The rise and challenges associated with development and testing of combination products

In the recent years, pharmaceutical developers have been engaged in the development of devices that can combine the drug and its drug delivery device, for delivering pharmaceutical drugs efficiently, as well as enable higher patient compliance rates.

These products, commonly referred to as combination products, have made a tremendous impact on the healthcare landscape in recent years, given their potential for significant therapeutic advantages over conventional dosage forms, maintaining dosage compliance, thereby improving patient experience.

In simpler terms, a combination product can be defined as a product which is composed of two or more pharmacological products. A combination product is comprised of two or more regulated components – drug / device, drug / biologic, or drug / device / biologic. Each drug, device, and biologic included in a combination product is referred to as a constituent part of the combination product. According to the United States Food and Drug Administration (USFDA), a combination product can be classified based on its constituent parts. The combination product services market is likely to witness a significant growth in the coming years.

To request a sample copy / brochure of this report, please visit
https://www.rootsanalysis.com/....reports/combination-

However, development and testing of combination products is a highly complex process, fraught with multiple of challenges, such as need for advanced technologies, consistent drug volume, multiple interactions between the drug and the device, and safety and efficacy-related issues. Given the growing demand for combination products and technical complexities associated with the manufacturing of such products, developers are increasingly relying on organizations that can provide services related to development and testing of combination products.

As highlighted above, there are various types of combination products and manufacturing platforms / technologies available for their production. The methods for manufacturing such complex products are usually associated with high degrees of complexity. It is worth mentioning that several contract organizations, across the globe offer a wide range of services to cater to the development / testing needs of various pharmaceutical companies. The presence of such organizations has significantly reduced commercial risk and deployment of capital to develop in-house facilities. According to our proprietary scoring criteria, very small / small - prefilled syringe combination product developers, are likely to have high value addition on outsourcing their product development and testing operations. The drug device combination product is used for delivery of biologics via the subcutaneous route.


Given the challenges associated with the development of combination products has increased the extent of outsourcing activity in this domain. Numerous service providers with varying strengths and capabilities, are contributing actively in the testing / development of the device constituent and / or the finished product. Driven by the growing demand for such advanced medical products, expanding existing capabilities and augmenting efforts to develop, test and pack combination products and contributions of several big pharma players. this market is anticipated to witness tremendous growth in the coming years.

For more information, please click on the following link:
https://www.rootsanalysis.com/....reports/combination-

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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

The bacteriophage therapeutics market is anticipated to grow at a CAGR of 10%, till 2035, claims Roots Analysis

Given the low toxicity, specific targeting and ability to offer higher biosafety, the bacteriophage therapeutics are actively being evaluated for the treatment of various infectious diseases

London

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

With the ever-increasing burden of antimicrobial resistance, the focus of the research community has shifted towards the development of alternatives for the treatment of infectious diseases. One of such alternatives is bacteriophage therapeutics. The innovators suggests that the success of these therapies lies in the effectiveness of phages to target the desired bacterial strains. With the growing need for therapies targeting AMR infections, bacteriophage therapy is now gaining more traction.


Key Market Insights

Close to 15 bacteriophage therapeutics are commercialized, while more than 90 are currently at different stages of development
Close to 50% of the pipeline candidates are under clinical evaluation; majority (91%) of these candidates are being developed for the treatment of infectious diseases, targeting wide range of bacterial strains.

40+ industry stakeholders claim to have the required capability to manufacture bacteriophage therapeutics
The bacteriophage therapy market is currently dominated by the presence of various small players (48%); of these 55% of the players are located in North America, followed by Europe (35%).

More than 2,200 articles focused on bacteriophage therapeutics have been published, since 2018
Around 40% of these were published in the last two years, indicating the extensive research activity being carried out in this domain.

Close to USD 1,200 million has been invested by both private and public investors, since 2017
Of the total amount invested, over USD 330 million was raised through venture capital funding, representing close to 30% of the overall funding activity in this domain. Further, close to 40% of the instances were, wherein players were collectively awarded more than USD 300 million.

Partnership activity within this domain has grown significantly between the time period, 2017-2021
Maximum number of partnerships were established in 2021, indicating a recent rise in the interest of players engaged in this domain. It is worth highlighting that, majority of the deals were related to the research and development (20%), followed by agreements signed for product development (15%).

