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The solubility enhancement excipients for OSDF market size are forecast to increase by USD 6.37 billion at a CAGR of 16.25% between 2023 and 2028. The growth rate of the market depends on several factors, including the rising demand for polymer excipients, the growth in the global pharmaceutical industry, and the growing demand for pharmaceutical drugs and binders owing to the increasing geriatric population.
The report offers extensive research analysis on the Solubility Enhancement Excipients for OSDF Market, with a categorization based on Technology, including solid dispersion, particle size reduction, micellar solubilization, lipid solubilization, and others. It further segments the market by Type, encompassing lipids, polymers, surfactants, and others. Additionally, the report provides Region segmentation, covering APAC, Europe, North America, Middle East and Africa, and South America. Market size, historical data (2018-2022), and future projections are presented in terms of value (in USD billion) for all the mentioned segments.
Solubility enhancement refers to the improvement of the solubility of a drug in a given solvent or medium. In the context of OSDF, excipients play a crucial role. Excipients are inactive substances added to pharmaceutical formulations to aid in the manufacturing process, improve stability, or enhance drug delivery. In solubility enhancement for OSDF, excipients like surfactants, co-solvents, and solid dispersions are commonly used to increase the solubility of poorly soluble drugs, ultimately improving their bioavailability.
One of the key factors driving the solubility enhancement excipients for OSDF market growth is the rising demand for polymer excipients. Currently, most drug substances are manufactured using innovative methods to enhance their water solubility. In addition, to overcome poor water solubility, polymer-based soluble excipients are used. Furthermore, these excipients significantly improve the dissolution of poorly aqueous soluble compounds.
Moreover, this drug substance is generally dissolved in gastric fluid to improve the absorption and bioavailability of an orally administered drug. Furthermore, to improve the efficiency of pharmaceutical drugs, vendors of solubility enhancement excipients are focusing on nanonization technology, which is known for enhancing the solubility of drugs. Therefore, such factors will drive the growth of the global solubility enhancement excipients market for OSDF during the forecast period.
A key factor shaping the solubility enhancement excipients for OSDF market growth is the high adoption of solid dispersion technology. Solid dispersion can be referred to as a process that has been intensively used to improve drugs' solubility and dissolution rate and enhance their oral bioavailability. In addition, this technology is used for improving the oral absorption and bioavailability of Class II drugs. Class II drugs are medicinal drugs that are listed under Drug Schedule II/IIN.
Moreover, these drugs have higher medicinal value than other drugs. In addition, the solid dispersion technique is more prevalent in manufacturing medicinal drugs using solubility enhancement excipients. Furthermore, this method improves the dissolution rate of poorly soluble drugs. Hence, such factors are positively impacting the solubility enhancement excipients for oral solid dosage forms (OSDF) market. Therefore, it is expected to drive the market growth during the forecast period.
Rising concerns about patents related to solubility enhancement excipients for OSDF are one of the key challenges hindering the solubility enhancement excipients for OSDF market growth. Stringent regulations on the use of different chemicals in the pharmaceutical industry adversely impact the adoption of solubility enhancement excipients. In addition, pharmaceutical products can be sold only after the approval of regulatory bodies such as the US FDA and the European Medicines Agency.
Moreover, pharmaceutical manufacturers need to have patents for their drugs to be sold in the market, and drugs can be sold only until the expiry of their patent. In addition, in developed countries such as Germany, the US, and the UK, patents are granted for 20 years from the date of filing. Furthermore, the expiry of a patent leads to the entry of a new seller in the market with a new patent for a drug. Hence, such factors are negatively impacting the solubility enhancement excipients for oral solid dosage forms (OSDF) market. Therefore, it is expected to hinder the market growth during the forecast period.
The solid dispersion segment is estimated to witness significant growth during the forecast period. Solid dispersion technology segment refers to a method of dispersing one or more active ingredients in an inert matrix in the solid stage to achieve an increased dissolution rate of the drug. In addition, solid dispersion technology is mainly used to improve drug solubility and dissolution rates, thereby enhancing oral bioavailability.
