Stringent regulatory guidelines for CRRT in North America
Northrook, IL -- (SBWIRE) -- 02/14/2020 -- Increasing prevalence of AKI and renal disorders, growing number of ICU patients, rapid growth in the aging population, and clinical advantages of CRRT over intermittent blood purification techniques are some key factors propelling the growth of this market.
The overall continuous renal replacement therapy market is estimated to reach $1.53 billion by 2022; growing at a CAGR of 7.0% during the forecast period.
CRRT product manufacturers in North America face several regulatory barriers due to multi-layered regulations set by the FDA, thereby negatively impacting the demand for various CRRT products. Due to high regulatory barriers, a number of CRRT products approved in other countries have yet to be approved by the FDA. For instance, in Europe, CRRT is approved for multiple indications such as liver support, elevated Intracranial Pressure (ICP), intoxication, cardiac failure, rhabdomyolysis, tumor lysis syndrome, and post-cardiac surgery. However, in North America, no CRRT machine is approved by the FDA for the treatment of multiple indications. Similarly, no anticoagulating agent for blood infusion during a CRRT procedure is approved by the FDA to date, whereas it has been approved in Europe.
The significant share of the U.S. in the global CRRT market is mainly due to its huge AKI population base. Thus, the presence of stringent and time-consuming regulatory policies for the approval of new CRRT products in the region poses a key hindrance to the growth of the global CRRT market.
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Geographical Region Covered
Europe held the largest share of the market. However, the developing Asia-Pacific countries including China and India are expected to emerge as the new revenue-generating regions for prominent market players during 2017-2022. The growth of this Asia-Pacific market is attributed to the growing patient population, increasing sepsis incidence, increasing prevalence of hypertension and diabetes (which are the major causes for developing AKI), high use of CRRT in Australia and Japan, improving healthcare expenditure, and increasing accessibility to CRRT for AKI treatment.
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Baxter International Inc. (U.S.) held the leading position in the market. Over the past three years, the company has adopted product launches & enhancements, strategic acquisitions, and market expansion as its key business strategies to ensure its dominance in this market. Fresenius Medical Care AG & Co. KGAA (Germany), Nikkiso Co., Ltd. (Japan), B. Braun Melsungen AG (Germany), Nxstage Medical, Inc. (U.S.), Asahi Kasei Medical Co., Ltd. (Japan), Bellco S.R.L. (Italy) Infomed SA (Switzerland), Medica S.p.A (Italy), Medical Components, Inc. (U.S.), and Toray Medical Company Limited (Japan) were few other key players operating in the continuous renal replacement therapy market.
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