Global Enzyme Replacement Therapy Market by Enzyme (Agalsidase Beta, Pancreatic Enzymes) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

Global enzyme replacement therapy market was valued at USD 6.74 Billion in 2018. It is projected to grow at a compound annual rate (CAGR of 7.7%) between 2019 and 2026. Market potential is driven by the increasing availability of enzyme replacement therapies, increased awareness and looser guidelines for rare diseases. According to the Genetic and Rare Diseases Information Center (GRDIC), a rare disease refers to a condition that affects fewer than 200,000 people. Diverse organizations are taking strategic initiatives to raise awareness about these diseases and increase the lives of patients.

Genetic Alliance UK estimates that a single rare disease could affect more than 30,000 people in the UK. To decrease mortality rates, it is important to receive prompt medical treatment for chronic diseases. Gaucher, Fabry and Pompe are the most common lysosomal-storage diseases. There are also various MPS forms and SCID diseases. These rare diseases are not common. Orphanet estimates Gaucher's Disease to be present in one person in every 100,000 people. Its limited growth in the pharmaceutical sector is due to the low incidence of rare orphan diseases.

Market growth is being driven by rising awareness and a growing number of market players entering orphan disease management. These rare diseases will see an increase in the number of orphan drugs. This is due to the increasing investment by players in R&D.

The 1983 U.S. Orphan Drug Act is a U.S. law that was instrumental in the development and approval of new drugs to treat Tourette syndrome, ALS, muscular dystrophy and Huntington's diseases. Many regions, including Australia, Japan, the European Union and Japan, followed the lead of the Act to provide better treatment for orphan diseases. This helped propel the market growth.

Enzyme Type Insights

The market can be segmented by enzyme type into pegademase and velaglucerase fa, agalsidase Beta, imiglucerase and taliglucerase as well as galsulfase and idursulfase. A large market share for enzymes like imiglucerase and verlaglucerase alfa is due to the high prevalence of Gaucher disease.

For the treatment of exocrine (or pancreatic) insufficiency (EPI), a rising number of pancreatic enzymes like amylase, lipase and protease is being used. This condition is common in patients with cancer. According to the American Cancer Society, more than 55,440 people were expected to develop pancreatic cancer. Market growth is expected to be driven by rising pancreatic cancer incidence during the forecast period.

The CAGR for Agalsidase beta, which is used to treat Fabry's Disease, is expected to be 14.1% over the forecast period. Fabrazyme, an enzyme replacement therapy for inherited diseases by Sanofi Genzyme, is available from Sanofi Genzyme. It replaces the enzyme that is responsible for low levels GL-3 in people with Fabry's Disease.

Early treatment is crucial for decreasing mortality rates, as most of these diseases can be traced back to genetics. These diseases are becoming more common, which has led to a rise in demand for enzyme replacement therapy products. The enzymes will see a lucrative growth in the future.

Therapeutic Condition Insights

The market can be divided into Gaucher’s disease (Fabry’s disease), Pompe's disorder, SCID, MPS and other therapeutic conditions. MPS can further be divided into MPS I- Hurler, Hurler Scheie & Scheie, MPS 2 - Hunter, MPS 3 - Sanfilippo and other segments. Its large market share is responsible for the high incidence of Gaucher’s disease.

Gaucher disease, which is caused by recessive mutation, is an inherited condition. Based on the location, the U.S. National Library of Medicine estimates that Gaucher disease will affect one in 50,000 to 100,000 people. Clinicaltrials.gov data shows that there are over 60 active studies on Gaucher's disease, most of which are funded primarily by pharmaceutical companies.

Increasing awareness by organizations like NORD (National Organization for Rare Disorders), Global Genes (Genetic and Rare Diseases Information Center), and National Institutes of Health (among others) is helping diseases such as Fabry and Pompe gain traction on the market.

Market growth will be accelerated by increasing awareness from both pharmaceutical companies and the public. Due to large pharmaceutical companies like Shire and Pfizer investing heavily in rare diseases drugs, diseases such as SCID or MPS will gain significant market share over the forecast period.

Route of Administration Insights

The market for enzyme replacement therapy can be divided into two types based on the route of administration. The parenteral route of administration accounted for the largest share of the market in 2018, due to its ability to deliver drugs quickly and efficiently. There are many market players that offer parenteral enzyme replacement therapy. This segment is expected to see the highest CAGR over the forecast period.

The market is gaining popularity because of its ease of use, including pre-measured doses, portability and non-invasive nature. ZAVESCA, an oral drug that Actelion Pharmaceuticals Ltd has developed to treat Gaucher's Disease, is one example.

