Melatonin API Market

Melatonin API Market Outlook (2023 to 2033)

The global melatonin API market recorded a CAGR of 14.3% in the last 5 years and reached a valuation of US$ 1.7 billion in 2022. The market is forecasted to expand at a high-value CAGR of 15.1% to surge to US$ 2.3 Billion by the end of 2033.

According to this study by Persistence Market Research, GMP grade manufacturing accounted for a market share of 93.5% in 2022. Overall, melatonin API sales accounted for 6.4% revenue share of the global sleep aids market in 2022.

Melatonin is a commonly found molecule in living organisms that has a variety of functions in biological, hormonal, and physiological processes at the cellular, tissue, and organ levels. Its content varies greatly and is commonly found in a variety of medicinal and food plants. Certain seeds in particular produce high levels of melatonin that are noticeably greater than those found in mammalian tissues. Seeds are also a rich supply of additional compounds, which provide the germination process with energy resources.

Due to its regulator function in the internal scheduling of biological cycles, including the promotion/regulation of sleep, exogenous melatonin (over-the-counter pills/tablets) has become one of the most requested sleep aids. Melatonin is promoted to assist in enhancing total sleep time, alleviate jet lag weariness, and balance circadian rhythms caused by jet lag and rotating shift work. Melatonin appears to shorten the time it takes individuals with delayed sleep phase syndrome to fall asleep.

Insomnia is one of the most common reasons adults seek medical attention. While medication should not be used as the only treatment for insomnia, it can be used in conjunction with behavioral techniques and the treatment of related comorbidities.

Melatonin was once thought to be an animal neurohormone that affected the control of the circadian rhythm, seasonal reproductive cycles, and mammalian immune system; however these studies are now outdated. Because of its small size and high solubility in both water and lipids, melatonin is now widely acknowledged to be a universal amphiphilic antioxidant molecule that can enter all cellular compartments.

OTC medications are often distributed to customers without the need for a prescription from a healthcare physician. Most OTC medications have been approved by regulatory agencies as containing ingredients that are both safe and effective when used without the supervision of a physician. Adults are treated with a variety of drugs and substances, including over-the-counter (OTC) sleep aids (e.g., diphenhydramine and doxylamine, alone or in 'PM' designed pharmaceuticals) and several synthetic melatonin formulations.

Most melatonin API companies prefer to work with a small number of suppliers to reduce the expenses and hazards associated with technology transfer while also saving time. Melatonin API companies are thus merging to strengthen their competitiveness, either to expand their range of services or to assist pharmaceutical and biotechnology customers in accelerating and optimizing the future product pathway, from early research & development activities and clinical development through manufacturing, regulatory submission, commercialization, and distribution.

Why is the Need for Melatonin APIs Rising So Fast?

“Application of Melatonin API in Cancer and Integration of Automated Technologies for API Production”

Phylogenetically speaking, melatonin is a very old chemical. It can be found in practically all living things, including humans and microorganisms. It is a pleiotropic chemical with multiple biological functions, including those of an immunostimulant, anti-inflammatory, anti-cancer, plant growth hormone, and circadian rhythm regulator.

Melatonin has been shown in numerous studies to have anti-cancer properties against a variety of cancer types. The anti-cancer properties of melatonin have been the subject of numerous investigations over the past few decades. Both receptor-dependent and receptor-independent strategies can help this hormone fight cancer.

Several melatonin API producers are concentrating on customized API and CDMO services to implement continuous manufacturing techniques. An API CDMO is a crucial partner in the research and production of pharmaceuticals, providing a wide range of services that speed up the path to commercialization. This entails making continuous improvements to process design, preserving up-to-date knowledge from both existing and new technologies, and constructing efforts to ensure transparency and open customer engagement, which is leading to the emergence of vast market opportunities.

API CDMOs have a wide variety of technical skills that are supported by expert knowledge, a track record of reliable quality, and regulatory compliance. A majority of continuous and flexible manufacturing is done by CMOs to satisfy the growing demand for melatonin APIs and supplements. It is projected that major CMOs will adopt continuous manufacturing techniques because of the development of APIs and the shift to customized medicine. This method can be used to manufacture prescription drugs in large quantities.

Development of the Internet of Things (IoT) and a shift toward automation have caused a considerable digital transition in the manufacturing of melatonin APIs. To advance the development of pharmaceuticals and dietary supplements and to scale up their production, several API manufacturing businesses are investing in digital transformation, which will open up a wide range of options for melatonin API producers.

What Issues Do Providers of Melatonin APIs Face?

“High Raw Material Costs and Need for Greater Investments for API Production”

Chemical conversion of essential raw materials into highly refined and controlled chemical outputs is necessary for the production of APIs. The infrastructure necessary to distribute APIs affordably can be found in large-scale manufacturing facilities that can produce 10 or more different APIs. The production of thirty or more APIs for the international market is possible at truly large-scale facilities.

Investment requirements for producing APIs vary depending on several criteria. The size, capacity, and level of automation of the production equipment, as well as the location and infrastructure, determine these expenses. The level of confinement, the caliber of the equipment in the facility, and cGMP regulations all play a role in how sophisticated a manufacturing facility is.

These variables collectively result in significant investor demand. Because quality is necessary for API manufacturing, no organization can compromise on the quality and standards required for API production. Licensing is a significant additional expense in production. Additionally, time is required for processes such as analytical screening and quality assurance. To ensure that there is no contamination during the manufacturing batches, scale-up procedures require high-capacity equipment that is maintained.

The quality of raw materials is important for producing APIs because they serve as the foundation for these drugs. These factors, when taken into consideration, indicate a large requirement for capital investment in API manufacturing, as well as indicates a rise in raw material prices, thus limiting market expansion to some extent.

