Amyotrophic Lateral Sclerosis Therapeutics Market Size, Share & Industry Analysis, By Drug Type (Tofersen, Edaravone, Riluzole, and Others), By Route of Administration (Oral and Parenteral), By Distribution Channel (Hospital Pharmacy and Retail & Online Pharmacy), and Regional Forecast, 2024-2032

The global amyotrophic lateral sclerosis therapeutics market size was valued at USD 1.01 billion in 2023. The market is projected to grow from USD 0.77 billion in 2024 to USD 1.80 billion by 2032, exhibiting a CAGR of 11.3% during the forecast period.

Amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, is a progressive nervous system disorder that weakens muscles and impacts the physical function of the person. Amyotrophic lateral sclerosis (ALS) can be diagnosed through physical examination, neurological examinations, blood and urine tests, electromyograms, and other diagnostic methods. As there is no cure for ALS, certain medications, assistive devices, physical and speech therapy, and other treatments can help slow down the disease’s progression. The drugs approved for treating amyotrophic lateral sclerosis include tofersen, edaravone, and riluzole, which help alleviate symptoms.

The increasing prevalence of Lou Gehrig's disease has been fueling the demand for these drugs for effective treatment. 

• For instance, as per the research study published by John Wiley & Sons, Inc. in 2021, ALS is expected to grow from 222,000 in 2015 to 376,000 in 2040 globally.

Moreover, the increasing focus of organizations such as Asha Ek Hope, ALS Association, I AM ALS, Asociación Colombiana de Esclerosis Lateral Amiotrófica (ACELA),  Asociación ELA Argentina, and ALS Netherlands have been focusing on raising awareness regarding the diseases, further increasing the demand for effective treatment. This heightened awareness and demand are fueling the global amyotrophic lateral sclerosis therapeutics market growth.

During the COVID-19 pandemic, the global amyotrophic lateral sclerosis therapeutics market experienced a decline in its value. This was due to the limited number of people visiting the doctor’s clinic and hospitals for ALS diagnosis and treatment in order to control the spread of the virus. Furthermore, the revenue generated by market players from the sale of ALS drugs was negatively impacted due to supply chain disruption.

However, in 2021 and 2022, the amyotrophic lateral sclerosis therapeutics market experienced significant growth due to the growing burden of the disease and the increasing number of patients visiting doctors for effective treatment and diagnosis.

Amyotrophic Lateral Sclerosis Therapeutics Market Trends

Increasing Development of Novel Drugs for Effective Treatment of Amyotrophic Lateral Sclerosis is a Latest Trend

The prevalence of Lou Gehrig's disease has been growing at a significant rate. This growing occurance, along with the increasing focus of the market players on the development of novel drugs for effective treatment, has also been fueling amyotrophic lateral sclerosis therapeutics market growth.

• For instance, in September 2021, AL-S Pharma initiated phase 2 clinical trials of its drug candidate AP-101 for the effective treatment of amyotrophic lateral sclerosis. The estimated completion date of the trial is January 2025.


• Similarly, Clene Nanomedicine initiated a phase 2 clinical trial to study the safety and efficacy of its drug candidate CNMAu8 in treating Lou Gehrig's disease in December 2021. The expected completion date of the trial is December 2024.

The increasing emphasis of pharmaceutical companies on the development and commercialization of novel drugs for effective treatment is expected to fuel market growth in the forecast period.

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Amyotrophic Lateral Sclerosis Therapeutics Market Growth Factors

Growing Burden of Amyotrophic Lateral Sclerosis and Increasing Government Initiatives are Expected to Fuel the Demand for Effective Drugs

Drugs such as tofersen, edaravone, and riluzole are effective in the treatment of ALS. For instance, as per the data published by the National Center for Biotechnology Information (NCBI) in 2022, Mitsubishi Tanabe Pharma’s Radicava (edaravone), approved by the U.S. Food and Drug Administration (FDA) for the treatment of ALS, has been observed to slow the progression of the disease.

Due to this, the demand for these drugs has been increasing significantly for the treatment of  Lou Gehrig's disease. Therefore, the high burden of the disease has been fueling the global market growth.

