Global Regenerative Medicine Industry 2016 Market Research Report

Chapters

1 Industry Overview

1.1 Definition of Regenerative Medicine

Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the "process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function". It is through the use of innovative medical means rebuilding diseased or damaged tissue or to support diseased or damaged tissue regeneration. The methods used include cell therapy, tissue engineering, chemically induced and therapeutic cloning, etc. Any combination of these technologies may be used to harness or stimulate the body’s innate healing ability in order to treat a wide range of ailments, including musculoskeletal-related conditions, cardio- and peripheral vascular diseases, neurological disorders, stroke, non-healing wounds and ocular diseases.

Regenerative medicine is defined as the process of replacing or "regenerating" human cells, tissues or organs to restore or establish normal function and has been called the "next evolution of medical treatments" and “the vanguard of 21st century healthcare” by the U.S. Department of Health and Human Services.

Figure Picture of Regenerative Medicine

Source: QYR Pharma & Healthcare Research Center, Oct 2016

1.2 Classification of Regenerative Medicine

In this report, we can through the treatment to classify regenerative medicine.

Table Classification of Regenerative Medicine

Source: International Journal of Bone Science, QYR Pharma & Healthcare Research Center, Oct 2016

1.3 Applications of Regenerative Medicine

Regenerative medicine as an advanced medical technology is widely used in the medical field.

Table Application Fields of Regenerative Medicine Products

Source: QYR Pharma & Healthcare Research Center, Oct 2016

1.4 Stakeholders of Regenerative Medicine

Figure Stakeholders of Regenerative Medicine

Source: Alliance, QYR Pharma & Healthcare Research Center, Oct 2016

1.5 Industry Overview and Major Regions Status of Regenerative Medicine

1.5.1 Industry Overview of Regenerative Medicine

During the last century, efforts toward preventing and battling disease frequently focused on the use of drugs, specifically small molecules and protein therapeutics designed to somehow alter or slow the course of a disease by affecting how a cell or a group of cells behave. This pharmacological approach has played, and will continue to play, an invaluable role in efforts to ensure a long and healthy life. It has led to the development of drugs that can combat infection, slow down cancer progression, and help in a myriad of diseases. Yet, even with this large and complex arsenal of drugs, there are many occasions where this type of medicine falls short.

1.5.2 Global Major Regions Status of Regenerative Medicine

1.6 Industry Policy Analysis of Regenerative Medicine

2 Analysis of Regenerative Medicine Technology and Market Opportunity

Regenerative medicine is not new; it has not sprung anew out of stem cell science as has often been suggested. There is a rich history of study of regeneration, of development, and of the ways in which understanding regeneration advances study of development and also has practical and medical applications. This paper explores the history of regenerative medicine, starting especially with T.H. Morgan in 1901 and carrying through the history of transplantation research in the 20th century, to an emphasis on translational medicine in the late 20th century.

2.1 Regenerative Medicine Technology

2.1.1 Cell Therapy

The stem cells are removed (or obtained from a donor) first. Before the transplant is done, the patient receives high-dose chemotherapy and/or radiation therapy to destroy diseased cells. Then the stem cells are returned to the patient, where they can produce new blood and immune cells and replace the cells destroyed by the treatment. The stem cell preparation is infused into a vein and, once in the bloodstream, the stem cells migrate to the bone marrow space.

Figure Picture of Cell Therapy

Source: QYR Pharma & Healthcare Research Center, Oct 2016

Figure Industry-Sponsored Cell Therapy Trials by Location

Source: Alliance, QYR Pharma & Healthcare Research Center, Oct 2016

2.1.2 Tissue Engineering

In the 1970s, Dr WT Green a paediatric orthopedic surgeon at Boston’s Children’s Hospital undertook a number of experiments to generate new cartilage by implanting chondrocytes seeded on bone spicules in nude mice. He was unsuccessful but his experiments were among the first attempts at what we now describe as tissue engineering. He had positively concluded that with the advent of biomaterials science it would be possible to regenerate and produce new tissues by loading viable cells onto “smart” engineered scaffolds. The term “tissue engineering” was first used in 1985, by Y.C. Fung, a pioneer of the field of biomechanics and bioengineering. Fung's concept drew on the traditional definition of "tissue" as a fundamental level of analysis of living organisms, between cells and organs. The term was coined at key workshops held at the Granlibakken Resort, Lake Tahoe, California, in February 1988 and UCLA symposium in 1992. These forums recommended that tissue engineering be designated as an emerging engineering technology. The new specialty was then famously described in an article by Langer and Vacanti in Science. They wrote: “Tissue engineering is an interdisciplinary field that applies the principles of engineering and the life sciences toward the development of biological substitutes that restore, maintain, or improve tissue function”. Since then the novel specialty has successfully expanded and excited scientists and clinicians alike.

