NEW YORK /PRNewswire/ -- INTRODUCTION
The early stages of drug discovery research, which include the identification of a relevant biological target and a viable lead compound with therapeutic potential, play a crucial role in the overall success of a drug candidate in both preclinical and clinical studies. It is also important to note that the process of drug discovery is extremely demanding, both in terms of capital and time. In fact, the overall amount spent in R&D initiatives in the pharmaceutical / biotechnology sector has increased from around USD 128 billion in 2008 to USD 165 billion in 2018. Moreover, only a small fraction of early stage therapeutic candidates are able to make it past preclinical evaluation. According to a study conducted on terminated drug development programs, the high rate of failure of drugs in clinical trials was primarily attributed to problems associated with their pharmacokinetic profiles, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity. As a result, the industry is currently under tremendous pressure to not only meet the expectations of a growing patient population, but to also identify ways to mitigate the risks associated with discovery programs of novel drug / therapy molecules.
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Specifically, ADME studies are considered to be critical in establishing the safety and efficacy of drug candidates. Currently, there are a number of contract research organizations (CROs) that claim to have the necessary capabilities to offer in vitro ADME services. Over time, such service providers have grown to become an indispensable part of the pharmaceutical / biopharmaceutical market. Moreover, advances in combinatorial chemistry and high throughput screening in the last decade have made it possible to carry out early stage ADME screening for a large number of compounds in a more cost and time efficient manner. In less than a decade, the ADME services industry has witnessed noteworthy consolidation, with many of the smaller players being acquired by more established firms in efforts to augment services portfolios and widen geographical reach. Further, given the growing demand for high quality pharmacological interventions, and the cost and time-related benefits of outsourcing in vitro ADME research, the demand for CROs is projected to grow significantly in the foreseen future.
SCOPE OF THE REPORT
The 'In Vitro ADME Testing Services Market, 2019-2030' report features a comprehensive study of the current landscape of in vitro ADME testing service providers. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders across different global regions. Amongst other elements, the report includes:
A detailed assessment of the current market landscape, featuring a comprehensive list of over 90 CROs that offer in vitro ADME testing services, and analyses based on a number of parameters, such as year of establishment, headquarter location(s), company size, type of additional service(s) offered (in vivo ADME, in silico ADME and toxicology testing), range of assays offered within in vitro ADME service portfolio (blood to plasma ratio, Caco-2 permeability, cytochrome (CYP) enzyme induction / inhibition, metabolic stability, plasma protein binding, reaction phenotyping and others), type of molecule(s) (biologics and small molecules), and type of clientele (pharmaceutical / biotechnology companies and academic / research institutes).
A schematic logo landscape of in vitro ADME service providers, highlighting their geographical distribution (on the basis of location of headquarters) and company size (small-sized (1-50 employees), mid-sized (51-200 employees), large (201-1,000 employees), and very large (>1,000 employees)).
A discussion on the various outsourcing business models adopted in this domain, along with a list of key considerations that need to be taken into account by industry stakeholders while selecting a CRO partner.
Elaborate profiles of popular in vitro ADME testing service providers, featuring a brief overview of the company, its financial information (if available), information on in vitro ADME service(s) capabilities, and a comprehensive future outlook.
A comprehensive benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, and thereby, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2005-2018, along with the geographical distribution of this activity. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
A detailed discussion on the various regulatory guidelines related to in vitro ADME testing, which have been laid down by major international / regional regulatory bodies (namely European Medicine Agency (EMA), US Food and Drug Administration (USFDA), Ministry of Health, Labor and Welfare (MHLW), International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use, the Organisation for Economic Co-operation and Development (OECD), and World Health Organization (WHO)).
One of the key objectives of the report is to evaluate the current opportunity and the future potential of the in vitro ADME testing services market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] different global regions (North America, Europe, Asia-Pacific and rest of the world), [B] type of services (absorption, distribution, metabolism and excretion), [C] type of assays (across 5+ categories), [D] type of molecule(s) (biologics and small molecules), [E] type of sponsor company (pharmaceutical / biotechnology companies and academic / research institutes) and [F] therapeutic areas (across 10+ categories). To account for the uncertainties associated with the in vitro ADME testing services market 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.
The opinions and insights presented in the report were also influenced by discussions conducted with several stakeholders in this industry. 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.
RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry 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 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 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 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 current scenario within the in vitro ADME testing services market and its likely evolution in the short-mid and long term.
Chapter 3 provides an introduction to the overall drug discovery process, with details on the time taken for a drug to traverse through the various stages of drug development and into the market. It includes an overview of ADME testing, featuring a detailed discussion on the significance of evaluating various ADME parameters within the drug discovery and development process. Further, the chapter presents insights on the benefits of carrying out ADME testing at early stages of drug development. It also features details related to various contract services that can be availed by industry stakeholders seeking to outsource ADME testing.
Chapter 4 features a detailed discussion on the various outsourcing related business models that are commonly adopted by the industry stakeholders in relation to ADME testing. The chapter includes a list of factors that drive sponsors to outsource their ADME testing operations. It also highlights several key parameters that sponsors need to take into consideration while choosing a CRO partner. The chapter features an elaborate discussion on benefits of outsourcing ADME services, along with the affiliated risks and challenges.
