La búsqueda de tratamientos contra la COVID-19 quedó rezagada

El desarrollo de las vacunas superó las expectativas de todos. Pero durante los próximos meses muchas personas enfermarán y, lamentablemente, los médicos tienen pocos fármacos para tratarlas.

La búsqueda de tratamientos contra la COVID-19 quedó rezagada

El desarrollo de las vacunas superó las expectativas de todos. Pero durante los próximos meses muchas personas enfermarán y, lamentablemente, los médicos tienen pocos fármacos para tratarlas.

How the Search for Covid-19 Treatments Faltered While Vaccines Sped Ahead

Vaccine development exceeded everyone’s expectations. But the next few months will still bring many sick people — and doctors have woefully few drugs with which to treat them.

Single-Cell Sequencing: The New Era of Gene Expression Analysis

For developing an improved understanding of the interactions of individual cells within their microenvironment, advanced molecular probing solutions are being used by researchers across the globe. In this context, high-throughput single-cell analysis, has emerged as a powerful analytical technique for studying individual cells, enabling researchers to study gene expression at single cell resolution. Single-cell sequencing techniques enable the detection of complex and rare cell populations, and elucidate the development trajectories of distinct cell lineages. Future advancements in this domain are likely to bring about a paradigm shift in the field of clinical research, and disease diagnosis, progression and treatment. Further, the potential of single-cell RNA sequencing (scRNA-seq) technologies to reveal previously unknown cellular mechanisms, and identify novel biomarkers, such technologies are likely to witness significant adoption in biomedical research over the next decade.

Players Engaged in Offering Single-Cell Sequencing Services

Close to 100 industry and non-industry players claim to offer single-cell sequencing services to consumers across the globe

SINGLE-CELL SEQUENCING: THE NEW ERA OF GENE EXPRESSION ANALYSIS

Geographical Location of Single-cell Sequencing Service Providers

Majority of the industry players engaged in offering single-cell sequencing services are based in developed regions, primarily in North America (72%) and Europe (17%). It is worth noting, that a large number of non-industry players offering single-cell sequencing services are concentrated in the North American region, followed by Europe and Asia-Pacific.

THE NEW ERA OF GENE EXPRESSION ANALYSIS

Companies Engaged in Offering Single-cell Sequencing Technologies

In the last few years, several companies have introduced innovative technology platforms for application in single-cell sequencing. Prominent examples of companies offering innovative technology platforms include (in alphabetical order, no selection criteria) 10x Genomics, Becton Dickinson, Fluidigm and Illumina.

Companies Engaged in Offering Single-cell Sequencing Technologies

More Than 2,300 Academic Grants have been Awarded to Institutions Working in the Single-Cell Sequencing Domain

The last five years have witnessed monumental increase in the number of grants awarded to academic institutions amounting to USD 1.15 billion

More Than 2,300 Academic Grants have been Awarded to Institutions Working in the Single-Cell Sequencing Domain

Demand for Single-cell Sequencing Services and Technologies is Anticipated to Grow at a CAGR of 15%, During 2020-2030

Owing to the potential applications of single-cell sequencing in drug discovery, diagnostics and other areas of healthcare domain, the single-cell sequencing services and technologies market is likely to grow at an annualized CAGR of 17% over the next decade. Analysis of market opportunity on the basis of application area revealed that majority of the current market share (70%) is held by application of such techniques in drug discovery (early stage research). Further, in terms of geographical distribution North America currently holds 40% market share within the single-cell sequencing market, and is expected to dominate the market in the coming decade.

Demand for Single-cell Sequencing Services and Technologies is Anticipated to Grow at a CAGR of 15%, During 2020-2030

To get a detailed information on the key players, intellectual property portfolio, academic grant awards, and the likely market evolution.

Check out our new Reports Here-

Single-Cell Sequencing: The New Era of Gene Expression Analysis

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An introduction to the new NIHR National Patient Recruitment Centres

A new network of patient recruitment centres is set to shape the future of commercial clinical trials in the UK by offering new approaches to conduct late-phase, large-scale research projects. In a recent pharmaphorum webinar leaders from the NIHR’s five National Patient Recruitment Centres (NPRCs) outlined how they could bring cutting-edge therapies to greater numbers of UK patients.

