Personalized medicine has brought about a paradigm shift within the healthcare sector. However, therapies tailored to specific disease-related molecular signatures require appropriate companion diagnostics in order to make physicians aware of patients’ unique genetic profiles, enabling them to make informed treatment related decisions. In fact, a clinical study of nearly 200 unique pharmacological interventions, which were evaluated across more than 670 clinical trials, suggests that the likelihood of a lead compound passing through various phases of clinical development and eventually getting approved is only 11%. The same study pointed out that using disease-specific biomarker information (indicative of susceptibility to particular types of therapeutics) to recruit patients for clinical research has been associated with a manifold increase in trial success rates. In addition, it is worth noting that companion diagnostics guided drug development efforts have demonstrated to effectively reduce clinical trial costs by almost 60%.   Given the aforementioned advantages, the industry is gradually shifting from the traditional, one-drug-for-all, paradigm to using tailored pharmacological interventions. This shift is subsequently expected to increase the demand for companion diagnostics. However, given the complexity associated with the co-development of a drug and a corresponding companion diagnostic test, pharmaceutical developers have shown preference to outsource the diagnostics development operations. In fact, nearly 80% of the companies are known to rely on external diagnostics developers for companion diagnostics development, mostly owing to the lack of in-house expertise.  As a result, numerous contract service providers are striving to expand their respective portfolios and developing the capabilities to offer end-to-end services to sponsor companies in this domain. Amidst tough competition, the availability of cutting-edge tools and technologies (such as in situ hybridization (ISH), immunohistochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR)) has emerged as a differentiating factor and is likely to grant a competitive advantage to certain service providers over other players in the industry. Scope of the Report The “Companion Diagnostics Development Services Market, 2020-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of diagnostic development services over the next decade. It features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of companies offering companion diagnostics services, including information on the type of services offered, type of analytical technique used and regulatory certifications / accreditations, and other company-specific details (such as year of establishment, company size and geographical location). Tabulated profiles of companion diagnostics service providers (shortlisted on the basis of the number of services offered), featuring an overview of the company, its financial information (if available), and companion diagnostics-related service portfolio details. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth. An analysis of the partnerships and collaborations pertaining to companion diagnostics services from 2017 to 2019, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, analytical technique used and the most active players. A list of stakeholders generated based on a detailed analysis of a set of relevant parameters (namely number of clinical trials sponsored by a developer and the time to market for proprietary personalized medicine products), which are anticipated to partner with companion diagnostics services providers in the foreseen future.  A detailed competitiveness analysis of companion diagnostics services providers, taking into consideration the supplier power (based on the year of establishment of developer) and key specifications, such as portfolio strength, type of available technology platform, number of deals signed between 2017-2019. A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages. An analysis of completed, ongoing and planned clinical trials featuring disease-specific biomarkers. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials. One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostic services providers, over the next decade. Based on multiple parameters, we have provided informed estimates on the evolution of the market for the period 2020-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key services offered (biomarker discovery, assay development, clinical validation, analytical validation and manufacturing), [B] analytical techniques used (ISH, IHC, NGS, PCR and others), and [C] key geographical regions (North America, Europe, Asia 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, representing different tracks of the industry’s growth.   The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of discussions held with the following industry stakeholders: Pablo Ortiz (Chief Executive Officer, OWL Metabolomics) Paul Kortschak (Senior Vice President, Novodiax) Lawrence M. Weiss (Chief Scientific Officer, NeoGenomics Laboratories) 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. ...read more

[COVID-19 SERIES] Advances in DNA sequencing technologies have led to significant developments in a variety of healthcare-focused research fields, such as precision medicine and diagnostics. Particularly, the impact of next generation sequencing (NGS) methods, enabling whole genome and whole exome sequencing, has been the most profound. This high throughput, parallel genome sequencing technology has greatly reduced the overall cost and time investment. In fact, compared to the Human Genome Project (~USD 3 billion), the cost of sequencing a single genome has decreased to USD 1,000, using currently available technologies. Owing to the ongoing innovation in this field, stakeholders believe that the aforementioned cost may get further reduced to USD 100 over the next decade.  This decrease in genome sequencing costs has led to a marked increase in the number of genomes being sequenced around the world. In fact, several large scale efforts, such as UK Biobank and GenomeAsia 100k, have been initiated in order to collect genomic data for use in medical research. Big pharma players, including AstraZeneca, GSK, Pfizer, Merck and Roche, are actively on the lookout for collaborating with such data repositories in order to access the aforementioned information.  