Global Remifentanil Hydrochloride Market

Remifentanil Hydrochloride Market Outlook

The Global Remifentanil Hydrochloride market was valued at USD 272.2 million in 2022 and is expected to reach USD 346.7 million in 2031, expanding at a CAGR of 2.8% during the forecast period.

Remifentanil hydrochloride is a potent opioid analgesic medication used for pain relief during surgery or other medical procedures. Drugs & other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. Remifentanil hydrochloride is a scheduled II drug.  Schedule II drugs have a high potential for abuse and addiction, which may lead to severe psychological or physical dependence.

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These drugs are also considered dangerous as they have a high potential for abuse.  Remifentanil hydrochloride is a small molecule type with a molecular formula (C20H29ClN2O5) and selectively binds to and activates the mu-opioid receptor, thereby producing analgesia, respiratory depression, miosis, reduced gastrointestinal motility, and euphoria.

Remifentanil hydrochloride belongs to the category of drugs called synthetic opioids and is known for its rapid onset and short duration of action, which makes it particularly useful for procedures that require brief periods of analgesia. Regarding analgesia, remifentanil HCl appears to have similar potency to fentanyl. It is associated with a rapid onset of action (around 1 minute) and rapid offset of action following discontinuation of a continuous infusion (3-10 minutes).  

It is used to provide analgesia and sedation in mechanically ventilated patients under intensive care. It is administered intravenously by a trained healthcare professional, typically in a hospital or clinical setting, and is considered a controlled substance due to its potential for abuse and addiction, and thus it can only be used under the close supervision of a skilled and qualified medical practitioner.

Practitioners prefer to use it (remifentanil HCl), as they are able to achieve a very high-dose narcotic effect; however, it is short-acting enough that patients restore to normal condition easily at the end of the procedure. However, patients experience postoperative pain owing to the high dose used and resulting tolerance, and the use faded. Commercially, remifentanil HCl is available as a lyophilized powder that needs to be reconstituted and diluted before administering to the patient.

Macro-economic Factors

Increasing Healthcare Expenditure

Healthcare expenditure refers to the amount of money spent on healthcare goods and services, such as medical treatments, hospitalizations, medical equipment, and other healthcare-related expenses. This includes public and private spending on healthcare, such as expenditures by governments, insurance companies, and individuals.

High healthcare spending leads to an increased number of medical procedures that requires anesthesia, including those that use remifentanil hydrochloride, and thus rises its demand. Governments of various countries are committed to improving healthcare in various ways and ensuring universal access to good quality healthcare services without anyone having to face financial hardship.

Global spending on health more than doubled in real terms over the past two decades, reaching around USD 8.5 trillion in 2019, or 9.8% of global GDP. Moreover, high-income countries accounted for nearly 80% of global spending on health, with the US accounting for more than 40% alone.

Market Competition

The pharmaceutical industry is highly competitive, and the introduction of new drugs or generic versions of existing drugs impacts the demand and pricing of remifentanil hydrochloride. Market competition plays a significant role in the production, pricing, and availability of remifentanil hydrochloride.

Remifentanil hydrochloride is a prescription drug used for the management of acute pain, and it competes with other opioid analgesics and non-opioid analgesics in the market. There are various substitutes of remifentanil hydrochloride that are used for similar indications. This implies that changes in the prices of available substitutes have a significant effect on the remifentanil hydrochloride market.

For instance, if effective substitutes are readily available, then there is a high chance that healthcare providers choose to use these substitutes instead of remifentanil hydrochloride. This results in reduced demand for remifentanil hydrochloride. Additionally, increased competition has led to decreased profit for individual manufacturers, potentially leading to reduced investment in R&D for new drug formulations.

Research and Development

The development of new drugs, including remifentanil hydrochloride is a costly and time-consuming process. Pharmaceutical companies invest heavily in R&D to produce new drugs, which affects the cost of the drug when it is eventually released in the market.