The NPRCs are one of the Sector Deal 2 commitments from the government’s Life Sciences Industrial Strategy and are the first centres to be funded by the NIHR that are 100% dedicated to delivering commercial research.

The regional centres have been distributed across the country to provide opportunities for patients in areas of England who may not previously have been able to take part in the latest clinical studies.

They have also been designed to improve the speed and consistency through which commercial research is delivered in the NHS.

The goal is to attract life sciences R&D projects by making it easier and quicker to deliver commercial research, in turn improving the UK’s competitiveness in the global market.

pharmaphorum’s webinar, held in association with the NIHR, featured contributions from the directors of the NPRCs, the medical leaders who are leading the programme.

Dr William van’t Hoff, chief executive officer of the NIHR’s Clinical Research Network, began proceedings by highlighting some of the successes that have already been achieved.

“Our aim is to establish a relationship and build trust with our local community, to develop understanding, reduce the fear of research and increase engagement in that way”
Yan Yiannakou

These include the delivery of COVID-19 vaccine trials and one of the UK’s first fully virtual interventional commercial clinical trials.

These studies have been made possible by the franchise-like operating model underpinning the network, which allows them to work in a harmonised manner, he said.

Franchise like operating model and collaborative working

The NIHR has provided £1.3 million in funding to each centre over three years to support their activities. Their collaborative model means the NPRCs will operate in an identical manner, offering a number of advantages to study sponsors.

As pointed out by Dr van’t Hoff, there will be a consistency of approach that could boost the UK’s competitiveness in a global market for late-stage clinical trial research.

The centres will benefit from shared standard operating procedures and will collaborate with each other as they host trials, the webinar heard.

Van’t Hoff said: “Each centre will provide a dedicated space and facilities for commercial clinical research, guaranteed access to NHS services to support research delivery, access to NHS clinicians to work as investigators, and a team of dedicated and highly-skilled research delivery staff to conduct the trials.”

Helen Quinn, director of the Joint Office for Clinical Research (University of Exeter and Royal Devon and Exeter NHS Foundation Trust), added that the centre in Exeter has been able to work with others across the country, costing and contracting for commercial research studies in a swift way.

“We can set trials up quickly for our patients, which is the most important consideration for us,” she said.

Speed, ease and volume

Using a franchise like operating model with standard operating procedures can speed up patient recruitment because of improved efficiency.

This was demonstrated by the swift set-up of a phase 3 COVID-19 vaccine study, which took just two weeks to set up and launch with over 1,900 patients recruited across the three NPRCs involved when it closed.

Dr Gavin Galasko is a consultant interventional cardiologist and director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust, home to the Blackpool Patient Recruitment Centre.

He said: “We were the first in the world to recruit to this phase 3 study. We want to be there for pharma to show that the UK is a place to offer these latest state of the art late phase commercial studies that we can get to the patients quickly, efficiently, and in high numbers.”

Dinesh Saralaya, director of the NIHR Patient Recruitment Centre in Bradford, added that another factor that can allow trials to be quickly set up is the unified approach to costing across all the centres.

Each centre is also supported by research nurses, pharmacists and other research support staff who are dedicated resources available to the commercial trials run at the sites.

NPRCs are entirely focused on commercial research, further reducing the time to set up trials, the webinar heard.

The ‘recruitment engine’

Each centre is also driven by a ‘recruitment engine’ that uses several proactive strategies to reach out into the local community to empower patients to take part in, and to volunteer for, research.

As well as being linked to large hospitals, each centre will also collaborate with other healthcare organisations across primary, community and social care.

They can interact with primary care networks and integrated care partnerships (ICPs) for example to recruit from the local population.

This can help them find trial participants who are not hospitalised but who live with common chronic conditions and are not presenting in secondary care.

At the same time they benefit from links to large hospitals and their experience and expertise.

The centres can easily link with a wide network of GP surgeries and other local healthcare organisations, using linked NHS data sets to help identify patients to take part in research.

