Congenital Anomalies Treatment Market Outlook:
Congenital Anomalies Treatment Market size was valued at USD 166 million in 2024, is projected to garner a revenue of USD 375 million by the end of 2037, expanding at a CAGR of 6.5% from 2025 to 2037. In 2025, the industry size of congenital anomalies treatment is estimated at USD 177 million.
The worldwide congenital anomalies treatment market demand is driven by a noteworthy patient pool. In the U.S., roughly 3.1% of live births, or about 122,000 infants yearly, are seen to have structural or functional birth defects, thus contributing to half of pediatric inpatient admissions. Prematurity-related congenital anomalies affect nearly one-third of births globally. Key components of the supply chains supporting congenital anomalies care consist of active pharmaceutical ingredients (API) for prenatal and postnatal diagnostics, surgical devices for corrective interventions, and specialized nutritional/therapeutic products. Furthermore, emerging trends offer proxy awareness about the producer price index (PPI) and consumer price index (CPI) as tracked by the U.S. Bureau of Labor Statistics (BLS). It has identified the PPI commodity indexes in healthcare and their relative importance as of December 2022. In terms of government support and aids, U.S. grants such as NIH’s PAR 25 146 and PAR 25 185 offer uninterrupted federal investment in congenital anomaly mechanisms and treatments translational research.
PPI Commodity Indexes in Healthcare And Their Relative Importance As Of December 2022
|
Index title |
Relative Importance in Final Demand, December 2022 (%) |
Relative Importance in Health Care services, December 2022 (%) |
|
Health care services |
16.6 |
100 |
|
Outpatient care |
10.6 |
63.6 |
|
Physician care |
4 |
23.7 |
|
Medical laboratory and diagnostic imaging center care |
0.3 |
2.4 |
|
Home health and hospice care |
0.9 |
5.3 |
|
Hospital outpatient care |
4.3 |
25.4 |
|
Dental Care |
1.1 |
6.7 |
|
Inpatient Care |
6 |
35.8 |
|
Hospital inpatient care |
4.5 |
26.9 |
|
Nursing home care |
1.2 |
7.3 |
|
Intellectual and developmental disability center care |
0.3 |
1.5 |
|
Sales of blood and blood products, organs, and tissues |
0.1 |
0.6 |
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 congenital anomaly cases. Globally, public health expenditure for congenital anomalies and other non-communicable ailments was USD 1.52 trillion in 2024. In 2023, the U.S. Medicare spent USD 2.2 billion on treatments, including cardiac surgeries. Germany sanctioned USD 1.9 billion for congenital anomaly treatments and care. A 2022 Agency for Healthcare Research and Quality report suggests that early interventions for congenital heart abnormalities in the form of surgeries reduced hospitalizations by over a quarter share and saved USD 1.22 billion in the U.S. in two years. Additionally, standardized protocols comprising AHRQ’s Team STEPPS have drastically minimized surgical complications.
-
Unmet needs in emerging markets & company innovations: The prevalent gap in demand and supply of healthcare services offers key opportunities for established players and new entrants. Among emerging technologies, telemedicine has taken the center stage as it has significantly enhanced consultation processes. Such affordable solutions are estimated to capture the 26.2 million annual Indian birth congenital anomalies treatment market. Over 18% of congenital anomaly cases in India are untreated as a result of limited facilities and infrastructure. Similarly, over a quarter of patients in Japan are deprived of advanced treatments owing to high healthcare costs, averaging around USD 10,000 per procedure, which creates significant growth potential for insurers and entry-level players. Government and private player partnerships have the potential to reach more marginalized communities around the world. In 2024, European hospitals and Medtronic entered into a partnership to push the deployment its Harmony Transcatheter Pulmonary Valve adoption in the congenital anomalies treatment market. Moreover, CRISPR-based therapies for neural tube defects are offering personalized treatments.
Challenges
-
Stringent Regulatory Approvals: The congenital anomalies treatment market growth and adoption are largely hindered by the rigorous approval and regulatory norms before drug and product launch. 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.
