세계의 유전성 강직성 하반신마비(HSP) 시장 : 약제별, 중증도별, 유통 채널별, 지역별, 기회 및 예측(2018-2032년)

Global hereditary spastic paraplegia (HSP) market is projected to witness a CAGR of 14.65% during the forecast period 2025-2032, growing from USD 115.90 million in 2024 to USD 346 million in 2032. The market's growth is supported by the rising cases of HSP, advancements in genetic research, supportive regulatory measures, and rising investments towards research and development activities. Additionally, advancements in gene editing platforms and neurorehabilitation solutions are also expected to play a significant role in driving the growth of the market.

Increasing emphasis on advanced diagnostic solutions and gene therapies is also supporting the market's growth and expansion. Whole-exome sequencing and next-generation sequencing are allowing early therapeutic interventions and improving diagnostic accuracy. Researchers are also exploring gene silencing and replacement strategies to address the underlying cause of HSP. Pharmaceutical companies and academic and research institutions are investing in preclinical research activities to test the safety and efficacy of novel therapies and understand genotype-phenotype correlations.

Moreover, healthcare systems across the globe are focusing on improving diagnostic efficiency and treatments for rare diseases and neurological disorders, supporting the market's expansion. Various governments are implementing policies to combat the growing threat of rare diseases, including HSP and providing tax credits, accelerated approvals, and research grants to incentivize pharmaceutical companies.

Increasing Regulatory Support Boosts Market Growth

Increasing support from different regulatory bodies such as the Food and Drug Administration (FDA) is accelerating the clinical evaluation and development of innovative therapeutic solutions for treating and managing neurogenetic disorders. For instance, in May 2025, BlackfinBio Limited received approval from the US FDA to begin phase 1/2 clinical trial for adeno-associated virus (AAV) gene therapy targeting HSP, Type 47. The trial aims to assess the tolerability, safety, and efficacy of the AAV gene therapy in patients with HSP, Type 47. Such approvals validate scientific advancements and incentivize pharmaceutical companies to invest in research and development activities.

Additionally, the provision of rare pediatric disease status and orphan drug designation further encourage pharmaceutical companies to pursue novel therapeutic solutions by providing benefits such as financial incentives and market exclusivity. Such supportive initiatives foster collaboration between industry leaders, clinical centers, and academic institutions, resulting in the expedition of molecular and genetic discoveries, improving treatment outcomes and bolstering the availability of treatment options, positively influencing the market's expansion.

Rising Research Activities Support Market Expansion

Advances in molecular genetics and next-generation sequencing have already identified over 80 genetic causes of HSP, laying the groundwork for variant-specific therapies. Researchers across the globe are focusing on developing gene therapies for HSP. For instance, in January 2024, a team of researchers from the Korea Research Institute of Bioscience & Biotechnology (KRIBB) developed gene therapy for HSP. The team identified the role of ARL6IP1 gene in the onset of HSP. Their findings showed that ARL6IP1 is involved in maintaining homeostasis of cellular organelles and is located in the mitochondrial associated ER membrane. The presence of a robust research environment that fosters innovations and supports development of new therapies is allowing researchers to bridge the gaps in HSP care and develop disease modifying treatments.

Hospitals Pharmacies Account for Significant Share of the Market

The segment's dominance can be attributed to the central role played by hospitals and clinics in the management and treatment of HSP. The condition requires multidisciplinary care involving physiotherapies and neurologists, among other specialists, which is only available and effectively coordinated in hospitals and clinics. Additionally, hospitals and clinics also offer medication management and comprehensive patient monitoring, which is essential for diseases such as HSP. They are equipped with the necessary technology and professionals to handle complex cases, provide patient education to improve treatment adherence, and adjust treatment regimens. Additionally, hospitals algo participate in various clinical trials to elevate the understanding of different mechanisms associated with HSP, further strengthening the segment's position. For instance, Boston Children's Hospital is conducting an observational study to better understand the role of genetic factors in HSP. The study is estimated to conclude in April 2027.

North America Holds Major Market Share

The rapid growth of the market in North America can be attributed to the availability of high fundings for rare disease research, strong presence of leading market players, availability of advanced genetic testing services, and rising incidences of HSP. As per the estimates of the Spastic Paraplegia Foundation, in the United States the HSP incidence rate is approximately 20,000.

The strong presence of leading academic and research institutions and pharmaceutical companies is supporting innovations and new product launches, driving the market's growth and expansion. In countries such as the United States, supportive framework and initiatives including the Orphan Drug Act are enabling early-stage clinical research and providing financial incentives for HSP drug development. Additionally, the rising popularity of telehealth services is improving patient access to specialists and neurologists, especially in rural locations, allowing patients to receive timely diagnosis, supporting the market's expansion.

Future Market Scenario (2025 - 2032F)

The market is expected to witness significant growth over the forecast period, due to rising awareness, technological advancements, and increasing research in curative gene therapies. With rising investments from both private and public sectors, the focus on disease-modifying treatments is increasing, bolstering the availability of therapeutic solutions that tackle the root cause of the condition and just symptomatic management. Additionally, rising emphasis on research activities to bolster the availability of new treatments for HSP is also expected to propel the market's expansion. For instance, Shanghai Sixth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine is conducting an interventional study to explore the safety and efficacy of calcium folinate for treating patients with spastic paraplegia 56. The study is estimated to conclude in May 2030. Additionally, advancements in AI-powered diagnostic and biomarker analysis are expected to support early disease detection, providing lucrative growth opportunities for the market.

Key Players Landscape and Outlook

The leading market players are focusing on conducting clinical trials, developing new therapies, and working on improving the understanding of the genetic factors responsible for HSP. The key players are also focusing on seeking investments to support their research and development activities and bolster the availability of novel therapeutic solutions. For instance, in December 2023, BlackfinBio Limited raised approximately USD 3.7 million in seed investment to advance treatments for HSP. Such investments are expected to accelerate the translation of laboratory discoveries to therapies, improving prospects for the patient population across the globe and allowing companies to expand their presence in the industry.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Medication
    • 4.2.1.1. Skeletal Muscle Relaxants
    • 4.2.1.2. Anxiolytics
    • 4.2.1.3. Benzodiazepines
    • 4.2.1.4. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
    • 4.2.1.5. Others
  • 4.2.2. By Severity
    • 4.2.2.1. Mild
    • 4.2.2.2. Moderate
    • 4.2.2.3. Severe
  • 4.2.3. By Distribution Channel
    • 4.2.3.1. Hospital Pharmacies
    • 4.2.3.2. Retail Pharmacies
    • 4.2.3.3. Online Pharmacies
  • 4.2.4. By Region
    • 4.2.4.1. North America
    • 4.2.4.2. Europe
    • 4.2.4.3. Asia-Pacific
    • 4.2.4.4. South America
    • 4.2.4.5. Middle East and Africa
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Medication
  • 4.3.2. By Severity
  • 4.3.3. By Distribution Channel
  • 4.3.4. By Region

5. North America Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Medication
    • 5.2.1.1. Skeletal Muscle Relaxants
    • 5.2.1.2. Anxiolytics
    • 5.2.1.3. Benzodiazepines
    • 5.2.1.4. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
    • 5.2.1.5. Others
  • 5.2.2. By Severity
    • 5.2.2.1. Mild
    • 5.2.2.2. Moderate
    • 5.2.2.3. Severe
  • 5.2.3. By Distribution Channel
    • 5.2.3.1. Hospital Pharmacies
    • 5.2.3.2. Retail Pharmacies
    • 5.2.3.3. Online Pharmacies
  • 5.2.4. By Country Share
    • 5.2.4.1. United States
    • 5.2.4.2. Canada
    • 5.2.4.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Medication
        • 5.3.1.2.1.1. Skeletal Muscle Relaxants
        • 5.3.1.2.1.2. Anxiolytics
        • 5.3.1.2.1.3. Benzodiazepines
        • 5.3.1.2.1.4. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
        • 5.3.1.2.1.5. Others
      • 5.3.1.2.2. By Severity
        • 5.3.1.2.2.1. Mild
        • 5.3.1.2.2.2. Moderate
        • 5.3.1.2.2.3. Severe
      • 5.3.1.2.3. By Distribution Channel
        • 5.3.1.2.3.1. Hospital Pharmacies
        • 5.3.1.2.3.2. Retail Pharmacies
        • 5.3.1.2.3.3. Online Pharmacies
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Turkey
• 6.9. Poland

7. Asia-Pacific Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Hereditary Spastic Paraplegia (HSP) Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa

10. Demand Supply Analysis

• 10.1. Supply Chain Analysis
• 10.2. Value Chain Analysis

11. Porter's Five Forces Analysis

12. PESTLE Analysis

13. Pricing Analysis

14. Market Dynamics

• 14.1. Market Drivers
• 14.2. Market Challenges

15. Market Trends and Developments

• 15.1. Clinical Trials
• 15.2. New Developments and Innovations

16. Case Studies

17. Competitive Landscape

• 17.1. Competition Matrix of Top 5 Market Leaders
• 17.2. SWOT Analysis for Top 5 Players
• 17.3. Key Players Landscape for Top 10 Market Players
  • 17.3.1. Novartis A.G.
    • 17.3.1.1. Company Details
    • 17.3.1.2. Key Management Personnel
    • 17.3.1.3. Products and Services
    • 17.3.1.4. Financials (As Reported)
    • 17.3.1.5. Key Market Focus and Geographical Presence
    • 17.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 17.3.2. Pfizer Inc.
  • 17.3.3. BlackfinBio Limited
  • 17.3.4. Sanofi S.A.
  • 17.3.5. Elpida Therapeutics
  • 17.3.6. Genetic Cures for Kids Inc.
  • 17.3.7. Daiichi Sankyo Company, Limited

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

18. Strategic Recommendations

19. About Us and Disclaimer