세계의 양막 - 시장 점유율 분석, 산업 동향 및 통계, 성장 예측(2024-2029년)

The amniotic membrane market is expected to register a CAGR of 11.1% over the forecast period.

Key Highlights

• The outbreak of the COVID-19 pandemic impacted the amniotic membrane market initially. Most elective surgeries were suspended globally to mitigate the spread of COVID-19 infection. Due to delayed surgeries and the closure of elective procedures, most of the end-users witnessed the expiry of their stock of amniotic membranes coinciding with the COVID-19 outbreak, which adversely impacted the market. However, the growth of the market studied was balanced by the increasing need for surgeries and ophthalmic procedures accompanied by increased childbirth globally.
• An article, 'Amniotic membrane harvesting during COVID-19 pandemic,' published in March 2021, suggested that whether amniotic membranes from infected donors carry COVID-19 is unknown, and the probability of vertical transmission is low risk and not definite. Hence, followed by several research studies, the usage of amniotic membranes significantly increased in ophthalmic centers. Thus, the COVID-19 pandemic is anticipated to have a positive impact on the market studied.
• Factors such as a rise in the number of accident and trauma cases, increasing awareness about the benefits offered by an amniotic membrane, and rising research on stem cell biology and regenerative medicine are the major driving factors for the studied market growth. Additionally, the growing number of surgeries performed and rising expenditure on research and development (R&D) in the field of stem cells and regenerative medicine are also some of the key factors driving the overall market.
• For instance, as per the data published by the United States Department of Labor in December 2022, over 5,190 fatal work injuries were reported in the United States in 2021, which increased from 4,764 cases compared to 2020. Burn injuries represent a significant disease burden on the world population, with nearly 9 million injuries and an estimated 120,000-180,000 deaths annually, as mentioned in the research paper 'Burn injury prevention in low- and middle- income countries (LMICs): scoping systematic review' published in October 2021. According to the above-mentioned research, almost 18 million disability-adjusted life years (DALYs) can be accounted for burns, with a disproportionate 90% of this burden which is borne by LMICs. Also, in Bangladesh, Colombia, Egypt, and Pakistan, burn injuries account for up to 18% of permanent disabilities, as per the same research above. The amniotic membrane is commonly used to treat up to second-degree burn wounds. Thus, the rising burden of burn injuries globally is expected to create a high demand for the amniotic membrane for the purpose of tissue repair and regeneration, and it is expected to boost the market growth over the forecast period.
• The market studied consists of several major players, and their strategic product innovation is garnering market growth. For instance, in August 2021, Vivex Biologics, Inc., a leading regenerative medicine company, launched Cygnus Matrix Disks, which is the latest configuration from the Cygnus family of amniotic tissue allografts. Thus, the continuous innovation in the amniotic membrane segment is expected to drive the overall growth of the market studied.
• Therefore, owing to the aforementioned factors, it is anticipated that the studied market will witness growth over the analysis period. However, the lack of standardized guidelines and skilled professionals will likely impede market growth.

Amniotic Membrane Market Trends

Surgical Wounds Segment is Expected to Grow Significantly Over the Forecast Period

• Amniotic membrane has several antimicrobial and biological properties in corneal surgery, as it enhances epithelialization, reinforces adhesion of basal epithelial cells, maintains epithelial phenotype, and modulates the proliferation of normal corneal, conjunctival, and limbal fibroblast. These membranes also prevent apoptosis as well as inhibit scarring, inflammation, and neovascularization. Several research studies have underlined the diverse applications of amniotic membranes for the surgical treatment of various wounds. For instance, a study published in the journal Membrane in June 2021 highlighted the vast potential of the human amniotic membrane in tissue engineering and tissue regeneration and has shown desirable results in vascular, bone repair, cartilage repair, and oral surgery.
• Furthermore, the key developments by the market players are expected to boost the growth of the segment. For instance, in October 2022, the hydrated human amnion membrane allograft product by BioLab Sciences, Membrane Wrap - Hydro, was recognized by the United States Food and Drug Administration (US FDA) Tissue Reference Group (TRG) as a human cell, tissue/ cellular/tissue-based product (HCT/P). The product is indicated for the management of surgical wounds and other wounds. Such recognition by the USFDA would enable the product to be easily reimbursed by the insurance bodies, which would make the product very affordable and in high demand.
• In September 2022, MiMedx Group, Inc. launched its Amnioeffect, a tri-layer Purion processed human tissue allograft, which consists of the chorion, amnion, and intermediate membrane layers of the placenta. The products offer suitable healing of the surgical wound. The company stated that the product launch would expand its surgical recovery product portfolio. Such developments would create more opportunities for the amniotic membrane to be used in the management of surgical wounds, which would be able to meet the high demand for surgical wound healing.
• Therefore, owing to the factors stated above, the surgical wounds segment is growing, and it is expected to have significant growth over the forecast period. Hence driving the growth of the studied market.

