The global market is dominated by a few companies that are largely focused on Europe and North America (see table 44). The majority of the prostheses market is made up of products from companies including Ottobock, Ossur, Blatchford, and Proteor.
These companies have all developed more affordable solutions for LMIC markets. For example, Blatchford has formed the Endolite subsidiary and line of prostheses, which targets LMIC markets such as China and India. Ottobock has similarly acquired a Brazilian company, Polior, to enter the basic component segment and has also partnered with ALIMCO (India) to jointly make quality components in India. Proteor components are commonly found in Francophone Africa, partially through partnerships with Humanity & Inclusion, with whom they have developed an emergency prosthetic kit.
102Table 44: Leading global prostheses manufacturers
Company | Product types | LMIC Presence | Manufacturing Sites | Quality |
Becker (USA) i |
|
Africa, Middle East, Latin America, Asia. Countries include Brazil, Egypt, India, South Africa, Thailand, Türkiye, and Venezuela. |
United States | ISO 13485 |
Blatchford (UK) |
|
Africa, Middle East, Asia. Countries include Pakistan, India, Bangladesh, Myanmar, Tunisia, Algeria, Malaysia etc. |
United States, United Kingdom | CE, ISO |
Fillauer (USA) |
|
Asia, Africa. Sales across the world | Information not available | ISO 22675, ISO 9001 |
Ottobock (Germany) |
|
Asia, Africa | North America, Europe, China | CE, US FDA, ISO |
Össur (Iceland) |
|
Africa, Asia, America, Middle East | Iceland, Scotland, Mexico, China, US, France | CE, US FDA, ISO, MDSAPii, EU MDR |
Proteor (France) |
|
Africa, Asia, Middle East | France (22,000 pcs/year), United States | CE, ISO |
WillowWood iii (USA) |
|
Asia, Africa, South America, Oceania. Has 20 distributors across five continents | Information not available | ISO 13485 |
iBecker company official website, https://www.beckerorthopedic.com/.↩︎
iiAccording to FDA, The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. https://www.fda.gov/media/90179/download. ↩︎
iiiWillowWood company official website, https://willowwood.com/about-willowwood/.↩︎