Research Insights

Biologics Fill / Finish Services Market, 2019 - 2030

Biologics constitute a majority of the top selling drugs and presently represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, since the launch of recombinant protein-based therapies around three decades earlier, the overall biologics market has grown at an annualized rate of over 12%. It is also worth highlighting that more than 5,000 biopharmaceutical product candidates are currently under development.  Despite the fact that biopharmaceuticals offer significant profit margins, the sponsors of such pharmacological interventions are plagued by high costs of development and complex production protocols. As a result, several start-ups / small-sized companies and certain pharma giants have begun outsourcing different aspects of their business operations to contract service providers. According to the 2017 Nice Insight CDMO survey, about 54% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects.  Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant benefits, such as reduction in capital investment, access to larger production capacities, reductions in time-to-market and reduced commercialization risk.  Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologics drug products require special procedures and equipment for fill / finish operations in order to ensure product integrity and safety. As this operation is heavily outsourced, the rise in demand for biologics has resulted in an equivalent need for flexible aseptic fill / finish technologies. Pharmaceutical drug manufacturers have not hesitated to collaborate with contract service providers to leverage the latter’s experience and expertise in the latest fill / finish technologies. Currently, over 115 companies are actively providing fill / finish services for biologics. In the recent past, many service providers have also forged alliances / acquired other players in order to enhance their service offerings.  Scope of the Report The ‘Biologics Fill / Finish Service Providers, 2019-2030’ report features an extensive study on the contract service providers offering drug product manufacturing services within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of companies that claim to specialize in fill / finish operations. Amongst other elements, the report includes:  A detailed review of the overall landscape of contract fill / finish services market for biopharmaceuticals, featuring a list of active service providers and detailed analysis based on a number of relevant parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), year of establishment, company size and geographical location of the service provider, count and location of affiliated fill / finish facilities, number of additional services offered (lyophilization, labelling, quality testing, storage and distribution services), dosage forms handled (liquid and lyophilized), and types of primary packaging containers handled (ampoules, cartridges, syringes and vials),  including details on fill / finish capacity and fill volume range. A region-wise, company competitiveness analysis, highlighting prominent fill / finish service providers across various packaging types, based on supplier strength (considering experience and company size of the service provider), service strength (considering number of fill / finish facilities, number of continents where the aforementioned facilities are located, number of additional services offered and scale of operation) and types of biologics handled.      Elaborate profiles of key players across key geographies (North America, Europe and Asia-Pacific), which were shortlisted based on our proprietary company competitiveness analysis. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on partnerships, expansions and recent awards and accolades, as well as an informed future outlook.  An analysis of the recent collaborations (signed since 2013) focused on the contract fill / finish services for biologics, based on various parameters, such as year of agreement, type of agreement, scale of operation of the project, focus area, types of services mentioned in the deal, types of biologics involved and location of facility where the project is to be executed.  A detailed analysis of the expansions undertaken (since 2013) by various service providers for augmenting their respective fill / finish service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of facility, type of packaging container involved, scale of operation (as mentioned in the expansion terms), types of services and biologics involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances). An estimate of the global, contract fill / finish capacity, by taking into consideration the capacities of various fill / finish service providers (as available on respective company websites), collected via secondary and primary research. The study examines the distribution of number of packaging units and volume of biologics filled, across various types of packaging containers (ampoules, cartridges, syringes, and vials), based on the size of the company / organization (small-sized, mid-sized and large)  and geography (North America, Europe and Asia Pacific). An informed estimate of the annual demand for fill / finish of biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of the abovementioned products.  An analysis to identify the key performance indicators for service providers active in the domain, based on information gathered via secondary research (for top-ten pharmaceutical players) and primary research. A case study to highlight the benefits of using robotic / automated equipment for aseptic fill / finish processes; the study provides a list of equipment manufacturers providing robots suitable for pharmaceutical operations. A case study to highlight the role of ready-to-use packaging containers in aseptic fill / finish operations; the study provides a list of suppliers providing the ready-to-use components. A discussion on the potential growth areas, such as growing biopharmaceutical pipeline, increasing outsourcing of fill / finish operations, rising focus on self-administration enabling drug delivery devices and growing opportunities in Asia-Pacific region, which are likely to present in the coming years. One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of drug product manufacturing costs, and outsourcing trends related to fill / finish operations, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the period 2019-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] types of primary packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] types of biologics (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), [C] company size (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial), [E] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications), and [F] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia-Pacific (Japan, China, South Korea, India and Australia)). To account for the uncertainties associated with the fill / finish of biopharmaceuticals and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.   The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Ales Sima, Business Development Manager, oncomed manufacturing  Gregor Kawaletz, Chief Commercial Officer, IDT Biologika Jos Vergeest, International Business Developer, HALIX Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene International All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Elastomeric Closures Market: Focus on Parenteral Containers, 2019-2030

