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

Since the approval of Orthoclone OKT3® in 1986, monoclonal antibodies have become an important part of modern healthcare practices. In fact, several experts consider monoclonal antibodies to be the backbone of the biopharmaceutical industry. It is worth noting that, till date, more than 100 therapeutic monoclonal antibodies have been approved across different geographies; recent approvals include (in reverse chronological order) Adakveo® (November 2019), Beovu® (October 2019), SKYRIZI™ (April 2019) and EVENITY™ (April 2019). Owing to their high specificity and the favorable safety profile associated with the therapeutic use of such molecules, antibody based interventions presently constitute the largest class of biologics in the industry. This trend is unlikely to change in the near future as advanced variants, such as bispecific antibodies and antibody fragments-based products, are steadily gaining traction. Further, owing to legacy challenges associated with the development and production of biologics, such as advanced supply chain requirements, outsourcing antibody production operations is a popular trend.  The antibody contract manufacturing market is highly competitive, featuring companies of all sizes, some of which claim to offer end-to-end solutions, ranging from antibody development to commercial production. Historical and prevalent trends suggest that sponsor companies are likely to continue relying on contract service providers for various aspects of antibody-based product development and manufacturing. This dependence on outsourcing can be attributed to the high cost and time investment required to establish the necessary infrastructure and expertise in biologics. The competition among contract manufacturing organizations (CMOs) engaged in this domain is high, with the availability of cutting-edge tools and technologies being one of the key differentiating factors that grant a competitive advantage over other players. Therefore, in order to establish a strong foothold in the market and also meet the growing demand for antibody therapeutics / reagents, CMOs are actively expanding their capacities and capabilities. Scope of the Report The "Antibody Contract Manufacturing Market, 2020-2030" report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of antibodies. The study also features a detailed analysis of key drivers and trends related to this evolving domain. Amongst other elements, the report includes: A detailed review of the overall landscape of companies, offering contract services for the manufacturing of antibodies, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number of manufacturing facilities and location of these facilities, type of antibody manufactured (monoclonal antibodies, bispecific antibodies and polyclonal antibodies), type of expression systems used (mammalian, microbial and others), fill / finish operations and affiliations to regulatory agencies.  A competitiveness analysis of key players engaged in this domain, featuring an assessment based on their supplier strength (related to the experience of a contract manufacturer), and service strength (which takes into account the size of service portfolio and scale of operation). A benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective (geography-based) peer groups. An analysis of the various partnerships pertaining to contract manufacturing of antibodies, which have been established since 2013, based on several parameters, such as the year of agreement, type of partnership, project scale and focus therapeutic area. An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective antibody manufacturing capabilities, over the period 2017-2019 (till October), taking into consideration parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), type of antibodies manufactured and location of manufacturing facility. An estimate of the overall, installed capacity for manufacturing antibodies based on data reported by industry stakeholders in the public domain; it highlights the distribution of available antibody production capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia).  Informed estimates of the annual commercial and clinical demand for antibodies, based on various relevant parameters, such as target patient population, dosing frequency and dose strength. Elaborate profiles of the key industry players that offer contract manufacturing services at all scales of operation and have more than two manufacturing facilities. Each profile features a brief overview of the company, information on its service portfolio, details related to its manufacturing capabilities and facilities, and an informed future outlook.   A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps and challenges involved in their respective manufacturing processes.  A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.  One of the key objectives of the report was to estimate the existing market size and the future growth potential within the antibody contract manufacturing market. Based on multiple parameters, such as projected growth of overall antibody-based products market, cost of goods sold and direct manufacturing costs, we have developed informed estimates on the financial evolution of the market over the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of antibodies (monoclonal antibodies, bispecific antibodies and others), [B] company size (small, mid-sized and large / very large), [C] scale of operation (preclinical / clinical and commercial), [E] expression systems (mammalian, microbial and others), and [F] key geographical regions (North America, Europe, Asia). In order to account for future uncertainties and to add robustness to our model, we have provided three 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. The report features detailed transcripts of interviews held with the following individuals: Dietmar Katinger, Chief Executive Officer, Polymun Scientific  David C Cunningham, Director Corporate Development, Goodwin Biotechnology    Claire Otjes, Assistant Marketing Manager, Batavia Biosciences 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