Stromal Vascular Fraction Market

Stromal Vascular Fraction Market Outlook (2023-2033)

Global revenue from the market was about US$ 89.5 Million in 2022 with the worldwide market estimated to surge ahead at a CAGR of 3.9% to reach a valuation of around US$ 136.1 Million by the end of 2033.

According to Persistence Market Research, SVF isolation products segment of the market based on tests secured a market value of US$ 72.04 Million in 2022.

Sales Analysis of Market from 2012 to 2022 Vs Market Outlook for 2023 to 2033

The market value for stromal vascular fraction market was approximately 8.6% of the overall ~US$ 1035.1 Million of the global adipose-derived stem cell market in 2022.

The global market recorded a historic CAGR of 3.9% in the last 10 years from 2012 to 2022.

Stromal vascular fraction is similar to other skin-treatment techniques. Adipose tissue is isolated and used to execute the procedure while the patient is undergoing liposuction, lipo-aspiration and other procedures.

Numerous pre-clinical and clinical studies are carried out to determine the use of stromal vascular fraction in the treatment of rheumatoid arthritis, osteoarthritis, cartilage regeneration, and several soft tissue illnesses. Due to its anti-inflammatory, immune-modulating, and homeostatic capabilities, it is a potential tool in the market for orthopaedics, and is highly lucrative. This is expected to provide growth prospects for the market in upcoming years.

Soluble substances with multipotent differentiation properties and a heterogeneous cell population that includes endothelial cells, pericytes, mesenchymal stem cells, leukocytes, and red blood cells are sources of regenerative potential. In the field of orthopedics, SVF injections are a potential, minimally invasive non-surgical approach for the treatment of musculoskeletal diseases that will increase the market expansion in the forecasted period.

Rising demand for non-enzymatic isolation technique is an advantage to increasing the sales of the market. Cells from the adipose matrix are separated using physical forces in non-enzymatic separation techniques. There are alternatives to the safety risks offered by enzymatic treatments, including mechanical segregation options.

The use of non-enzymatic alternatives is growing for enhanced volume retention of fat grafts to address issues including high cost, lengthy procedure duration, and regulatory scrutiny.

Additionally, non-enzymatic separation technology is made more approachable in a clinical setting by technique simplification, increased uniformity, and the reduction of operator-dependent variability, which have a substantial positive impact on the sales of the market.

The global stromal vascular fraction market is thus likely to show high growth over the coming years with a CAGR of 3.9% and reach a global market size of around US$ 136.0 Million by 2033.

How Can Stromal Vascular Fraction Market Grow?

“Development of New Automated Point-of-care (POC) Devices”

Despite complex scientific and regulatory pathways, stem cell therapies have steadily progressed towards becoming a promising standard of care. However, in most healthcare facilities, the knowledge, infrastructure, and supplies needed for the practical method of SVF isolation are relatively rare. Several companies together with research laboratories are developing automated POC (Point of Care) devices to perform a part of or even the whole SVF isolation process, to fill this gap in the penetration of SVF procedures.

Some equipment made to enrich adipose tissue for autologous fat transplants in cosmetic surgery earlier, and it is latterly upgraded to separate cell fractions from adipose tissue.

These point-of-care devices eliminate the steps of transport, which is very hectic as the SVF sample has to be maintained at temperatures of -70 °C to -80 °C and has the shortest life span of 24 hours. New automated POC devices avoid many of the other limitations, such as processing, which takes it over the minimal manipulation threshold, and removes the process from costly cGMP-compliant processing facilities.

Penetration of POC devices is thus growing due to the elimination of these extra steps, which is expected to push market growth. Cost saving over traditional methods will increase the market expansion in the forecasted period.

For a variety of reasons, including cost-effectiveness, autologous adipose or fat grafting tissue-derived stem cell transplant is being used more frequently as an auxiliary approach in breast reconstruction. The lower cost is almost saving 70% per patient when using the latest automated SVF processing technique compared to the traditional techniques.

Considering the reoperation cost, automated SVF isolation techniques were found to be 75% cost-effective over the traditional methods Thus, the cost-effective nature of the technique is the prime factor driving the growth of the SVF market.

This will create opportunities for the expansion of the market size over the forecast period.

Are There Any Barriers That Can Affect the Growth of the Market in Any Way?

“Failure to Meet Regulatory and cGMP Requirements”

Previously many medical device companies were operating in the SVF market and were pushing their products beyond the regulatory boundaries because the enforcement of regulations in this market is remarkably slow. This has led to violation of regulations, which may create a wrong perception of adipose-derived stem cell therapies in patients, and patients may become reluctant to adopt these therapies.

For instance, there are many cell therapy devices being sold in the U.S. market, which are not approved by the U.S. FDA for commercial use. In January 2018, FDA issued a warning letter to American CryoStem Corporation for marketing its Atcell cell therapy product without approval.

Companies are exceeding the limit for minimal manipulation of autologous adipose tissue and structural tissue. As a result, the processing would not consider for minimal manipulation of structural tissue, including adipose tissue.

In August 2017, the Stem Cell Clinic of Sunrise received further notice of warning from the FDA for marketing stem cell products without receiving FDA approval and for significantly departing from the standards of the current good manufacturing practice.

Limited penetration due to the requirement for advanced infrastructure will hinder market expansion in the forecasted period. Despite huge therapeutic potential of SVF, there exist significant challenges to their implementation from labs to beds. Isolation of SVF requires specialized infrastructure such as a clean room facility, equipment, reagents technical capabilities and strict compliance to cGMP practices.

