Infertility Diagnosis and Treatment Market Valued at $7.4 billion in 2025, Set to Grow at a 8.2% CAGR

Infertility diagnosis and treatment market was valued at $7.4 billion in 2025 and is projected to reach $16.2 billion by 2035, growing at a CAGR of 8.2% during the forecast Period (2026-2035). FDA clearance enhances the credibility of next-generation fertility therapies, promoting their global adoption and driving the market growth of advanced infertility treatments. For instance, in January?2025, the US Food and Drug Administration (FDA) granted clearance for a phase?3 clinical trial of Fertilo, an innovative fertility therapy based on induced pluripotent stem cells (iPSCs). This treatment aims to mature eggs outside the body using lab?grown ovarian support cells, significantly reducing hormone stimulation needs in IVF protocols. The phase?3 trial, conducted across 15 U.S. sites, is a key step toward wider clinical use and represents one of the most advanced new reproductive therapeutics in recent years.

Browse the full report description of “Infertility Diagnosis and Treatment Market Size, Share & Trends Analysis by Diagnosis Type (Male Infertility Diagnosis, and Female Infertility Diagnosis), By Treatment Type (Male Infertility Treatments, and Female Infertility Treatment), and By End-User (Fertility Centers & Clinics, Hospitals & Surgical Clinics, Cryobanks (for gamete/embryo storage), Research Institutes, and Others), Forecast Period (2026-2035)” at https://www.omrglobal.com/industry-reports/infertility-diagnosis-and-treatment-market

FDA Clears New Minimally Invasive Infertility Devices

• In December 2025, Femasys secured US FDA 510(k) clearance for its next?generation FemVue Controlled diagnostic device. This tool is designed to simplify and improve fallopian tube patency testing a key component of infertility diagnosis, offering clinicians a more efficient, less invasive method to assess tubal function, which can directly influence fertility treatment planning and success rates.
• The US Food and Drug Administration (FDA) granted 510(k) clearance for FemaSeed, an innovative infertility treatment designed to deliver sperm directly into the fallopian tube where fertilization normally occurs, offering a less invasive and potentially more cost?effective alternative to traditional assisted reproductive technologies like IVF or ICSI. This clearance allows FemaSeed to be marketed and used clinically in the US for enhanced natural fertilization support in women experiencing infertility.

Market Coverage

• The market number available for – 2025-2035
• Base year- 2025
• Forecast period- 2026-2035
• Segment Covered-
  • By Therapeutic Type
  • By Drug Form
  • By End User
• Regions Covered-
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Competitive Landscape - AbbVie Inc., Eli Lilly and Co., Johnson & Johnson, Novo Nordisk A/S, Pfizer Inc., among others

Key questions addressed by the report.

• What is the market growth rate?
• Which segment and region dominate the market in the base year?
• Which segment and region will project the fastest growth in the market?
• Who is the leader in the market?
• How are players addressing challenges to sustain growth?
• Where is the investment opportunity?

Global Infertility Diagnosis and Treatment Market Report Segment

By Diagnosis Type

• Male Infertility Diagnosis
  • Semen analysis
  • Genetic testing
  • Testicular biopsy
  • Hormone testing
  • Others
• Female Infertility Diagnosis
  • Ovulation testing
  • Hysterosalpingography (HSG)
  • Hysteroscopy
  • Imaging testing
  • Ovarian reserve testing
  • Hormonal level testing
  • Genetic testing
  • Others

By Treatment Type

• Male Infertility Treatments
  • Drugs & Medicines
  • Surgical Procedures
  • Assisted Reproductive Technologies (ART)
  • Others
• Female Infertility Treatment
  • Drugs and Medicine
  • Surgical Procedures
  • Intrauterine Insemination (IUI)
  • Assisted Reproductive Technology (ART)
    • In?Vitro Fertilization (IVF)
    • Intracytoplasmic Sperm Injection (ICSI)
    • Assisted Hatching
  • Others

By End User

• Fertility Centers & Clinics
• Hospitals & Surgical Clinics
• Cryobanks (for gamete/embryo storage)
• Research Institutes
• Others

Global Infertility Diagnosis and Treatment Market Report Segment by Region

North America

• United States
• Canada

Europe

• UK
• Germany
• Italy
• Spain
• France
• Russia
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia and New Zealand
• ASEAN Economies
• Rest of Asia-Pacific

Rest of the World

• Latin America
• Middle East & Africa

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