Enzyme Replacement Therapy Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

The global Enzyme Replacement Therapy market size is expected to be worth around US$ xx billion by 2028, according to a new report by Vision Research Reports.

The global Enzyme Replacement Therapy market size was valued at US$ 6.78 billion in 2020 and is anticipated to grow at a CAGR of 7.11% during forecast period 2021 to 2028.

Growth Factors

Genetic and Rare Diseases Information Center or GARD, a rare disease is defined as a condition that affects lesser than 200,000 individuals. These disorders are also called orphan diseases due to the lack of support exhibited by pharmaceutical companies previously. Since the passing of the Orphan Drug Act of 1983 in the U.S., several large pharmaceutical and biopharmaceutical companies have invested heavily in the development of orphan drugs. Thus, rising awareness, increasing R&D investment, growth in the number of lysosomal storage and genetic disorders, and easy drug approval process are factors propelling the market growth during the forecast period.

According to data from the National Institutes of Health, it is estimated that over 25 million Americans suffer from rare diseases. These facts are indicative of the fact that although the number of these ailments is low, individuals suffering from these are large. Some of the most common lysosomal storage disorders that make use of enzyme replacement therapy are Gaucher, Fabry, Pompe, MPS, SCID, and Shwachman-Diamond Syndrome among others.

In the recent past, these disorders have been gaining significant attention, impacting growth positively. Various grants and acts are in place to accommodate drug makers to invest in the development of orphan drugs. Orphan Drug Designation Program, Rare Pediatric Disease Priority Review Voucher Program, Humanitarian Use Device (HUD) Program, and Orphan Products Clinical Trials Grants Program are programs that aid in the development of orphan drugs.

Report Highlights

Based on enzyme type, the market is segmented into pegademase, velaglucerase alfa, agalsidase beta, imiglucerase, taliglucerase, laronidase, alglucosidase alfa, galsulfase, idursulfase, pancreatic enzymes, and other enzymes. The highest prevalence of Gaucher disease is one of the key factors for a large market share of enzymes such as imiglucerase and velaglucerase alfa.

Rising use of pancreatic enzymes such as amylase, lipase, and protease are used for the treatment of exocrine pancreatic insufficiency (EPI) seen commonly in cancer patients. Estimates from the American Cancer Society indicate that over 55,440 individuals were anticipated to be diagnosed with pancreatic cancer in the year 2018. Rising incidence of pancreatic cancer is thus expected to drive market growth during the forecast period.

Agalsidase beta which is used for the treatment of Fabry’s disease is anticipated to witness a CAGR of 14.8% during the forecast period. Sanofi Genzyme’s Fabrazyme is an enzyme replacement therapy used for the treatment of inherited disease. It works by replacing the enzyme responsible for low levels of GL-3 which is absent or deficient in individuals suffering from Fabry’s disease.

As the majority of these diseases are genetically acquired, early treatment is key in decreasing mortality rates. Rising awareness related to these diseases has been key in the increasing demand for enzyme replacement therapy products. Thus, are anticipated to witness lucrative growth over the forecast period.

Diseases such as Fabry, Pompe, and MPS are also seen to be gaining traction in the market owing to rising awareness brought about by organizations such as NORD (National Organization for Rare Disorders), Global Genes, GARD (Genetic and Rare Diseases Information Center) and National Institutes of Health among others.

Thus, rising awareness among pharmaceutical companies and the general public are anticipated to further propel market growth soon. Diseases such as SCID and MPS are anticipated to gain considerable market share during the forecast period owing to the increasing number of large pharmaceutical companies such as Pfizer and Shire investing heavily in the development of rare disease drugs.

Based on the route of administration, the enzyme replacement therapy market is divided into oral and parenteral routes. Parenteral route of administration held the largest market share in 2020 owing to its ability to facilitate rapid absorption and drug delivery. A large number of market players offer a wide range of parenteral enzyme replacement therapy; thus, this segment is anticipated to witness the highest CAGR during the forecast period.

