The biopharmaceutical excipient manufacturing market is projected to grow at an annualized rate of 5.8%

The demand for biopharmaceutical excipients has grown considerably in the past few years; they play a critical role in biologics development by enhancing the solubility and bioavailability, controlling pH and tonicity of the active pharmaceutical ingredients (APIs).

Roots Analysis has announced the addition of “Biopharmaceutical Excipient Market” report to its list of offerings

Owing to the highly complex and capital-intensive manufacturing processes of biopharmaceutical excipients, many contemporary biologic developers prefer to rely on CMOs for the supply of GMP grade excipients. In order to cater to the growing demand for biopharmaceutical excipients across both clinical and commercial scales, CMOs with expertise in this field are anticipated to expand their capabilities and existing capacities in the coming years.

Key Market Insights

Over 40 companies, across the world, claim to offer biopharmaceutical excipients
Majority of the firms (34%) engaged in this domain are mid-sized players, followed by large firms (32%) and very large companies (19%). Close to 30% of the stakeholders were established post 2000. Further, 37% players are based in North America; within this region, the US emerged as a most prominent hub.

Partnership activity within this domain has grown at a CAGR of 70%, between 2016 and 2021
Over 40 agreements have been inked in the last 5 years in this domain; 32% of which were distribution agreements. Other popular types of partnership models adopted by players engaged in this domain include acquisitions (23%) and supply agreements (13%).

~ 40% rise in expansion initiatives in this field, during the period 2016-2021
More than 45% of such initiatives were focused on capacity expansion of manufacturing facilities, followed by those undertaken for expanding existing facilities (43%). It is worth mentioning that most of expansion initiatives (78%) were carried out in Europe and North America.

Approximately 95% of the total installed capacity is dedicated to commercial scale manufacturing
The remaining 5% of the installed capacity is focused on preclinical / clinical scale manufacturing of biopharmaceutical excipients. In addition, over 50% of the total current global, installed biopharmaceutical excipient manufacturing capacity is installed in Europe.

North America and Europe are anticipated to capture over 70% of the market share, by 2035
In addition, the market in Asia Pacific is likely to grow at a relatively faster pace (6.4%) in the long term. Further, in 2035, biopharmaceutical excipient manufacturing market for antibodies is expected to capture the majority share (~52%) of the total market.

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

Key Questions Answered
 Who are the key players engaged in biopharmaceutical excipient manufacturing?
 Which global regions are considered as key hubs for biopharmaceutical excipient manufacturing?
 What type of partnership models are commonly adopted by stakeholders in this industry?
 What kind of expansion initiatives have been undertaken by biopharmaceutical excipient manufacturers?
 What is current, global biopharmaceutical excipient manufacturing capacity of contract manufacturers?
 How is the current and future market opportunity likely to be distributed across key market segments?

The financial opportunity within the protein design and engineering services market has been analyzed across the following segments:

 Type of Biologic
 Antibodies
 Vaccines
 Cell and Gene Therapies
 Other Biologics

 Type of Excipient
 Carbohydrates
 Polymers
 Solubilizers / Surfactants
 Polyols
 Proteins / Amino Acids
 Others

 Company Size
 Small
 Mid-Sized
 Large / Very Large

 Scale of Operation
 Preclinical
 Clinical
 Commercial

 Key Geographical Regions
 North America
 Europe
 Asia-Pacific
 Latin America
 MENA
 Rest of the World

The report also features inputs from eminent industry stakeholders, according to whom, growing demand for biopharmaceutical excipients will drive the growth of manufacturers engaged in the biopharmaceutical excipient manufacturing domain, in the coming future.

