The undescended testicle market size is expected to reach US$ 7.38 billion by 2030, from US$ 4.51 billion in 2023, at a CAGR of 7.3% during the forecast period. Undescended testicle, also known as cryptorchidism, is a condition in which one or both testicles fail to descend from the abdomen into the scrotum. The treatment options include hormone therapy and surgery. The rising prevalence of undescended testicles is driving market growth.

The global undescended testicle market is expected to witness steady growth due to rising incidences of undescended testis among newborn babies. Undescended testis, also known as cryptorchidism, is a congenital condition where one or both testes fail to descend into the scrotum. Left untreated, it can lead to infertility and testicular cancer. With growing awareness about the long-term effects of undescended testis and the availability of surgical procedures to treat it, the undescended testicle market is gaining traction globally. Furthermore, initiatives by governments and health organizations to screen newborns for this condition are supporting early diagnosis and treatment, driving market growth.

The undescended testicle market is segmented by treatment type, end-user, and region. By treatment type, the market is segmented into hormone therapy, surgery, and others. The hormone therapy segment accounts for the largest market share due to its high adoption rate as the first line of treatment. It is preferred due to its non-invasive nature.

Global Undescended Testicle Market Drivers:

• Increasing prevalence of undescended testicles globally: The rising incidence of undescended testicles, or cryptorchidism, is a major factor driving the growth of the undescended testicle market. Cryptorchidism is one of the most common genital disorders in newborn males, affecting 2-9% of full-term and 1-45% of preterm male infants worldwide. This high prevalence creates a consistent demand for treatment options. The rising cases globally are expected to boost the demand for drugs, therapies, and devices for correcting undescended testicles.
• Growing awareness about available treatment options: There is increasing awareness among patients and healthcare providers regarding the available treatment methods for undescended testicles. The two main treatment options are hormone therapy and surgical intervention. The key hormone drugs prescribed are human chorionic gonadotropin and gonadotropin-releasing hormone. Promotional activities by drug manufacturers are also helping to increase awareness. Moreover, the emergence of advanced laparoscopic devices for orchidopexy has led to greater adoption of surgical procedures. This growing awareness is consequently fueling the expansion of the undescended testicle market.
• Strong product pipeline and new product launches: The undescended testicle market is witnessing continuous new product development and launches. Pharmaceutical companies are investing in research and development to develop improved drugs and formulations for cryptorchidism treatment. For instance, Ferring Pharmaceuticals has newly approved recombinant human chorionic gonadotropin product, KOVALTRY, offers stable potency over the entire shelf life. Similarly, Pfizer's new Human Chorionic Gonadotropin (HCG) drug, NGENLA, requires fewer injections. These product launches are creating new growth avenues for market players. The strong pipeline is indicative of upcoming commercialization opportunities.

Global Undescended Testicle Market Opportunities:

• Growing demand for minimally invasive procedures: There is an increasing patient preference for minimally invasive surgeries over open surgeries for correcting undescended testicles. Laparoscopic orchidopexy is gaining traction over conventional orchidopexy surgeries owing to advantages such as smaller incisions, a shorter hospital stay, less pain, and a lower complication risk. Robotic surgeries are also emerging for cryptorchidism treatment. Device manufacturers are developing improved versions of laparoscopes and miniaturized surgical systems. The rising demand for minimally invasive procedures presents significant opportunities for market players.
• Developing novel hormone therapies: Pharmaceutical companies are engaged in developing new hormone drugs and combination therapies for effectively managing undescended testicles. Long-acting hormone formulations are being evaluated to reduce the frequency of injections and improve patient compliance. For instance, Takeda Pharmaceuticals, a pharmaceutical company investigational long-acting GnRH analog TAK-385XR is undergoing phase 3 trials for treating cryptorchidism. Novel non-invasive hormone delivery methods, such as nasal sprays, are also being explored. Such innovations are expected to help expand the drug treatment options available for cryptorchidism.

Global Undescended Testicle Market Restraints:

• High costs associated with surgical interventions: The high cost of surgical procedures like orchidopexy and laparoscopic orchiopexy is a major factor hampering the growth of the undescended testicle market. These surgeries require specialized infrastructure and equipment, leading to significant hospitalization and procedural costs. Moreover, there are chances of postoperative complications that further increase expenses. The high costs limit the adoption of surgical treatments, especially in developing regions with poor reimbursement. This is restricting market expansion.
• Side effects associated with pharmacological therapies: The various side effects associated with hormone therapy drugs such as hCG and GnRH analogs are limiting their adoption for cryptorchidism treatment. The commonly reported side effects include injection site reactions, allergic responses, headaches, fatigue, mood changes, etc. Moreover, long-term safety concerns related to effects on fertility and hormone levels also exist. The fear of side effects makes many patients apprehensive about pharmacological treatments. Safer drugs with minimal adverse effects are still in the pipeline. These factors are challenging the growth of the undescended testicle market.