Congenital Anomalies Treatment Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
6.5% |
|
Base Year Market Size (2024) |
USD 166 million |
|
Forecast Year Market Size (2037) |
USD 375 million |
|
Regional Scope |
|
Congenital Anomalies Treatment Market Segmentation:
Treatment Segment Analysis
The congenital heart anomalies treatment segment in the congenital anomalies treatment market will capture a share of 32% by 2037. Procedures such as atrial septal defects and Tetralogy of Fallot are vital in mitigating congenital anomalies due to the high global birth incidence. Also, minimally invasive pediatric cardiac tools like robotic-assisted thoracoscopy and cutting-edge surgical precision technologies provide stellar recovery rates and reduce hospital stays, thus boosting adoption. Public healthcare schemes in India and Brazil now subsidize complex cardiac surgeries under national health missions, expanding the addressable population. WHO-backed neonatal screening programs in Asia Pacific and Europe are fostering timely diagnoses, further propelling surgical demand.
End User Segment Analysis
Specialized pediatric hospitals segment is likely to dominate the congenital anomalies treatment market with a share of 35% in the forthcoming years. The growth is ascribed to the centralization of congenital anomaly expertise, emerging gene therapy capabilities, and advanced neonatal ICUs. As of 2024, over half of the complex congenital treatments conducted in the U.S. were at children’s hospitals. Public/government funding like the EU4Health program has proven to be pivotal in Europe, in terms of boosting accessibility to early genetic correction. Moreover, partnerships between biotech firms and medical facilities are fueling translational research pipelines, with facilities including Great Ormond Street Hospital and Boston Children’s Hospital expanding hybrid operating theaters.
Our in-depth analysis of the global congenital anomalies treatment market includes the following segments:
|
Segment |
Subsegments |
|
Treatment Type |
|
|
End user |
|
|
Application |
|
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Congenital Anomalies Treatment Market - Regional Analysis
North America Market Insights
North America congenital anomalies treatment market is estimated to capture the largest market share of 39% by the end of 2037, largely due to the U.S. and Canada’s flourishing provincial initiatives to bridge the gaps between supply and demand. Canada congenital anomalies treatment market is likely to register a CAGR of 6.3% during the forecast period. The federal government allocated a lion's share of its budget in 2023, amounting to USD 3.3 billion for congenital anomalies. This underscores a 12.1% surge when compared to 2020. reflecting a 12% increase from 2020. Ontario's funding was increased by 18% between 2021 and 2024. This boost led to medical accessibility for over 200,000 patients yearly. Alberta and British Columbia have expanded prenatal screening infrastructure and pediatric cardiac surgery. The Canadian Institute for Health Information reports that about 85% of pediatric congenital cases are diagnosed by age 2 due to cutting-edge newborn screening programs.
North America Congenital Anomalies Treatment Market Overview - Key Insights
|
Country |
FDI (2023) |
Budget Allocation |
Govt Spending |
R&D Funding |
Payer Pricing ($/case) |
Raw Material Sourcing |
Trade (Devices, 2022) |
|
USA |
$336.1M by CDC for birth defect programs |
NBSSLA grants: $30.5M/year |
$22.21B hospitalization cost in 2019 |
NIH congenital disorder funding: $120.2M |
~$62.2k average infant hospitalization |
Cardiac device kits from Germany |
$1.3.3B in congenital devices exported |
|
Canada |
Surveillance & research: $14M (PHAC) |
Federal budget 8% healthcare (CA$3.2B) |
Hospital stay 17 days vs 3 days |
Folic acid fortification R&D (~$5M/year) |
Price covered by provincial insurance |
Prenatal test kits from domestic labs |
Devices trade: ~$200M |
Prevalence of Selected Congenital Anomalies (per 10,000 births, Canada 2008-2023)
|
Anomaly Type |
Rate (per 10,000) |
Trend |
|
Neural tube defects |
4.8 |
Stable |
|
Genital anomalies |
68 |
Stable |
|
Congenital heart defects |
20.8 |
Stable |
|
Limb deficiency defects |
4 |
Stable |
|
Oro-facial clefts |
15.8 |
Stable |
|
Diaphragmatic hernia |
3.1 |
Stable |
|
Abdominal wall defects |
5.8 |
Decreasing |
|
Gastrointestinal defects |
14.2 |
Stable |
|
Chromosomal defects |
18 |
Stable |
|
CNS defects |
5.3 |
Decreasing |
|
Urinary tract defects |
13.8 |
Increasing |
|
Sense organ defects |
4.9 |
Stable |
Asia Pacific Market Insights
Asia Pacific congenital anomalies treatment market is anticipated to capture the largest revenue share of 22% by the end of 2037. This is attributed to swelling healthcare and pharmaceutical investments, technological advancements, and rising disease occurrence. Japan, India, and China hold a high potential for congenital anomalies treatment market expansion and opportunities for players to reach a huge patient base and capitalize on the supply-demand gap. Government initiatives like India’s Ayushman Bharat are fostering medical accessibility. and Malaysia’s expanding healthcare infrastructure, coupled with South Korea’s focus on digital health, further propel growth.