The research includes profiles of key players (listed below); each profile features a brief overview of the company, financial information (if available), details related to its biopharmaceutical excipients portfolio, manufacturing facilities, recent developments, and an informed future outlook.
 ABITEC
 Avantor
 BASF
 Corden Pharma
 DFE Pharma
 Evonik
 Kirsch Pharma
 Merck KGaA
 Pfanstiehl
 Roquette
 Spectrum Chemical Manufacturing
 SPI Pharma

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

You may also be interested in the following titles:
1. Gene Editing beyond CRISPR Market: Industry Trends and Global Forecasts, 2022-2035
2. Cell and Gene Therapy Bioassay Services Market: Industry Trends and Global Forecasts, 2022-2035
3. Thermostable Vaccines and Thermostable Biologics Market: Industry Trends and Global Forecasts, 2021-2035
4. Protein Design and Engineering Market: Industry Trends and Global Forecasts, 2021-2035
5. Next Generation Sequencing (NGS) Kits Market: Industry Trends and Global Forecast, 2021-2035

About Roots Analysis
Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com


Contact Information
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Ben Johnson
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Top Selling Biologics Market - Current Market Landscape

The “Top Selling Biologics Market, report features an extensive study of the current market landscape and future potential of the top selling biologics available for the treatment of a variety of disease indications.

As of today, most of the top revenue generating drugs, across the globe, are biologics. During our biologics market research, we were able to identify 67 top selling biologics (revenues equal to or above USD 500 million in 2020). Top selling biologics market has so far been primarily led by industry players. Majority of industry players have taken a step towards investing their time and resources for the development of biologic therapies. Genentech, Amgen, Janssen Biotech, Sanofi and Novo Nordisk are amongst the major players in this domain. Biogen, AstraZeneca, Merck, Bristol Myers Squibb, GlaxoSmithKline, Alexion Pharmaceuticals, AbbVie and Novartis are other players that have entered the Top Selling Biologics domain in the past.

To request a sample report: https://www.rootsanalysis.com/....reports/top-selling-

It is worth highlighting that most of the therapies are monoclonal antibodies capture the highest share (54%) of the top selling biologics market. This can be attributed to the various advantages offered by them, including high reproducibility and specificity. It is also worth mentioning that these therapeutic modalities are being used for many cancer indications. Further, most of the top selling biologics are currently delivered via subcutaneous route of administration. However, most of the top selling biologics are available in the form of vials. This can be attributed to the better sterility assurance and reduced particle presence offered by such packaging formats.

To order customize report: https://www.rootsanalysis.com/....reports/top-selling-

It is worth highlighting that most of the therapies are being developed against autoimmune and oncological disorders; Oncological indications targeted by biologics include colorectal cancer (6), Non-Small Cell Lung Cancer (3), Breast Cancer (3), Hepatocellular Carcinoma (3), bladder cancer (3), urothelial carcinoma (3), and melanoma (3).

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

You may also be interested in the following reports:
1. Antibody Drug Conjugates Market
2. Cell and Gene Therapy CROs Market
3. Bispecific Antibody Therapeutics Market
4. Genome Editing Services Market


About Roots Analysis
Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information
Roots Analysis Private Limited
Ben Johnson
+1 (415) 800 3415
ben.johnson@rootsanalysis.com
Facebook - https://www.facebook.com/RootsAnalysis
LinkedIn - https://www.linkedin.com/compa....ny/roots-analysis/my
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The vaccine contract manufacturing market is poised to become a multi-billion-dollar market in 2030

The steadily growing demand for vaccines, fueled by the COVID-19 pandemic, coupled to the discovery and development of a variety of preventive and therapeutic vaccine products, has presented lucrative opportunities for contract manufacturers

London

Roots Analysis has announced the addition of “Vaccine Contract Manufacturing Market (3rd Edition), 2021-2030” report to its list of offerings.

Given that vaccine manufacturing requires highly regulated, state-of-the-art technologies, it has become challenging for stakeholders to establish in-house expertise for large-scale manufacturing of vaccines. For this purpose, numerous vaccine developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs); these service providers are consolidating their capabilities and are expanding their respective service portfolios through substantial acquisition activity.

To order this 350+ page report, which features 135+ figures and 160+ tables, please visit https://www.rootsanalysis.com/....reports/view_documen

Key Market Insights

Presently, over 120 companies offer a multitude of contract manufacturing services for vaccines
The vaccine contract manufacturing market features a mix of small, mid-sized, and experienced players. Majority of such service providers claim to offer analytical development and fill / finish services. It is worth highlighting that over 80% of the vaccine CMO are able to operate at all scales of operation.

