Low bioavailability is one of the primary concerns associated with marketed drugs; in fact, various studies indicate that around 40% of available drugs are poorly bioavailable / soluble. As the drug developers shift their focus towards development of lipophilic drug compounds, the issue with aqueous solubility / bioavailability of the drugs is likely to increase further. It is estimated that around 90% of NCEs belong to BCS class II and IV, which are known to be associated with low solubility / permeability. Given that a large number of drugs fail to reach the market due to poor bioavailability, the industry is looking for various tools / methods to mitigate this challenge. Moreover, as many companies seek to re-formulate existing product candidates that exhibit poor bioavailability (via the 505(b)(2) pathway), the demand for novel bioavailability enhancement methods has grown significantly.
To cater to this increasing demand, several contract manufacturers and technology providers have emerged in this domain. With more than 150 companies offering technologies / services for bioavailability enhancement, the market is highly fragmented; having said that, several mergers / acquisitions have also taken place as stakeholders strive to broaden their respective service portfolios. A number of players have developed novel, state-of-the art technologies to maintain a competitive edge in this rapidly emerging market. As drug developers continue to evaluate novel drug targets and classes, the bioavailability enhancement domain is expected to grow at a steady pace. In fact, since 2010, more than 4,000 articles, evaluating various bioavailability enhancement technologies have been published across several reputed journals. In addition, more than 6,000 patents have been filed post 2010, providing a significant scientific push to the development of novel approaches.
SCOPE OF THE REPORT
The ‘Bioavailability Enhancement Technologies and Services Market, 2018-2030’ report provides a comprehensive study on the current scenario of technologies and contract services related to bioavailability enhancement. The study features an elaborate discussion on the novel approaches adopted by different players offering solutions for altering the bioavailability of various drugs.
Amongst other elements, the report features:
• An overview of the current market landscape, featuring a comprehensive list of over 150 active contract services / technology providers, and a detailed analysis based on a number of parameters, such as geographical location of the company, approach adopted for bioavailability enhancement (size reduction, solid dispersion, lipid based methods and other novel approaches), type of dosage forms (solid, liquid, semi-solid, others), route of drug administration (oral, injectable, inhalation and topical).
• Elaborate profiles of key players (identified on the basis of the breadth of their respective service portfolios) that are offering bioavailability enhancement services. Each profile features an overview of the company, its financial performance (if available), services portfolio, recent collaborations and the future outlook of the company.
• An analysis of ongoing clinical studies evaluating the bioavailability of various drug compounds. The chapter features a comprehensive view on the focus areas of these clinical studies, highlighting the key players involved.
• A review of the published scientific literature on bioavailability enhancement technologies, highlighting the heightened research activity and the focus areas of research groups across different types of bioavailability enhancement technologies.
• A detailed analysis of over 6,000 patents that have been filed related to bioavailability enhancement technologies. The study presents a high-level view on the valuation of these patents and also highlights the emerging trends related to the innovation in this domain.
• An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, co-service agreements, manufacturing and service agreements, and other relevant types of deals.
• A comprehensive benchmark analysis, highlighting the key focus areas of small, mid-sized and large sized companies; the benchmark analysis provides a means to compare the existing capabilities within respective peer groups and help industry stakeholders identify ways to achieve a competitive edge over contemporary players.
• 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 over the period 2018-2030.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as likely number of candidates in BCS II and IV, likely adoption rates of bioavailability enhancement approaches, expected trend in outsourcing and likely pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. To account for the uncertainties associated with the expected future demand and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
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 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.
1. We identified more than 155 players that are offering solutions / technologies for bioavailability enhancement of drugs. Of these, 17% are very large companies (more than 1,000 employees), 22% are large companies (201-1,000 employees), 21% are mid-sized companies (51-200 employees) and 40% are small sized players (less than 50 employees).
2. Around 80 companies are headquartered in the Americas (North America and South America), primarily in the US, of which, about 14% are based in New Jersey and 13% in California. Over 50 companies are headquartered in the European region, of which about 21% are based in Germany and 18% in the UK. In addition, around 20 companies are headquartered in the Asia Pacific region, with majority of the players (55%) based in India, followed by 14% companies in Israel and Japan.
3. Close to 55% of the companies have adopted size reduction-based approaches for bioavailability enhancement. The key size reduction technologies offered by these companies include (in order of popularity) nanoparticles (63), high pressure homogenization / micronization (40), milling (30), microfluidics (5), and bead layering (4).
4. Solid dispersion-based methods have been adopted by more than 50% of the technology / service providers; these include (in order of popularity) spray dried dispersion (45), hot melt extrusion (38), lyophilization (21), solvent evaporation (5), super critical fluids (4), agglomeration (3), and other polymer-based approaches (13).
5. We were also able to identify close to 50 companies that offer lipid-based approaches. The key technologies / services offered by these companies involve the use of (in order of popularity) liposomes (22), self-emulsifying drug delivery systems (14), nano-lipids (11), excipients (7), and other lipid-based systems (13). In addition, over 80 companies are presently offering services / technologies based on other novel approaches, such as co-use of cyclodextrin (16), use of micelles (8), and crystallization (5), for bioavailability enhancement.
6. Close to 80 partnerships have been inked in this domain in the last five years. The maximum number of partnerships (23) were inked in 2017, followed by 18 instances in 2016. More than 30% of the collaborations were focused on acquiring some or all the assets of a company. In addition, around 13% of the collaborations were service alliances, wherein, contract service / technology providers have combined their expertise to offer novel solutions for bioavailability enhancement to their clients.
7. In the past few years, several advancements have taken place in the field, wherein industry stakeholders have tried to develop novel approaches for improving the solubility / bioavailability of drugs. We came across more than 11,500 patents, of which 53% were filed after 2010. A significant proportion (>35%) of the patents have been filed by companies that are based in China, followed by companies in the US and Japan.
8. We expect the bioavailability enhancement services market to grow at an annualized rate of ~14.6% between 2018 and 2030. Lipid-based and solid dispersion approaches for bioavailability enhancement occupy the biggest share of the current bioavailability enhancement services market. These techniques are likely to continue to occupy a larger share of the market in 2030 as well.