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The solid dispersion segment was the largest segment and was valued at USD 1.02 million in 2018. Moreover, most new drugs have poor water solubility, posing a major problem in the formulation of drug delivery systems. Thus, solubility enhancement of poorly water-soluble drugs is one of the required steps for pharmaceutical drug manufacturing. Furthermore, many pharmaceutical companies are spending a lot of time and effort to improve the solubility and bioavailability of drugs. In addition, modern drug manufacturing processes such as melt extrusion, spray drying, and coprecipitation have been developed to use solid dispersion technology, which minimizes the drawbacks resulting from initial techniques such as salt formation or incorporating polar groups in the drug structure. Hence, such factors are fuelling the growth of this segment which in turn drives the market growth during the forecast period.
Based on the type, the segment is classified into lipids, polymers, surfactants, and others. The lipids segment will account for the largest share of this segment. Poor solubility is a significant challenge in many pharmaceutical drug formulations. Thus, a large number of pharmaceutical drugs will have challenges regarding absorption and bioavailability. Therefore, to solve this issue, end-users are adopting lipids-based excipients such as Compritol 888 ATO. Furthermore, end-users are offering lipid-based drug delivery systems (LBDDS). In addition, LBDDS are formulations that comprise drugs dissolved in lipid excipients. Hence, such factors are fuelling the growth of this segment which in turn drives the market growth during the forecast period.
North America is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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The US, Canada, and Mexico have world-class healthcare facilities, and some of the main countries contributing to the market growth in North America. In addition, the pharmaceutical industry in the US is the largest in the region, which mainly contributes to the solubility enhancement excipients market for OSDF in the region. Moreover, companies such as Pfizer Inc., Johnson and Johnson, Roche Holding AG, and AbbVie Inc. are leading pharmaceutical manufacturing companies based across the US. Furthermore, major pharmaceutical manufacturers have manufacturing units in the country and focus on improving technology for medical applications. Hence, such factors are driving the market growth in North America during the forecast period.
Companies are implementing various strategies by analyzing factors such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product or service launches, to enhance their presence in the market.
Abitec: The company offers solubility enhancement excipients namely Acconon excipients that used to improve the bioavailability of poorly water soluble drugs by direct solubilization.
The report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:
Air Liquide SA, Ashland Inc., BASF SE, CD Formulation, Clariant International Ltd., Croda International Plc, DuPont de Nemours Inc., Evonik Industries AG, Freund Corp., Fuji Chemical Industries Co. Ltd., GATTEFOSSE SAS, Merck KGaA, Roquette Freres SA, Shin Etsu Chemical Co. Ltd., Solvay SA, SPI Pharma Inc, and The Lubrizol Corp.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028.
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Solubility Enhancement Excipients Market for OSDF Scope |
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Report Coverage |
Details |
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Page number |
185 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 16.25% |
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Market Growth 2024-2028 |
USD 6.37 billion |
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Market structure |
Fragmented |
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YoY growth 2023-2024(%) |
15.72 |
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Regional analysis |
North America, Europe, APAC, South America, and Middle East and Africa |
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Performing market contribution |
North America at 37% |
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Key countries |
US, Canada, China, Germany, and Italy |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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Key companies profiled |
Abitec, Air Liquide SA, Ashland Inc., BASF SE, CD Formulation, Clariant International Ltd., Croda International Plc, DuPont de Nemours Inc., Evonik Industries AG, Freund Corp., Fuji Chemical Industries Co. Ltd., GATTEFOSSE SAS, Merck KGaA, Roquette Freres SA, Shin Etsu Chemical Co. Ltd., Solvay SA, SPI Pharma Inc, and The Lubrizol Corp. |
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Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period. |
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Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
We can help! Our analysts can customize this report to meet your requirements. Get in touch
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Technology
7 Market Segmentation by Type
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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