Partnership activity within this domain has increased at a CAGR of 42%, between 2013 and 2021
The maximum number of partnerships (148) for vaccine contract manufacturing services were signed in 2020. Manufacturing and supply (47%) emerged as the most popular type of partnership model adopted by the stakeholders, followed by product / process development and manufacturing (12%), acquisition (12%), product development and commercialization (11%) and licensing (6%).

The demand for vaccines is estimated to be over 0.035 million liters in 2021, which is likely to increase significantly in the coming years
This is expected to be driven by public immunization initiatives and health programs. In addition, the COVID-19 pandemic has resulted in an increased demand for vaccines.

CMOs are actively investing in expanding their existing capabilities to meet future requirements
With an aim to acquire competencies across the supply chain and to cater to the evolving needs of clients / sponsors, CMOs are expanding their capabilities. Over 70 instances of facility expansions and new facility establishment were reported since 2013.

The installed vaccine manufacturing capacity is currently estimated to be over 0.8 million liters
The maximum share belongs to large and very large companies, representing more than 90% of the overall global capacity. In terms of location, the maximum vaccine manufacturing capacity is installed in Europe (47%).

North America and Europe are anticipated to capture ~70% of the market share by 2030
Overall, the market is anticipated to witness an annualized growth rate of over 17.4% over the next decade. Contrary to North America and Europe, the market in the Asia Pacific region is also anticipated to grow at a relatively faster rate.

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

Key Questions Answered
 Who are the leading CMOs with expertise in vaccine production?
 What are the most commonly used expression systems used in vaccine development and manufacturing?
 What are the key challenges faced by vaccine manufacturers?
 What kind of partnership models are commonly adopted by vaccine contract manufacturers?
 What is the estimate on the annual commercial demand for vaccines?
 How does the global vaccine manufacturing capacity compare to the total biopharmaceutical contract manufacturing capacity?
 To what extent are the vaccine manufacturing operations outsourced to CMOs?
 Which region presently makes the maximum contribution to the production of vaccines?
 How is the current and future market opportunity likely to be distributed across key market segments?
The financial opportunity within the vaccine contract manufacturing market has been analyzed across the following segments:
 Scale of Operation
 Preclinical
 Clinical
 Commercial
 Type of Expression System
 Mammalian
 Microbial
 Others
 Outsourced Business Operations
 API Manufacturing
 Fill / Finish
 Others
 Company Size
 Small
 Mid-sized
 Large / Very Large
 Key geographical regions
 North America
 Europe
 Asia-Pacific
 Rest of the World
The report also features inputs from eminent industry stakeholders, according to whom, the current vaccine manufacturing revenues are primarily driven by outsourcing of various processes involved in the development of preventive vaccines. The report includes detailed transcripts of discussions held with the following experts:
 Menzo Havenga (President and Chief Executive Officer, Batavia Biosciences) and Claire Otjes (Marketing Manager, Batavia Biosciences)
 Dietmar Katinger (Chief Executive Officer, Polymun Scientific)
 David C Cunningham (Director Corporate Development, Goodwin Biotechnology)

The report includes profiles of key players (listed below) ; each profile features a brief overview of the company, information on its service portfolio, manufacturing facilities, financial performance (if available), recent developments, and an informed future outlook.
 AGC Biologics
 Albany Molecular Research (AMRI)
 Bharat Biotech
 Biological E
 BioReliance
 Boehringer Ingelheim BioXcellence
 Catalent
 Charles River Laboratories
 Cobra Biologics
 Eurofins Amatsigroup
 Eurogentec
 GreenPak Biotech
 Hong Kong Institute of Biotechnology
 IDT Biologika
 Lonza
 Meridian Life Science
 Syngene International
 Wockhardt
 WuXi Biologics
For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com


You may also be interested in the following titles:
1. mRNA Synthesis and Manufacturing Services Market, 2021-2030
2. Biopharmaceutical CROs Market, 2021-2030
3. Cold Chain Logistics Market for Vaccines, 2021 –2030

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


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The site management organizations (SMO) market is projected to grow at an annualized rate of ~10%

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
Roots Analysis has announced the addition of “Site Management Organizations (SMO) Market, 2021 – 2035” report to its list of offerings

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.

