Congenital Anomalies Treatment Market Trends

  • Report ID: 2702
  • Published Date: Oct 06, 2025
  • Report Format: PDF, PPT

Congenital Anomalies Treatment Market - Growth Drivers and Challenges

Growth Drivers

  • Government spending on healthcare & advancements in healthcare quality improvement: Governments are keen on expanding their healthcare budgets to mitigate rising cases in the congenital anomaly treatment market. As per a report by the World Health Organization in December 2023, there was a new high level of spending on health at USD 9.8 trillion or 10.3% of worldwide gross domestic product (GDP) in the previous 4 years. Moreover, Low-income countries shared 0.24% of the global health spending, even though they had an 8% population share of the world. The increasing financial investment is anticipated to be the driver for significant growth in the market, with growing funds to be the fuel for advancements in diagnostics, therapeutics, and surgery across the world.
  • Unmet needs in emerging markets & company innovations: The gap between the demand for healthcare services and the available supply creates important opportunities for both established companies and new businesses to grow in the congenital anomalies treatment market. Among emerging technologies, telemedicine has taken center stage as it has significantly enhanced consultation processes. As per a report by NLM in October 2023, this innovation becomes much more critical considering nearly 50% of birth defects remain without any well-defined etiology, making diagnosis and timely intervention difficult. However, the known etiologic factors are parental chromosomal abnormalities (2 to 4%), anatomical and endocrine conditions (10 to 27%), and antiphospholipid antibody syndrome (17 to 20%), requiring the initial input of a specialist, oftentimes difficult to obtain in low-resource settings.
  • Rising Prevalence of Birth Defects and Improved Regional Reporting Systems: For the market, an increasing number of reported congenital anomalies accounts significantly toward the growth of the market. As per a report by the World Health Organization in 2025, births were recorded in over 150 hospitals 2025 across the region, with more than 3,000 cases of birth defects recorded. Therefore, growing awareness about congenital anomalies and reporting them highlights the magnitude of the problem  and the need for early diagnosis, intervention, and specialized treatment. Better healthcare infrastructure and stronger birth defect surveillance systems lead to better opportunities for early detection and improved management of congenital anomalies. As awareness grows amongst the medical professionals and parents, the demand for surgical interventions, therapeutic devices, and ongoing medical care will also grow.

Risk of Major Congenital Malformations Associated with Select Drugs (2025)

Drug

(Livebirths/MCM %) (major congenital malformations)

Adjusted OR

Adjusted OR

Butylscopolamine

72/6 (8.3%)

2.92 (1.26-6.79)

1.79 (0.61-5.25)

Budesonide

89/10 (11.2%)

3.35 (1.68-6.69)

2.38 (0.82-6.92)

Liraglutide

55/8 (14.5%)

3.52 (1.59-7.82)

0.74 (0.20-2.70)

Insulin glargine

460/45 (9.8%)

2.71 (1.98-3.72)

0.93 (0.39-2.24)

Insulin (human)

601/49 (8.2%)

2.59 (1.91-3.51)

0.61 (0.29-1.31)

Insulin (human)

1069/86 (8.0%)

2.53 (2.01-3.17)

0.81 (0.44-1.50)

Insulin aspart

1495/125 (8.4%)

2.43 (2.01-2.93)

1.34 (0.52-3.46)

Insulin detemir

473/35 (7.4)

2.12 (1.48-3.02)

1.09 (0.46-2.62)

Source: NLM

Challenges

  • Stringent Regulatory Approvals: The market growth and adoption are largely hindered by the rigorous approval and regulatory norms before drug and product launch in the congenital anomalies treatment market. The high cost of research, development & deployment has led to high CapEx requirements. Clinical trials, followed by strict approvals, are cost-intensive, making it a challenge for smaller players to gain a competitive edge. Furthermore, the approval process's time span being long can hold up the introduction of innovative treatments and affect market dynamism. The regulatory complexities lead to further costs for the end consumer, limiting accessibility and adoption in emerging markets.
  • Limited awareness and early diagnosis: The market is constrained due to a lack of general awareness about congenital defects among parents and, in some instances, even among healthcare providers, especially in a few resourcefully constrained settings. This often results in delayed diagnosis and treatment, thus decreasing intervention efficacy. In addition, poor access to more advanced diagnostic techniques and specialized medical establishments in rural or backward areas renders early detection and timely intervention impossible, thereby inhibiting market expansion and better patient outcomes.

Base Year

2025

Forecast Year

2026-2035

CAGR

5.2%

Base Year Market Size (2025)

USD 179.5 million

Forecast Year Market Size (2035)

USD 283.2 million

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC, North Africa, South Africa, Rest of the Middle East and Africa)

Browse key industry insights with market data tables & charts from the report:

Frequently Asked Questions (FAQ)

In 2026, the industry size of congenital anomalies treatment is estimated at USD 188.8 million.

Congenital anomalies treatment market size is valued at USD 179.5 million in 2025 and is projected to reach USD 283.2 million by the end of 2035, rising at a CAGR of 5.2% during the forecast period, i.e., 2026-2035.

North America market is expected to hold the highest market share of 39% by the end of 2035, largely due to the U.S. and Canada’s flourishing provincial initiatives to bridge the gaps between supply and demand.

The major players in the market are Medtronic plc, Johnson & Johnson (Ethicon), Siemens Healthineers, Abbott Laboratories, Boston Scientific, GE HealthCare, F. Hoffmann La Roche Ltd., Terumo Corporation, B. Braun Melsungen AG, Dr. Reddy’s Laboratories, Samsung Medison, CSL Limited (CSL Behring), Sanofi S.A., Baxter International Inc., Duopharma Biotech Berhad.
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