Moreover, R&D is critical for innovation in the pharmaceutical industry. The industry invests in R&D to innovate new drugs that address unmet medical needs or improve upon existing treatments. These innovations lead to improved patient outcomes and increased revenue for the company.

Regulatory Environment

The regulatory environment is a significant factor that considerably affects the production, distribution, and use of remifentanil hydrochloride. The government’s regulations, including patent laws and drug approval, affect the pricing of remifentanil hydrochloride.

Government patent laws give the manufacturer the exclusive right to produce and sell the medication for a limited period, which results in high prices to recoup research and development costs. Additionally, manufacturers have to face a complex approval process by the regulatory body. Thus, delays and changes in the regulatory environment impact the remifentanil hydrochloride considerably.

Remifentanil Hydrochloride Market Dynamics

Market Driver

• Increasing Number of Surgical Procedures

As medical technology advances and more people seek out medical treatment, surgical procedures are common. For instance, there has been an increment of 27% in the number of admissions for surgical procedures between 2003-2004 and 2013-2014 in England.  An increasing number of surgical procedures in worldwide is driving the demand for analgesic drugs such as remifentanil hydrochloride to help manage pain during and after these procedures.

Remifentanil hydrochloride is a highly effective pain reliever that is well-suited for use in surgical procedures. It is considered safe when used appropriately. This makes it an attractive option for use in surgical procedures where patient safety is a top priority. Hence, an increasing number of surgical procedures is likely to drive the demand for drugs such as remifentanil hydrochloride

• Rapid Onset and Offset of Drug Action

The short duration of action of remifentanil hydrochloride is one of the key drivers of its use in the medical industry, and consequently its market demand. Remifentanil hydrochloride has a rapid onset of action, which means it takes effect quickly after administration. This makes it useful in a situation where rapid pain relief is needed, such as during surgical procedures.

Additionally, its short duration of action means that its effect wears off quickly after administration, which is beneficial in cases where a shorter duration of pain relief is desired. Moreover, remifentanil hydrochloride is an ultra-short-acting opioid that undergoes rapid metabolism by tissue and plasma esterases, which reduces the risk of drug accumulation in patients.

This is especially important in cases where patients need repeated doses of the drug over an extended period, as the risk of accumulation leads to dangerous side effects.

Market Restraint

High Abuse Potentiality

Remifentanil hydrochloride is a potent opioid analgesic medication that is used for the treatment of acute pain during surgery or other medical procedures. However, the abuse potential of remifentanil hydrochloride is a significant concern, which acts as a restraint for its use. The abuse potential of a drug refers to its ability to produce psychological or physical dependence in an individual who uses it.

It has a high potential for abuse as it produces feelings of euphoria and sedation, which ultimately leads to addiction. Remifentanil hydrochloride is a Schedule II controlled substance, which means that it has a high potential for abuse and dependence. Many individuals use remifentanil hydrochloride as a regular habit for the sake of pleasant feelings, which creates addiction. This is a major factor restraining the market.

Market Opportunity

Growing Number of Researches and Investment in Healthcare

Increasing research and investment in healthcare worldwide. For instance, various levels of government in Canada collectively invest multiple billions of dollars in health-related research per annum, above and beyond investments in the management and delivery of healthcare and public health services. Growing research in healthcare provides numerous opportunities for the remifentanil hydrochloride drug in several ways.

Researchers are able to explore the potential for remifentanil hydrochloride to be used for different medical conditions or in combination with other drugs This is helpful for investigating the mechanisms of pain and testing new pain management strategies. Additionally, ongoing research help identify potential safety concerns or side effects associated with remifentanil hydrochloride use, which ultimately leads to the development of novel strategies to minimize these risks.