To order this 270+ page report, which features 95+ figures and 120+ tables, please visit
https://www.rootsanalysis.com/....reports/site-managem



Key Market Insights

Around 250 companies across the world claim to offer clinical trial site management services
Majority (43%) of the industry stakeholders are headquartered in North America, followed by those based in Asia-Pacific (32%) and Europe (19%). In addition, 25% of the companies engaged in this domain offer site management services across the globe, followed by those providing services in Asia-Pacific (23%).

200+ partnerships were established in this domain, during the period 2016-2021
Service alliances (26%) and clinical trial agreements (23%) emerged as the most common types of partnership models adopted by stakeholders engaged in this domain. Nearly 65% of the deals in this domain were established after 2018, with the maximum activity being reported in 2021 (56).

~USD 1 billion invested in various domain focused initiatives, since 2015
Maximum number of funding instances (21%) were reported in 2021, amounting to USD 614 million in capital investments. A significant number of funding instances (43%) were venture capital rounds, followed by instances of other equity (29%) and grants (7%).

Till 2035, annual demand for clinical trial study participants is expected grow at a CAGR of 8.2%
Currently, North America and Asia-Pacific hold the majority share of the overall demand for clinical trial study participants (60%). By 2035, the demand for patients in clinical trial studies is projected to reach 25 million. Further, currently, the highest demand is generated via phase III trials (43%), followed by phase IV studies (38%).

North America and Europe are anticipated to capture close to 65% of the market share, by 2035
In addition, in Asia-Pacific the Site Management Organization Market Growth is likely to be at a relatively faster pace (9%) in the long term. Further, in 2035, the majority share (~45%) of clinical trial site management revenues is likely to be generated from trials focused on phase III evaluation of clinical studies.

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


Key Questions Answered
 Who are the leading players engaged in the clinical trial site management domain?
 What is the relative competitiveness of different site management organizations?
 What type of partnership models are commonly adopted by stakeholders in this industry?
 What is the capital investments trend in the site management organizations domain?
 Which are the most active clinical trial centers?
 What are the major market trends and driving factors that are likely to impact the growth of site management organizations market?
 How is the current and future market opportunity likely to be distributed across key market segments?

The financial opportunity within the SMOs market has been analyzed across the following segments:

 Therapeutic Areas
 Oncological Disorders
 CNS Disorders
 Infectious Diseases
 Respiratory Disorders
 Cardiovascular Diseases
 Endocrine Disorders
 Gastrointestinal Disorders
 Musculoskeletal Diseases
 Immunological Disorders
 Others

 Trial Phases
 Phase I
 Phase II
 Phase III
 Phase IV

 Clinical Trial Components
 Site Management
 Onsite Monitoring
 Project Management
 Data Management
 Regulatory Affairs
 Logistics
 Quality Control
 Others

 Types of Interventions
 Therapeutics
 Devices
 Surgical Procedure

 Key Geographical Regions
 North America
 Europe
 Asia-Pacific
 Latin America
 MENA
 Rest of the World

The report also features inputs from eminent industry stakeholders, according to whom, complexities associated with clinical trial processes and increasing clinical pipeline will drive the growth of the third-party service providers, such as SMOs, engaged in this domain, in the coming future. The report includes detailed transcripts of discussions held with the following experts:
 Vinod Gyanchandani (Country Head - Clinical Operations, GDD Experts)
 Marisa Vico (Medical Director and Operations Manager, SMO – Dra. Marisa Vico)
 Eugene Winifred (Project Manager, Syncretic Clinical Research Services)

The research includes profiles of key players (listed below); each profile features a brief overview of the company, details related to its site management service portfolio, recent developments and an informed future outlook.
 FOMAT Medical Research
 Parexel
 Pharm-Olam
 Veristat
 WCCT Global
 Worldwide Clinical Trials
 CROMSOURCE
 Fidelis Research
 Scandinavian CRO
 TFS HealthScience
 Trialbee
 CMIC
 George Clinical
 Tigermed
 Veeda Clinical Research

