stem cells market trends based on primary industry – primary market data of markers used to...
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GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
> Enal Razvi, Ph.D.Biotechnology Analyst,Managing DirectorSELECTBIO [email protected]
GENReports: Market & Tech Analysis
Stem Cells Market Trends based on Primary
Industry Analysis
> Gary Oosta, Ph.D.Biotechnology Analyst,SELECTBIO US
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
• The focus of this GEN Market & Tech Analysis Report is tocharacterize the stem cells marketplace based on the followingclasses of data which we have been collecting as part of ourindustry analysis of this field:
– Industry SWOT– Primary Market Data of Markers Used to Characterize Different
Cellular Classes– Publications Landscape
• Taken together, these data provide a backdrop for understandingthe stem cells marketplace as it exists today
Topic Introduction and Scope
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Stem Cells Market Segmentation and Industry Structure
Toxicity Testing, Screeningin Drug Discovery and
DevelopmentDisease Modeling
[Pharma, Biotech Focus]
AutologousCell Therapy
AllogeneicCell Therapy
100% Adult Stem Cells Today
Primarily HSC and MSCClinical Trials of hESC-
derivedin progressiPSC Clinical Trials Soon[ACT, Kobe, et al.]
Tools Space Cellular Therapeutics Space
100% Adult Stem Cells
HSCs, MSCs, SVF,..PBL, BM, Cord Blood,Adipose,..
Basic Research intoStem cell Biology,
Function[Life Science Research]
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Autologous versus Allogeneic Business Models in the Cellular Therapy Space: Industry SWOT
Autologous AllogeneicCan be Profitable but is Not ScalableCreates Strong Relationships between Caregivers and PatientsNo Immunological Rejection
Scalable Business Model in Terms of Patient PopulationsLower COGS—Cost Structure is ScalableCan Compete against Biologics and Possibly Small Molecules
Small Patient PopulationsNot ScalablePersonalized MedicinePatients Need to be in Proximity to Research Hospital/Provider
Long Development TimesProduction Must be Scalable—ie., Starting Cell Populations Must Support Massive ExpansionImmunological Rejection is anIssue
Specialty Service BusinessTarget Disease Areas for which Personalized Care is Appropriate—such as CancersHigh Potential Barriers to Entry
Cost Structure Spread Across Multiple TherapeuticTargets/ProgramsDevelop for Diseases where Point-of-Care Therapy is Required [such as AMI, Trauma]
iPSC-based Cellular Therapy is a Disruptive Technology/Approach
iPSC-based Cellular Therapy is a Disruptive Technology/Approach
Strength
Weakness
Opportunity
Threat
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
• >$1 Billion in Product Sales Currently in the Broader Cellular Therapy Marketplace Currently
• 30 percent compound annual growth rate• Product Classes Breakout
– Dermatologic/Wound Care– Musculo‐skeletal– Other Classes
Current State of the Stem CellsMarketplace
Stem Cell Research Trends based on Primary Market Research performed
by SELECTBIO
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Market Penetrance of Various Vendors into the Different Segments of the Stem Cells Research Marketplace
0
10
20
30
40
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60
70
80
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100Hepatocytes for ToxicityScreening
Cardiomyocytes for ToxicityScreening
Reagents for Stem CellCharacterization (eg.,antibodies)Cell Separation Products
Small Molecules forDifferentiation
Genetic Constructs (vectors,reporter constructs, promoterconstructs)Plasticware
Cell Culture Supplements
Cell Culture GrowthFactors/Cytokines
Cell Culture Media
Other Stem Cell Types (Cells)
Ordinate Represents the Penetrance of a Given Vendor into aParticular Stem Cell Research Market Segment
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Markers [Surface or Intracellular] Used to Characterize Pluripotent Cells (ESCs, iPSCs)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Height of Each Bar is Proportional to the Penetrance of the Given Marker for Characterization of the Cell Type.
For Pluripotent Cells, the Most Penetrant Markers are Oct4 & Nanog
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
0%
10%
20%
30%
40%
50%
60%
Markers [Surface or Intracellular] Used to Characterize Mesenchymal Stromal Cells (MSCs)
Height of Each Bar is Proportional to the Penetrance of the Given Marker for Characterization of the Cell Type.
For MSCs, the Most-Penetrant Markers are: STRO-1, CD44, CD73, and CD105
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Markers [Surface or Intracellular] Used to Characterize Neural Stem Cells (NSCs)
0%
10%
20%
30%
40%
50%
60%
70%
80%
Height of Each Bar is Proportional to the Penetrance of the Given Marker for Characterization of the Cell Type.
For NSCs, the Most-Penetrant Markers are: Nestin and Sox-2
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
CD34 CD45 CD59 CD133 Thy-1 CD38 c-Kit Lin ABCG2 Sca-1
Markers [Surface or Intracellular] Used to Characterize Hematopoietic Stem Cells (HSCs)
Height of Each Bar is Proportional to the Penetrance of the Given Marker for Characterization of the Cell Type.
For HSCs, the Most-Penetrant Markers are: CD34 and CD45
Stem Cells Publications Analysis en bloc performed by SELECTBIO
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Stem Cells En Bloc Publications Hot Spot Mapgives an immediate picture of what’s big, small and not there at all
Stem Cell Types
Clin.Trials
CancerTypes
Autoimmune
HeartEpigenetics
Neurological
Diseases
Transplant
More
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
Observations
The hotspot map (stem cells vs disease type) shows that
Transplant dominates publication activity in stem cellsAssay Methods and Bioreactors are significant themesCulture methods and types are an important theme
Epigenetics is well represented in stem cell research Histone, methylation, phosphorylation and even some sumoylation appear to be connected to stem cells
The hotspot map shows many areas not yet explored
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
• Expansion of the Cellular Therapy Space– CAGR @ 30%
• Increasing Number of Clinical Trials in the US and EU– 415 cellular therapy product trials under ATMP guidelines in the EU
• Stem Cells Publications Space being Populated Across Disease Classes
• Products for Stem Cell Research from Research Product Vendors Proliferating This space is very fragmented and is ripe for consolidation
Key Takeaways from the Data
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2013GENengnews.com
• This conference brings together researchers as well as clinicians involved in cellular therapy
• Keynotes by CIRM and Clinician‐Scientists Provide Trajectory of the Field, Regulatory Trends, Opportunities for Entry, Status of Grants
• Focus on Adipose‐derived Stem Cells, Cord blood‐derived Stem Cells, Adult Stem Cells• Clinical Practicum Presents Harvest of Adipose‐derived Stem Cells and SVF Preparation• For more information to attend, exhibit or sponsor, please e‐mail: [email protected]
SELECTBIO Clinical Translationof Stem Cells 2014 Conference