NEOSTIGMINE METHYLSULFATE INJECTION MARKET ANALYSIS

The global neostigmine methylsulfate injection market size is projected to be valued at US$ 156.7 Mn in 2023 and is projected to reach US$ 213.3 Mn by 2030, registering a CAGR of 4.5% during the forecast period. The growth of the market is driven by the increasing prevalence of myasthenia gravis, Chronic obstructive pulmonary disease COPD, and other neuromuscular disorders. Additionally, the rising demand for neostigmine methylsulfate injection in the hospital setting is also driving the market growth.

Neostigmine Methylsulfate Injection Market Regional Insights

• North America is the largest market for neostigmine methylsulfate injection, accounting for 33.5% of the global market share. The high prevalence of chronic diseases, such as myasthenia gravis and Alzheimer's disease, in the region is driving the growth of the market.
• Europe is the second largest market for neostigmine methylsulfate injection, accounting for 26.2% of the global market share. The increasing number of surgical procedures in the region is driving the growth of the market.
• Asia Pacific is the third largest market for neostigmine methylsulfate injection, accounting for 19.1% of the global market share. The rising incidence of neurological disorders in the region is driving the growth of the market.

Figure 1. Global Neostigmine Methylsulfate Injection Market Share (%), by Region, 2023

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Analyst’s Views on the Neostigmine Methylsulfate Injection Market

The neostigmine methylsulfate injection market is currently dominated by North America owing to higher reversal agent drug adoption. However, Asia Pacific is expected to witness the fastest growth during the forecast period. The growth will be driven by rising anticholinesterase overdose cases coupled with the growing healthcare expenditures in China and India. Additionally, increasing number of gastrointestinal surgeries requiring the reversal of neuromuscular blockade will further aid the market expansion in Asia Pacific.

The market is expected to face few restraints such as availability of alternative reversal agents like sugammadex sodium and strict regulatory guidelines for drug approval. Nonetheless, increasing research for expanding neostigmine methylsulfate injection therapeutic indications will create new opportunities. Moreover, growing geriatric population vulnerable to anticholinesterase poisoning also works in favor of the market growth.

Overall, rising anesthesia usage along with surgical procedures will boost the need for neuromuscular blockade reversal therapeutics. On the other hand, pricing pressure and limited research funding for neostigmine methylsulfate remain as challenges. Nonetheless, market players could benefit from collaborating with key opinion leaders and research institutes to strengthen their product portfolio.

Neostigmine Methylsulfate Injection Market Drivers

• Rising prevalence of diseases like myasthenia gravis and postoperative ileus requiring neostigmine: Neostigmine methylsulfate injection is primarily used as a cholinesterase inhibitor to treat various neurological disorders such as myasthenia gravis and postoperative urinary retention. The increasing prevalence of these conditions drives the demand for neostigmine methylsulfate injections. For instance, according to Myasthenia Gravis Foundation of America, publication ‘CLINICAL OVERVIEW OF MG’ published on 2021, the prevalence of myasthenia gravis reported in past 50 years for different regions is increasing, in the U.S. it is estimated at 14 to 20 per 100,000 population, and around 36,000 to 60,000 cases are in the U.S.
• Growing geriatric population vulnerable to conditions like postoperative ileus: The elderly population is more susceptible to neurological disorders, including myasthenia gravis, which often requires treatment with neostigmine methylsulfate injections. The growing geriatric population is one of the key factors driving the demand for neostigmine methylsulfate injection. Older adults aged 65 years and above are more susceptible to postoperative ileus, a temporary paralysis of the intestines following surgery. For instance, as per the data from the United Nations, the number of persons aged 65 years or over is projected to grow from 727.20 million in 2020 to 1.50 Billion in 2050 globally. This rising burden of aging population implies a higher number of older adults undergoing various surgical procedures annually.

Neostigmine Methylsulfate Injection Market Opportunities

• Emerging markets in developing countries: There is a significant opportunity for neostigmine methylsulfate injections in emerging markets, where healthcare infrastructure and access to essential medications are expanding. The increasing focus on improving healthcare facilities in countries across Asia Pacific, Latin America, and Africa creates a favorable environment for market growth. According to data from the World Bank, smartphone ownership in lower-middle income countries jumped from 22% to 50% from 2019 to 2021. This widens the potential customer base who can utilize RPM applications and connected health sensors. Younger demographics are especially receptive to new tools that make healthcare more convenient without requiring visits to crowded clinics or hospitals. Remote monitoring allows existing healthcare resources to stretch further by catching issues earlier and preventing costly hospitalizations.

Neostigmine Methylsulfate Injection Market Trends

• Increased adoption of biologics and biosimilars: The rising adoption of biologics and biosimilars has significantly impacted the neostigmine methylsulfate injection market in recent years. As biologics have become more widely used for treating various chronic conditions like arthritis, cancers, and Crohn's disease, there is higher demand for reversal agents after biologics administration as well. Neostigmine methylsulfate is commonly used to reverse the effects of non-depolarizing neuromuscular blocking agents which are often given before or during surgeries and medical procedures. With the number of people undergoing complex surgeries rising significantly due to the increasing global disease burden, the need for reversal agents like neostigmine methylsulfate has also gone up considerably.

