효소보충요법(ERT) 시장 예측(-2030년) : 제품별, 질환별, 투여 경로별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Enzyme Replacement Therapy Market is accounted for $10.1 billion in 2023 and is expected to reach $18.1 billion by 2030 growing at a CAGR of 8.6% during the forecast period. Enzyme replacement therapy (ERT) is carried out to replace a missing or deficient enzyme in a person with an inherited enzyme deficiency syndrome. Enzyme replacement therapy is a process in which different types of enzymes are administered in patients to overcome enzyme deficiencies or related malfunction. The rising prevalence of rare, chronic, and inherited disorders, including various kinds of lysosomal storage diseases and genetic disorders is fostering the demand for effective treatment options.

According to the Genetic and Rare Diseases Information Center (GARD), at present, there are around 25 to 35 million people in the United States that suffer from rare diseases.

Market Dynamics:

Driver:

Growing government spending on healthcare infrastructure

Governments of different nations are focusing on expanding the healthcare sector to treat people and combating health issues. Increasing initiatives by government and non-profit organizations in various countries to promote awareness among the general population lead to a gradual rise in the diagnosis rate of rare diseases. As a result of rising investment in healthcare infrastructure, the market size of enzyme replacement therapy is expected to expand in the assessment period.

Restraint:

Lack of Awareness

Lack of awareness about enzyme replacement therapy among developing nations is slowing down the adoption rate of enzyme replacement therapy. Also, the deficiency of technology and adequate infrastructure is expected to hamper the market growth. However, the lack of skilled healthcare technicians for this therapy and inadequate reimbursement policies in emerging countries are some of the factors limiting the market growth.

Opportunity:

Technological advancements

Significant developments around biotechnology have produced increasingly sophisticated and specialised enzyme replacement treatments. Recombinant enzymes may now be produced with better qualities such higher stability, specificity, and half-life due to advancements in recombinant DNA technology. Further investigation into gene therapy and other cutting-edge therapeutic approaches has the potential to boost ERT's efficacy in the future.

Threat:

High cost of these treatments

Due to the intricate manufacturing procedures required, the need for specialised infrastructure, and the relatively limited patient populations affected by uncommon genetic illnesses, medications are sometimes costly. For individuals, healthcare systems, and insurance companies, this high cost may provide access difficulties. The high cost of medications may make them difficult to afford and reimburse. The cost of treatments is also made more expensive by their duration.

COVID-19 Impact:

The COVID-19 pandemic is an unprecedented global public health challenge and is anticipated to have a negative impact on the enzyme replacement therapy market. The continuous spread of the pandemic and the measures taken by the governments of various countries have affected, and could continue to affect, the businesses, including future disruptions to supply chain and the manufacture or shipment of drug substance and finished drug products. In addition, has resulted in decreased public mobility, as well as impacted the diagnostic industries. Several diagnostic procedures and therapies that are non-emergent were put on hold to prevent the transmission of the novel corona virus.

The oral segment is expected to be the largest during the forecast period:

The oral segment is estimated to have a lucrative growth, due to the increasing patient preference for oral administration as it is convenient and non-invasive method of drug delivery. Ease of self-administration that allow patients to take their medication at home without the need for healthcare professional assistance, growing R&D efforts to develop oral formulations of enzyme replacement therapies and the potential advantages such as improved bioavailability and stability of certain enzymes when administered orally further boost the growth rate of the oral segment in the global market.

The hospital segment is expected to have the highest CAGR during the forecast period:

The hospital segment is anticipated to witness the fastest CAGR growth during the forecast period, due to the availability of advanced healthcare infrastructure, specialized medical personnel, and supportive facilities for administering enzyme replacement therapy. The growing number of collaborations between hospitals and pharmaceutical companies to ensure the availability and proper administration of enzyme replacement therapies and hospital-based clinical research and development activities further boost the growth rate of the hospital segment in the ERT market.

Region with Largest share:

North America is projected to hold the largest market share during the forecast period owing to the availability of infusion centers, increase in acceptance of newer therapies, and rise in prevalence of enzyme deficiency. The presence of advanced healthcare infrastructure, including well-established hospitals, research centers, and pharmaceutical companies that contribute to the development and adoption of enzyme replacement therapies is one of the major factors propelling the market growth.

