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Cholesterol API Market size was over USD 281.3 million in 2023 and is expected to exceed USD 504.76 million by 2036, witnessing over 4.6% CAGR during the forecast period i.e., between 2024-2036. In the year 2024, the industry size of cholesterol API is evaluated at USD 291.65 million. The growth of the cholesterol API 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 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.
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.
Challenges
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Base Year |
2023 |
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Forecast Year |
2024-2036 |
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CAGR |
4.6% |
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Base Year Market Size (2023) |
USD 281.3 million |
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Forecast Year Market Size (2036) |
USD 504.76 million |
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Regional Scope |
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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 2036. Further, the non-GMP segment is anticipated to garner a market share of 30% in the same year.
Our in-depth analysis of the cholesterol API market includes the following segments:
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By Type |
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By Source |
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By End-User |
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By Application |
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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. North America is projected to hold 39% industry share by 2036, backed by 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.
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
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