Additionally, the rise of biosimilars has augmented the usage of biologics further due to their reduced costs compared to reference biologics. For instance, according to the World Health Organization's biosimilars report from December 2022, global spending on biosimilars increased by 35% from 2020 to 2021 with savings of over US$ 230 billion for healthcare systems. This wider uptake of low-cost biosimilars means more patients are accessing biologic treatments which again raises the requirement for neostigmine methylsulfate to reverse their muscle blocking effects during operations. The surging demand stemming from broader biologics and biosimilars adoption presents lucrative growth opportunities for manufacturers in the neostigmine methylsulfate injection segment in the coming years.

• Shift towards precision medicine & personalized medicine: Regulatory authorities play a vital role in ensuring the safety, quality, and efficacy of pharmaceutical products including neostigmine methylsulfate injections. Ongoing regulatory updates and evolving guidelines can impact the market dynamics, particularly in terms of product approvals, labeling requirements, and manufacturing standards. Adhering to regulatory compliance is crucial for market participants to maintain and expand their market presence. For instance, according to the data published by Personalized Medicine Coalition Organization, ‘In personalized medicine at U.S. Food and Drug Administration (FDA) for the year 2022’ for year 2021 around 12 personalized medicines representing approximately 34 percent of all newly approved therapeutic molecular entities were approved by U.S. Food and Drug Administration (FDA). Personalized medicines have now accounted for at least a quarter of new drug approvals for each of the last eight years.

Neostigmine Methylsulfate Injection Market Restraints

• Availability of substitute drugs: The availability of substitute drugs in the market is posing as a major restraint to the growth of the neostigmine methylsulfate injection market. Neostigmine methylsulfate injection has traditionally been used to reverse the effects of non-depolarizing neuromuscular blocking agents which are used during surgeries to temporarily paralyze voluntary muscles. However, in recent times, alternative drugs that can perform the same function of reversal have emerged. Pyridostigmine, Sugammadex, and Selective relaxant binding agent (sugammadex) are some of the substitute drugs that are capturing market share from neostigmine methylsulfate injection. For instance, Caplin Steriles, a subsidiary company of Caplin Point Laboratories a fully integrated Pharmaceutical company with a dominant presence in Latin America, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Neostigmine Methylsulfate Injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL), Multiple-Dose vial presentations, a generic therapeutic equivalent version of (RLD), BLOXIVERZ Injection, of Exela Pharma Sciences, LLC., developer, manufactures and markets sterile injectable pharmaceuticals.

Recent Developments

New product launches

• Hikma Pharmaceuticals, a U.K.-based pharmaceutical company, announced the launch of Neostigmine Methylsulfate Injection, USP in prefilled syringe (PFS) form in the U.S. in 2022. This is a cholinesterase inhibitor, indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBAs) after surgery.
• Endo International, a U.S.-based global generic and specialty branded drug pharmaceutical company, launched PREVDUO (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe in the U.S. in 2023. This is the first and only U.S. Food and Drug Administration (FDA) approved neostigmine glycopyrrolate combination product in the U.S. It is indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBAs) after surgery.

Acquisitions and partnerships

• Pfizer Inc.: In 2021, Pfizer Inc., a U.S.-based global pharmaceutical company, announced the acquisition of Anacor Pharmaceuticals, a biopharmaceutical company that specializes in the development and commercialization of dermatological therapies. Anacor Pharmaceuticals had a neostigmine methylsulfate injection product in its portfolio.
• Mylan: In 2020, Mylan, a U.S.-based global generic and specialty pharmaceuticals company, announced the acquisition of Agila Specialties, a pharmaceutical company that specializes in the development and commercialization of generic injectable products. Agila Specialties had a neostigmine methylsulfate injection product in its portfolio.

Figure 2. Global Neostigmine Methylsulfate Injection Market Share (%), by Distribution Channel, 2023

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Top Companies in the Neostigmine Methylsulfate Injection Market

• Baxter International Inc.
• Pfizer Inc.
• Fresenius Kabi AG
• Boehringer Ingelheim GmbH
• Mylan N.V.
• Novartis International AG
• Teva Pharmaceutical Industries Ltd.
• Hikma Pharmaceuticals PLC
• GlaxoSmithKline plc
• Sun Pharmaceutical Industries Ltd.
• Sandoz (a division of Novartis)
• Accord Healthcare Inc.
• Lannett Company, Inc.
• Mallinckrodt Pharmaceuticals
• Lupin Limited

Definition: The neostigmine methylsulfate injection market refers to the market for the pharmaceutical product that contains neostigmine methylsulfate as an active ingredient. Neostigmine methylsulfate is a medication used for the treatment of certain neuromuscular disorders such as myasthenia gravis and postoperative urinary retention. The market involves the production, distribution, and sale of neostigmine methylsulfate injections by pharmaceutical companies to healthcare providers and patients.