Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
Tissue Glue and Bio-adhesive Sealants Market – Insights
Tissue glue is used as an alternative method for wound closure that is painless, fast, and does not require a follow-up visit for removal. Tissue glue is made from cyanoacrylate compounds. Tissue glue finds application in superficial lacerations, low wound tension, and after placement of deep sutures to close skin.
Bio-adhesive sealants are developed from proteins, collagen, thrombin, fibrin, gelatin, and polysaccharides such as chitosan are used for acute thoracic aortic dissection repair, controlling intraoperative bleeding in vascular procedures, and for soft tissue sealing.
The global tissue glue and bio-adhesive sealants market is estimated to account for US$ 1,509.6 Mn in terms of value in 2019 is expected to reach US$ 2,876.9 Mn by the end of 2027.
Global Tissue Glue and Bio-adhesive Sealants Market: Drivers
Increasing prevalence of bone-related disorders is expected to propel growth of the global tissue glue and bio-adhesive sealants market over the forecast period. For instance, according to the paper ‘New Osteoporotic/Vertebral Compression Fractures’, published in 2018 by National Center for Biotechnology Information (NCBI), the U.S. records 700,000 cases of vertebral compression fractures, annually.
Increasing number of arthroplasty procedures is also expected to aid in growth of the market. For instance, in 2018, the American Academy of Orthopaedic Surgeons (AAOS) and the American Joint Replacement Registry (AJRR) recorded over 1 million patients and over 1.4 million hip and knee arthroplasty procedures.
North America region held dominant position in the global tissue glue and bio-adhesive sealants market in 2018, accounting for 51.5% share in terms of value, followed by Europe.
Global Tissue Glue and Bio-adhesive Sealants Market: Restraints
There are several complications in cemented arthroplasty such as inflammation of surrounding soft tissue and breakdown of cement, which may prompt the need for second arthroplasty surgery. Such risks decrease the demand for cemented arthroplasty, which in turn restrains growth of the global tissue glue and bio-adhesive sealants market to a certain extent.
Moreover, lack of adoption of tissue glue and bio-adhesive sealants in emerging economies is also expected to hamper growth of the market. This can be attributed to lack of awareness regarding the benefits, clinical efficacy, safety, and cost-effectiveness of tissue glue and bio-adhesive sealants compared to substitute products or procedures and tissue repair therapies.
Global Tissue Glue and Bio-adhesive Sealants Market: Opportunities
Increasing number of surgeries and amputations is expected to offer lucrative growth opportunities for players in the global tissue glue and bio-adhesive sealants market. For instance, according to the study, ‘Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050", published in the Archives of Physical Medicine and Rehabilitation, there will be an estimated 3.6 million people in the U.S. living with limb loss by 2050.
Moreover, increasing R&D in tissue glue and bio-adhesive sealants is also expected to aid in growth of the market. For instance, in December 2018, researchers from Uppsala University and Stockholm University reported development of new class of bioinspired calcium phosphate cements that can glue tissues together and bond tissues to metallic and polymeric biomaterials.
Market Trends/Key Takeaways
The market is witnessing increasing adoption of inorganic activities by market players. For instance, in December 2019, CryoLife, Inc. partnered with Misonix for commercialization of CryoLife's NeoPatch product for the treatment of various indications outside of cardiac and vascular surgery.
Key players in the market are focused on adopting tissue glue and bio-adhesive sealants in reconstruction of peripheral nerves. For instance, in January 2018, Gecko Biomedical received a funding of US$6 million under the Investments for the Future Program for R&D in reconstruction of peripheral nerves using 3D-printed micro-conducts secured by one of the company’s exclusive adhesives.
U.S. FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
- Human cells, tissues, and cellular and tissue-based products (HCT/P's) are regulated by the Center for Devices and Radiological Health (CDRH)
- Products are included under Section 361 of PHS Act
- Premarket review and approval not required; Product regulated solely under Tissue Regulations to control spread of communicable disease (21 CRF 1271)
- Establishment registration and product listing required (21 CRF 1271 -Subpart B)
These HCT/P's are regulated solely as "361 products" when they meet all of the criteria in 21 CFR 1271.10(a):
- Bone (including demineralized bone)
- Ocular tissues (corneas & sclera)
- Vascular grafts (veins & arteries), except preserved umbilical cord veins
- Amniotic membrane (when used alone (-without added cells-) for ocular repair)
- Dura mater
- Heart valve allografts
- Hematopoietic stem cells derived from peripheral or umbilical cord blood
Value Chain Analysis
Global Tissue Glue and Bio-adhesive Sealants Market: Competitive Landscape
Major players operating in the global tissue glue and bio-adhesive sealants market include, Cryolife, Baxter International Inc., Luna Innovations Incorporated, B. Braun Melsungen AG, Johnson and Johnson, Dentsply Sirona Inc., Cohera Medical, Inc., Chemence Medical, Inc., Tissuemed Ltd., C.R. Bard Inc., and Integra LifeSciences Corporation.
Global Tissue Glue and Bio-adhesive Sealants Market: Key Developments
Key players in the market are focused on product development and approval to expand their product portfolio. For instance, in January 2020, Polyganics received CE marking for LIQOSEAL, its easy-to-use and innovative dural sealant patch.
Key players in the market are focused on adopting MA&A strategies to expand their product portfolio. For instance, in December 2019, Advanced Medical Solutions Group plc., a provider of tissue adhesives, acquired Biomatlante SA, a developer and manufacturer of surgical biomaterial technologies.