Hirschsprung Disease Treatment Market to Grow at 6% CAGR by 2031 | Fresenius Kabi USA, LLC, Aurobindo Pharma Limited, Sanofi, Allergan, Inc

Hirschsprung Disease Treatment Market is estimated to grow at a CAGR of 6% during the forecast period 2024-2031.

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Key clinical / research developments:

✅ (06 Aug 2025) Vanderbilt University teams published/announced progress toward a nonsurgical approach for Hirschsprung disease - work that advances regenerative/neurotrophic approaches and brings a pharmacologic (non-pull-through) strategy closer to translation.

✅ (2025, review published) A 2025 review of management for Hirschsprung disease highlighted the growing prospect of regenerative cell therapy (enteric neural replacement) as a future curative strategy to replace missing enteric neurons and potentially eliminate pull-through surgery.

✅ (01 Jul 2024 - still influencing 2025 work) Human-tissue stem-cell experiments (Sheffield research) that generated enteric nerve precursors in HD tissue have continued to underpin 2025 translational activity and preclinical programmes. (important background to 2025 cell/regenerative efforts).

Regulatory / product / pipeline milestones (2025):

✅ (05 Mar 2025 / 04 Mar 2025 press releases) Neurenati Therapeutics - NEU-001: the company announced that the U.S. FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to NEU-001, a novel intrarectal neurotrophic combination therapy intended to regenerate the enteric nervous system as a non-surgical option for newborns with Hirschsprung disease. The programme was positioned in 2025 as preclinical with human trials projected later.

✅ (02 Jul 2025 - grant record) Public-sector support: a Canadian government grant (agreement recorded 2 Jul 2025) funded preclinical development of a non-surgical combination therapy for Hirschsprung disease - a concrete public R&D investment in 2025.

Guidelines, care pathway & complication management (2025):

✅ (19 May 2025) UK/NHS regional guidance (tertiary paediatric surgical network guidance) updated/issued practical recommendations for suspected Hirschsprung-associated enterocolitis (HAEC) emphasising early tertiary discussion and standard HAEC risk stratification / escalation pathways.

✅ (2025 - PubMed report) A validated HAEC Action Plan aimed at caregivers was reported in 2025 literature focused on home-management recognition and early irrigation/escalation to reduce HAEC morbidity.

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Key market growth drivers:

✅ Wider and earlier diagnosis + newborn screening / awareness - improved neonatal care and greater clinician awareness increase case detection and referral for definitive treatment.

✅ Adoption of minimally invasive & transanal techniques - laparoscopic, transanal endorectal pull-through (TERPT) and increasing interest in robotic-assisted approaches shorten recovery and are expanding surgical volumes and hospital willingness to offer definitive single-stage repairs.

✅ Centralization of pediatric surgical care & better perioperative protocols - growth of specialized pediatric surgical centers and standardized post-op management improves outcomes and supports market expansion for related services and supplies.

✅ Technology & device improvements - advances in instrumentation for MIS and perioperative imaging/diagnostics drive procedure uptake and incremental spending.

✅ Unmet need & access expansion in emerging markets - investments in healthcare infrastructure across Asia-Pacific and parts of Latin America are increasing treated case volumes.

Regional share:

➠ North America - market leader (largest share): due to high diagnosis rates, established pediatric surgical infrastructure, and early adoption of advanced techniques.

➠ Europe - 2nd largest: advanced healthcare systems and strong pediatric surgery networks support a sizable share.

➠ Asia-Pacific - fastest growth / rising share: increasing healthcare investment, rising awareness, and expanding surgical capacity point to strong CAGR and an expanding share over the coming years.

➠ Latin America & MEA - smaller current share but growing: limited access remains a constraint but infrastructure projects are creating opportunities.

Segments Covered in the Hirschsprung Disease Treatment Market:

By Type (Short-segment, Long-segment)

By Treatment Type (Surgery, Medication, Others)

By Route of Administration (Oral, Parenteral)

By End-User (Hospitals, Clinics, Homecare, Others)

By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others)

Regional Analysis for Hirschsprung Disease Treatment Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Major Key Players: Pfizer Inc., Fresenius Kabi USA, LLC, Aurobindo Pharma Limited, Sanofi, Allergan, Inc., Laborate Pharmaceuticals.

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