Convenience in terms of storage, pre-measured doses, portability, and non-invasive nature of this route are some of the major factors that further accelerating oral drug adoption in the market. For instance, ZAVESCA is an oral drug developed by Actelion Pharmaceuticals Ltd which is used to treat Gaucher’s disease.

A considerable number of sustained and controlled release dosages are being preferred for the treatment of lysosomal storage diseases. These dosages tend to have a longer therapeutic effect leading to their preference over other conventional forms of drug delivery. Technologies such as microencapsulation and targeted delivery are being considered as options for enzyme treatment therapy.

Based on end-use, the market is segmented into hospitals, infusion centers, and others. Hospitals are the primary care settings facilitating easy treatment for a wide range of diseases. Thus, these end-use settings held the largest market share owing to frequent visits by patients and their ability to cater to a varied range of lysosomal storage diseases.

Infusion centers are anticipated to gain the highest CAGR during the forecast period. Since these centers are specialized centers for IV infusions, they facilitate easy treatment for a wide range of inherited diseases. In some instances, specialized staff performs infusions at home enhancing the patient experience.

Other end-use settings that offer enzyme replacement therapy consist of specialty clinics and home care settings. These are also anticipated to gain considerable market share during the forecast period owing to effective therapies and easy treatment options.

North America dominated the market in 2020. Well-developed healthcare infrastructure and the presence of leading market players in North America have fueled the growth of the regional segment. Moreover, the adoption of advanced technologies and increased focus on drug development in this region is expected to drive the sector growth.

The European region accounted for the second-highest revenue after North America and is expected to grow with a CAGR of 7.1%. The healthcare system in the European region is publicly funded and some countries have adopted universal health care systems. The presence of a large number of patients suffering from MPS and SCID are factors propelling market growth in the European region.

Key Players

• 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.

Market Segmentation

• Enzyme Outlook 

  • Imiglucerase

  • Agalsidase Beta

  • Taliglucerase

  • Velaglucerase Alfa

  • Laronidase

  • Alglucosidase Alfa

  • Galsulfase

  • Idursulfase

  • Pancreatic Enzymes

  • Pegademase

  • Others

• Therapeutic Condition Outlook 

  • Gaucher Disease

  • Fabry Disease

  • Pompe Disease

  • SCID

  • MPS

    • MPS I - Hurler, Hurler Scheie and Scheie

    • MPS II - Hunter

    • MPS III - Sanfilippo

    • Others

  • Others

• Route of Administration Outlook 

  • Oral

  • Parenteral

• End-Use Outlook 

  • Hospitals

  • Infusion Centers

  • Others

• Regional Outlook 

  • North America

    •  The U.S.

    • Canada

  •  Europe

    •  Germany

    •  UK

    •  France

    •  Italy

    •  Spain

    • Russia

  • Asia Pacific

    •  Japan

    •  China

    •  India

    •  Australia

    • South Korea

  • Latin America

    •  Brazil

    •  Mexico

    • Argentina

  •  MEA

    • South Africa

    • Saudi Arabia

    • UAE

The Enzyme Replacement Therapy market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Enzyme Replacement Therapy market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Enzyme Replacement Therapy market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Enzyme Replacement Therapy market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Enzyme Replacement Therapy market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Enzyme Replacement Therapy capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Enzyme Replacement Therapy by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Enzyme Replacement Therapy market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Enzyme Replacement Therapy market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Enzyme Replacement Therapy market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Enzyme Replacement Therapy industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Enzyme Replacement Therapy market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Enzyme Replacement Therapy market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Enzyme Replacement Therapy market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Enzyme Replacement Therapy market. These factors have benefited the growth of the global market for Enzyme Replacement Therapy. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Enzyme Replacement Therapy. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Enzyme Replacement Therapy are as follows:

• Historic Year: 2017-2020
• Base Year: 2020
• Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.