Pipeline Tracking
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August 2019
Cancer is known to be one of the leading causes of death worldwide. In the US, 0.6 million deaths were reported to have been caused due to cancer in 2018 alone. Further, according to the International Agency for Research on Cancer (IARC), close to 17 million new cancer cases were reported in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million. It is worth mentioning that in the past five years, the United States Food and Drug Administration (USFDA) has approved more than 100 drugs for the treatment of different types of cancer. However, as the growing global population is gradually being exposed to a growing list of risk factors and cancer causing agents, there is a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. Over time, conventional treatment options, such as chemotherapy, surgery and radiation therapy, have shown limited efficacy in treating late-stage cancers. In addition, the non-specific and highly toxic nature of these therapies have severe detrimental effects on patients’ quality of life. Defects in deoxyribonucleic acid (DNA) repair have been shown to be one of the primary causes of cancer. Moreover, tumor cells that are characterized by impaired DNA repair pathways typically become reliant on alternative DNA repair pathways for survival. This phenomenon is commonly referred to as oncogene addiction. Inhibitors of such compensatory repair pathways have the potential to sensitize cancer cells to DNA damaging agents and other therapeutic regimens. On the other hand, the simultaneous inactivation of certain pairs of genes have been shown to cause cell death. This phenomenon is known as synthetic lethality. In cancers, where mutations have led to the loss of function of one gene, using a drug molecule that specifically targets the corresponding gene of the synlet pair has been demonstrated to be a viable and effective therapeutic regimen. Recent advances in biomarker research, including the development of companion diagnostics, in combination with modern molecular screening platforms, which include clustered regularly interspaced short palindromic repeats (CRISPR)- and RNA interference (RNAi)-based screening techniques, have led to the identification of a number of synthetically lethal gene pairs. Currently, there are four approved (and marketed) poly-ADP ribose polymerase (PARP) inhibitor drugs, which have been shown to operate based on the concept of synthetic lethality. Further, several such drugs are being investigated for the treatment of a myriad of advanced oncological and non-oncological indications. A number of companies are engaged in this domain; moreover, both venture capital (VC) firms and government bodies are actively funding such research initiatives. Scope of the Report The ‘Synthetic Lethality-based Drugs and Targets Market, 2019-2030: Focus on DNA Repair (including PARP Inhibitors) and Other Novel Cellular Pathways’ report features an extensive study of the current market landscape and the future potential of the synthetic lethality-based therapeutics. It features an in-depth analysis, highlighting the capabilities of various companies engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape, providing information on drug developer(s) (year of establishment, headquarters and size of the company), phase of development (marketed, clinical, preclinical, and discovery stage) of lead candidates, type of molecule (small molecule and biologic), type of therapy (monotherapy and combination therapy), type of synlet target, target patient segment, key therapeutic area(s), target indication(s), and route of administration. In addition, the chapter includes a list of screening platforms that are being used by industry players to study synlet interactions between gene pairs. Detailed profiles of large players that are engaged in the development of synthetic lethality-based drugs (shortlisted on the basis of phase of development of pipeline products), featuring a brief overview of the company, its financial information (if available), detailed profiles of their respective lead drug candidates, and an informed future outlook. Additionally, each drug profile features information on the type of drug, route of administration, target indications, current status of development and an excerpt on its developmental history. In addition, the chapter includes tabulated profiles of small-sized and mid-sized players (shortlisted on the basis of the number of pipeline products), featuring details on the innovator company (such as location of headquarters, year of establishment, number of employees, and key members of the executive team), recent developments, along with descriptions of their synthetic lethality-based drug candidates. An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, posted during the period 2010-2019 (till May), highlighting the historical trend of tweets, most prolific contributors, frequently discussed synlet targets, popular disease indications and a multivariate tweet benchmark analysis. An analysis of close to 700 peer-reviewed scientific articles related to synthetic lethality, published during the period 2017-2019 (till May), highlighting the research focus within this niche industry segment. It includes an informed opinion on the key trends observed across the aforementioned publications, including information on target disease indications, synlet targets, and analysis based on various relevant parameters, such as study type (review article, research article and case report), research objective, year of publication, key research hubs, most popular authors, provision of grant support, and most popular journals (in terms of number of articles published in the given time period and journal impact factor). An analysis of various abstracts presented at the American Society of Clinical Oncology (ASCO) in the time period 2013-2019 (till May), highlighting several parameters, such as year of (abstract) publication, popular drugs, synlet targets, target cancer indications, popular authors, author designations, industry type (industry and academia) and most active organizations (in terms of number of published abstracts). In addition, this analysis features a multi-dimensional bubble chart analysis to assess the relative level of expertise of the key authors / researchers based on the number of publications, citation count and research gate score. An in-depth analysis of close to 750 grants that have been awarded to research institutes engaged in projects related to synthetic lethality, between 2014 and 2019 (till May), highlighting various important parameters associated with grants, such as year of award, support period, amount awarded, funding institute, administration institute center, funding institute center, funding mechanism, spending categorization, grant type, responsible study section, focus area, type of recipient organization and prominent program officers. It also features a detailed analysis on most popular synlet targets and target indications, along with a multivariate grant attractiveness analysis based on parameters, such as amount awarded, support period, grant type, number of synlet targets and number of indications under study. An analysis of the investments made into companies that have proprietary synthetic lethality-based drugs / screening platforms, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. An in-depth benchmark