DRIVEN BY THE GROWING DEMAND FOR MEDICAL DEVICES, NOVEL COATINGS PROVIDING UNIQUE FEATURES ARE BEING INTRODUCED IN THE MARKET

Over the past 50 years, the medical device industry has seen several notable developments. In fact, the use of biomedical devices, such as medical implants, surgical instruments, and prostheses has increased substantially over the time.

Cardioverter defibrillators, prosthetic hips and knees, contact lenses, and cardiac pacemakers are some of the most commonly implanted medical devices, while fixation devices and artificial joints account for about 44% of all medical devices. Despite significant advancements in the design and implantation of medical devices, a number of challenges still persist. Patients, particularly those who are immunocompromised, are at high risk of healthcare-associated infections (HAIs) due to the in-dwelling nature of implanted devices and surgical tools. The risk of infections along with limitations including, implant rejection, osseointegration, degradation and wear, loom over the prosthetic integration. Coatings on biomedical implants can affect this biological interaction between the implant and host, mitigate joint wear, and combine the properties of several materials to enhance device performance as well as reduce the risks associated with invasive medical devices. Medical device coatings also endow properties like lubrication, anti-fouling nature, as well as enhanced durability to the surface of the device. Driven by the surge in demand for various types of medical devices and the need for a wide array of coatings for these devices, the medical device coatings market is anticipated to witness a steady growth in the coming decade.

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One of the key challenges associated with in-dwelling medical devices lies in the fact that they are in constant association with the bodily fluids, therefore, interacting with a wide variety of proteins and other biomolecules. This results in denaturization of the biomaterials over time, reducing the overall functional life of the device. As a counter to this problem, surface modification can be utilized. Generally, protein adsorption and biological interactions are significantly impacted by the biomaterial surface modifications, such as modifying the chemistry of polymers, coefficient of friction, domain layout, and shape. Surface modifications, such as plasma spraying, vacuum depositions, etching, and electro-depositions are some of the most frequently procedures to achieve the necessary alterations on medical device surfaces.

Various medical devices are associated with the risk of infections, cytotoxicity, thrombogenesis, and immune rejection, which has garnered the attention towards appropriate selection of suitable biomaterials and strategies for modifying the medical devices surface. One of the key developments in the area has been made in creating non-fouling / antibacterial surfaces. A breakthrough in this field has been witnessed in graphene coatings developed to elicit antimicrobial properties. As an alternative to the use of silver nanoparticles earlier, the use of graphene in healthcare applications has a promising future, given the fact that graphene would provide more secure antibacterial properties than metal nanoparticles along with cost efficiency. The detailed competitiveness analysis of various medical device coating providers identified during our research, which are based in North America, Europe, and Asia.

Integration of new technologies like advanced laser processing, machine learning, and automation using Artificial Intelligence (AI) also drives the field towards more precise and reproducible coating / surface treatment applications, which can revolutionize the biomedical devices industry.

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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
+44 (122) 391 1091
Ben.johnson@rootsanalysis.com

The mRNA synthesis and manufacturing market is projected to be worth USD 1.5 billion by 2035, claims Roots Analysis

Given the current technical and operational challenges associated with the manufacturing of mRNA-based products, innovators in the biopharmaceutical industry are increasingly relying on the mRNA synthesis and contract manufacturing service providers.

Roots Analysis has announced the addition of “mRNA Synthesis and Manufacturing Services Market (2nd Edition), 2022–2035” report to its list of offerings.

Owing to the recent success and growing pipeline of mRNA-based products in the market, mRNA, as a therapeutic agent, has gained significant traction from the medical community. However, due to challenges, such as high capital requirement, stringent regulations and lack of technical expertise, outsourcing has become a preferred business model and CMOs are upgrading their existing capabilities and service portfolios to meet the increased demand for mRNA-based products.

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Key Market Insights

Presently, 30+ companies claim to offer custom synthesis services for mRNA, globally.
Majority of the service providers are mid-sized players (44%), followed by small (35%), large (12%) and very large players (9%). Additionally, more than 25% of the stakeholders were established post 2010. It is also worth mentioning that over 50% of the total players are based in North America, specifically in the US.