More than 3,500 patients have been enrolled in over 40 clinical trials, worldwide
Clinical research activity, in terms of number of trials registered, is reported to has significantly increased in the past few years. Of the total number of trials, close to 35% have already been completed, while 41% are active and still recruiting patients.

Europe are anticipated to capture larger share (~95%) of the market by 2035
Currently, in bacteriophage therapeutics market, gastrointestinal infections capture the highest share (~50%) and this trend is unlikely to change in the foreseen future. Further, more than 55% share of the market is captured by oral bacteriophage therapeutics.


To request a sample copy / brochure of this report, please visit https://www.rootsanalysis.com/....reports/bacteriophag


Key Questions Answered
 Which bacteriophage therapeutics candidates are currently under clinical stage of development pipeline?
 Who are the leading players engaged in the development of bacteriophage therapeutics?
 Which geographies are the most active in conducting clinical trials related to bacteriophage therapeutics?
 What is the focus of various publications related to bacteriophage therapeutics?
 Which partnership models are commonly adopted by industry and non-industry stakeholders?
 What are the investment trends in the industry?
 What are the different initiatives undertaken by start-ups for the development of bacteriophage therapeutics in the recent past?
 How is the current and future market opportunity likely to be distributed across key market segments?


The financial opportunity within the bacteriophage therapeutics market has been analyzed across the following segments:
 Type of Therapeutic Area
 Gastrointestinal Infections
 Bacterial Dysentery
 Multiple Infections
 Other Infections

 Distribution by Route of Administration
 Oral Route
 Rectal Route
 Intravesical Route
 Topical Route

 Key Geographical Regions
 North America
 Europe
 Asia-Pacific
 Latin America
 Middle East and North Africa

The report features inputs from eminent industry stakeholders, according to whom upcoming generations of bacteriophage therapeutics are likely to garner significant interest among therapy developers and end users alike. The report includes detailed transcripts of discussions held with the following experts:
 Antoine Culot (Chief Executive Officer, Rime Bioinformatics)
 Mathieu Medina (Project Leader, Hospices Civils De Lyon)
 Iddo Weiner (Senior Director, Head of Data-Science, BiomX)
 Mohammadreza Azizkhani (Independent Consultant)

The research also includes detailed profiles of key players (listed below), featuring an overview of the company, its financial information (if available), detailed information on the advanced stage pipeline candidates and an informed future outlook.
 Adaptive Phage Therapeutics
 ContaFect
 Eliava BioPreparations
 Micreos
 NPO Microgen
 Phagelux
 Pherecydes Pharma

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

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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

The women’s digital health market is anticipated to grow at an annualized rate of more than 17% by 2035, claims Roots Analysis

The COVID-19 pandemic has led to an increase in the adoption of digital solutions, specifically among women, allowing remote monitoring of health and improvement in overall quality of life of the female population across all age groups

Roots Analysis has announced the addition of “Women’s Digital Health Market, 2022-2035” report to its list of offerings.
Given the fact that digital healthcare offers solutions to enable health monitoring in the comfort and safety of homes, experts believe that 75% women are more likely to adopt digital tools to understand complications related to their bodies through articles and videos.

To request a sample copy / brochure of this report, please visit
https://www.rootsanalysis.com/....reports/women-digita

Key Market Insights
Currently, more than 220 solutions are available / being developed for women’s digital health
Close to 50% of the women’s health solutions are application / software targeting various therapeutic application areas. Among these, more than 60% of the application / software are focused on menstrual health and reproductive health.
Over 130 start-ups have emerged in the last 10 years in the domain of women’s digital health
Over 40% of the start-ups were established in North America. Among these, more than 90% of the firms are based in US. This is followed by Europe, accounting for more than 30% of the start-ups focused on women’s digital health.
Partnership activity within this domain has increased at a CAGR of 73%, between 2017 and 2021
More than 60% of the reported deals were established since 2020, with the maximum activity (~50%) being reported in 2021. Majority of the partnerships were product / technology integration agreements (26%), followed by product development agreements (21%).
Close to USD 3 billion has been invested in the development of women’s digital health solutions
Majority of the companies (~50%) engaged in this domain primarily received funding through venture capital rounds. Further, close to 60% of the funding instances were reported by players headquartered in the US. Overall, more than 280 investors have actively financed various projects / initiatives focused on women’s digital health.
Over 65 global events related to women’s digital health have been organized since 2018
Majority (~70%) of the events related to women’s digital health were organized virtually in order to comply with the COVID-19 pandemic. It is worth highlighting that the agendas of the events planned to be organized in 2022 include overcoming the stigma attached to the reproductive well-being of women, women’s exclusion of from medical trials and healthcare gender prejudice.
North America is anticipated to capture larger share of the market by 2035
In terms of type of solution, the major share is captured by application / software developed specifically for women users; this trend is unlikely to change in the foreseen future. Further, among therapeutic application areas, solutions focused on reproductive health and menstrual health hold the larger market share.

