The viral vector, non-viral vector and gene therapy manufacturing market is projected to grow at a CAGR of ~15% till 2035, claims Roots Analysis

Rise in clinical research activity for genetically modified therapies has resulted in the increase in demand for vectors, offering lucrative opportunities to players having capabilities for in-house and contract manufacturing of various types of vectors.

Roots Analysis has announced the addition of “Viral Vector, Non-Viral Vector and Gene Therapy Manufacturing Market (5th Edition), 2022-2035” report to its list of offerings. Over the past few years, cell and gene therapies have gained significant popularity owing to their therapeutic potential.

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SEVERAL PHARMACEUTICAL COMPANIES HAVE DEMONSTRATED A PREFERENCE TO OUTSOURCE THEIR PATIENT RECRUITMENT OPERATIONS

Clinical trials form an essential part of the overall drug development process, evaluating the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of a drug candidate is dedicated to clinical trials.

However, the conduct of such trials is often fraught with challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. Further, owing to the inherent complexity of the overall process and involvement of several different stakeholders, these trials are prone to delays.

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The ADC contract manufacturing market is projected to grow at a CAGR of more than 13% till 2035

Owing to the fact that a number of ADC developers are outsourcing various aspects of their business processes, CMOs engaged in this domain have undertaken several expansion initiatives to become one-stop-shops to cater to the diverse needs of ADC developers.

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Roots Analysis has announced the addition of “ADC Contract Manufacturing Market (5th Edition), 2022-2035” report to its list of offerings.

In order to mitigate the challenges associated with Antibody Drug Conjugate manufacturing, around 70-80% of the therapeutics developers prefer to outsource their operations to contract manufacturing organizations (CMOs), which claim to have the required expertise and experience to leverage their capabilities and yield cost savings opportunities.

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MANUFACTURING EXECUTION SYSTEM PROVIDERS IN HEALTHCARE MARKET

Every year, the healthcare industry generates a massive amount of data. In fact, the healthcare data currently constitutes around 30% share of the global data volume. Further, it is estimated that, by 2025, the data generated via the healthcare sector will rise at a compound annual growth rate of 36%.

It is important to consider that the constant management of such enormous volumes of data is a quite tedious process and challenging process. Specifically, management and handling of huge datasets in the healthcare industry often requires a large workforce of specialized personnel. According to the American Hospital Association, by 2026, there is likely to be a shortage of 3.2 million healthcare workers.

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THE INTRICACIES ASSOCIATED WITH CELL THERAPY MANUFACTURING HAVE PAVED THE WAY FOR NOVEL AUTOMATION TECHNOLOGIES

Over the years, several advanced and innovative automation tools and technologies have been developed; these have been demonstrated to hold the potential for significant reduction in the cost associated with the manufacturing of advanced therapy medicinal products, thereby, making such products more affordable.

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is important to mention that we have forecasted the evolution of the overall cell therapy manufacturing market, focusing on T-cell immunotherapies, dendritic cell therapies, NK cell therapies and stem cell therapies.

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The companion diagnostics development services market, is anticipated to grow at a CAGR of over 10%

Given the various challenges associated with co-development of companion diagnostics and drug / therapy, drug developers prefer to rely on third-party service providers that offer customized services and advanced technologies.

The growing pipeline of patient-centric targeted therapies has led to a surge in demand for companion diagnostics; these tests are known to improve the success rates of late-stage trials by almost three-fold. The development and approval of these FDA classified high-risk devices requires multidisciplinary expertise and an established network of R&D and production facilities that can be accessed through service providers.

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The biopharmaceutical contract manufacturing market is projected to grow at a CAGR of 10% during 2022-2035, claims Roots Analysis

With the advent of novel technologies and rising preference for such therapeutic interventions, biologics have made a significant impact in the pharmaceutical domain, delivering a ground-breaking treatment regimen for a myriad of disease indications.

In pursuit of both time and cost savings, as well as to access higher scales of production, outsourcing has emerged as a lucrative option for biologic drug developers. Driven by several blockbuster products, a burgeoning pipeline of biologic drugs, the demand for reliable contract service providers, which have the required expertise and advanced manufacturing capabilities, is expected to grow at a commendable pace in the coming years.

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The pharmaceutical secondary packaging market is projected to grow at an annualized rate of 7.6%

In order to avail benefits, such as higher flexibility, reduced cost and assistance in meeting the rising demands, several pharmaceutical companies have demonstrated a preference to outsource their secondary packaging requirements to contract packaging organizations.

