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Features

The global market for minor orthopedic replacement implants exceeded $1.5 billion in 2017. Analysts from The Business Research Company forecast the market value to grow at a rate of over 7 percent and to reach $2.2 billion in 2021 in their report “Minor Orthopedic Replacement Implants.”1 According to the report, the primary reason for this growth is the high incidence of arthritis and fractures. Osteoarthritis and rheumatoid arthritis are the major causes for joint replacement surgery, including minor orthopedic joints. The other cause for joint replacement surgery is failed previous joint replacement surgery. This article examines the trends that are driving this market, including a look at materials, regions, procedures, and regulatory developments that are shaping the future of orthopedic implants.

The United States accounts for more than half of all minor orthopedic replacement implants. (Credit: The Business Research Company)

Market Segments. Minor orthopedic implants include implants used in shoulder, wrist, ankle, and foot joints. Shoulder replacement holds the largest market share. Growth in all four segments — shoulder, wrist, elbow, and foot and ankle implants — has accelerated recently (see Figure 1).

Fig. 1 - Minor orthopedic replacement implants market segmentation. (Credit: The Business Research Company)

Regional Analysis. With more than three-fifths of the market share, North America was the largest region in the minor orthopedic replacement implants market in 2017, with the United States, being the largest country in the market, accounting for more than half the market share. The smallest market for minor orthopedic implants was in South America with a market share of just over 1 percent.

Market Drivers

Better Materials. Minor joint replacements are highly complex and have previously suffered from a high failure rate. Recent technological advances in both the implants themselves and the surgeries involved have both contributed to the growth of the market. For example, metals such as titanium, cobalt, chromium, molybdenum, and other materials such as polyethylene, have replaced the plastics and ceramics that were earlier being used in the design and manufacture of implants. The metals have a porous surface that enhances osteointe-gration, thus reducing revision rates. Polyethylene, by contrast, reduces wear and improves the longevity of the minor joint replacement implants. This shift toward new high-quality materials in implants has driven the market since 2013. Longer life for implants makes them suitable for use in younger fracture patients, for whom they were previously not recommended owing to the need for replacement every 10-15 years.

Technological advances in implants themselves and in orthopedic surgical techniques have contributed to the growth of the orthopedics market. (Credit: The Business Research Company)

Other major trends are also shaping the minor orthopedic replacement implants market, including the availability of generic implants and the growth of economies in the BRIC countries (Brazil, Russia, India, and China).

Generic Implants. Generic orthopedic implant companies have also gained traction. Following the expiry of patents for implants, some 16 generic companies have entered the orthopedic replacement implants market in the United States, including Orthosolutions, Covenant Orthopedics, Ortho Direct USA, and Emerge Medical. These generic companies are making copies of legacy implants, capitalizing on the proven designs and biomaterials.

These generic orthopedic implant companies’ offer lower prices compared to branded implants and thus could pose a threat to the big orthopedic devices manufacturers such as Stryker, J&J/DePuy/Synthes, Zimmer/Biomet, Smith & Nephew, and Medtronic Spine. Because there is a wide scope of entry for many generic orthopedic device manufacturing companies, these generic companies should focus on marketing strategies in order to compete with the big orthopedic manufacturers.

Fig. 2 - Minor orthopedic replacement implants market, 2017, estimated competitor market shares. (Credit: The Business Research Company)

Emerging Markets. The big orthopedic implant manufacturers are showing interest in emerging markets. The BRIC countries are faster growing economies than the United States, and these countries represent around 41 percent of total world population. Converging uncertainty about regulatory, economic, and reimbursement trends in the U.S. market are driving the big orthopedic device companies (Stryker, J&J/DePuy/Synthes, Zimmer/Biomet, Smith & Nephew, and Medtronic Spine) to shift their resources, training, inventories, clinical studies, and R&D efforts to these big four emerging orthopedic countries. Due to high growth for orthopedic implants in BRIC countries, other orthopedic implant manufacturers (other than the big five orthopedic companies) should also consider entering the market to profit from its growth.

Positive Trends for Minor Joint Procedures

Recently, small bone plating, especially in the distal radius segment, has been a major trend. There is also an increasing trend toward new shoulder prostheses and total ankle replacements. For example, 100,000 shoulder arthroplasties were performed in 2016 in the United States, compared to only 14,000 in 2000. This rapid rate of growth is largely due to the expanding indications for minor joint procedures and their rising popularity, as well as the size of an aging population that desires to remain active.

The healthcare market has seen an increased use of reverse shoulder arthro-plasty. The procedure numbers for reverse shoulder arthroplasty are continuously increasing. According to the BRC report on minor orthopedic replacement implants, approximately half of the shoulder replacements in the United States and more than two-thirds of shoulder replacements in Europe are reverse shoulder replacement surgeries.

The balance of shoulder replacements are total shoulder arthroplasty or hemi-arthroplasty procedures. This upward trend of reverse shoulder arthroplasties is due to their increasing utilization to treat shoulder fracture patients and expanding applications to both elderly and more active patients. The highly successful outcomes of the procedure and surgeons becoming more comfortable with the procedure are also leading to an increase in the number of arthroplasties.

Regulation Dominates the Minor Orthopedic Market

The medical device market is highly regulated with authorities and regulatory bodies governing the development and marketing activities of medical device manufacturers in each country. Medical devices must comply with quality standards developed by International Organization for Standardization (ISO).

Due to the financial pressures on healthcare budgets in many European countries, several governments are trying to reduce the cost of healthcare devices and improve their efficiency. Increasing privatization of healthcare is also forcing manufacturers to reduce product costs. In some European countries, several healthcare segments such as orthopedics, plastic and corrective surgery, aesthetic surgery, and total pain management, are being privatized.

In the United States, medical device manufacturers must submit a premarket notification to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. The changes may be related to the design, material, and chemical composition, energy source, manufacturing process, or intended use.

In terms of the price of the implants, the U.S. government, for instance, is unwilling to intervene directly to reduce the cost of joint replacement implants. This has led to insurance companies pressuring implant manufacturers to reduce their prices. Even though the U.S. government does not cap the prices of medical devices, it is worth noting that a 2.3 percent medical device excise tax applies to sales of taxable medical devices. By contrast, the Indian government has capped the prices for orthopedic implants, which thus regulates the margin for these implant companies.

This article was written by Abhilash Pyata, Research Consultant for The Business Research Company, Hyderabad, India. TBRC is a market research and intelligence company with research professionals at its offices in the U.K., India, and the United States, as well as a network of trained researchers globally. For more information, Click Here.