Soft Tissue Repair Market Size to Hit USD 21.2 Billion by 2030

According to Nova one advisor, the global Soft Tissue Repair market was valued at USD 10.7 billion in 2022 and it is expected to hit around USD 21.2 billion by 2030 with a CAGR of 7.7% during the forecast period 2022 to 2030.

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Growth in this market is mainly driven by the growing incidence of sports injuries, increasing aging population and obesity rate, strong focus on R&D leading to the launch of technologically advanced products, etc. But uncomplimentary reimbursement scenario of soft tissue repair products are the key factors restraining the growth of the market. In this report, the market is segmented on the basis of product, end user, application, and region.

Report Scope of the Soft Tissue Repair Market

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Impact of Covid-19 on soft tissue repair market

To assess the impact of COVID-19 and provide market forecasts, scenario-based approaches are considered.

Due to the COVID-19 outbreak, we estimate that a major share of the medical device industry, including imaging devices, dental care devices, and surgical products, among other products, which contribute 60– 75% of the overall medical devices market, witnessed a stagnant growth rate/significant reduction in the growth rate in 2020 and the first half of 2021. A new USD 5–7 billion market opportunity (by the second half of 2021) is opening up in the medical device industry, including for critical care medical devices.

Owing to the growing incidence of COVID-19, hospitals became high-risk zones, specifically for patients suffering from chronic conditions. As a result, non-critical procedures such as elective surgeries were either canceled or postponed during the first and second quarters of 2020, which resulted in a significant decline in the total number of elective surgical procedures performed. As a result, the demand for soft tissue repair products witnessed a sharp decline in 2020. The second wave of COVID-19 further deprioritized elective surgical procedures. Governments across the globe have also issued limitations and bans on medical procedures and elective surgeries.

With the current pandemic scenario, surgical procedures have witnessed a decline and are only expected to increase in the third quarter of 2021 in countries such as the US. Some countries in the EU have resumed surgical interventions, which has increased the demand for soft tissue products in the region.

Smith & Nephew reported a decline of ~13.1% in the net sales of its Sports Medicine segment (that offers products for soft tissue repair) in FY 2020 (compared to FY 2019). Similarly, Johnson & Johnson reported a decline of ~13.4% in its revenue growth in the surgery segment in FY 2020.

The following factors are playing a key role in shaping the growth of the global market:

• The outbreak of COVID-19 increased at an exponential level in the US in the first half of 2020. This led to a decline in regular patient visits to hospitals and clinics and also led to a decline in the number of elective surgeries being conducted per week. However, as of June 10, 2021, the lockdowns have been lifted in the US as well as several countries globally, which is expected to contribute to the slow recovery of the market. Additionally, as soon as hospitals reprioritize elective surgeries, market growth would resume in several countries.
• Due to the rapid spread of COVID-19, medical supplies experienced a risk of supply shortage due to the temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipments in countries like India. However, owing to the increasing vaccination drives and growing control over the spread of the COVID-19 pandemic, the market is expected to normalize during the forecast period.

Soft Tissue Repair Market Dynamics:

Drivers: Increasing aging population and obesity rate

Age-related physiological changes and metabolic inefficiencies often result in chronic diseases such as cystic fibrosis, hepatitis, cardiovascular disorders, and cancer. The elderly are more susceptible to various soft tissue injuries. For example, according to a register study from the United Kingdom, the prevalence of hernia increased with age from 5% in the age group 25 to 34 years, through 10% in the age group 35 to 44 years, 18% in the age group 45 to 54 years, 24% in the age group 55 to 64 years, 31% in the age group 65 to 74 years, and 45% among men aged 75 years and over. According to an article published in Advances in Orthopedic Surgery journal, more than 40% of the population aged 60 years and above suffers from a rotator cuff tear.

Globally, there were 900 million persons aged 65 years or over in 2020. Since women live longer than men, on average, they comprise the majority of older persons, especially at advanced ages. Over the next three decades, the number of older persons worldwide is projected to more than double, reaching over 2 billion in 2050. All regions will see an increase in the size of the older population between 2020 and 2050. Globally, the share of the population aged 65 years or over is expected to increase from 9.3 per cent in 2020 to around 16.0 percent in 2050.

As per FDA, more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias. Similar trends are observed in other developed and developing countries as well. Thus, the increasing aging population, coupled with rising disposable income and greater per capita healthcare expenditure, is expected to drive the demand for soft tissue repair surgeries in the forecast period of 2022 to 2025.