The anticipated growth in the therapeutics pipeline is likely to translate into a significant rise in the demand for cost-effective and quality secondary packaging solutions, presenting lucrative opportunities for contract packaging organisations. Driven by the growth of the overall pharmaceutical industry and increasing preference of drug developers for outsourcing certain operations, the secondary packaging providers market is expected to witness a steady increase.

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The site management organizations (SMO) market is projected to grow at an annualized rate of ~10% during the period 2021-2035, claims Roots Analysis

The rapidly growing clinical pipeline and challenges associated with the conduct of clinical trials in a cost and time effective manner, has presented lucrative opportunities for service providers with expertise in clinical trial site management

In recent years, drug / device developers have demonstrated a preference to continue relying on SMOs for conducting clinical trials in order to significantly optimize trial cost and research timelines. Driven by the steady growth in clinical research activity and inherent benefits offered by Site management organizations (SMO), the market opportunity for such players is projected to grow at a significant pace in the foreseen future.

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The companion diagnostics development services market, is anticipated to grow at a CAGR of over 10%, till 2035

Given the various challenges associated with co-development of companion diagnostics and drug / therapy, drug developers prefer to rely on third-party service providers that offer customized services and advanced technologies.

The growing pipeline of patient-centric targeted therapies has led to a surge in demand for companion diagnostics; these tests are known to improve the success rates of late-stage trials by almost three-fold. The development and approval of these FDA classified high-risk devices requires multidisciplinary expertise and an established network of R&D and production facilities that can be accessed through service providers.

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SINGLE-USE SENSORS FOR BIOPROCESSING MARKET– CURRENT AND FUTURE MARKET POTENTIAL

The sensors can be classified based on the type of variables measured, which include chemical variables (pH, dissolved oxygen or substrate or product concentration), physical variables, and biological variables.

Sensors are used to detect events or changes in environment parameters during a bioprocess control. These sensors can also be classified on the basis of different principles used for measuring the variables, such as electrochemical sensors, optical chemosensor systems, optical spectroscopic sensors, and calorimetric sensors.
Further, sensors can be classified on the basis of their placement and integration within the bioreactor. sensors and controllers can be submerged in a liquid phase inside the bioreactor, placed with no physical connection to the bioreactor.

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MANUFACTURING EXECUTION SYSTEM PROVIDERS IN HEALTHCARE MARKET

Every year, the healthcare industry generates a massive amount of data. In fact, the healthcare data currently constitutes around 30% share of the global data volume. Further, it is estimated that, by 2025, the data generated via the healthcare sector will rise at a compound annual growth rate of 36%.

It is important to consider that the constant management of such enormous volumes of data is a quite tedious process and challenging process. Specifically, management and handling of huge datasets in the healthcare industry often requires a large workforce of specialized personnel. According to the American Hospital Association, by 2026, there is likely to be a shortage of 3.2 million healthcare workers.

For additional details, please visit
https://www.rootsanalysis....

The needlestick safety injection devices market is anticipated to grow at a commendable pace by 2035

An exponential increase in the annual cost burden due to needlestick injuries, has fueled a corresponding rise in demand for safe and highly advanced safety devices to be developed by the stakeholders engaged in the healthcare industry to generate a stringent regulation for the prevention of needle-stick injuries.

Given the inherent benefits of needlestick safety injection devices, number of developers have launched their proprietary devices for minimizing the risk of needlestick injuries. Moreover, stringent regulatory requirements have further prompted the stakeholders to improve product design and integrate better safety measures in their products, including needle shielding.

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The mini bioreactors and microbioreactors market is anticipated to grow at an annualized rate of 8% till 2035, claims Roots Analysis

Given the need for accelerated bioprocessing operations, low-volume bioreactors have emerged as a relatively economic solution for parallelized cell cultivations and applications ranging from media development to process optimization.

Mini bioreactors and microbioreactors enable faster experimental throughput at relatively lower costs and allow bioprocessing of samples, thereby reducing the downtime and increasing the number of batches produced in a given period of time. Moreover, stakeholders in this domain are also focused on incorporating a variety of features for monitoring of different control parameters, such as CO2 levels, dissolved oxygen, in order to analyze and optimize the overall performance.

