Pipeline Tracking
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February 2020
New coronavirus (COVID-19) is a previously unidentified strain of coronavirus, that first emerged in the Chinese city of Wuhan in December 2019. The virus belongs to the same family as the virus that causes severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). On 30th January 2020, the World Health Organization (WHO) declared the coronavirus outbreak as a global health emergency. In fact, the virus is estimated to have infected more than 45,000 individuals, around the globe (estimates till the second week of February 2020). In order to deal with this outbreak and prevent the spread of virus to new geographies, countries are adopting various precautions. The WHO has recently released the Strategic Preparedness and Response Plan (SPRP) that lays out activities and resources needed by international health organizations globally, including WHO, to implement priority public health measures in support of countries to prepare and respond to COVID-19 for a period between February to April 2020. Close to 30 pharmaceutical / biotechnology companies, government agencies, and research institutes have disclosed research programs focused on developing vaccines / drugs to prevent or treat COVID-19 infections. In addition, more than 40 diagnostic tests are currently being developed for effective diagnosis of patients. The rising healthcare burden of the disease has also attracted significant funding to fuel drug development efforts in this space; recent funding initiatives include USD 100 million funding by Bill & Melinda Gates Foundation, and USD 26 million vaccine development fund by the UK government. Scope of the Report The “Novel coronavirus (COVID-19): Preventive Vaccines, Therapeutics and Diagnostics in Development” report features an extensive study of the vaccine / drug candidates and diagnostic tests being investigated for COVID-19 infection prevention, treatment and diagnosis. Amongst other elements, the report includes: A detailed assessment of the current market landscape of vaccines and drugs being developed for the prevention and treatment of COVID-19 infection, providing information on the developer(s), phase of development (clinical, preclinical, discovery) of product candidates, type of molecule (vaccines, antibodies, small molecules, others), mechanism of action, route of administration, funding agency, and key collaborators. A detailed clinical trial analysis of completed, ongoing and planned studies of candidates being evaluated for the treatment of COVID-19, highlighting prevalent trends across various relevant parameters, such as current trial status, trial registration date, enrolled patient population and regional distribution of trials, type of drug being evaluated, phase of development, study design, leading industry and non-industry players (in terms of number of trials conducted), study focus, and clinical endpoints. A detailed assessment of the diagnostic tests being developed for the diagnosis of COVID-19 infection, providing information on test developer(s), development geography, technology being used in the test, time to result, and, test sample type. An analysis depicting the prevalent and emerging trends related to this domain as represented on the social media platform, Twitter. In addition to providing information on day-on-day trends related to the volume of tweets, the analysis highlights the most frequently talked about areas, active players, and influential authors. An in-depth analysis of more than 2,100 grants that have been awarded to research institutes engaged in projects related to coronavirus, 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 2X2 plot comparing the key opinion leaders based on parameters, such as amount awarded and number of awarded grants. An analysis of the investments made across different companies/ academic institutes driving development efforts in this space. The analysis specifically highlights the key investors involved in this space. Elaborate profiles of the key players involved in vaccine / drug and diagnostic development. Each profile features a brief overview of the company, information on its development programs, details related to funding, and collaborations related to COVID-19. 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 2020
Among drug delivery devices, prefilled syringes represent one of the fastest growing primary packaging formats, which are also designed for dose administration. In fact, over the past ten years, there has been an evident increase in the development of parenteral drugs (especially with the introduction of several classes of biologics), which has resulted in an increased consumption of prefilled syringes, by approximately three fold. The sustained preference for such products can be attributed to the fact that prefilled syringes are safe and easy-to-use, and current variants are designed with provisions to reduce dosing errors, the risk of occlusions, extravasation and phlebitis. Owing to the aforementioned benefits, several injectable drugs (such as Humira®, Enbrel®, Avastin®, PREVNAR 13®, ALPROLIX® and Benefix®), diluents and other products requiring parenteral administration, are packaged in prefilled syringes. In fact, over the past seven years, around 90 drugs have been approved in combination with prefilled syringes across different geographies, including the North America, Europe and Asia-Pacific. Moreover, several clinical-stage drugs are being evaluated in combination with prefilled syringes, across different phases of development. The filling of sterile drugs into prefilled syringes (and other primary drug containers) is considered to be one of the most crucial steps in the pharmaceutical production process. Proper fill / finish operations, carried out under aseptic conditions, is a necessity for not only maintaining pharmacological efficacy and quality, but also ensuring end user safety. The prefilled syringe filling operation is considered complex as it requires close monitoring of both the syringe fill volume as well as the headspace between the liquid in the syringe and the bottom of the plunger. Additionally, the rise in complexity of small molecule APIs and the increasing diversity of biologic drugs have also contributed towards the demand of advanced aseptic fill / finish operations. A number of small-sized companies and some large companies have outsourced their fill / finish operations to contract service providers. According to the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, biomanufacturers have been shown to outsource