• For instance, as per the study published by NCBI in November 2023 reported that the prevalence of ALS in Sardinia, Italy, increased to 18.31 per 100,000 in January 2019 from 15.26 per 100,000 in January 2015.

Furthermore, in order to provide treatment options, government organizations in many countries have increased their focus on investing in effective therapeutic development.

• For instance, as per the data published by the Government of Canada in June 2023, the Canadian Government Health authorities invested around USD 40.0 million in research for Lou Gehrig's disease through the Canadian Institutes of Health Research (CIHR).

Therefore, the increasing prevalence of the disease, along with the growing focus of government authorities in many countries on the development of effective treatment options, have been fueling the market growth worldwide.

RESTRAINING FACTORS

High Costs and Side Effects Associated with the Use of ALS Therapeutics to Limit Market Growth

The growing burden of ALS, along with increasing awareness of the disease, has been fueling the demand for effective treatment options. However, certain factors, such as high treatment costs, side effects associated with these therapeutics, and the presence of alternative treatment options, have been limiting the adoption of these therapeutics.

There are no therapeutics currently available that can cure ALS. However, some drugs help in treating the symptoms of the disease. For instance, treatment with Radicava ORS, a Mitsubishi Tanabe Pharma product, can be quite costly, at around USD 171,000.0 per year.

Furthermore, these drugs can cause certain side effects such as dizziness, weakness, breathing problems, bladder pain, and blurred vision. Due to the side effects and high cost associated with the use of these drugs, patients prefer going for alternate treatment options such as nutritional support, speech therapy, physical therapy, and surgeries. Therefore, the shift in patient preference toward alternate treatment options has been restricting the adoption of these drugs, thereby limiting market growth.

Amyotrophic Lateral Sclerosis Therapeutics Market Segmentation Analysis

By Drug Type Analysis

Others Segment Dominated due to Strong Sales of Relyvrio

On the basis of drug type, the market for amyotrophic lateral sclerosis therapeutics is segmented into tofersen, edaravone, riluzole, and others.

The others segment accounted for the largest market share in 2023. The dominance is attributed to the significant revenue generated by Relyvrio, an AMYLYX Pharmaceuticals product. However, the drug was withdrawn in April 2024 due to failure in late-stage clinical trials. Furthermore, the others segment is expected to grow at a significant CAGR during the forecast period. This is due to the presence of drug candidates such as CNMAu8, MRG-001, and AP-101 in the pipeline, which are expected to receive approval during the forecast period.

The edaravone segment is expected to dominate the market during the forecast period. The dominance is attributed to the approval of edaravone in major countries, including the U.S., Brazil, Canada, Switzerland, China, and Thailand, among others. Moreover, the drug is present in both oral and parenteral forms. This factor is responsible for the strong sales of the drug.

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By Route of Administration Analysis

Oral Segment Led due to Presence of Oral Branded Drugs

Based on route of administration, the market is segmented into oral and parenteral. 

The oral segment dominated the market in 2023. The segment’s dominance is attributed to the strong sales of Relyvrio in 2023. Additionally, out of all the approved drugs among the amyotrophic lateral sclerosis therapeutics, most of them are in oral form such as Radicava, Rilutek, and Tiglutik. Moreover, increasing number of oral pipeline drugs such as CORT113176 and BRAVYL (WP-0512), among others is expected to fuel the market growth during the forecast period.

Moreover, the parenteral segment is expected to grow at the highest CAGR during the forecast period. The segment's growth is attributed to the approval of QALSODY, a Biogen branded drug indicated for Lou Gehrig's disease.

By Distribution Channel Analysis

Hospital Pharmacy Dominated the Market owing to Presence of Well-trained Staff

Based on distribution channel, the amyotrophic lateral sclerosis therapeutics market is segmented into hospital pharmacy and retail & online pharmacy.

The hospital pharmacy captured the majority share of the market in 2023. The high share of the segment is attributable to the inclination of the patient population toward hospital pharmacies due to the presence of well-trained staff, reducing medication errors and medication-related risks to patients.