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RNAI THERAPY OFFERS THE POTENTIAL TO REVOLUTIONIZE THE BIOPHARMACEUTICAL INDUSTRY

Owing to their vast potential in controlling disease-associated gene expression, RNAi therapeutics have emerged as a key segment of the market; several big pharma players have undertaken RNAi focused initiatives.

In addition to effective gene silencing, these candidates can be deployed for applications related to precision medicine. Studies have also demonstrated the safety of RNAi therapeutics for in systemic delivery, paving the way for systemic applications of the therapy. A number of novel and sophisticated technologies / platforms have been / are being developed to overcome the challenges associated with RNAi therapeutics, as well as further enhance their specificity and stability.

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The taste masking market is anticipated to grow at a steady pace till 2035, claims Roots Analysis

Driven by the growing need to enhance palatability of oral drugs and drug adherence among pediatric and geriatric population, the demand for novel and advanced taste masking and taste assessment technologies is expected to rise in the coming years.

The inherent expertise of CMOs and CDMOs in taste masking and taste assessment of bitter drug formulations, along with capabilities to identify globally accepted tastes, develop flavor matching placebo formulations (for testing) having compliance with stringent regulatory guidelines and good clinical practices (GCPs) and proprietary technologies offering significant cost-benefits, have rendered outsourcing as a crucial aspect of taste masked formulation development and production.

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Steadily growing demand for biologic fill / finish services has generated a range of new opportunities for contract service providers

The current landscape of biologics fill / finish contract service providers features the presence of several established and emerging players, with a diverse set of production capabilities. The fill / finish services market is presently dominated by service providers (more than 95) based in North America and Europe.

It is worth highlighting that some of these players operate fill / finish facilities in emerging regions of Asia-Pacific as well. Examples of such companies include (in alphabetical order) Boehringer Ingelheim, Hisun Pharmaceuticals USA, Lonza, PCT and Recipharm.
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The human microbiome market is anticipated to grow at a CAGR of 24% till 2035

With the increasing concept of precision medicine, several scientists have demonstrated interest in the therapeutic manipulation of human microbiome (commonly gut bacteria) for the treatment of a wide range of disease indications.

The microbiome-based therapies pipeline features six drugs in phase III clinical development, over 200 candidates in other clinical and preclinical stages of development along with more than 60 diagnostics and screening / profiling tests that are commercialized for the detection of various diseases. However, the current microbiome market is driven by the fecal microbiota therapies approved by the FDA, particularly for the recurrent CDI and the commercialized diagnostic tests available to the patients.

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Oral Proteins and Peptides Market

Over the years, advances in recombinant DNA technology and ex vivo synthesis of biomolecules have led to the development and (in some cases) approval of several protein / peptide-based therapeutics.

Considering the therapeutic advantages associated with proteins and peptides, this field has witnessed significant activity; researchers are actively evaluating orally bioavailable interventions. However, owing to their inherently complex structure and comparatively low stability (in in vivo conditions), proteins / peptides are predominantly administered parenterally.

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The needlestick safety injection devices market is anticipated to grow at a commendable pace by 2035

An exponential increase in the annual cost burden due to needlestick injuries, has fueled a corresponding rise in demand for safe and highly advanced safety devices to be developed by the stakeholders engaged in the healthcare industry to generate a stringent regulation for the prevention of needle-stick injuries.

Roots Analysis has announced the addition of “Needlestick Safety Injection Devices Market, 2022-2035” report to its list of offerings.

Given the inherent benefits of needlestick safety injection devices, number of developers have launched their proprietary devices for minimizing the risk of needlestick injuries.

For additional details, please visit https://www.rootsanalysis....

The cell invasion and migration assays market is projected to grow at a CAGR of 8%

In recent years, the potential of cell invasion and migration assays with respect to discovery, diagnosis and screening of diseases has been widely recognized, which has further presented lucrative opportunities for players offering such products.

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Roots Analysis has announced the addition of the “Cell Invasion and Migration Assays Market, 2022–2035” report to its list of offerings.
Owing to several advantages offered by cell invasion and migration assays in analyzing and quantifying cellular mechanisms, industry stakeholders have undertaken numerous R&D initiatives focused on exploiting the use of such assays to expediate discovery timelines and optimize the total development cost.

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The RNA sequencing services market is anticipated to grow at a CAGR of ~8% by 2035

In order to avail benefits, such as technical competence in sequencing large-sized genes, reduced cost, and fast delivery of high-quality data, researchers and industry players have demonstrated a preference to outsource RNA sequencing.

