Memphasys’ electrophoresis membrane separation technology for sperm has been developed in conjunction with the University of Newcastle to select the best sperm from semen samples used for in vitro fertilisation (IVF) and artificial insemination (AI). The very successful clinical validation results have been published in important international publications and have generated worldwide interest throughout the human IVF market. The company is now committing major resources to commercialising this application in conjunction with Prof John Aitken, a world-leader in reproduction science, and University of Newcastle.
THE SPERM SEPARATION MARKET
Human Assisted Reproduction Market
The large and increasing use of assisted reproduction techniques in human infertility is driven by the growing incidence of both female and male infertility.
Increasingly, couples are planning to have children relatively late in life, when natural fertility in both males and females declines significantly.
Male fertility is in long-term decline worldwide and is a factor with more than 45% of infertile couples.
The human assisted reproduction services market performs about 1.5 million IVF monthly cycles worldwide each year, and produces approximately 400,000 babies. This is done in ~4,000 human IVF clinics worldwide. Europe has the largest volume of IVF activity, markedly exceeding the US, due to the reimbursement available for fertility treatments. Human IVF activity in Asia is also increasing rapidly, particularly in China and India.
The human IVF industry is estimated to have revenues of ‘around US$9.3bn worldwide, and is forecast to grow to US$21.6bn in 2020¹. Of this total, global human IVF disposables revenues were estimated to have been US$370 million in 2013², with 12% year-on-year growth driven by geographic expansion³. [1 - Allied Market Research, 2014. 2 - Vitrolife 2013 Annual Report. 3 - Origio/Cooper, 2011]
IVF centre numbers in developing countries are still growing strongly (~10% p.a.) but the growth in the major developing countries (China, India) is around 30% and up to 50% p.a.in certain countries. (Source: Industry Interviews, ESHRE Market Statistics 2016, Vitrolife Annual Report 2013, 2016). Key growth drivers are: Increasing numbers of older parents wanting to have children, China’s new 2-child policy, growing affluent middle classes in developing countries and greater social acceptance of ART (Source: Vitrolife Annual Report 2016).
The key statistics on the IVF market are set out in the table below.
|Human Assisted Reproduction Technology (ART)
Key Market Statistics
|Couples with fertility issues||> 50 million|
|Couples of child bearing age seeking IVF treatments||9%|
|N°. IVF Clinics Globally||> 4,000|
|IVF BABIES PER YEAR||~ 400,000|
|Global IVF market size, 2012||$9.3 billion|
|Growth rates :|
|Developed World||~ 10%|
|N°. of cycles per year||~ 6 million|
|Cost of consumables per cycle||~$400|
|Cost to patient per cycle :|
|Developed countries (ave.)||~ $10,000|
|Developing countries||~ $1,500|
|Total Felix addressable market||> $1.2 billion|
|Sources : Vitrolife Annual Report 2016, Industry interviews, ESRE, SART, ANZARD|
Key Market Statistics
There is very limited reliable data regarding the number of treatments in the world (1).
Furthermore, there is substantial under-reporting in the data that is collected as there is no mandatory nor standardised reporting on ART and many clinics simply do not report.
This is particularly so of developing economies such as China and India, which are growing very rapidly in their demand for ART.
The figures in the table have been derived from industry sources such as ASARD, the Australian and New Zealand Assisted Reproduction Database, ESHRE, the European Society of Human Reproduction and Embryology, SART, Society for Assisted Technology in the USA, Annual Reports of industry suppliers such as VitroLife and industry interviews. 1.Vitrolife Annual Report 2013.
Male Infertility Statistics: Male infertility is a major issue for over 40% of infertile couples and its incidence is increasing globally. It is highly correlated with age, affecting fertility in 1/3 of men over 40, and is adversely affected by chronic diseases and poor lifestyle.
With the increasing number of children born to IVF procedures, there is also a corresponding growth in research that indicates infants conceived using IVF have a higher risk of genetic defects. One of the factors thought to be responsible is the presence of DNA damage in the fertilising spermatozoa (“sperm”). Current sperm separation techniques do not reliably remove the DNA-damaged sperm cells. The process itself also increases damage through two steps in the sperm preparation procedure: centrifuging, which imparts shear stresses on the sperm; and culturing in media that contains trace amounts of heavy metals which are damaging to the sperm. DNA-damaged sperm cells increase the risk of infertility, miscarriages, and birth defects. Longer term they also increase the risk of cancers, metabolic and neurological diseases.
In the IVF lab, the current sperm separation processes are labour intensive, taking up to 30 minutes of lab technician time per sample.
There is significant market need for a simple, quick, cost effective and reliable method of selecting the best sperm cells from IVF sperm samples in a manner that does not contribute to DNA damage and oxidative stress to the fertilising sperm. Memphasys’ sperm separation system is the first automated instrument that does this in a quick 10 minute clinical process that requires the lab technician to just load the semen sample and press a button.
ANIMAL ARTIFICIAL REPRODUCTIVE MARKET
There has been a long history of AI in the veterinary industry, early in dairy cattle and pigs, and now extensively in the beef cattle, sheep and goat sectors. Growth is also occurring in camel breeding in the Middle East, and in protecting endangered species.
Artificial insemination (AI) is one of the most effective tools available to livestock producers to improve productivity and profitability of their operation. In the USA, artificial insemination has been commercially available for more than 65 years and utilized very effectively. About 95% of the nation’s dairy cows are bred by AI, and the use of AI by commercial pig producers is currently 70-75%. In Europe, almost 90% of pigs and dairy cows are produced by AI. The thoroughbred horse racing industry bans AI, but it is used in breeding specialty horses for other uses.
In the AI process, the semen is usually chosen from proven sires and each ejaculate split into many ‘straws’ which are then frozen and shipped for use to artificially inseminate the females. AI increases the usefulness of superior sires: eg, by natural servicing of cows, a bull can be bred to 50 to 60 cows per year; but by artificial insemination thousands of cows can be sired in one year by one bull. A single semen sample can be processed to produce up to 20 semen samples for multiple services.
The animal AI consumables market is worth US$213m per annum globally. Memphasys is working with its Minitüb GmbH, to develop applications in the animal artificial reproduction market. Minitüb is the largest supplier of artificial reproduction equipment and consumables to the animal market. New animal products resulting from this partnership are at least two years from launch.
Sperm Separation Technology
CLINICAL - The Felix™ System
Further adaptation and engineering of the research device CS10 described below has resulted in Memphasys' researchers and engineering collaborators developing the next-generation sperm separation technological, the Felix™ System, for clinical IVF use. The Felix™ System, which will be tested in leading global IVF centres, will also employ the new biocompatible separation membrane technology recently developed by Memphasys.
RESEARCH - CS10
The CS10 is one of the original research devices developed by Memphasys which was adapted to separate sperm from semen. It has a custom-designed sample cartridge with the appropriate membranes for semen separation, and it has been used for fertility research and early clinical assessment in human IVF. The CS10 separates normal sperm (normal motility, vitality, functionality, morphology and level of DNA damage) from the damaged sperm cells and other contaminating materials in human semen.
NOTE: The Felix™ System is currently not available for supply.