Cholesterol API Market

Cholesterol API Market Outlook (2023 to 2033)

The global cholesterol active pharmaceutical ingredient (API) market size is expected to reach a valuation of US$ 280.6 million in 2023, and further expand at a CAGR of 4.7% during the forecast period from 2023 to 2033. The global cholesterol API market is anticipated to be valued at US$ 445.3 million by 2033. Animal-derived sources are leading the market and held a share of about 52.38% in 2022.

Cardiovascular diseases, including heart attacks and strokes, are becoming increasingly prevalent worldwide. High cholesterol levels significantly contribute to the development of these conditions. As a result, there is a growing demand for cholesterol-lowering medications, leading to increased demand for cholesterol APIs.

In recent years, there has indeed been a significant development in the approval of new cholesterol-lowering drugs by regulatory agencies. These include PCSK9 inhibitors, bile acid sequestrants, and selective cholesterol absorption inhibitors, among others. These drugs have shown promising results in clinical trials, demonstrating their ability to effectively lower LDL cholesterol levels. This breakthrough in pharmaceutical innovation has led to an increased demand for cholesterol APIs

Governments and healthcare organizations across the globe have implemented initiatives and policies to address the escalating burden of cardiovascular diseases. These efforts often encompass cholesterol screening programs, awareness campaigns, and measures to improve access to affordable cholesterol-lowering medications. Consequently, the demand for cholesterol APIs is bolstered.

Lipid shells employed in the manufacturing of RNA vaccines contain cholesterol API, which gives the vaccine high stability by preventing the action of enzyme degradation. They can be chemically synthesized in laboratories and are generally sourced from plants and animals.

To assure their effectiveness as a targeted drug carrier, they are often combined with liposomes, which contain cholesterol, in monoclonal antibodies. The cholesterol in this context helps to stabilize the delivery system for therapeutic targets. Antimalarial, anticancer, antiviral, and gene therapy are some of the other applications of drug delivery systems that utilize cholesterol APIs.

The global cholesterol API market held approximately 5.9% of the global pharmaceutical lipids market share in 2021. The global pharmaceutical lipids market is likely to embrace a profit of US$ 4.93 billion in 2023.

2018 to 2022 Global Cholesterol API Demand Outlook Compared to 2023 to 2033 Forecast

The market for cholesterol APIs expanded at a CAGR of 3.7% during the historic period from 2018 to 2022 owing to their growing adoption in the field of drug delivery.

In the production of vaccines and medicines, cholesterol acts as a stabilizing agent. Lipid nanoparticles have become popular in the pharmaceutical sector as potential drug delivery vehicles. They are essential for efficiently encapsulating and delivering mRNA to cells.

Cholesterol API is often utilized in targeted drug delivery systems as it is considered to be an efficient drug carrier for monoclonal antibodies. Growing need for vaccines and drug delivery systems, as well as various beneficial properties of cholesterol, will drive growth in the market during the upcoming decade.

However, there is a general lack of formalized government guidelines regarding good manufacturing and distribution practices in the cholesterol API and other formulation-based excipients industries.

But, as more companies are starting to adhere to guidelines on manufacturing and distribution mandated by the International Pharmaceutical Excipient Council (IPEC), the supply of better quality ingredients for drug manufacturing will pick up pace.

As a result of the aforementioned factors, it is anticipated that the global cholesterol API market is set to expand at a CAGR of 4.7% from 2023 to 2033.

Top Trend Pushing Demand for Cholesterol APIs

• Outsourcing of Manufacturing Capabilities

The pharmaceutical industry has witnessed rapid growth in terms of outsourcing of pharmaceutical services. Due to technological and regular operational hurdles, a large number of companies are outsourcing their lipid manufacturing operations to specialists.

Contracting a supplier for medical-grade lipids, for instance, allows companies to take advantage of new technologies used by the service provider, gain access to higher capacities, and improve their operational flexibility.

