Endocrine Targets of Infertility Testing and the Benefits of Recombinant Reagents

Join us in this blog post as we look at the current landscape for human infertility testing, focusing on endocrine targets and the benefits of recombinant solutions when sourcing critical reagents.

Roughly one in six people of reproductive age experiences infertility during their lifetime, which translates to approximately 680 million people globally. Notably, the prevalence of infertility is relatively consistent across different regions.

While the exact causes of infertility vary, factors such as age, lifestyle, and underlying medical conditions play significant roles. It is important to note that infertility can affect both men and women and, in many cases, the issue may stem from a combination of factors affecting both partners.

Due to the high prevalence of infertility in the general population, there is growing demand for effective testing, treatments, and interventions.

Endocrine Targets of Infertility Testing

Human infertility testing typically involves blood tests that measure the levels of circulating hormones related to the reproductive process. By measuring the levels of specific hormones, healthcare providers can assess the overall reproductive health of individuals and identify underlying issues, such as structural problems or genetic conditions.

Early detection is crucial in fertility treatment because it allows for timely intervention and personalised care. Addressing hormonal imbalances early on can help patients achieve better ovulation and pregnancy outcomes, and enables individuals to explore suitable treatment options, including lifestyle changes, medications, or assisted reproductive technologies (ART).

Endocrine targets of infertility testing include:

• Follicle-stimulating hormone (FSH), which stimulates the growth of follicles in the female ovaries and sperm production in the male testes. Elevated FSH levels may indicate diminished ovarian reserve in women.
• Luteinising hormone (LH), which triggers ovulation (i.e. the release of a mature egg from the ovary). Elevated LH levels are often associated with polycystic ovarian syndrome (PCOS), while low LH levels may indicate hypogonadism, a condition that affects sex hormone production.
• Chorionic Gonadotropin (CG), which is primarily produced by the placenta during pregnancy. It is often referred to as "the pregnancy hormone" because it is detectable in blood and urine shortly after implantation.
• Thyrotropin (TSH), which plays a crucial role in regulating thyroid function. Thyroid function in turn influences various bodily functions, including fertility.
• Sex hormone-binding globulin (SHBG), which is produced by the liver and binds to sex hormones, like testosterone and oestradiol, helping to transport them via the bloodstream. Circulating SHBG levels can provide valuable insights into fertility, with lower levels potentially linked to a variety of female infertility issues.
• Prolactin (PRL), which plays a role in fertility by inhibiting follicle stimulating hormone (FSH) and gonadotropin-releasing hormone (GnRH). These hormones promote development and maturation of eggs and trigger ovulation. As such, high PRL levels are associated with anovulation.

The markets for both clinical and at-home testing of fertility markers are significant and growing. In 2023, for example, the global market for fertility and pregnancy rapid test kits was valued at $1.5 billion. That figure is expected to increase to $3.1 billion by 2033, with a compound annual growth rate (CAGR) of 7.4 %.

Recombinant sources of human sex hormones

In the context of both clinical and at-home testing, a reliable source of biological reagents is paramount. In recent years, there has been a notable shift towards recombinant sources of antigens and antibodies in the in vitro diagnostics industry. This shift has largely been driven by a need for consistency of supply and pricing and has been backed up by the IVDR regulatory framework, which has sought to promote greater consistency of critical raw materials.

The benefits of using recombinant solutions are wide-ranging and include:

• Consistency. Recombinant proteins, as opposed to materials derived from native sources, are produced by cell culture in controlled laboratory settings. This helps to ensure a reliable and consistent source of material in terms of quality and purity. Unlike native proteins, which can vary depending on source, recombinant proteins have a standardised composition.
• Cost. The fact that recombinant protein production is highly scalable means that reagents produced this way are generally more readily available. This, in turn, leads to economies of scale which reduces the overall cost of reagents. Furthermore, by reducing reliance on native sources, the cost and supply of reagents also become more stable.
• Ethical and biological safety considerations. Native sources of reagents include animals and human blood banks, which raises ethical and biological safety concerns. The risk of contamination with infectious agents or other unwanted substances can be largely eliminated using recombinant solutions. Recombinant protein production also alleviates issues around consent.
• Customisation. Recombinant proteins can be customised and engineered to contain specific modifications, such as altered glycosylation patterns or fusion tags. By tailoring the specific properties of analytes, diagnostic assays can be optimised and refined in terms of performance. Furthermore, genetic engineering can enhance the stability and shelf life of recombinant proteins.

As the volume of global testing for clinical biomarkers increases year-on-year, the need for diagnostic manufacturers to ensure the security of supply chains is more important than ever. The issue of supply chain security in the human diagnostics market has been further compounded in recent years as, in many cases, the availability of native sources of raw materials has decreased.

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