Yan Yiannakou, clinical director of the Newcastle NPRC, said that rather than going to a single GP surgery with 5,000 patients on its books, the centre works with federations of surgeries with 250,000 patients.

He said: “By working with a single point of contact in that federation and by working with the core federations around Newcastle, we can cover a population of 650,000 with a single search.”

Driving innovation

Other innovative strategies employed at the NPRCs include virtual consultations, something that many other organisations have tried to implement but not succeeded.

Recruitment is further aided by digital consent, data capture and online eligibility checks, with the model already leading to a ground-breaking virtual trial, possibly the first in Europe.

Yiannakou said that the model has already been used to conduct a virtual trial in irritable bowel syndrome with diarrhoea (Relieve IBS-D).

The trial is currently recruiting 10 patients a week, which is twice as many as was being recruited by 28 sites before the study went virtual.

It’s just one of several innovative approaches to patient recruitment that are being explored at the NPRCs.

NIHR

Yiannakou said:Our aim is to establish a relationship with our local community, to build trust with the local community, to develop understanding, reduce the fear of research and just increase engagement in that way.”

Other approaches to recruitment will be explored, aiming to put patients and their needs at the centre of the process.

Melanie Davies, professor of diabetes medicine at the University of Leicester and director of the NPRC in Leicester, said: “This is all about bringing research closer to patients across the patch, across the NHS, but to provide it in a way that is attractive and accessible to patients.”

The cutting-edge of global life sciences research

A theme running all the way through the webinar was the sense of collaboration that each centre will bring to research projects.

The NPRC clinical directors all highlighted the centres’ ability to work together and with the wider healthcare ecosystem, such as primary, community and social care to enable access to a wider cohort of patients.

Yiannakou said: “The key is a willingness to develop and a willingness to change, and we have both the drivers and the substrates for that. The drivers are the fact that we are a novel concept centre, that we specialise in a particular area.

“We want to be the best in that area, we are focused in that area, and we have a remit and an intent to refine process and improve recruitment.”

According to Saralaya, the centres are sending a “strong message” to industry about the UK’s intent to be at the cutting edge of global life sciences research.

He said that the work already under way at the five centres shows they can deliver trials at speed, with quality and with very unified costing.

He concluded: “What better advocate can it be for a sponsor wanting to come to the UK?”

About the interviewees

Helen Quinn is the director of the Joint Office for Clinical Research, a collaboration between the University of Exeter and the Royal Devon and Exeter NHS Foundation Trust.

 

Dinesh Saralaya is a consultant respiratory physician and honorary senior lecturer at Bradford Teaching Hospitals NHS Foundation Trust. He has served as Director of the National NIHR Patient Recruitment Centre, Bradford since June 2020.

 

Yan Yiannakou is a consultant gastroenterologist and Clinical Director of the NIHR Patient Recruitment Centre (Newcastle).

 

 

Melanie J Davies is Professor of Diabetes Medicine at the University of Leicester and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust.

 

Dr Gavin Galasko is a consultant interventional cardiologist and the director of research, development and innovation at Blackpool Teaching Hospitals NHS Foundation Trust.

 

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Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Shots:

  • Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies
  • Egle has leveraged its unique bioinformatic & translational capabilities to identify targets
  • Following the achievement of the target identification, Egle will receive an R&D milestone payment & equity funding from Takeda

Click here ­to­ read full press release/ article | Ref: Businesswire| Image: Businesswire

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Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Shots:

  • Precision to receive $100M upfront, $35M as an equity investment and will receive $420M as milestones/ product along with royalties on sales of licensed products emerges from the collaboration
  • Precision will lead to pre-clinical research and IND-enabling activities while Lilly will lead clinical development and commercialization and have the right to select up to 3 additional gene targets. Precision can co-fund clinical development of one product in exchange for an increased royalty rate on co-funded product sales
  • The agreement will utilize Precision’s ARCUS genome editing platform for the development of in vivo therapies for genetic disorders, focusing on DMD and two other undisclosed gene targets

Click here ­to­ read full press release/ article | Ref: Lilly | Image: KMS Lighthouse

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Havas Health & You launches Behind the Mask

Behind the Mask is a global research initiative to document health experiences during the COVID-19 pandemic and beyond.