APAC Country Analysis: Market Demand, Spending, and Patient Growth
|
Country |
Spending 2013 ($M) |
Spending 2023 ($M) |
Spending Growth (%) |
Patients 2013 (M) |
Patients 2023 (M) |
Patient Growth (%) |
Key Insights (2023-2024) |
|
Japan |
35,100 |
40,050 |
15 |
1.22 |
1.57 |
25.2 |
MHLW allocated $40.12B (10% of healthcare budget) to anomaly treatments; robotic surgery adoption grew 15% |
|
China |
1,300.5 |
2,100 |
54 |
1.23 |
1.82 |
50.9 |
NMPA reported $2.4B in funding; anomaly surgeries rose 10% to $1.3B |
|
India |
800.7 |
1,850 |
126 |
1.51 |
2.43 |
59 |
Ayushman Bharat drove $1.81B in spending; 2.42M patients treated |
|
Malaysia |
210 |
420 |
101 |
0.3 |
0.5 |
100.12 |
Patient pool doubled; funding rose to $400.3M with infrastructure upgrades |
|
South Korea |
504 |
1,000.6 |
101 |
0.35 |
0.7 |
100.3 |
Digital health investments drove $1.1B in spending; 0.61M patients treated |
India congenital anomalies treatment market is projected register the fastest growth rate during the forecast period. This is priimarily driven by supportive government policies and initiatives. India’s National Medical Device Policy of 2023 aids local manufacturing, limiting foreign reliance for healthcare resources by 16%. Rashtriya Bal Swasthya Karyakram program catered to 60.82 crore children via 11,821 mobile health teams between FY 2014-15 and FY 2023-24. During this timeline, 5.63 crore children were able to seek secondary/ tertiary care. As per a December 2024 meta-analysis and systematic review by the NIH, the birth prevalence of 184.48 per 10,000 births or 95% CI 164.74-204.21 was estimated.
Europe Market Insights
The Europe congenital anomalies treatment market is approximated to observe a 4.9% CAGR during the analysis period. Key drivers consist of high prevalence of congenital anomalies across over a million annual births, with Germany and the UK leading in congenital anomalies treatment market adoption. EU Health Programme funding of €2.41 billion aids R&D of rare disease therapies, including anomalies. Environmental factors and aging maternal populations drive demand, while screening programs and partnerships enhance access. The following document summarizes the characteristics of Europe's 14 congenital anomaly registers with national coverage, extracted from the National Congenital Anomaly Registers dataset. It includes coding systems, registry details, pregnancy outcomes, and surveillance practices, which are aligned with EUROCAT and ICBDSR standards.
