Neurological applications of products in cellular therapy and preclinical, clinical and approved stages

Cellular therapeutics with neurology applications currently encompass the entire range of development from preclinicals to approved, commercially available products in use.

See the specific selected neurology cell therapy products on the market or in development by companies in the market:

  • Personalized stem cell therapies for tissue regeneration
  • Cell treatment for amyotropic lateral sclerosis
  • Biopharmaceutical for stroke
  • MultiStem for attentional/cognitive areas; MultiStem Stroke
  • Cellular (embrionic stem cell) implants for the regeneration of damaged or sick neural tissue
  • Stem cells for neurodegenerative diseases
  • Autologous cell-based therapies for neurosurgical applications
  • Neural progenitor cells
  • Biopharmaceuticals for chronic regenerative disorders, including spinal cord injury (glial cells)
  • Biotech diagnostic assays for neurodegeneration and other applications
  • Regenerative implants for neurosurgical applications
  • Neurotrophin cellular therapy for Parkinson’s disease, Alzheimer’s disease, Huntington’s disease and stroke
  • Stem cell-based therapies for neurological and other applications
  • Human neural stem cell transplantation
  • Neural stem therapies for patients with neurological diseases such as Parkinson’s, Alzheimer's, epilepsy, spinal cord injury, stroke and multiple sclerosis and amyotropic lateral sclerosis
  • Biotherapeutics for amyotropic lateral sclerosis and Parkinson’s
  • Bioregeneration matrix
  • Stem cell therapies for neurological applications (multiple sclerosis, stroke)
  • Bioresorbable nerve guide
  • Cellular therapy for spinal cord injury
  • Neurological cell growth and function
  • Stem cell therapy for disabled stroke victims
  • Plans to develop and commercialize products for Parkinson's, spinal cord injury, and other diseases
  • Stem cell-based biopharm for neurodegenerative and other diseases
  • Cell-based technologies for CNS and liverHuCNS-SC (purified human neural stem cells) for neurodegenerative disorders
  • Therapeutics for neurodegenerative diseases
  • Dura substitute for repair of cranial dura mater, spinal dura mater (marketed by Medtronic)
  • Biopharmaceutical for Alzheimer's
  • Stem cells created from adult cells (retrodifferentiation technology) possibly to be developed for spinal cord injury applications

The global market for neurological applications of cellular and tissue engineered therapeutic products is currently under $300 million, but is on pace to near $1 billion by 2018. (See MedMarket Diligence report #S520.)

U.S., Europe lead cell/tissue therapeutics markets

Worldwide sales of cell therapy and tissue engineering products eclipsed $6.9 billion in 2009 on pace to reach $32 billion by 2018.  This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury. 

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Specifically, President Obama’s repeal of a Presidential Executive Order has given researchers sponsored with Federal funding increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a healthy 20% (CAGR 2009–2018), as shown below.

 

 

Source: Report #S520, MedMarket Diligence, LLC

Regenerative medicine promises realized

The first annual Translational Regenerative Medicine Forum that was held April 6-10, 2010, and sponsored by the Regenerative Medicine Foundation highlighted the future promise and needs in this field encompassing succinctly:

  • replacement tissues and organs
  • cell therapies to restore function

Other issues addressed include the perennial discussion of policy, funding and the challenges of stem cells, both for embryonic and pluripotent stem cells.

The specific applications discussed at the forum included:

  • regeneration of the pancreas' islet cells to restore insulin production for diabetics
  • application of regenerative medicine to treatment of battlefield injuries
  • cell applications to degenerative retinal disease
  • outpatient procedure to regenerate disc tissue
  • injectable therapy to treat heart tissue after heart attack

Given the thrust of the forum, as a forward-looking event that looked at challenges of the field, the promise of new developments and the needs of regenerative medicine, there is a tendency to underestimate the extent the current successful status of regenerative medicine.  (Of course, the forum did include presentations by 18 regenerative medicine technologies seeking potential investment from VC groups like DeNovo Ventures, Excel Venture Management, InterSouth Partners, Livingston Securities, Proteus Ventures, and Quaker BioVentures.)  As much as the forum focused on the great potential of regenerative medicine market and the challenges it faces, one might say that the forum could not possibly represent the extent to which regenerative medicine promises have already been realized.  Here are some examples:

  • The global market for cell therapy and tissue engineering technologies is currently $6.9 billion per year, growing at an aggregate 18%.
  • The global market includes $4.35 billion from orthopedics and musculoskeletal applications, $679 million from skin/integumentary applications, $374 million from dental/oral surgery applications and $468 million from cardiology applications.
  • There are currently hundreds of active companies in this global market.
  • The top five major medtech companies account for a total of $4.3 billion in regenerative medicine revenues annually.

Indeed, the discussion of promise in the field of regenerative medicine — from the standpoint of patients treated, clinical problems solved, future market realized and all of the above — remains huge and, to a great and practical extent, very much within reach.  By our projections, the advances in approved products, clinical applications and resulting market for regenerative medicine will reach $32 billion annually by 2018.

For further detail, see Report #S520.