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.
Scope of the Report
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.
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 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?
Table of Contents
Executive Summary
Research Methodology
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where 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 2030, the report also provides our independent view on various trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter Outlines
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the bioavailability enhancement technologies and services market in the short-mid and long term.
Chapter 3 is a general introduction to bioavailability. In this section, we have discussed, in detail, the concept of bioavailability and the current problems associated with bioavailability across various drug compounds. The chapter also features a detailed discussion on the current approaches being used for bioavailability enhancement.
Chapter 4 provides a comprehensive review of the global landscape of bioavailability enhancement technologies and service providers. It includes information related to over 150 companies that are currently operating in this domain. It features an in-depth market review, including a study of the regional distribution of players, analysis by company size and year of establishment, approach adopted for bioavailability enhancement, type of drug dosage form, route of administration, and the location of the company.
Chapter 5 features detailed profiles of some of the key players that are active in this domain and offer a wide range of services. Each profile presents an overview of the company, its financial information (if available), details related to its service(s) portfolio, recent developments (acquisitions / mergers, collaborations and expansions) and a comprehensive future outlook.
Chapter 6 presents a benchmark analysis of all the players engaged in this domain. It highlights the capabilities of these companies in terms of their expertise across bioavailability enhancement. The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to become more competitive in the industry.
Chapter 7 features an elaborate discussion on the collaborations and partnerships that have been inked amongst players in this market. We have also discussed the various partnership models that have been implemented, highlighting the most common forms of deals / agreements prevalent in this domain. In addition, we have highlighted the key players, on the basis of the number of collaborations and also discussed the expansion of services (via acquisitions / mergers) by key players.
Chapter 8 provides a comprehensive publication analysis, highlighting the recent trends in published literature related to bioavailability enhancement technologies. It presents a relative comparison of key technologies, on the basis of the trend in number of publications (CAGR) and the impact factors of the journals wherein these articles were published.
Chapter 9 provides detailed analysis of the patents that have recently been filed related to bioavailability enhancement technologies. The study also highlights the upcoming trends in innovation in this domain. In addition, it presents a high-level view on the valuation of these patents
Chapter 10 features an overview of the various ongoing clinical studies that are evaluating the bioavailability of various drug candidates that are currently under development. The chapter features a comprehensive view on the focus areas of these clinical studies, highlighting the key players involved as well.
Chapter 11 presents a detailed estimation of the likely demand for bioavailability enhancement technologies / services. It provides a comprehensive view in terms of the annual number of projects that are likely to require bioavailability enhancement in the period 2018-2030.
Chapter 12 provides a comprehensive market forecast analysis, highlighting the future potential of contract services for bioavailability enhancement till the year 2030. It features the likely distribution of the market based on [A] approach used for bioavailability enhancement (solid dispersion, size reduction, lipid-based approaches, and other approaches), [B] region (North America, Europe, Asia-Pacific and rest of the world), and [C] opportunity from drugs across different BCS classifications (BCS II and BCS IV).
Chapter 13 is a summary of the overall report. 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. It also provides a brief overview of some of the upcoming future trends, which, we believe, are likely to influence the growth of this market in the foreseen future.
Chapter 14 is a collection of transcripts of the discussions by various stakeholders across the public domain.
Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- AbbVie Contract Manufacturing
- ABITEC
- Absorption Systems
- Accu-Break Pharmaceuticals
- Aché Laboratórios Farmacêuticos
- Acorda Therapeutics
- Actavis
- Adare Pharma Solutions
- Admas Pharmaceuticals
- ADYA
- Aegis Therapeutics
- Aeon Respire
- Aerami Therapeutics
- Agere Pharmaceuticals
- Agios Pharmaceuticals
- Aizant Drug Research Solutions
- Ajinomoto Bio-Pharma Services
- Alcami
- Alembic Pharmaceuticals
- Alexion Pharmaceuticals
- Alimera Sciences
- Alkermes
- Allergan
- Altasciences
- Althea Technologies
- Altus Drug Development
- Amador Bioscience
- Amatsigroup
- AMRI
- APONTIS PHARMA
- Applied Manufacturing Science (AMS)
- Aptuit
- Aragen Life Sciences (Formerly GVK Bio)
- Arbro Pharmaceuticals
- Arcinova
- Ardena
- Ascendia Pharmaceuticals
- Ascentage Pharma
- Ash Stevens
- Ashland
- Astex Pharmaceuticals
- Aurigene Discovery Technologies
- Avista Pharma Solutions
- Axsome Therapeutics
- BASF
- Bend Research
- Betta Pharmaceuticals
- BiGEN
- Bio-Concept Laboratories
- BioConnection
- BioCorRx
- BioDuro-Sundia
- BioGeneration Ventures (BGV)
- Biolingus
- Bionpharma
- Bioqube Ventures
- Biosidus
- BIOTTS
- Bristol Myers Squibb
- Calvert Laboratories
- Cambrex
- Camurus
- Capsugel
- Cara Therapeutics
- Caraway Therapeutics
- Catalent
- CD Formulation
- ChemConnection
- CMC Pharmaceuticals
- Co-Formulate
- Colorcon
- Comera LIFE SCIENCES
- COREALIS Pharma
- CoreRx
- Coripharma
- Creative Biolabs
- CritiTech Particle Engineering Solutions
- Crystal Pharmatech
- Crystallics
- CrystecPharma
- Curia (Formerly AMRI)
- CuriRx
- Curis
- Cyclolab
- Dalton Pharma Services
- Dana Farber Cancer Institute
- Dauntless Pharmaceuticals
- DisperSol Technologies
- Dizal Pharmaceutical
- Dolomite Microfluidics
- Drug Delivery Experts (Acquired by Pace Life Sciences)
- DSM Nutritional Products
- Eagle Pharmaceuticals
- Element Materials Technology
- Emmerson Resources
- Ennaid Therapeutics
- Enteris BioPharma
- EPFL
- Epigeneron
- Equinox Science (Acquired by Betta Pharmaceuticals)
- ESSA PHARMA
- Eurofarma
- Eurofins CDMO
- Evonik Health Care
- Evotec
- ExCellThera
- Excivion
- Exelead
- ExxPharma Therapeutics
- EyePoint Pharmaceuticals
- Federal Equipment
- Ferring Pharmaceuticals
- Flexion Therapeutics
- Forbion
- Forest Laboratories
- Formac Pharmaceuticals
- Formex
- Formulex Pharma Innovations (Formerly SoluBest)
- Foster Delivery Science
- Frazier Healthcare Partners
- Fudan University
- Fuji Chemical Industries
- Gattefossé
- GB Sciences
- Gen-Plus
- Glatt
- Glenmark Pharmaceuticals
- GP Pharm
- Halo Pharmaceutical (Acquired by Cambrex)
- Harvard University
- Hemmo Pharmaceuticals
- Hofseth BioCare (HBC)
- Honeywell
- Hovione
- Hubei Yuyang Pharmaceutical (Acquired by Proton)
- IACTA Pharmaceuticals
- iCeutica (Acquired by Iroko Pharmaceuticals)
- Icon Bioscience (Acquired by pSivida)
- Iconovo
- Idifarma
- Nutrition & Biosciences (A subsidiary of IFF)
- I-Mab
- Impact Therapeutics
- Inflexion
- InfraRed Integrated Systems (Irisys)
- Inspira Pharmaceuticals
- Instillo Group
- Intas Pharmaceuticals