Growing incidence of sports injuries

Globally, there is increasing awareness about the benefits of sports and physical activities on health. This has increased the popularity of sports among the youth. Owing to this, the number of people participating in various sports has also increased significantly over the years. For instance, according to national basketball league of US, In 2020, the number of participants (aged six years and older) in basketball amounted to approximately 24.23 million.

These sports are also becoming popular in Asian countries such as China, Korea, India, and the Eastern Bloc countries. According to the annual High School Athletics Participation Survey conducted by the National Federation of State High School Associations (NFHS), the number of participants in high school sports increased for the 25th consecutive year in 2020–2021.

Research by Sports Medicine Research Institute shows a significant rise of soft tissue injuries in a younger generation involved in athletic activities. Sports and many recreational activities for children can lead to a number of accidents and soft tissue injuries as well as hard tissue injuries such as fractures. With the increasing sports participation across the globe, the number of sports-related soft tissue injuries is estimated to increase, which will drive the soft tissue repair market.

According to the American Academy of Orthopaedic Surgeons (AAOS), an estimated 200,000 anterior cruciate ligament (ACL) injuries are reported annually in the U.S., with around 100,000 ACL reconstructions performed each year. According to papers published by the IEEE Journal of Biomedical and Health Informatics, the number of Americans suffering from ACL injury disease and knee joint osteoarthritis is estimated to cross 60 million by 2025. This significant increase in soft tissue injury is expected to drive the market of soft tissue repair in the next decade.

Strong focus on R&D leading to the launch of technologically advanced products

The biosurgery market is witnessing a significant rise in the launch of new and advanced products, globally. Vendors across the globe are relying on organic growth strategies to efficiently address end-user requirements and demands. As a result, a significant share of their capital investments is being diverted to R&D. This is an important trend in this market as new products with high efficacy and success rates gain rapid adoption among end users. As a result, product launches and innovations in products have become key strategies to gain a competitive edge in this market.

Over the last few decades, a continuous rise in R&D investments has been observed specifically among the established players. This has led to the development of soft tissue repair products for various applications. In FY 2020, Smith & Nephew invested ~USD 492 million in R&D, an increase of 15.3% in comparison to FY 2019. Similarly, Baxter International invested ~USD 521 million in R&D.

Regulatory bodies in several countries have approved various products, such as grafts and adhesion barriers, for use in a number of medical applications. A rising number of products are also getting approved for additional indications, which is increasing the application/use of these products and also helping companies to enter into additional markets through their existing products.

Some of the recent approvals for biosurgery products are mentioned below:

• In February 2020, Baxter announced FDA 510(k) clearance for its Peri-Strips Dry with Veritas Collagen Matrix product with Secure Grip. The product is a staple line reinforcement agent and is indicated for mitigating bleeding during bariatric surgeries and other surgical procedures.
• In February 2020, Integra LifeSciences Holdings Corp. launched the AmnioExcel Plus Placental Allograft Membrane for use in soft-tissue repair.
• In October 2020, Orthofix Medical Inc. (US) announced the launch of the O-GENESIS Graft Delivery System and AlloQuent Structural Allograft Q-Pack, which are ready-to-use cervical and lumbar spacers for allograft procedures.

In September 2019, Medtronic launched several new procedural solutions, including Fibercel Viable Bone Matrix, to reinforce its product portfolio for spine surgeries.

Increasing volume of surgeries and growing prevalence of severe trauma injuries

Over the years, there has been a significant rise in the number of surgical procedures across the globe. According to WHO estimations (2019), approximately 235 million major surgical procedures are undertaken worldwide every year. This is attributed to the growing prevalence of obesity and other lifestyle diseases, rising geriatric population, increasing prevalence of orthopedic conditions, and the increasing incidence of spinal injuries and sports-related injuries.

According to the Heart and Circulatory Disease Statistics 2019 from the British Heart Foundation (UK), there has been a significant increase in the number of cardiac surgical procedures such as angioplasty and aortic valve replacement in the UK over the last decade, and this trend is expected to continue in the coming years.

Soft tissue repair products are finding substantial application in severe trauma injuries, including traumatic brain injuries (TBIs), spinal cord injuries, spine fractures, collapsed lungs, and subarachnoid hemorrhage. According to the Centers for Disease Control and Prevention (CDC), in 2019, TBIs accounted for about 61,000 injury-related deaths in the US, which is about ~166 deaths due to TBIs every day. The growing prevalence of trauma injuries such as TBIs and injuries caused due to falls and accidents is expected to increase the number of trauma surgeries performed across the globe. This is a key indicator of market growth during the forecast period.

