Increasing approval rates and clinical activity are boosting regenerative medicines, says Frost & Sullivan

The majority of treatments for chronic and fatal diseases are currently palliative or delay disease progression, while regenerative medicine has the potential to transform healthcare and is uniquely capable of altering the underlying disease mechanism and enabling cures, new analysis from Frost & Sullivan's Global Regenerative Medicine Market says.

The report finds that increasing approval rates and clinical activity are helping regenerative medicine to become an attractive sector for investors. It covers the cell therapy (CT), tissue engineering (TE), gene therapy (GT) and small molecules and biologics segments.

Frost & Sullivan's Senior Research Analyst Aiswariya Chidambaram said: 'Cell-based models are anticipated to speed-up the discovery of new molecules and biologics, the safety and toxicity testing of newly discovered drugs, and provide a solid understanding of underlying disease mechanisms.

'As more pharma companies acquire profitable cell therapy companies or strategically invest in emerging cell and advanced therapy organisations, the consolidation wave is likely to rise higher in the industry.'

A significant number of regenerative medicine products, particularly in CT and TE, are already commercially available. In 2012, seven CT products were approved by regulatory agencies worldwide, compared with only five between 2009 and 2011, and none from 2002 to 2008.

But, in spite of the huge value of regenerative medicine, there is a lack of consensus and strategic interaction among members of the regenerative medicine community. There has to be greater assessment of activities at various federal agencies including government, industry, academia, and patient advocates, particularly in the US, to identify areas of redundancy and eventually bridge the gap.

To set up a more efficient coverage and a solid reimbursement framework, the various stakeholders have to streamline regulatory policies. They could achieve this by establishing a clear point of contact at the national level that will act as an interface among the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), National Institutes of Health (NIH), National Center for Health Statistics (NCHS), other federal agencies and the private sector, says Frost & Sullivan.

They should also create platforms to present recommendations for regulatory, reimbursement and research policies in order to foster product and clinical development.

'On the whole, governments all over the world are expected to implement legislative policies favouring the establishment of centres of excellence, manufacturing infrastructure, research networks and economic diversification to support the development of regenerative medicine,' added Chidambaram.