Key Questions Answered
• Who are the leading industry players offering solutions for women’s digital health?
• Which women’s digital health applications and devices have been approved by the FDA?
• What kind of partnership models are commonly adopted by industry and non-industry stakeholders?
• Who are the key investors active in the field of women’s digital health?
• What is the focus of global events / conferences held for women’s digital health?
• What is the roadmap for the development of women’s digital health solutions?
• What are the various unmet needs across different therapeutic application areas in the current women’s digital health market?
• How is the current and future opportunity related to women’s digital health likely to be distributed across key market segments?

The financial opportunity within the women’s digital health market has been analyzed across the following segments:
Type of Solution
• Application / Software
• Devices
• Services

Analysis by Therapeutic Application Area
• Reproductive Health / Fertility
• Menstrual Cycle
• General Wellness
• Pelvic Area
• Fetal Health
• Other Therapeutic Application Areas

Key Geographical Regions
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and North Africa
The report features inputs from eminent industry stakeholder(s), who were very optimistic concerning the adoption of women’s digital health solutions. The report includes detailed transcripts of the discussions held with the following industry experts:
• Maryam Ziaei (Founder and Chief Executive Officer, iSONO Health)
• Ann Garnier (Founder and Chief Executive Officer, Lisa Health)
• Honny Hillegonda Kipnis Groen (Chief Marketing Officer, Illumigyn)
• Sven Mulfinger (Co-Founder & Chief Operating Officer, A Thousand Collibris)
The report includes profiles of key players (listed below) engaged in the development of women’s digital health solutions; each profile features a tabulated overview of company, product portfolio, recent developments, and an informed future outlook.
• Flo Health
• Garmin
• Hubble Connected
• International Medical Center
• Kindbody
• LetsGetChecked
• Maven Clinic
• Ro
• Willow Innovations

For additional details, please visit https://www.rootsanalysis.com/....reports/women-digita

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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

The spatial omics solutions market is anticipated to grow at a CAGR of 11.9%, till 2035, claims Roots Analysis

Recent advancements in multiplexed profiling and tissue imaging methods have enabled the assessment of spatial heterogeneity in intact tissues; as a result, adoption of spatial omics solutions offering benefits over traditional methods, is increasing


Roots Analysis has announced the addition of “Spatial Genomics, Transcriptomics and Proteomics Solutions Market, 2022-2035” report to its list of offerings.

Currently used histological methods measure limited number of biomarkers at a time and the fluorescent tags introduced interfere with the natural function of genes and proteins. Stakeholders are on the lookout for platforms that can simultaneously capture the arrangement of multiple biomolecules with single-cell or subcellular resolution, while preserving the tissue integrity. The up-and-coming field of spatial biology addresses this unmet need, while bridging the gap between high plex, high throughput, and high resolution.


To request a sample copy / brochure of this report, please visit https://www.rootsanalysis.com/....reports/spatial-geno


Key Market Insights

Presently, 45 industry and non-industry players claim to offer spatial genomics, spatial transcriptomics and spatial proteomics solutions
Majority (72%) of the solution providers are based in North America, followed by those headquartered in Europe (22%). A large proportion (50%) of these companies are large players, followed by small (30%) and mid-sized firms (20%).

More than 70 solutions are available / being developed for spatial profiling of biomolecules
Majority (51%) of the solutions are used for analyzing RNA transcripts, followed by 26% and 15% of the solutions that can analyze protein signatures and DNA molecules, respectively.

