Drug Bioavailability Enhancement Market
The drug bioavailability enhancement market is driven by the increase in number of BCS II and BCS IV molecules in early phases of development, is likely reach $10 billion by 2035, growing at a CAGR of ~11%. Bioavailability is known to form an integral part of the drug pharmacokinetics. As a result, over the last couple of years, the concept of bioavailability has garnered significant attention in the pharmaceutical industry. Further, a study conducted on terminated drug development projects revealed that majority of the candidates fail in early phases. The study further highlighted that the aforementioned drug failures can primarily be attributed to the problems associated with pharmacokinetic profiles, ADME (distribution, metabolism, absorption and excretion) properties and toxicity-related concerns. At present, more than 40% of the marketed drugs are believed to possess low bioavailability, while around 90% of all New Chemical Entities (NCEs), which are being evaluated in pre-clinical and clinical stages of development, exhibit solubility / permeability related issues.Consequently, recent years have seen a rise in drug developers evaluating various re-formulation strategies to improve the bioavailability of existing drugs / drug candidates. In fact, an increasing number of drug candidates have been granted approval via the 505(b)(2) pathway; the aforementioned pathway is used to gain approval for novel formulations consisting of previously approved active pharmaceutical ingredient (API). Additionally, given the shifting focus of drug developers towards development of lipophilic drug compounds, the industry is actively undertaking efforts to identify various bioavailability enhancement techniques, in order to mitigate the challenge of low bioavailability and stability.
In this context, it is also important to mention that a significant number of players engaged in the development of therapeutic interventions currently prefer to outsource their bioavailability enhancement operations to contract service providers. This trend can be attributed to the fact that service providers usually have specialized facilities and equipment, along with established processes, which can help drug developers to accomplish the desired goals in shorter timelines. In order to cater to the requirement for such services, a number of bioavailability enhancement focused service providers for API have been established in the past few years, across various regions of the globe. At present, the bioavailability enhancement service providers are actively trying to consolidate their presence in this field by entering into strategic alliances, to meet the indubitably rising demand for effective therapeutics. For this purpose, substantial mergers and acquisitions have been reported in this market, as service providers strive to become one-stop-shops, to cater to the diverse needs for their clientele. In addition, several stakeholders are engaged in the development of proprietary technologies, based on sustained release principle and bioavailability enhancers, to maintain a competitive edge in this rapidly emerging market. In fact, since 2017, close to 6,000 research articles, evaluating various bioavailability enhancement techniques have been published across several reputed journals. In addition, close to 10,000 patents have been filed, till 2022, providing a significant scientific push for the development of novel approaches. Driven by the increase in number of BCS II and BCS IV molecules being evaluated in early phases of development, the drug bioavailability enhancement market is expected to witness a steady market growth during the forecast period.
Key Companies in Drug Bioavailability Enhancement Market
Examples of key companies engaged in drug bioavailability enhancement market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Adare Pharma Solutions, Ascendia Pharmaceuticals, Catalent, Lonza, Lubrizol Life Science Health, Pace Life Sciences, Quotient Sciences and WuXi STA (A Subsidiary of WuXi AppTec). This market report includes an easily searchable excel database of all the companies providing drug bioavailability enhancement services and technologies, worldwide.
Recent Developments in Drug Bioavailability Enhancement Market
Several recent developments have taken place in the field of drug bioavailability enhancement market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
- In August 2023, Mountain Valley MD published Soluvec™ Trial Data in Therapeutic Delivery demonstrating significant enhancement in Ivermectin solubilization and bioavailability.
- In July 2023, Zeon Lifesciences launched liquid filled capsules. These capsules have capability to offer a unique delivery system enclosing a host of advantages including enhanced bioavailability and absorption rate.
- In May 2023, AustinPx announced the expansion of its capabilities by installing PROCEPT modular 4M8-Trix with an aim of developing spray dried amorphous solid dispersions. This will strengthen company’s portfolio of bioavailability enhancement technologies.
Scope of the Report
The “Drug Bioavailability Enhancement Market (2nd Edition) by Drug Class (New Drug Approvals and Generics), BCS Classification (BCS II Drugs and BCS IV Drugs), Bioavailability Enhancement Approach (Solid Dispersion, Size Reduction, Lipid-based, and Other Approaches), Dosage Form (Liquids, Solids, Semi-Solids, and Fine Particles) and Key Geographies (North America, Europe, Asia, Latin America, Middle East and North Africa and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the drug bioavailability enhancement market. The market research report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in providing bioavailability enhancement technologies and services. The table below highlights various market segmentations done in the market research report.