Havas Health & You (HH&Y) has launched the details of a long-term global research project, Behind the Mask, a longitudinal, multi-armed study that focuses on documenting the ongoing evolution of health and wellness. This sector has seen dynamic shifts in the past years that have only been accelerated by C19. The project was launched in May and contains both qualitative and quantitative arms, providing a direct and continuous window into the changing nature of the health industry, and exploring how medical care is delivered in the 21st century.

“We know that the health category has been changing at a rapid clip, and the global pandemic has acted as a major accelerant of some of those changes”, said Brian Robinson, Global Chief Strategy Officer at HH&Y. “The changes that were taking place prior to the pandemic were already posing unique challenges as well as creating great opportunity, not just to those who serve the health community, but to all members of society. It was important that we create a record of the experiences of this time to help guide our thinking in this complex, shifting environment.”

Taking a long-term approach to collecting these unique viewpoints becomes increasingly valuable as more data is collected. The first wave of surveys showed that 70% of clinicians described a resurgence of C19 as “almost inevitable”. When the next round of surveys was collected, this number jumped to 79%. When interviewees are revisited over time and their views are accompanied by quantitative accounts, the story gains clarity and it becomes increasingly possible to present key moments in time in modern health.

“We wanted to create an ongoing baseline of data from different stakeholders, and then triangulate those points of view,” said Andrew Gardner, Chief Strategy Officer at Havas Lynx Group in London. “We know that both doctors and patients find the current medical delivery system stressful, but they find different parts of it stressful. The pandemic has made us all think about how care is delivered, so it seemed like an excellent time to understand what seems to be working, and what isn’t, and to follow the people involved over time.”

The qualitative arm is being led by Brad Davidson, Director of Medical Anthropology across the HH&Y network. “People are incredibly busy right now, and many doctors were already working at near-task-overload levels prior to the pandemic. So, we’ve asked doctors and other participating HCPs to conduct an “auto-ethnography”, essentially recording their own observations from the inside. We’ve gotten some very powerful footage of doctors nearly asleep recording themselves at the end of a 12-hour shift, and their concerns and desire to be heard is palpable.”

The study is designed primarily with an aim to understand the right strategies to build stronger health and wellness brands in this new environment. This will equip HH&Y and their clients with the information needed to connect with their audiences, patients and providers, on a more human level, by painting a complete picture of care providers as people with their own ambitions, worldviews, and opinions.

The ongoing research can be found at http://behindthemask.health, with regular publications on future topics following the original subsets of studied individuals to be posted on an ongoing basis through the remainder of 2020 and plans to document these findings longer-term. You can subscribe to receive updates on the most current information available as the global situation unfolds.

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About Havas Health & You

Havas Health & You unites Havas Life, Health4Brands (H4B), Havas Lynx Group, Havas Life PR, and Havas Health Plus, all wholly owned health and communications networks, with consumer health businesses and practices of Havas Creative Group. Its customer-centric approach has the talent, tenacity, and technology that health-and-wellness companies, brands, and people need to thrive in today’s world. For more information, go to www.HavasHealthandYou.com.

About Havas Lynx Group

Havas Lynx Group has grown from a small creative agency formed in the Northern Quarter of Manchester into a global healthcare communications agency, offering campaign development, brand strategy, capability building, and education services to the pharmaceutical industry.

Informed by experience and driven by innovation, the people of Havas Lynx Group are agents of the next era in health. Dedicated to helping clients connect consumers, professionals, and brands with information services, and influences to drive new relationships and better outcomes. Formerly Creative Lynx, Havas Lynx Group is a member of the Havas Health & You global network. For more information, go to www.havaslynx.com

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Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Shots:

  • TScan signs exclusive research and option to license agreement with Qiagen to develop T cell-based laboratory tests for detecting prior exposure to the SARS-CoV-2
  • Qiagen gets an option to license the rights and IP for several of TScan discovered immunodominant T cell targets, associated sequences and relevant data for the development and commercialization of IVD tests. In advance of exercising its option, Qiagen has the right to evaluate TScan’s discoveries
  • The targeted immunodominant were identified through the T-Scan TCR/Target discovery platform enabling the mapping of the specific epitopes in SARS-CoV-2

Click here­ to­ read full press release/ article | Ref: Businesswire | Image: TrialSite News

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Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept the “new normal” until we have a vaccine.