over 30% of their fill / finish operations. With the increase in the demand for prefilled syringes, along with the growing complexity of fill / finish processes, the outsourcing of these operations is likely to increase further in the future. Currently, over 100 companies are actively providing fill / finish services for prefilled syringes. In order to cope up with the current and future market demand, service providers are actively investing in expanding their existing infrastructure and capabilities; companies are also expanding their client reach through service agreements in the past few years. Given that around 55% of drug candidates in the global R&D pipeline are injectables, the opportunities for prefilled syringe developers / manufacturers and affiliated service providers is anticipated to continue to grow over the next decade. Scope of the Report The ‘Prefilled Syringe Fill / Finish Service Providers, 2020-2030’ report features an extensive study of the current market landscape and future opportunities for contract service providers offering fill finish services for prefilled syringes. The study features an in-depth analysis of the 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 fill / finish services for prefilled syringes, along with analyses based on a number of relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of the headquarters, location of fill / finish facilities, type of drug molecule (small molecule and biologic), syringe barrel material (glass and plastic), syringe fill volume and additional services offered (drug formulation, regulatory support, labelling and packaging, terminal sterilization, quality control, storage and logistics). In addition, the chapter includes details on prefilled syringe fill / finish installed capacity of the service providers. Tabulated profiles of key players (shortlisted based on a proprietary criterion) across key geographies, such as North America, Europe and Asia-Pacific. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on recent developments as well as an informed future outlook. An analysis of the recent developments (since 2015) pertaining to contract fill / finish services, based on various parameters, such as year of development, type of activity / development (collaboration and expansions), scale of operation of the project, location of expanded facility, type of drug molecule involved, additional services offered and most active players (based on the number of instances of collaborations / expansions). An estimate of the global, contract fill / finish capacity of prefilled syringes, 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 prefilled syringe units and volume of drug filled, based on the company size of manufacturer (small-sized, mid-sized and large), scale of operation (preclinical / clinical and commercial), location of headquarters and fill / finish facilities (North America, Europe and Asia-Pacific) and type of drug molecule (small molecule and biologics). An informed estimate of the annual demand for fill / finish of prefilled syringes (in number of units), taking into account the marketed drugs available in prefilled syringes and other relevant parameters, such as target patient population, dosing frequency and dose strength. The study provides the distribution of the annual demand, based on the geography (North America (US), Europe (UK, France, Italy, Spain, Germany and rest of Europe), Latin America (Brazil, Mexico, Argentina and rest of Latin America), Asia-Pacific (Japan, China, India, South Korea and rest of Asia-Pacific), and the Middle East and Africa (Saudi Arabia, UAE, Africa and rest of the Middle East)), type of drug molecule (small molecule and biologics), therapeutic area (blood disorders, infectious diseases, metabolic disorders, oncological disorders and others), syringe barrel material (glass and plastic) and number of barrel chambers (single chamber and dual chamber). A detailed demand and supply assessment of geographies, based on a number of parameters, such as the number of prefilled syringe combination product developers, number of prefilled syringe manufacturers, number of prefilled syringe fill / finish service providers, number of prefilled syringe fill / finish facilities, capacity and demand of prefilled syringes in that particular geographical region. An analysis presenting potential strategic partners (primarily drug developers) for prefilled syringe fill / finish service providers, based on different parameters, such as pipeline strength, number of target therapeutic indication(s), type of drug molecule, year of establishment, company size and location of the headquarters of the company. A discussion on the potential growth areas, such as growing injectable drugs pipeline, increasing fill / finish outsourcing operations, rising preference of self-medication, increasing popularity of prefilled syringes and technological advancements in aseptic fill / finish processes. A review of the landscape of prefilled syringe manufacturers, featuring a list of key prefilled syringes and their manufacturers, analyzed based on a number of relevant parameters, such as syringe barrel material (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) barrel volume, year of establishment, company size and location of the headquarters of manufacturers. 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 pharmaceutical and 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 time period 2020-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] scale of operation (preclinical, clinical and commercial), [B] key geographical regions (North America (the US), Europe (the UK, France, Italy, Spain, Germany and rest of Europe) and Asia-Pacific (Japan, China, India, South Korea and rest of Asia-Pacific), [C] type of drug molecule (small molecules and biologics), [D] key therapeutic areas (blood disorders, infectious diseases, metabolic disorders, oncology disorders, neurological disorders, autoimmune disorders and others), [E] syringe barrel material (glass and plastic) and [F] number of barrel chambers (single chamber and dual chamber). To account for the uncertainties associated with the fill / finish of prefilled syringes 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: Kirti Maheshwari, Chief Technical Officer, Intas Pharmaceuticals Gregor Kawaletz, Chief Commercial Officer, IDT Biologika Jesse Fourt, Design Director, IDEO Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene Anonymous, Associate Director, Head of Process Sciences Formulation and Fill / Finish, a large CMO 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.