Figure Picture of Tissue Engineering

Source: QYR Pharma & Healthcare Research Center, Oct 2016

2.1.3 Others

Figure Picture of Biomaterials

Source: QYR Pharma & Healthcare Research Center, Oct 2016

Therapeutic Cloning:

The earliest cloning experiments on animals were conducted by German embryologist Hans Spemann. In 1952, American embryologists Robert Briggs and Thomas J. King conducted a milestone experiment on frog eggs using the nuclei from early embryonic cells of leopard frogs. They succeeded in forming a multi-cellular embryo and then a tadpole. The British developmental biologist John Gurdon succeeded in the 1970s in producing tadpoles by transferring the nucleus of adult frog skin into enucleated frog eggs. These early experiments had a low success rate and remain scientifically controversial. However, they led the way to research using mammals, beginning with mice in the 1980s. The result of that research was the successful birth of Dolly the sheep in 1996. Since then, scientists have cloned other mammals, including goats, pigs, cats, and rabbits. None of these experiments were intended to advance possible techniques for human cloning.

Figure Picture of Therapeutic Cloning

Source: QYR Pharma & Healthcare Research Center, Oct 2016

Biomolecules:

It includes angiogenic factors, growth factors, differentiation factors and bone morphogenic proteins.

Engineering Design Aspects:

It includes 2D cell expansion, 3D tissue growth, bioreactors, vascularization, cell and tissue storage and shipping (biological packaging).

2.2 Regenerative Medicine Market Opportunity

Data from the Centers for Disease Control and National Center for Health Statistics show that annual healthcare expenditures in the U.S. are approximately $2.5 trillion dollars, which represents 17.4 percent of GDP. Demographic analysis of healthcare expenditures shows that average per capita healthcare expenses increase significantly with age, particularly for individuals beyond the age of 65 who are more susceptible to heart and vascular disease, cancer, acute and chronic neurological conditions, inflammatory and immune diseases, and a range of other conditions.

2.2.1 Heart Failure

Figure Global Market Share of Heart Failure Patients

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Source: Medisun, QYR Pharma & Healthcare Research Center, Oct 2016

2.2.2 Ophthalmology

2.2.3 Transforming Diabetes

Diabetes, also known as diabetes mellitus, is a group of metabolic diseases in which a person has high blood sugar either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. There are two primary types of diabetes. Type1 diabetes, also known as insulin-dependent or juvenile diabetes is an autoimmune disorder in which the immune system attacks and destroys the insulin-producing beta cells in the pancreas. Type 2 diabetes, known as adult onset or noninsulin dependent diabetes, is caused when either there is a deficiency in the insulin being produced, or when the cells of the body become resistant to the action of insulin. Over time, the pancreas becomes unable to make enough insulin, and glucose accumulates in the bloodstream in the same manner as in type 1 diabetes.

2.2.4 Skin Burns

There is an urgent need for new treatment options for burns. Severe burns and other major traumas to the skin are life-threatening injuries that require immediate surgical intervention. Currently, the standard of care for patients with severe second and third degree burns involves skin transplants called autografts, in which skin is mechanically harvested from healthy donor sites and relocated to trauma sites on the same patient. These donor sites are painful, and are prone to infection and scarring. When insufficient donor site tissue is available, burns are typically covered with cadaver skin or other synthetic dressings, and later autografted when it becomes feasible. Despite intense research efforts, to date there has not been a cell-based or synthetic product developed that has been able to accomplish clinical outcomes similar to autografting.

2.2.5 Orthopedic

2.3 Key Suppliers Products, Technology, and Application

Conclusions:

1. Currently, some companies in the world can provide regenerative medicine service, mainly concentrating in USA. The main market players are DePuy Synthes, Medtronic, ZimmerBiomet, Stryker, Acelity, MiMedx Group, Organogenesis, UniQure, Cellular Dynamics International, etc. The revenue of regenerative medicine will increase from 1531 million USD in 2011 to 4396 million USD in 2016, registering a Compounded Annual Growth Rate (CAGR) of 23.49% during the analysis period, 2011-2026.

2. USA is a huge market, and the total sum of the industry is more than 1825 million USD in 2015. At the same time, this industry continuously increases, with the development of global economy.

3. USA is the largest market of regenerative medicine, which occupies 51.09 percent of global regenerative medicine market share in 2015. It is followed by EU, which has around 16.66 percent of the global total industry. Other main regions which take important part in this industry include Japan and China.

4. According to the research, the most potential market in the main countries of regenerative medicine industry is Asia, determined by the rising level of medical care. Besides, South America, Middle East should also be focused by the investors. They are the potential consumers of regenerative medicine.

5. Despite the presence of competition problems, due to the huge industry profits, investors are still optimistic about this area; there will be more investments to enter the field.

6. The relatively-mature technology is cell transplantation; tissue engineering and therapeutic cloning has its technical advantages, which is the direction of future research and development.

Global Regenerative Medicine（ 再生医学）Industry 2016 Market Research目录