Country-wise Insights

What Makes the United States a Huge Market for Melatonin APIs?

“Extensive Regulatory Overlooking for API Manufacturing”

The United States accounted for 95% share of the North American market in 2022.

The FDA has established criteria for the manufacturing of APIs based on the procedures used, the source of the API, and other factors. These processes include chemical synthesis, extracting, cell culture/fermentation, recovery from natural sources, and any combination of these processes.

These recommendations are meant to make sure that manufactured APIs adhere to GMP standards while maintaining the quality and purity claims they make or are represented to make. Clinical trials (CT) and new drug application (NDA) approval are the two stages in the FDA's new drug approval procedure.

Market expansion in the United States has been aided by the presence of established norms.

Will Germany Be a Lucrative Market for Melatonin API Manufacturers?

“Lucrative Trials for Natural Sources of Melatonin”

Germany accounted for 21.8% share of the European market in 2022.

Since it can only be purchased with a prescription, melatonin made by pharmaceutical companies has been the only kind available in Europe. Due to limited bioavailability, large doses of melatonin from pharmaceutical production must be taken.

A Munich-based company has succeeded in producing milk with a high quantity of melatonin after more than five years of diligent study. This is available as food in Europe without a prescription and contains 100 times the amount of melatonin found in regular milk.

A placebo-controlled double-blind study has demonstrated significant efficacy of the product with naturally greater melatonin levels, and this is a driving force behind the expansion of the market in Germany.

Why is China Emerging as a Prominent Market for Melatonin APIs?

“Increasing CMO Activities and cGMP Practices”

China enjoyed 62.5% share of the East Asian market in 2022.

The Ministry of Health in China submits new drug registration clearances to the Chinese Food & Drug Administration (CFDA). Foreign businesses that want to produce or import medicines in China must register their imported drug applications. Excipients, packaging components, and APIs produced overseas must register as DMFs.

Growing contract manufacturing activities for API production in China have propelled the growth of the market in the country. Moreover, with an increase in the number of production capabilities with regulatory conformations, the market for melatonin APIs in China is set to witness significant growth during the forecast years.

Category-wise Insights

Which Source is Widely Adopted for Melatonin API Production?

“No Risk of Viral Contamination with Synthesized Melatonin”

Synthetic sources of melatonin APIs held 56.5% share of the overall market in 2022.

Although melatonin can be produced from microorganisms or animals, synthetic melatonin is the most prevalent form. Natural melatonin is derived from the pineal gland of vertebrates. It is not advised to use this form since it can be infected with a virus. This risk is not present while using synthetic melatonin.

The FDA does not oversee Trusted Source supplements despite the fact that synthetic melatonin is a dietary supplement. The FDA, for any usage, does not technically approve melatonin. Because it is not contaminated by biological agents, synthetic melatonin is safer to use, which will increase the value of this market segment over the coming years.

Where is There Substantial Use of Melatonin APIs?

“Clinical Use of Melatonin in Treatment of Sleep Disorders”

Clinical use of melatonin APIs accounted for a market share of 83.2% in 2022, globally.

Numerous clinical investigations have looked at the therapeutic value of melatonin in several medical specialties during the past 20 years. Currently, a large variety of drugs is available to treat sleep disorders, but their usage is not always accompanied by satisfying outcomes. Because of the unfavorable side effects of this therapy, the pharmaceutical treatment approaches that have been developed have led to an increase in the frequency of sleep problems during the past ten years.

The many clinical effects of melatonin show its universal modulating influence on physiological processes within the body as well as some associated elements of the pathogenesis of pathological conditions like insomnia and circadian rhythm disturbances, which encourages the clinical use of melatonin in the development of new therapeutic strategies.

Which Melatonin API Grade is Highly Sought-after?

“Established Guidelines for Safe Production of Pharmaceutical APIs”

GMP grade melatonin APIs held a share of 93.5% in 2022 within the global market.

GMPs are the Guidelines for the Manufacturing Process for the production of Active Pharmaceutical Ingredients (APIs) within an appropriate quality management system. They are designed to ensure that APIs meet the quality and purity requirements that they advertise or are reported to have. In the global community, materials might not all fall into the same legal category as APIs.

Conforming to GMP grade manufacturing thus holds a greater segment share, thus propelling the global market value for melatonin API.

Competition Landscape

The growth of the melatonin API industry has been facilitated by low-cost inventions, production, skilled labor, and innovative research and development activities in countries such as India. Additionally, businesses are able to accomplish complex synthesis with efficiency and in a significantly shorter amount of time.

Companies that produce melatonin APIs are concentrating on forming alliances with new businesses to expand their presence in the industry and attract more clients to meet demand. Acquisitions are another important promotional strategy used in this market. Through acquisitions, businesses can improve their capabilities, increase their geographic coverage, and diversify their product portfolio.

Some key market developments include:

• Biosynth Carbosynth, which is financed by KKR, acquired Vivitide in March 2022 and welcomed Ampersand Capital Partners as a new shareholder.
• The launch of Bio-Techne Corporation's unique GMP facility, which is located in St. Paul, Minnesota, and measures about 61,000 square feet, was implemented in September 2020. The purpose of the new facility is to support the industrial-scale manufacturing of GMP-grade components.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies producing melatonin APIs, which are available in the full report.

Melatonin API Industry Report Scope

Key Segments of Melatonin API Industry Research

Source:

• Natural
• Synthetic
• Bio-Synthetic

Grade:

• GMP
• Non-GMP

Application:

• Clinical
• Research

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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