Chapter 5 provides a comprehensive view on the global landscape of in vitro ADME testing service providers. It includes information related to over 90 CROs that claim to offer in vitro ADME services, featuring in-depth analyses of the players based on their year of establishment, headquarter location(s), company size, type of additional service(s) offered, range of assays offered within in vitro ADME service portfolio, type of molecule(s), and type of clientele. The chapter also includes a list of 70 players offering in silico ADME services. In addition, it also features a logo landscape of the players that claim to offer in vitro ADME services, distributed on the basis of the location of their respective headquarters and company size.
Chapter 6 features detailed profiles of key CROs that claim to offer in vitro ADME testing services, across different geographies. Each company profile includes a brief overview of the company, financial information (if available), information on in vitro ADME service(s) capabilities, and a comprehensive future outlook.
Chapter 7 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of the companies in terms of their expertise across various services related to in vitro ADME testing. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, and thereby, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
Chapter 8 features a detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired from 2005 to 2018. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
Chapter 9 features information on the regulatory guidelines that have been laid down by key regulatory bodies / organizations, specific to ADME testing in the pharmaceutical industry. These are EMA, ICH, MHLW, OECD, USFDA and WHO.
Chapter 10 features a comprehensive market forecast, highlighting the future potential of in vitro ADME testing services market till 2030. The projected opportunity has been further analyzed to develop a better perspective related to its distribution across [A] different global regions (North America, Europe, Asia-Pacific and rest of the world), [B] type of services (absorption, distribution, metabolism and excretion), [C] type of assays (across 5+ categories), [D] type of molecule(s) (biologics and small molecules), [E] type of sponsor company (pharmaceutical / biotechnology companies and academic / research institutes) and [F] therapeutic areas (across 10+ categories).
Chapter 11 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the biopharmaceutical industry.
Chapter 12 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with Dan Close (Chief Scientific Officer, 490 BioTech), and Sridhar Iyer (Director and Global Head, Business Development, JRF Global) and Sarang Gorte (Assistant Manager, Business Development, JRF Global).
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix, which contains the list of companies and organizations mentioned in the report.
EXAMPLE HIGHLIGHTS
1. More than 90 CROs currently offer in vitro services for testing ADME properties of drug candidates. The market landscape is highly fragmented, featuring a mix of small-sized (less than 50 employees, 42%), mid-sized (51-200 employees, 17%), large (201-1,000 employees, 16%) and very large (more than 1,000 employees, 25%) companies. Examples of some very large players active in this domain, include (in alphabetical order) Charles River Laboratories, Citoxlab Group, Corning Life Sciences, Eurofins Scientific, Piramal Pharma Solutions, QPS, RTI International, Sigma-Aldrich (acquired by Merck), SRI International, Tecan Group and Unilabs Serving Pharma. On the other hand, players that have recently (since 2013) entered the market include (in alphabetical order) APhaD, Aravali Pharma & Lifesciences, Concept Life Sciences, Envigo, IONTOX, Neuro-Sys, Q2 Solutions and Touchstone Biosciences.
2. Majority of the aforementioned CROs (80%) are based in North America and Europe. However, a growing proportion of such players are situated in the Asia-Pacific region. Examples of large companies based in this region include (in alphabetical order, no selection criteria) ChemPartner, GVK Biosciences, JOINN Laboratories, JRF Global, Jubilant Biosys, Medicilon, Pharmaron, Sai Life Sciences, Suven Life Sciences, Syngene International, TCG Lifesciences, Viva Biotech and WuXi AppTec.
3. Of the total number of in vitro ADME service providers, over 85% companies claim to offer assays for drug metabolism testing, which include UGT / CYP enzyme inhibition / induction assays (73), metabolite profiling and screening / identification (60), metabolic stability / metabolic clearance (55), reaction phenotyping (36), metabolite production (21) and transporter interactions (20). Further, over 60 companies claim to have capabilities to conduct absorption and distribution related studies, respectively.
4. Around 55% of the CROs claim to have the necessary expertise to offer services for testing the absorption, distribution, metabolism profiles of drug molecules. Examples of popular companies that claim to offer the required expertise to evaluate the aforementioned parameters, include (in alphabetical order, no selection criteria) AMRI, CanAm Bioresearch, CEMSA, Galapagos, InrexTest, Novamass, PharmaCadence, Pharmacelsus, Pharmidex Pharmaceutical Services, Shanghai Medicilon, Signature Discovery and Q3 Analytical.
5. Over 35 instances of acquisitions have taken place in this domain over the last decade. Examples of companies that were recently acquired include (in reverse chronological order) SNBL USA's preclinical business by Altasciences (August 2018), Optivia Biotechnology by BioIVT (July 2018), MetaSafe by Admescope (June 2018), Concord Biosciences by Frontage Laboratories (April 2018), MPI Research by Charles River Laboratories (April 2018) and SOLVO Biotechnology by Citoxlab Group (March 2018).
6. Driven by a rising number of candidate drugs that enter the discovery stage across various therapeutic areas, we expect the in vitro ADME testing services market to grow at an annualized rate of nearly ~6% between 2019 and 2030. Based on our estimates, therapies targeting various cancers are expected to be responsible for 46% of the revenues generated within the market by 2030; this is likely to be followed by candidates targeting neurological disorders (13%), immunological disorders (7%) and infectious diseases (5%).
7. North America (primarily the US) and Europe currently hold the larger share (in terms of revenues, over 70%) within the overall in vitro ADME testing services market. This is followed by the Asia-Pacific region and the rest of the world. Within Asia-Pacific, markets in China and Japan are expected to grow at a relatively faster rate (~7%) in the coming decade. We are led to believe that the abovementioned trend is not likely to change significantly in the foreseen future.
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