RECENT EMEA REGULATIONS TO DRIVE AUTOLOGOUS CHONDROCYTE IMPLANTATION PROCEDURES THROUGH 2013, ACCORDING TO MILLENNIUM RESEARCH GROUP

The number of autologous chondrocyte implantation (ACI) procedures, a novel treatment for knee cartilage repair, will expand robustly through 2013

August 3, 2009—Waltham, Massachusetts— According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the number of autologous chondrocyte implantation (ACI) procedures, a novel treatment for knee cartilage repair, will expand robustly through 2013. MRG’s European Markets for Orthopedic Biomaterials 2009 report examines how the implementation of European Medicines Agency (EMEA) regulations will contribute to the steady growth in the ACI market.

The EMEA’s advanced therapy medicinal products regulations, which took effect in December 2008, aim to centralize the regulatory and scientific requirements for advanced therapies, such as ACI treatments, and will replace national regulations regarding tissue-engineered products. These therapies will have Europe-wide approval if they meet the guidelines, which manufacturers have four years to meet. During this four-year period, countries that previously had more stringent regulations, such as France and Spain, will experience higher-than-usual growth in the knee cartilage repair market as regulations become less rigid. Furthermore, ACI treatments are more expensive than traditional microfracture and debridement procedures, further bolstering the robust growth of the knee cartilage repair market over the next four years.

“In July 2009, ChondroCelect from TiGenix received positive feedback from two EMEA committees,” says Kevin Flewwelling, Manager of the Orthopedics division at MRG. “ChondroCelect was the first product in the ACI market to receive such feedback. The Committee for Medicinal Products for Human Use (CHMP)’s opinion for ChondroCelect will be sent to the European Commission for the adoption of the final marketing authorization decision – typically issued between 60 and 90 days from adoption of the CHMP opinion. This process will serve as a benchmark for other companies that offer ACI treatments hoping to receive Europe-wide approval from the EMEA.”

MRG’s new report, European Markets for Orthopedic Biomaterials 2009, covers the markets for bone graft substitutes, hyaluronic acid viscosupplementation, and knee cartilage repair in Austria, France, Germany, Italy, Spain, and the UK. Additionally, the report provides full breakdowns of orthopedic biomaterial procedures and units by type, including five-year forecasts, up-to-date market shares, and in-depth qualitative insights, allowing clients to gain valuable knowledge into these rapidly evolving markets.

About Millennium Research Group
Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.

About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information, and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

###

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

 


For more information, contact:


Christopher Comfort
Decision Resources, Inc.
781-296-2597
ccomfort@dresources.com
Amy Krohn
Millennium Research Group
416-364-7776 x101
akrohn@mrg.net

Search Products

News & Events

round up image
Need the latest medtech industry intelligence?

Register to receive updates from Millennium Research Group.