Soft tissue repair products such as tissue and grafts, and suture anchors play a key role in cosmetic surgeries and reconstructive plastic surgeries. The American Society of Plastic Surgeons (ASPS) released its annual plastic surgery procedural statistics, reporting that 1.8 million surgical cosmetic procedures and 15.9 million minimally invasive cosmetic procedures were performed in the US in 2020; this represented an increase of 2% and 1% over the procedures conducted in 2017, respectively. In addition, 5.8 million reconstructive procedures were performed in the US during the same period.

Accident and trauma cases and sports injuries are among the major factors increasing the volume of surgeries performed across the globe. According to the WHO global status report (2020), there is a growth in the global number of accidents and trauma cases. About 1.35 million people die each year due to accidents, and about 20 to 50 million sustain non-fatal injuries due to road crashes.

Hands, upper extremities, and legs are the most vulnerable body parts to sports injuries. According to the facts and statistics for sports injuries provided by the National Safety Council (NSC, US), in 2020, the incidence of sports injuries across sports activities such as martial arts, boxing, and skateboarding increased by 3.7% from 2007 to 2020 in the US. The rising incidence of sports injuries is increasing the number of orthopedic and reconstructive surgeries performed across the globe. This is expected to drive the growth of dependent markets, including the markets for Tissue Patch/Mesh.

Restraints: Unfavorable reimbursement scenario

The unfavorable reimbursement scenario in most countries across the globe is a major factor restricting the growth of the soft tissue repair market. According to the Centers for Medicare & Medicaid Services (CMS), there have been a number of changes in payment policies and rates for physicians and non-physician practitioners with regard to services paid under the Medicare Physician Fee Schedule in 2020. CMS has issued a five-year review of work relative value units (RVUs) with orthopedic procedures. The total RVU includes the following three components—the work RVU, which captures the time and effort required by the physician to perform the procedure; the practice expense RVU, which captures the cost in terms of staff labor, equipment, supplies, and rent; and the malpractice RVU, which captures a portion of the malpractice cost.

As a result of the CMS review, the overall procedural reimbursements from Medicare have decreased. In 2019, RVUs for orthopedic surgery decreased by about 1%. Any further decrease in Medicare reimbursements is expected to have a negative impact on the growth of the soft tissue repair market in the coming years.

In addition to this, From 2011 to 2021, the national inflation rate was 16.3%. Unadjusted reimbursement rates for open and laparoscopic inguinal hernia repairs increased by 6.5% and 7.2%, respectively. There was an increase in unadjusted reimbursement for open appendectomies of 5.1% and 6.1% for laparoscopic. Unadjusted reimbursement for open cholecystectomies increased by 4.4%, butdecreasedby 6.8% for laparoscopic. When adjusted to 2021 values, reimbursement for all six operations decreased. Laparoscopic and open cholecystectomies experienced the largest decreases (19.8%, 10.2%).

High price of soft tissue repair products and the rising cost of surgical procedures

The high cost, coupled with the unfavorable reimbursement scenario for these products in several countries, makes them unaffordable for a large section of the target patient population. Currently, the soft tissue market is extremely competitive in terms of pricing, owing to the high competitive intensity among existing players. Most of the products available in this market are priced at a premium. To reduce the growing healthcare costs, governments in several countries across the globe have undertaken efforts to redesign their respective healthcare reimbursement systems. For instance, the US government has planned to reduce Medicare spending by USD 716 billion from 2012 to 2022. This is being achieved by bringing about a 2% cut in the Critical Access Hospitals (CAH) Medicare payments. The reduction in such expenditure has negatively affected the overall quality of healthcare provided to patients. In addition, in 2018, the CMS cut payments by 0.4% (USD 80 million) for home healthcare agencies over the 2017 budget.

Due to the high cost further restricting the adoption of many soft tissue repair products. Also, the these products currently available in the market are made of complicated reconstitutes with a poor shelf life. Hence, there is a growing need for low-priced products that are easy to handle and have a better shelf life.

Opportunitie: Increasing adoption of soft tissue repair products in emerging markets

The penetration of soft tissue repair products is increasing across emerging countries based in the Asia Pacific, Latin America, and the Middle East and Africa. In the coming years, countries such as China, India, and Brazil are expected to offer significant growth opportunities for players operating in the soft tissue repair market. This is because the markets in these countries are characterized by a large patient base for target indications (such as cardiovascular, orthopedic, general/abdominal, and gynecological disorders), rising health awareness, growing healthcare expenditure, rising medical tourism, and rapidly developing healthcare infrastructure. For instance, cardiovascular diseases are currently the leading cause of mortality in India. In 2020, about 25% of deaths in India were caused due to heart diseases and stroke, responsible for about 80% of the healthcare burden.