Leading manufacturers are striving to make their R&D effortless and are focusing on increasing the speed of drug manufacturing processes. It would enable them to reduce their overall drug development and manufacturing costs. It would further help contract development and manufacturing organizations (CDMOs) to have a strong run in the next decade owing to the cost-effectiveness achieved through outsourcing their manufacturing capabilities.

The need for niche competencies for manufacturing complex APIs has encouraged pharma companies to outsource production activities rather than manufacturing them in their own facilities. During the foreseeable years, this factor is expected to provide lucrative growth opportunities to key players in the global cholesterol API market.

Sabyasachi Ghosh

Principal Consultant

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What Factors Are Restraining the Demand for Cholesterol APIs?

Implementation of various stringent regulations by government agencies with ongoing expansion of the pharmaceutical industry worldwide may hamper growth. Regulatory bodies play a vital role in defining the requirements and legal procedures related to the drug development process in a country.

Regulations for manufacturing lipid-based excipients are not currently defined by any established guidelines. Even though the majority of manufacturers abide by IPEC rules, several industrial facilities still do not follow the same.

This often results in physical audits by regulatory agencies governed by several acts such as the 2012 U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) and the EU Falsified Medicines Directive (FMD or Directive 2011/62/EU) to ensure a secure supply chain.

The majority of manufacturers noted that regulatory compliance is extremely difficult to achieve when multiple suppliers provide excipients. For instance, Pfizer reported having 4,000 excipient suppliers after its merger with Pharmacia in 2003.

If all of these 4,000 were to be audited, it would call for over 10 audits per day, which could lead the company to incur substantial regulatory costs. These factors may negatively affect the cholesterol API market.

Country-wise Insights

What Makes the United States a Highly Lucrative Market for Cholesterol APIs?

Presence of Many API Manufacturing Companies to Drive the United States Market

The United States has seen a shift toward preventive healthcare, with a growing emphasis on managing cholesterol levels to reduce the risk of cardiovascular diseases. This trend has led to increased demand for cholesterol-lowering medications. Presence of various renowned pharmaceutical companies in the United States, and implementation of stringent government norms revolving around drug production are anticipated to push growth in the country.

According to data published by the CDC, in April 2022, an estimated 58.5 million adults in the United States had arthritis. Among them, about 25.7 million adults had limitations in their usual activities. It is predicted that by 2040, the number of adults with arthritis could reach 35 million. In 2021, as per the statistics published by IDF, about 32 million people in the United States were suffering from diabetes. The IDF estimates that this number could increase to 34.7 million by 2030 and further to 36.2 million by 2045. Individuals with diabetes have a heightened susceptibility to cardiovascular disease and elevated cholesterol levels. This has increased the focus on developing advanced and safe drugs. These drugs require a significant amount of Cholesterol API. Consequently, this has led to the growth of the market.

The presence of a well-established healthcare infrastructure and high healthcare expenditure in the country contribute to market growth. The CMS released statistics in March 2022 that indicated that from 2021 to 2030, the average annual growth in national health spending is going to be 5.1%. The National Health Spending in 2020 was reported to be US$ 4.1 trillion and is projected to reach US$ 6.8 trillion by 2030. As a result of the increasing healthcare spending, the company is expected to intensify its activities in developing pharmaceutical products, which is likely to drive the demand for drug development APIs. This is anticipated to fuel the growth of the United States cholesterol API market over the forecast period.

Is Germany Poised to Lead the Cholesterol API Market in Europe?

The Surging Health Awareness in Germany Propels the Escalating Demand for Cholesterol API

Germany is one of the leading pharmaceutical markets in Europe. The country has a well-established healthcare infrastructure. It also has a high prevalence of cardiovascular diseases, which has led to an increased demand for cholesterol-lowering medications. The market in Germany has shown a preference for natural and plant-based cholesterol-lowering products. This has increased the demand for cholesterol API derived from natural sources, such as plant sterols.