Analyst’s View on Global Undescended Testicle Market

The global undescended testicle market is expected to grow steadily over the forecast period. Factors such as increasing awareness about testicular cancer risks associated with undescended testicles and benefits of early corrective treatment will drive more people to seek medical help. Additionally, growing healthcare expenditures in developing nations will boost market opportunities. North America currently dominates the market and is expected to continue its leadership over the next five years. High awareness levels about men's health issues and easy availability of quality treatment options in the US and Canada are major factors supporting the region's large share. Europe is poised to be the second largest market owing to supportive public healthcare coverage and technological advancements in orchiopexy procedures. However, low consciousness, lack of health insurance, and socio-economic challenges in developing countries may negatively impact the overall industry expansion. High costs associated with surgeries also restrict the market potential in some regions. Looking forward, the market is likely to witness the fastest growth in Latin America and parts of Asia Pacific due to increasing healthcare spending, medical tourism, and rising per capita incomes in emerging nations. Improving access to care as a result of various government initiatives will provide new opportunities for market participants in these underpenetrated developing markets

• Shift towards outpatient care settings: There is an increase in the performance of orchidopexy procedures in outpatient settings rather than inpatient hospital settings. Advancements in surgical techniques have made it possible to conduct cryptorchidism correction surgeries on an outpatient basis. Outpatient surgeries offer benefits like lower costs, reduced hospital stay, and fewer chances of hospital-acquired infections. Many healthcare providers encourage outpatient orchidopexies for suitable candidates. This rising trend will impact the dynamics of the undescended testicle market.
• Use of 3D printing and surgical simulations: The application of 3D printing technology for surgical planning and simulations is rising in the treatment of undescended testicles. Patient-specific 3D-printed models help surgeons understand anatomy better and increase precision. Simulators allow for surgical training and practice. For instance, a study in the Journal of Pediatric Urology found that 3D printed models improved understanding of anatomical defects in cryptorchidism cases. The increasing adoption of such technologies will shape the future progress of the undescended testicle market

Global Undescended Testicle Market Regional Insights:

• North America is expected to be the largest market for undescended testicle during the forecast period, accounting for over 40.5% of the market share in 2022. The growth of the market in North America is attributed to the high prevalence of cryptorchidism, advanced healthcare infrastructure, and favorable reimbursement policies in the region.
• The Europe market is expected to be the second-largest market for undescended testicle, accounting for over 25.2% of the market share in 2022. The growth of the market is attributed to rising awareness about the condition, the presence of prominent players, and high healthcare expenditures in the region.
• The Asia Pacific market is expected to be the fastest-growing market for undescended testicle, with a CAGR of over 22.3% during the forecast period. The growth of the market in Asia Pacific is attributed to the large patient pool, improving healthcare infrastructure, and increasing penetration of market players in the region.

Figure 1. Global Undescended Testicle Market Share (%), by Region, 2023

Major players operating in the global undescended testicle market include Ferring Pharmaceuticals, Pfizer, Eli Lilly, Sanofi, Merck & Co., Bayer, Endo International, AstraZeneca, Johnson & Johnson, Takeda Pharmaceutical

New product launches:

• In January 2021, Pfizer launched NGENLA, a new formulation of human chorionic gonadotropin (hCG), for the treatment of cryptorchidism in boys. The new formulation provides lower drug exposure and fewer injections.
• In October 2020, Ferring B.V., a pharmaceutical company launched a new recombinant human chorionic gonadotropin (r-hCG) product, KOVALTRY, for subcutaneous injection to treat cryptorchidism. It helps descent testicles into the scrotum in boys.
• In June 2019, Merck & Co., Inc. received U.S. Food and Drug Administration approval for its GnRH antagonist ELIGARD for the treatment of undescended testicles in boys aged 2 years and older. It offers a longer duration of action and fewer injection site reactions.

Acquisition and partnerships:

• In September 2021, Pfizer Inc., a pharmaceutical company acquired Trillium Therapeutics for US$2.3 billion to enhance its immuno-oncology portfolio. Trillium's CD47 programs show promise to treat hematological malignancies and solid tumors.
• In April 2020, Ferring Pharmaceuticals partnered with I-Mab Biopharma, biopharmaceutical company to develop olamkicept for treating ulcerative colitis. Ferring will get exclusive global rights outside Greater China.
• In January 2020, Sanofi S.A. , a pharmaceutical company acquired Synthorx for US$2.5 billion to acquire its immuno-oncology pipeline. Synthorx’s IL-2 therapeutics can help treat various forms of cancer.

• By Treatment Type
  • Hormone Therapy
  • Surgery and Others
• By End User
  • Hospitals
  • Clinics
  • Others
• By Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa