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세계의 폼페병 시장 보고서(2025년)
Pompe Disease Global Market Report 2025
상품코드 : 1824442
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

폼페병 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년 연평균 복합 성장률(CAGR) 6.5%로 23억 1,000만 달러로 성장할 것으로 예상됩니다. 예측기간의 성장은 지속적인 연구개발, 신생아 스크리닝 프로그램의 확대, 유전자 치료의 진보, 희소질환에 대한 세계 투자 증가, 환자 중심의 의약품 개발, 임상시험 및 연구 이니셔티브의 확대, 맞춤형 의료 접근 시장 중시 등에 기인한다고 생각됩니다. 예측기간 중 주요 동향으로는 제품혁신, 기술진보, 환자지원프로그램의 실시, 환자관리를 위한 원격의료 채택 확대, 접근확대 프로그램을 위한 제휴 등을 들 수 있습니다.

향후 5년간의 성장률 6.5%라는 예측은 전회 예측으로부터 0.1%의 소폭 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 무역 마찰은 벨기에와 네덜란드에서 생산되는 생물학적 제제의 가격을 상승시켜 치료 개시 지연과 희귀질환 치료 비용을 증가시켜 미국에서 효소 보충 요법의 채택을 방해할 수 있습니다. 또한 상호관세나 무역마찰·제한의 격화에 의한 세계경제 및 무역에 대한 악영향에 의해 그 영향은 보다 광범위하게 미칠 것으로 보입니다.

폼페병의 유병률 증가는 폼페병 시장의 성장을 가속할 것으로 예측됩니다. 글리코겐 저장병 유형 II 또는 산성 말타제 결핍으로도 알려진 이 드문 유전 질환은 복잡한 당 분자인 글리코겐이 다양한 신체 조직, 특히 근육과 기관에 축적되는 것을 특징으로 합니다. 폼페병의 치료에는 단백질 보충 요법, 알글루코시다아제 알파, 정맥 주사용 넥스비아자임(Nexviazyme) 등이 포함됩니다. 2022년 6월에 유럽 Medicines Agency Highlights가 보고한 폼페병 사례 증가는 폼페병 시장 확대에 기여할 것으로 예측됩니다. 유럽에서만 폼페병의 원인이 될 수 있는 돌연변이를 가진 유아 발병 환자는 약 224명, 소아 발병 환자는 471명, 성인 발병 환자는 2만490명입니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

Pompe disease is a genetic disorder characterized by the accumulation of a complex sugar known as glycogen within the cells of the body. This condition arises due to a deficiency in the enzyme acid alfa glucosidase (GAA), responsible for breaking down complex carbohydrates in the body.

Pompe disease manifests in several forms, including the classic infantile form, non-classic infantile form, late-onset form, and others. The classic infantile form is the most widely recognized, presenting significant heart dysfunction and noticeable hypotonia within a few months of birth. Diagnosis involves various methods such as blood tests, genetic tests, prenatal tests, and others. Treatment options for Pompe disease encompass oral, parenteral, and alternative approaches. Therapies include enzyme replacement therapy (ERT), substrate reduction therapy (SRT), gene therapy, and other modalities utilized by hospitals, clinics, pharmaceuticals, researchers, and other stakeholders.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The pompe disease market research report is one of a series of new reports from The Business Research Company that provides pompe disease market statistics, including pompe disease industry global market size, regional shares, competitors with a pompe disease market share, detailed pompe disease market segments, market trends and opportunities, and any further data you may need to thrive in the pompe disease industry. This pompe disease market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pompe disease market size has grown steadily in recent years. It will grow from $1.74 billion in 2024 to $1.8 billion in 2025 at a compound annual growth rate (CAGR) of 3.3%. The growth in the historic period can be attributed to increased awareness and diagnosis, orphan drug designation and incentives, global collaborations and research initiatives, patient advocacy, and support groups.

The pompe disease market size is expected to see strong growth in the next few years. It will grow to $2.31 billion in 2029 at a compound annual growth rate (CAGR) of 6.5%. The growth in the forecast period can be attributed to continued research and development, expansion of newborn screening programs, advancements in gene therapy, increasing global investment in rare diseases, patient-centric drug development, expansion of clinical trials and research initiatives, market emphasis on personalized medicine approaches. Major trends in the forecast period include product innovation, technological advancements, implementation of patient support programs, growing adoption of telemedicine for patient management, and collaborations for expanded access programs.

The forecast of 6.5% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. adoption of enzyme replacement therapies by inflating prices of biologics manufactured in Belgium and the Netherlands, resulting in delayed treatment initiation and higher rare disease care costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The rising prevalence of Pompe disease is anticipated to drive the growth of the Pompe disease market. Also known as glycogen storage disease type II or acid maltase deficiency, this rare genetic disorder is characterized by the accumulation of glycogen, a complex sugar molecule, in various body tissues, particularly in muscles and organs. Treatments for Pompe disease include protein replacement therapy, alglucosidase alfa, and Nexviazyme for intravenous infusion. The increase in Pompe disease cases, such as those reported by the European Medicines Agency Highlights in June 2022, is expected to contribute to the expansion of the Pompe disease market. In Europe alone, there are approximately 224 infantile-onset, 471 juvenile-onset, and 20,490 adult-onset individuals with mutations potentially causing Pompe disease.