The growing healthcare expenditure in the country demonstrates the commitment of both the government and companies to develop safe and effective drugs for the treatment of various chronic and other diseases. For example, based on data published by the OECD in June 2022, Germany witnessed a notable increase in health spending as a percentage of its GDP, rising from 12.5% in 2020 to 12.8% in 2021. This rise in healthcare expenditures is anticipated to stimulate the development of treatment drugs and APIs, thereby contributing to the positive growth of the Germany cholesterol API market.

The market growth is also driven by rising company activities in facility and business expansions. Evonik declared in August 2022 that a new cGMP plant is going to be built in Hanau, Germany. The facility is going to produce lipids for clinical development and innovative medicines. It intends to offer smaller batch sizes of lipids tailored to the needs of clinical development. The new facility expands Evonik's portfolio of System Solutions for advanced drug delivery. This portfolio includes mRNA and nucleic acid therapies like siRNA, oligonucleotides, and gene delivery.

What Factors Contribute to the Rising Prevalence of Cholesterol Diseases in Japan?

Demand for Cholesterol-lowering Medicines is Primarily Driven by Japan's Aging Demographic

Given its significant proportion of elderly individuals, Japan boasts one of the world's most aged populations. As advanced age poses a risk factor for cardiovascular diseases, there is strong anticipation that the demand for cholesterol-lowering medications and APIs is expected to continue to be substantial within the country. Around 13.5% of the population in Japan presently experiences type 2 diabetes. This substantial occurrence of type 2 diabetes is connected to a notable financial strain, as diabetes contributes to as much as 6% of the overall healthcare expenditure. In Japan, the average yearly medical cost for outpatient services amounted to US$ 3273 per individual in 2020. This translates to a total of US$ 16,365 over a span of five years.

The population in Japan is becoming more conscious about maintaining a healthy lifestyle to prevent chronic diseases like cardiovascular disorders. This has led to a significant increase in the demand for cholesterol-lowering medications and APIs. To alleviate the burden of cardiovascular diseases, the Japanese government has implemented various initiatives aimed at promoting preventive healthcare. These factors are likely to impact Japan cholesterol API market during the forecast period positively.

Is the United Kingdom Experiencing a Surge in Cholesterol-related Health Issues?

The Burgeoning Elderly Population in the United Kingdom propels Cholesterol API Market Growth

The United Kingdom cholesterol API market's growth is influenced by various factors, including

• the rising incidence of infectious, genetic, cardiovascular, and other chronic disorders
• the increasing number of elderly individuals
• advancements in cholesterol drug research

According to the British Heart Foundation's England Factsheet released in January 2022, about 6.4 million individuals in England are living with cardiovascular diseases. Additionally, as stated in the British Heart Foundation's 2020 fact sheet, around 7.4 million people in the United Kingdom are affected by heart and circulatory diseases.

The market growth is further driven by the substantial healthcare expenditure in the country. An example of this is evident in the data published by the OECD in June 2021, which showed a significant increase in the United Kingdom's health spending as a percentage of GDP. The expenditure rose from US$ 273 billion in 2020 to US$ 293.2 billion in 2021. As a result of the escalating healthcare spending, there is an expected boost in company activities, and government initiatives focused on the development of safe and effective treatment drugs. This, in turn, is expected to fuel the demand for APIs, propelling market growth.

What is the China Cholesterol API Market Outlook?

API Manufacturing Companies in China to Invest in Supply Chain Expansions

China is expected to continue to grow favorably throughout the forecast period, says FMI. Growth is attributed to the presence of numerous local and international API manufacturers in China and their consistent investments in the expansion of supply chains around the globe.