analysis of over 230 synlet targets identified from various credible sources (research publications, government fundings, clinical studies, recent news / tweets and abstracts presented in global conferences), highlighting targets that have already been validated in clinical studies, preclinical studies and early-stage research (cases where there is no lead (therapeutic) candidate being investigated). Further, it highlights the long-term opportunities (for drug developers) associated with individual targets, based on their popularity across different portals. An analysis of the role of innovative companion diagnostics in synthetic lethality on the basis of several parameters, such as synlet target, drug candidate(s) being investigated, target biomarker(s), target disease indication(s) and assay technique used. It also includes case studies, highlighting those companion diagnostic tests that are available and are being used to evaluate the therapeutic efficiency of approved PARP inhibitors using the principle of synthetic lethality. One of the key objectives of the report was to estimate the existing market size and identify the future opportunity for synthetic lethality-based drugs, over the next decade. Based on multiple parameters, such as target consumer segments, region-specific disease prevalence, anticipated adoption of the marketed and late stage drugs and the likely selling price, we have provided informed estimates on the evolution of the market over the period 2019-2030. The report includes potential sales forecast of drugs that are currently marketed or are in late stages of development (phase II and above). The report also features the likely distribution of the current and forecasted opportunity across [A] type of molecules (small molecule and biologic), [B] different target indications (breast cancer, colorectal cancer, fallopian tube cancer, gastric cancer, head and neck cancer, lung cancer, ovarian cancer, peritoneal cancer and others), [C] synlet targets (APE1 / Ref-1, Chk1, GLS1, PARP, Pol θ, PP2A and Wee1), [D] route of administration (oral and intravenous), and [E] key geographical regions (North America, EU5, Asia-Pacific and Rest of the World). To account for the uncertainties associated with the growth of synthetic lethality-based drugs market 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 also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names): Simon Boulton (Vice President, Science Strategy, Artios Pharma) Yi Xu (Associate Director, Business Development, IMPACT Therapeutics) Norbert Perrimon (Professor, Department of Genetics, Harvard Medical School) Vivek Dharwal (Professor, Department of Biochemistry, Panjab University) Alfred Nijkerk (Chief Executive Officer, UbiQ) 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.
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August 2019
Advances in the fields of cell biology and regenerative medicine have led to the development of various cell-based therapies, which, developers claim, possess the potential to treat a variety of clinical conditions. In 2018, it was reported that there were more than 1,000 clinical trials of such therapies, being conducted across the globe by over 900 industry players. Moreover, the total investment in the aforementioned clinical research efforts was estimated to be around USD 13 billion. Given the recent breakthroughs in clinical testing and the discovery of a variety of diagnostic biomarkers, the isolation of one or multiple cell types from a heterogenous population has not only become simpler, but also an integral part of modern clinical R&D. The applications of cell separation technologies are vast, starting from basic research to biological therapy development and manufacturing. However, conventional cell sorting techniques, including adherence-based sorting, membrane filtration-based sorting, and fluorescence- and magnetic-based sorting, are limited by exorbitant operational costs, time-consuming procedures, and the need for complex biochemical labels. As a result, the use of such techniques has, so far, been restricted in the more niche and emerging application areas. Over the years, extensive research in the field of flow cytometry has enabled the development of a variety of novel technologies that are capable of efficiently isolating cells from tissue samples and / or heterogenous cell populations. In fact, since 2014, over 3,000 patents were reported to have been filed / granted related to such advanced techniques, indicating the rapid pace of innovation in this domain. Developers of the aforementioned technologies claim that these new techniques offer numerous benefits, including fast and precise cell sorting, reduced sample requirement, improved portability, reduced risk to cell viability, and negligible need for expensive biochemical / magnetic labels. Moreover, they have been shown to be compatible for use across a myriad of applications, including research studies (bacteriology, immunology, stem cell research, and viral titering and infectivity), biomedical diagnostics (circulating tumor cell detection, in vitro fertilization, and non-invasive prenatal diagnosis), biological therapy-related process operations (bio-banking, drug discovery, sample preparation, single cell sequencing, and tumor cell characterization), and cell-based therapeutics (B- or T-cell immunotherapies). Consequently, these techniques have captured the interest of several stakeholders in the biopharmaceutical industry. It is also worth highlighting that stakeholders in this domain have received significant support from both private and public investors. Scope of the Report The ‘Novel Cell Sorting and Separation Market: Focus on Acoustophoresis, Buoyancy, Dielectrophoresis, Magnetophoretics, Microfluidics, Optoelectronics, Traceless Affinity, and Other Technologies, 2019-2030’ report features an extensive study of the current landscape and future outlook of the growing market for novel cell sorting and separation technologies (beyond conventional methods). The study presents detailed analyses of cell sorters, cell isolation kits, and affiliated consumables and reagents, that are based on the aforementioned technologies. Amongst other elements, the report features: A detailed assessment of the current market landscape, featuring a comprehensive list of over 200 innovative cell sorters, cell isolation kits, and affiliated consumables and reagents, along with information on their respective specifications (such as size, weight, cell flow rate, cell sort rate, cell analysis rate, cell purity and viability, process time, and operating temperature and pressure), cell sorting technology (acoustophoresis, buoyancy-activated, dielectrophoresis, magnetic levitation, microfluidics, optoelectronics, photoacoustics, traceless affinity, and others), type of cell (animal cells, cancer cells, immune cells, microbial cells, red blood cells / platelets, stem cells, and others), cell separation approach (positive selection, negative selection and depletion), basis for separation (cell morphology and physiology, cell size and density, surface biomarkers, surface charge and adhesion, and others), and end use / application (research studies, biomedical diagnostics, biological therapy-related process operations, and cell-based therapeutics). An insightful company competitiveness analysis, taking into consideration the supplier power (based on size of employee base and experience in this segment of the industry) and portfolio-related parameters, such as number of products offered, number of target cells, end use(s) / application(s), and key product specification(s). Comprehensive profiles of key industry players (shortlisted on the basis of company competitiveness analysis scores) that are currently offering novel cell sorters / consumables and cell isolation kits, featuring an overview of the company, its financial information (if available), and a detailed description of its proprietary product(s). Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. An in-depth analysis of the patents that have been filed / granted related to novel cell sorting and separation technologies, since 2014. It highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation. A detailed publication analysis of more than 200 peer-reviewed, scientific articles that have been published since 2014, highlighting the research focus within the industry. It also highlights the key trends observed across the publications, including information on innovative technologies, potential application areas, target disease indications, type of cell, and analysis based on various relevant parameters, such as year of publication, and most popular journals (in terms of number of articles published in the given time period) within this domain. An analysis of the partnerships that have been established in the domain, in the period 2014-Q1 2019, covering R&D collaborations, licensing agreements, distribution agreements, mergers / acquisitions, asset purchase agreements, product development agreements, product utilization agreements, and other relevant deals. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants / awards, capital raised from IPOs and subsequent offerings, by companies that are engaged in this field. An analysis to estimate the likely demand for novel cell sorting products and solutions across key application areas, including research studies, biomedical diagnostics (circulating tumor cell detection, in vitro fertilization, and non-invasive prenatal diagnosis), and cell-based therapeutics, in different global regions for the period 2019-2030. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the novel cell sorting and separation market. Based on multiple parameters, such as potential application areas, likely adoption rate and expected pricing, we have provided an informed estimate on the likely evolution of the market, over the period 2019-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] potential application areas (research studies, circulating tumor cell detection, in vitro fertilization, non-invasive prenatal diagnosis, and cell-based therapeutics), [B] type of offering (cell sorters, and consumables and isolation kits), [C] cell sorting technology (buoyancy-activated, magnetic levitation, microfluidics, optoelectronics, and other advanced technologies), [D] type of cell (animal cells, cancer cells, immune cells, microbial cells, red blood cells / platelets, and stem cells), and [E] key geographical regions (North America, Europe and Asia-Pacific). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of organization names): John Younger (Co-founder and Chief Technology Officer, Akadeum Life Sciences) Sean Hart (Chief Executive Officer and Chief Scientific Officer, LumaCyte) Soohee Cho (Product Manager, Namocell) 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.
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July 2019
Mitochondrial diseases are characterized by chronic, genetic and progressive medical symptoms that arise due to inherited or spontaneous mutations in mitochondrial DNA (a small, circular, double-stranded with ~16,500 base pairs that exists outside of the nucleus), or in some cases, nuclear DNA, which adversely alter the function of mitochondria. Such clinical conditions are rare and are known to affect multiple parts of the body, including neurons and nerves, kidneys, heart, liver, eyes, ears, and pancreas. It is worth highlighting that over 300 mutations have been identified and are associated with various mitochondrial diseases. Examples of diseases that are caused due to mutations in mitochondrial DNA include Leber's hereditary optic neuropathy (LHON), Leigh syndrome, mitochondrial DNA depletion syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS), and myoclonic epilepsy with ragged red fibers (MERRF). In the US, mitochondrial diseases are known to annually affect 1 in 5,000 individuals. It is also estimated that 1,000-4,000 children are born with a mitochondrial disease every year, in the same region. Primary mitochondrial diseases are usually difficult to diagnose. In many cases, clinicians and medical professionals are compelled to use the term possible mitochondrial disease, indicating that based on the presenting symptoms they suspect a patient to be suffering from a mitochondrial disease. However, they are unable to confirm the condition via genetic diagnosis. Such instances are further complicated by the aforementioned uncertainty, leading to delays in treatment and subsequent deterioration in the patient’s quality of life. Currently, several industry stakeholders are engaged in efforts to develop disease modifying interventions for treating different mitochondrial diseases, in addition to drug / therapy candidates that offer symptomatic relief. There are several non-profit organizations that have been established across the globe to support individuals suspected / diagnosed with mitochondrial diseases and also fund research / clinical studies being conducted for treatment of such conditions. In the coming years, the market is anticipated to grow at a significant pace as more novel therapy solutions are approved by regulatory authorities and enter the market. Scope of the Report The “Mitochondrial Disease Therapies Market, 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of therapeutics designed to treat mitochondrial diseases. It features an in-depth analysis, highlighting the capabilities of stakeholder companies / organizations engaged in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, type of molecule (small molecule and biologic), type of therapy (monotherapy and combination therapy), path to clinic (dedicated, repurposed and repositioned), target disease indication, and route of administration of the drugs / therapies that are being developed for the treatment of different mitochondrial diseases. Detailed profiles of the players that are engaged in the development of therapies for mitochondrial diseases (shortlisted on the basis of the number / phase of products), featuring an overview of the company, its financial information (if available), a description of its product portfolio, recent collaborations and an informed future outlook. An analysis of close to 200 peer-reviewed, scientific articles published during the period 2014-2019 (till February), highlighting the research focus within this niche industry segment. It includes an informed opinion on the key trends observed across the aforementioned publications, including information on target disease indications, target mutations across different indications, and analysis based on various relevant parameters, such as study type (review article, research article and case report), year of publication, and most popular journals (in terms of number of articles published in the given time period). A list of key opinion leaders (KOLs) within this domain, featuring detailed 