This article was also published on MedTech Intelligence.
With differing cultural attitudes towards tissue donation and transplantation, be prepared for some complex hurdles.
Tissue banks are facilities where the tissues of deceased donors are stored together and securely processed. When these tissues are given to a patient in need of a skin or bone transplant, they are referred to as allograft tissue. It stands in contrast to xenograft tissue, where the material for the transplant comes from different species.
Allograft tissue can be used for a variety of conditions, including skin burns, dental implants and diabetic ulcers, among others. Another large use of allografts is for orthopedic procedures. For tissue transplantation to be safe and effective, the tissues must be sterilized, a process most effectively done through radiation.
Western Companies Succeeding in the Asian Tissue Bank Markets
Some Western tissue banks have had success selling their products in Asia, with limited competition from domestic tissue banks. Examples include:
- Geistlich. A Swiss company that specializes in the production and sales of animal-based biomaterials for regenerative medicine. It has had major success in the Asia markets, establishing subsidiaries in China and Korea, and obtaining a large share of the xenograft market in those two markets, as well as in some other Asian countries.
- BioHorizons. A dental company that focuses on allograft-based products. It holds annual symposia on prosthetic dentistry in the Asia Pacific region, which helps increase the number of individuals in the region with the skills and capabilities to use their tissue products.
- Other Western tissue bank companies such as the Musculoskeletal Transplant Foundation, RTI Surgical, Organogenesis, Lifenet Health, Allosource and Acelity should have opportunities in Asia as well.
There is a wealth of opportunities for tissue banks throughout the Asian region, including in Malaysia, Indonesia, China, Korea and Singapore, among others. Keys for success include studying the specific Asian market to determine local product needs and crafting an intelligent, effective regulatory strategy. While some Asian countries require that tissue be registered, others do not. As always, finding a qualified local Asian distributor that really understands your particular product is imperative for successful sales.
Asian Tissue Bank Markets and Opportunities for Foreign Suppliers
In 2005, a law was enacted that gave explicit recognition to human tissue transplantation in Korea. The allograft market is dominated by Hans Biomed, a local Korean company that has become the most successful Asian company in the field of human tissue transplantation. Korea also has a large network of tissue banks, and they have significant experience in storage techniques. Some Korean tissue is even exported to Japanese dentists, which helps alleviate the issue of the scarcity of human tissue supply in Japan.
In China, the Shanxi Provincial Tissue Bank (SPTB) is the leading tissue bank. In 2001, SPTB became a private company, SPTB Osteorad. There are other tissue banks at Chinese universities, but they lack the scale and expertise of SPTB. There are also a number of local companies that focus on xenograft transplants. There is a major gap between supply and demand, with a large demand for tissue transplants that local Chinese companies cannot meet. The huge size of the Chinese market and the insufficient domestic supply makes this a promising market for Western exporters that are able to enter. However, China is still struggling to determine how these products will be regulated.
Tissue banking has made significant progress in Indonesia over the past 20 years. The International Atomic Energy Agency helped Indonesia establish a network of several tissue banks at major hospitals. However, domestic production of allograft is still limited, opening up opportunities for foreign suppliers. The number of allograft transplants per year is in the thousands.
Tissue banking has made significant inroads in Malaysia since the early 1990s, with the establishment of the Malaysian National Tissue Bank in 1994 and several others founded over the years as well. As the country’s per capita income is significantly higher than Indonesia’s, Malaysia provides more of a market for expensive imported tissue grafts. Additionally, Malaysia has the 15th highest rate of adult diabetes in the world, making it a promising market for allograft products that treat diabetic ulcers.
Tissue banking has made very little progress in Japan for a variety of reasons. Damaging a dead body, even for the purpose of donation, is taboo in Japan. There is also a widespread stigma against accepting tissue from non-Japanese donors, a potential barrier for foreign tissue exporters. However, Japanese law does not cover the buying and selling of human tissue, so in theory, imported materials can be used even though they are not yet covered under the national health insurance.
The tissue banking market in Asia is one with significant potential. However, each Asian market has a different culture and unique attitude toward tissue donation and transplantation. For example, the current negative attitude about receiving foreign tissue in Japan may make it a less promising location than other Asian countries. Those looking to enter the Asian tissue bank market should be well prepared for the complex set of challenges that await them.