The increase in the number of people affected by cardiovascular diseases is likely to raise the demand for cholesterol API production. According to WHO's 2022 statistics, China had an obesity rate of 6.40% in 2022. IDF's 2022 statistics state that 140.8 million people in China had diabetes in 2021. By 2050, this number is projected to reach 174.4 million in China. The high diabetic and obese population in the country has led to a stronger focus on developing advanced and safe drugs. Consequently, this is driving the growth of the China cholesterol API market.

According to the WHO analysis, the Chinese government shifted its economy from centrally-planned to market-based. As part of this transition, the government established specialized industrial zones specifically dedicated to production plants. Therefore, the market growth is also driven by the growing expansion and establishment of API manufacturing facilities in the country. One noteworthy instance is WuXi STA, which in June 2022 inaugurated a brand-new high-potency active pharmaceutical component factory at its Changzhou location in Jiangsu, China. This expansion was in response to the increasing demand for high-potency API process research and development and manufacturing services.

Consumers in China are increasingly opting for natural and herbal supplements to manage cholesterol levels. This trend has created opportunities for manufacturers to develop cholesterol API from plant-based sources. Moreover, the country's well-established manufacturing infrastructure and competitive pricing make it an attractive sourcing destination for global pharmaceutical companies.

How is the India Cholesterol API Market Progressing?

India to Witness the Entry of International API Pharma Businesses by 2033

Presence of numerous generic API manufacturers in India, as well as expansion of the country’s pharmaceutical industry would drive the market. Besides, entry of a large number of international players in India owing to the availability of relatively low-cost raw materials and labor is projected to aid growth. Rapid expansion of the country’s bioprocess industry is also set to push the demand for cholesterol APIs.

The pharmaceutical industry in India has experienced remarkable growth in recent decades. India is one of the leading producers of generic drugs worldwide, accounting for 20% of the world's generic medicine demand by volume. India's API industry holds the third leading position globally, with around 57% of APIs on the WHO prequalified list originating from the country.

The Indian government has implemented regulatory reforms. The reforms aim to streamline the approval process for generic drugs and APIs. The objective is to promote domestic manufacturing. The reforms also seek to reduce dependency on imports. In July 2022, Piramal Pharma Limited's Pharma Solutions business launched a new API plant. The facility is situated within the business' Aurora, Ontario headquarters. As a top Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Limited is a market leader. The ultimate goal is to ensure the availability of quality medications in the market.

To further support the industry, the Indian government has implemented several schemes, including promoting API production through clusters and the Production Linked Incentive (PLI) program. These initiatives aim to facilitate domestic manufacturing and align with the "Make in India" initiative. In June 2020, the Indian government introduced schemes worth US$ 100 billion to enhance the domestic production of APIs. Therefore, the India cholesterol API market is projected to witness robust growth by 2033.

Category-wise Insights

Which is the Highly Preferred Cholesterol API Source?

Generic API Manufacturers to Look for Animal Derived Sources

Animal derived sources of cholesterol API are readily available and have been extensively used in the past few years for the manufacturing of biopharmaceuticals. Widespread use of materials sourced from animals is attributed to its high market share. Animal sources, including the liver of cattle, pigs, and chickens, naturally contain high cholesterol levels. This abundance of cholesterol in animal tissues makes them easily available for extraction. The high cholesterol concentration in animal sources enables efficient and cost-effective sourcing methods.

Animal-derived cholesterol has a robust regulatory history and has obtained approval from prestigious bodies such as the United States Food and Drug Administration and the European Medicines Agency. Compliance with stringent regulatory standards serves as evidence of the safety, purity, and efficacy of animal-derived cholesterol. Meeting these rigorous regulations instills trust across the industry, establishing animal-derived cholesterol as a reliable and trusted ingredient.

Animal-derived cholesterol has gained widespread acceptance in the pharmaceutical industry. It is extensively utilized in the production of hormones, vitamins, and steroidal drugs. The established track record of animal-derived cholesterol and its proven efficacy and safety has solidified its position as the preferred source for cholesterol API.

Which Manufacturing Process is Mainly Used to Produce Cholesterol APIs?