2X2 matrices to assess the relative experience of key individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It also includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs, based on number of publications, number of citations, number of clinical trials, number of affiliations and strength of professional network (based on information available on LinkedIn). A study of the various grants that have been awarded to research institutes engaged in projects related to different types of mitochondrial diseases, between 2015 and 2019 (till May), highlighting various important parameters, such as year of award, support period, amount awarded, funding institute, grant type, responsible study section, focus area and type of recipient organization. One of the key objectives of the report was to estimate the existing market size and the future opportunity of therapies for mitochondrial diseases, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption of the forecasted therapies and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different target indications (Leigh syndrome, LHON, MELAS, mitochondrial DNA depletion syndrome, mitochondrial myopathy and others), [B] type of therapy (combination and monotherapy), [C] route of administration (oral, intravenous, and others) and [D] key geographical regions (the US, EU5 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. 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.
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February 2019
Clinical trials represent an arduous step in the drug development process and are crucial to understanding the safety and efficacy profiles of novel therapeutic interventions. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. Amongst several known challenges, patient recruitment is considered to be one of the rate limiting steps when it comes to getting drugs to the market. It is estimated that 80% of clinical trials do not meet their designated patient enrolment deadlines. In fact, around 37% of research sites fail to meet their subject accrual goals, while more than 10% don’t even enroll a single patient. In addition, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. Delays in product launch, due to inability of the sponsors to recruit / retain patients, are highly common and are estimated to result in an average loss of USD 8 million per day in opportunity costs, for a blockbuster drug. The abovementioned challenges have led several players in the pharmaceutical industry to outsource their patient recruitment-related needs to capable, specialty service providers. Employing contract service providers has been shown to expedite the patient recruitment process. Such service providers employ a variety of outreach methods, such as social media, mobile technologies, electronic health records (EHRs) and real-world evidence (RWE), and, over time, have attained a vital role in the successful conduct of clinical research. Although some big pharma players carry out patient recruitment in-house, the growing complexity of clinical trials and demand for niche patient populations for studies evaluating orphan drugs / personalized medicines is likely to prompt more developer companies to outsource various aspects of their clinical research-related operations in the foreseen future. In fact, the market has recently witnessed the establishment of several partnerships, which include agreements between study sponsors and patient recruitment firms (outsourcing deals) and partnerships between stakeholders aimed to combine their respective services portfolios related to patient recruitment and retention (service alliances). This niche services industry has also witnessed some consolidation as multiple smaller players have been acquired by more established entities, in an effort to expand geographical reach. Scope of the Report The ‘Patient Recruitment and Retention Services, 2019-2030’ report offers a comprehensive study of the current scenario and future potential of the players providing patient enrollment and retention services. The study 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 patient recruitment and retention services, including information on over 10 types of patient outreach methods employed, types of services offered ([A] patient recruitment (including pre-screening and Institutional Review Board (IRB) / Ethics Committee (EC) submission), [B] patient retention (considering various strategies, such as the use of study-branded gifts, study-branded reminders, providing education and support materials, reimbursement programs, transportation programs, patient engagement web site, patient reconnect programs, mobile applications to track patient engagement and others) and [C] other associated services (including site identification and selection,study feasibility / protocol development, project management, clinical trial monitoring and other services), year of establishment, geographical location, and size of company. The chapter also covers an analysis of the geographical reach and therapeutic expertise of service providers, along with details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded by regulatory bodies. An analysis of the most active regions (in terms of patient recruitment activity), based on the locations of headquarters of companies engaged in this domain, featuring schematic world map representations that highlight key hubs across the globe. An insightful 2X2 representation of the results of a competitiveness analysis of various service providers (segregated into three peer groups based on their employee count (small-sized (1-50 employees), mid-sized (50-200 employees) and large (>200 employees)), highlighting capable players in this domain, based on their respective capabilities. Comprehensive profiles of patient recruitment and retention service providers, featuring information on the location of their headquarters, year of establishment, patient recruitment services / platforms portfolio, recent developments and a comprehensive future outlook. An analysis of the partnerships that have been established in the recent past, covering outsourcing agreements, service alliances, acquisitions, joint ventures, mergers, technology licensing and development agreements, and other forms of partnerships. A review of emerging trends in the industry, including the use of social media, mobile technologies, EHRs and RWE, to overcome the challenges associated with patient recruitment and retention. One of the key objectives of the report was to estimate the existing market size and review the potential growth opportunities for patient recruitment service providers over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this 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] therapeutic area (oncology, infectious diseases, cardiovascular diseases, CNS disorders, respiratory disorders, metabolic disorders, and others), [B] steps in patient recruitment process (pre-screening and screening), [C] phases of development (phase I, phase II, phase III and phase IV), and [D] different global regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution. 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 (in alphabetical order of company names): Simon Klaasen (Co-founder and Managing Director, Link2Trials) Hagit Nof (Chief Operation Officer and Business Development, nRollmed) Paul Ivsin (Managing Director, Seeker Health) 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.
