Bioavailability Enhancement Technologies and Services Market (2nd Edition), 2022-2035

Bioavailability Enhancement Technologies and Services Market (2nd Edition), 2022-2035

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 bioavailability enhancement domain is expected to grow at a steady pace in the foreseen future.

The “Bioavailability Enhancement Technologies and Services 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” report features an extensive study of the current market landscape and future potential of the bioavailability enhancement technologies and services market. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in providing bioavailability enhancement technologies and services. Amongst other elements, the 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 this field.

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 this domain, 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 this domain. 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 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.

A detailed market forecast analysis, highlighting the likely evolution of the bioavailability enhancement services market in the short to mid-term and long term, over the 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.

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.

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

MARKET SEGMENTATIONS

Bioavailability Enhancement Technologies and Services Market (2nd Edition): Market Segmentations

Market Segments Details

Forecast Period 2022-2035

Drug Class New Drug Approvals

Generics

BCS Classification BCS II Drugs

BCS IV Drugs

Bioavailability Enhancement Approach Solid Dispersion

Size Reduction

Lipid-based

Dosage Form Liquids

Solids

Semi-Solids

Fine Particles / Powders

Key Geographies North America

Europe

Asia

Latin America

Middle East and North Africa

Rest of the World

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary research. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary sources of information.

KEY QUESTIONS ANSWERED

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 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?

CHAPTER OUTLINES

Chapter 2 is 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.

Chapter 3 provides 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 this field.

Chapter 4 provides a detailed review of the overall market landscape of bioavailability enhancement service providers, along with the information on their 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 / micronization, 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).

Chapter 5 provides a detailed assessment of the current market landscape of bioavailability enhancement technology providers, featuring information on their 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.

Chapter 6 provides an analysis, highlighting the contemporary market trends through six schematic representations, including 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, a waffle chart representation, highlighting the regional distribution of bioavailability enhancement service providers, based on various types of bioavailability enhancement approaches employed by them, a heat map representation of bioavailability enhancement service providers, based on bioavailability enhancement approaches and type of dosage form, a horizontally grouped bar chart, highlighting the distribution of bioavailability enhancement service providers based on their company size and type of bioavailability enhancement principles, 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 a 3D bubble analysis comparing the key players engaged in this domain, based on several relevant parameters (such as year of establishment, company size, number of bioavailability enhancement approaches offered and region).

Chapter 7 includes detailed profiles of various prominent players (identified on the basis of the breadth of their respective service and technology portfolios as well as their partnership activity) engaged in offering bioavailability enhancement 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.

Chapter 8 presents a company benchmarking analysis of various players engaged in this domain. 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.

Chapter 9 features an elaborate discussion and analysis of various collaborations and partnerships that have been inked amongst players in this market, during the period 2013-2022. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership (such as mergers and acquisition, licensing agreements, alliances, product development and manufacturing agreements, research and development agreements, product development and commercialization agreements, service agreements, and other agreements), and regional distribution of the collaborations.

Chapter 10 presents a detailed review of 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 the top journals, top publishers and top copyright holders (in terms of number of articles published)

Chapter 11 provides an in-depth analysis of the nearly 10,000 patents filed / granted related to 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.

Chapter 12 presents a detailed 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.

Chapter 13 includes 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.

Chapter 14 presents an insightful market forecast analysis, highlighting the future potential of the spatial genomics, transcriptomics, and proteomics solutions market, till 2035. In order to provide a detailed future outlook, our projections have been segmented across different segments on the basis of [A] drug class (new drug approvals and generics), [B] BCS classification (BCS II drugs and BCS IV drugs), [C] bioavailability enhancement approach (solid dispersion, size reduction, lipid-based, and other approaches), [D] dosage form (liquids, solids, semi-solids, and fine particles) and [E] key geographies (North America, Europe, Asia, Latin America, Middle East and North Africa and Rest of the World).

Chapter 15 features 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. Further, it also provides a value addition matrix for respective bioavailability enhancement approaches currently employed by stakeholders.

Chapter 16 presents the summary of the overall report. Additionally, in this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 17 is an appendix, which contains the list of companies and organizations mentioned in the report.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.