Pharmaceutical packaging plays a crucial role in ensuring the sterility and quality of a drug product, while also providing information related to its identity and, in certain cases, dosing instructions. Primary packaging material, owing to the fact that it is in immediate contact with the drug / therapy formulation, is considered to be extremely important when it comes to preserving the stability, efficacy and safety of the packaged drug product. Further, given the growing complexity of modern pharmacological interventions, especially biologics, it has become imperative for drug / therapy packaging considerations to be re-evaluated, taking into consideration the evident shift from large batches of one remedy for everyone to smaller batches of more personalized therapeutic solutions. In addition to optimizing drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have also adopted a number of other flexible solutions to reduce the overall cost and expedite time to market.  The use of elastomeric materials, along with various types of coatings (such as FluoroTec® and Teflon®), has emerged as a promising alternative to conventional, non-coated closures used for primary packaging containers, which were prone to leaching and shedding of particulate contaminants. The advantages of using elastomeric materials in manufacturing container closures are many, including low leaching potential, minimal chemical interaction with the pharmacological formulation, and the fact that they can be used to make waterproof and airtight closures. Moreover, such closures can also be manufactured in the ready-to-use (RTU) format, which saves a significant amount of time by eliminating the need for multiple steps in the overall fill / finish process. Owing to the aforementioned benefits, the industry has witnessed an evident growth in preference for elastomeric container closures.  Scope of the Report The ‘Elastomeric Closures Market: Focus on Parenteral Containers, 2019-2030’ report features a comprehensive study of the current scenario and future potential of the elastomeric, primary packaging closure market. It features an in-depth analysis, highlighting the various types of elastomeric closures including stoppers, needle shields and plungers, available in the market for various types of primary packaging containers, such as cartridges, syringes and vials. In addition to other elements, the study includes:  A detailed assessment of the current market landscape of companies manufacturing elastomeric container closures, featuring information on the type of closure (cap, needle shield, plunger, seal, stopper, and tip cap), type of respective primary container(s) (vial, syringe, and cartridge), elastomeric material(s) used for fabricating the aforementioned closures (such as bromobutyl, chlorobutyl, and others), drug type(s) that are compatible with elastomeric closures, sterilization status of closures (pre-sterilized and unsterilized), affiliated sterilization technique (if the closure(s) is available in the pre-sterilized format), scale of production (small scale, and large scale), type of customization (if available), affiliated dimensions, along with compliance certifications of the product.  A comprehensive analysis on the packaging trends of over 230 drug products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014), featuring an assessment of the packaging requirements of various container-closure systems based on parameters, such as year of approval of drug, type of molecule, dosage form, route of administration, holding temperature, type of packaging material(s) used for manufacturing primary container and affiliated closure, and leading drug developers (in terms of number of drugs packaged using elastomeric closures).  An analysis of various developments / recent trends related to elastomeric packaging materials, offering insights on [A] partnerships and collaborations established within the industry, and [B] recent global conferences related to pharmaceutical packaging industry. Elaborate profiles of key players in this domain (shortlisted on the basis of size of product portfolio), featuring a brief overview of the company (including information on company headquarters, year of establishment, number of employees, and key members of the executive team), financial information (if available), detailed description of proprietary elastomeric closures, recent developments, and an informed future outlook. A case study on the role of robotics in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. It includes profiles of industry players offering such equipment for the aseptic processing of pharmaceutical products.  An elaborate discussion on emerging trends (such as focus on personalized therapies, shift towards more flexible packaging, upgrading packaging components to enhance drug product safety, and growing adoption of smart packaging solutions) that are likely to have an impact on the future adoption of elastomeric container-closure components in the pharmaceutical packaging industry. It also features a Harvey ball analysis, highlighting the relative effect of each trend on the overall pharmaceutical packaging industry. An in-depth analysis to estimate the current and future demand for elastomeric closures across key primary packaging containers, including vials, syringes and cartridges, in different regions for the period 2019-2030. Input parameters considered for this analysis include current supply of different primary packaging components and their respective closures and the estimated the proportion of elastomeric closures that are likely to be supplied, which is indicative of the demand.  One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for elastomeric closures over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report provides sales forecasts for the overall elastomeric closure market, wherein both the current and upcoming opportunity is segmented across [A] type of packaging container(s) (vials, syringes and cartridges), [B] type of closure(s) used (seal, stopper, cap, plunger, barrel, and needle shield), [C] sterilization status (pre-sterilized and unsterilized), and [D] key geographies (North America, Europe, Asia-Pacific, 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 also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):  Julien Maréchal (Business Development and Technology Director, Aseptic Technologies) Malcolm Gilmore (Facilitator, BioPhorum Operations Group) Marco Pederiva (Marketing and Sales Director, Lonstroff) Konstantin Kazarian (Project Manager of Business Development, PYRAMID Laboratories) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Depressive Disorders: Pipeline Review, Developer Landscape and Competitive Insights