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February 2020
Over the past few years, peptides (including oligopeptides, polypeptides and synthetic peptides) and macrocycle-based pharmacological interventions have gained a lot of attention from clinical researchers; drug development efforts focused on such molecules have significantly increased. This can be attributed to the benefits offered by the aforementioned drug classes, which include high target specificity, low toxicity and favorable safety profiles. , In fact, more than 60 peptide-based therapies and macrocycle drug molecules have been approved till date, across the globe. In addition, more than 400 peptide based drugs are currently being evaluated in clinical trials, while over 500 molecules are still in the early stages of development. It has been reported that the overall process of drug development, from discovery of a molecule to its commercial launch, takes around 10-15 years and involves capital investments worth USD 4-10 billion. However, only a small proportion of the molecules, which are selected for further investigation during the initial stages of research, actually enter the market. Given the complexities associated with the drug discovery process, the overall research and development (R&D) expenditure in the pharmaceutical / biotechnology sector has steadily increased over time. Specifically, the discovery of peptides and macrocycles for therapeutic use is a long, arduous and cost intensive process. As a result, many developers are opting to outsource such operations to contract research organizations (CROs) that claim to specialize in this regard. In addition, there are multiple technology platform providers, which offer licenses to proprietary peptide discovery platforms that can be used by interested drug developers / manufacturers. We believe that, as the demand for peptide-based therapeutics increases, the opportunity for contract service provides and technology developers engaged in this domain is also likely to grow in the foreseen future. Scope of the Report The “Peptides and Macrocycle Drug Discovery: Services and Platforms Market, 2020-2030” report features an extensive study on the current market landscape and future of companies offering services for peptides and macrocycle drug discovery operations. The study includes in-depth analyses, highlighting the capabilities of various service / technology providers engaged in this market. Amongst other elements, the report includes: A detailed assessment of the current market landscape of companies offering peptide and macrocycle drug discovery services, including developer information (year of establishment, company size and location of headquarters), type of peptide manufactured (linear, cyclic, helical and others), drug discovery steps covered in service portfolio (target validation, hit identification, lead generation and lead optimization), peptide generation methods used (liquid phase synthesis, solid phase synthesis, microwave-assisted synthesis, recombinant methods and others), peptide modification services (C-terminal, N-terminal, fret / quenching tags, immunogenic conjugates, linkers / spacers, unnatural AAS, cyclization, stable isotope labels and post-translational modification services) and other services offered (peptide isolation / purification service, peptide detection / identification service and peptide quantification service). An insightful geographical benchmarking of the capabilities of companies of various sizes, highlighting the key focus areas, comparing their existing strengths both within and beyond their respective peer groups (based on geography and company size). An in-depth analysis of peptide platform and library service providers, featuring information on their company details (year of establishment, company size and location of headquarters), purpose of the platform, type of peptide manufactured (linear, cyclic, helical and others) and platform access model (pipeline licensing, technology licensing, strategic alliance and library provider). Profiles of peptides and macrocycle drug discovery service providers, featuring information on the year of establishment, location of headquarters, peptide discovery service / platform portfolio, recent developments and an informed future outlook. An analysis of the partnerships that have been established in the recent past, covering R&D agreements, licensing agreements, acquisitions and other form of collaborations. One of the key objectives of the report was to estimate the existing market size and the future growth potential within the peptides and macrocycle drug discovery services market. Based on multiple parameters, such as R&D spend, we have developed an informed estimate 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] different type of product (synthetic peptides, biological and recombinant peptides and macrocycles), [B] drug discovery steps (target identification and validation, hit identification, lead generation and lead optimization), [C] therapeutic area (oncological disorders, metabolic disorders, cardiovascular disorders, infectious disorders, urological disorders, endocrine disorders, CNS disorders, and other diseases), [D] company size (small, mid-sized and large and very large companies) and [E] geography (North America, Europe, Asia Pacific). To account for the uncertainties associated with the drug discovery services 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 influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interview(s) held with the following industry stakeholders: Mark L Peterson (Chief Operating Officer, Cyclenium Pharma) Anonymous 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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October 2019
Over the last 12 months, the pharmaceutical industry reported a year-on-year increment of nearly 75% in funding to support the development of various cell and gene therapies. In fact, close to USD 5 billion has been invested into research on gene-based therapies in the previous two decades. Interestingly, over 2,600 clinical studies have been initiated in this field of research, since 1989. The aforementioned numbers are indicative of the rapid pace of development in this upcoming segment of the biopharmaceutical industry. The development of such therapy products require gene delivery vehicles, called vectors, to desired locations within the body (in vivo) / specific cells (ex vivo). The growing demand for such therapies and the rising number of clinical research initiatives in this domain has led to an increase in demand for preclinical and clinical grade gene delivery vectors. Fundamentally, genetic modifications can be carried out using either viral (such as adenovirus, adeno associated virus (AAV), lentivirus, retrovirus, Sendai virus, herpes simplex virus, vaccinia virus, baculovirus and alphavirus) or non-viral (such as plasmid DNA) vectors. Moreover, recent advances in vector research have led to the development of several innovative viral / non-viral gene delivery approaches. At present, 10+ genetically modified therapies have received approval / conditional approval in various regions of the world; these include (in the reverse chronological order of year of approval) Zynteglo™ (2019), Zolgensma® (2019), Collategene® (2019), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017), INVOSSA™ (2017), Zalmoxis® (2016), Strimvelis™ (2016), Imlygic® (2015), Neovasculagen® (2011), Rexin-G® (2007), Oncorine® (2005) and Gendicine® (2003). In addition, over 500 therapy candidates are being investigated across different stages of development. The growing number of gene-based therapies, coupled to their rapid progression through the drug development process, has created significant opportunities for companies with expertise in vector manufacturing. Presently, a number of industry (including both well-established companies and smaller R&D-focused initiatives), and non-industry players (academic institutes) claim to be capable of manufacturing different types of viral and non-viral vectors. In addition, there are several players offering novel technology solutions, which are capable of improving existing genetically modified therapy products and upgrading their affiliated manufacturing processes. Considering prevalent and anticipated future trends, we believe that the vector and gene therapy manufacturing market is poised to grow steadily, driven by a robust pipeline of therapy candidates and technical advances aimed at mitigating existing challenges related to gene delivery vector and advanced therapy medicinal products. Scope of the Rpeort The “Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market (3rd Edition), 2019-2030 (Focus on AAV, Adenoviral, Lentiviral, Retroviral, Plasmid DNA and Other Vectors)” report features an extensive study of the rapidly growing market of viral and non-viral vector and gene therapy manufacturing, focusing on contract manufacturers, as well as companies with in-house manufacturing facilities. The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: An overview of the current status of the market with respect to the players involved (both industry and non-indutry) in manufacturing viral vectors, non-viral vectors and other novel types of vectors. It features information on the year of establishment, scale of production, type of vectors manufactured, location of manufacturing facilities, applications of vectors (in gene therapy, cell therapy, vaccines and others), and purpose of production (fulfilling in-house requirements / for contract services). An informed estimate of the annual demand for viral and non-viral vectors, taking into account the marketed gene-based therapies and clinical studies evaluating vector-based therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength. An estimate of the overall, installed vector manufacturing capacity of industry players based on information available in the public domain, and insights generated via both secondary and primary research. The analysis also highlights the distribution of the global capacity by vector type (viral vector and plasmid DNA), scale of operation (clinical and commercial), size of the company / organization (small-sized, mid-sized and large) and key geographical regions (North America, Europe, Asia Pacific and the rest of the world). An in-depth analysis of viral vector and plasmid DNA manufacturers, featuring three schematic representations; namely [A] a three dimensional grid analysis, representing the distribution of vector manufacturers (on the basis of type of vector) across various scales of operation and purpose of production (in-house operations and contract manufacturing services), [B] a logo landscape of viral vector and plasmid DNA manufacturers based on the type (industry and non-industry) and the size of the industry player (small-sized, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical locations of vector manufacturing hubs. An analysis of recent collaborations and partnership agreements inked in this domain since 2015; it includes details of deals that were / are focused on the manufacturing of vectors, whihc were analyzed on the basis of year of agreement, type of agreement, type of vector involved, and scale of operation (laboratory, clinical and commercial). An analysis of the various factors that are likely to influence the pricing of vectors, featuring different models / approaches that may be adopted by product developers / manufacturers in order to decide the prices of proprietary vectors. An overview of other viral / non-viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification. Elaborate profiles of key players based in North America, Europe and Asia-Pacific (shortlisted based on scale of operation). Each profile features an overview of the company / organization, its financial performance (if available), information on its manufacturing facilities, vector manufacturing technology and an informed future outlook. A discussion on the factors driving the market and the various challenges associated with the vector production process. One of the key objectives of this report was to evaluate the current market size and the future opportunity associated with the vector manufacturing market, over the coming decade. Based on various parameters, such as the likely increase in number of clinical studies, anticipated growth in target patient population, existing price variations across different vector types, and the anticipated success of gene therapy products (considering both approved and late-stage clinical candidates), 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 order to provide a detailed future outlook, our projections have been segmented on the basis of [A] type of vectors (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), [B] applications (gene therapy, cell therapy and vaccines), [C] therapeutic area (oncological disorders, inflammation & immunological diseases, neurological disorders, ophthalmic disorders, muscle disorders, metabolic disorders, cardiovascular disorders and others), [D] scale of operation (preclinical, clinical and commercial) and [E] geography (North America, Europe, Asia Pacific and rest of the world). 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. For the purpose of the study, we invited over 160 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions held with several key players in this domain. The report features detailed transcripts of interviews held with the stakeholders: Menzo Havenga (Chief Executive Officer and President, Batavia Biosciences) Nicole Faust (Chief Executive Officer & Chief Scientific Officer, CEVEC Pharmaceuticals) Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) Olivier Boisteau, (Co-Founder / President, Clean Cells), Laurent Ciavatti (Business Development Manager, Clean Cells) and Xavier Leclerc (Head of Gene Therapy, Clean Cells) Joost van den Berg (Director, Amsterdam BioTherapeutics Unit) Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital) Colin Lee Novick (Managing Director, CJ Partners) Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) Semyon Rubinchik (Scientific Director, ACGT) Eduard Ayuso, DVM, PhD (Scientific Director, Translational Vector Core, University of Nantes) Alain Lamproye (President of Biopharma Business Unit, Novasep) Astrid Brammer (Senior Manager Business Development, Richter-Helm) Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing) Marco Schmeer (Project Manager, Plasmid Factory) and Tatjana Buchholz (Marketing Manager, Plasmid Factory) Nicolas Grandchamp (R&D Leader, GEG Tech) Beatrice Araud (ATMP Key Account Manager, EFS-West Biotherapy) 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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October 2019
