Reportlinker Adds Immunosuppressants, Organ Transplants, and the Potential of Regenerative Medicine: Market size, competitive landscape, and pipeline analysis
NEW YORK, Sept. 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
The development of novel immunosuppressants, coupled with advances in immunology, surgical techniques, donor selection and postoperative care have all contributed to improved outcomes for solid organ transplants, which is now established treatment for organ failure of the kidney, pancreas, liver, heart or lung. While modern immunosuppressive regimes have led to important improvements in short-term graft survival rates, these have not been accompanied by a proportionate increase in long-term graft survival.
There remains a need for novel agents that can reduce the incidence of acute and chronic rejection: however, achieving large increases in long-term graft survival will be challenging as most causes of graft loss are not due to a lack of efficacy of current immunosuppressants, but are due to medical complications, disease recurrence, non-adherence and most importantly, death with a functioning graft.
Bristol-Myers Squibb's belatacept is likely to become the first new class of primary immunosuppressant approved for over ten years, with potential to improve long-term graft outcomes in kidney transplantation. As with calcineurin inhibitors, belatacept must be administered for the lifetime of the graft to minimize the risk of rejection, which can take years to manifest clinically. Hence, there is considerable interest in the use of stem cells to induce graft tolerance, which represent a major disruptive technology which could potentially replace, or reduce, the use of current primary immunosuppressants.
Since the introduction of ciclosporin in the 1980s short-term graft survival rates have improved significantly, although there remains a need for safer and more effective therapies to improve long-term outcomes. The development of novel primary immunosuppressants has proven challenging and no new class of maintenance immunosuppressants have been approved in the last ten years. Calcineurin inhibitors remain the most effective therapies available to prevent rejection, despite the fact that they cause progressive nephrotoxicity and have substantial side-effects. This report helps companies active in the transplantation market to increase their success by providing:
- An in-depth analysis of the major classes of immunosuppressants, examining how treatment protocols have evolved over the last ten years
- Appraisal of novel compounds in development, highlighting potential clinical advances
- An analysis of the potential impact of regenerative medicine (stem cells) on the market, with drivers and resistors to market growth
- Ten-year forecasts of the number of transplants by organ and country, including estimates of the size of the maintenance populations
Features of this report
- Ten-year forecasts of the number of organ donors, transplants and maintenance populations by organ and country
- Review of the regenerative medicine market, including estimates of the current market size, analysis of over 200 clinical trials and focus on potential applications in cardiovascular, kidney and liver disease
- In-depth analysis of late-stage pipeline products, with discussion of potential clinical advances and how they address current unmet needs
- Overview of organ donation trends including maximum theoretical supply, impact of initiatives to increase the number of donors and how changing donor demographics may impact treatment practice
- Analysis of US treatment protocols at discharge by drug class and review of graft survival rates by organ including causes of graft loss
- Comparison of business models for cellular therapies and relevance to transplantation medicine
Key findings
1. Cellular-based therapies, which have the potential to induce graft tolerance, represent a major disruptive technology which could potentially replace, or reduce, the use of primary immunosuppressants
2. Belatacept may revolutionize kidney transplantation as it has potential to improve long-term graft survival rates, although a drawback for some patients is that it is given by monthly IV administration
3. Despite steady annual increases in the number of transplants over the last ten years, the limited supply of donor organs continues to hinder transplantation: in 2009, around 170,000 patients were on the waiting list for a transplant
