NEW YORK, Sept. 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Immunosuppressants, Organ Transplants, and the Potential of Regenerative Medicine: Market size, competitive landscape, and pipeline analysis

http://www.reportlinker.com/p0289099/Immunosuppressants-Organ-Transplants-and-the-Potential-of-Regenerative-Medicine-Market-size-competitive-landscape-and-pipeline-analysis.html

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

To order this report:

Biotechnology Industry: Immunosuppressants, Organ Transplants, and the Potential of Regenerative Medicine: Market size, competitive landscape, and pipeline analysis

Biotechnology Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

SOURCE Reportlinker

Back to top

RELATED LINKS
http://www.reportlinker.com