New technology has evolved to tackle degenerative spinal disease, but is enough post-surgery data available to make claims on the efficacy of vertebral implants, asks a new report by research and consulting firm GlobalData?
Around 11 million people across the globe reportedly suffered from symptomatic cervical disc disease (SCDD) in 2011, and this number is set to grow as the global population ages. For several decades, anterior cervical discectomy and fusion (ACDF) represented the hallmark surgical intervention for SCDD, alleviating pain by removing the affected intervertebral disc and fusing adjacent vertebrae together. However, years after the commencement of these procedures, many individuals post-operatively developed SCDD in intervertebral disc levels adjacent to those which were operated on. It is thought that the fusing of adjacent vertebrae may have prompted the progression of SCDD along the spine. Cervical total disc replacements (CTDR) were thus invented to alleviate pain by replacing the damaged disc completely, retaining the motion of the operated level.
The CTDR marketplace is still relatively new, and evidence has been established of the device’s safety and efficacy performance, with two to five year follow-ups having been produced. However, there remain several clinically unexplored avenues in the CTDR market.
Heterotopic ossification – the formation of bone outside of the skeleton – has become a growing concern for CTDR patients, as an increasing prevalence has been documented years after procedures are performed. The durability and longevity of the devices has also raised questions, since they are intended for permanent implantation. In addition, there is a lack of clinical investigation into the performance of CTDR devices in the over-65-year-old patient population. There has been some surgeon hesitance on treating this group with these devices largely because of recommendations produced in literature for lumbar disc replacements. There is also a lack of large-scale trials assessing the performance of CTDR against ACDF in double level procedures.
“The C-TDR market is becoming increasingly competitive with players routinely obtaining non-inferiority performance to ACDF,“ says Joseph Gregory, GlobalData’s Research Analyst covering General Surgery Devices. “Companies can leverage these clinically unmet needs to further differentiate themselves.“
GlobalData estimate that 2018 CTDR sales will reach over US$756m across the US, France, Germany, Italy, Spain, the UK, Brazil, India, and China. Future market growth will be primarily fuelled by increased adoption in the United States and the Asia Pacific region.
