REPORT HIGHLIGHTS

• The total U.S. market for wound care products in 2000 exceeded $2.1 billion. Growing at an average annual rate (AAGR) of 10.1%, this market is forecast to exceed $3.4 billion in 2005.
• The market share for wound closing technologies will rise from 58.7% to over 63% in 2005, as this segment rises at an AAGR of 11.7%.
• At 34%, synthetic dressings represent the second largest market segment, but, growing at an AAGR of 7.1%, will drop to 30% in 2005.
• Biological and biosynthetic dressings will feature the fastest growth, rising at an AAGR of 14.2% during the period.

REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

The market for advanced wound care products has been rapidly evolving over the past 25 years and has recently entered a new phase with the introduction of several sophisticated products based on biotechnology and biomaterials science. Some of the new entrants projected to become dominant in the coming years were technically not feasible until recently. These novel products and technologies have made it through the regulatory hurdles and now face the daunting task of changing traditional wound care practices. Although traditional practices continue to dominate many sectors of wound care, advanced wound dressings and related technologies offer impressive, often lifesaving, advancements being increasingly accepted by both the hospital and alternative care markets. Growth is coming largely at the expense of traditional gauze and impregnated gauze dressings which still hold a majority share of the market.

Our report analyzes the current market for wound care products and focuses on emerging products and technologies. Markets are divided into hospital and alternative care sectors. The alternate care sector includes all medically supervised care of wounds in non-hospital settings. Both markets are huge consumers of wound care products and the newer dressings and technologies are gaining broad acceptance within each sector.

This report describes the types of wound care products and technologies being used in the year 2000 as well as those poised to become major market factors by the turn of the decade. Discussion of wound care products is divided into the following product and technology sections:

• Alginate dressings
• Composite dressings
• Contact layer dressings
• Foam dressings
• Gauze dressings (non-impregnated)
• Gauze dressings (impregnated)
• Hydrocolloid dressings
• Hydrogel dressings
• Specialty absorptive dressings
• Transparent film dressings
• Allografts, heterografts, and tissue culture products
• Artificial skin
• Enzymatic debriding agents
• Wound cleansers
• Skin sealants, protectants, and moisturizers

o   Electrical stimulation

o   Hyperbaric oxygen

o   Autologous growth factors.

o   Tissue growth factors

o   Miscellaneous emerging products.

• Available novel products and technologies
• Emerging novel products and technologies
• Synthetic Dressings
• Biological and Biosynthetic Dressings
• Topical Adjuvants
• Novel Products and Technologies

The plethora of synthetic dressings on the market makes organization of this section difficult. In the interest of following already established systems, we use a categorization system developed by the Durable Medical Equipment Regional Coordinators (DEMERC). DEMERC was established in October 1993 to streamline the Medicare Part B claims procedures. An overview of DEMERC is included in the Regulatory Issues chapter of this report.

The above listing of synthetic dressing categories includes some minor deviations from the DEMERC system. DEMERC has a category for wound fillers not otherwise listed and a category for miscellaneous surgical supplies. We have deleted these categories and created a section, Biological and Biosynthetic Dressings, that includes most of the dressings listed by DEMERC under the deleted DEMERC categories.

Under the Topical Adjuvant section, skin sealants, protectants, and moisturizers are reimbursed by DEMERC, but wound cleansers and enzymatic debriding agents are not. Enzymatic debriding agents are classified as drugs, and wound cleansers were dropped by DEMERC in 1995 for the apparent reason that they are considered expendable. We include a discussion of these three topical products in this report as each is widely used and intimately related to wound healing.

The Novel Products and Technologies section includes products and technologies now or will soon be at the vanguard of wound management, especially with reference to chronic wounds and severe burns.

This report provides the reader with a comprehensive analysis of the markets for wound care products and technologies and illuminates the important and emerging products, technologies, and companies. It also includes discussion and analysis of topical issues relating to pricing, evolving market trends, and regulation. It provides the reader with an accurate bearing on where the industry is heading as we move into the next century.