The concept of RNA interference (RNAi) was identified in the 1980s. It is based on the selective silencing of specific sequences of mRNA, thereby, inhibiting the ability to translate into disease causing proteins. This phenomenon was first demonstrated in the petunia flower and later studied in C. elegans. Interestingly, the discovery was awarded the Nobel Prize in 2006. Even though the technique was discovered less than two decades ago, RNAi has had a significant impact within the pharmaceutical domain, and currently there is a robust pipeline of drug candidates based on this principle. The approval of the first RNAi therapeutic, ONPATTRO® (developed by Alnylam Pharmaceuticals), in August 2018 by the USFDA and the EMA, has led to a rise in the interest in this field. , In fact, the growing popularity of this upcoming class of targeted therapeutics can also be validated by the substantial increase (more than 85%) in the number of patents that have been filed / granted between the period 2014-2019. It is worth noting that a variety of RNAi therapeutics, targeting a wide range of therapeutic areas, have already been discovered / developed. However, certain challenges exist; these include concerns related to renal and reticuloendothelial clearance, low extravasation and tissue perfusion and cellular update of nucleic acid-based payloads. Presently, various technology developers are actively engaged in the development of novel technologies and improvement of existing platforms, thereby, attempting to enhance and optimize both RNAi payloads and affiliated excipients. Experts believe that some of the more complex and technical challenges in this domain may need the combined efforts of both synthetic chemists and biologists. In this context, it is important to highlight that substantial collaboration activity, related to RNAi, has been reported in the recent past. Several big pharma players have also demonstrated renewed interest in this field of research. Moreover, during the same time period, more than USD 5.5 billion in capital has been invested by various private and public investors to fund research activities in this domain. Given the pace of innovation and developments in this upcoming market, we can expect RNAi therapeutics to become a major therapeutic modality in the foreseen future. Scope of the Report The “RNAi Therapeutics Market (2nd Edition), 2019-2030: Focus On siRNA, miRNA, shRNA and DNA” report features an extensive study of the current market landscape and future opportunities associated with RNAi therapeutics. The study also features a detailed analysis of key drivers and trends within this evolving market. Amongst other elements, the report includes: A detailed review of the overall landscape of companies developing RNAi therapeutics, including information on phase of development (marketed, clinical, and preclinical / discovery stage) of pipeline candidates, target disease indication(s), key therapeutic areas (oncological disorders, infectious diseases, genetic disorders, ophthalmic diseases, respiratory disorders, hepatic disorders, metabolic disorders, cardiovascular disorders, dermatological disorders, and others), type of RNAi molecule (siRNA, miRNA, shRNA, sshRNA and DNA), target genes, type of delivery system used, route of administration and special drug designations (if any). A competitiveness analysis of key players engaged in this domain, evaluating their respective product portfolios, type of RNAi molecule, target therapeutic areas, company size and year of establishment. An analysis of completed, ongoing and planned clinical studies for different types of RNAi molecules. The trials were analyzed on the basis of various relevant parameters, such as registration year, current status, phase of development, type of RNAi molecule, regional distribution of clinical trials and enrolled patient population. An in-depth analysis of the various patents that have been filed / granted related to RNAi therapeutics, since 2014. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, regional applicability, CPC symbols, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation. An analysis of the various partnerships pertaining to RNAi therapeutics, which have been established till August 2019, based on various parameters, such as the type of partnership, year of partnership, target disease indications, therapeutic area, type of RNAi molecule, financial details (wherever applicable), focus area of collaboration and most active players. An analysis of the investments made at various stages of development in companies engaged in this domain, between 2014-2019, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. An analysis of the key promotional strategies that have been adopted by developers of marketed oligonucleotide therapeutics, namely Defitelio®, Exondys® and Onpattro®. A review of emerging technology platforms and delivery systems that are being used for targeted therapeutic delivery, featuring detailed profiles of technologies. Detailed profiles of drug candidates that are in the advanced stages of development (phase II/III and above), including information on their current development status, mechanism of action, route of administration, affiliated delivery technology, dosage, recent clinical trial results along with information on their respective developers. An elaborate discussion on the use of miRNA as a potential biomarker, along with a list of diagnostic kits that are either available in the market, or likely to be approved in the foreseen future. One of the key objectives of the report was to estimate the existing market size and the future growth potential within the RNAi therapeutics market, over the coming decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the financial evolution of the market for the period 2019-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (oncological disorders, genetic disorders, metabolic disorders, hematological disorders, ophthalmic disorders and others), [B] route of administration (subcutaneous, intravenous, topical and intradermal), [C] share of leading industry players, [D] type of RNAi molecule and [E] key geographical regions (US, Europe and Asia-Pacific). 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. The report features detailed transcripts of interview(s) held with Amotz Shemi, CEO, Silenseed. 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