Depression is a chronic medical condition characterized by a persistent feeling of sadness and lack of interest in external stimuli. It is a commonly diagnosed mental health disorder and is considered among the leading causes of disability across the globe. It has been estimated that over 300 million people (considering all age groups) suffer from depression worldwide. Further, depression and other depressive disorders are projected to be responsible for an economic burden of up to USD 210 billion per year in the US. Despite the high prevalence and significant impact of this disease, less than 50% of affected individuals receive treatment in high-income countries; this figure stands at less than 10% for low-income countries. According to the World Health Organization, barriers to effective care for depression and other depressive disorders, include lack of resources, lack of trained healthcare professionals, inaccurate diagnoses of the condition and the social stigma associated with to mental health disorders. A number of blockbuster drugs are available to treat depression; these include Prozac and Celexa (approved in 1980s), Paxil and Zoloft (approved in 1990s), and Lexapro and Cymbalta (approved in 2000s). These drugs work by modulating monoamine levels in the brain, a mechanism that has been re-evaluated and improved across the last six decades. Since the 1950s, around 30 branded drugs and more than 150 generic products have been approved by the FDA to treat various forms of depression. Currently, selective serotonin reuptake inhibitors (SSRIs) form the mainstay of treatment options for depression. Despite the availability of generics and other branded drugs, patients have voiced the need for better antidepressants as currently available SSRIs take a long time (few weeks) to demonstrate therapeutic benefit. In addition, around 50% of treated patients do not respond to the first prescribed antidepressant and need to go through months of trial and error-based therapy regimens before an appropriate drug is identified to treat their underlying condition. Further, there are many patients who never respond to any of the available therapeutic strategies, highlighting an urgent need for effective treatment solutions for depression. Several stakeholders in the pharmaceutical industry are currently engaged in efforts to develop various types of interventions and drug / therapy candidates with novel mechanisms of action to treat depression.  Scope of the Report The “Depressive Disorders Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed (approved post 2010), clinical and preclinical molecules available / being developed, for the treatment of depressive disorders. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail, in the document. Amongst other elements, the report includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of therapy (monotherapy, adjunctive therapy or combination therapy), type of depression (major depressive disorder, bipolar disorder, postpartum depression, treatment-resistant depression and depression (type unknown)), type of drug class (anti-depressant and anti-psychotic), mechanism of action, dosing frequency (twice daily, once daily, twice weekly, once weekly, once in 28 days, twice yearly and once only) and route of administration (oral, nasal and parenteral) of the drugs / therapies being developed for the treatment of depressive disorders. A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinued drug development programs, year of discontinuation, geographical location (of discontinued trial), phase at which the development program was discontinued, mechanism of action of discontinued drug, disease indication (for which the drug was being investigated), reason(s) for discontinuation and information on affiliated developer companies. An analysis of the partnerships that have been established between 2012 and 2019 (till March), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, clinical trial agreements, and other relevant deals. An analysis of the investments (between 2010 and 2019 (till March)) made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other offerings. A comprehensive clinical trial analysis of completed, ongoing and planned studies for different types of depressive disorders. For the purpose of this analysis, we considered the clinical studies registered till February 2019, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, type of depressive disorder, mechanism of action, leading industry and non-industry players with highest number of completed / ongoing trials, regional distribution of clinical trials, and enrolled patient population across different geographies.  An insightful analysis on clinical end-points being evaluated in late-stage ongoing and planned studies, for various types of depressive disorders. For the purpose of this analysis, we considered the phase III clinical studies registered till February 2019, and identified the most important, primary endpoints being evaluated. An insightful market assessment summary, highlighting the clinical and commercial attractiveness of pipeline molecules (phase II and phase III), taking into consideration size of enrolled patient population (for the trial in the highest phase of development), route of administration, therapy type and dosing frequency (for quantifying clinical attractiveness), and target patient population, expected launch date and size of developer company (for quantifying commercial attractiveness). An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, post-marketing, and near patent expiry, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.  A case study on the upcoming digital health solutions for the management / treatment of depression, featuring information on the various product development pathways adopted by companies involved in this segment of the market; it includes brief descriptions of popular digital solutions as well. The insights presented in this report are backed by a deep understanding of data gathered from secondary sources. The opinions generated over the source of the study, were influenced by inputs from key players in this domain. All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.   

