Global Lysosomal Acid Lipase Market Overview
The key driver impacting the lysosomal acid lipase (LAL) market is the rapid approval of therapy by the FDA. For instance, In 2015, the U.S. Food and Drug Administration (FDA) had approved Kanuma (sebelipase alfa), of Alexion Pharmaceuticals. It is a novel enzyme replacement therapy (ERT). Kanuma is the first therapy which is approved by the FDA that treats the latent cause of the disease. It is the only therapy approved for LAL deficiency treatment across the globe. It is approved in the EU (September 2015), Japan (March 2016), and in U.S. (December 2015) for LAL-D patients. Moreover, continued use of supportive care therapies and high unmet needs contribute to market growth.
According to Value Market Research, the global lysosomal acid lipase market size was valued at around USD 500 million in 2020 and is estimated to grow at a CAGR of about 11% during the forecast period 2021 to 2027.
The growing incidences of liver complications due to LAL deficiency raised liver transplants' need and are estimated to augment lysosomal acid lipase demand in the forecast period. For instance, It is likely to be between 1:40,000 to 1:300,000. Infantile-onset LAL-D usually is fatal within the first 12 months of life. According to the National Institute for Health and Care Excellence (NICE) 2016, around 87% of patients have LAL deficiency signs in more than one organ. It is expected that about 50% of children and adults with LAL deficiency progress to have liver complications such as cirrhosis, fibrosis and require a liver transplant within three years from the onset of clinical symptoms. However, the low awareness and high treatment cost may hamper the global lysosomal acid lipase market in the long run. Also, the threat of unavailability of seamless internet connectivity globally is negatively impacting the market. The current industry trends, such as the rising adoption of enzyme replacement therapy, continued research and development, are expected to provide market players with new market opportunities.
The lysosomal acid lipase market is vast, with many local and global players. The lysosomal acid lipase market is extensive, with many local and international players. The key leaders follow several strategies to mount their market position, such as contracts, mergers, amalgamation, product upgrades, extending product portfolio, and acquisitions, to raise their market share across the globe. The significant players studied in the report are AstraZeneca plc., Alexion Pharmaceutical Inc., Pfizer, Merck & Co., Inc., Pfizer, Inc., and Teva Pharmaceutical Industries Ltd.
In this research report, the lysosomal acid lipase market is segmented by indication, treatment class, and region.
Analysis by Indication:
By indication, the report is segmented into cholesteryl ester storage disease (CESD), and Wolman disease (WD). The Wolman disease (WD) dominates the indication segment with a 40% share in 2020. Wolman disease is considered the most severe expression of LAL deficiency. A mild form of LAL deficiency is recognized as cholesteryl ester storage disease (CESD), which is highly prevalent globally. Moreover, to growing uptake of enzyme replacement therapy (ERT) for treating Wolman disease contributes to Wolman disease's growth in the forecast period.
Analysis by Treatment Class:
By treatment class, the report is segmented into enzyme replacement therapy, lipid-modifying agents (statins), surgery (liver transplant), stem cell transplantation, and supportive care. The enzyme replacement therapy dominates the treatment class segment with a 20% share in 2020. It is due to the high efficacy and long-term disease control after treatment. Enzyme Replacement Therapy is majorly preferred due to lesser side effects, available for both children and adults and even breastfeeding and pregnant women, driving its demand in the forecast period. Moreover, the growing usage for treating lysosomal storage diseases such as Fabry disease, Gaucher disease, Pompe disease, MPS I, MPS II (Hunter syndrome), and MPS VI drives the enzyme's demands replacement therapy segment in the forecast period.
Analysis by Region:
In the regional outlook of the global lysosomal acid lipase market, the North America region dominates with over 30% market share during the forecast period. It is due to the growing novel innovations, increasing research, and drug development activities in U.S. and Canada. Moreover, increasing uptake of Kanuma, high disease prevalence, and the prevalence of a large patient pool in the U.S. contribute to the growth of the market across North America.
Market Segmentation covered in the Report:
By Indication
- Wolman Disease (WD)
- Cholesteryl Ester Storage Disease (CESD)
By Treatment Class
- Enzyme Replacement Therapy
- Lipid-Modifying Agents (Statins)
- Surgery (Liver Transplant)
- Stem Cell Transplantation
- Supportive Care
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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