Over the last few decades, countries such as India and Malaysia have emerged as hubs for medical tourism. This is because the cost of medical procedures across these emerging countries is significantly less in comparison to developed countries such as the US, Germany, France, and the UK. Also, the presence of skilled surgeons and the availability of well-equipped surgical care facilities across private hospital chains are driving the number of medical tourists traveling to these countries for treatment.

Government agencies in several Asia Pacific countries are undertaking initiatives to support their respective healthcare systems. Owing to the healthcare reforms in China and the 13th Five-year plan, about 1.35 billion people participated in the basic medical insurance program, and about 95% of Chinese citizens were insured. Similarly, according to 2020 statistics from the World Bank, healthcare spending in Latin America increased to about 7.93% of total GDP in 2019 from about 6.53% of total GDP in 2002. Such developments have further opened up the soft tissue repair market across emerging countries. As a result, a number of players operating in the global market are focusing on capturing a greater share in emerging markets. With the growing market potential in the APAC region, many leading players in the biosurgery market are making significant investments in emerging APAC countries.

Similarly, countries such as Saudi Arabia and the UAE are focusing on building healthcare facilities for primary care, secondary hospital segment, and preventive and diagnostic care for their population. Authorities in the UAE are also undertaking initiatives to convert the country into a medical tourism hub. This is expected to create various growth opportunities for stakeholders operating in the healthcare market in the Middle East.

Rising use of grouping materials for enhancing product efficacy

The performance of soft tissue repair products significantly depends on the type of biologics and materials used in their manufacturing. The use of new materials and agents is helping vendors to overcome the limitations (related to biocompatibility, infection, and inflammation) with conventional products and to launch products that outperform popular products in terms of biological response and effectiveness.

Several vendors are using the combination approach, which makes use of the best traits of two different materials in an attempt to provide improved care. For instance, many vendors are offering polyester- and polytetrafluoroethylene-based combined meshes for use in hernia repair procedures. With the increasing success rate of combination materials and the benefits offered by the unique combination of materials, several companies are focusing on the development and launch of these products. For instance, the Fibrin-PTH (KUR-113) product candidate is about to enter Phase 2a clinical trials in the US. The product is a drug-biologic combination for use in spinal interbody fusion.

Such novel approaches with material use have helped vendors to improve product performance and reduce the duration of patient stay across healthcare settings (after surgical procedures). As a result, soft tissue products made using combined biocompatible materials are gaining rapid adoption, thereby providing lucrative growth opportunities to market players.

Challenges: Stringent regulatory framework

The development of new soft tissue repair products requires significant investments, and new products generally take more than 7–8 years for gaining marketing approval. For instance, in the US, the FDA has made it mandatory for soft tissue repair product manufacturers to obtain Premarket Approval (PMA) for their products before they are introduced in the market. For this, the product has to demonstrate proper clinical trial data, which has to be submitted along with the application for PMA. The cost and time required for a product to enter the clinical trial step and then clear the clinical trials are very high, with minimum chances of the product gaining approval. Also, the possibility of obtaining clinically significant data showing clinical trial clearance has been low for soft tissue repair products such as adhesion barriers, semi-synthetic sealants, and hemostatic agents. Soft tissue repair products are considered Class III products, owing to which these products require strict adherence to regulatory guidelines. Hence, despite huge investments in R&D, the risk of failure is very high in the case of soft tissue repair products. This is a major factor limiting the development of novel soft tissue repair products in the market.

In the US, For specific applications such as in ophthalmology, urology, and neurology, approval requires preclinical and clinical data demonstrating safety and efficacy during surgical use. Thus, stringent regulations, requirement of significant investments for clinical studies, and uncertainty of approval during studies make the development and commercialization of soft tissue products a challenging task for vendors.

Requirement of skilled personnel for the effective use of soft tissue repair products

Conventional products used in wound closure, such as sutures and staples, are increasingly being replaced by advanced biosurgery products. Though these products offer improved outcomes, they need skilled surgeons and physicians for their effective utilization. As the use of soft tissue repair products has different effects and contradictions, the application of these products is very complex. For instance, the improper application of these products can lead to complications such as anastomotic leaks in patients.