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

You may also be interested in the following titles:
1. Patient Recruitment and Retention Services Market (2nd Edition): Industry Trends and Global Forecasts, 2021-2030
2. Pharmaceutical Contract Research Services Market: Industry Trends and Global Forecasts, 2021-2030
3. Clinical Trial Planning and Design Services Market: Industry Trends and Global Forecasts, 2021-2030
4. Biospecimen Contract Research Services Market: Industry Trends and Global Forecast, 2021-2030
5. Biologics Fill / Finish Services Market (2nd Edition): Industry Trends and Global Forecasts, 2021-2030

About Roots Analysis
Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information
Roots Analysis Private Limited
Ben Johnson
+1 (415) 800 3415
ben.johnson@rootsanalysis.com
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LinkedIn - https://www.linkedin.com/compa....ny/roots-analysis/my
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The Herceptin® biosimilars market is projected to witness considerable growth over the coming years

Herceptin® sales peaked in 2018, a year before the primary patent covering the drug expired in the US; in order to carve out a share of the associated opportunity, stakeholders in the pharma industry have long been developing follow on products

Roots Analysis has announced the addition of the “Herceptin® Trastuzumab Biosimilars Pipeline Review and Partnerships” report to its list of offerings.

The first trastuzumab biosimilar was approved in Europe in 2017 and within a year, the EMA approved four more (2018). Considering the opportunity associated with this blockbuster product, its corresponding biosimilar developer landscape is also vast.


Key Report Highlights

Herceptin®, the first targeted anti-cancer therapy, is an established itself standard of care for a number of different cancers
However, competition from marketed biosimilars was reported to be responsible for over USD 6 billion in losses from Roche’s international revenues in 2020; experts believe that, so far, this is the biggest decline in originator product sales attributable to competition from enemy products.

There are around 30 companies, across the world, involved in the development of biosimilars of Herceptin®
KANJINTI™, developed by Amgen, was one of the first biosimilars to Herceptin® to be approved by European Commission (2018) and the US FDA (2019). In order to enter the market, most developers of trastuzumab have entered into licensing agreements with the originator, Genentech.

Several biosimilar candidates are presently under development across 50+ trials, in various global regions
Many of such investigational leads are in the late stages of development and for several product candidates, new drug applications (NDAs) / marketing authorization applications (MAAs) have already been submitted to regulators in different nations across the world.

Partnership activity, related to biosimilars of trastuzumab, has grown at a gradual pace since 2011
Most of the deals reported in the public domain are licensing and commercialization agreements; this trend can be attributed to the fact that biosimilar developers generally tend to partner with local business entities in order to launch their proprietary offerings across different geographies.

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

Key Questions Answered
 Who are the key players engaged in the development of biosimilars of trastuzumab?
 In which global marketplaces are Herceptin® biosimilars currently available?
 What is the current scenario within the clinical development landscape of trastuzumab biosimilars?
 How many biosimilar development programs have and what were the reasons?
 Who are the key players involved in the commercialization of trastuzumab biosimilars across the world?
 What kind of partnerships have been inked between stakeholders in this domain?

The research includes detailed profiles of companies having approved / launched biosimilars across different global regions; each profile features an overview of the company, information related to its current portfolio of trastuzumab biosimilars, financial information (if available) and key product related specifications.
 Amgen
 AryoGen Pharmed
 Biocad
 Biocon
 Celltrion
 Intas Pharmaceuticals
 Pfizer
 Samsung Bioepis
 Shanghai Henlius Biotech

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

You may also be interested in the following titles:
1. HUMIRA® (Adalimumab) Biosimilars – Pipeline Review and Partnerships
2. Avastin® (Bevacizumab) Biosimilars – Pipeline Review and Partnerships

About Roots Analysis
Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information
Roots Analysis Private Limited
Ben Johnson
+1 (415) 800 3415
ben.johnson@rootsanalysis.com
Facebook - https://www.facebook.com/RootsAnalysis
LinkedIn - https://www.linkedin.com/compa....ny/roots-analysis/my
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