Region with highest CAGR:

Europe is projected to have the highest CAGR over the forecast period, owing to supportive regulatory frameworks, the growing awareness and diagnosis of genetic disorders and favorable reimbursement policies. The presence of well-developed healthcare systems and robust infrastructure in that enable efficient diagnosis, treatment, and management of rare diseases requiring enzyme replacement therapy drive the growth of the market.

Key players in the market

Some of the key players profiled in the Enzyme Replacement Therapy Market include Takeda pharmaceutical Company Ltd., Leadiant Biosciences Inc., Biomarin Pharmaceuticals Inc., Genzyme Corporation, Pfizer Inc., Shire plc, Amicus Therapeutics, Sigma-Tau Pharmaceuticals, Inc., Essential Pharmaceuticals Limited, Merck KGa, AbbVie Inc, Sanofi Genzyme, Alexion Pharmaceuticals, Nestle Health Science and Astrazeneca Plc.

Key Developments:

In June 2023, BioMarin Pharmaceutical Inc. , announced that the United States Food and Drug Administration (FDA) approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.

In February 2023, Nestle Health Science and Codexis Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing pancreatic enzyme replacement therapy (PERT).

Products Covered:

• Galsulfase
• Velaglucerase Alfa
• Laronidase
• Idursulfase
• Imiglucerase
• Agalsidase Beta
• Alglucosidasealfa
• Pancrelipase
• Elosulfasealfa
• Asfotasealfa
• Other Products

Diseases Covered:

• Exocrine Pancreatic Insufficiency (EPI)
• Pompe Disease
• Mucopolysaccharidosis
• Gaucher Disease
• Fabry Disease
• Hunter Disease
• Scheie Syndrome
• Maroteaux-Lamy Syndrome
• Other Diseases

Route of Administrations Covered:

• Oral
• Parenteral
• Other Route of Administrations

End Users Covered:

• Infusion Centers & Home Healthcare Setting
• Hospitals
• Clinics
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Enzyme Replacement Therapy Market, By Product

• 5.1 Introduction
• 5.2 Galsulfase
• 5.3 Velaglucerase Alfa
• 5.4 Laronidase
• 5.5 Idursulfase
• 5.6 Imiglucerase
• 5.7 Agalsidase Beta
• 5.8 Alglucosidasealfa
• 5.9 Pancrelipase
• 5.10 Elosulfasealfa
• 5.11 Asfotasealfa
• 5.12 Other Products

6 Global Enzyme Replacement Therapy Market, By Disease

• 6.1 Introduction
• 6.2 Exocrine Pancreatic Insufficiency (EPI)
• 6.3 Pompe Disease
• 6.4 Mucopolysaccharidosis
• 6.5 Gaucher Disease
• 6.6 Fabry Disease
• 6.7 Hunter Disease
• 6.8 Scheie Syndrome
• 6.9 Maroteaux-Lamy Syndrome
• 6.10 Other Diseases

7 Global Enzyme Replacement Therapy Market, By Route of Administration

• 7.1 Introduction
• 7.2 Oral
• 7.3 Parenteral
• 7.4 Other Route of Administrations

8 Global Enzyme Replacement Therapy Market, By End User

• 8.1 Introduction
• 8.2 Infusion Centers & Home Healthcare Setting
• 8.3 Hospitals
• 8.4 Clinics
• 8.5 Other End Users

9 Global Enzyme Replacement Therapy Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Takeda pharmaceutical Company Ltd.
• 11.2 Leadiant Biosciences Inc.
• 11.3 Biomarin Pharmaceuticals Inc.
• 11.4 Genzyme Corporation
• 11.5 Pfizer Inc.
• 11.6 Shire plc
• 11.7 Amicus Therapeutics
• 11.8 Sigma-Tau Pharmaceuticals, Inc.,
• 11.9 Essential Pharmaceuticals Limited
• 11.10 Merck KGa
• 11.11 AbbVie Inc
• 11.12 Sanofi Genzyme
• 11.13 Alexion Pharmaceuticals
• 11.14 Nestle Health Science
• 11.15 Astrazeneca Plc.