The Lambert-Eaton Myasthenic Syndrome market report provides current treatment practices, emerging drugs, Lambert-Eaton Myasthenic Syndrome (LEMS) market share of the individual therapies, current and forecasted Lambert-Eaton Myasthenic Syndrome (LEMS) market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Lambert-Eaton Myasthenic Syndrome (LEMS) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
Lambert-Eaton Myasthenic Syndrome (LEMS) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of LEMS, Total Diagnosed Prevalent Cases of LEMS, Gender-specific Diagnosed Prevalent Cases of LEMS, Type-specific Diagnosed Prevalent Cases of LEMS, and Diagnosed Prevalent Cases of LEMS by Malignancy scenario of LEMS in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030.
- Total prevalent cases of LEMS in the 7MM was found to be 5,977 in 2017.
- Based on the etiology, LEMS is divided into two types; paraneoplastic and idiopathic. There were a total 1,978 diagnosed prevalent cases of LEMS in the United States in 2017, out of which 1,154 accounted for paraneoplastic and 824 cases accounted for idiopathic.
- As per the assessments, in the 7MM, the majority of cases of LEMS are paraneoplastic form as compared to idiopathic form.
- Among the two forms of LEMS, the paraneoplastic form constitutes more than half of the cases and is mostly associated with intrathoracic neoplasms. Most of the cases were seen with small cell lung cancer (SCLC); other subtypes of lung cancer are extremely rare.
- Among the EU-5 countries, Germany witnessed the highest prevalent population accounting for 6.93% of the total prevalent cases in 7MM, followed by France and the United Kingdom. On the other hand, Spain witnessed the lowest number of prevalent cases in 2017.
- Japan was assessed with 21.32% of the total prevalent population, with 1,274 cases observed in 2017.
Lambert-Eaton Myasthenic Syndrome (LEMS) Market Outlook
The therapeutic market of LEMS in the seven major markets was assessed to be USD 59.43 million in 2017 (With Base Case Scenario* and Downside Scenario**) and is expected to grow during the study period (2017–2030).
Currently, there is no cure for LEMS and treatment is mainly symptomatic. This includes 3, 4-diaminopyridine phosphate (DAP), which is usually well-tolerated and effective. In some patients, the combination of pyridostigmine with 3, 4-DAP has been suggested to have an additional positive effect. If symptomatic treatment is insufficient, immunosuppressive therapy with prednisone, alone or in combination with azathioprine, can achieve long-term control of the disorder. Plasmapheresis and high dose administration of intravenous immunoglobulins (IVIGs) have a short effect. An effective treatment against any tumor present is mandatory, both to control the tumor and to improve the clinical symptoms of LEMS.
So far, there are only two FDA approved the medication for LEMS, i.e., Firdapse and Ruzurgi. The FDA’s approval of Firdapse is a potentially transformative milestone in the lives of patients in the US suffering from LEMS, as it now gives adult LEMS patients access to a new first-in-class-therapy. Firdapse is approved in the US and the European Union for use by patients with LEMS.
After the approval of Firdapse, Ruzurgi is the second drug to be approved in the US for the treatment of LEMS and first approved the medication for the treatment of LEMS in patients 6 years to less than 17 years of age. Despite being a potential therapy in the treatment, a lawsuit has been filed by Catalyst Pharma against the US FDA and several related parties challenging the recent approval of an NDA and related drug labeling for Ruzurgi for the treatment of LEMS in pediatric patients. The lawsuit alleges that the approval of Ruzurgi, Catalyst’s rival medicine from privately held Jacobus Pharmaceutical, in May violated provisions of US FDA’s regulations and Catalyst’s rights to exclusivity for its drug, Firdapse. Both drugs are approved to treat LEMS, but Firdapse was approved for adults, while Jacobus’ drug was for children.
Presently there are no approved therapies of LEMS in Japan, Catalyst Pharma announced the plan to expand sales of Firdapse in Japan. They recently had talks with the Japanese Ministry of Health, Labor and Social Affairs (MHLW) to get Firdapse approved in Japan. About two years ago, the Japanese government approved Firdapse as a primary drug for the MHLW and actively asked companies to develop and submit an NDA for the drug. Once Catalyst and MHLW have reached agreement on what will be required to file this NDA in Japan, an update of the approval process for filing an NDA in Japan will be released.
According to DelveInsight, the market size of LEMS in the seven major market (7MM) is expected to change during the study period 2017–2030.
*Base Case Scenario: With the Base Case Scenario, DelveInsight’s analysts estimate that Ruzurgi will not be launch in the market because Catalyst has filed a suit against Jacobus’ drug (Ruzurgi). Therefore, it is estimated that Firdapse will cover a decent market in the upcoming years without any competition
**Downside Scenario: With Downside Scenario, DelveInsight is expecting the launch of Ruzurgi in the United States in the second half of 2020, which will compete and likely to take the market share of Firdapse.
This section includes a glimpse of the Lambert-Eaton Myasthenic Syndrome (LEMS) market in 7MM.
- In 2017, the market size of LEMS in the 7MM was USD 59.43 million.
- Among the 7MM, the United States accounted for the majority of the market size with USD 32.85 million in 2017.
- The current market size of LEMS is entirely dependent on symptomatic treatment regimens, includes Firdapse, 3, 4-diaminopyridine (base), pyridostigmine, immunoglobulin, and others). Others include guanidine, acetylcholinesterase (AChE) inhibitors, prednisone, azathioprine, cyclosporine, and plasmapheresis.
- Firdapse (Catalyst Pharmaceuticals) is the only approved therapy for the treatment of LEMS in adults in the United States and EU5.
- Another Molecule Ruzurgi (Jacobus Pharmaceuticals), is approved by the US FDA in May 2019, for the treatment of patients with LEMS age six to less than 17 years. However, In June 2019, Catalyst filed its lawsuit in the US District Court for the Southern District of Florida and is seeking a reversal of FDA’s decision.
- DelveInsight estimates that Japan has the second-highest market size after the United States in 2017, which is accounted for USD 9.59 million.
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