4. Modern immunosuppressive protocols have resulted in improvement in short-term graft survival rates and the focus is now shifting towards improving long-term graft survival, although achieving this goal will be challenging
5. Initiatives to boost donor supply may increase the annual number of transplants to 70,500 by 2020: nevertheless, the "organ gap" is likely to widen further as increasing morbidities, such as diabetes mellitus, drive demand
6. A distant goal of regenerative medicine is to develop bioengineered organs and tissues, although the replacement of whole kidneys, hearts or livers is not yet clinically feasible and the development of spatially complex organs will require many advances in tissue engineering
Why you should buy this report
- Understand the driving forces in the transplantation market
- Evaluate current market dynamics
- Learn which novel products offer the greatest potential clinical advances over the next several years and why
- Assess your competitive position vis-à-vis other companies
- Understand which market areas offer the greatest potential growth prospects
- Develop strategies to optimize your transplantation portfolio and identify new areas for market entry
Questions answered by this report
- What will overall sales growth be? Probably low due to the familiarity of physicians with current generic immunosuppressants which limits the impact of novel therapies, in addition to the projected low growth in the number of transplants
- Which products could reshape the landscape? BMS's belatacept in the near term followed by Pfizer's tasocitinib
- Which areas offer the most substantial growth potential? Probably the use of CNI-sparing agents in kidney transplantation
- How innovative is the market? The market is mature and entering a downward growth trend and none of the products in clinical development, with the possible exception Astellas's ASKP-1240, appear likely to offer a step change in efficacy
- Which companies are in the strongest position? Astellas has the broadest transplantation pipeline, although Pfizer and BMS have products with near-term impact
- Which smaller companies are attractive for investment? No small-molecule/biological opportunities were identified, although if stem cells are effective in inducing tolerance, Osiris Therapeutics would likely be an industry leader
- What are current unmet needs? Belatacept should address a major need in kidney transplantation (reduced nephrotoxicity) although across all transplant types a more effective primary immunosuppressant is still required
- What are the greatest areas of uncertainty? Whether stem cells can induce graft tolerance
Table of Contents
Shaun Falkingbridge 2
Disclaimer 2
Executive summary 10
Market environment 10
Solid organ transplants 11
Regenerative medicine 11
Pipeline analysis 12
Chapter 1 Market environment 14
Summary 14
Background 15
Immunosuppression 15
Types of rejection 15
Immunosuppressive therapy 16
Blood group compatibility 18
Tapering of immunosuppression 18
Market valuation 18
Prograf 19
Background 19
Impact of new formulation and generics 19
Conclusion 21
Neoral 22
Background 22
Impact of tacrolimus and generics 22
Conclusion 23
CellCept 23
Background 23
Impact of generics 24
Other brands 24
Evolution in therapeutic protocols 25
Calcineurin inhibitors 26
Shift from ciclosporin to tacrolimus 26
Safety and efficacy 27
Side effects 27
Conclusion 28
Adjunctive agents 28
mTOR inhibitors 30
Enhancing long-term graft survival 30
Sirolimus 30
CNI avoidance 30
Combination use 30
Early/late CNI conversion 30
Everolimus 31
Side effects 32
Conclusion 32
Induction therapies 33
Trends in graft-survival rates 35
Incremental/steady improvements in survival 35
Factors affecting survival rates 37
Non-related patient death 37
Immunosuppressants increase cardiovascular risk factors 38
Cancer 39
Acute rejection 39
Interstitial fibrosis/tubular atrophy 39
CNI nephrotoxicity 41
Glomerular disease 41
Delayed graft function 41
Non-adherence 42
Conclusion 42
Future outlook 43
Chapter 2 Solid organ transplants 45
Summary 45
Introduction 46
Trends in organ donation 47
Regional trends 47
Cause of death 50
Donor legislation 51
Religious factors 52
Number of transplants 52
Organ gap 53
Indications for transplants 54
Kidney 54
Liver 56
Heart 57
Increasing donor supply 57
