Market Challenges: Stringent Regulations for Approval of New Treatment Options

Stringent regulations for the approval of new treatment options is one of the major factors restraining the growth of global critical limb ischemia treatment market. The approval process for any new drug or treatment in this market is extremely lengthy and complex. Clinical trials and vast amount of clinical data is required to prove the safety and efficacy of new treatment modalities before they can be cleared for market use. This prolonged approval timeline poses significant challenges for pharmaceutical and medical device companies. For example, according to the World Health Organization, the average time required for approval of a new drug in the U.S. is over 7 years. This includes several phases of clinical trials involving thousands of subjects and gathering vast amount of data on clinical endpoints such as reduction in amputation rates, improvement in pain levels and overall quality of life. Any minor issues or deficiencies found during regulator reviews can significantly delay the approval process. This lengthy and expensive drug development process acts as a deterrent for many small to mid-sized companies to invest in development of new critical limb ischemia treatments.

Market Opportunities: Increased Healthcare Expenditure

Increased healthcare expenditure on critical limb ischemia treatment presents a great opportunity for the Global Critical Limb Ischemia Treatment Market. Critical limb ischemia is a severe blockage of arteries that reduces blood flow to the limbs. It can lead to pain and serious complications including sores, infections and amputation if left untreated. As per the World Health Organization, the global prevalence of peripheral artery disease or PAD, of which critical limb ischemia is a severe form, is around 200 million cases. It is estimated that 10–20% of PAD patients will progress to critical limb ischemia if left untreated. With rapid aging of the population globally and rising prevalence of diseases like diabetes that increase the risk of critical limb ischemia, there is expected to be a significant increase in the number of critical limb ischemia cases in the coming years. At the same time, healthcare expenditure is also projected to increase substantially across many countries. For example, healthcare spending as percentage of GDP in the U.S. is projected to increase from 17.7% in 2018 to 19.4% by 2023 according to data from The Centers for Medicare and Medicaid Services. Similarly, healthcare spending as percentage of GDP in China, Germany and India is also projected to increase in the coming years.