...read more
Companion Diagnostics Market (2nd Edition), 2019-2030

The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions / side effects are reported to be the fourth leading cause of death in the US.  To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular / genetic signatures.  Personalized therapies demand companion diagnostics to make physicians aware of patients’ unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates.  It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%.   Since the approval of the HercepTest™ (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Further, several companies have also undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders.  Industry stakeholders are forging strategic alliances with diagnostic developers to develop diagnostic solutions for a diverse array of drugs / therapies. Such initiatives are focused on improving clinical trial success rates, and subsequently optimizing R&D expenditure in the pharmaceutical industry. Scope of the Report The “Companion Diagnostics Market (2nd Edition), 2019-2030” report features an extensive study of the current market landscape and the likely adoption of these diagnostic tests over the next decade. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes: A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, 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). Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth. A detailed brand positioning analysis of leading industry players (shortlisted on the basis of 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 of each company. An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players. A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages. A comprehensive analysis of completed, ongoing and planned clinical trials featuring the 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. One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostics developers, over the next decade. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, 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 therapeutic areas (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), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). 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 also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Biopharma Contract Manufacturing Market (3rd Edition), 2019 - 2030

Over the years, the biopharmaceutical market has grown into a prominent and promising segment of the overall pharmaceutical industry. Characterized by a number of blockbuster therapies (Humira,  Rituxan,  Lantus,  Avastin,  Herceptin  and Remicade ) and a robust pipeline of product / therapy candidates, the market is poised for significant growth in the coming years. It is worth mentioning that much of the anticipated success of the biopharmaceutical market is dependent on new biologics currently under development and biosimilars. The impending growth also indicates the rising importance of manufacturing capacity within the industry. The costs associated with acquiring manufacturing capabilities are exorbitant and, therefore, it is difficult for companies with limited finances and capacity constraints to succeed by themselves. These constraints have led many of the smaller players in the industry and, at times, certain pharma giants as well, to outsource a significant part of their business operations to contract service providers. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant cost-benefits, access to larger production capacities and reductions in time-to-market. Owing to the growing number of start-ups that are engaged in R&D of novel biologics, there is significant opportunity for the CMOs in this domain. It is worth highlighting that, since 2000, more than115 new CMOs have been established in order to cater to the growing demand for novel biologics that have specific manufacturing requirements. The contemporary contract services market features a mix of large and small-sized CMOs and is characterized by multiple mergers and acquisitions as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to offer end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings. Despite the fact that the biopharmaceutical sector is amongst the most highly regulated industries, we expect the demand for core competencies to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor and is likely to grant a competitive edge to certain CMOs over other stakeholders.   Scope of the Report The “Biopharmaceutical Contract Manufacturing Market (3rd edition), 2019 – 2030” report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and CDMOs. Amongst other elements, the report includes: A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of active 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 size, 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.  Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biologics. 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 a comprehensive future outlook.  A detailed 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. A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs.  A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.  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. An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of biologics; the analysis is based on various parameters, such as the year in which the agreement was signed, type of agreement, focus area and type of biologics.  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, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired company.  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.  A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) 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).  An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on a various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products. 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. 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, and direct manufacturing costs, we have provided 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. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] size of the company (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia)). To account for the uncertainties associated with the manufacturing 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 influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: Astrid Brammer, Senior Manager Business Development, Richter-Helm 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 All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030