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July 2019
The cancer therapeutics market is considered to be one of the most active segments within the pharmaceutical industry. In the past five years, the USFDA has approved more than 100 drugs for the treatment of different types of cancer. However, there is still a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. It is also worth highlighting that, in the coming years, the number of cancer patients is anticipated to increase substantially along with the growing global population. According to the International Agency for Research on Cancer (IARC), close to 17 million new cases of cancer were diagnosed in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million. In fact, the global cancer burden is anticipated to increase by 70% in the next 20 years. Among the current initiatives focused on developing targeted anti-cancer therapies, T-cell therapies (specifically CAR-T, TCR and TIL therapies) have emerged as a promising option owing to their capability to eradicate tumor cells from the body with minimal treatment-related side effects. These adoptive T-cell therapies (ACT) are based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. With the recent approval of KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences) for the treatment of CD19-positive relapsed / refractory leukemias and lymphomas, such ACTs have become a part of mainstream healthcare solutions. Encouraging clinical trial results and therapeutic response rates achieved across various hematological cancers and solid tumors have further inspired research groups to focus their efforts on the development of these novel therapies. So far, more than 150 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential therapy candidates. In fact, multiple collaborations have been inked in the past decade between various therapy developers and academic / research institutes to advance the development of various pipeline candidates. The ongoing research activity in this field has also led to the discovery of several novel molecular targets. Further research and characterization of the aforementioned targets have significantly strengthened the research pipelines of companies engaged in this market. Driven by the availability of innovative technology platforms, lucrative funding and encouraging clinical trial results, the T-cell immunotherapies market is poised for success in the long-run as multiple product candidates are expected to be approved over the coming decade. Scope of the Report The “Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030” report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies (focusing particularly on CAR-T therapies, TCR therapies and TIL therapies). The report highlights the efforts of both industry players and academic organizations. Amongst other elements, the report features the following: An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers. A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of therapy, type of developer (industry / non-industry), phase of development, target therapeutic indication(s), key target antigen(s), source of T-cells (autologous / allogenic), and route of administration. In addition, we have provided an overview of the competitive landscape, key challenges and anticipated future trends associated with CAR-T, TCR and TIL-based therapies. Comprehensive profiles of marketed and mid to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results. An analysis of the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used. A detailed analysis highlighting several key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of T-cell therapies. An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China. An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers. Further, it includes a relative competitiveness analysis of different T-cell immunotherapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology. An analysis of the partnerships that have been established in the recent past, covering R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures and others. An analysis of the investments that have been made into companies that have proprietary T-cell based products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing. A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs. It presents a detailed analysis of the approved / pipeline products in this domain, including information on the current phase of development, target therapeutic area(s), type of T-cells used and source of T-cells. A case study on manufacturing cell therapy products, highlighting the key challenges, and a list of contract service providers and in-house manufacturers that are involved in this space. An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a T-cell based immunotherapy that is likely to be marketed in the coming years. A review of the key promotional strategies that have been adopted by the developers of the marketed T-cell therapies, namely KYMRIAH® and YESCARTA®. One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for T-cell immunotherapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report includes potential sales forecasts of T-cell immunotherapies that are currently marketed or are in late stages of development. Additionally, it provides forecasts for the overall T-cell immunotherapies market, wherein both the current and upcoming opportunity is segmented across [A] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others) and [D] key geographies (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapies 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 this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individualss: Tim Oldham (Chief Executive Officer, Cell Therapies) Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics) Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Miguel Forte (Chief Operating Officer, TxCell) Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Peter Ho (Director, Process Development, Iovance Biotherapeutics) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) 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.