What is a Vaccine?

Vaccines, in a way, activate the immune system without the disease. Getting a particular vaccine is somewhat like having survived the disease once, without the health burden. Vaccines can be made with weakened viruses, inactivated viruses, and protein from a virus or even just the biological material (mRNA).

How Do Vaccines Provide Immunity?

Immunity is the body’s defense mechanism is to resist the effects of a microorganism. Immunity induced by a vaccine is weaker than that induced naturally after an infection. After you get a vaccine shot, your body will develop long-lasting antibodies that circulate in the blood. Such virus-specific antibodies will help to prevent severe disease. The vaccine will not prevent the entry of the virus into the body (infection), but it will prevent severe infection.

Vaccine Development

Scientists have gone from the discovery of the virus to more than 165 candidate vaccines in record time, with 27 vaccines already in clinical trials.

Challenges in Vaccine Development

  • Laboratory development & Preclinical testing
  • Large Clinical Trials
  • New technology for production
  • Availability: manufacturing millions of doses especially of a novel coronavirus
  • Developing an integrated and fair plan for vaccine distribution
  • Order of priority – health workers, elderly, and those with underlying conditions
  • Logistic –storage temperature
  • Resistance from the public – lack of awareness
  • Supply to rural areas
  • Multiple-dose may be needed

When Can We Expect A Vaccine And How Has Development Been Stepped Up?

Vaccine development normally takes years to complete, but the continuing crisis has prompted the multilateral system to accelerate the process. Regulatory approvals are up to speed but no important stages are skipped. This means that different tests of the vaccine are conducted in “parallel”.

The pandemic situation requires multiple activities and tests to be conducted at financial risk to stakeholders without knowing whether the vaccine candidate will be safe and effective.

Clinical Status of Vaccines Around the Globe

Research in India

The Indian government agency is working at lightning speed to test and approve an Indian origin COVID-19 vaccine. The government has permitted six Indian companies to develop vaccines against COVID-19. Recently, Bharat Biotech and Zydus Cadila were granted permission to start Phase I and II human clinical trials of their most advanced vaccines, named COVAXIN and ZyCoV-D respectively.

India Will Be The Manufacturer of The Covid-19 Vaccine

India is known for its mass manufacturing of pharmaceuticals. Leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation to obtain their vaccines from India. Now is the time when India can definitely leverage its ability to mass-produce a Covid-19 vaccine whenever it is ready and also help reduce the price of these vaccines. Reasonable price provided by India`s mass production ability would be the only factor in assuring the Covid-19 vaccine’s access across the globe.

Serum Institute of India (SII) located in Pune has entered a manufacturing partnership with British pharmaceutical giant AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine. These vaccines will be for India and middle- and low-income countries across the world (GAVI countries).

What Happens If You Choose Not To Get A Vaccine?

Firstly, you will not be protected from the deadly respiratory disease and may end up suffering from a severe infection. Secondly, refusal by many people might not get the country to herd immunity.

What Lies In The Future?

Even when a vaccine is introduced, we will have several months of significant infection or at least a risk of infection to take care of. This means that we may have to face more months under the threat of the novel coronavirus than we have already survived. If precautions are not taken and guidelines are not followed, there will continue to be more outbreaks, more deaths. The availability of the vaccine will be the slow start of the flattening of the curve. The total time taken to completely flatten the curve cannot be predicted, as it depends on awareness, accessibility, affordability, and adoption. With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing. It is a race between humans and the virus, rather than between countries or pharmaceutical companies.