- Interpublic (IPG)
- iX Syrinx (A subsidiary of iX Biopharma)
- Janssen Pharmaceutica
- Jetpharma
- Ji Xing Pharmaceuticals
- Jina Pharmaceuticals
- JLL Partners
- Johns Hopkins University
- J-Star Research
- Juniper Pharmaceuticals
- KC Pharmaceuticals (Acquired by Kangen Pharmaceuticals)
- Kuecept
- Kuraray
- LakePharma
- Larodan
- LATITUDE Pharmaceuticals
- Leonard Green & Partners
- leon-nanodrugs
- Lexaria Bioscience
- Ligand Pharmaceuticals
- Lipomize
- Lonza
- Losan Pharma
- Lubrizol Life Science Health
- LYOCONTRACT
- Marinus Pharmaceuticals
- Massachusetts Institute of Technology
- Mayne Pharma
- Merck Millipore
- Merrion Pharmaceuticals
- Metrics Contract Services
- MGB Biopharma
- Micro-Macinazione
- Micro-Sphere
- Midas Pharma
- MIKA Pharma
- Moderna
- Monash University
- MRM Health
- Nanocopoeia
- Nanomaterials
- NanoMaterials Technology (NMT)
- Nanomerics
- Natco Pharma
- Nemus Bioscience
- NETZSCH Premier Technologies
- NeutriSci International
- New York Center for Nanomedicine Research
- Nextar Chempharma Solutions
- Nicox
- NLS Pharmaceutics
- Nordic Bioscience
- Novan
- Novo Nordisk
- Nuance Pharma
- Nuformix Technologies
- OcuMension Therapeutics
- Okklo Life Sciences
- Opiant Pharmaceuticals
- Orbis Biosciences
- Oryn Therapeutics
- Oxilio
- Pace Life Sciences
- Pacira BioSciences
- Particle Sciences
- Patheon
- PCI Pharma Services
- Peak Proteins
- Pensatech Pharma
- Permira
- Pfizer
- Pharmaceutical Manufacturing Research Services (PMRS)
- Pharmaceutical Product Development
- Pharmaceutics International
- Pharmaron
- PharmaSol
- Pharmatek
- Pharmaterials
- Pharmavize
- Phasex
- Phenom Pharmaceuticals (Acquired by Thermo Fisher Scientific)
- Phosphorex
- Piramal Pharma Solutions
- PixarBio
- Porton Pharma Solutions
- PowderSize
- ProJect Pharmaceutics
- ProMed Pharma
- PSC Biotech
- Pulmatrix
- QDevelopment
- QS Pharma
- Quay Pharma (A subsidiary of SGS)
- Quotient Sciences
- RenaSci (Acquired by Sygnature Discovery)
- Rhythm Pharmaceuticals
- Rottendorf Pharma
- Samyang Biopharmaceuticals
- SARA Pharm Solutions
- Scripps Research
- SEPS Pharma
- Serán Bioscience
- Sever Pharma Solutions (Formerly Foster Delivery Science)
- SGS
- Sichuan University
- Siegfried Holding
- SignalRx Pharmaceuticals
- Singota Solutions
- Sino German M&A Service
- SiTec PharmaBio
- SkyePharma
- SocietalTM CDMO (Formerly Recro)
- Sofpromed
- SolMic Research
- Solvay
- Solvias
- SRAX
- STA Pharmaceutical
- Standard Industries
- Stanipharm
- Sundia
- Supernus Pharmaceuticals
- Sygnature Discovery
- Syntagon
- Tapemark
- Temasek
- Tergus Pharma
- The University of Texas
- Thermo Fisher Scientific
- Thomas H Lee Partners
- Univar
- University of California
- UPM Pharmaceuticals
- Upperton Pharma Solutions
- Vaccine Manufacturing Innovation Centre (VMIC)
- Vectura
- Vertex Pharmaceuticals
- Vesifact
- Virpax Pharmaceuticals
- VxP Pharma
- Water Street Healthcare Partners
- Wolfe Laboratories
- W. R. Grace
- WuXi AppTec
- Xcelience
- Xedev
- Yale University
- Ypsomed
- Zerion Pharma
Methodology
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