North America is Expected to Grow Significantly Over the Forecast Period

• North America is the largest regional market in terms of revenue, owing to high healthcare expenditure, highly developed healthcare infrastructure, and the recent developments by the market players. For instance, according to the data published by the United States Centers for Medicare & Medicaid Services in February 2023, the national healthcare expenditure has increased by 2.7% to USD 4.3 trillion in 2021 compared to 2020.
• The same source also stated that Medicare and Medicaid expenditures increased by 8.4% to USD 900.8 billion in 2021 and 9.2% to USD 734.0 billion, respectively, in 2021 as compared to 2020. The increase in reimbursement of medical products will make medical care products more affordable, and it will enable more patients to adopt medical care, including amniotic membrane products, which will boost the market growth in the region.
• Furthermore, the key developments by market players are anticipated to boost market growth in the North American region. For instance, in March 2021, TissueTech received clearance from the Food and Drug Administration (FDA) to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01.
• Again, in May 2021, Vivex Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced treatments, launched Viagenex, which is a family of amniotic allografts are processed to retain the inherent mechanical properties of amniotic tissue and rich supply of extracellular matrix, growth factors, and cytokines. Thus, the rigorous product development in countries across North America is expected to boost the amniotic membrane market growth in the region.
• Therefore, owing to the aforementioned factors, the growth of the studied market is anticipated in the North America Region.

Amniotic Membrane Industry Overview

The amniotic membrane market is moderately competitive in nature due to the presence of a few companies operating globally as well as regionally. The competitive landscape includes an analysis of some international as well as local companies that hold market shares and are well known, including Human Regenerative Technologies, LLC, Katena Products. Inc., Mimdex, Amnio Technology, LLC, TissueTech, Inc. (BioTissue). Integra LifeSciences Corporation, Skye Biologics Inc., Amniox Medical Inc., Laboratoire CCD, Vivex Biologics, Inc., Merakris Therapeutics, and Akorn Operating Company LLC, among others.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rise in the Number of Accident and Trauma Cases
  • 4.2.2 Increasing Awareness about the Benefits Offered by Amniotic Membrane
  • 4.2.3 Rising Research on Stem Cell Biology and Regenerative Medicine
• 4.3 Market Restraints
  • 4.3.1 Lack of Standardized Guidelines and Skilled Professionals
• 4.4 Porter's Five Forces Analysis
  • 4.4.1 Threat of New Entrants
  • 4.4.2 Bargaining Power of Buyers/Consumers
  • 4.4.3 Bargaining Power of Suppliers
  • 4.4.4 Threat of Substitute Products
  • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD million)

• 5.1 By Enzyme
  • 5.1.1 Cryopreserved Amniotic Membrane
  • 5.1.2 Dehydrated Amniotic Membrane
• 5.2 By Application
  • 5.2.1 Ophthalmology
  • 5.2.2 Surgical Wounds
  • 5.2.3 Other Applications
• 5.3 By End-User
  • 5.3.1 Hospitals
  • 5.3.2 Ambulatory Surgical Centers
  • 5.3.3 Other End-Users
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Amnio Technology, LLC
  • 6.1.2 TissueTech, Inc. (BioTissue)
  • 6.1.3 Human Regenerative Technologies, LLC
  • 6.1.4 Katena Products. Inc.
  • 6.1.5 MIMEDX
  • 6.1.6 Integra LifeSciences Corporation
  • 6.1.7 Skye Biologics Inc.
  • 6.1.8 Amniox Medical Inc.
  • 6.1.9 Laboratoire CCD
  • 6.1.10 VIVEX Biologics, Inc.
  • 6.1.11 Merakris Therapeutics
  • 6.1.12 Thea Pharma

7 MARKET OPPORTUNITIES AND FUTURE TRENDS