The retail & online pharmacy segment is expected to grow at the fastest CAGR during the forecast period. The segment's growth is attributed to the increasing number of retail pharmacies globally and the sale of orphan drugs through online platforms in countries where these drugs are not approved.

REGIONAL INSIGHTS

Based on geography, the market for amyotrophic lateral sclerosis therapeutics is studied across Europe, North America, the Asia Pacific, and the rest of the world.

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North America dominated the market in 2023, accounting for USD 0.72 billion of the global amyotrophic lateral sclerosis therapeutics market. The increasing focus of key players in introducing drugs in developed countries in North America is a key factor driving the growth of the market in the region. Key players target approvals from the U.S. FDA and other regulatory bodies in order to expand their product portfolio for multiple sclerosis treatment in the region.

The market in Europe accounted for a substantial market share in 2023. The market growth in the region is attributed to the commercialization of QALSODY and Radicava. Along with this, the expected approval of pipeline drugs such as   PTC857 and AP-101 in the forecast period is anticipated to fuel the amyotrophic lateral sclerosis therapeutics market growth in the region.

The Asia Pacific market is expected to grow at the fastest CAGR during the forecast period. The growth in the region is attributed to the increasing awareness regarding the efficiency of amyotrophic lateral sclerosis therapeutics and the growing focus of market players such as PTC Therapeutics and Clene Nanomedicine on conducting clinical trials for their drug candidate in the region.

The market in the rest of the world is expected to grow at a substantial CAGR during the forecast period. This growth is attributed to the growing prevalence of amyotrophic lateral sclerosis and increasing awareness about rare diseases in the region.

KEY INDUSTRY PLAYERS

Market Players Focus on Mergers and Acquisitions to Enhance their Product Portfolio

Market players such as Biogen, Mitsubishi Tanabe Pharma, and Sanofi accounted for a significant global amyotrophic lateral sclerosis therapeutics market share in 2023. The strong presence of these players in the market is attributed to their focus on commercializing their products globally.

• For instance, Mitsubishi Tanabe Pharma commercializes its product Radicava in countries such as the U.S., Japan, Brazil, Canada, and Switzerland.

Moreover, other players such as Corcept Therapeutics, Annexon, Inc., PTC Therapeutics, Revalesio Corporation, and Clene Nanomedicine have been focusing on conducting clinical trials for the launch of novel therapeutics.

• For instance, Corcept Therapeutics initiated phase 2 clinical trials to study the safety and efficacy of its drug candidate, CORT113176, for treating amyotrophic lateral sclerosis.

List of Top Amyotrophic Lateral Sclerosis Therapeutics Companies:

• Biogen (U.S.)


• Mitsubishi Tanabe Pharma (Japan)


• Sanofi (France)


• EDW Pharma, Inc. (U.S.)


• Aquestive Therapeutics (U.S.)


• Otsuka Pharmaceutical, Inc. (Japan)


• Novartis Pharmaceuticals (Switzerland)


• Zydus Lifesciences Limited (India)


• Clene Nanomedicine (U.S.)


• Annexon, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• May 2024 – Biogen received European Commission approval for commercializing its drug QALSODY, indicated for treating amyotrophic lateral sclerosis in Europe.


• May 2022 – Mitsubishi Tanabe Pharma received U.S. FDA approval for its drug Radicava, indicated for amyotrophic lateral sclerosis treatment.


• May 2022 – Sanofi initiated Phase 2 HIMALAYA Study for its candidate SAR443820 in patients with amyotrophic lateral sclerosis.


• March 2022 – Aquestive Therapeutics entered into a licensing agreement with Haisco Pharmaceutical Group to supply Riluzole oral film in China.


• January 2021 – Aquestive Therapeutics signed license and supply agreements with Mitsubishi Tanabe Pharma America to distribute EXSERVAN in the U.S.

REPORT COVERAGE

The global market report provides a detailed competitive landscape and market insights. It also includes key insights, such as top industry developments covering partnerships, mergers, and acquisitions. Additionally, it focuses on key points, such as new solution launches in the market. Furthermore, the report covers regional analysis of different market segments, profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that have contributed to the market's growth.

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