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May 2019
Biologics constitute a majority of the top selling drugs and presently represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, since the launch of recombinant protein-based therapies around three decades earlier, the overall biologics market has grown at an annualized rate of over 12%. It is also worth highlighting that more than 5,000 biopharmaceutical product candidates are currently under development. Despite the fact that biopharmaceuticals offer significant profit margins, the sponsors of such pharmacological interventions are plagued by high costs of development and complex production protocols. As a result, several start-ups / small-sized companies and certain pharma giants have begun outsourcing different aspects of their business operations to contract service providers. According to the 2017 Nice Insight CDMO survey, about 54% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant benefits, such as reduction in capital investment, access to larger production capacities, reductions in time-to-market and reduced commercialization risk. Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologics drug products require special procedures and equipment for fill / finish operations in order to ensure product integrity and safety. As this operation is heavily outsourced, the rise in demand for biologics has resulted in an equivalent need for flexible aseptic fill / finish technologies. Pharmaceutical drug manufacturers have not hesitated to collaborate with contract service providers to leverage the latter’s experience and expertise in the latest fill / finish technologies. Currently, over 115 companies are actively providing fill / finish services for biologics. In the recent past, many service providers have also forged alliances / acquired other players in order to enhance their service offerings. Scope of the Report The ‘Biologics Fill / Finish Service Providers, 2019-2030’ report features an extensive study on the contract service providers offering drug product manufacturing services within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of companies that claim to specialize in fill / finish operations. Amongst other elements, the report includes: A detailed review of the overall landscape of contract fill / finish services market for biopharmaceuticals, featuring a list of active service providers and detailed analysis based on a number of relevant parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), year of establishment, company size and geographical location of the service provider, count and location of affiliated fill / finish facilities, number of additional services offered (lyophilization, labelling, quality testing, storage and distribution services), dosage forms handled (liquid and lyophilized), and types of primary packaging containers handled (ampoules, cartridges, syringes and vials), including details on fill / finish capacity and fill volume range. A region-wise, company competitiveness analysis, highlighting prominent fill / finish service providers across various packaging types, based on supplier strength (considering experience and company size of the service provider), service strength (considering number of fill / finish facilities, number of continents where the aforementioned facilities are located, number of additional services offered and scale of operation) and types of biologics handled. Elaborate profiles of key players across key geographies (North America, Europe and Asia-Pacific), which were shortlisted based on our proprietary company competitiveness analysis. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on partnerships, expansions and recent awards and accolades, as well as an informed future outlook. An analysis of the recent collaborations (signed since 2013) focused on the contract fill / finish services for biologics, based on various parameters, such as year of agreement, type of agreement, scale of operation of the project, focus area, types of services mentioned in the deal, types of biologics involved and location of facility where the project is to be executed. A detailed analysis of the expansions undertaken (since 2013) by various service providers for augmenting their respective fill / finish service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of facility, type of packaging container involved, scale of operation (as mentioned in the expansion terms), types of services and biologics involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances). An estimate of the global, contract fill / finish capacity, by taking into consideration the capacities of various fill / finish service providers (as available on respective company websites), collected via secondary and primary research. The study examines the distribution of number of packaging units and volume of biologics filled, across various types of packaging containers (ampoules, cartridges, syringes, and vials), based on the size of the company / organization (small-sized, mid-sized and large) and geography (North America, Europe and Asia Pacific). An informed estimate of the annual demand for fill / finish of biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of the abovementioned products. An analysis to identify the key performance indicators for service providers active in the domain, based on information gathered via secondary research (for top-ten pharmaceutical players) and primary research. A case study to highlight the benefits of using robotic / automated equipment for aseptic fill / finish processes; the study provides a list of equipment manufacturers providing robots suitable for pharmaceutical operations. A case study to highlight the role of ready-to-use packaging containers in aseptic fill / finish operations; the study provides a list of suppliers providing the ready-to-use components. A discussion on the potential growth areas, such as growing biopharmaceutical pipeline, increasing outsourcing of fill / finish operations, rising focus on self-administration enabling drug delivery devices and growing opportunities in Asia-Pacific region, which are likely to present in the coming years. 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 growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of drug product manufacturing costs, and outsourcing trends related to fill / finish operations, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the period 2019-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] types of primary packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] types of biologics (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), [C] company size (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial), [E] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications), and [F] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia-Pacific (Japan, China, South Korea, India and Australia)). To account for the uncertainties associated with the fill / finish of biopharmaceuticals 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 held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Ales Sima, Business Development Manager, oncomed manufacturing Gregor Kawaletz, Chief Commercial Officer, IDT Biologika Jos Vergeest, International Business Developer, HALIX Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene International All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
...read moreAugust 2019