Roots Analysis has announced the addition of “RNA Sequencing Services Market, 2022-2035” report to its list of offerings.

Despite the various technological advancements in RNA sequencing, there are several existing challenges, including difficulty in the sequencing of large-sized genes, shortage of human resources, lack of tools for data manipulation and analysis, and high capital requirement.

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The adeno-associated viral vector market is anticipated to grow at a CAGR of more than 10% by 2035

Given their low immunogenicity, diversified targets and ability to offer higher biosafety, the adeno-associated viral vectors are actively being evaluated for the development of various therapies for the treatment of chronic diseases and infections.

Owing to their unique biology, simple structure and lack of disease correlation, the adeno-associated viral vectors have garnered significant interest within the medical community. In fact, various adeno-associated viral vector-based therapies have been developed for the treatment of multiple indications, including retinitis pigmentosa, cystic fibrosis and Duchenne muscular dystrophy.

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VIRAL VACCINE CELL CULTURE MEDIA: OVERALL MARKET LANDSCAPE

Innovation is considered to be one of the key drivers of the pharmaceutical industry. Over the past few decades, various technological advances and a few fortuitous discoveries have significantly changed the practice of medicine. One such advancement that came into light was the development of vaccines, which have demonstrated significant therapeutic potential.

Over time, vaccine research has evolved significantly, which is now being driven by several innovative technologies, including those involving the use of recombinant deoxyribonucleic acid (DNA) and nucleic acids. Further, with the discovery of more disease targets, players engaged in vaccine development have shifted their focus towards the development of vaccines that target a myriad of disease indications other than infectious diseases.

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The novel cardiovascular drug delivery devices market is projected to grow at a CAGR of 9.3%

Given the growing number of patients suffering from cardiovascular disorders and the high associated financial burden, cardiovascular drug eluting stents have emerged as a safe and efficient novel drug delivery device to assist in providing effectual treatment.
In order to prevent the critical effects of vessel narrowing and plaque buildup in arteries, various coronary interventional devices are being used; cardiovascular stents have emerged as one of the most preferred solutions to mitigate the aforementioned concerns. Traditionally, bare-metal stents were used extensively to open the blocked passages and restore adequate blood flow to the heart.

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The needlestick safety injection devices market is anticipated to grow at a commendable pace by 2035

An exponential increase in the annual cost burden due to needlestick injuries, has fueled a corresponding rise in demand for safe and highly advanced safety devices to be developed by the stakeholders engaged in the healthcare industry to generate a stringent regulation for the prevention of needle-stick injuries.

Given the inherent benefits of needlestick safety injection devices, number of developers have launched their proprietary devices for minimizing the risk of needlestick injuries. Moreover, stringent regulatory requirements have further prompted the stakeholders to improve product design and integrate better safety measures in their products, including needle shielding.

For additional details, please visit https://www.rootsanalysis....

AROUND 70% OF RNA EXTRACTION AND PURIFICATION KITS DEPLOY SPIN COLUMN TECHNOLOGY FOR EXTRACTION AND PURIFICATION OF RNA

Amongst the total players involved in the development of RNA extraction and purification kits and reagents, majority of the players engaged in the development of RNA extraction and purification kits were established between 1981-2000.

During our research, we were able to identify more than 60 developers were involved in the development of RNA extraction and purification kits and reagents. The RNA extraction and purification kits market is currently dominated by the presence of small companies. This is followed by the presence of well-established players in this domain.

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APTAMERS: THERAPEUTICS, TECHNOLOGIES, AND SERVICES MARKET

Aptamers have gained a lot of momentum in the past decade. It is worth highlighting that in 2005, Macugen became the first and the only USFDA approved aptamer drug for treating age-related macular degeneration (AMD).

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The companion diagnostics development services market, is anticipated to grow at a CAGR of over 10%

Given the various challenges associated with co-development of companion diagnostics and drug / therapy, drug developers prefer to rely on third-party service providers that offer customized services and advanced technologies.

For additional details, please visit
https://www.rootsanalysis....

The Artificial Intelligence in Oncology market is anticipated to grow at a CAGR of 54% claims Roots Analysis

The success of currently employed artificial intelligence (AI) solutions has encouraged researchers to explore the potential of such technologies in the healthcare sector, with its prime focus being oncology, to enable the treatment of several prevalent malignancies.

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