Maximum theoretical number of donors 57
Strategies to increase the number of donors 57
Spain: active detection 58
The UK: establishment of the Organ Donation Taskforce 58
The US: the Organ Donation Breakthrough Collaborative 60
Forecast number of transplants/functioning grafts 61
Future outlook 65
Chapter 3 Regenerative medicine 66
Summary 66
Introduction 67
Types of cellular therapies 67
Embryonic stem cells 68
Adult stem cells 70
Fully differentiated cells 71
Organ augmentation and replacement 71
Clinical application of cellular therapies 73
Introduction 73
Cardiovascular disease 75
Bone marrow mononuclear cells 75
Endothelial progenitor cells 75
Mesenchymal stem cells 76
Stem cells and heart transplantation 76
Outlook 76
Kidney disease 77
Kidney repair and regeneration 77
Mesenchymal stem cells and transplantation 77
Mesenchymal stem cells and chronic/acute kidney disease 79
Development of whole organs 80
Outlook 81
Liver disease 81
Stem cells and treatment of cirrhosis 81
Hepatocyte transplantation 82
Stem cells and transplantation 82
Regenerative medicine market 82
Market value 82
Autologous chondrocyte implantation 83
Skin-substitutes 84
Apligraf 84
Dermagraft 85
Regulation of cellular therapies 86
US 86
EU 87
Japan 87
China 88
Future outlook 89
Chapter 4 Pipeline analysis 90
Summary 90
Introduction 91
Bristol-Myers Squibb 91
Belatacept 91
Astellas 93
Alefacept 93
ASKP-1240 (4D11) 94
ASP-015K 94
Novartis 95
Sotrastaurin 95
Pfizer 96
Tasocitinib 96
Isotechnika 96
Voclosporin 96
Other companies 96
Novel immunosuppressive agents impact on the market 97
Business models in cell therapy 100
Key success factors 100
Manufacturing process 101
Acute versus elective indications 101
Risk of product substitution 102
Estimates revenues for Prochymal in transplantation 103
Future outlook 104
Appendix 105
Primary research methodology 105
IMS sales data 105
Transplant data 106
Glossary 107
Bibliography 109
Table of figures
Figure 1: Market share of Advagraf, Prograf and Neoral, Spain, 2006-2009 22
Figure 2: Ciclosporin and tacrolimus use in US kidney transplants prior to discharge, 1998–2007 28
Figure 3: Adjunctive agents used in US kidney transplant patients prior to discharge, 1998–2007 29
Figure 4: Sirolimus use in US kidney transplant patients between discharge and one year following transplantation, 1997–2006 33
Figure 5: Induction therapy use in US kidney transplants recipients, 1998–2007 34
Figure 6: Graft survival at one, five and ten years, deceased donor kidney transplants, US 36
Figure 7: Graft survival at one, five and ten years, deceased donor liver transplants, US 37
Figure 8: Graft survival at one, five and ten years, heart transplants, US 38
Figure 9: Reasons for loss of kidney grafts 40
Figure 10: Age of deceased donor kidney recipients (non-ECD), 1998–2007 43
Figure 11: Number of donors by type in the 7MM, 2000–2009 48
Figure 12: Organ donation rates per million population by donor type, 2009 49
Figure 13: Living donation rates per million population, 2000–2009 50
Figure 14: Kidney waiting list and kidney transplants, US, 2000–2009 54
Figure 15: Indications for kidney transplant, US, 1990–2009 55
Figure 16: Indications for liver transplant, US, 1990–2009 56
Figure 17: Number of deceased donors by type, UK, 2000–2009 60
Figure 18: Number of transplants and organ donors, 2010–2020 63
Figure 19: Types of cellular therapies 68
Figure 20: Number of clinical trials by stem cell type, 2002–2009 74
Figure 21: Drivers and resistors to regenerative medicine 88
Figure 22: The challenges of developing immunosuppressants 94
Figure 23: Comparison of uptake of Prograf and CellCept US kidney transplants, 1993–2006 98
Figure 24: Drivers and resistors for primary immunosuppressants 99
Table of tables
Table 1: Types of immunosuppressants 17
Table 2: Immunosuppressants sales ($m) in the 7MMs, by class and brand, 2009 20
Table 3: Current access of donor supply by country 58
Table 4: Number of transplants and organ donors, 2010–2020 62
Table 5: Prevalence of functioning grafts, by country and organ, 2010–2020 64
Table 6: Selected stem cell clinical trials 78
Table 7: Examples of approved cell-based therapies 85
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Biotechnology Industry: Immunosuppressants, Organ Transplants, and the Potential of Regenerative Medicine: Market size, competitive landscape, and pipeline analysis
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