DUBLIN--(BUSINESS WIRE)--The "Orthobiologics Devices And Equipment Global Market Report 2020" report has been added to ResearchAndMarkets.com's offering.
The global orthobiologics devices and equipment market was valued at about $3.7 billion in 2018 and is expected to grow to $4.55 billion at a CAGR of 5.3% through 2022.
The orthobiologics devices and equipment market consists of sales of orthobiologics devices and equipment. Orthrobiologics devices are implants composed of cells and proteins naturally found in human body that provide accelerated healing by stimulating efficient regrowth of musculoskeletal tissues including bones, cartilage, tendons and ligaments. They consist of tissues and bone replacement materials used for recovery of ligaments, tendons, muscles and bones. Orthobiologics devices and equipment include demineralized bone matrix, synthetic bone substitute, bone marrow aspirate concentrate and viscosupplementation.
The aging population profile of most countries contributed to the growth of orthobiologics devices and equipment market globally. According to the United Nations report in 2017, there were 962 million people aged over 60 across the globe, comprising 13% of the global population. The population aged over 60 is expected to grow at a rate of about 3% every year. The report further estimated that Europe had the highest percentage of the population aged over 60 in 2017. During 2013-2017, the number of people globally over the age of 65 grew from by 33%, according to estimates based on Population Reference Bureau data. The increase in the aging population has increased the patient pool of many orthopedic disorders and led to increase the demand for orthobiologics devices and equipment market.
Rising incidences of post-surgical complications in patients implanted with orthobiologics devices is one the major restraints in the orthobiologics devices and equipment market. Surgical procedures with orthobiologics grafts, implants and devices have become increasingly common in recent years. Major post-operative complications include device failures, bleeding, postoperative infections, immune responses and rejections. These procedures may develop post-surgery complications which refer to development of any unwanted or unexpected conditions related to the device, graft, or implant. These complications may vary with the type of procedure, implant, graft or device, experience of the surgeon, improper device testing procedures before market launch, device location in the body and the health and biological response of the individual. The increasing post-operative complications and device failures can limit the orthobiologics devices and equipment market.
Biodegradable implants are increasingly being used in orthobiologics treatment and trauma orthopedic surgeries. Biodegradable implants are used to replace a missing biological structure, support a damaged biological structure, and enhance the existing bone structure. Biodegradable products such as reabosorbable polymers composed of polyglycolic acid and poly lactic acid manufactured in the form of plates, screws, and pins are replacing traditional devices like plates and screws which are more expensive. Surgeons are preferring biodegradable implants to replace conventional implants, as biodegradable implants can be engineered to provide temporary support for bone fractures, can degrade at a rate matching new tissue formation, eliminate the need for second surgery, and highly useful in fracture fixation in children with less implant related infections. For instance, Stryker Corp. offers orthobiologics such as bone repair biodegradable products that are used in bone regeneration and bone healing, soft tissue regeneration and muscle connection to bone
Regulatory changes are likely to lead to increased costs relating to new product development and supply of orthobiologics devices. These changes are related to customer data protection such as the European Union's General Data Protection Regulation (GDPR), changes to equipment approval procedures and other regulatory changes. The GDPR regulation is a EU law on data protection and privacy of individuals residing the European Union and the European Economic Area (EEA). It also regulates the export of personal data outside the EU and EEA areas. Additionally, the FDA is requesting more clinical data to support claims, therefore increasing the time to process 510(k)s by over 55% over the last decade. In November 2017, the USFDA has announced comprehensive regenerative medicine policy framework to facilitate innovation.
This policy deals with the manufacture of tissues, human cells, and cellular and tissue-based products other procedures to prevent the introduction, transmission, and spread of communicable diseases. Orthobiologics such as stem cell therapies are approved through this framework. The potential loss of revenue due to delays in product release, additional costs incurred the time consuming approval processes and changing regulations puts strain to investments relating to orthobiologics devices development.
Major players in the market are Medtronic, Arthrex Inc., DePuy Synthes (A Subsidiary of Johnson & Johnson), Stryker Corporation, Zimmer Biomet
- Bioventus LLC
- Baxter International Inc.
- Integra Lifesciences Holding Corporation
- Nuvasive INC.
- Seaspine Holdings Corporation
- Bone Biologics Corp.
- Pioneer Surgical Technology
- Smith & Nephew plc
- Osiris Therapeutics Inc.
- Globus Medical
- Wright Medical Technology
- Orthofix Inc.
- Harvest Technologies Corporation (A Terumo Bct Company)
- Globus Medical Inc.
- RTI Surgical Inc
- K2M Group Holdings Inc.
- Kuros Biosciences Ltd.
- Xtant Medical Holdings Inc.
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