The regenerative medicine industryhas been rapidly expanding over the past few years, making it a high-value, fast-growth market.Key drivers for the market include high rates of clinical trials,accelerated pathwaysfor product approvals, new technologies to supportcell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.
The regenerative medicine market gained major momentum when the Swiss pharmaceutical giantNovartismade history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah).In October 2017,Kite Pharmabecame the second company to get FDA approval of a CAR-T cell therapy (Yescarta).
With swelling momentum to support the CAR-T technology, there are now close to 40 companies developingredirected T cells or NK cellsfor therapeutic use.
On November 13, 2017, the FDA approved Abilify MyCite as the worldsfirst digital pill. With 7 out of 10 Americas taking at least one prescription drug, approval of the antipsychotic medication represents a breakthrough in digital medicine. Made by Japan-based Otsuka Pharmaceutical, the tablet works by containing a sensor to track when and if patients take their medication.
On December 19th, 2017, the FDA approved Spark TherapeuticsLuxturna,a novel gene therapy to treat patients with an inherited form of vision loss.
In addition to product approvals, there are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea.Legislation took effect in Japan in late 2014, in South Korea in 2016, and in the United States in 2017.Additionally, the EU has a program for product acceleration the Adaptive Pathways. Although it is not explicitly for cell and gene therapies, it has been given a lot of attention by the group.
These historic events demonstrate to investors, the public, and funding providers alike that regenerative medicine is a sector that has emerged, no longer one that is evolving in the future.
Big Pharma is also demonstratingsnowballing interest in regenerative medicine.At its core, this is a strategic way for pharmaceutical companies to diversity their product development pipeline.In recent examples:
Finally, direct cell reprogramming is gaining momentum. Fortuna Fix, a company specializing in direct cell reprogramming applications to restore neuronal functionality, secured $25 million in Series B financing. The proceeds will enable the company to conduct Phase I/IIaclinical trials in Parkinsons Disease and Spinal Cord Injury.
Over the past 12-months, regenerative medicine has accelerated as a movement. With more than 600+ brave companies now composing the marketplace,immunotherapies, gene therapy, and digital medicinehave introduced true disruption of healthcare.
Today, the regenerative medicine industryincludes companies that are developing:
Interested to learn more about the industry? We spent exhaustivehours uncovering 600+ companies across the globe that are developing regenerative medicine therapeutics for use in humans.
2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare
Recommendation and review posted by G. Smith