RootsAnalysis

RootsAnalysis's articles

EXPANSION OF THE PRESENCE OF SEVERAL WELL-ESTABLISHED PLAYERS ACROSS THE GLOBE WITH NORTH AMERICA EM

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 […]

ANTISENSE OLIGONUCLEOTIDE THERAPEUTICS – MARKET LANDSCAPE

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 […]

DIGITAL SOLUTIONS FOR BIOMARKERS – CURRENT MARKET LANDSCAPE

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 […]

PRESENCE OF MORE THAN 225 MANUFACTURING EXPERTS DEMONSTRATES THE RISING POPULARITY OF GENETICALLY MO

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 […]

ANTISENSE OLIGONUCLEOTIDE THERAPEUTICS MARKET

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 […]

Digital Solutions for Biomarkers Market

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 […]

Medical Device CROs Market: Future Trends and Opportunities

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 […]

Impact of Coronavirus Outbreak on Medical Device Industry

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, […]

Medical Device CROs Market: Current and Future Market Opportunity Across Key Market Segments

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 […]

Over the Years, the Domain has Witnessed an Increase in Merger and Acquisition Activity, With Many CROs Expanding Their Presence Across Multiple Geographies And Growing Their Respective Service Portfo

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 […]

Since 2015, Over 7,500 Medical Device Focused Clinical Trials, Involving the Participation of Close to 2.9 Million Patients Across Different Hospitals / Medical Centers, have been Registered Worldwide

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 […]

Several Companies in this Domain have Established Strong Brand Positions Across Different Regions; In Future, Such Companies are Anticipated to Contribute the Most to the Overall Revenue Generation Po

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 […]

Owing to the High Competition in this Field, Stakeholders are Steadily Expanding Their Capabilities in Order to Augment Their Respective Service Portfolios and Also Comply to Evolving Industry Benchma

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 […]

Medical Device Developer and CRO Relationships: Key Value Drivers and Performance Indicators

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 […]

Regulatory And Reimbursement Landscape For Medical Devices

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 […]

Over 300 CROs Presently Claim to Possess the Necessary Capabilities to Offer a Wide Range of Preclinical and Clinical Research-Related Services to Medical Device-Focused Business Entities

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 […]

Medical Device CROs Market – The Next Growth Opportunity

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 […]

Owing to the Complexities Associated with the Manufacturing and Assembly of Autoinjector Drug Delivery Systems, Industry Players are known to Frequently Engage the Services of Contract Service Provide

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 […]

Several Investors have Realized the Opportunity within this Upcoming Segment (Antibody Drug Conjugates) of Targeted Cancer Therapeutics Industry

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 […]

Peptide Therapeutics: Contract API Manufacturing Market-Impact of COVID-19 Pandemic

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 […]

Peptide Therapeutics: Contract API Manufacturing Market-Outsourcing versus In-House Manufacturing, Decision Making

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 […]

Geographical Estimation of the Peptide API Contract Manufacturing Market

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 […]

Peptide Therapeutics: An Analysis on the Clinical Trials

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 […]

Peptide Therapeutics: Contract API Manufacturing Market- Recent Partnerships, Expansions and Innovative Technologies

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 […]

Peptide Therapeutics: Contract API Manufacturing Market- Likely Evolution of the Different Regions

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 […]

An Overview of Peptide Therapeutics and its Contract Manufacturing Market

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 […]

Case Study: Several stakeholders have engaged the services of CMOs to cater to the complexities related to manufacturing and assembly of large volume wearable injectors

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 […]

Large Volume Wearable Injectors: Current and Future Market Opportunities Across Key Market Segments

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 […]

Close to 200 Marketed and Pipeline drugs have the potential to be formulated for delivery via the Large Volume Wearable Injectors

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 […]

Status of Patents that have been Filed / Granted in the Large Volume Wearable Injectors Domain related to Pharmaceutical and Biopharmaceutical Industry

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 […]

The Increasing Traction in the Field of Large Volume Wearable Injectors is Reflected in the Partnership Activity Focused on the delivery of both insulin and non-insulin drugs, Involving Stakeholders a

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 […]

Large Volume Wearable Injectors Market – Market Landscape (non-insulin delivery devices, insulin delivery devices and Drug Device combinations)

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 […]

Large Volume Wearable Injectors – A Breakthrough in the field of self-injection devices and the Growing Future Potential

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 […]

Future of the China Biopharmaceutical CMO Market

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 […]

Determining the Strength, Weakness, Opportunities and Threats related to China Biopharmaceutical Contract Manufacturing Market

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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