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

Press Release   •   Oct 10, 2010 12:15 IST

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

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