Roots Analysis has announced the addition of “Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030” report to its list of offerings. Encouraging clinical results reported across trials of various hematological cancers and solid tumors have inspired research groups to focus their efforts on the development of this relatively novel class of immunotherapies. With two approved therapies, namely KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences), the T-cell immunotherapy pipeline has evolved significantly over the past few years. Of these, certain pipeline candidates have also entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years. The report presents opinions on several key aspects of the market. Among other elements, it includes: Close to 650+ candidate therapies in the development pipeline CAR-T cell products continue to dominate the clinical / preclinical pipeline, representing 75% of the total number of molecules, followed by TCR (18%) and TIL (7%) based therapies. It is worth highlighting that 63% of pipeline therapies are presently in the clinical stage. Examples of late-stage clinical candidates include bb2121 (bluebird bio and Celgene), JCAR017 (Celgene, Juno Therapeutics and WuXi AppTec), GSK3377794 (GlaxoSmithKline, Adaptimmune Therapeutics and Merck), IMCgp100 (Immunocore and MedImmune) and Lifileucel (Iovance Biotherapeutics). Currently, the focus is on hematological malignancies and solid tumor indications More than 85% of the products in the development pipeline are presently being developed to treat various types of cancers, including (in decreasing order of number of pipeline products) acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma and melanoma. Only 3% of pipeline candidates are being evaluated for the treatment of non-oncological indications. Extensive efforts are underway to improve the CAR constructs Majority of the CAR-T cell therapies in the clinical development, including the two recently approved products, are based on second generation CARs. Further, lentivirus and retrovirus are presently the preferred type of vectors used for CARs transduction into T-cells. China is leading the product development efforts related to CAR-T cell therapies, in terms of number of active trials and supporting hospitals In the last 10 years, over 410 clinical trials, evaluating various types of CAR-T cell therapies, were registered across different geographies; interestingly, over 50% of these are trials are being conducted in China. Over to USD 13.8 billion invested by both private and public investors, since 2012 Around USD 4.4 billion was raised through venture capital financing, representing around 37% of the total capital raised by industry players in the given time period (till May 2019). Further, in the last five years, there have been 18 IPOs accounting for more than 2.4 billion in financing of T-cell therapy related initiatives. 280+ partnerships established between 2012 and 2019 The partnership activity in this domain has increased at a CAGR of over 30%. In fact, around 70% of the deals were established post 2015, with the maximum activity being reported in 2018. Majority of the abovementioned agreements were observed to be focused on research and development of T-cell therapies. North America and Europe anticipated to capture over 85% of market share by 2030 With a promising development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of over 40% during the next decade. In addition to North American and Europe, the market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate. The USD 26 billion (by 2030) financial opportunity within the T-cell immunotherapies market has been analyzed across the following segments: Type of therapy CAR-T cell therapy TCR-based therapy TIL-based therapy Type of target disease indication Acute lymphoblastic leukemia Non-Hodgkin’s lymphoma Melanoma Bladder cancer Lung cancer Head and neck cancer Multiple myeloma Sarcoma Chronic lymphocytic leukemia Ovarian cancer Esophageal cancer Colorectal cancer Nasopharyngeal carcinoma Hepatocellular carcinoma Acute myeloid leukemia Renal cell carcinoma Type of target antigens CD19 BCMA CD19/22 EGFR NY-ESO-1 gp100 p53 EBV MUC1 WT-1 Others Key geographical regions North America Europe Asia Pacific The report features inputs from eminent industry stakeholders, according to whom T-cell immunotherapies are expected to be the next big step in cancer immunotherapy. The report includes detailed transcripts of discussions held with the following experts: Tim Oldham (Chief Executive Officer, Cell Therapies) Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics) Wei (William) Cao (Co-Founder, Chairman and Chief Executive Officer, Gracell Biotechnologies) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Miguel Forte (Chief Operating Officer, TxCell) Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) Vincent Brichard (Vice President, Immuno-Oncology, Celyad) Peter Ho (Director, Process Development, Iovance Biotherapeutics) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) The research covers brief profiles, featuring an overview of the company, its financial information (if available), and a description of its product(s), highlighting type of therapy and current development status. Each company profile includes technology portfolio (if available), recent developments related to T-cell immunotherapies and manufacturing capabilities of the companies. Adaptimmune Therapeutics Autolus bluebird bio CARsgen Therapeutics Celgene Cell Medica Cellectis Cellular Biomedicine Group Immunocore Innovative Cellular Therapeutics Iovance Biotherapeutics Kite Pharma Lion TCR Noile-Immune Biotech Novartis Shanghai GeneChem Sinobioway Cell Therapy Takara Bio Unum Therapeutics Ziopharm Oncology For additional details, please visit https://www.rootsanalysis.com/reports/view_document/global-t-cell-car-t-tcr-and-til-therapy-market-4th-edition-2019--2030/261.html or email sales@rootsanalysis.com Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com
...read moreJuly 2019
Roots Analysis has announced the addition of “Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019 – 2030” report to its list of offerings. Over time. pharmaceutical players have demonstrated significant interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of these novel biomarkers. Several companies have already developed / are developing analytical tests for novel cancer biomarkers (TMB, MSI / MMR and TILs), intended to assist physicians in making personalized treatment decisions. The report presents opinions on several key aspects of the market. Among other elements, it includes: Close to 90 tests are available for the assessment of TMB / MSI / MMR and TILs More than 50% of the aforementioned tests use next generation sequencing (NGS) technology, followed by tests based on polymerase chain reaction (22%) for the assessment of biomarker expression levels in cancer tissue samples. Examples of NGS based tests include (in alphabetical order, no specific selection criteria) FoundationOne® CDx™ (Foundation Medicine), Guardant360 (Guardant Health), NeoTYPE® Discovery Profile (NeoGenomics Laboratories). More than 180 novel biomarker related research articles have been published since 2016 Majority (~37%) of published scientific articles are focused on the potential use of these biomarkers in evaluating how patients are likely to respond to various types of immunotherapies, such