Since the approval of the first therapy, Genedicine® in 2003, the gene therapy domain has evolved significantly. Specifically, in 2019, three gene therapies, namely Zolgensma® (US), Zynteglo™ (Europe) and Beperminogene Perplasmid (Japan), have received approval / conditional approval, leading to a marked upward surge in the interest in this field. In fact, the growing popularity can be correlated to the substantial increase (more than 90%) in the number of patents that have been filed / granted in the last three years. Moreover, in the same time period, more than USD 12.5 billion in capital has been invested by various private and public investors to fund research activities. Presently, there are more than 10 approved gene therapies in the market, while many others are being investigated across various phases of clinical research. Over time, the efforts of industry stakeholders and clinical researchers have led to the discovery of novel molecular targets, thereby, strengthening the research pipelines of companies involved in the development of gene therapies. Further, several technology developers have designed innovative ways to improve the efficacy and safety of gene therapies and introduced advanced therapy development and vector engineering platforms. It is also worth mentioning that, in the last 4-5 years, there has been a marked rise in the M&A activity in this domain, including the involvement of several big pharma players as well. The capability of such therapies to target diverse disease indications is considered to be amongst the most prominent growth drivers of this market. Backed by promising clinical results and several therapy candidates in late phases of development, we believe that the overall market is expected to witness tremendous growth in the coming decade. Scope of the Report The “Gene Therapy Market (3rd Edition), 2019-2030” report features an extensive study of the current market landscape of gene therapies, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies and genome editing therapies. The study also features an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report features: A detailed review of the overall landscape of gene therapies and genome editing therapies, including information on various drug / therapy developer companies, phase of development (marketed, clinical, and preclinical / discovery stage) of pipeline candidates, key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others) and target disease indication(s), information on gene type, type of vector used, type of therapy (ex vivo and in vivo), mechanism of action, type of gene modification (gene augmentation, oncolytic viral therapy and others) and special drug designation (if any). A discussion on the various types of viral and non-viral vectors, along with information on design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. A world map representation, depicting the most active geographies, in terms of the presence of companies engaged in developing gene therapies, and a bull’s eye analysis, highlighting the distribution of clinical-stage pipeline candidates by phase of development, type of vector and type of therapy (ex vivo and in vivo). A discussion on the regulatory landscape related to gene therapies across various geographies, namely North America (the US and Canada), Europe and Asia-Pacific (Australia, China, Japan and South Korea), providing details related to the various challenges associated with obtaining reimbursements for gene therapies. Detailed profiles of marketed and phase II/III and gene therapies, including a brief history of development, information on current development status, mechanism of action, affiliated technology, strength of patent portfolio, dosage and manufacturing details, along with information on the developer company. An elaborate discussion on the various commercialization strategies that can be adopted by drug developers for use across different stages of therapy development, namely prior to drug launch, at / during drug launch and post-marketing. A review of various emerging technologies and therapy development platforms that are being used to design and manufacture gene therapies, featuring detailed profiles of technologies that were / are being used for the development of four or more products / product candidates. An in-depth analysis of the various patents that have been filed / granted related to gene therapies and genome editing therapies, since 2016. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, regional applicability, CPC classification, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation. A analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis also provides information on the key value drivers and deal multiples related to the mergers and acquisitions that we came across. An analysis of the investments made at various stages of development in companies that are focused in this area, between 2014-2019, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. An analysis of the big biopharma players engaged in this domain, featuring a heat map based on parameters, such as number of gene therapies under development, funding information, partnership activity and strength of patent portfolio. A case study on the prevalent and emerging trends related to vector manufacturing, with information on companies offering contract services for manufacturing vectors. The study also includes a detailed discussion on the manufacturing processes associated with various types of vectors. A discussion on the various operating models adopted by gene therapy developers for supply chain management, highlighting the stakeholders involved, factors affecting the supply of therapeutic products and challenges encountered by developers across the different stages of the gene therapy supply chain. An analysis of the various factors that are likely to influence the pricing of gene-based therapies, featuring different models / approaches that may be adopted by manufacturers to decide the prices of these therapies. One of the key objectives of the report was to estimate the existing market size and the future opportunity for gene therapies, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, 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] key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others), [B] various types of vectors used for therapy development (adeno associated virus, adenovirus, lentivirus, plasmid DNA, retrovirus and others), [C] type of therapy (ex vivo and in vivo), [D] type of gene modification (gene augmentation, oncolytic viral therapy and others) and [E] key geographical regions (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. 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): Adam Rogers (CEO, Hemera Biosciences) Al Hawkins (CEO, Milo Biotechnology) Buel Dan Rodgers (Founder & CEO, AAVogen) Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) Christopher Reinhard (CEO and Chairman, Cardium Therapeutics) Jeffrey Hung (CCO, Vigene Biosciences) Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) Michael Triplett (CEO, Myonexus Therapeutics) Robert Jan Lamers (CEO, Arthrogen) Ryo Kubota (Chairman, President and Chief Executive Officer, Acucela) Tom Wilton (Chief Business Officer, LogicBio Therapeutics) 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 moreFebruary 2020