Active Pharmaceutical Ingredient Production Companies to Opt for GMP

High demand for pharmaceutical-grade cholesterol for RNA vaccines and monoclonal antibodies, as well as other drug delivery systems is likely to drive the segment. GMP manufacturing processes prioritize stringent quality control measures, from raw material sourcing to final product release, throughout the production cycle. This emphasis on quality assurance helps minimize the risk of impurities, contamination, and variability in the cholesterol API. Pharmaceutical companies and buyers prefer GMP-certified suppliers due to their reputation for reliable and high-quality products.

GMP certification serves as a mark of reliability, professionalism, and adherence to international quality standards. Pharmaceutical companies, healthcare professionals, and regulatory authorities place significant emphasis on reputation and trust when selecting suppliers for cholesterol APIs. GMP-compliant manufacturers have established a strong reputation. This trust in GMP-certified manufacturers allows them to dominate the cholesterol API market, as buyers prefer suppliers with a proven track record of quality and compliance.

Competitive Landscape

The global cholesterol API market is highly fragmented with the presence of a large number of companies. To meet high consumer demand and expand their customer base, these companies are implementing various strategies such as mergers & acquisitions, partnerships, collaborations, and new product launches.

Some of the recent developments in the global cholesterol API market are

• In June 2023, Sanofi Consumer Healthcare Korea partnered with AB-BIOTICS to introduce probiotics in South Korea that offer advantages beyond improving gut health. Its primary objective is to assist individuals in managing their cholesterol levels. It is the first probiotic product that received approval from the Ministry of Food and Drug Safety. The South Korean market is known for its greater willingness to utilize probiotics for various therapeutic uses.
• In May 2023, ProBiotix Health unveiled a cholesterol tablet with a dual-action mechanism. This innovative tablet aids the liver in eliminating cholesterol from the bloodstream and also decreases the absorption of dietary cholesterol.
• In May 2022, Sun Pharma revealed that its fully-owned subsidiary is going to soon introduce a new oral medication called Bempedoic Acid in India. This drug is specifically designed to lower low-density lipoprotein (LDL) cholesterol levels. The subsidiary plans to market the drug in India using the brand name Brillo.
• In February 2021, Evkeeza, developed by Regeneron Pharmaceuticals, Inc., received approval from the United States Food and Drug Administration as an adjunct to other therapies that reduce low-density lipoprotein cholesterol (LDL-C) levels. Evkeeza is notably the first treatment sanctioned by the FDA to bind to and inhibit the activity of angiopoietin-like 3 (ANGPTL3), a vital protein involved in lipid metabolism.
• In December 2021, CordenPharma and Wacker announced signing of a R&D collaboration agreement to expand their position in the field of lipid nanoparticles (LNP) formulations.
• In June 2021, Centrient Pharmaceuticals, a leading provider of next-generation statins and sustainable antibiotics, started the production of its novel statins manufacturing unit. The company is aiming to double its statins production capacity to help meet the high demand for Rosuvastatin and Atorvastatin APIs.

Key Market Players

• Merck KGaA
• Cayman Chemical Company (Matreya)
• CordenPharma
• Croda International Plc (Avanti)
• NOF (Nippon Oil & Fats) Corporation
• Nippon Fine Chemical Co. Ltd.
• Akums Drugs & Pharmaceuticals Ltd
• Tokyo Chemical Industry Co., Ltd.
• Evonik Industries AG
• Dishman Group
• Hänseler AG
• Caesar & Loretz GmbH
• Fisher Scientific Co, LLC (Thermo Fisher)

Cholesterol API Market Outlook by Category

By Source:

• Animal Derived
• Plant Derived
• Synthetic

By Manufacturing Process:

• GMP
• Non – GMP

By End User:

• RNA Vaccines
• Monoclonal Antibodies
• Others

By Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• The Middle East and Africa (MEA)