Cholesterol API Market Size & Share, by Type (NF Grade, BP Grade); Manufacturing Process (GMP, Non-GMP); Source (Animal Derived, Plant Derived, Synthetic); End-user (RNA Vaccines, Monoclonal Antibodies); Application (Pharmaceuticals, Feeds, Cosmetics) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2031

  • Report ID: 4243
  • Published Date: Feb 14, 2023
  • Report Format: PDF, PPT

Global Cholesterol API Market Size, Forecast, and Trend Highlights Over 2022 - 2031

Base Year  2021
Forecast Year                                                                                               2022-2031                                        
CAGR ~5%
Base Year Market Size (2021) ~USD 260.7 Million
Forecast Year Market Size (2031) ~USD 416.6 Million
The global cholesterol API market is estimated to garner a revenue of ~USD 416.6 Million by the end of 2031 by growing at a CAGR of ~5% over the forecast period, i.e., 2022 – 2031. Further, the market generated a revenue of ~USD 260.7 Million in the year 2021. The growth of the market is primarily attributed to its being a significant compound for stability of a liposomal membrane formulation which is used in numerous kind of vaccines and drugs delivery systems to get optimum results. For instance, the revolutionary liposome delivery system enables the body to absorb 25 to 100 times more than conventional drug delivery system, making it more effective to cure diseases.

Cholesterol API Market Overview

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Cholesterol API is frequently used in various types of targeted drugs delivery systems as a very efficient drug carrier. Cholesterol serves as a stabilizing agent in the production of vaccines and medicines. Its lipid nanoparticles are gaining popularity in the pharmaceutical industry as potential drug delivery systems. They are necessary for effective encapsulation and delivery of mRNA to cells. Therefore, increasing demand for novel vaccines and drug delivery methods to tackle the growing prevalence of diseases are anticipated to drive the growth of the cholesterol API market during the forecast period. As per the data provided by the UNICEF, more than 3.8 billion doses of the COVID-19 vaccine have been given till July 2022.

Global Cholesterol API Market: Growth Drivers and Challenges

Growth Drivers

  • Growing Use of Liposomal Formulations in Drug Delivery Systems - When compared to conventional drug delivery systems, liposomes are considered to be promising and adaptable drug particles. Site-targeting, sustained or controlled release, protection of drugs from deterioration and clearance, enhanced therapeutic effects, and fewer toxic side effects are just a few of their great properties. Such properties lead the growing use of liposomal formulation in various drug delivery systems. For instance, approximately 15 different commercial liposomal product types have received FDA and EMA approval. A whopping 45% of the marketed products were approved before the year 2000, and 55% were approved before the year 2010.

  • Surge in Anticancer Therapies – Surge in cancer cases are leading towards the discovery of various anticancer therapies. Such therapies use the applications of drug delivery systems that utilize cholesterol APIs. For instance, in 2021, a staggering 32 oncology novel active substances (NASs) were introduced globally.

  • Escalating Clinical Trials of mRNA Vaccines - Messenger RNA (mRNA) vaccines contain mRNA, a single-stranded RNA molecule that accentuates DNA. It is developed in the nucleus when RNA polymerase transcribes DNA to generate pre-mRNA. Before to the COVID-19 pandemic, mRNA vaccines for communicable diseases such as HIV-1 and rabies were already in clinical trials. For instance, it was observed in research, as a result of COVID-19 pandemic, in 291 vaccine trials, there are 18 vaccines in the clinical phase, and 24 in the preclinical phase among the RNA-based vaccines under consideration.

  • Worldwide Expansion of Pharmaceutical Industry - The increase in life expectancy for both men and women around the world is owing to the pharmaceutical industry. The industry is driving medical advancement by conducting research, enhancing, and bringing new medications that enhance patients' health and quality of life worldwide. For instance, by 2023, the pharmaceutical industry is anticipated to reach approximately USD 1 trillion across the globe.

  • Huge R&D Funding by Pharmaceutical Companies – For instance, the 16 biggest pharmaceutical companies spent around USD 134 billion on R&D in 2021, which denotes a 45% expansion from 2016.


  • Lack of Government Guidelines Regarding Manufacturing of Cholesterol API
  • Requirement of High Initial Investments
  • Clinical Trial Limitations with Several Therapies

The global cholesterol API market is segmented and analyzed for demand and supply by end-user into RNA vaccines, monoclonal antibodies, and others. Out of these, the monoclonal antibodies segment is estimated to significantly grow over the forecast period owing to the growing implementation of monoclonal antibodies in treatment of various types of cancers and SARS diseases including COVID- 19. For instance, it is observed in a research that monoclonal antibodies that are administered to patients via infusion are anticipated to be used alone or in combination with other medications. Depending on the antigen targeted, each monoclonal antibody works in one or more ways. Some monoclonal antibodies specifically bind to cancer cells, killing them. They are effective since they target specific receptors in cells. Trastuzumab (Herceptin), for example, is used to treat HER2-positive breast cancer and stomach cancer. Trastuzumab binds to the HER2 receptors on cancer cells, preventing them from increasing, that halt growth and slow down cancer progression. Additionally, as per the report of the Centers for Medicare & Medicaid Services, under EUA the FDA approved the use of EVUSHELD (tixagevimab co-packaged with cilgavimab) in adults and paediatric patients for COVID-19 pre-exposure prophylaxis.