With multi-billion funding initiatives publicly disclosed by various government agencies, and private investors, various leading pharma companies are developing novel drug candidates for the treatment of patients infected with COVID-19 Roots Analysis has announced the addition of “Novel Coronavirus (COVID-19) – Therapeutics and Diagnostics in Development” report to its list of offerings. New coronavirus (COVID-19) is a previously unidentified strain of coronavirus, that first emerged in the Chinese city of Wuhan in December 2019. The virus belongs to the same family as the virus that causes severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). On 30th January 2020, the World Health Organization (WHO) declared the coronavirus outbreak as a global health emergency. In fact, the virus is estimated to have infected more than 45,000 individuals, around the globe (estimates till the second week of February 2020). To order this report, please visit this link Key Market Insights More than 30 drug developers presently claim to be developing drugs for the treatment of COVID-19 infections The market landscape is fragmented, featuring a mix of companies of all sizes; however, large and very-sized companies represent 60% of the overall number of industry stakeholders. It is worth highlighting that more than 30% of the developers involved in the development of therapeutic agents are academic institutes. Besides DNA and RNA vaccines, companies are focused on monoclonal antibodies, as well as small molecule inhibitors Majority of the companies are evaluating biologic drug candidates, while some of the players are working on repurposing previous approved small molecule drug candidates for the treatment of patients infected with COVID-19. Close to 25 clinical trials already registered enrolling over 2000 patients till date More than 80% of the patients enrolled in the clinical trials are based in China. Some of the top clinical trial sponsors include (illustrative list) Huazhong University of Science and Technology, French National Institute of Health and Medical Research, Beijing 302 Hospital, Shanghai Public Health Clinical Center, Peking Union Medical College Hospital, Capital Medical University, and Chinese Academy of Medical Sciences. Over 40 diagnostic tests under development for timely detection of the infection More than 50% of the diagnostic tests are being developed by the companies based in Asia Pacific, with over 85% of these based in China and South Korea. Of the disclosed diagnostic tests, close to 60% are based on RT-PCR. Evaluation of historical grant data has revealed over 140 KOLs related to coronavirus Since 1995, over 2000 NIH funded grants have been awarded for research related to coronavirus with cumulative grant amount totaling over USD 2 billion, provided through various funding mechanisms. To request a sample copy / brochure of this report, please visit this link Key Questions Answered Which are the leading drug candidates being developed against COVID-19 infections? What are the key diagnostic platforms (available / under development) for detection of COVID-19 infections? Who are the leading (industry and non-industry) players involved in the development of these products? Where are the clinical trials for therapeutic agents against COVID-19 being carried out? What is the trend in capital investments in COVID-19 related R&D? What is the social media trend related to COVID-19 and who are the key opinion leaders on these platforms? Which academic institutes have received grants for research on coronavirus and who are the key researchers in this space? For additional details, please visit https://www.rootsanalysis.com/reports/view_document/coronavirus-treatment-landscape/302.html or email sales@rootsanalysis.com Contact: Gaurav Chaudhary +1 (415) 800 3415 Gaurav.Chaudhary@rootsanalysis.com
...read moreFebruary 2020
The genome sequencing domain has witnessed a surge in the availability of service providers, With gene sequencing costs having come down by several orders of magnitude, a number of players have expended significant resources in building elaborate service portfolios to cater to the needs within the biotech and life sciences industries. Roots Analysis has announced the addition of “Next Generation Sequencing (NGS) Market, 2020-2030” report to its list of offerings. At present, industry stakeholders are actively collaborating in order to integrate their respective resources for mining large and complex datasets to generate clinically relevant, actionable insights. Ongoing innovation in this domain, coupled to the increasing demand for genome data, is expected to bring a paradigm shift in the fields of drug discovery, biomarker research and companion diagnostics, and personalized medicine. To order this 270+ page report, which features 120+ figures and 150+ tables, please visit this link Key Market Insights Over 120 industry and non-industry players claim to offer next generation sequencing services Companies engaged in this domain are known to primarily use second and third generation technologies for whole genome, whole exome and targeted sequencing. Over 2,600 registered clinical trials (till September 2019) involved the use of gene sequence data Close to 80% of these trials were sponsored by non-industry players, which were focused on the development of both drug products and diagnostic solutions. 5,200+ patents related to genome sequencing have been filed in the last four years alone Close to 55% of the patents were filed in North America, with applications primarily focused on biomarker discovery, for use across a variety of cancer indications. The primary focus of majority of the patents is on cancer treatment and biomarker discovery. Big pharma players engaged in this domain have undertaken close to 100 such initiatives Of these, 76% were reported to be collaborations with companies engaged in the genomics space. Examples of such big pharma players include (in alphabetical order) AbbVie, Amgen, AstraZeneca, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche and Sanofi. Close to 50 population genomics initiatives were established over the last ten years These government sponsored efforts indicate the beginning of a new era in modern medicine. Of these, 77% are being carried out on a national level, while 23% are being conducted on an international level. North America currently holds the majority share within the next generation sequencing market However, the market in the Asia-Pacific is projected grow at a relative higher CAGR of ~20%. In terms of area of application, next generation sequencing technologies intended for drug development and precision medicine currently represents the highest share (56%); this trend is unlikely to change in the foreseen future. To request a sample copy / brochure of this report, please visit this link Key Questions Answered Who are the leading industry and non-industry service and technology providers in the genome sequencing market? What are the key sequencing platforms available in the market? What kind of research-based initiatives are characteristic of this domain? What is the role of big pharma players and eminent government bodies in this field? How is the current and future market opportunity likely to be distributed across key market segments? The USD 19 billion (by 2030) financial opportunity within the next generation sequencing market has been analyzed across the following segments: Type of Offering Products Services Type of sequencing technology used Sequencing by synthesis (SBS) Ion semiconductor sequencing Single Molecule, Real-Time (SMRT) sequencing Nanopore sequencing Others Key application areas Diagnostics Drug discovery and personalized medicine Reproductive health End-users Academic and research institutes Hospitals and clinics Pharmaceutical companies Others The report features inputs from eminent industry stakeholders, according to whom next generation technologies have already revolutionized the way genomes are sequenced, and demonstrated significant cost saving potential. It includes detailed transcripts of discussions held with senior industry stakeholders. The research covers detailed profiles of genome sequencing service providers and technology providers, featuring an overview of the company, its financial information (if available), and a description of service(s) / technology(s) offered. 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. Admera Health Applied Biological Materials BGI Group CD Genomics DNA Link Eurofins Genomics (Eurofins Scientific) Fulgent Genetics Gene By Gene GENEWIZ MedGenome Novogene Omega Biosciences Psomagen Veritas Genetics Xcerlis Labs Oxford Nanopore Technologies Thermo Fisher Scientific For additional details, please visit https://www.rootsanalysis.com/reports/view_document/next-generation-sequencing/290.html or email sales@rootsanalysis.com You may also be interested in the following titles: Companion Diagnostics Development Services Market, 2020-2030 Genome Editing Services Market-Focus on CRISPR, 2019-2030 Gene Therapy Market (3rd Edition), 2019 - 2030 Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com
...read moreFebruary 2020
With over 100 therapeutic monoclonal antibodies and antibody-based products in the market, the demand for developing and manufacturing of such products is anticipated to increase beyond the capabilities of innovator companies alone Roots Analysis has announced the addition of the “Antibody Contract Manufacturing Market, 2020-2030” report to its list of offerings. Although biopharmaceuticals offer significant profit margins and have been proven to be effective in treating a myriad of diseases, they are generally associated with high costs of development and complex manufacturing protocols; this is true for antibody-based products as well. Presently, there are a number of companies that claim to offer end-to-end solutions, ranging from antibody development to commercial production. 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. To order this 300+ page report, which features 105+ figures and 115+ tables, please visit this link Key Market Insights Over 100 CMOs presently claim to offer manufacturing services for antibodies The antibody contract manufacturing market is currently dominated by the presence of small and mid-sized companies, which represent 70% of the industry stakeholders. It is also worth highlighting that 55% of CMOs claim to have the capabilities to manufacture antibodies across all scales of operation (preclinical, clinical and commercial). More than 90% service providers are focused on the production of monoclonal antibodies However, players based in Asia are now increasingly focusing on the development of bispecific antibodies for therapeutic use. It worth highlighting that close to 20% of the CMOs engaged in this domain claim to offer manufacturing services for both bispecific antibodies and antibody fragments. Europe has emerged as a key manufacturing hub for antibody-based products Globally, 120+ manufacturing facilities have been established by various players. 40% of the total installed capacity is in Europe, followed by Asia. Some of the prominent regions in Asia include (in decreasing order of number of manufacturing facilities) China, South Korea, India, Japan and Taiwan. 90+ partnership agreements have been inked between 2013 and 2019 Majority of these agreements were focused on manufacturing of various types of antibodies. Other popular types of collaboration models include process development and manufacturing agreements (22%), product development and manufacturing agreements (10%) and licensing agreements (7%). Multiple expansion initiatives were undertaken by CMOs between 2017 and 2019 More than 50% of such initiatives were reported to be focused on the expansion of manufacturing facilities, followed by building new facilities (38%). It is worth noting that close to 50% of the total number of expansion initiatives were undertaken in Europe, of which, 25% were in the UK. Demand for therapeutic antibodies is anticipated to grow at a CAGR of 10%, during 2020-2025 Given the fact that there are a number of antibody-based products in the market, the commercial demand for antibodies is significantly higher than the clinical demand. Across the three major global regions, North America represents over half of the overall global manufacturing demand for antibodies. North America and Europe are anticipated to capture over 70% of the market share by 2030 However, the market in the Asia is anticipated to grow at a relatively faster rate. Further, presently, more than 90% of the antibodies are being developed using mammalian expression systems, and this trend is unlikely to change significantly in short to mid-term. To request a sample copy / brochure of this report, please visit this link Key Questions Answered Who are the leading CMOs engaged in the production of antibody-based therapeutics? What kind of partnership models are commonly adopted by stakeholders in this industry? What is the annual clinical and commercial demand for antibody-based products? What is the current installed capacity for manufacturing of antibodies? What are the various expansion initiatives undertaken by antibody CMOs? How is the current and future market opportunity likely to be distributed across key market segments? The USD 13.8 billion (by 2030) financial opportunity within the antibody contract manufacturing market has been analyzed across the following segments: Type of Antibodies Monoclonal Antibodies Bispecific Antibodies Others Company Size Small Mid-sized Large / Very Large Scale of Operation Clinical Commercial Type of expression system used Mammalian Microbial and others Key geographical regions North America Europe Asia The report features inputs from eminent industry stakeholders, according to whom antibody therapeutics developers are increasingly outsourcing their manufacturing operations owing to complex nature of the overall process, as well as the high investments associated with setting-up in-house expertise. The report includes detailed transcripts of discussions held with the following experts: Dietmar Katinger (Chief Executive Officer, Polymun Scientific) David C Cunningham (Director, Corporate Development, Goodwin Biotechnology) Claire Otjes (Marketing Manager, Batavia Biosciences) The research covers profiles of key players that offer manufacturing services for antibodies, featuring a company overview, information on their respective service portfolios, manufacturing facilities and capabilities, and an informed future outlook. AGC Biologics Aldevron AMRI Boehringer Ingelheim BioXcellence Emergent BioSolutions Eurofins CDMO FUJIFILM Diosynth Biotechnologies KBI Biopharma Lonza Nitto Avecia Pharma Services Novasep Pierre Fabre Samsung BioLogics Synthon Thermo Fisher Scientific For additional details, please visit https://www.rootsanalysis.com/reports/view_document/antibody-cmo-market/295.html or email sales@rootsanalysis.com You may also be interested in the following titles: Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030 Antibody Drug Conjugates (ADCs) - Linker and Conjugation Technologies Market, 2019-2030 Antibody Drug Conjugates Market (5th Edition), 2019-2030 Biopharma Contract Manufacturing Market (3rd Edition), 2019 - 2030 ADC Contract Manufacturing Market (3rd Edition), 2018-2030 Contact: Gaurav Chaudhary +1 (415) 800 3415 +44 (122) 391 1091 Gaurav.Chaudhary@rootsanalysis.com
...read more
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