIKEN Center in Japan investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration. While the trial was initiated in 2013 and production of iPSCs from patients began at that time, it was not until August of 2014 that the first patient, a Japanese woman, was implanted with retinal tissue generated using iPSCs derived from her own skin cells. A team of three eye specialists, led by Yasuo Kurimoto of the Kobe City Medical Center General Hospital, implanted a 1.3 by 3.0mm sheet of iPSC-derived retinal pigment epithelium cells into the patient’s retina. Unfortunately, this trial has since been paused due to potential safety concerns and its continued progress is “on hold” until these safety issues are resolved.
By February 2015, Cellular Dynamics International had announced continued innovation with iPSCs, stating that it would be manufacturing cGMP HLA “Superdonor” stem cell lines that will support cellular therapy applications through genetic matching. Currently, CDI has two HLA superdonor cell lines that provide a partial HLA match to approximately 19% of the population within the U.S., and it aims to expand its master stem cell bank by collecting more donor cell lines that will cover 95% of the U.S. population. The HLA superdonor cell lines were manufactured using blood samples, and used to produce pluripotent iPSC lines, giving the cells the capacity to differentiate into nearly any cell within the human body.
Also in February 2015, Kyoto University Hospital in Kobe, Japan announced it would be opening an iPSC therapy center by 2019, for purposes of conducting clinical studies on iPSC therapies. The announcement 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.
By March 2015, FUJIFILM Holdings Corporation had acquired Cellular Dynamics International (CDI) for $307 million, making CDI a holding company underneath its mutlinational Japanese parent company. FUJIFILM Holdings is a multinational company headquartered in Tokyo that has historically been known as a photography and imaging company. However, it recently re-positioned itself to become a major stakeholder in the regenerative medicine industry. In addition to acquiring CDI, FUJIFILM has been gradually increasing its reach within the regenerative medicine field, with another notable acquisition being the majority position that it took in Japan Tissue Engineering Co., Ltd., in December 2014.
Finally, a small American biotechnology company, ORIG3N, is now bringing iPSC banking directly to the public through its creation of the world’s largest blood cell repository for iPSC production. Founded in April 2014 and funded by a February 2015 investment of $3.1 million from an investor syndicate led by Hatteras Venture Partners, ORIG3N has been doing this through an innovation program called “LifeCapsule,” in which individuals can store their own iPSCs for future regenerative medicine needs.
In summary, the past three years have seen major advances in iPSC clinical research applications, production and differentiation technologies, and biobanking. It is clear that iPSCs are a vital research trend within the scientific community and that the cells represent a promising tool for use in the reversal and repair of many previously incurable diseases.
Market Metrics & End-User Survey Results from iPSC Researchers
Since their discovery in 2006, a large and thriving research products market has grown into existence for iPSCs. Indeed, the number of iPSC research products sold worldwide has been growing at a double-digit rate, and 22% of all stem cell researchers now self-report as having used induced pluripotent stem cells within a research project. It is clear that iPSCs are a vital research trend within the scientific community.
To assess opportunities and threats within the rapidly changing iPSC marketplace, BioInformant recently released a global strategic report, the “Complete 2015-16 Induced Pluripotent Stem Cell Industry Report.”
A distinctive feature of this report is an end-user survey of 274 researchers (131 U.S. / 143 International) that identify as having induced pluripotent stem cells as their core research focus. These survey findings reveal iPSC researcher needs, technical preferences, key factors influencing buying decisions, and more. Therefore, they can be used to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.
Key Report Findings
Furthermore, this 2015 report contains 175 pages of detailed industry analysis, including:
- Charts, Timelines, and Forecasts for the iPSC Market
- Trend Rate Data for iPSC Grants, Scientific Publications, Clinical Trials, and Patents
- Market Size Determinations, with 5-Year Forecasts
- Competitive Environment Analysis, including Market Share by Competitor
- Preferred Species for iPSC Research
- Breakdown of Market Share by iPSC Product Category
- Consumer Behavioral Patterns
- Preferred Providers of iPSC Products
- Crucial Trends and Unmet Market Needs
- “Tested Sentences” for Selling to iPSC Scientists
- Breakdown of the Marketing Methods Used by Industry Participants
- End-User Survey of iPSC Researchers (131 U.S. / 143 International)
In summary, the “”Complete 2015-16 Induced Pluripotent Stem Cell Industry Report” is a must-read industry report for executives and investors 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 marketplace, and take advantage of crucial iPSC trends.
Remember, all BioInformant products come with a “Greater than 100% Money Back Guarantee.” If the strategies and tools aren’t helpful to you, then we will cheerfully refund your money and you can keep the product.
Claim this report now to profit from this expanding market – or your competition will.