The increasing healthcare expenditure is playing a significant role in driving the growth of the Pompe disease market in the future. Governments and insurance providers are progressively acknowledging the importance of ensuring access to innovative therapies. For example, in May 2023, a report from the Office for National Statistics, a UK government department, revealed that healthcare spending in the UK rose by 5.6% from 2022 to 2023, compared to a growth of just 0.9% in 2022. In 2023, the UK's healthcare expenditure was approximately $317.63 billion (£292 billion). Thus, the rising healthcare expenditure is expected to propel the Pompe disease market forward.

Product innovations are a prominent trend in the Pompe disease market, with major companies adopting innovations to maintain their market position. For example, in September 2023, Amicus Therapeutics received approval from the U.S. Food and Drug Administration (FDA) for Pombiliti and Opfolda, a two-component therapy designed for adults with late-onset Pompe disease. The therapy combines a recombinant human GAA enzyme (rhGAA) for increased uptake into muscle cells with an enzyme stabilizer (Opfolda) to stabilize the enzyme in the blood. This FDA approval highlights the importance of advancements in science and medicine.

Major companies in the Pompe disease market are prioritizing strategic partnerships to enhance product development, broaden market reach, and improve solutions for animal health. A strategic partnership generally refers to a collaborative relationship between two or more organizations that combine their resources, expertise, and efforts to achieve shared goals or objectives. For example, in June 2024, Shionogi & Company, Limited, a Japanese pharmaceutical firm, entered into a global licensing agreement with Maze Therapeutics, a US-based biotechnology company, for MZE001, an investigational oral medication aimed at treating Pompe disease. Under this agreement, Shionogi secures exclusive rights to MZE001 and its associated intellectual property, which includes an initial payment of $150 million, along with potential milestone and royalty payments. This agreement was finalized following the necessary 30-day review period mandated by U.S. antitrust law (HSR Act).

In January 2022, Hansa Biopharma AB and Asklepios BioPharmaceutical Inc. collaborated to assess the potential use of imlifidase as a pre-treatment before administering AskBio's gene therapy for Pompe disease. This partnership involves a pre-clinical and clinical feasibility program for patients with pre-existing neutralizing antibodies to adeno-associated virus (AAV). Hansa will receive a $5 million payment, and AskBio holds an exclusive option for a full development and commercialization agreement based on the results of an initial Phase I/II study. AskBio will lead the pre-clinical and clinical studies, while Hansa will provide materials and additional support outlined in the feasibility program.

Major companies operating in the pompe disease market include F. Hoffmann-La Roche AG, Sanofi S.A., Amicus Therapeutics Inc., Sangamo BioSciences Inc., Asklepios BioPharmaceutical Inc., Audentes Therapeutics Inc., Genethon, Maze Therapeutics Inc., Avidity Biosciences Inc., EpiVax Inc., M6P Therapeutics, Oxyrane UK Limited, Valerion Therapeutics LLC, Abeona Therapeutics Inc., BioMarin Pharmaceutical, Genzyme Corporation, Novartis AG, Ultragenyx Pharmaceutical, Aro Biotherapeutics Company, Akashi Therapeutics, Protalix BioTherapeutics, AVROBIO Inc., Catabasis Pharmaceuticals

North America was the largest region in the pompe disease market in 2024. The regions covered in the pompe disease market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the pompe disease market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The pompe disease market includes revenues earned by entities by lumizyme, alglucosidase alfa, nexviazyme, and aval glucosidase alfa. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Pompe Disease Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on pompe disease market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for pompe disease ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pompe disease market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Pompe Disease Market Characteristics

3. Pompe Disease Market Trends And Strategies

4. Pompe Disease Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Pompe Disease Growth Analysis And Strategic Analysis Framework

6. Pompe Disease Market Segmentation

7. Pompe Disease Market Regional And Country Analysis

8. Asia-Pacific Pompe Disease Market

9. China Pompe Disease Market

10. India Pompe Disease Market

11. Japan Pompe Disease Market

12. Australia Pompe Disease Market

13. Indonesia Pompe Disease Market

14. South Korea Pompe Disease Market

15. Western Europe Pompe Disease Market

16. UK Pompe Disease Market

17. Germany Pompe Disease Market

18. France Pompe Disease Market

19. Italy Pompe Disease Market

20. Spain Pompe Disease Market

21. Eastern Europe Pompe Disease Market

22. Russia Pompe Disease Market

23. North America Pompe Disease Market

24. USA Pompe Disease Market

25. Canada Pompe Disease Market

26. South America Pompe Disease Market

27. Brazil Pompe Disease Market

28. Middle East Pompe Disease Market

29. Africa Pompe Disease Market

30. Pompe Disease Market Competitive Landscape And Company Profiles

31. Pompe Disease Market Other Major And Innovative Companies

32. Global Pompe Disease Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Pompe Disease Market

34. Recent Developments In The Pompe Disease Market

35. Pompe Disease Market High Potential Countries, Segments and Strategies

36. Appendix

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