Clinically Isolated Syndrome Treatment Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Global Clinically Isolated Syndrome Treatment Market is segmented By Treatment (Disease Modifying Therapies, Vitamin D Supplements), By Route of Administration (Oral, Intravenous, Other), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and By Region (North America, South America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

Clinically Isolated Syndrome Treatment Market Overview

Global clinically isolated syndrome treatment market is expected to reach at a high CAGR during the forecast period 2023-2030.

The global clinically isolated syndrome treatment market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Rising multiple sclerosis cases, research and development and government investments in pharmaceuticals and biotechnology are among the key drivers impacting clinically isolated syndrome treatment globally. After the challenging year of 2020, the clinically isolated syndrome treatment industry showed decent resilience and adaptability.

Government investments in multiple sclerosis, particularly in developing economies, will continue to drive utilization of disease modifying treatment and boost the global clinically isolated syndrome treatment market. The global clinically isolated syndrome treatment industry is placing increasing emphasis on better management of clinically isolated syndrome. The respective initiatives includes the use of other treatment, such as vitamin D supplements for management of gangliosidosis.

The disease modifying therapy, accounts for over two third of the market share. Similarly, the North America dominates the clinically isolated syndrome treatment market, capturing the largest market share of over 1/3rd. The region’s rapid investments in healthcare and rising major players in the clinically isolated syndrome treatment market globally, makes it the largest market share holder. United States has the largest pool of manufacturers as well as consumers.

Clinically Isolated Syndrome Treatment Market Scope

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Clinically Isolated Syndrome Treatment Market Dynamics

Growing Research and Development for Multiple Sclerosis

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high income levels, investments and infrastructure development. Several countries have experienced substantial demand for clinically isolated syndrome treatment, reflecting their expanding healthcare industries. Rising research and development for multiple sclerosis will be a crucial factor driving the growth of the market. 

On May 16, 2023, Positive findings from the second phase of the FENopta study testing experimental oral fenebrutinib in people with relapsing episodes of multiple sclerosis (RMS) were released by Genentech, a subsidiary of the Roche Group. The research demonstrated that oral fenebrutinib significantly decreased magnetic resonance imaging (MRI) biomarkers of MS disease progression in the brain when compared to placebo, demonstrating that it accomplished its primary and secondary goals. 

In addition, pre-clinical studies demonstrated the potency and good selectivity of fenebrutinib, the only reversible inhibitor now being tested in Phase III trials for MS. The trial's primary outcome, total new gadolinium-enhancing T1 brain lesions, was significantly decreased with fenebrutinib when compared to placebo (p=0.0022). A secondary goal showed that fenebrutinib significantly decreased the overall number of new or growing T2 brain lesions in comparison to placebo.

Rising Number of Clinical Outcomes with Positive Outcomes

Rising clinical trials with positive outcomes for treatment of GM1 gangliosidosis will drive the growth of the market in coming period of time. For instance, on April 17, 2021, In addition to demonstrating high persistence and strict adherence to twice-yearly (six-monthly) dosing, Roche announced novel OCREVUS (ocrelizumab) analyses promoting its significant advantage on progression of the disease in the initial stages relapsing-remitting multiple sclerosis (RRMS) and progressive primary MS (PPMS). 

At the 73rd Annual Meeting of American Academy of Neurology (AAN), which held on April 17–22, 2021, these results were virtually presented. In the post-hoc evaluation of the ORATORIO study in PPMS, OCREVUS therapy significantly reduced the buildup of atrophied T2-lesion volume (aT2-LV) when compared to placebo at 120 weeks. In the United States, OCREVUS is the most popular MS drug administered to patients beginning a new course of treatment, and over 200,000 people are currently receiving OCREVUS treatment globally.

High Cost Associated with the Drugs  

The BNF was used to get the price of DMT. IFN--1a (Avonex) therapy had a yearly expense of US$ 9178 based on a dose of 30 g once per week. Based on a dosage of 44 g three times per week, IFN--1a (Rebif) therapy has an annual cost of US$ 11405. For treatment with 250 g of SC IFN-1b on alternate days (Betaferon/Extavia) and 20 mg of SC GA every day (Copaxone), researchers calculated annual expenses of US$ 7836 and US$ 7232, respectively. Based on clinical expert advice for resource utilization, the monitoring costs were calculated using NHS reference prices and data from Curtis and Burns. 

Costs associated with initial and ongoing monitoring were calculated. For patients who received treatment using 30 g of IM IFN-1a once per week (Avonex), 250 g of SC IFN-1b on alternate days (Betaferon/Extavia), and 20 mg of SC GA daily (Copaxone) within the first year of starting medication, researchers calculated an expense of US$ 597 for monitoring. It was calculated that the IFN treatment regimen will cost between US$1,120 and US$1,962 in total. The price range for the Peg-IFN treatment plan was $2,156 to $5,887.

Adverse Reactions of Disease Modifying Therapies   

Injection site reactions, such as swelling, discomfort, or redness of skin at the location where the drug is injected, are common adverse reactions of beta interferon medications. Chills, fever, muscle aches, unusual fatigue, weakness, and/or headaches are flu-like symptoms. Reduced white blood cell counts can also result after taking Betaseron and Extavia. 

Betaseron and Extavia may also cause skin breakdown (skin surface damage) at the injection site, difficulty sleeping, stomach ache, and elevated liver enzymes (visible on a blood test). All beta interferon medications have the potential for major adverse effects, such as liver failure as well as mental health issues like depression or suicidal thoughts. Other side effects of some of the medications include skin tissue destruction, convulsions, and issues with the heart and blood vessels. 

