Figure 1. Worldwide market for OTC pregnancy and fertility testing products

Pregnancy tests represent the dominant segment of the market, accounting for 85% of combined pregnancy and fertility testing product sales in 2008. Growth is expected to be somewhat higher in the fertility segment, and price competition is also expected to be somewhat more intense because of the introduction of products from new suppliers. Unit volume for fertility tests will grow at 4.4%, as adoption of fertility testing continues to be limited by a lack of consumer awareness of the causes of infertility, and by reluctance of at least some couples to perform their own testing. Unit volume in the pregnancy segment is expected to increase at a 3.8% compound annual rate, indicating the mature state of the market.

Some markets outside the US, particularly the rest of world market, are expected to grow more rapidly than the US sector. Combined sales of OTC pregnancy and fertility testing products in the Japan/ROW segment, which were around at $160m in 2009, are forecast to growth at a 9.1% compound annual rate. Meanwhile, sales in the European market are forecast to grow at a 5.2% rate, compared with growth of 6.4% in the US market. The relative growth rates reflect the less developed status of the markets in the ROW sector, as well as more rapid population growth in many of these countries compared to the US and Europe.

Suppliers' sales and market shares

Swiss Precision Diagnostics, the joint venture between Procter & Gamble and Alere, is the worldwide market leader with an estimated share of 36.5% in 2008. Sales for the purposes of the market analysis shown here are computed at the manufacturer level, not at the retail level. In the case of SPD, the estimated sales figure is for P&G as the entity selling to the retailer or wholesaler, while revenues for Alere in the home pregnancy/fertility segment as the manufacturer supplying products sold by the SPD joint venture were $103m in 2008.

The number-two player is Johnson & Johnson, which acquired the pregnancy and fertility testing products business of Pfizer, and now operates it as part of the J&J Consumer Products division focused on women's health. The third-largest supplier worldwide is Church & Dwight. Omega Pharma, a long-time supplier in the European pregnancy and fertility testing market, has a relatively small share worldwide but ranks number two in Europe. There have been significant changes in the key players in the market over the past five years, due mainly to acquisitions, including those completed by Alere which brought many leading brands into its portfolio.


Year	Pregnancy ($million)	Growth (%)	Fertility ($millions)	Growth (%)	Total market ($millions)	Growth (%)
2009	499	3.6	85	3.4	584	3.6
2010	526	5.5	89	5.0	615	5.4
2011	564	7.1	96	7.4	659	7.2
2012	595	5.6	102	7.0	698	5.8
2013	632	6.1	109	6.7	741	6.2
2014	673	6.4	116	6.5	789	6.4
2015	719	6.9	124	7.0	843	6.9
CAGR 2010-2015	6.4%	6.9%	6.5%
Numbers may not add due to rounding\| Source: Supplier reports, InteLab Corporation

Figure 2. 2008 worldwide sales and market share for the leading suppliers of OTC pregnancy and fertility testing products


Company	2008 sales in $millions				Market share (%)
Company	US	Europe	Japan/ ROW	Worldwide	Market share (%)
Swiss Precision/Alere	66	49	91	206	36.5
J&J	76	8	25	109	19.4
Church & Dwight	78	22	- - -	100	17.7
Omega Pharma	- - -	33	- - -	33	5.9
Other	87	16	12	115	20.5
Total	307	128	129	564	100.0
Other includes Humasis, Germaine Labs, Arax, Rohto, Syntron Bioresearch, Princeton BioMeditech, SA Scientific, Phamatech, Preventx and Home Health Testing Numbers may not add due to rounding Source: Supplier reports, InteLab Corporation

SPD/Alere is the dominant player in the Japan/ROW segment. Rohto leads the market in Japan, but experienced stagnant sales of its Dotest pregnancy and ovulation products in its last two fiscal years due to increased competition.