Partnership activity in this field has increased at a CAGR of over 70%, between 2016 and 2020 The highest number of partnership agreements (16) were signed in 2021. Majority of the partnerships (31%) were signed for technology / platform integration; followed by deals inked for commercialization of spatial omics solutions.
Grants worth over USD 20 million have been awarded to support research on spatial omics solutions, since 2018
Till June 2022, over 15 grants have been awarded for the research projects related to spatial phenotyping and profiling of biomolecules targeting various oncological and non-oncological disorders. Around 38% of the total number of grants were provided by the National Institutes of Health (NIH).
More than 530 patents have been filed / granted for spatial omics solutions, since 2003
Close to 70% of the patent applications have been filed by various industry and non-industry players in this domain, post 2018.

North America is anticipated to capture larger share of the spatial omics solutions market by 2035
North America has currently captured half of the overall market share and is estimated to be worth USD 9.61 billion by 2035, growing at a CAGR of 11.5%.

Instruments are anticipated to capture larger share of the market by 2035
Our estimates suggest that the overall market is likely to be driven by the revenues generated through the sales of spatial-omics instruments in the foreseen future due to their high cost.

The financial opportunity within the spatial genomics, spatial transcriptomics and spatial proteomics market has been analyzed across the following segments:

 Type of Solution
 Instruments
 Consumables
 Services

 Sample Type
 DNA
 RNA
 Protein

 Research Area
 Oncological Disorders
 Immunological Disorders
 Neurological Disorders
 Infectious Diseases
 Others


For additional details, please visit https://www.rootsanalysis.com/....reports/spatial-geno
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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

The exosome therapeutics market is anticipated to grow at a commendable pace by 2040, claims Roots Analysis

Owing to their potential in effective intracellular shuttling, therapeutic molecular delivery and treatment of multiple disorders, exosomes have garnered significant attention of researchers and industry stakeholders in the past few years

Roots Analysis is pleased to announce the publication of its recent study, titled, “Exosome Therapeutics Market, 2022-2040.” The report features an extensive study on the current market landscape, offering an informed opinion on the likely evolution of the exosome therapies in the treatment of various diseases.

To request a sample copy / brochure of this report, please visit
https://www.rootsanalysis.com/....reports/exosome-ther


The study presents an in-depth analysis, highlighting the diverse capabilities of players engaged in this domain, across different geographies. In addition to other elements, the study includes:
 A detailed assessment of the current market landscape of drug developers engaged in the development of exosome (membrane bound extracellular vesicles) therapeutics.
 Detailed profiles of key players involved in the development of exosome therapeutics (shortlisted on the basis of the number of pipeline products).
 Detailed drug profiles of key therapeutics in the highest phase of development.
 A detailed analysis of more than 50 completed, ongoing and planned clinical studies of exosome therapeutics.
 An in-depth analysis of more than 500 academic grants that have been awarded to research institutes engaged in exosome therapeutics-related projects.
 A detailed analysis of the global events attended by the exosome therapy developers.
 An analysis of the partnerships that have been established in this domain, in the recent past.
 An in-depth analysis of various investments made since 2017.
 An analysis of start-ups / small companies engaged in the development of exosome therapeutics.
 A case study highlighting the companies engaged in offering exosome development and manufacturing services.
 An in-depth analysis of exosome therapeutics that failed to progress to later stages of clinical development.
 A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
 Type of Therapeutic
 Allogeneic Therapy
 AutologousTherapy

 Target Indication(s)
 Degenerative Meniscal Injury
 Dystrophic Epidermolysis Bullosa
 Fistula Perianal
 Retinitis Pigmentosa

 Therapeutic Area
 Dermatological Disorders
 Muscoskeletal Disorders
 Ophthalmic Diseases
 Rectal Disorders


 Route of Administration
 Fistula Tract
 Intra-articular
 Intra-ocular

 Geography
 North America
 Europe
 Asia-Pacific and Rest of the World

Key companies covered in the report
 Codiak BioSciences
 Coya Therapeutics
 Curexsys
 EV Therapeutics
 Evox Therapeutics
 SHIFTBIO
 AEGLE Therapeutics
 AVEM Healthcare
 Cellular Biomedicine Group
 OBCTCD24
 ReNeuron
 Stem Cell Medicine

For more information, please click on the following link:
https://www.rootsanalysis.com/....reports/exosome-ther

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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