2022 – 2035
|New Drug Approvals, Generics
|BCS II drugs, BCS IV drugs
Bioavailability Enhancement Approach
|Solid dispersion, size reduction, lipid-based
|Liquids, solids, semi-solids, fine particles / powders
|Key Geographical Regions
|North America, Europe, Asia-Pacific, MENA, Latin America and Rest of the World
Amongst other elements, the market report features:
- An executive summary of the insights captured in our research. It offers a high-level view on the current state of bioavailability enhancement technologies and services market and its likely evolution in the mid-long term.
- A general introduction to bioavailability enhancement, featuring information on the historical overview of bioavailability, assessment of drug bioavailability, need for bioavailability enhancement, and general factors affecting drug bioavailability. Additionally, the chapter includes details on the various types of bioavailability enhancement approaches / technologies employed by various industry stakeholders. The chapter concludes with a discussion on the key growth drivers, as well as upcoming trends in drug bioavailability enhancement market.
- A detailed assessment of the overall market landscape of bioavailability enhancement service providers, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, bioavailability enhancement principle supported (solubility enhancement, absorption enhancement, sustained release and others), bioavailability enhancement approach employed, including [A] solid dispersion (spray-dried dispersion, hot melt extrusion, polymers, agglomeration / granulation, lyophilization, inclusion complexes, super critical fluid, solvent evaporation and other solid dispersion approaches), [B] size reduction (conversion to nanotechnology-based formulation, high pressure homogenization / mirconization, bead layering, microfluidics, and other miscellaneous size reduction approach), [C] lipid-based (liposomes, self-emulsifying drug delivery system, excipients, micelles, lipid-nanotechnology based formulations and other lipid-based formulations), and other bioavailability enhancement approaches (co-crystallization, chemical modification, and other miscellaneous bioavailability enhancement technologies), type of dosage form supported (solids, liquids, fine particles and semi-solids), and route of administration of drug product (oral, topical, parenteral and others).
- A detailed assessment of the current market landscape of bioavailability enhancement technology providers, featuring analysis based on several parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters. In addition, the chapter highlights an in-depth analysis of various bioavailability enhancement technologies based on bioavailability enhancement principle supported (solubility enhancement, absorption enhancement, sustained release, and others), bioavailability enhancement approach employed (solid dispersion, nanotechnology, lipid-based, other size reduction, chemical modification, and others), type of molecule (small molecules and biologics), type of dosage form supported (solids, liquids, fine particles, and semi-solids), route of administration (oral, topical, parenteral, and others), availability for license and associated intellectual property rights.
- An in-depth analysis, highlighting the contemporary market trends, using six schematic representations, including [A] a world map representation depicting the region-wise distribution of various stakeholders engaged in offering bioavailability enhancement services, on the basis of their company size, [B] a waffle chart representation, highlighting the regional distribution of bioavailability enhancement service providers, based on various types of bioavailability enhancement approaches employed by them, [C] a heat map representation of bioavailability enhancement service providers, based on bioavailability enhancement approaches and type of dosage form, [D] a horizontally grouped bar chart, highlighting the distribution of bioavailability enhancement service providers based on their company size and type of bioavailability enhancement principles, [E] an insightful tree map representation of bioavailability enhancement service providers (in terms of bioavailability enhancement principles employed and bioavailability enhancement approaches offered), as well as [F] a 3D bubble analysis comparing the key players engaged in drug bioavailability enhancement market, based on several relevant parameters (such as year of establishment, company size, number of bioavailability enhancement approaches offered and region).
- Elaborate profiles of various prominent players that are engaged in offering bioavailability enhancement technologies and services. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives), details related to its financial performance (if available), bioavailability enhancement services portfolio, recent developments and an informed future outlook.
- A company benchmarking analysis of various players engaged in drug bioavailability enhancement market. It highlights the capabilities of industry players in terms of their expertise across various services related to bioavailability enhancement of drug compounds and / or drug candidates. The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to gain a competitive edge in the industry.
- An analysis of partnerships that have been inked between several stakeholders engaged in providing bioavailability enhancement services and technologies, during the period 2013-2022, covering mergers and acquisitions, licensing agreements, alliances, product development and manufacturing agreements, research and development agreements, product development and commercialization agreements, service agreements, and other agreements.
