RootsAnalysis's articles

As per Roots Analysis, most of the viral vector and gene therapy manufacturers (66%) are located in North America, followed by the players headquartered in Europe (32%) and Asia-Pacific (9%). Within North America, majority of the companies focused on manufacturing viral vectors and gene therapies are based in the US (65). Further, in Europe, most […]
Given the multifaceted advantages of antisense oligonucleotide therapeutics, the field has witnessed an increase in the number of players involved in the development of such solutions. The domain features the presence of over 30 companies which are involved in the development of over 170 antisense oligonucleotide drugs. Majority of the developers (55%) of antisense oligonucleotide […]
During our research, we came across 32 industry players that are presently engaged in the development of digital solutions for biomarkers. Most of the developers (44%) engaged within this domain were established during the period 2010-2013. Specifically, nine new companies have been established in the last five years (since 2016). Majority of the companies engaged […]
Since Martin Cline’s initial attempts at modifying human DNA to cure thalassemia in 1980, a number of genetically modified therapies have been / are being investigated in clinical trials, across the world. Initially, genetically modified therapies were being developed for the treatment of rare genetic disorders; however, of late, such advanced therapies are also being […]
Oligonucleotides (commonly referred to as oligos), are short single stranded DNA or RNA molecules, typically containing 15-20 nucleotide residues. In the modern biopharmaceuticals and biotechnology, the applications of these molecules are vast, including (but not limited to) genetic testing, fundamental biomolecular research, and forensic analysis. Presently, researchers are actively exploring the applications of oligonucleotides as […]
Seeing the extended applications of digital biomarkers, regulatory bodies are establishing a standard developmental pathway for them In general, biomarkers or biological markers are defined as distinctive physiological features in an individual, which can be detected and quantified in order to gain insights about health and disease. On the other hand, digital biomarkers are defined […]
The contract service providers have established themselves as an indispensable part of the supply chain in the pharmaceutical / medical device industry. Given the ongoing efforts to minimize product costs, growing complexity to conduct clinical trials, profound technological advancements and introduction of stringent regulatory standards, outsourcing is considered as a viable and strategically beneficial solution […]
The medical device sector, a part of the pharmaceutical industry, is one of the few businesses that has been relatively less impacted amidst the COVID-19 pandemic. Moreover, as the disease spreads, the demand for accurate diagnostic measures, medical devices (including handled scanners, and personal protective equipment (PPE)), and effective preventive and treatment solutions for COVID-19, […]
Over the years, outsourcing has become an indispensable business strategy within the global medical devices market. Moreover, the increasing regulatory stringency worldwide, is causing many innovator companies to rely on the expertise of CROs to liaise regulators and handle the intricacies associated with product approval. As per our analysis, we expect the overall medical device […]
The medical device CRO domain is witnessing significant consolidation activity since the past few years. This can be attributed to the rise in competition within this domain, which has further compelled medical device service providers to diversify their portfolios through mergers and acquisitions. More than 35 instances of mergers and acquisitions have been reported in […]
The number and geographical distribution of clinical trials are important indicators of both therapeutic viability and future potential of innovative pharmacological interventions and medical devices. Pharmaceutical / medical device companies are likely to invest in conducting extensive clinical studies on only those devices that are likely to translate into commercial success stories. Moreover, the geographical […]
Brand positioning analysis of the key industry players helps to develop an understanding on how the brands of companies are currently perceived / positioned in different market segments relative to their competitors. In addition, this analysis can help players to determine improvement areas by identifying gaps between their existing capabilities as well as recognize ways […]
Competitive benchmark analysis allows the companies to compare their existing capabilities within their respective peer groups (based on company size and location of headquarters) and thereby, identify ways to gain a competitive edge in the industry. In addition, this analysis can be used by companies to spot potential improvement areas by identifying gaps between their […]
Over the last decade, there has been a change in the nature of outsourcing relationships. Associations between sponsor companies and service providers have evolved from one-time contracts to long-term strategic alliances. In addition, with constant updates in regulations in the medical devices industry, innovator companies are increasingly opting to partner with experienced contract service providers […]
Technical advances and innovation in design within the medical devices industry have prompted regulatory authorities to update the laws governing various aspects of the development, manufacturing, design and approval of such products. Further, it is imperative that various stages of medical device development and production are closely monitored and regulated in order to avoid serious […]
During our research, we were able to identify over 250 industry players that presently claim to offer contract services for clinical development of medical devices. In addition, there are more than 40 companies that are presently offering contract services for preclinical development of medical devices. The market is currently dominated by the presence of very […]
Numerous scientific and technological breakthroughs in the medical device industry, over the past decade, have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for advanced and minimally invasive medical devices has been augmented due to the increase in expenditure on healthcare. However, one of the primary challenges faced […]