European Congenital Anomalies Registers with National Coverage, January 10, 2020
|
Country |
Registry Name |
Year Created |
Type |
Network |
Births (thousands, % coverage) |
Compulsory |
Time Limit |
Anomaly Type |
Coding |
Pregnancy Outcomes |
Surveillance |
|
Czech Republic |
National Registry of Congenital Anomalies (NRCA) |
1964 |
Population |
ICBDSR, EUROCAT |
110 (100%) |
Yes |
15 years |
– |
ICD |
Live birth, Stillborn, TOPFA |
Yes |
|
Denmark |
Danish Medical Birth Registry |
1973 |
Population |
– |
– |
– |
1 year |
– |
ICD |
Live birth, Stillborn, TOPFA |
– |
|
England |
NCARDRS |
2015 |
Population |
BINOCAR, ICBDSR |
610 (100%) |
No |
– |
Major, minor |
ICD |
Live birth, Stillborn, TOPFA |
– |
|
Finland |
Register of Congenital Malformations |
1963 |
Population |
ICBDSR, EUROCAT |
60 (100%) |
Yes |
1 year |
Major |
ICD |
Live birth, Stillborn, TOPFA |
Yes |
|
Hungary |
Hungarian Congenital Abnormality Registry (HCAR) |
1962 |
Population |
ICBDSR, EUROCAT |
100 (100%) |
Yes |
1 year |
Major, minor |
ICD (modified) |
Live birth, Stillborn, TOPFA |
– |
|
Latvia |
Register of Patients Suffering from Certain Diseases |
1987 |
Population |
EUROCAT |
19.2 (100%) |
Yes |
18 years |
– |
– |
Live birth, Stillborn, TOPFA |
– |
|
Malta |
Malta Congenital Anomalies Register (MCAR) |
1985 |
Population |
ICBDSR, EUROCAT |
4 (100%) |
No |
1 year |
Major, minor |
ICD |
Live birth, Stillborn |
– |
|
Norway |
Medical Birth Registry of Norway (MBRN) |
1967 |
Population |
ICBDSR, EUROCAT |
60 (100%) |
Yes |
1 year |
– |
ICD-BPA |
Live birth, Stillborn, TOPFA |
Yes |
|
Poland |
Polish Registry of Congenital Malformations (PRCM) |
1997 |
Population |
EUROCAT |
300 (85%) |
Yes |
2 years |
Major, minor |
ICD |
Live birth, Stillborn, TOPFA |
Yes |
|
Portugal |
Portuguese National Registry of Congenital Anomalies (RENAC) |
1995 |
Population |
EUROCAT |
– |
No |
Neonatal period |
Major |
ICD |
Live birth, Stillborn, TOPFA |
Yes |
|
Scotland |
Scottish Linked Routine Data Congenital Anomaly Register |
2018 |
Population |
EUROCAT |
50-55 (100%) |
Hybrid |
1 year |
Major |
ICD |
Live birth, Stillborn, TOPFA |
– |
|
Slovakia |
Teratologic Information Centre, Slovak Medical University |
1964 |
Population |
ICBDSR |
55 (100%) |
Yes |
Hospital-based |
– |
– |
Live birth, Stillborn, TOPFA |
– |
|
Sweden |
Swedish Medical Birth Registry (MBR) |
1964 |
Population |
ICBDSR, EUROCAT |
100-120 (100%) |
Yes |
1 year |
– |
ICD |
Live birth, Stillborn, TOPFA |
Yes |
|
Wales |
Congenital Anomaly Register & Information Service for Wales (CARIS) |
1998 |
Population |
BINOCAR, ICBDSR, EUROCAT |
35 (100%) |
No |
1 year |
Major, minor |
ICD |
Live birth, Stillborn, TOPFA |
– |
Source: Scielosp
Worldwide Distribution & Annual Coverage of the Registers, Highlighting the European Continent, January 2020
Germany congenital anomalies treatment market is poised for a noteworthy share during the forecast period, with a patient pool of 1.22 million. In 2023, the budget allocated was roughly €40 billion to advance the country's diagnosis and surgical capacities. As per a 2022 NIH study report, neonatal screening comprises 19 congenital anomalies, of which 13 are metabolic diseases and affect one in 1300 newborns. Positive screening in Germany suggests that primary hypothyroidism (1:3338), cystic fibrosis (1:5400), phenylketonuria/hyperphenylalaninemia (1: 5262), and medium-chain acyl-CoA dehydrogenase deficiency (1:10,086) are the most prevalent types.
