The global enzyme replacement therapy market is anticipated to grow at a significant CAGR during the forecast period. The enzyme replacement therapy is a favorable solution to the people diagnosed with a rarer disease such as Hunter syndrome, Fabery disease, Pompe disease, and many more. The enzyme replacement therapy is not a complete cure for rarer diseases, however, patients who have been treated through the enzyme replacement therapy have their conditions significantly improved. Additionally, enzyme replacement therapy has to be given to the patients for a long time and the end results are completely in favor of the patients. This is anticipated to drive the growth of the enzyme replacement market.

However, the high cost associated with the enzyme replacement therapy as it has to be given to the patient for a longer period is anticipated to challenge the growth of the global enzyme replacement market. Additionally, the less diagnosis rate in the developing countries and low awareness regarding the rarer disease will restrict the growth of the enzyme replacement market during the forecast period.

Segmental Outlook 

The enzyme replacement therapy market is segmented on the basis of the enzyme types and indication. Based on the enzyme type, the market is sub-segmented into agalsidase beta, agalsidase alfa, gulsulfase, and others. Based on the indication, the market is sub-segmented into Fabry disease, Gaucher disease, Pompeo disease, and others.

Global Enzyme Replacement Therapy Market Share by Indication, 2018 (%)

Gaucher Disease to Contribute a Prominent Share

The Gaucher disease segment is anticipated to hold a significant market share in the enzyme replacement therapy market owing to the increasing adoption of enzyme therapy treatment for the Gaucher disease across the globe. Additionally, there is no specific treatment available for the Gaucher disease, however, the symptoms of the disease can be minimized with the enzyme replacement therapy. According to the National Organization for Rarer Disorders (NORD) in 2019, around 6,000 individuals have some form of Gaucher disease in the US alone. Hence, the vast patient population diagnosed with Gaucher disease will increase the enzyme replacement therapy market. 

Regional Outlooks

The global enzyme replacement therapy market is further segmented based on geography into North America, Europe, Asia-Pacific, and Rest of the World. North America is expected to hold the largest market share in the Enzyme replacement therapy during the forecast period. Owing to the well-developed healthcare structure in the region coupled with the huge number of patients diagnosed with rarer diseases in the region. According to the Genetic and Rare Disease Information Center (GARD), the number of people living with a rare disease is estimated at between 25-30 million in the US.

Asia-Pacific will Augment with the Fastest Growth Rate in the Enzyme Replacement Therapy Market

Asia-Pacific is anticipated to exhibit the fastest growth rate in the enzyme replacement therapy market owing to the increased R&D activities and government funding. For instance, according to the draft of rare diseases policy 2020, the Government of India has proposed financial support of up to $19,874 under the Rashtriya Arogaya Nidhi (RAN) Scheme for the one-time treatment of patients with rare diseases. Additionally, new drug approval and launches by key players in the region will also fuel the enzyme replacement therapy market. For instance, in May 2019, Teijin Pharma Ltd launched Revcovi 2.4 mg for intramuscular injection [Elapegademase (Genetical Recombination)], effective immediately. Revcovi 2.4 mg, Japan's first drug for Adenosine deaminase (ADA) deficiency, is an enzyme replacement therapy that is expected to improve ADA activity and the immune system of ADA-deficiency patients.

Market Players Outlook

Some of the key players of the global enzyme replacement therapy market includes Amicus Therapeutics Inc., Sanofi SA, BioMarin Pharmaceutical Inc., Horizon Therapeutics plc, Pfizer Inc., Takeda Pharmaceutical Co. Ltd., Protalix BioTherapeutics Inc. Teijin Ltd., and others. The market players are considerably contributing to the market growth by the adoption of various strategies including new product launch, merger, and acquisition, collaborations with government, funding to the start-ups, and new drug approvals to stay competitive in the market. 

Recent Activities

• In March 2020, Protalix BioTherapeutics Inc. investigated the PRX-102 (pegunigalsidase alfa) enzyme replacement therapy’s data from two Phase 1/2 trials. PRX-102 is anticipated to lead clinical improvements in adults with Fabry disease. The results are further confirming its potential to lessen Fabry disease.
• In May 2019, Teijin Pharma Ltd., launched Revcovi 2.4 mg for intramuscular injection [Elapegademase (Genetical Recombination)]. The Revcovi 2.4 mg, is an enzyme replacement therapy and considered to be Japan's first drug for Adenosine deaminase (ADA) deficiency. This enzyme replacement therapy is expected to improve ADA activity and the immune system of ADA-deficiency in patients.
• In October 2018, FDA Approves Revcovi, an enzyme replacement therapy produced by the Leadiant Biosciences, Inc. in the form of injections to be marketed in the US. This is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric as well as adult patients. 

The Report Covers

• Market value data analysis of 2018 and forecast to 2025.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the global enzyme replacement therapy market. Based on the availability of data, information related to pipeline products, and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.