Chronic disorders, such as diabetes, cancer, heart disease, obesity, and certain types of mental health problems, are considered among the leading causes of death and disability across the globe. According to a report published by the Center for Managing Chronic Disease at the University of Michigan in 2018, more than 50% of the global population lives with some form of chronic illness. In 2018, the global prevalence of diabetes (considered to be one of the fastest-growing clinical conditions) was estimated to be around 425 million; likewise, around 450 million people worldwide are suffering from some form of mental health problem and / or neurological disorder. In addition, the World Health Organization (WHO) reported that different forms of cancers account for about 0.6 million deaths annually in the US alone. Over the years, advances in cell biology and regenerative medicine have led to the development of various cell-based therapies, which claim to possess the potential to address several unmet needs related to the treatment of different chronic clinical conditions. However, there are certain evident challenges, such as scarcity of viable donors, inherent immunogenicity, complications related to supply of oxygen / essential nutrients to grafted cells, drug delivery limitations, and the need for frequent re-administration of cells, which have so far restricted the use of cell-based interventions. Extensive research on cell encapsulation strategies have enabled the development of a variety of technologies capable of confining therapeutic entities within biocompatible matrices / carriers. Encapsulated therapy products offer a myriad of advantages, and have been shown to be capable of addressing existing concerns related to cell sourcing, obviating the need for complex surgical procedures, and enabling targeted drug delivery without the need for immunosuppressive follow-on regimens. In fact, since 2013, over 3,000 patents have been published related to the aforementioned type of therapy, indicating the rapid pace of R&D activities in this domain. Stakeholders have also received significant support from both private and public investors. However, the commercial success of such products is still dependent on ongoing clinical studies, as no such therapy has yet been approved.   Scope of the Report The ‘Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030’ report features an extensive study of the current market landscape and the future potential of encapsulated cell therapies and affiliated technologies. It is worth mentioning that the study also provides insights on therapy products wherein other active drug substances have been encapsulated within living cells. Amongst other elements, the report features: A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development, 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 use in storage and transportation of cells, as well as other applications.  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. Each profile also 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 in the foreseen future. 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. 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, and enrolled patient population and regional distribution of trials. 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. 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. An analysis highlighting potential strategic partners (for instance, manufacturers) for encapsulated therapy developers based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing collaborations, and developer strength 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 likely licensing deal structures and agreements that are expected to be signed in the foreseen future, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. In addition, we have provided information on (potential) sales-based revenues generated by encapsulated cell therapies 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. The report features likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (eye disorders, metabolic disorders, neurological disorders, and oncological disorders), [B] target disease indications (ataxia telangiectasia, breast cancer, diabetes, glaucoma, head and neck cancer, macular telangectasia, pancreatic cancer, Parkinson's disease, and retinitis pigmentosa), [C] type of encapsulation material used (alginate-based microcapsules, cellulose hydrogels, medical-grade plastics, and red blood cells), and [D] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.  The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: 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) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Bone Cement Delivery Systems Market, 2019-2030