Drivers and limiters

The market for OTC pregnancy and fertility testing products is being driven by the continued trend for consumers to take more responsibility for their own healthcare, as well as the demand for greater convenience. An increased awareness of the importance of prenatal care, including the need for lifestyle modification during pregnancy to optimise outcomes, began in the 1970s and has continued to have a positive impact on the market. Women want to be aware of their pregnancy at the earliest possible stage in order to make changes to their diet, alcohol intake, and other lifestyle practices. The legalisation of abortion in the US also had a positive impact on the pregnancy test market.

Continued improvements in home pregnancy test kit formats have improved ease of use and thus lowered barriers to adoption, further stimulating sales. Epidemiological factors continue to be an important cause of infertility, which, coupled with increased awareness of the causes of infertility and the potential for therapy, have combined to drive growth in fertility testing. Chlamydia infections, which are an important cause of pelvic inflammatory disease and can lead to infertility, have remained at a high level. The incidence of reported infections has grown over the past two decades, increasing from 78.5 cases per 100,000 in 1987 to 370 cases per 100,000 in 2007 in the US, according to statistics from the Centers for Disease Control and Prevention. Reported cases totalled 1,108,374 in 2007 in the US, up 7.5% versus 2006. Much of that growth is due to improved testing methods, including nucleic acid tests, which have allowed more cases to be diagnosed, as well as expanded screening programmes and improved reporting methods. However, according to the CDC the incidence of infection has also remained high.

Since essentially all home pregnancy and fertility testing products are purchased directly by consumers and are not covered by insurers, the continued pressure from government-controlled healthcare systems in European countries and from agencies such as Medicaid in the US to limit utilisation and pricing for healthcare products has little impact on the home pregnancy and fertility testing market. Purchase of such kits does not generally represent a major investment for most consumers, since they are only used for a short interval of a few months at most.

The market is also being driven by the widespread availability of pregnancy and fertility test kits, a factor that now allows essentially anyone to purchase a test kit at retail outlets that are frequented at least weekly by most consumers. A wide variety of vendors including Drugstore.com, the CVS and Walgreen pharmacy chains, as well as certain pharmacy suppliers in Europe now also sell kits online, with websites that provide a considerable amount of information on product features and applications.

Limiters of the market include concerns about the accuracy of existing test kits, skepticism on the part of physicians about the usefulness of such tests, and continued stable rates of pregnancy in developed countries. While the size of the childbearing population is continuing to grow, the growth rate is well below that for older segments of the population. The number of people of childbearing age worldwide (18-35 years) is projected to increase by about 1% per year between 2009 and 2020 based on population projections by the US Census Bureau. That trend, coupled with continued stable birth rates, will limit the growth potential for the target user population for pregnancy and fertility tests. Consequently, the rise in demand is likely to be much greater for products tailored for diagnosis and treatment of diseases afflicting people in the older age groups than for the childbearing age group.

The fertility testing market is also limited at present by a lack of consumer awareness of the availability of such products, and the potential benefits of using these tests to manage infertility. The large population of infertile couples, however, creates a significant potential market opportunity. This is now estimated at more than 72 million worldwide, of which only about 60% are being treated.

Direct testing for infertility due to genetic causes is now available from service providers such as DNA Direct. This enables an individual to order a laboratory test from a testing lab without needing to consult a physician. Typically, the consumer orders the test via the internet or telephone, and a sample collection kit is mailed which provides instructions and materials needed to collect and send a urine or other type of specimen to the laboratory. Tests such as molecular genetic analyses are then performed and the results are sent to the consumer along with interpretative information. Genetic causes of infertility are believed to be a contributing factor in 5-10% percent of cases, according to data published by the US Centers for Disease Control and Prevention. Such causes are often missed by physical exams and standard laboratory tests. By identifying the true cause of infertility, direct genetic testing could eliminate the need for fertility self-testing by affected individuals. The overall impact on the self-testing market will be limited, however, to 10% or less of the target population.

* This article is an extract from the report, Worldwide Markets and Emerging Technologies for Point-of-Care Testing, published in August 2009 by InteLab Corporation. For more information about the report, go to www.intelabcorp.com

Point-of-care testing: the over-the-counter pregnancy and fertility testing market

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