Future of Stem Cell Therapeutics- The Global Scenario.
Thursday, October 16, 2008 |
Stem Cells in the Drug Development Process
Stem cells therapeutics is an emerging technology that could be employed in the drug development process to help screen new products. Over 90% of drugs entering clinical trials fail to get to market, due to lack of effectiveness or adverse side effects that were not detected in animal tests. Such false positives could cost R&D facilities hundreds of millions of dollars, and the longer they go unidentified the more is spent on them. Early stage toxicity testing is a particular problem, since there are currently no good models for determining whether a drug will be toxic in humans. Stem cell technology could provide, for example, a virtually endless supply of cells that could be made into liver or heart cells, the two most common places for toxicity. This would allow for the early identification of problems that would otherwise only come up later, such as those found with Merck’s Vioxx or Pfizer’s Bextra.
In October 2007, GlaxoSmithKline, AstraZeneca and Roche announced the establishment of a new venture to use stem cells for safety testing of experimental medicines. Stem Cells for Safer Medicines Ltd. aims to develop effective ways of using human embryonic stem (ES) cells to screen for potentially dangerous side effects of new drugs before they go into clinical trials. The project will not however evaluate stem cells as potential treatments. The initiative will focus initially on developing better ways for testing liver toxicity, the single greatest cause of drug failures and withdrawals. The next step of the research is expected to be heart cells, where new tests could shed light on cardiovascular side effects. The companies each paid $200,000 to help fund the first year's work, while the British government contributed $1.5 million. Other drug firms are expected to join the initiative soon. However, there remain significant scientific hurdles to overcome in differentiating liver cells from existing stem cell lines.
Other groups are also beginning to utilise stem cell technologies in drug development. In September 2007, for example, Stem Cell Sciences was named to lead an EU funded, multinational novel drug screening collaboration using its proprietary Neural Stem (NS) cells. The project, named NEUROscreen, involves designing NS cell-based bioassays which will then be used to discover new candidate medicines for the treatment of cancer, Alzheimer's disease, stroke and epilepsy.
| Medical Condition |
2012 |
2015 |
2020 |
| Cardiovascular disease | 44.3 | 181.6 | 2582.7 |
| Orthopaedics | 38.9 | 159.3 | 591.3 |
| Lung disease | 15.8 | 43.4 | 533.2 |
| Diabetes | 11.4 | 38.5 | 405.6 |
| Arthritis | 14.6 | 40 | 373.9 |
| Cancer | 6.3 | 21.4 | 267.5 |
| Osteoporosis | 6.3 | 10.9 | 102.7 |
| Alzheimer’s disease | 2.9 | 9.6 | 85.4 |
| Crohn's disease | 0.5 | 1.6 | 8.6 |
| NH lymphoma | 0 | 0.1 | 1 |
| Leukemia | 0 | 0.1 | 0.6 |
Figure 1: Procedure Volume for Proprietary Stem Cell Therapies by Disease in Thousands
Source: Frost & Sullivan
Global Stem Cells Market Forecasts
Being an emerging technology, Frost & Sullivan’s forecasts for stem cell therapeutics is based on the following assumptions.
Being an emerging technology, Frost & Sullivan’s forecasts for stem cell therapeutics is based on the following assumptions.
- Research will continue to effectively utilise stem cells for therapeutics despite technological and ethical challenges.
- Government investment in Europe and Japan would be stable, if not high, for stem cell therapeutics development.
- Most of the technologies and therapeutics developed would be safe and manufacturers would be able to obtain regulatory clearances, although there may be delays due to ethical concerns.
- Patent ownership by academic and government institutions and related royalty payments will not inhibit financial incentives for most developers.
- Stem cell therapeutics would be more efficient than current therapies and affordable (to encourage use).
It is estimated that ongoing research and initiatives by manufacturers and Non-Governmental Organisations (NGOs) would enable manufacturers to launch stem cell therapeutic products in 2012.
The medical stem cells market is divided into three categories: stem cell therapeutics, cord blood banking and drug development tools based on the application. The global revenue forecasts for these segments are presented in Figure 2.
The medical stem cells market is divided into three categories: stem cell therapeutics, cord blood banking and drug development tools based on the application. The global revenue forecasts for these segments are presented in Figure 2.
Figure 2: Expected revenues from medical stem cell applications, global scenario.
Source: Frost & Sullivan
Stem Cell Therapeutics
The volume of treatments performed using proprietary stem cell therapies for the diseases mentioned in Figure 1 will rise from approximately 0.1 million in 2012 to 4.9 million in 2020. With a few exceptions in fast-tracked areas such as Crohn’s disease, most new therapies will become available around 2012. As of the end of 2007, just one proprietary stem cell product, Osiris Therapeutic’s Osteocel, was approved in the United States although many others were under development.
Frost & Sullivan estimates that most of the revenues will be derived from cardiovascular products, followed by therapies for respiratory disease, oncological conditions, insulin dependant diabetes and orthopaedics, since these are the indications for which there is a relatively high prevalence rate.