The report:

Describes the industry, its importance to the economy, and trends for the future;
Provides a brief historical perspective;
Provides the developmental history, describes the properties, and lists the benefits of each wound care product and technology;
Analyzes the market for wound care products and technologies according to the type of wound (acute, chronic, and burn wounds), and provides the volume and value of sales along with forecasts of the volume and value;
Separates the markets for wound care products and technologies into hospital and alternative care segments and describes the relationship of each wound care product and technology to these segments;
Estimates the market share of each category of wound care product and technique held by competing manufacturers;
Analyzes the impact of novel products and technologies on the industry;
Discusses the role and importance of distributors and the changes affecting the distribution of wound care products;
Discusses the role of third party payers and trends within the industry toward consolidation and strategic alliances; and
Profiles the important manufacturers.

REASONS FOR THE STUDY

Although the medical sector as a whole has been undergoing a gradual revolution over the past hundred or more years, progress in the dressing and management of wounds has been more erratic. The use of the term "modern" dressings, the primary subject of this report, did not occur until the 1960s. Since the 1980s, developments have been fast paced and growth of gauze dressing alternatives has mushroomed. These developments have seen the emergence of many new suppliers and the demise of others. Consolidation in the industry is occurring at a rapid pace and competition for market share within all categories is keen.

Change is affecting the industry in many ways. For example, less well-known suppliers are finding it more difficult to compete in a market in which demands for cost curtailment are causing hospitals, extended care facilities, and other large buyers to narrow their listing of approved vendors and to take advantage of the cost incentives provided by volume purchases. A smaller vendor list also simplifies paperwork and inventory costs.

Participants in the industry must remain acutely aware of market developments if they are to plan intelligently. This report provides manufacturers, distributors, health care providers, and other interested parties with the knowledge needed to make informed decisions relating to investment, strategic planning, procurement, product development, and related matters.

STUDY RATIONALE

The intent of this study is to help simplify the tough choices faced by today's health care industry executives. Market intelligence plays a critical role in decisions relating to research and development, sales planning and strategy, marketing planning and strategy, capital investment, and myriad other choices faced by buyers and sellers of wound care products and technologies. Many wound care products on the market are new and growing at double digit rates, while others are mature and subject to displacement. Product development is being pursued aggressively by all key manufacturers, while physicians, nurses, and other health care providers weigh the costs and benefits of the newer introductions against the exigencies of curtailed budgets and the comfort of doing things the old way.

In this environment, market ignorance can prove very costly. This report gives you the solid information you need to pursue an intelligent plan of action.

SCOPE AND FORMAT

The geographic scope of this report is the U.S. The wound care product scope includes wound dressings, topical medications, and novel products and technologies for wound healing used under the guidance of trained medical personnel. This categorization includes wounds treated within the home, provided a visiting nurse or similarly trained person is overseeing the wound management. The important types of wounds are listed and described. Categories of wound care products and technologies are listed and described, and are associated with a particular wound type. Neither the "over-the-counter" market for home-use products nor the industrial market for wound care products is covered.

METHOD USED TO PREPARE THIS REPORT

The extensive research capabilities of the Communications Co., Inc. staff were employed to analyze markets and access government and industry statistics. New technologies, market developments, and research and development expenditures and trends were identified through patent and data base searches and discussions with key industry sources. Person-to-person and telephone interviews were the primary method of information gathering.

METHODOLOGY

Research for this report began with an in-depth analysis of technical and literature, a well as a review of the history of the technology. Interviews with industry experts, company representatives, federal government researchers, and university scientists provided the basis for an assessment of the outlook for non-separating, semi-permeable membrane applications. Secondary sources of information included product literature from membrane system suppliers, and numerous scientific references, patent searches, and BCC, Inc.'s Membrane & Separation Technology News, Medical Materials Update.

The study is divided into certain key chapters dealing with the structure and properties of non-separating, semi-permeable membranes and other main components of their applications, including critical components, such as chemical raw materials, and manufacturing processes necessary for the final function. The study emphasizes areas under research and the resulting trends.

The report makes projections for each market in terms of constant dollars. Historical values are presented for the given year, with focus on the U.S. Overseas activity is also mentioned, putting the U.S. market into global context. Estimates of the membrane areas installed in particular application areas were obtained, either from surveys done or from estimates of those knowledgeable in the industry.

INFORMATION SOURCES

The information sources for this study include extensive online research, patent literature, worldwide technical journals and magazines, and principals in the industry.

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