Soft Tissue Repair Market Analysis

Human body soft tissue comprises tendons, muscles, ligaments, skin, nervous tissue, cartilage, and synovial membrane. Tissue damage causes change in structure and biochemical composition. Soft tissue repair refers to replacement of the destroyed body tissue with living tissue and it is segmented into two categories namely repair and regeneration.

Statistics:

The global soft tissue repair market is estimated to account for US$ 8,702.5 Mn in terms of value by the end of 2027.

Global Soft Tissue Repair Market: Drivers

High prevalence of obesity is expected to propel growth of the global soft tissue repair market over the forecast period. For instance, the study, ‘Rising incidence of obesity in Saudi residents. A threatening challenge for the surgeons’, published in the International Journal of Health Sciences, in January 2018, reported obesity in 42% of the study population with low physical activity levels and unhealthy dietary habits.

Moreover, increasing geriatric population is also expected to aid in growth of the global soft tissue repair market. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034.        

Statistics:

North America held dominant position in the global soft tissue repair market in 2019, accounting for 47.5% share in terms of value, followed by Europe and Asia Pacific, respectively.

Figure 1: Global Soft Tissue Repair Market Share (%) Value, By Region, 2019

Global Soft Tissue Repair Market: Restraints

Lack of acceptance for biological products and lack of appropriate knowledge regarding products among physicians and surgeons is expected to hinder growth of the global soft tissue repair market. Lack of appropriate knowledge regarding products among physicians and surgeons may lead to misuse and ineffectively use of products, resulting in unsatisfactory patient outcomes or patient injury.

Moreover, lack of R&D and regulatory constraints for biological mesh are also expected to hinder growth of the global soft tissue repair market. Stringent regulations for biological meshes (Allografts, Xenografts, and Alloplasts) due to regulatory hurdles on human tissue banks across few regions are observed as these biological meshes are originated from dermal tissue.

Soft Tissue Repair Market Report Coverage

Report Coverage	Details
Base Year:	2019	Market Size in 2019:	US$ 5,618.7 Mn
Historical Data for:	2016 to 2019	Forecast Period:	2020 to 2027
Forecast Period 2020 to 2027 CAGR:	5.6%	2027 Value Projection:	US$ 8,702.5 Mn
Geographies covered:	North America: U.S., Canada Latin America: Brazil, Argentina, Mexico, Rest of Latin America Europe: Germany, U.K., France, Spain, Italy, Russia, Rest of Europe Asia Pacific: China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific Middle East: GCC Countries, Israel, Rest of Middle East Africa: North Africa, Central Africa, South Africa
Segments covered:	By Product Type: Synthetic, Allograft, Xenograft, Alloplast. By Application: Breast Reconstruction, Hernia, Dermatology, Orthopedics, Dental, Vaginal Sling, Others. By End User: Hospitals, Ambulatory Surgical Centers, Clinics.
Companies covered:	B. Braun Melsungen AG, Baxter, BD, Johnson & Johnson Private Limited, Stryker Corp., Integra LifeSciences Corporation, Medtronic plc, Acera Surgical, Inc., Anthrex, Inc., Acelity L.P. Inc., Biorez, Aroa Biosurgery Limited, Misonix, Inc., and Ortho Regenerative Technologies Inc.
Growth Drivers:	Approval and launch of new products
Restraints & Challenges:	High Cost Stringent regulatory guidelines

Global Soft Tissue Repair Market: Opportunities 

Increasing number of emergency surgeries is expected to offer lucrative growth opportunities for players in the global soft tissue repair market. For instance, according to Australian Institute of Health and Welfare’s Hospitals at a glance 2017–18 report updated in August 2019, admissions for emergency surgery increased between 2016-2017 and 2017-2018 by 2.9% in public hospitals and by 5.1% in private hospitals in Australia.

Moreover, increasing investment in soft tissue repair is also expected to aid in growth of the market. For instance, in September 2020, Biorez, a tendon and ligament repair technology developer, raised US$ 3.5 million in a seed financing round.

Statistics:

The global soft tissue repair market was valued at US$ 5,618.7 in 2019 and is forecast to reach a value of US$ 8,702.5 Mn by 2027 at a CAGR of 5.6% between 2020 and 2027.

Figure 2: Global Soft Tissue Repair Market Value (US$ Mn), 2016 – 2027

Market Trends/Key Takeaways

High prevalence of diabetes is expected to propel growth of the global soft tissue repair market over the forecast period. For instance, according to the study, “Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition”, published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045.

Moreover, availability therapies for allograft rejection is also expected to aid in growth of the global soft tissue repair market. For instance, in June 2020,      TFF Pharmaceuticals, Inc. received the U.S. Food and Drug Administration’s orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection.

Regulations

U.S.

U.S. FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)

Tissue (“361 HCT/P”)

• 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
• LIGAMENTS
• TENDONS
• FASCIA
• CARTILAGE
• OCULAR TISSUES (CORNEAS & SCLERA)
• SKIN
• VASCULAR GRAFTS (VEINS & ARTERIES), except preserved umbilical cord veins
• PERICARDIUM
• 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
• SEMEN
• OOCYTES
• EMBRYOS

Figure 3: Value Chain Analysis

Global Soft Tissue Repair Market: Competitive Landscape

Major players operating in the global soft tissue repair market include, B. Braun Melsungen AG, Baxter, BD, Johnson & Johnson Private Limited, Stryker Corp., Integra LifeSciences Corporation, Medtronic plc, Acera Surgical, Inc., Anthrex, Inc., Acelity L.P. Inc., Biorez, Aroa Biosurgery Limited, Misonix, Inc., and Ortho Regenerative Technologies Inc.

Global Soft Tissue Repair Market: Key Developments

Major players in the global soft tissue repair market are focused on R&D of new products to expand their product portfolio. For instance, in December 2019, Misonix, Inc., a manufacturer of minimally invasive ultrasonic medical devices used for precise bone sculpting, removal of soft and hard tumors and tissue debridement, announced publication of two new large real-world studies proving the clinical effectiveness of its all human split thickness skin allograft TheraSkin for the treatment of complex wounds.

Major players in the market are also focused on R&D of new products to expand their product portfolio. For instance, in August 2020, Aroa Biosurgery Limited, a soft tissue regeneration company, announced that a study published in respected international peer-reviewed journal PLOS ONE described the ability of components found within the Endoform ECM platform technology, its flagship extracellular matrix (ECM), to signal stem cells in laboratory models.