The stem cell therapeutics market is estimated to yield revenues of $246.3 million in 2012 and will increase at a CAGR of 56.6 per cent from 2012 to 2020. The large number of variables involved further complicates prediction, as a wide variety of circumstances and factors could significantly affect these models to either enhance or reduce estimates. Despite of the current non-availability of commercialised therapies and continuing challenges faced by researchers, there are strong drivers that favour a healthy market. These include the large and growing markets and extensive government investments in US, Europe and Japan; a large and growing number of research groups actively engaged in stem cell activities; and recent technological breakthroughs in several areas of basic research.
Umbilical Cord Blood Banking
The cord blood banking market was worth $365.4 million in 2007. The industry has expanded on growing awareness of the benefits of stem cell storage and ongoing news about stem cell therapy developments. This favourable publicity will accelerate from its current rate, although questions about practical implications will loom large. This will drive revenues to reach more than $1.2 billion by 2020, as cord blood banking becomes more accepted and a rising number of healthcare providers educate their patients about available options.
Drug Development Tools
Although applications for stem cells in the drug development process, such as in screening and toxicity testing, currently represent a very small portion stem cell research related activities, it is likely to become an important tool in pharmaceutical R&D. The revenue forecasts are based on the level of utilisation and the expected fees since there are currently no such commercial tools available for pharma biotech R&D. Commercial availability of such tools is expected from 2013 onwards. The market is estimated to yield revenues close to $162.3 million in 2015 and is set to grow at a CAGR of approximately 41.5 percent to reach $919.0 million in 2020.
Conclusion
Stem cell research has several promising medical applications due to its ability to replace defective or damages cells. Despite of the technological and ethical challenges surrounding the utilisation of embryonic stem cells, Frost & Sullivan believes that researchers will continue to make breakthrough discoveries that will ensure hassle free regulatory approval in the future. Research is also underway for the use of stem cells as drug development tools that will simplify the drug discovery and validation process. In the United States alone, there are more than 720 studies underway for developing medical therapies based on adult stem cells. Technological advances in genomics, proteomics, imaging tools and cell culture would ensure the smooth transfer of stem cell research from a basic research module to an applied research area which would mutually benefit investors and patients alike.
The volume of treatments performed using proprietary stem cell therapies for the diseases mentioned in Figure 1 will rise from approximately 0.1 million in 2012 to 4.9 million in 2020. With a few exceptions in fast-tracked areas such as Crohn’s disease, most new therapies will become available around 2012. As of the end of 2007, just one proprietary stem cell product, Osiris Therapeutic’s Osteocel, was approved in the United States although many others were under development.
Frost & Sullivan estimates that most of the revenues will be derived from cardiovascular products, followed by therapies for respiratory disease, oncological conditions, insulin dependant diabetes and orthopaedics, since these are the indications for which there is a relatively high prevalence rate.
The stem cell therapeutics market is estimated to yield revenues of $246.3 million in 2012 and will increase at a CAGR of 56.6 per cent from 2012 to 2020. The large number of variables involved further complicates prediction, as a wide variety of circumstances and factors could significantly affect these models to either enhance or reduce estimates. Despite of the current non-availability of commercialised therapies and continuing challenges faced by researchers, there are strong drivers that favour a healthy market. These include the large and growing markets and extensive government investments in US, Europe and Japan; a large and growing number of research groups actively engaged in stem cell activities; and recent technological breakthroughs in several areas of basic research.
Umbilical Cord Blood Banking
The cord blood banking market was worth $365.4 million in 2007. The industry has expanded on growing awareness of the benefits of stem cell storage and ongoing news about stem cell therapy developments. This favourable publicity will accelerate from its current rate, although questions about practical implications will loom large. This will drive revenues to reach more than $1.2 billion by 2020, as cord blood banking becomes more accepted and a rising number of healthcare providers educate their patients about available options.
Drug Development Tools
Although applications for stem cells in the drug development process, such as in screening and toxicity testing, currently represent a very small portion stem cell research related activities, it is likely to become an important tool in pharmaceutical R&D. The revenue forecasts are based on the level of utilisation and the expected fees since there are currently no such commercial tools available for pharma biotech R&D. Commercial availability of such tools is expected from 2013 onwards. The market is estimated to yield revenues close to $162.3 million in 2015 and is set to grow at a CAGR of approximately 41.5 percent to reach $919.0 million in 2020.
Conclusion
Stem cell research has several promising medical applications due to its ability to replace defective or damages cells. Despite of the technological and ethical challenges surrounding the utilisation of embryonic stem cells, Frost & Sullivan believes that researchers will continue to make breakthrough discoveries that will ensure hassle free regulatory approval in the future. Research is also underway for the use of stem cells as drug development tools that will simplify the drug discovery and validation process. In the United States alone, there are more than 720 studies underway for developing medical therapies based on adult stem cells. Technological advances in genomics, proteomics, imaging tools and cell culture would ensure the smooth transfer of stem cell research from a basic research module to an applied research area which would mutually benefit investors and patients alike.
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