Additionally, another area of research opportunity is in exploring potential improvements to the delivery of remifentanil hydrochloride. Research in this area focuses on optimizing dosing regimens, exploring new delivery methods, or investigating the use of novel technologies to improve drug effectivenes

Advances in the Development and Use of Analgesic

Remifentanil hydrochloride is a powerful analgesic that is used in the management of acute pain during medical surgeries and procedures. It is a recent addition to the group of narcotic analgesics. Advances in the development and use of analgesics are creating lucrative opportunities in the remifentanil hydrochloride market in several ways. Growing demand for effective pain management during medical surgeries has created a larger market for analgesics such as remifentanil hydrochloride.

Rising number of surgeries and medical procedures each year, is boosting the demand for effective pain management solutions continues. Additionally, the development of analgesic and pain management techniques is helping increase awareness about the importance of effective pain management. This creates opportunities for the wide adoption of remifentanil hydrochloride due to its excellent feature.

Scope of Remifentanil Hydrochloride Market Report      

The report on the global Remifentanil Hydrochloride market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Remifentanil Hydrochloride Market Segmental Outlook

Based on type, the global remifentanil hydrochloride market is segmented into 1mg/Vial, 2mg/Vial, and 5mg/Vial. This basically denotes the different strengths of the dosage of remifentanil hydrochloride available in the market. Strength of drug products is generally expressed in terms of the amount of drug substance (active ingredient) in the drug product, it is sometimes expressed in terms of the amount of the active moiety.

1mg/Vial and 2mg/Vial refers to the quantity of active ingredient present in the vial, which is 1 milligram and 2 milligrams of the base form of remifentanil HCl. This type of FDA-approved remifentanil hydrochloride is provided by players such as Fresenius Kabi, Viatris Inc., B.Braun, and many others. For Instance, the Drug Controller General of India (DCGI) gave approval to Themis Medicare Ltd for Remifentanil Hydrochloride of 1mg/ vial and 2mg/vial for import and marketing with the brand name REMITHEM.

5mg/Vial refers to the quantity of active ingredient present in the vial, which 5 milligrams of the base form of remifentanil HCl respectively. This type of FDA-approved remifentanil hydrochloride is provided by players such as Teva Pharmaceutical Industries, Fresenius SE & Co. KGaA, and others. With a manually-controlled infusion, Remifentanil can be diluted to concentrations of 20-250 μg/mL. The recommended dilutions are 50 μg/mL for adults and 20-25 μg/mL for pediatric patients aged 1 year and over.

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On the basis on application, the global remifentanil hydrochloride market is segmented into Endotracheal Intubation Operation, Neurosurgery, Outpatient surgery, Postoperative analgesia, and Others. The Endotracheal Intubation Operation segment is expected to account XX% share of the market during the forecast period it is a surgical procedure that’s performed on people who are unconscious or who can’t breathe on their own.

Patient undergoing Endotracheal Intubation Operation is generally under anesthesia such as remifentanil hydrochloride. In the US annually, ~15 million operating room intubations and ~650,000 hospital intubations outside the operating room are performed, including ~346,000 emergency department (ED) intubations. Neurosurgery is projected to grow at XX% CAGR during the forecast period as it deals with the surgical treatment of the nervous system, including the brain, spinal cord, and peripheral nerves.

Synthetic opioids including remifentanil HCl are commonly used in neurosurgical anesthesia owing to their short duration of action and their ability to minimize cortical effects through continuous infusion. Each year, an estimated ~22.6 million patients suffer from neurological disorders, of whom ~13.8 million require surgery.

On the basis of distribution channels, the global remifentanil hydrochloride market is segmented into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies. Hospital Pharmacies are projected to account for XX% of the global remifentanil hydrochloride market during the forecast period as they are involved in compounding and dispensing of medication in hospital settings.

The Hospital Pharmacy Section of the Federation of International Pharmacists (FIP) was founded in 1957 and focuses on monitoring the practices of hospital pharmacy, including education and communication. Retail Pharmacies is anticipated to grow at a CAGR of XX% during the forecast period as it is the most common type of pharmacy that allows the public access to their medications.

Most retail pharmacies have a commercial store with a combination of medicinal goods only available with a prescription and those with that can be purchased over-the-counter. According to OCED, in 2019, the number of community pharmacies per 100,000 people ranged from 9 in Denmark to 88 in Greece, with an average of 28 across OECD countries.

Online Pharmacies is forecasted to register 12.6 Mn revenue in 2030 owing to an increase in advancements in online procurement of medications through e-commerce channels. While online pharmacies have been around for decades, they gained more traction throughout the COVID-19 pandemic because of their convenience during quarantine protocols. According to a study published by Software Advice revealed that on average 61% people save over $20 through online pharmacies.

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Remifentanil Hydrochloride Market Regional Outlook

On the basis of region, the global remifentanil hydrochloride market is divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in North America is projected to expand at a CAGR of XX% during the forecast period, owing to the increasing number of chronic diseases in the region that require more medical surgeries.

Chronic diseases, including cancer, diabetes, hypertension, stroke, and heart disease, are considered among the most prevalent and expensive health conditions in the US. Moreover, there is a significant rise in the national health expenditure (NHE) of the region, especially in the US, which is anticipated to boost the market. According to the Centers for Disease Control and Prevention (CDC), four in 10 adults in the US have two or more chronic diseases.

Moreover, according to National Health Council (NHC), in 2020, 157 million Americans suffered from chronic diseases, with 81 million having multiple conditions. Also, NHE grew 2.7% with USD 4.3 trillion in 2021, or USD 12,914 per person in the US, and accounted for 18.3% of the gross domestic product (GDP).

Europe accounted for XX% share of the market in 2021, and the market is expected to expand in the coming years, due to the rising number of surgical procedures in the region. Increasing surgical procedures in the region ultimately leads to rising demand for remifentanil hydrochloride. According to the British Journal of Anesthesia (BJA), in the UK, approximately one in ten people undergo a surgical procedure each year.

Moreover, as per the Royal College of Surgeons (RCS), approximately 4.7 Mn surgical admissions were reported in 2013-2014 in England. Asia-Pacific accounted for XX% share of the market in 2021, and the market is expected to expand in the coming years, due to the rising number of road accidents in the region, particularly in India.

Accidents lead to major injuries, which ultimately require remifentanil hydrochloride in the treatment. According to Road Transport and Highway of India, during the year 2021, a total number of 4,12,432 road accidents have been reported in the country, claiming 1,53,972 lives and causing injuries to 3,84,448 people.

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Key Benefits for Industry Participants & Stakeholders

• In-depth Analysis of the Global Remifentanil Hydrochloride Market
• Historical, Current and Projected Market Size in terms of Value
• Potential & Niche Segments and Regions Exhibiting Promising Growth Covered
• Industry Drivers, Restraints, and Opportunities Covered in the Study
• Recent Industry Trends and Developments
• Competitive Landscape & Strategies of Key Players
• Neutral Perspective on Global Remifentanil Hydrochloride Market Performance

Segments

By Type

• 1mg/Vial
• 2mg/Vial
• 5mg/Vial

By Application

• Endotracheal Intubation Operation
• Neurosurgery
• Outpatient surgery
• Postoperative analgesia
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Key Market Players Profiled in the Report

• Teva Pharmaceutical Industries Ltd
• Viatris Inc
• Novartis AG (Sandoz International GmbH)
• Fresenius SE & Co. KGaA
• Hikma Pharmaceuticals PLC
• B. Braun SE

Competitive Landscape

• Manufacturers operating in the global Remifentanil Hydrochloride market include Teva Pharmaceutical Industries Ltd, Viatris Inc, Novartis AG (Sandoz International GmbH), Fresenius SE & Co. KGaA, Hikma Pharmaceuticals PLC, B. Braun SE, and many others.
• Market Players are pursuing key strategies such as acquisitions, collaborations, and geographic expansion where a potential opportunity arises for the Remifentanil Hydrochloride Market.