The global cholesterol API market is also segmented on the basis of manufacturing process into GMP, and non-GMP. Amongst these segments, the GMP segment is projected to garner the highest market share of about 70% by the end of 2031. Further, the non-GMP segment is anticipated to garner a market share of 30% in the same year.

Major Macro-Economic Indicators Impacting the Market Growth

Cholesterol API Market Regional Chart

According to the statistics by the World Health Organization, the global per capita healthcare expenditure amounted to USD 1,064.741 in the year 2017. The worldwide healthcare expenditure per person grew from USD 864.313 in 2008 to USD 1,110.841 in 2018, where the U.S. is the top country that amounted to healthcare expenditure of USD 10, 623.85 per capita in 2018. As of 2018, the domestic general government healthcare spending in the U.S. was USD 5355.79, which grew from USD 3515.82 in 2008. These are some of the factors responsible for market growth over the past few years. Moreover, as per the projections by the Centers for Medicare & Medicaid Services (CMS), the estimated average annual percent change related to National Health Expenditures (NHE) in the U.S. was 5.2% in 2020 as compared to 2019 (4.5%). Furthermore, the National Health Expenditures are projected to reach USD 6,192.5 Billion in 2028, where the per capita expenditure is estimated to touch USD 17,611 in the same year. These are notable indicators that are anticipated to create lucrative business opportunities in upcoming years.

Global Cholesterol API Market Regional Synopsis

Regionally, the global cholesterol API market is studied into five major regions including North America, Europe, Asia Pacific, Latin America and Middle East & Africa region. Amongst these markets, the market in North America is projected to hold the largest market share of 39% by the end of 2031 backed by the growing cases of various types of cancers, rising healthcare expenditure, increasing expenditure in research and development of medical and health paradigm, and the existence of several well-known drug manufacturers in the region. As per the data provided by the Centers for Medicare & Medicaid Services, in 2020, national healthcare spending increased by 9.7% to USD 4.1 trillion, representing 19.7% of GDP.

Cholesterol API Market Regional Synopsis

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The global cholesterol API market is further classified on the basis of region as follows:

  • North America (U.S. & Canada) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC (Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Middle East and Africa (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook

Market Segmentation

Our in-depth analysis of the global cholesterol API market includes the following segments:

By Type

  • NF Grade
  • BP Grade
  • Others

By Source

  • Animal Derived
  • Plant Derived
  • Synthetic

By End-User

  • RNA Vaccines
  • Monoclonal Antibodies
  • Others

By Application

  • Pharmaceuticals
  • Feeds
  • Cosmetics
  • Others

Top Featured Companies Dominating the Global Cholesterol API Market

  • Thermo Fisher Scientific Holdings, Inc.
    • Company Overview
    • Business Strategy
    • Key Product Offerings
    • Financial Performance
    • Key Performance Indicators
    • Risk Analysis
    • Recent Development
    • Regional Presence
    • SWOT Analysis
  • Croda International Plc
  • Bristol Myers Squibb Company (BMS)
  • Evonik Industries AG
  • Dishman Carbogen Amcis Ltd
  • Hänseler AG
  • Caesar & Loretz GmbH
  • Akums Drugs & Pharmaceuticals Ltd.
  • Tokyo Chemical Industry Co., Ltd.
  • Cayman Chemical Company


In the News

  • Croda International Plc, announced the support of the UK government to the expansion of its manufacturing facility which is estimated to boost the development of high-purity lipid systems for next-generation nucleic acid drugs such as mRNA vaccines.

  • Bristol Myers Squibb Company (BMS), announced the successful acquisition of Turning Point Therapeutics, Inc. ("Turning Point"). As a result of the acquistion, Bristol Myers Squibb gains access to an investigational medicines pipeline focused on repotrectinib, the most common mutation associated with oncogenesis.

Author Credits:  Radhika Pawar

  • Report ID: 4243
  • Published Date: Feb 14, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Growing use of liposomal formulations in drug delivery systems, surge in anticancer therapies, and escalating clinical trials of mRNA vaccines are some major factors driving the growth of the market.

The market is anticipated to attain a CAGR of ~5% over the forecast period, i.e., 2022 – 2031.

Lack of government guidelines regarding manufacturing of cholesterol API, requirement of high initial investments, and clinical trial limitations with several therapies are estimated to hamper the market growth.

The market in North America is projected to hold the largest market share by the end of 2031 and provide more business opportunities in the future.

The major players in the market are Thermo Fisher Scientific Holdings, Inc., Croda International Plc, Bristol Myers Squibb Company (BMS), Evonik Industries AG, Dishman Carbogen Amcis Ltd, Hänseler AG, Caesar & Loretz GmbH, and others.

The company profiles are selected based on the revenues generated from the product segment, geographical presence of the company which determine the revenue generating capacity as well as the new products being launched into the market by the company.

The market is segmented by type, source, end-user, application, and by region.

The monoclonal antibodies segment is anticipated to garner the largest market size by the end of 2031 and display significant growth opportunities.

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