More than 40 companies, across the globe, claim to provide contract manufacturing and fill / finish services for mRNA vaccines / therapeutics.
Of the aforementioned players, nearly 85% of the contract manufacturing service providers are based in North America and Europe. Notably, more than 50% of the total players engaged in this space offer services for drug substance (APIs) manufacturing.

Currently, more than 95 mRNA synthesis kits are available in the market.
Close to 70% of the mRNA synthesis kits contain capping enzymes; of these, 96% use T7 RNA polymerase enzyme mix for the synthesis of modified mRNAs. It is worth highlighting that majority (54%) of the kit developers are small players.

More than 170 clinical trials have been registered for the evaluation of mRNA-based therapeutics / vaccines, worldwide.
The clinical research activity, in terms of number of trials registered, is reported to have increased at a steady CAGR of 44%, during the period 2017-2022. Of the total number of trials registered, close to 22% have already been completed, while 46% of the studies are actively recruiting participants.

Partnership activity within this domain has grown at a CAGR of 60%, between 2019 and 2022.
Nearly 34% of the deals were inked in 2021. Majority of the instances captured in the report were manufacturing agreements, representing 22% of the total partnerships. Further, most of the intercontinental deals have been inked by players based in North America.

North America and Europe are anticipated to capture close to 65% of the global market share, by 2035.
The market in Asia Pacific is likely to grow at the highest CAGR during the period 2022-2035. In terms of type of product, drug substance (APIs) is expected to occupy a larger share (70%) of the overall mRNA synthesis and manufacturing service market in 2035.



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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

LONG-ACTING DRUG DELIVERY TECHNOLOGIES AND SERVICES

Long-acting drug delivery has emerged as the novel and advanced drug delivery system which manipulate the dosing regimen of the drug in the body in order to sustain its therapeutic level.

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases. The long-acting delivery of drug candidates confers several advantages, such as improved patient compliance, reduced dosage requirement, better medication adherence, decrease in failure risk due to inconsistent usage and more convenience to patients. In addition, long acting drug delivery formulations can improve the chemical stability, solubility and polymorphic transformation issues of the active pharmaceutical ingredients.

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Lately, many technologies are being explored to develop long-acting drugs in various dosage formats, such as long-acting injectables, depot injections, implantable devices and combination products. The long-acting drug delivery technologies have come a long way with the inclusion of liposomes, microspheres and polymers for the fabrication of biodegradable and biocompatible delivery system. Apart from this, the interdependency of drug, excipient and release environment plays a crucial role to decide the release kinetics of the drug. Long-acting formulations are more patient compliant, in terms of sharp reduction in the dosing regimen. These drugs are administered infrequently (ranging from once weekly to yearly) owing to the prolonged drug release after a single shot.

The technological advancements for the long-acting profile of the drugs (small molecules, peptides, biologics) have led to the rise in number of novel therapeutics in the market along with the growing number of long-acting molecules in the clinical development pipeline. Of late, the demand for the availability of long-acting vaginal rings as multipurpose prevention technologies for women is also surfacing. Further, the pharmaceutical industry is extensively focusing on the development of long-acting injectables for protein-based drugs and multidrug therapies. Moreover, the potential of long acting injectables is being explored in several debilitating chronic diseases, such as Alzheimer’s, Parkinson’s disease, blindness and HIV. Owing to the advanced LADD technologies, formulation and developmental challenges associated with these complex dosage forms, the reliability on the stakeholders having the expertise in this domain has upsurged. This will eventually aid the drug developers to address the bottlenecks stemming from conventional treatment options and improve the clinical outcome.

For additional details, please visit
https://www.rootsanalysis.com/....reports/long-acting- or email sales@rootsanalysis.com

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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

TIL-BASED THERAPY: AN INNOVATIVE WAY TO TREAT SOLID TUMORS

Modified tumor-infiltrating lymphocytes (TIL)-based interventions have emerged as a viable and potent option to selectively eradicate the tumor population, with minimal side effects.

Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority (over conventional treatment options) of TIL therapies . Their tumor-cell killing efficiency is attributed to the fact that they are pre-sensitized to cancer specific antigens. Additionally, this emerging class of biologics is believed to possess the potential to cater to the unmet pharmacological needs, across both oncological and non-oncological disorders, even those where small molecule drugs have proven to be inadequate.

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Over the years, various studies have validated the successful use of tumor-infiltrating lymphocytes (TILs) in treating patients diagnosed with refractory diseases. TILs are a heterogeneous population of mononuclear lymphocytes that comprise of T-cells, B-cells, NK cells and macrophages isolated from the tumor. These lymphocytes selectively mediate the elimination of tumor cells. Ongoing and planned clinical research initiatives in this direction are driven by encouraging results achieved in past trials, which were mostly focused on various solid tumors. Driven by the ongoing pace of innovation in this field, sufficient financial support from investors and encouraging clinical trial results, the TIL-based therapy market is likely to witness significant growth in the foreseen future. With a growing focus on the development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of 40% in the next decade. Specifically, in terms of target indication, the market is anticipated to be driven by therapies being developed to target melanoma and head and neck carcinoma. Additionally, close to 90% of the market is anticipated to be captured by players based in North America and Europe, in 2035. Overall, we are led to believe that the global TIL therapies market is poised to witness significant growth in the foreseen future.

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https://www.rootsanalysis.com/....reports/til-therapie or email sales@rootsanalysis.com

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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

DIGITAL THERAPEUTICS - THE INCREASING REGULATORY SUPPORT HAS FACILITATED THE ESTABLISHMENT OF A STANDARD DEVELOPMENTAL PATHWAY FOR THESE SOLUTIONS

Digital Therapeutics, popularly known as DTx, represent a digital health solution which delivers medical interventions directly to the patients in order to treat, manage and prevent a disease. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications, providing motivational support and inculcating healthy lifestyle changes. Several organizations have undertaken diverse initiatives in the field of digital therapeutics to support its growth as a new frontier in the healthcare sector.

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Given the current activity in this domain and the growing demand for such solutions, the digital therapeutics market is likely to grow at a healthy pace over the next decade. Traversing a digital therapeutic from the R&D stage to the market is a long process. The various developmental stages involved in this process have been discussed in detail in the following sections.
 Discovery and Preclinical Phase: The discovery phase involves the identification of a novel digital therapeutic intervention. At this stage, researchers publish their work in academic journals and continue to investigate the potential applications of their digital solutions in disease treatment / management.

 Clinical Trials and Validation: This phase involves the conduct of proper clinical trials to validate the claims made by a digital therapeutic solution provider, and to evaluate its potential in a real-world setting. It includes testing of the digital therapeutics software / hardware on a specific patient population. In case of clinical studies, health outcomes are measured and tracked through data driven insights provided by the software. Disease specific improvements (post application / implementation of the intervention) are also tracked to evaluate the performance of a product.
 Negotiations with Insurance Providers / Payers: Post the successful completion of clinical studies, developer companies generally tend to avail reimbursement opportunities for their products in order to promote the use of their proprietary solutions and provide financial benefits to patients / consumers. As is the case with pharmacological interventions, reimbursement plans for these products can be achieved based on the outcomes of clinical trials and depending on the USFDA’s (or the concerned regulatory authority of a particular region) clearance. A number of health insurance providers, such as Medicare and Humana, are actively working to include digital therapeutics as a part of health insurance coverage plans for patients suffering from chronic diseases.

 Distribution and Marketing: The pharmaceutical and medical device distribution / marketing system is an established network with well-defined channels through which manufacturers can reach the end-users of their products. Product developers in this domain are presently looking to create a distribution network to sell their offerings in the market via both B2B (healthcare providers, regulators and payers) and B2C (customer) models.

For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com

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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com