Conclusion

Putting an end to this viral disaster with a vaccine has led to a global vaccine race to coherently extinguish Covid-19. Each week brings news on early success, low cost, fast track results, promising effects because of vaccine optimism. There is too much uncertainty that continues to be pondered upon. The vaccine won’t extinguish the disease itself but offer protection and immunity. It certainly will not immediately return life to “old normal”. The virus is too widespread but the vaccine could make Covid-19 easier to live with and prevent severe cases.

Finally, there seems to be a ray of hope amidst this tunnel of misery!

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Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent, and nurturing strong relationships with external stakeholders. Holding Senior Management Position for the last 20 years and involved in strategic decision making. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

Sunaina Anand

Dr. Sunaina Anand, Pharm. D is a Clinical Pharmacist. She currently serves as Medical Affairs Executive in IntelliMed Healthcare Solutions. She previously interned in Tata Memorial Hospital and Columbia Asia Hospital, Bengaluru.

Related Post: Insights+ KOL Articles: Immunity & Pregnancy: Unique and Complex

Image Source: DNAIndia




Fill / Finish Services Industry: Impact of the Swelling Biopharmaceutical Pipelines

Biopharmaceuticals represent the most rapidly growing and high-value segment of the pharmaceutical industry. Growing at an annualized rate of ~12%, the industry stands tall with more than 5,000 biologics in development and over 300 FDA approved biologics, since 2002. Biologic drug development is characterized by high quality standards and a rapidly growing demand for novel and effective treatment options. Even though it is a technically challenging field, outsourcing has grown into a promising and prominent segment, especially for manufacturing and fill / finish operations. In spite of the fact that fill / finish services are one of the crucial stages of product development, these operations represent one of the most heavily outsourced activities in the pharmaceutical industry. Currently, it is estimated that about one-third of the total fill / finish operations are outsourced to contract service providers.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

What are the Opportunities for the Players Active in the Field?

Owing to the recent advances in the product development technologies and innovative drug products, there are multiple growth opportunities for companies providing fill / finish services to biopharmaceutical drug manufacturers. the demand for contract services continues to be driven by a variety of needs, including requirement of single use systems, rising adoption of RABS and isolator barriers, introduction of robotic solutions and automation, and carrying out fill / finish in diverse type of drug-delivery devices; these are some of the areas where developer companies claim to benefit from engaging the services of capable CMOs.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Who are the Leading Players in the Industry?

There are more than 115 service providers actively providing fill / finish services for various biologics. In addition to fill / finish, these provide an array of services for late stage product development, including lyophilization, quality control testing, labeling, storage and distribution services. Further, the service providers can be distinguished on the basis of their headquarters, year of establishment, company size, location of fill / finish facilities, type of packaging used for filling, services offered in addition to fill / finish, scale of operation, type of biologics handled and other details related to the fill / finish capabilities of service providers (such as number of units filled per batch).

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

How is the Industry Landscape Changing in Response to Increase in Demand?

Owing to the complexities related to the handling of biologics and the requirement of fully automated fill / finish equipment, several contract service providers have made significant investments for expanding their respective production capabilities and capacities. Certain players have also established new facilities to cater to the growing demand for both conventional biologics and novel biologics. Since 2013, the industry has witnessed about 70 such developments; of which more than 30% were associated with establishment of new facilities.  

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Further, since 2013 the industry has witnessed ~70 instances wherein players have joined hands to offer their combined services, including fill / finish of biologics. Several players have entered into mergers and acquisitions with other service providers in order to expand their service offerings.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

Do the Contract Service Providers have Enough Capacity to Fulfill the Current and Future Demand for Biologic Drug Products?

The global installed fill / finish capacity of companies providing contract services for biologics is estimated to be about 17 million units, per day (or per batch). The current global installed capacity is primarily driven by players operating at commercial scale, which together account for 85% of the installed fill / finish capacity.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

The demand for commercial biologics is driven by antibodies; this trend is likely to continue in future as well. Currently, vials are estimated to be the most prevalent format of packaging container. In addition, by 2030, majority of the demand is likely to come from biologics commercialized for oncological disorders.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

How will the Market Evolve in the Foreseen Future?