Target Diseases of Neonatal Screening In Germany, Their Prevalence, And Their Year Of Inclusion In The National Screening Program.
|
Disease |
Classification |
Prevalence |
Year of inclusion in the national screening program |
|
Very-long-chain-acyl-CoA-dehydrogenase deficiency (VLCAD) |
Fatty acid oxidation disorder, metabolic disease |
1:75 562 |
2005 |
|
Medium-chain acyl-CoA-dehydrogenase deficiency (MCAD) |
Fatty acid oxidation disorder, metabolic disease |
1:10 086 |
2005 |
|
Long-chain-3-OH-acyl-CoA-dehydrogenase deficiency (LCHAD) |
Fatty acid oxidation disorder, metabolic disease |
1:141 824 |
2005 |
|
Carnitine palmitoyl transferase 1 deficiency (CPT-1) |
Carnitine cycle defect, metabolic disease |
1:576 159 |
2005 |
|
Carnitine palmitoyl transferase 2 deficiency (CPT-2) |
Carnitine cycle defect, metabolic disease |
2005 |
|
|
Carnitine acylcarnitine translocase ‧deficiency (CACT) |
Carnitine cycle defect, metabolic disease |
2005 |
|
|
Phenylketonuria (PKU) and hyperphenylalaninemia (HPA) |
Amino acid metabolism disorder, metabolic disease |
1:5 262 |
1964 in individual West German states, 1969 throughout West and East Germany |
|
Maple syrup urine disease (MSUD) |
Amino acid metabolism disorder, metabolic disease |
1:170 714 |
2005 |
|
Tyrosinemia type 1 |
Amino acid metabolism disorder, metabolic disease |
1:135 000*2 |
2018 |
|
Glutaraciduria type 1 (GA1) |
Metabolic disease, organoacidopathy |
1:139 675 |
2005 |
|
Isovaleric acidemia (IVA) |
Metabolic disease, organoacidopathy |
1:89 500 |
2005 |
|
Biotinidase deficiency |
Metabolic disease |
1:28 365 |
2002 |
|
Galactosemia |
Carbohydrate metabolism disorder, metabolic disease |
1:76 821 |
1975 |
|
Primary hypothyroidism |
Endocrinopathy |
1:3 338 |
1978 |
|
Adrenogenital syndrome (AGS) |
Endocrinopathy |
1:14 917 |
2002 |
|
Cystic fibrosis (CF) |
Lung disease |
1:5 400*1 |
2016 |
|
Severe combined immunodeficiency (SCID) |
Immune disease |
1:32 500*2 |
2019 |
|
5q-associated spinal muscular atrophy (SMA) |
Muscular disease |
2021 |
|
|
Sickle cell disease (SCD) |
Hematological disease |
2021 |
|
|
Total |
1:1 333 |
Source: NIH
Key Congenital Anomalies Treatment Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The key players are striving to position themselves as major contenders and gain high congenital anomalies treatment market shares. They are incorporating strategic initiatives such as mergers & acquisitions, RD&D, new drug and technology launches, and geographical expansion, among others.
Here are some of the top companies dominating the congenital anomalies treatment market:
|
Company Name |
Country |
Market Share |
|
Medtronic plc |
Ireland |
~16% |
|
Johnson & Johnson (Ethicon) |
USA |
~13% |
|
Siemens Healthineers |
Germany |
~11% |
|
Abbott Laboratories |
USA |
~10% |
|
Boston Scientific |
USA |
~9% |
|
GE HealthCare |
USA |
xx% |
|
F. Hoffmann‑La Roche Ltd. |
Switzerland |
xx% |
|
Terumo Corporation |
Japan |
xx% |
|
B. Braun Melsungen AG |
Germany |
xx% |
|
Dr. Reddy’s Laboratories |
India |
xx% |
|
Samsung Medison |
South Korea |
xx% |
|
CSL Limited (CSL Behring) |
Australia |
xx% |
|
Sanofi S.A. |
France |
xx% |
|
Baxter International Inc. |
USA |
xx% |
|
Duopharma Biotech Berhad |
Malaysia |
xx% |
Recent Developments
- In December 2024, the U.S. FDA approved Crenessity (crinecerfont) in combination with glucocorticoids (steroids) to treat pediatric patients 4 years of age and older suffering from classic congenital adrenal hyperplasia.
- In November 2024, PTC Therapeutics received the FDA approval for AADC Deficiency Gene Therapy. This is the first-ever U.S.-based approved drug that is directly administered to the brain. This revolutionary drug is designed to address both children and adul age groups.
- Report ID: 2702
- Published Date: Jul 22, 2025
- Report Format: PDF, PPT
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