The pharmaceutical industry witnessed a gradual increase in the adoption of autoinjectors for drug delivery. These devices can be designed / modified to cater to drug specific administration requirements; as a result, autoinjectors are being used for dosing purposes for a variety of drugs, including epinephrine, insulin and human growth hormones, and therapies for fertility […]
Over the years, monetary assistance from angel investors, venture capitalists and funding schemes of various public and private organizations / funds, along with assistance from regulatory authorities, have allowed start-ups / small companies to further their R&D efforts related to the ADC therapeutics. In this chapter, we have reviewed the various capital investments that have […]
The pharmaceutical sector is one of the few industries that has been relatively less impacted amidst the COVID-19 pandemic. As the disease spreads, the demand for accurate diagnostic measures, and effective preventive and treatment solutions for COVID-19, is growing at a rapid pace. At the time of writing this article, more than 70 vaccines and […]
Given the growing preference for outsourcing in the pharmaceutical industry, it is imperative for stakeholders to be able to draw a distinction between making a product (insourcing) or buying it from a third-party supplier (outsourcing). The same paradigm is applicable to services as well.  Over the last few decades, there has been a lot of […]
An informed capability assessment of different geographies, such as North America, Europe and Asia Pacific, is based on a variety of relevant parameters, such as number of CMOs, number of clinical sites, number of completed / active / planned clinical trials, number of patients enrolled, number of manufacturing facilities, number of CMOs offering manufacturing for […]
The number and geographical distribution of clinical trials are important indicators of both the therapeutic viability and future potential of innovative pharmacological interventions. These trials enable CDMOs / CMOs to estimate the clinical demand of peptide therapeutics across different geographies, therapeutic areas and trial phase. Moreover, the geographical distribution is a direct indicator of the […]
During our research, we came across several partnerships and collaborations that have been inked, during the period 2014-2019, between various stakeholders involved in the peptide therapeutics contract manufacturing domain. Of which, the manufacturing and supply agreements emerged as the most popular type of partnership model adopted by companies engaged in this domain, representing 35% of […]
Several industry players have established peptide manufacturing facilities across the world. During our research, we came across North America and Europe emerged as the current manufacturing hub for peptides, as 75% of the total facilities are presently located in these regions. Various companies were found to be involved in the manufacturing of peptide APIs, while […]
The introduction of insulin therapy in the 1920s, for the treatment of diabetes, marked the beginning of the therapeutic use of peptides. Presently, peptide-based therapeutics represent a prominent class of therapeutic interventions. Currently, many peptide therapeutics are being developed for the treatment of oncological disorders. In fact, in 2018, about 75% of such therapeutic products […]
Rising complexities related to handling and administration of novel / advanced therapeutic options, have caused many device developers to outsource certain aspects of their businesses to contract service providers. Moreover, development process of drug delivery devices, such as high-volume injectors, involves multiple components (including electronic and mechanical modules), which need to have an appropriate design […]
Currently, three drug-device combinations, namely Herceptin® SC Injector (Roche),  Neulasta® (pegfilgrastim) OnPro™ Kit (Amgen / Insulet) and Repatha® Pushtronex™ System (Amgen / West Pharmaceutical Services) have received USFDA approval and  D-Mine® Pump (EVER Pharma / Sensile Medical) has received the CE approval. The market is poised to witness significant growth as several more large volume […]
To meet the increasing demand for patient-friendly and safe options for drug administration, the drug developers are expected to broader their portfolio of drug candidates to make them favorable for delivery through self-injection systems. We identified several parameters which affect the likelihood of the drug to be delivered via the large volume wearable injectors. These […]
With the increase in popularity of self-injection devices, several industry stakeholders have attempted to innovate the devices by incorporating advanced features to improve patient compliance and ensure accurate dosing. The ongoing R&D activity in this domain has led to a significant increase in the number of patents filed / granted associated with novel large volume […]
Stakeholders in the pharmaceutical and medical-device development industry are known to adopt a variety of partnership models to collaborate with other companies / organizations. Such deals are inked to not only allow companies to expand their respective product / service portfolios, but also gain additional capabilities in emerging technologies. In the domain of large volume […]
Given the multifaceted advantages of large volume wearable injectors, the field has witnessed an increase in the number of players involved in the development of such devices. The domain features the presence of over 35 companies which are involved in the development of over 70 large volume wearable injectors for the delivery of insulin and […]
Over the past few years, there has been an evident shift towards the self-administration of drugs / therapies. This is largely attributed to the several limitations associated with the conventional drug delivery systems, such as chances of dosing / medication errors, possible risk of microbial contamination, needlestick injuries, and affiliated costs (of diagnosing and treating […]
China is a giant market buoyed with international scientific and technical capabilities in biopharmaceuticals. However, various challenges associated with the development process of biologics, such as complex stages of manufacturing, limitations of analytical sciences, lack of incentives and the current statutory and regulatory framework, have contributed heavily to the demand for consistent evolution of product […]
There has been an evident increase in the overall popularity of biopharmaceuticals. In fact, the pipeline of niche biopharmaceutical classes is growing at a relatively fast pace, which is closely matched by the entry of several biosimilar versions of products that have lost marketing exclusivity. Overall, the need for manufacturing biologics has grown significantly, creating […]


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