Owing to the surge in efforts for development of various types of biologic drugs, the overall opportunity for contract fill / finish service providers is significant. Overall the market is likely to grow at an annualized rate of over 10% till 2030 and be worth more than USD 4 billion.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

The current opportunity lies heavily with the service providers packaging biologic drug products in vials. Antibodies which represent the most prominent type of biologic are likely to continue to dominate this market in the future as well.

Impact of the Swelling Biopharmaceutical Pipelines on Fill / Finish Services Industry

To get a detailed information on the key players across different geographies, key performance indicators for the service providers, role of robotic fill / finish systems and ready-to-use primary packaging, and other key industry trends impacting this domain, visit this link

Biologics Fill / Finish Services Market

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In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

According to the US Food and Drug Administration (USFDA), less than 10% of investigational new drug (IND) candidates progress beyond the submission of a new drug application (NDA); this implies that majority of the drug / therapy candidates fail to reach the market owing to unacceptable safety and efficacy profiles and the problems associated with their pharmacokinetic profiles, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity. ADME studies are considered to be critical in establishing the safety and efficacy of drug candidates.

In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

What is the current market landscape of in vitro ADME testing service providers?

Nearly 100 CROs, featuring a mix of small-sized (less than 50 employees, 42%), mid-sized (50-200 employees, 17%), large companies (200-1,000 employees, 15%) and very large companies (more than 1,000 employees, 26%), offer contract services for in vitro ADME testing.  Around 65% of the CROs claim to have the necessary expertise to conduct studies for testing absorption, distribution, as well as metabolism and elimination profiles of a lead molecule.

In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

Wat is the trend of acquisitions and mergers in this domain?

In order to maintain a competitive edge in the market, CROs are rapidly expanding their capabilities to offer a wider range of in vitro ADME testing services, thereby, consolidating their positions. Over 35 acquisitions have taken place amongst various stakeholders in this domain.

In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

What are the likely growth opportunities of the in vitro ADMEtesting services market?

Driven by the increasing demand for effective pharmacological interventions, the in vitro ADME testing services market is poised to grow at a significant pace (9.8%) in the coming years, with developed regions holding the dominant share. Currently, North America holds the largest share (46%) in the overall in vitro ADME testing services market. This is followed by Europe and Asia-Pacific; these account for 25% and 29% share, respectively.

In Vitro ADME Testing Services: Emerging Opportunities for Service Providers

For More Insights check out the report here

In Vitro ADME Testing Services Market, 2019-2030

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Peptide APIs – A Deeper Look Into Contract Manufacturing Market

The recent years have portrayed the renaissance of peptide APIs, as pharma industry has once again turned its attention towards the potential of therapeutic peptides. Adoption of peptides as therapeutic agents have side-lined some of the earlier concerns associated with them, such as bioavailability, and has led to manufacturing of high-quality peptides in a larger quantity. The upscaled trend in adoption of peptide therapeutics has been due to the advancements in the drug delivery technologies. Over time, peptide manufacturing has significantly evolved and has led to innovative techniques for peptide API production.  Moreover, the peptide API market have steadily become more competitive and advanced in the last decade.

In order to combat the COVID-19 infection, drug developers are actively investigating the efficacy of the peptide drugs to serve as the potential treatment option for the novel coronavirus. It is worth highlighting that the team of chemists at Massachusetts Institute of Technology (MIT) are intended to design a peptide (short protein fragment) based drug candidate, which mimics the protein found on the surface of the human cells. It has been further stated that the investigational drug product will have the potential to block the coronaviruses’ ability to enter human cells, by binding to the viral protein. Such development initiatives within this domain, along with the growing clinical and preclinical pipeline of therapeutic peptides, is likely to increase the overall demand of peptide APIs, and in return offer business opportunities to the contract manufacturers.

Companies Involved in Peptide API / FDF Manufacturing

Over 50 contract manufacturers are actively involved in the production of therapeutic peptides; of which 85% claim to offer services for peptide APIs, while 46% players have the required capabilities for the manufacturing of both peptide APIs and finished dosage formulation (FDF). More than 20% of the CMOs are engaged in providing services related to analytical testing and regulatory support, while 20% provide services related to peptide modification.