This limits the reach of SVF to only major or tertiary care hospitals, which are mostly located in tier 1 cities. Obtaining reimbursement for these device-based procedures is often very difficult, which further reduces market penetration. This all are factors responsible to reduce the, market expansion in forecasted period.

Country-wise Insights

Why is the U.S. Market Booming?

“Massive Pipeline of SVF-Derived Cell Therapies”

The U.S. accounted for around 93.9% market share in the North American market in 2022, and this is expected to continue throughout the forecast period.

The use of SVF treatments in regenerative medicine has enormous potential, and extensive clinical trials are being carried out in the U.S. to assess their efficacy for various purposes. These clinical trials use proprietary SVF isolation, aspiration and transfer devices and thus the growing number of active clinical trials fuels the demand for SVF products in the U.S. market.

The systems are installed at the site of clinical trials and thus as the number of clinical trials are increasing the install base of SVF isolation devices will increase and create more demand for consumables required in the processing of SVF samples in the U.S. According to these clinical trials, adipose-derived stem cell treatment for neurological and orthopedic conditions are the most promising.

Will the India be a Lucrative Market?

“Increase in Research and Development Activities in India”

The India held around 6.1% market share of the global market in 2022 and market value is US$ 5.46 Million in 2022.

This is due to the increase in research and development activities, for the development of innovative technologies, for SVF as an alternative option for better clinical solutions. This represented a continuous rise in demand for advanced technologies and the expansion of private hospitals in rural areas boosting the demand for the market in the Asian region representing an attractive market.

How is Germany Emerging as a Prominent Market?

“Increasing Awareness of Stem Cell Therapy”

Germany holds a market share of about 6.8% in the global market in 2022.

Musculoskeletal disorders in the country, like osteoarthritis are expected to drive demand, owed to the rising ageing population in Germany. Furthermore, awareness of stem cell therapy and demand for healthcare professionals, are all factors which are expected to contribute to Germany's dominance in the global market.

SVF injections are the alternative to surgery used in the field of orthopedics to treat musculoskeletal problems. The majority of German specialists expect a relaxation of legal constraints as well as open-mindedness to stem-cell research as well as therapy in this country.

Hence, the country's market growth will be further boosted over the forecast timeframe.

Category-wise Insights

Which Product is Driving Growth of the Global Market?

“Widely used in the isolation of SVF from lipoaspirate”

The SVF isolation products segment hold around 80.5% share of the total global market in 2022.

The extracellular matrix (ECM) and the binding of adipocytes and other cells are disrupted by the enzymatic technique, which is particularly indicated in SVF. Enzyme collagenase (Enzymatic Isolation Products) is used to break down the fatty portion of lipoaspirate, separating the contents into two different phases, and is the method most frequently used to isolate SVF from lipoaspirate. The majority of the methods use mechanical agitation to break down adipose tissue and release stromal cells.

Automated point-of-care devices perform an aspiration, SVF isolation, filtration and concentration in a single device and provide product for final use within a few hours.

Which Application is Driving Growth of the Global Market?

“Highly used in chronic skin wounds and cosmetic breast augmentation”

The soft tissue applications segment hold around 42.8% share of the global market in 2022.

Soft tissue applications of stromal vascular fraction include post-mastectomy breast reconstruction, cosmetic breast augmentation, sports injuries, burn and trauma injuries, scleroderma, diabetic foot ulcer, etc. Post-mastectomy breast reconstruction constitutes a considerably higher proportion in all the applications of the stromal vascular fraction. Using a fat grafting technique, dermal replacement scaffolds, and platelet-rich plasma to treat soft tissue defects and chronic wounds.

Which End User Poses a Greater Adoption of Viral Vectors?

“Major use in hospitals”

Hospitals hold the largest share of about 43.1% with a market value of around US$ 38.58 Million in 2022. In terms of end users, the significant number of stromal vascular fraction easily available in hospitals gains the largest proportion. As healthcare workers are more demanding and have professional training, people tend to prefer hospitals for therapy.

The stromal vascular fraction of adipose-derived tissue, or SVF, is a sort of stem cell therapy that targets the root cause of inflammatory disorders rather than primarily the symptom. Such treatments are usually carried out in hospitals under the supervision of qualified medical professionals to prevent infection and other side effects. Hospitals are becoming more popular among patients due to their close proximity to residential areas and the availability of doctors.

As a result, hospitals has taken the lead among end users in terms of market share.

Competitive Landscape

Major market players concentrate on product launches, strategic alliances, mergers, and acquisitions to have a stronger position in the market. In addition to this, one of the main strategies employed by the manufacturers is growth, or the opening of new facilities in order to increase the company's capacity for the production of new advanced product.

For instance:

• On 29 November 2022, Hairline International added the stromal vascular fraction (SVF) procedure to their extensive list of skin and hair treatments.
• On 10 June 2021, Orgenesis Inc. announced that registration has started for a clinical trial at the hospital for special surgery using the Tissue Genesis Icellator. Injecting vascular fraction cells (SVF) and autologous stromal after surgical rotator cuff repair will be evaluated for safety and effectiveness in the phase 2, randomised, placebo-controlled experiment.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies manufacturing stromal vascular fraction, which are available in the full report.

Stromal Vascular Fraction Market Scope

Key Segments Covered in Manufacturing of Industry Research

Product:

• SVF Aspiration Products
• SVF Transfer Products
• SVF Isolation Products
  • Enzymatic Isolation Products
  • Non-enzymatic Isolation Products
  • Automated POC Devices

Application:

• Cosmetic Applications
• Orthopedic Applications
• Soft Tissue Applications
• Others

End User:

• Hospitals
• Specialty Clinics
• Stem Cell Banks/Laboratories
• Others

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• The Middle East & Africa (MEA)

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