According to a study conducted by the International Osteoporosis Foundation (IOF), more than 200 million individuals around the world suffer from osteoporosis. In fact, a total of 8.9 million fractures per year are attributed to osteoporosis, implying that an osteoporotic fracture (of the hip, knee, spine, shoulder, or wrist) occurs after every three seconds. The annual socioeconomic burden associated with this condition is estimated to be around USD 19 billion and EUR 37 billion, in the US and Europe, respectively. Further estimates suggest that, by 2030, nearly 3.5 million knee replacements and 572,000 hip replacements are likely to be performed every year in the US alone. A recent United Nations’ study projected the global elderly population (aged 60 years and above) to rise to 1.3 billion by 2030; given the susceptibility of this population segment to developing osteoporosis, the global burden related to this particular disease is anticipated to increase significantly in the foreseen future. Over time, bone cement delivery systems have become widely popular in diverse types of orthopedic surgeries / procedures. There are many benefits of using such devices, including ease-of-use, targeted and controlled delivery of bone cements, integrated safety mechanisms, and an almost negligible risk of injury to patients. Companies involved in the development / manufacturing of bone cement delivery systems have also captured the interest of several stakeholders / bone cement developers that are looking for novel ways to deliver various types of bone cements to target sites during surgical procedures. In fact, since 2010, over 6,000 patents have been published in this domain, indicating the rapid pace at which research is being carried out. It is anticipated that such efforts are likely to boost the overall growth of this market in the coming years. Scope of the Report The ‘Bone Cement Delivery Systems Market, 2019-2030’ report features an extensive study of the current landscape and the likely future evolution of such systems in the next twelve years. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different global regions. Amongst other elements, the report includes: A detailed assessment of the current landscape of bone cement delivery systems market, highlighting the contributions of industry players engaged in this domain, along with key system specifications. It features information on the type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), compatibility with different types of bone cements (polymethyl methacrylate, calcium phosphate and others), viscosity of bone cements delivered (high, medium and low), system functionality (delivery and mixing), approval date of various products, and maximum capacity. An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, including bone cement delivery systems, across different countries. It also includes an insightful multi-dimensional heat map analysis, featuring a review of the contemporary regulatory scenario in key geographies across the globe. Elaborate profiles of large companies offering bone cement delivery systems (shortlisted on the basis of the number of systems), featuring an overview of the company, its financial information (if available), detailed descriptions of their bone cement delivery systems, and a comprehensive future outlook. In addition, the chapter features tabulated profiles of small-sized and mid-sized bone cement delivery system providers (shortlisted on the basis of number of systems), featuring details on company headquarters, year of establishment, number of employees, executive team, recent developments, along with detailed descriptions of their proprietary bone cement delivery systems. 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 2014-2018, based on parameters, such as year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, key value drivers, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on bone cement delivery systems, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals. An in-depth analysis of the various patents that have been filed / granted related to bone cement delivery systems since 1976. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, CPC classification, emerging focus areas (in terms of number of patents filed / granted), type of surgical procedures (arthroplasty, kyphoplasty and vertebroplasty), industry type and leading industry / non-industry players (in terms of size of intellectual property portfolio). It also features a valuation analysis taking into consideration older patents, which have expired, highlighting the upcoming opportunity for generic product developers and manufacturers in this domain. A comprehensive clinical trial analysis of completed, ongoing and planned studies of different types of bone cements and associated delivery systems for various surgical procedures. For the purpose of this analysis, we considered the clinical studies that started in 1997, and analyzed them on the basis of various parameters, such as trial registration year, current trial status, current trial phase, study design, type of surgical procedure, study focus, leading industry and non-industry players, regional distribution, and enrolled patient population across different geographies. In addition, it features an insightful clinical end-points analysis of ongoing and planned studies. A detailed study on the various grants that have been awarded to research institutes conducting projects related to different types of bone cements, between 2010 and 2018. The analysis highlights various important parameters associated with grants, such as year of award, support period, amount awarded, type of surgical procedures, grant type, responsible study section, focus area and type of bone cements. An analysis to estimate the likely demand for bone cement delivery systems across key surgical procedures, including kyphoplasty, vertebroplasty, hip arthroplasty and knee arthroplasty, in different global regions for the period 2019-2030. One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for bone cement delivery systems over the coming decade. Based on several parameters, such as prices of systems, surgical procedure / region specific adoption trends, and competitive landscape, we have provided an informed estimate on the likely evolution of the market, over the period 2019-2030. The report provides sales forecasts for the overall bone cement delivery systems market with the current and upcoming opportunity segmented across [A] surgical procedure(s) (hip arthroplasty, knee arthroplasty, kyphoplasty and vertebroplasty), [B] type of end-user(s) (ambulatory surgery centers, hospitals and specialty clinics), and [C] key geographies (North America (the US, Canada and Mexico), Europe (EU5 countries), Asia-Pacific and Rest of the World (Australia, China, India, and Japan)). 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 also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of organization names): Soren Toksvig-Larsen (Associate Professor, Department of Orthopedics, Lund University) Francesco De Paola (International Product Manager, Medacta International) Ana Bettencourt (Associate Professor, University of Lisbon) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Alzheimer's Disease: Pipeline Review, Developer Landscape and Competitive Insights