as immune checkpoint inhibitors; in this context, it is worth highlighting that several such tests are available to assess the likely response to anti PD-1 / PD-L1 therapies. Further, close to 25% of such publications discuss the potential of novel biomarker testing in colorectal cancer, followed by lung cancer (nearly 20%). Over 170 clinical trials have been initiated over the last 5 years In fact, leading industry players, such as (in alphabetical order, no specific selection criteria) Bristol-Myers Squibb, Merck Sharp & Dohme, Merck KgaA, Novartis, Pfizer and Roche / Genentech have been involved in most of the novel biomarker related clinical research initiatives. North America (primarily the US) is expected to capture the majority share (~43%) of the forecasted opportunity in 2030 This growth is anticipated to be driven by the approval of more biomarker-based tests for guiding cancer treatment related decisions in the near future. Further, the market for tests designed for lung cancer and colon / colorectal cancer, is expected to capture the majority share in the coming decade. The USD 860 million (by 2030) financial opportunity within the cancer biomarkers market has been analyzed across the following segments: Type of test Laboratory Developed Tests (LDTs) Companion Diagnostic Tests (CDx) Type of disease indication Breast cancer Blood cancer Colon / Colorectal cancer Lung Cancer Melanoma Prostate Cancer Type of cancer biomarker TMB MSI / MMR TILs Type of analytical technique Next Generation Sequencing (NGS) Polymerase Chain Reaction (PCR) Immunohistochemistry (IHC) Others Key geographical regions North America Europe Japan China Australia The research includes detailed profiles, featuring an overview of the company, its financial information (if available), and a description of the service(s) offered. Each company profile includes recent developments related to cancer biomarkers and an informed opinion on the likely strategies that may be adopted by these players to fuel growth in the foreseen future. Dr Lal PathLabs Foundation Medicine NeoGenomics Laboratories Novogene Q2 Solutions Personal Genome Diagnostics Shenzhen Yuce Biotechnology For additional details, please visit https://www.rootsanalysis.com/reports/view_document/cancer-biomarkers-market-focus-on-tmb-msi--mmr-and-tils-testing-2019--2030/253.html or email sales@rootsanalysis.com Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com
...read moreJune 2019
Roots Analysis has announced the addition of “Neoantigen Targeted Therapies, 2019-2030” report to its list of offerings. The use of neoantigens in therapy has demonstrated the ability to elicit a strong T cell mediated immune response. Several therapy candidates are being investigated both as monotherapies and in combination with various immune checkpoint inhibitors, such as atezolizumab, durvalumab, ipilimumab, and nivolumab. Of these, certain pipeline candidates have already entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years. The report presents opinions on several key aspects of the market. Among other elements, it includes: Over 150+ candidate therapies in the development pipeline Nearly 13% of the pipeline therapies are being developed for the treatment of GI cancers, followed by lung cancer (11%). Examples of molecules being developed for the aforementioned indications include (in alphabetical order, no specific selection criteria) MicOryx, NCI-4650, and Tedopi®. 1,100+ patents filed / granted in 2018 In fact, more than 6,000 patents were filed / granted related to neoantigen targeted therapies, since 1978. Based on existing intellectual property, the R&D activity was observed to be concentrated in the US. Other key regions with significant intellectual capital include (in decreasing order of number of patents filed / granted) Australia, Europe, China, and Canada. Close to USD 7.5 billion invested by both private and public investors, since 2014 Around USD 3,200 million was raised through venture capital financing, representing around 43% of the total capital raised by industry players in the given time period (till April 2019). Further, in the last five years, there have been 10 IPOs accounting for more than 800 million in financing of neoantigen related initiatives. Companies are collaborating actively for the advancement of clinical trials Majority of the abovementioned agreements were observed to be focused on conducting Phase I / Phase II clinical studies of neoantigen targeted therapies for the treatment of different cancer indications. Agreements signed for research purposes (19%) were also observed to be popular among industry stakeholders, during 2014-2019 (till April). More than 350 publications have been published since 2014 It is worth noting that between the period 2014-2019, over 150 research articles were published related to neoantigen targeted therapies. Further, more than 190 review articles have been published related to this upcoming field. Therapies using personalized neoantigens are anticipated to increase at a CAGR of over 60% between 2024 and 2030 This growth is anticipated to be primarily driven by the reduced risk of adverse effects and improved efficacy of personalized therapies. North America (primarily the US) and Europe are expected to capture the majority share by 2030, in terms of the sales-based revenues. The USD 3 billion (by 2030) financial opportunity within the neoantigens market has been analyzed across the following segments: Type of target disease indication Bone cancer Colorectal cancer Gynecological cancer Non-small cell lung cancer Renal cell carcinoma Other cancers Type of neoantigens Personalized neoantigens Off-the-shelf neoantigens Type of immunotherapy Dendritic cell vaccines DNA / RNA-based vaccines Protein / peptide-based vaccines TIL-based therapies Route of administration Intradermal Intravenous Subcutaneous Other routes Key geographical regions North America Europe Rest of the World The report features inputs from eminent industry stakeholders, according to whom neoantigen targeted therapies are expected to be the next big step in cancer immunotherapy. Similar to CAR-T cell therapies, these therapies have, so far, demonstrated significant therapeutic potential and promising clinical outcomes. The report includes detailed transcripts of discussions held with the following experts: Gabriel Nistor (Chief Science Officer, AIVITA Biomedical) Ella Sorani (Vice President Research and Development, BioLineRx) Heinz Lubenau (Chief Operating Officer & Co-founder, VAXIMM) The research covers detailed profiles, featuring an overview of the company, its financial information (if available), and a description of its product(s), highlighting type of therapy, current development status, and key preclinical / clinical trial results. Each profile also includes a list of recent developments, and an informed opinion on the likely strategies that may be adopted by these players to fuel growth in the foreseen future. Bavarian Nordic Genocea Biosciences Gradalis Immunicum Immunovative Therapies Iovance Biotherapeutics Medigene Neon Therapeutics Precision Biologics Vaxon Biotech For additional details, please visit https://rootsanalysis.com/reports/view_document/cell-encapsulation-focus-on-therapeutics-and-technologies-2019-2030/249.html or email sales@rootsanalysis.com Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com
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