Currently, the lack of skilled surgeons, both in developed and developing economies, is one of the major factors limiting the adoption of these products. For instance, the Association of American Medical Colleges (AAMC) projects a shortage of about 122,000 physicians by 2032 in the US. Of these, a shortage of 67,000 specialists and 23,000 surgeons is expected to occur by 2032. Similarly, the Health Resource and Services Administration (HRSA) projects a shortage of 5,080 orthopedic surgeons in the US by 2025.

The technology landscape and application areas of soft tissue repair products are changing rapidly, owing to technological advancements in this field. This necessitates physicians and other healthcare providers to acquire the necessary skills to apply advanced soft tissue repair products such as allograft, Xenograft, and Synthetic Mesh. Therefore, surgeons and physicians in hospitals and clinics are reluctant to use advanced surgical products for wound closure.

Market Overview- Executive summery

In this report, the soft tissue repair market is segmented on the basis of product, application, end user, and region.

“Tissue Patched/Mashes accounted for the largest share in the soft tissue repair market by product type”

Based on product, market is segmented into tissue patch/mash and laproscopic intrument injectors. In 2021, Tissue Patch/Mesh accounted for the larger share of 91.9% of the market. This product segment is projected to reach USD 15,892.3 million by 2027 from 12,547.2 million in 2022, at a CAGR of 4.8% during the forecast period. The large share of this segment is attributed to the increasing use of synthetic Mesh across different types of orthopedic surgeries as they reduce surgical time.

“Hernia Repair accounted for the largest share in the soft tissue repair market by Application”

Based on application type, the market is segmented into Hernia Repair, Dural Repair, Vaginal Sling Procedures, Skin Repair, Orthopedic repair, Dental repair, Breast Reconstruction Repair, and other applications. In 2021, the hernia repair is estimated to account for the largest share of 26.5% of the market, by application. The increasing incidence of hernia cases, sports injuries and the growing prevalence of lifestyle disorders, such as arthritis, osteoporosis, and obesity (leading to orthopedic problems), are some of the major factors responsible for the growth in the number of soft tissue repair surgeries performed globally.

“Hospital segment accounted for the largest share in the soft tissue repair market by End User”

Based on end users, the market is segmented into hospitals, clinics, and other end users (ambulatory surgery centers, emergency care centers, burn care centers, and research institutes). The hospitals segment accounted for the largest share of 93.3% of the market in 2021. This is primarily attributed to the increasing number of surgeries taking place across the globe due to the rising geriatric population and the incidence of various diseases. Moreover, the increasing need to control blood loss and achieve efficient hemostasis and wound closure in trauma cases, injuries, or surgical procedures is leading to the increasing adoption of soft tissue repair products by surgeons.

“North America segment accounted for the largest share in the soft tissue repair market by Region”

On the basis of region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2021, North America accounted for the largest share of 43.5% of the market, followed by Europe, the Asia Pacific, Latin America, and the Middle East & Africa. The large share of the North American market is attributed to the presence of an advanced healthcare system in the region, high and growing number of surgical procedures, higher adoption of advanced products, and the presence of several leading market players in the US.

Some of the prominent players in the Soft Tissue Repair Market include: Becton, Dickinson and Company (US), Smith & Nephew Plc. (UK), Stryker Corporation (US), Arthrex, Inc. (US), Johnson & Johnson (US), Medtronic Plc. (IE), LifeNet Health, Inc.(US), Zimmer Biomet (US), CryoLife, Inc. (US), Organogenesis Inc. (US), Baxter International, Inc. (US), ACell Inc. (US), Tissue Regenix Group Plc (UK) and Aroa Biosurgery Ltd. (NZ). These players have adopted various growth strategies such as acquisition, product launches, and expansion to increase their presence and reach in the soft tissue repair market.

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Soft Tissue Repair market

by Product

• Tissue Patch/Mesh
  • Synthetic Mesh
  • Biological Mesh
    • Allograft
    • Xenograft
  • Fixation Products
    • Suture Anchors
    • Interference Screws
    • Other Fixation Devices
  • Laparoscopic Instruments

By Application

• Hernia Repair
• Dural Repair
• Vaginal Sling Procedures
• Skin Repair
• Orthopedic
• Dental
• Breast Reconstruction Repair
• Other applications

By End user

• Hospitals
• Clinics
• Other end users

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Soft Tissue Repair industry analysis from 2022 to 2030 to identify the prevailing Soft Tissue Repair industry opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter’s five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the global Soft Tissue Repair industry segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as global Soft Tissue Repair industry trends, key players, market segments, application areas, and market growth strategies.

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