The growth of the drug bioavailability enhancement market is primarily fueled by the increasing prevalence of BCS II and BCS IV molecules in the early stages of development, and it is projected to reach approximately $10 billion by 2035, with a notable compound annual growth rate (CAGR) of approximately 11%.
The concept of bioavailability has gained substantial attention in the pharmaceutical industry recently due to its integral role in drug pharmacokinetics. An analysis of discontinued drug development projects revealed that a significant proportion of these candidates fail in their early phases, predominantly due to challenges related to pharmacokinetic profiles, ADME properties (distribution, metabolism, absorption, and excretion), and toxicity concerns. Currently, more than 40% of marketed drugs are believed to have low bioavailability, and approximately 90% of all New Chemical Entities (NCEs) under pre-clinical and clinical evaluation exhibit solubility and permeability-related issues. Consequently, drug developers have increasingly explored various re-formulation strategies to enhance the bioavailability of existing drugs and drug candidates. Notably, more drug candidates have received approval through the 505(b)(2) pathway, which is utilized for novel formulations containing previously approved active pharmaceutical ingredients (APIs). Furthermore, given the industry’s shift toward developing lipophilic drug compounds, efforts are actively underway to identify bioavailability enhancement techniques to address the challenges of low bioavailability and stability.
It is essential to highlight that a significant number of therapeutic intervention developers now prefer to outsource their bioavailability enhancement operations to contract service providers. This preference arises from the fact that service providers typically possess specialized facilities, equipment, and established processes, which expedite the achievement of project objectives within shorter timeframes. To meet the escalating demand for effective therapeutics, numerous bioavailability enhancement-focused service providers for APIs have emerged worldwide in recent years. These providers are actively working to strengthen their presence in the market by forming strategic alliances to become comprehensive solution providers for their clients. Consequently, there have been substantial mergers and acquisitions within this market as service providers seek to offer one-stop solutions to meet their clients’ diverse needs. Additionally, various stakeholders are engaged in the development of proprietary technologies based on sustained release principles and bioavailability enhancers to maintain a competitive edge in this rapidly evolving market. Over the years, a significant amount of research has been published on various bioavailability enhancement techniques, with nearly 6,000 research articles appearing in reputable journals since 2017. Moreover, almost 10,000 patents have been filed until 2022, providing significant scientific momentum for the development of novel approaches. With the increasing number of BCS II and BCS IV molecules being assessed in the early stages of development, the drug bioavailability enhancement market is poised for steady growth during the forecast period.
Key Market Segments
- New Drug Approvals
- BCS II drugs
- BCS IV drugs
Bioavailability Enhancement Approach
- Solid Dispersion
- Size Reduction
- Fine Particles / Powders
- North America
- Latin America
- Middle East and North Africa
- Rest of the World
- The report studies the drug bioavailability enhancement market by drug class, BCS classification, bioavailability enhancement approach, dosage form and key geographies.
- The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth.
- The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
- The report forecasts the revenue of market segments with respect to major regions.
- An overview of key findings from our research on the bioavailability enhancement market, offering insights into its current state and likely evolution in the short, mid, and long term.
- An exhaustive evaluation of the global landscape of bioavailability enhancement service providers, taking into account factors like their year of establishment, company size (in terms of employees), headquarters location, principles of bioavailability enhancement supported (solubility enhancement, absorption enhancement, sustained release, and others), the approaches used (solid dispersion, nanotechnology, lipid-based, other size reduction, chemical modification, and others), supported dosage forms (solids, liquids, fine particles, semi-solids), and routes of drug administration (oral, topical, parenteral, and others).
- A comprehensive analysis of the current market situation for bioavailability enhancement technologies, with a focus on parameters such as the year of establishment, company size (in terms of employees), and headquarters location. Additionally, this chapter delves into the various bioavailability enhancement technologies based on the supported principles (solubility enhancement, absorption enhancement, sustained release, and others), approaches employed (solid dispersion, nanotechnology, lipid-based, other size reduction, chemical modification, and others), type of molecules (small molecules and biologics), dosage forms supported (solids, liquids, fine particles, semi-solids), routes of administration (oral, topical, parenteral, and others), availability for licensing, and associated intellectual property rights.
- Detailed profiles of prominent players involved in offering bioavailability enhancement technologies and services, each profile encompassing an overview of the company (including establishment year, employee count, headquarters location, and key executives), details of their services portfolio, recent developments, and future outlook.
- A benchmarking analysis of various companies in the drug bioavailability enhancement market, assessing their expertise in various services related to bioavailability enhancement, enabling companies to compare their capabilities with peers and identify opportunities for a competitive edge.
- An exploration of partnerships between stakeholders in the bioavailability enhancement field, 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 during the period 2013-2022.
- A comprehensive review of over 5,800 peer-reviewed scientific articles related to research on bioavailability enhancement of drug compounds and candidates over the past five years, focusing on parameters like year of publication, article type, top publishers, popular journals, keywords, and top copyright holders (in terms of the number of articles published).
- An in-depth analysis of patents filed or granted for bioavailability enhancement approaches and technologies since 2003, with a focus on key parameters such as patent type, application year, publication year, enhancement approach, CPC symbols, geography, emerging areas, organization type, leading industry and non-industry players (in terms of the number of patents filed or granted), and individual patent assignees (in terms of the size of intellectual property portfolio). This chapter includes a benchmarking and valuation analysis of patents.
- An analysis of completed, ongoing, and planned clinical studies related to bioavailability enhancement of drug compounds and candidates, considering parameters such as trial registration year, trial phase, recruitment status, patient population, study design, sponsors/collaborators, industry and non-industry leaders (in terms of registered trials), molecule type, and key geographic regions.
- A comprehensive framework to assess bioavailability enhancement approaches based on various parameters, including the number of technologies, approved drugs, trends in literature and patents, and business models adopted by industry stakeholders. The framework also provides a value addition matrix for the respective approaches used by stakeholders.
- A detailed analysis aimed at estimating the current and future demand for bioavailability enhancement technologies and services, taking into account relevant parameters such as drug class (new drug approvals and generics), BCS classification (BCS II and BCS IV drugs), and dosage form (liquids, solids, semi-solids, fine particles/powders) for the period 2022-2035. Input parameters considered for this analysis include the number of New Chemical Entity (NCE) candidates and generic/reformulated drug products expected to undergo formulation development till 20335.
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Key Market Companies
- Adare Pharma Solutions
- Ascendia Pharmaceuticals
- Lubrizol Life Science Health
- Pace Life Sciences
- Quotient Sciences
- WuXi STA (A Subsidiary of WuXi AppTec)