Despite the progress made in this field of research, there are several existing challenges related to the NGS process affiliated workflow and data analysis. The lack of versatile in silico tools is considered to be the major rate-limiting step in NGS data analysis and interpretations. At present, industry stakeholders are actively collaborating in order to integrate their respective resources for mining these large and complex datasets to generate clinically relevant, actionable insights. Additionally, there is a need for better genomic library preparation protocols, which required less starting material, and are capable of generating libraries with more precisely estimated insert sizes and longer reads at reduced error rates. More efficient genome assembly algorithms and better processors (increased computational power) for genomic data processing are also likely to get developed. We are led to believe that, once the aforementioned challenges are addressed, this segment of the biopharmaceutical industry will witness significant growth. Scope of the Report The ‘Next Generation Sequencing (NGS) Market, 2020-2030: Service Providers (Whole Genome, Whole Exome and Targeted Sequencing) and Technology Platforms’ report features an extensive study of the current landscape and the future opportunities associated with service / technologies providers. Amongst other elements, the report features: An overview of the genome sequencing service providers landscape, featuring information on year of establishment, company size, geographical location and types of services offered (sanger sequencing, genotyping, whole genome sequencing, whole exome sequencing targeted sequencing and bioinformatics). Further, it provides details on the cost of services, sequencing systems used, average turn-around time and sequencing coverage, for certain types of sequencing-related services (whole genome, whole exome and targeted sequencing) offered by contract service providers. An overview of genome sequencing technologies landscape, featuring information on type of applications, run time, maximum reads per run, maximum sequencing output, maximum read length, type of sequencing technique, quality score and cost. It also provides information on the technology providers involved in this domain, including information on year of establishment, company size and geographical location.  An informed competitiveness analysis of the genome sequencing technologies captured in our database, taking into consideration relevant parameters, such as supplier power (based on company size of technology provider) and other important technology-related specifications, such as types of applications, maximum sequencing output, maximum reads per run, maximum read length, quality score and cost of sequencer. An in-depth analysis of intellectual property related to this field of research, in order to generate an opinion on how the industry has evolved from the R&D perspective. The analysis takes into consideration genome sequencing-related patents that have been filed / granted since 2015, highlighting publication year, issuing authority / patent offices involved, CPC symbols, emerging focus areas, leading players, patent characteristics and geography. An analysis of completed, ongoing and planned clinical studies related to genome sequencing, featuring details on registration year, type of sponsors / collaborators, current status of trials, type of study design, target therapeutic area, type of application, regional distribution of clinical trials and enrolled patient population. An analysis of the various genome sequencing-focused initiatives of the ten big pharma players (shortlisted based on extent of activity in genome sequencing domain), highlighting the key focus areas of such companies along with information on funding, collaboration and acquisition activity. A case study on the various national and international, government sponsored initiatives related to genome sequencing, analyzed on the basis of year of initiation, type of investors, type of participant organization, research objectives, geographical distribution, region-specific data access policies and key focus areas of research. One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the genome sequencing services and technologies market. Based on several parameters, such as number of genomes sequenced annually, average cost of sequencing, revenues generated by major players and expected annual growth rate, we have provided an informed estimate of the likely evolution of the market, for the period 2020-2030. The chapter also presents a detailed segmentation of the aforementioned opportunity across [A] key application areas (diagnostics, drug discovery, precision medicine and others), [B] end-users (hospitals and clinics, academics and research institutes, pharmaceuticals companies and others), [C] types of technologies (sequencing by synthesis, ion semiconductor, single-molecule real-time sequencing, nanopore and others), [D] types of services (whole genome sequencing, whole exome sequencing and targeted sequencing) and [E] key geographical regions (North America, Asia-Pacific, Europe, 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, representing different tracks of the industry’s growth.  The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Michael Powell (Chief Scientific Officer, DiaCarta) Mike Klein (Chief Executive Officer, Genomenon)  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. ...read more

The 1970s witnessed the introduction of one of the most revolutionary advances in biotechnology, when Hamilton Smith (a molecular biologist at Johns Hopkins University School of Medicine) purified the first site-specific restriction enzyme, called Hind II. This development enabled the scientific community to devise the means to manipulate living organisms at the genetic level, opening up a plethora of opportunities in fundamental and applied life science research. Soon after, in the 1980s, the US FDA approved the world’s first genetically engineered drug, which was human insulin marketed under the brand name HUMULIN®. Genetic engineering and genome editing concepts have evolved significantly over the last two decades, with the development of a variety of versatile DNA modulation technologies including zinc finger nucleases, transcription activator-like effector-based nucleases (TALENs), and the clustered regularly interspaced short palindromic repeats (CRISPR). These developments have enabled medical researchers to perform an array of gene / cell line engineering experiments, including gene knockdowns, gene overexpressions and single base editing, for a variety of R&D applications. It is worth highlighting that, of all the available genome manipulation technologies, CRISPR is currently considered to be the most popular tool, owing to its fast, accurate, and cost-effective approach. In fact, in 2018, scientists Emmanuelle Charpentier, Jennifer Doudna, and Virginijus Siksnys were felicitated for their pioneering efforts on the CRISPR-Cas9 technology, with the prestigious Kavli Prize in Nanoscience.   