Clinically Isolated Syndrome Treatment Market Segment Analysis

The global clinically isolated syndrome treatment market is segmented based on treatment, route of administration, distribution channel and region.

High Utilization of Disease Modifying Therapies 

For the treatment of relapse multiple sclerosis (MS), more than 15 immunotherapies—also known as disease-modifying treatments (DMTs)—with various modes of action and benefit-risk profiles have been licensed over the past three decades. These therapies, which primarily target the disease's specific inflammatory processes, decrease the development of brain white matter lesions as detected by magnetic resonance imaging (MRI), lower the number of relapses, and may even delay the development of new disabilities and the disease's overall course. Their potential long-term advantage is still unknown. 

As compared to later initiation, evidence from RCTs or observational research suggests that beginning a DMT shortly after diagnosis may result in better (long-term) results for people with relapsing-remitting MS (RRMS), such as a decreased likelihood of relapses and the transition to secondary progressive multiple sclerosis (SPMS). This advantageous effect appears to be more prominent for DMTs such as alemtuzumab, ocrelizumab, fingolimod, ozanimod, or natalizumab that have higher effectiveness. Higher toxicity is a characteristic of DMTs, which can occasionally result in severe and possibly fatal negative effects.

Clinically Isolated Syndrome Treatment Market Geographical Share

North America Accounted for Largest Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for clinically isolated syndrome treatment in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for clinically isolated syndrome treatment. 

Increasing expenditure on healthcare and rising research studies, advancement of technologies for different treatments of clinically isolated syndrome, and increase in pharmaceutical or biotech business establishment across the region are also contributing to the growth of clinically isolated syndrome treatment market share of this region. 

The key healthcare organizations' and businesses' joint research initiatives are also expected to contribute to the rising demand, as will new product development, which constantly looks to improve present options. The market in this area is growing as people become more aware of various novel treatments such as disease modifying therapies. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global clinically isolated syndrome treatment market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising multiple sclerosis cases have fueled the demand for clinically isolated syndrome treatment in the region. United States have been proactive in executing several initiatives or researches, stimulating clinically isolated syndrome treatment demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global clinically isolated syndrome treatment market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the medical device sector, with a significant consumer of clinically isolated syndrome treatment, was significantly impacted.

Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020. Major pharmaceutical or medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for clinically isolated syndrome treatment. As a result, many pharmaceutical plants either suspended or reduced production to align with the reduced demand.

The COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials to the pharmaceuticals manufacturing plants. Movement limitations and border closures caused production and supply delays. Additionally, some nations experienced a lack of raw resources as a result of supply chain network interruptions.

With the outbreak of the pandemic, many pharmaceutical or biotechnology manufacturing units faced labor shortages as workers fell sick or were unable to travel to work due to lockdown restrictions. To curb the spread of the virus, pharmaceutical plants implemented stringent safety measures, reducing the number of workers allowed on-site at a time. However, these precautions were required to protect employee health and continue crucial activities throughout the pandemic.

Russia-Ukraine War Impact Analysis

The medical device businesses are starting to worry regarding their capacity to continue operating, much like other parts of the world. Russia's invasion of Ukraine has an effect on millions of people not only in this nation in Eastern Europe but also all around the world. Drugs and therapies developers will thus experience delays in the development process, a loss of business consistency, and the possibility of non-compliance for therapies/drugs already on the market. 

For many years, clinical trials in several therapeutic fields have benefited significantly from the participation of Ukraine, Russia, and other CIS nations. Clinical trial durations can frequently be accelerated by incorporating more patients into studies when there is availability to skilled investigators, high-quality patient populations, and big patient populations. Trials that are delayed in Russia and Ukraine as well as relocation to other regions of Europe for fresh trials are currently viable choices. These factors will impact the global clinically isolated syndrome treatment market.

Key Developments

• On July 12, 2023, the Phase III OCARINA II trial testing Ocrevus (ocrelizumab) as a twice-yearly 10-minute subcutaneous injection accomplished its primary as well as secondary endpoints among individuals having relapsing forms of MS or progressive forms of MS (RMS or PPMS), according to a press release from Genentech, a part of the Roche Group. For the treatment of people with either RMS (such as relapsing-remitting MS (RRMS) and active progressive secondary MS (SPMS), along with clinically isolated syndrome (CIS)) or PPMS, Ocrevus IV is the first and sole medication approved by the FDA.
• On June 11, 2021, regarding the supplemental Novel Drug Application for Aubagio (teriflunomide) for adolescents and kids with relapsing forms of multiple sclerosis, aged 10 to 17, the U.S. Food and Drug Administration (FDA) released a Complete Response Letter. The FDA determined that the provided data were insufficient at this time to obtain authorization for a usage in the pediatric population. In order to integrate safety information from the adolescent clinical trial program, the FDA amended the Aubagio label. Aubagio's recommended age range for use in patients is still 18 years and older.

Clinically Isolated Syndrome Treatment Market Companies

The major global players in the market include F. Hoffmann-La Roche Ltd, Bayer, Opexa Therapeutics, Inc., Bristol Myers Squibb, Novartis AG, Sanofi, Teva Pharmaceutical Industries Ltd., Biogen, Merck KGaA and Pfizer Inc.

Why Purchase the Report?

• To visualize the global clinically isolated syndrome treatment market segmentation based on treatment, route of administration, distribution channel and region, as well as understand key commercial assets and players.
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• Excel data sheet with numerous data points of clinically isolated syndrome treatment market-level with all segments.
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The global clinically isolated syndrome treatment market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies