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  • Medical Device Contract Manufacturing Market, 2019-2030

    Medical Device Contract Manufacturing Market, 2019-2030

    May 2019

    Recent advances in data science technology solutions, such as Internet of Things, machine learning, artificial intelligence and real world evidence-based solutions, have enabled medical device developers to digitize and automate a number of product development and manufacturing processes. In 2020, the global medical devices market is estimated to reach a net worth of approximately USD 430 billion.  However, most developers lack adequate resources and the necessary expertise to manufacture medical devices and related components. Moreover, given the rapid rate of evolution, the costs associated with acquiring the necessary infrastructure and capabilities in this field are high; therefore, it is difficult for companies with limited finances to acquire such resources and carry out such operations by themselves. In addition, the evolving regulatory guidelines and complicated pathways to establishing reimbursement strategies render medical devices subject to rigorous quality assessments, especially for medium and high risk devices. The aforementioned constraints have led many of the smaller players and certain established players to outsource a significant part of their manufacturing operations to capable contract manufacturing organizations (CMOs). CMOs are known to offer significant cost-benefits, access to sophisticated / up-to-date infrastructure, large production capacities and reduction in time-to-market. Given the demand for medical devices, the opportunity for CMOs with expertise in medical devices is steadily rising. In fact, in 2018 alone, the USFDA approved over 100 medical devices. It is worth highlighting that, since 2000, more than 65 CMOs have been established. The demand for one-stop-shops and versatile supply chain management solutions have fuelled consolidation activity in this domain. Contemporary contract service providers have been focusing on bolstering in-house capabilities to offer a wider range of services to their clients, covering product design to distribution and marketing, along with regulatory assistance. The medical device sector is among the most highly regulated industries, and we expect the demand for core competencies, such as design and engineering, prototype development and high volume manufacturing, to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations to capable contract service providers. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor; CMOs that invest in such upgrades are likely to gain a competitive edge.   Scope of the Report The “Medical Device CMOs Market, 2019-2030” report features a comprehensive study on the current landscape of contract manufacturing service providers focused on medical devices (specifically for drug-delivery devices, diagnostic devices and therapeutic devices). The scope of the report primarily includes those manufacturers that offer finished product services for medical devices (excluding medical equipment, such as X-ray machines, ultrasound machines, operating tables and other similar products).  The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes: A detailed review of the overall landscape of the medical device contract manufacturing market, featuring a list of CMOs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, manufacturing facilities, geographical location, type of device manufactured (drug-delivery devices, diagnostic devices, therapeutic devices and others), scale of operation (precommercial and commercial) and types of services offered ([A] production services (such as design services, prototyping, component manufacturing, packaging, and sterilization), [B] post-production services (such as supply chain management services, labeling services, logistics, and shipping services) and [C] other services (such as regulatory services, project management services and documentation services). An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe. A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. An analysis of the medical device supply-chain, highlighting the role of CMOs engaged in this domain and analysis based on services offered, such as supply chain management services, logistics services, shipping services and warehousing services, to medical device companies.  Elaborate profiles of popular players that specialize in providing services for both precommercial and commercial scale manufacturing of medical devices. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, as well as an informed future outlook. A geographical clinical trial analysis of ongoing and planned studies related to medical devices, featuring details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, phase of development, type of sponsor, therapeutic area(s) and target disease indication(s), and number of patients enrolled. A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples. In addition, the analysis features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain. An elaborate discussion on the future opportunities / trends related to the medical device contract manufacturing market that are likely to influence the growth within this domain over the coming years. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CMO industry. One of the key objectives of this report was to evaluate the current opportunity and the future market potential of the medical device CMOs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] type of devices (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world) and [E] leading players. To account for the uncertainties associated with the growth of the medical device CMO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. 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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  • Neoantigen Targeted Therapies Market, 2019-2030

    Neoantigen Targeted Therapies Market, 2019-2030

    May 2019

    Cancer is known to be one of the leading causes of death worldwide, accounting for 0.6 million deaths in 2018, in the US alone.  The World Health Organization has estimated the number of new cancer cases, reported across the globe, to rise by 70% over the next 20 years.  Conventional treatment options, such as chemotherapy, surgery and radiation therapy, continue to demonstrate limited efficacy in late-stage cancers. Moreover, the non-specific and highly toxic nature of chemotherapy and radiation therapy, have severe detrimental effects on patients’ quality of life. Amongst the targeted anti-cancer therapies, immunotherapy has emerged as a potent option, capable of eliminating tumor cells with minimal side effects. For instance, the introduction of the immune check point inhibitors (such as PD-1/PD-L1 and CTLA-4 inhibitors) enabled healthcare providers to offer long term clinical benefit to patients suffering from metastatic tumors. However, these therapies have been reported to generate variable / inconsistent immune responses across different patients and, as a result, only a fraction of patients have actually ended up benefiting from such treatments. In fact, it is estimated that close to 70% of treated patients do not respond to single-agent immune checkpoint therapy.  Recent developments in genomic analysis and advances in bioinformatics have enabled the adoption of more personalized treatment approaches, such as neoantigen targeted therapies. Cancer neoantigens is a term used to refer to a subset of antigens encoded by tumor-specific, mutated genes, which have not previously been recognized by host’s immune system. These are considered to be potential biological targets that can be used to augment the therapeutic value of a number of cancer immunotherapies, including immune checkpoint inhibitors and cancer vaccines, having demonstrated the capability to elicit strong T-cell mediated immune response. Currently, several neoantigen-based therapies are being investigated in combination with various immune checkpoint inhibitors, such as atezolizumab, durvalumab, ipilimumab and nivolumab. In fact, multiple such initiatives by start-ups are backed by venture capital firms and other strategic investors.  Scope of the Report The “Neoantigen Targeted Therapies Market, 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders 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 treatment (personalized and off-the-shelf), type of therapy (monotherapy and combination therapy), type of immunotherapy, target indication, line of treatment, and route of administration of the drugs / therapies that are being developed for the treatment of cancer. Detailed profiles of developers of neoantigen targeted therapies (shortlisted on the basis of the number of pipeline products), featuring an overview of the company, its financial information (if available), a detailed description of its product portfolio and recent collaborations. In addition, each profile includes an informed future outlook. A detailed publication analysis of close to 300 peer-reviewed, scientific articles published during the period 2015-2019 (till February), highlighting the research focus within the industry. It also highlights the key trends observed across the publications, including information on target disease indications, affiliated cancer immunotherapies, and analysis based on various relevant parameters, such as study type (review article, research article and meta-analysis), year of publication, and most popular journals (in terms of number of articles published in the given time period) within this domain. An in-depth analysis of the various patents that have been filed / granted related to neoantigens till April 2019. It includes information on key parameters, such as patent type, publication year, issuing authority, assigned CPC symbol, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). An analysis of the various partnerships pertaining to neoantigen targeting therapies, which have been established till March 2019, based on various parameters, such as the type of partnership, year of partnership, target disease indications, type of immunotherapy and the most active players. An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are focused on developing neoantigen targeted therapies. One of the key objectives of the report was to estimate the existing market size and the future opportunity for neoantigen targeted therapies, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption of neoantigen targeted 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 (bone and cartilage cancer, colorectal cancer, head and neck cancer, renal carcinoma, hepatocellular carcinoma, lung cancer, gynecological cancer and others) [B] type of treatment (personalized and off-the-shelf), [C] type of immunotherapy (dendritic cell vaccine, DNA / RNA-based vaccine, protein / peptide-based vaccine and TIL-based therapy), [D] route of administration (intradermal, intravenous, subcutaneous, 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 of company names): Gabriel Nistor (Chief Scientific Officer, AIVITA Biomedical) Ella Sorani (Vice President Research and Development, BioLineRx) Heinz Lubenau (Chief Operating Officer and Co-Founder, VAXIMM) 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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  • Biologics Fill / Finish Services Market, 2019 - 2030

    Biologics Fill / Finish Services Market, 2019 - 2030

    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.

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  • Driven by the growing demand for personalized therapies, the companion diagnostics market is anticipated to grow at an annualized rate of ~7.5%, predicts Roots Analysis¬†

    May 2019

    Roots Analysis has announced the addition of “Companion Diagnostics Market (2nd Edition), 2019-2030” report to its list of offerings. Ishita Nanda and Rohan Mukhopadhyay, the principal analysts, stated, “Given the influx of novel technologies and growing demand for personalized medicine, companion diagnostics have gradually become a necessity for modern pharmacological interventions. Tailored therapies are expected to transform healthcare practices, offering improved treatment outcomes, eliminating adverse reactions and, in a way, reducing cost and time barriers associated with drug development and approval. Currently, over 140 companion diagnostics are available / under development for a range of disease indications.”  The report presents opinions on several key aspects of the market. Among other elements, it includes:  A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, availability to patients, corresponding drug(s) / drug class, affiliated biomarkers, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others). It is worth noting that around 87% of the pipeline candidates are being developed for the treatment of oncological indications; of these, more than 35% are being investigated for the treatment of breast and lung cancer. Examples include (in alphabetical order, no specific selection criteria) AmoyDx® EGFR 29 Mutations Detection Kit, FoundationOne CDx™, HER2 FISH pharmDx™ Kit, PathVysion HER-2 DNA Probe Kit, therascreen® EGFR RGQ PCR Kit and VENTANA PD-L1 (SP142) Assay.   Elaborate profiles of developers of companion diagnostics (shortlisted based on strength of product portfolio), featuring an overview of the company, its financial information (if available) and a detailed description of companion diagnostics available / under development. In addition, each profile includes a list of recent collaborations and the likely strategies that may be adopted by these players to support future growth.  An in-depth brand positioning analysis of leading industry players (shortlisted based on strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position. It highlights the key strengths / competitive advantages, including our rationale justifying its position as a competitive entity in the market.  An analysis of the partnerships and collaborations pertaining to companion diagnostics for the period 2014-2019, featuring a comprehensive set of analyses based on parameters, such as the type of partnership (R&D collaborations, licensing agreements, acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, and other relevant deals), affiliated biomarkers, therapeutic areas and the most active players. It is worth noting that product development agreement was the most popular type of deal inked in this domain, representing 33% of the total number of collaborations.  A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) that are involved in this domain. The analysis features a qualitative assessment of the current and long-term needs of different stakeholders involved in this domain. It further compares the needs of the drug developers that are involved in development of companion diagnostic tests for their drug molecules, offering a combined perspective on the current and the future scenarios. A discussion on various steps involved in the development of a companion diagnostic test, namely R&D, clinical assessment, manufacturing and assembly, payer negotiation and marketing / sales activities. It also includes and assessment of the cost requirements across each of the aforementioned stages. It is worth mentioning that presently R&D costs are estimated to account for 30-33% of the total expenditure involved in the development of a companion diagnostic. A comprehensive clinical trial analysis of completed, ongoing and planned studies of key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials. In the past few years, several organizations, such as (in alphabetic order), AbbVie, Amgen, AstraZeneca, Eli Lilly, Novartis emerged as the leading industry sponsors / collaborators that are engaged in clinical research efforts in this domain.  A comprehensive market forecast analysis based on the primary growth drivers, disease incidence, adoption of companion diagnostic tests and the likely prices, for the period 2019-2030.The report includes information on the likely distribution of the current and forecasted opportunity across the following segments: Type of therapeutic area (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV/AIDs))  Type of techniques used (In situ hybridization, immunohistochemistry, next-generation sequencing, and polymerase chain reaction)  Key geographical regions (North America, Europe and Asia Pacific). Companion diagnostics intended for the treatment of oncological disorders are expected to capture majority of the market share (~80%) by 2030, while those being evaluated for the treatment of neurological disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues.  Mukhopadhyay further remarked, “Despite the increasing demand of personalized medicine, the full potential of companion diagnostics continues to remain untapped owing to an array of concerns associated with their development, regulations and affiliated reimbursement policies. It is worth mentioning that various pharma giants have opted to collaborate or acquire diagnostic developers having broad testing portfolios, in order to meet the growing demand in this domain”.  The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria): Abbott Agilent Technologies Biocartis bioMérieux  Foundation Medicine Guardant Health Illumina Invivoscribe Myriad Genetics NanoString Technologies QIAGEN  Roche Thermo Fisher Scientific For additional details, please visit https://rootsanalysis.com/reports/view_document/companion-diagnostics-market-2nd-edition-2019-2030/251.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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  • With an investment of over USD 1 billion and an intellectual capital spread across ~3,000 patents, the Encapsulated Cell Therapies and Encapsulation Technologies Market is set to witness a rapid growth, predicts Roots Analysis

    May 2019

    Roots Analysis has announced the addition of “Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030” report to its list of offerings.  Nupur Singh, the principal analyst, stated, “Extensive research on cell encapsulation strategies has enabled the development of a variety of technologies capable of immobilizing / enclosing therapeutic entities within biocompatible matrices / carriers. Such products offer a myriad of advantages, and have demonstrated the capability to address existing challenges related to cell therapies and certain other types of interventions as well. Currently, more than 25 encapsulated therapy products are being evaluated across different stages of development for the treatment of various chronic disorders. Of these, some products are already in mid to late-stage (phase II and above) of development and are likely to enter the market in the next 5-10 years.”  The report presents opinions on several key aspects of the market. Among other elements, it includes: A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development of various encapsulated therapy candidates, encapsulation method, type of cells / API, and route of administration, along with information on various stakeholder companies that are developing novel encapsulation methods / techniques for various applications. It is worth noting that around 45% of the pipeline candidates are being developed for the treatment of metabolic disorders; of these, more than 70% are being investigated for the treatment of type 1 diabetes. Examples include (in alphabetical order, no specific selection criteria) ßAir Bio-artificial Pancreas (Beta-O2 Technologies), hPSC (Kadimastem), Neo-Islets (SymbioCellTech), PEC-Encap™ (ViaCyte), Sig-002 (Sigilon Therapeutics / Eli Lilly), SR-01 (Seraxis), and TARGETBCD (Evotec / Sanofi).  An in-depth analysis of the patents that have been published related to cell encapsulation technologies, since 2013. The analysis also 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. During our research, we came across more than 3,000 patents that have been filed / granted since 2013. In fact, since 2014, more than 500 patents have been filed / granted each year across the globe; close to 580 patents were filed / granted in 2018 alone. It is worth noting that the R&D activity was observed to be concentrated in the US, which is evident from over 1,600 patents that were filed / granted in this region during the given time period. Other key regions with significant intellectual capital related to encapsulated cell therapies include (in decreasing order of number of patents filed / granted) Australia, Europe, Canada, Japan, China, and Israel. A comprehensive clinical trial analysis of completed, ongoing and planned studies of various encapsulated cell therapies. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, leading industry and non-industry players (in terms of number of trials conducted), study design, target therapeutic area, key indications, study focus, clinical endpoints, enrolled patient population and regional distribution of trials. In the past few years, several organizations, such as (in decreasing order of number of trials conducted) Stanford University, National Eye Institute, National Institutes of Health Clinical Center, University Hospital Brussels, Lowy Medical Research Institute, and Thomas Jefferson University, have emerged as the leading non-industry sponsors / collaborators that are engaged in clinical research efforts in this domain. It is also worth highlighting that disease-related parameters and safety / efficacy are amongst the most important clinical end points (measured across all trial phases) considered in studies evaluating encapsulated therapy products. An analysis of contemporary development landscape of more than 300 stakeholders that are engaged in the cell therapies domain. The analysis reveals companies that have the necessary expertise to help encapsulated cell therapy developers across various development processes in this field, highlighting the likely strategic partners across different regions. More than 40 cell therapy developers emerged as the most likely potential strategic partners in North America, based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing partnerships and developer strength. Examples of such companies include (in alphabetical order, no specific selection criteria) Gradalis, Innovative Cellular Therapies, Iovance Biotherapeutics, Juno Therapeutics, Kite Pharma, Tmunity Therapeutics, and TVAX Biomedical. A comprehensive market forecast analysis based on the primary growth drivers, the licensing deal structures and agreements that are expected to be signed over the course of next ten years. In addition, the report also includes information on (potential) sales-based revenues generated by encapsulated therapy products that are currently in late stages of development for the treatment of different chronic disorders, based on parameters, such as target consumer segments, likely adoption rates and expected pricing. It features likely distribution of the current and forecasted opportunity across the following segments: Type of therapeutic area (eye disorders, metabolic disorders, neurological disorders, and oncological disorders) Type of target disease indication (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangiectasia, metastatic and non-metastatic pancreatic cancer, Parkinson's disease, and retinitis pigmentosa) Type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells) Key geographical regions (North America, Europe and Asia Pacific).  Licensing deals are expected to remain the primary source of income for stakeholders in the short-mid term. It is also worth highlighting that encapsulated therapy products intended for the treatment of oncological disorders are expected to capture majority of the market share (~45%) by 2030, while therapy candidates being evaluated for the treatment of metabolic disorders are anticipated to grow at a relatively faster rate during the forecast period. Further, North America (primarily the US) and Europe are anticipated to capture the majority share by 2030, in terms of the sales-based revenues. This can be attributed to the fact that majority of mid-late stage product development programs in this domain, are centered in these regions. In 2030, North America is projected to capture around 50% of the overall market share in this domain. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. The report also features a detailed study on the various grants that have been awarded to research institutes in this field. It is worth noting that close to USD 400 million was raised through venture capital financing, representing around 40% of the total capital raised by industry players in the period 2013-2018. Within these instances, we noted that the maximum amount invested was through Series B funding rounds, wherein a sum of over USD 150 million was raised by various companies, from multiple investors. Further, in the last six years, more than 70 grants were awarded to various academic / research institutes in the US alone. Majority of these grants were provided to support research projects (31%) under the R01 mechanism (research grants), followed by grants awarded under R21 mechanism (exploratory / development grants, 14%).   An analysis of the partnerships that have been established in the domain in the period 2013-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals. It is worth noting that research and product development agreements were the most popular type of deals inked in this domain, each representing 20% of the total number of collaborations. Other popular agreement models adopted by companies in this industry include product / technology licensing agreements, clinical trial agreements, distribution agreements, regulatory service agreements, and product development and commercialization agreements. Comprehensive profiles of industry players that are currently engaged in the preclinical / clinical development of their proprietary encapsulated cell therapies, featuring an overview of the company, its financial information (if available), and a detailed description of its product(s), highlighting mechanism of action, current development status, and key preclinical / clinical trial results. In addition, each profile includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the foreseen future. The report features inputs from a number of eminent industry stakeholders. Singh remarked, “Most industry experts concur on the opinion that the market is still niche and, in the short-term, technology developers will continue to rely on technology access fees, and other payments from licensing deals related to their proprietary technologies”. The report also features detailed transcripts of discussions held with the following experts: Alexander Scheer (Chief Scientific Officer, Erytech Pharma) Manuel Pires (Business Developer, Defymed) Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem) Mick McLean (Chief Executive Officer, Atelerix) Quinton Oswald (Former President and Chief Executive Officer, Neurotech Pharmaceuticals) William L Rust (Founder and Chief Executive Officer, Seraxis) Yuval Avni (Former Chief Executive Officer, Beta-O2 Technologies) The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no specific selection criteria): ALTuCELL Azellon Cell Therapeutics Beta-Cell Betalin Therapeutics CellProtect Biotechnology Diatranz Otsuka Encellin EryDel Gloriana Therapeutics Living Cell Technologies MaxiVAX Neurotech Pharmaceuticals PharmaCyte Biotech Semma Therapeutics Sernova 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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  • Driven by the growing demand for biologics, the biopharmaceutical contract manufacturing market is expected to grow at an annualized rate of 8.1%, predicts Roots Analysis

    April 2019

    Roots Analysis has announced the addition of “Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030” report to its list of offerings.  Souvik Mohanta, the principal analyst, stated, “Since 2000, more than 115 new CMOs, focused on biopharmaceuticals, have been established. The current biopharmaceutical contract manufacturing landscape features the presence of several established and emerging CMOs, with a diverse set of production capabilities.” The report presents opinions on several key aspects of the market. Among other elements, it includes:  A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of over 235 CMOs and detailed analysis of the manufacturing service providers based on a number of parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression systems used (mammalian, microbial and others), year of establishment, employee strength, geographical location of the CMO, number of manufacturing facilities, as well as the location of these facilities, GMP compliance, affiliations to regulatory agencies, type of bioreactors used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion) and bioprocessing capacity. It is important to mention that majority of these firms offer services for proteins and peptides (140+), antibodies (125+), and vaccines (80+).  A discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market. It is worth mentioning that antibody-based therapies, such as antibody drug conjugates (180+ candidates) and bispecific antibodies (150+ candidates), along with the more complex cell therapies (600+ candidates) and gene therapies (350+ candidates), require specialized infrastructure and handling expertise, thereby, causing innovator companies to rely more on specialty CMOs for their development and manufacturing. CMOs, such as (in alphabetical order, no selection criteria) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, KBI Biopharma, Waisman Biomanufacturing and WuXi AppTec, claim to specialize in offering services for complex biologics. An informed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical / clinical, commercial), size of company (small-sized, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world (including Australia)). It is worth mentioning that the current installed contract manufacturing capacity is over 4.5 million litres and is well distributed across various geographies. Currently, more than 50% of the capacity is captured by mammalian expression systems. The remaining share is occupied with microbial and other expression systems.  An analysis of the partnerships and collaborations focused on contract manufacturing of biologics, featuring a comprehensive set of analyses based on various parameters, such as the headquarters of partner companies, year of partnership, type of partnership, therapeutic area, most active players and geographical location. Over the last six years, close to 450 strategic partnerships have been inked between stakeholders in the biopharmaceutical contract manufacturing market. It is worth noting that 50% of these agreements were product-based deals signed for various purposes, including the development, manufacturing and commercialization of biologics. In addition, of the total number of partnership instances, majority were signed for cell therapies (25%) and antibodies (20%).  A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2013-2018. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired companies. Over 50 strategic mergers and acquisitions have recently taken place between different CMOs. It is important to highlight that 23% of the total acquisitions were signed for vaccines, followed by those signed for peptides / proteins (16%) and cell therapies (16%). An analysis on the recent trends within biopharmaceutical contract manufacturing industry, highlighting various facility and capability expansions. In addition, it provides information on the technology advancements related to biomanufacturing. Over 135 recent expansions were reported between 2013-2018; of these, 75% were focused on the addition of new facilities, or expansion of existing facilities.  An analysis of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products. Currently, the demand of biologics that are being marketed / investigated is primarily driven by patient segments of  oncological disorders and infectious disorders, accounting for ~40% of the total demand. A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs. With over 900 biosimilars under development, the market is highly likely to witness a surge in the demand for contract service providers.   A comprehensive market forecast analysis, based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, along with an informed estimate of the likely evolution of the market in the short to mid-term and mid to long-term, for the period 2019-2030. The report features likely distribution of the current and forecasted opportunity across the following segments: Commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)) Types of expression systems (mammalian, microbial and others)  Size of the company (small-sized, mid-sized and large / very large) Scale of operation (preclinical, clinical and commercial)  Key geographical regions (North America (the US and Canada), Europe (the UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)) North America currently holds the larger share (40%) of the market and is anticipated to grow at an annualized growth rate of 7.4%. However, markets in the Asia-Pacific are expected to grow at a significantly higher rate (8.9%), owing to inherent advantages, such as relatively low labor costs and less stringent regulatory constraints. A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.  A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to medical device developers. It is worth mentioning that one-third of the responders were at CXO level, 42% formed a part of senior management and 25% responders       A discussion on challenges related to in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource. The report features inputs from several eminent industry stakeholders. Mohanta remarked, “Most industry experts concur that the current bioprocessing challenges can be addressed / mitigated by the integration of emerging technologies, such as single-use technologies, resulting in enhanced productivity levels.” The report also features detailed transcripts of discussions held with the following experts: Astrid Brammer (Senior Manager Business Development, Richter-Helm Biotec) Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie) Christian Bailly (Director of CDMO, Pierre Fabre) Claire Otjes (Assistant Marketing Manager, Batavia Biosciences) David C Cunningham (Director Corporate Development, Goodwin Biotechnology)  Dietmar Katinger (Chief Executive Officer, Polymun Scientific)  Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma) Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) Kevin Daley (Director Pharmaceuticals, Novasep) Mark Wright (Site Head, Grangemouth, Piramal Healthcare) Nicolas Grandchamp (R&D Leader, GEG Tech) Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals) Sebastian Schuck (Head of Business Development, Wacker Biotech) Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies) Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Marco Schmeer (Project Manager, PlasmidFactory) Tim Oldham (Chief Executive Officer, Cell Therapies) The research covers detailed profiles and assesses service portfolios of several companies (illustrative list below); each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as an informed future outlook. 3P Biopharmaceuticals Abzena Albany Molecular Research Baxter International BioVectra BioXcellence™ (Boehringer Ingelheim) Catalent Celonic CEPiA - Sanofi Charles River Laboratories ChemPartner Cobra Biologics CordenPharma Cytovance Biologics Grand River Aseptic Manufacturing IDT Biologika Kemwell Biopharma LFB Biomanufacturing Lonza Meridian Life Science Patheon Pfizer CentreOne Piramal Pharma Solutions PX'Therapeutics Thermo Fisher Scientific Vetter Pharma International WuXi Biologics For additional details, please visit  https://rootsanalysis.com/reports/view_document/biopharma-contract-manufacturing-market-3rd-edition-2019-2030/250.html  or email sales@rootsanalysis.com  Contact: Gaurav Chaudhary +1 (415) 800 3415 Gaurav.Chaudhary@rootsanalysis.com

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