For the treatment of lysosomal-storage diseases, a large number of controlled and sustained release doses are preferred. These dosages have a longer therapeutic effect, making them preferable to other forms of drug delivery. Targeted delivery and microencapsulation are two options for enzyme treatment therapy.

End-Use Information

The market can be divided by end-use into hospitals and infusion centers. Hospitals provide easy access to treatment for many diseases. These end-use settings accounted for the largest market share due to their frequent visits and ability to treat a wide range of lysosomal storage disorders.

The highest CAGR is expected to be seen infusion centers during the forecast period. These centers offer IV infusions and are well-equipped to treat a variety of inherited conditions. Sometimes, the infusions can be done at home by specialized staff to enhance patient experience.

Specialty clinics and home-care settings are also end-use settings that provide enzyme replacement therapy. They are expected to grow in market share due to their easy and effective treatments. [email protected] A professional team of doctors and registered nurses administers home enzyme therapy programs. These initiatives are most commonly applicable to pediatric and geriatric populations, where home infusion is an effective and easy option.

Regional Insights

In 2018, North America was the dominant market. The growth of this segment has been fueled by the well-developed healthcare infrastructure in North America and the presence of major market players. The sector is expected to grow due to the increased use of advanced technologies and the increased emphasis on drug development in the region.

The European region was second in revenue behind North America, and it is expected to grow at a 7.1% CAGR. The European region's healthcare system is public-funded, and some countries have universal health care systems. Market growth is accelerated by the large number of people suffering from SCID and MPS in Europe.

Statistics from the Fabry Outcome Survey, prepared by Shire Outcome Surveys show that the UK, Japan, Germany and Japan have the highest rates of Fabry’s disease. According to FDA's Novel Drug Approvals, 39% of the novel drugs approved for 2017 were for orphan disease. These factors are expected to propel regional market growth.

Asia Pacific includes both developed and developing countries like India, China, and other countries in the region. The majority of countries in the region are economically developing, and disposable income is steadily increasing. This region is home to many multinational corporations. Aside from this, Japan and other countries are technologically advanced in healthcare and medical research. This helps in this region's market growth.

Market Share Insights & Key Companies

There are many players in the market, both local and global. These market players have a large portfolio of lysosomal diseases that can be easily treated.

The market leaders, including Shire Plc and Sanofi S.A. and AbbVie respectively, have strong geographic presences in terms of distribution networks and operating facilities. The key players are focused on the development and marketing of drugs that only target rare and genetic diseases. The Shire, plc, for example, has more than 40 products that are solely focused on rare and/orphan diseases. These diseases are also important to the company, so they constantly engage in campaigns to increase awareness. The company launched Rare Count in February 2017 as one of its many initiatives. This initiative was created to raise awareness about orphan diseases among the general public.

Key players are also pursuing mergers, acquisitions and strategic agreements, which will help propel the enzyme replacement therapy market. Most of the major players are focused on developing new products. To help patients more effectively, a variety of companies are involved in licensing and distribution. The following are some of the most prominent players in enzyme replacement therapy:

• Shire Plc; Sanofi S.A.

• Biomarin Pharmaceutical Inc.

• AbbVie

• Alexion Pharmaceuticals Inc.

• Allergan plc

• Horizon Pharma Public Limited Company

• Actelion (Janssen)

• Recordati Rare Diseases

• Protalix Biotherapeutics

• Amicus Therapeutics Inc.

Up Market Research published a new report titled “Enzyme Replacement Therapy Market research report which is segmented by Enzyme (Agalsidase Beta, Pancreatic Enzymes), By Players/Companies Actelion (Janssen), AbbVie, Amicus Therapeutics Inc, Protalix Biotherapeutics, Shire Plc; Sanofi SA, Recordati Rare Diseases, Alexion Pharmaceuticals Inc, Biomarin Pharmaceutical Inc, Allergan plc, Horizon Pharma Public Limited Company”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

Report Scope

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Enzyme Replacement Therapy Market Report Segments:

The market is segmented by Enzyme (Agalsidase Beta, Pancreatic Enzymes).

Enzyme Replacement Therapy Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Enzyme Replacement Therapy Market

Overview of the regional outlook of the Enzyme Replacement Therapy Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Enzyme Replacement Therapy Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Enzyme Replacement Therapy Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Agalsidase Beta

                2. Pancreatic Enzymes

7. Market scenario by region, sub-region, and country.
8. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
9. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
10. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Enzyme Replacement Therapy Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the Enzyme Replacement Therapy Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.