Currently, there is an evident increase in demand for complex biological therapies (including regenerative medicine products), which has created an urgent need for robust genome editing techniques. The biopharmaceutical pipeline includes close to 500 gene therapies, several of which are being developed based on the CRISPR technology. Recently, in July 2019, a first in vivo clinical trial for a CRISPR-based therapy was initiated. However, successful gene manipulation efforts involve complex experimental protocols and advanced molecular biology centered infrastructure. Therefore, many biopharmaceutical researchers and developers have demonstrated a preference to outsource such operations to capable contract service providers. Consequently, the genome editing contract services market was established and has grown to become an indispensable segment of the modern healthcare industry, offering a range of services, such as gRNA design and construction, cell line development (involving gene knockout, gene knockin, tagging and others) and transgenic animal model generation (such as knockout mice). Additionally, there are several players focused on developing advanced technology platforms that are intended to improve / augment existing gene editing tools, especially the CRISPR-based genome editing processes. Given the rising interest in personalized medicine, a number of strategic investors are presently willing to back genetic engineering focused initiatives. Prevalent trends indicate that the market for CRISPR-based genome editing services is likely to grow at a significant pace in the foreseen future. The “Genome Editing Services Market: Focus on CRISPR, 2019-2030” report features an extensive study of the current landscape of CRISPR-based genome editing service providers. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographical regions. Amongst other elements, the report includes: A detailed assessment of the current market landscape, featuring an elaborate list of over 80 companies that offer CRISPR-based genome editing services, and analyses based on a number of relevant parameters, such as type of gRNA service, availability of gRNA format, type of endonuclease, type of Cas9 endonuclease format, type of cell line engineering offering, type of cell line, type of animal model generation offering, availability of CRISPR libraries and important service provider details (year of establishment, company size and location of headquarters).   An insightful 2X2 representation, highlighting the competitiveness of various CRISPR-based genome editing service providers captured in our database (segregated across various peer groups based on company size), taking into consideration the supplier power and the specific genome editing capabilities (which include gRNA service(s), endonuclease service(s), cell line engineering service(s), animal model generation service(s) and availability of CRISPR library(s)) of different companies. Elaborate profiles of key players (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial performance (if available), a detailed description of its genome editing service offerings, recent developments and an informed future outlook. An in-depth analysis of over 10,000 patents related to CRISPR technology that have been filed / granted, since 2006, highlighting key trends associated with these patents, across type of patent, publication year and application year, regional applicability, CPC symbols, emerging focus areas, leading patent assignees (in terms of number of patents filed / granted), patent benhcmarking and valuation.   A detailed analysis of close to 2,000 grants that have been awarded to support research projects related to CRISPR, between 2015 and 2019 (till September), highlighting important parameters, such as year of award, amount awarded, administring institute center, support period, funding mechanism, type of grant application, grant activity, type of recipient organization, regional distribution of recipient organization, prominent project leaders and emerging focus areas. It also features a detailed multivariate grant attractiveness analysis based on the amount awarded, support period, grant type and funding mechanism. A discussion on the advanced technologies and systems that have been developed to improve CRISPR-related processes. It includes a list of companies that have developed such innovative technology platforms, along with details on a number of relevant parameters, such as year of establishment, company size, core expertise, location of headquarters and important technology specifications (including technology name, focus area and key features). In addition, it includes short profiles of key technology providers. Further, the chapter highlights a list of companies that offer CRISPR kits and CRISPR design tools. An analysis highlighting potential strategic partners, segregated based on likelihood of entering into collaboration with CRISPR-based genome editing services providers. The analysis takes into consideration multiple relevant parameters, such as type of therapy, pipeline strength, pipeline maturity, company strength and therapeutic area. A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market. One of the key objectives of the report was to evaluate the current opportunity and the future potential of CRISPR-based genome editing services market. 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] type of services offered (gRNA construction, cell line engineering and animal model generation), [B] type of cell line used (mammalian, microbial, insect and others) and [C] different geographical regions (North America, Europe, Asia Pacific and rest of the world). To account for the uncertainties associated with the CRISPR-based genome editing 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 research, analysis and insights presented in this report are backed by a deep understanding of key insights generated from both secondary and primary research. 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. ...read more