- A detailed review of more than 5,800 peer-reviewed, scientific articles related to research on bioavailability enhancement of drug compounds and / or drug candidates, based on parameters, such as year of publication, type of publication and popular keywords. The chapter also provides information on top journals, top publishers and top copyright holders (in terms of number of articles published)
- An in-depth analysis of the patents that have been filed / granted for bioavailability enhancement approaches and technologies since 2003, based on important parameters, such as type of patent, patent application year, patent publication year, bioavailability enhancement approach, CPC symbols, geography, emerging focus area, type of organization, leading industry and non-industry players (in terms of number of patents filled / granted), and individual patent assignees (in terms of size of intellectual property portfolio). The chapter also includes an insightful benchmarking and valuation analysis.
- An in-depth analysis of completed, ongoing, and planned clinical studies related to bioavailability enhancement of various drug compounds and / or candidates, based on several relevant parameters, such as trial registration year, trial phase, current recruitment status, enrolled patient population, study design, type of sponsor / collaborator, leading industry and non-industry players (in terms of number of registered trials conducted), type of molecule and key geographies.
- An insightful framework evaluating the bioavailability enhancement approaches based on various parameters, such as number of technologies, number of approved drugs, trends highlighted in published literature and patents, and business models adopted by industry stakeholders. It also provides a value addition matrix for respective bioavailability enhancement approaches currently employed by stakeholders.
- An elaborate analysis in order to estimate the current and future demand for bioavailability enhancement technologies and services, based on several relevant parameters, such as drug class (new drug approvals and generics), BCS classification (BCS II drugs and BCS IV drugs) and dosage form (liquids, solids, semi-solids, and fine particles / powders) for the period 2022-2035. Kindly note that input parameters considered for this analysis include number of New Chemical Entity (NCE) candidates and generic / reformulated drug products that are likely to undergo formulation development over the period of next 13 years.
The key objective of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for drug bioavailability enhancement market in the short to mid-term and long term, over the forecast period 2022-2035. Further, the year-wise projections of the current and future opportunity have been segmented based on relevant parameters, such as drug class (new drug approvals and generics), BCS classification (BCS II drugs and BCS IV drugs), bioavailability enhancement approach (solid dispersion, size reduction, and lipid-based), dosage form (liquids, solids, semi-solids, an fine particles / powders) and key geographies (North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, which represent different tracks of the industry’s growth.
All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this market research report are in USD, unless otherwise specified.
Frequently Asked Questions
- Who are the key players engaged in the bioavailability enhancement technologies and services market?
- Which are the key geographies where bioavailability enhancement technology and service providers are located?
- What are the recent developments and expected trends in the bioavailability enhancement industry?
- Which partnership models are commonly adopted by stakeholders offering bioavailability enhancement solutions?
- What is the evolving trend of publications focused on bioavailability enhancement technologies?
- Which companies are actively filing patents to drive innovation in the drug bioavailability enhancement market?
- What are the key market trends and driving factors that are likely to impact the growth of the bioavailability enhancement technologies and services market?
- How is the current and future opportunity likely to be distributed across key market segment?
Frequently Asked Questions
Question 1: What is bioavailability of drug? Answer:
Drug bioavailability refers to the amount of drug or other pharmaceutical entity which is available in the blood stream to reach the intended target destination.
Question 2: What is the projected drug bioavailability enhancement market size? Answer:
The size of drug bioavailability enhancement industry (for technologies and services) is estimated to be worth $10 billion in 2035.
Question 3: What is the projected market growth of the drug bioavailability enhancement market? Answer:
The drug bioavailability enhancement industry is expected to grow at compounded annual growth rate (CAGR) of 11% during the forecast period 2022 - 2035.
Question 4: Who are the leading players in the drug bioavailability enhancement industry? Answer:
Examples of key companies engaged in drug bioavailability enhancement market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Adare Pharma Solutions, Ascendia Pharmaceuticals, Catalent, Lonza, Lubrizol Life Science Health, Pace Life Sciences, Quotient Sciences and WuXi STA (A Subsidiary of WuXi AppTec).
Question 5: How many patents have been filed / granted related to drug bioavailability enhancement? Answer:
Since 2003, over 10,000 patents have been filed / granted related to drug bioavailability enhancement.
Question 6: Which region is the hub for players providing drug bioavailability enhancement technologies and services? Answer:
North America presently harbors the majority of the players providing drug bioavailability enhancement technologies and services, with close to 50% of the companies established in this region.
Question 7: How many clinical trials have been conducted for evaluating improved bioavailability? Answer:
Till date, over 4,500 clinical trials have been conducted for evaluating novel therapeutic interventions for improved bioavailability, highlighting the ongoing research in this field.