Alzheimer’s disease is a neurodegenerative condition characterized by progressive memory loss, cognitive dysfunction anddementia. Currently, it is the most commonly reported neurodegenerative disorder across the world, and the sixth leading cause of death in the US. It was estimated that, in 2018, nearly 5.7 million Americans (considering all age groups) were living with Alzheimer’s disease. During the same year, Alzheimer’s disease and other dementias were projected to be responsible for a healthcare burden amounting to USD 277 billion, in the US. Considering that only a limited range of diagnosis, treatment and disease management solutions are presently available, this segment of the healthcare industry is presently faced with a pressing need for accurate diagnostic (predictive) tests, and efficient treatment options that have the capability to slow the progression of the condition. Despite extensive research aimed at comprehending the etiopathogenesis of Alzheimer’s disease, only six drugs have been approved since 1996 for treatment. The rate of failure of drugs being developed for treating Alzheimer’s disease is alarming (~99.6%) and is even higher than that reported for cancer (~81%). Most of the existing therapeutic options have proven inadequate in arresting the progression of the disease and long term management of associated symptoms. Currently, several stakeholders in the pharmaceutical industry are engaged in efforts to develop various types of disease modifyinginterventions and drug / therapy candidates that offer symptomatic relief. In fact, multiple initiatives by start-ups are being backed by venture capital and other strategic investors. In the coming years, the market is anticipated to grow at a significant pace as more novel solutions clear clinical evaluation and get commercialized.   Scope of the Report The “Alzheimer’s Disease Market: Pipeline Review, Developer Landscape and Competitive Insights” report provides an extensive study on the marketed, clinical and preclinical molecules available / being developed for the treatment of Alzheimer’s disease. Figure 1.1 summarizes the scope of the report and the specific modules that have been covered in detail in the document. Figure 1.1 Alzheimer’s Disease: Scope and Competitive Insights Amongst other elements, the report includes: A detailed assessment of the current market landscape, providing information on drug developer(s), phase of development (marketed, clinical and preclinical / discovery stage), type of molecule (small molecule or biologic), type of treatment (disease modifying agents or drugs offering symptomatic relief), target stage of the disease (early, mid and late stages), type of therapy (monotherapy or combination therapy), path to clinic (dedicated, and repositioned / repurposed), mechanism of action, and route of administration of the drugs / therapies being developed for the treatment of the condition. An in-depth analysis of the product pipeline and developer companies, featuring three schematic representations; these include [A] a representation, highlighting the distribution of the marketed and development stage molecules based on the mechanism of action, [B] a 2X2 grid analysis, representing the distribution of drug candidates across type of therapy, path to clinic and stages of development, and [C] a diagrammatic representation of the regional landscape of industry players involved in the development of drugs in this domain, distributed based on the location of their headquarters. An analysis highlighting the key unmet needs across Alzheimer’s disease, featuring insights generated through data captured from 5000+ social media posts, 250+ recent scientific publications, 100+ patient blogs and the views of key opinion leaders expressed by both patients and industry experts. A detailed assessment of discontinued drugs / trials, featuring information on the number of discontinuations, year of discontinuation, phase of discontinuation, mechanism of action of the terminated drug, target stage of disease and the reason(s) for discontinuation. A detailed publication analysis of close to 300 articles, highlighting the therapeutic areas of focus within the industry. The analysis also highlights the key trends observed across the publications, including information on popular biological targets being investigated, study type (review article, research article and meta-analysis), year of publication, and the most popular journals (in terms of number of articles published within our dataset) within this domain. An analysis of the partnerships that have been established till 2019 (February), covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and commercialization agreements, manufacturing agreements, and other relevant deals. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings. The research, analysis and insights presented in this report is backed by a deep understanding of insights gathered from secondary sources. 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 name): Kenneth Moch (President and Chief Executive Officer, Cognition Therapeutics) Ram Bhatt (Chief Executive Officer, Chairman and Founder, ICB International) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more
Stem Cell Therapies for Cardiovascular and Metabolic Disorders, 2019-2030

Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders.  In the US, the annual economic burden associated with these disorders is estimated to be over USD 500 billion. According to a study conducted by RTI International for the American Heart Association, the prevalence of cardiovascular diseases is expected to rise to 45% of the overall US population, while affiliated costs are expected to be over USD 1 trillion by 2035. Despite considerable advances in healthcare, most of the currently available treatment options for cardiovascular disorders focus on palliative care and cannot actually repair damaged cardiac tissue. Although heart transplant is a viable option to treat complex cardiovascular conditions, the waiting time associated with this alternative is excruciatingly long. Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per IDF Diabetes Atlas, the treatment of diabetes and related complications incurred USD 727 billion in global healthcare expenditure in 2017. In 2017, it was estimated that 425 million individuals, between the ages 20 years to 79 years, were living with diabetes across the globe, and this number is expected to increase substantially in the foreseen future. Similar to cardiovascular diseases, most of the current treatment options for metabolic disorders are indicated for only controlling / managing disease related symptoms. Advances in cell biology and regenerative medicine have led to the development of stem cell therapies that can potentially address several unmet needs and potentially offer a cure for various cardiovascular and metabolic disorders. The field of regenerative medicine has evolved substantially in the recent past; the first stem cell therapy, called Cellgram®-AMI (2011), was approved by the Ministry of Foods and Drug Safety of Korea, for the treatment of acute myocardial infarction. Presently, two other stem cell-based treatment options, namely HeartSheet (heart failure, 2015) and Stempeucel (critical limb ischemia, 2017), are commercially available for cardiovascular disorders. For metabolic disorders, most stem cell therapy candidates are still under development. However, there is one approved product, called Strimvelis for ADA-SCID (2016). Several stakeholders are engaged in efforts to advance the development of regenerative therapies for both cardiovascular and metabolic disorders. In fact, venture capital (VC) firms and government bodies are actively funding several such ongoing research initiatives. Scope of the Report The “Stem Cell Therapies for Cardiovascular & Metabolic Disorders, 2019-2030” report features an extensive study of the current market landscape and the future potential of stem cell therapies in treating the aforementioned clinical conditions. The study includes all stem cell therapies that are being developed for the treatment of cardiovascular and metabolic disorders. In addition, we have provided a list of stem cell therapies being developed for stroke, a condition associated with vasculature in the brain. Amongst other elements, the report features the following: A detailed assessment of the current market landscape of stem cell therapies with respect to target therapeutic area (cardiovascular and metabolic), phase of development (approved, phase III, phase II, phase I and preclinical / discovery), target disease indications (Cardiovascular: heart failure, myocardial infarction, critical limb ischemia, angina, peripheral arterial / vascular diseases, myocardial ischemia, myocardial fibrosis, cardiomyopathy and coronary microvascular dysfunction; Metabolic: diabetes, mucopolysaccharidosis type III, ADA-SCID, obesity, mitochondrial disorders and metachromatic leukodystrophy), source of cells (autologous and allogenic), type of stem cells (adult multipotent, adult pluripotent, embryonic multipotent and embryonic pluripotent), stem cell lineage (bone marrow, peripheral blood, adipose tissue, cardiosphere, muscle, Wharton's jelly, umbilical cord, placenta, dental pulp, cord blood and pancreas), and route of administration (intramyocardial, intramuscular, intravenous, intracoronary and implantation). An analysis highlighting the key unmet needs across cardiovascular and metabolic disorders, featuring insights generated from social media posts, recent scientific publications, patient blogs and the views of contemporary key opinion leaders as expressed on online platforms. An overview of the focus areas of therapy developers, including an assessment of the existing opportunity for stem cell therapies across diverse therapeutic indications. An insightful company competitiveness analysis featuring a three-dimensional bubble representation, highlighting the key players in this domain on the basis of the strength of their respective product portfolios, taking into consideration the number of therapies under development, phase of development of these therapies, number of disease indications being targeted and geographical distribution of affiliated clinical trials. An analysis of the partnerships that have been established in the domain in the period 2012-2018, 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. An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, capital raised from IPOs / secondary offerings, debt financing and grants. An analysis of contemporary peer-reviewed scientific research articles published during the period 2013-2018, highlighting the key focus areas of the ongoing research activity, in terms of therapeutic area, target disease indication, and stem cell lineages. Comprehensive profiles of approved and late stage clinical products; each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on recommended dose, price and manufacturing process (wherever available). 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 target consumer segments, likely adoption rates and expected pricing, 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. The report includes information on (potential) sales-based revenues generated by stem cell therapies that are currently marketed or are in late stages of development for the treatment of cardiovascular and metabolic disorders. Additionally, it presents details on the likely distribution of the current and forecasted opportunity across [A] target therapeutic areas (cardiovascular and metabolic), [B] target disease indications (myocardial infarction, heart failure, critical limb ischemia, diabetes, ADA-SCID,  metachromatic leukodystrophy, and other cardiovascular and metabolic disorders ), [C] type of stem cells (adult multipotent, adult pluripotent and embryonic multipotent), [D] source of cells (autologous and allogenic), [E] stem cell lineage (bone marrow, peripheral blood and others), [F] route of administration (intramyocardial, intracoronary, intramuscular, intravenous and implantation) and [G] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals: Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem) Dr. William L. Rust (Founder and Chief Executive Officer, Seraxis) Xuejun H. Parsons (Chief Executive Officer, Xcelthera) All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

...read more

OUR CLIENTS

  • We are your partners with no equity

  • We fit in your budget

  • We love what we do

  • Chance to prove ourselves

  • Best in class quality of work

  • Most trusted consulting partner in the industry