PEPTIDE APIS - A DEEPER LOOK INTO CONTRACT MANUFACTURING MARKET

Location of Peptide API Manufacturing Facilities

North America and Europe emerged as the current manufacturing hub for peptides, as 75% of the total facilities are presently located in these regions. Within North America, the US emerged as the key hub for peptide manufacturing. Whereas, within Europe, the UK (22%) and Switzerland (17%) emerged as the key peptide manufacturing hubs. Further, in Asia Pacific it was observed that most of the manufacturing facilities are located in China (63%) and India (25%)

PEPTIDE APIS - A DEEPER LOOK INTO CONTRACT MANUFACTURING MARKET

Recent Advancements in Peptide API Manufacturing

The partnership activity in the peptide contract manufacturing market has increased at a steady pace since 2017. Majority of these deals were signed by players, such as Bachem, PolyPeptide and Dalton Pharma. Manufacturing and supply agreements emerged as the most popular type of partnership model adopted by companies engaged in this domain, representing 41% of the total number of deals. In October 2019, Pepscan doubled its capacity for production of peptides and personalized peptide medicines.

Likely Growth of the Peptide API Manufacturing Market

The peptide contract manufacturing market is anticipated to grow at an annualized rate of 11.2%, as the peptide drug developers are anticipated to continue to outsource their manufacturing services in mid to long term.

To get a detailed information on the key players, recent developments, number of clinical trials conducted, global demand and capacity and likely market evolution, visit this link.

Peptide Therapeutics: Contract API Manufacturing Market, 2020 – 2030

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Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

It is important to note that the process of drug discovery is extremely demanding, both in terms of capital and time. In fact, the overall amount spent on R&D initiatives in the pharmaceutical / biotechnology sector has increased from around USD 128 billion in 2008 to USD 165 billion in 2018. Moreover, only a small fraction of early stage therapeutic candidates are able to make it past preclinical evaluation. According to a study conducted on terminated drug development programs, the high rate drug failure in clinical trials was primarily attributed to problems associated with their pharmacokinetic profiles, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity.

With increasing cases of drug failure, due to problems associated with pharmacokinetic profiles of candidate therapies, ADME properties and inherent toxicity, industry players are actively looking for more advanced solutions. Drug developers prefer to opt for contract service providers that offer a range of capabilities, such as design, synthesis, initial scale-up, in vitro ADME testing, safety pharmacology, under one roof; this guarantees a certain degree of ease of operation, and enables sponsors to shortlist and rely on a capable partner for their outsourcing requirements.

Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

Service Providers Offering In Vitro ADME Testing Services

Over 95 CROs, featuring a mix of small-sized (less than 50 employees, 42%), mid-sized (50-200 employees, 17%), large companies (200-1,000 employees, 15%) and very large companies (more than 1,000 employees, 26%), offer contract services for in vitro ADME testing.

Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

To know about the companies that claim to offer in vitro ADME testing services, check out our report here

What is the Regional Distribution of Service Providers?

Majority of the CROs (nearly 80%) are based in North America and Europe. Within North America, the US has the maximum number of players, whereas, in Europe, most of the service providers are distributed across France, Germany, the UK, and Spain. A relatively smaller, but growing, proportion of such players are situated in the Asia-Pacific region; India, China, and Australia have a significant number of firms that claim to offer ADME testing services.

Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

Which Company Has an Edge Over Other Companies?

With so many players in the market, it may become baffling to decide on which company would serve your purpose. Some companies do have advantages over other competitors, in terms of their experience, and service portfolio. With the intention to develop a better understanding of the overall potential and capabilities of industry players involved in this domain, we carried out a benchmarking analysis of the various stakeholders across different geographies.

Increasing Rate of Drug Failure has Prompted the Drug Developers to Rely on CROs offering In Vitro ADME Testing Services for their Outsourcing Requirements

Recent Advances

Recently, in February 2020, Eurofins Discovery and PharmaResources, a leading CRO based in China, announced a commercial cooperation agreement to provide PharmaResources’ customers with expedited access to Eurofins Discovery’s pharmacology and ADMET portfolio to accelerate their client’s drug discovery timelines. Earlier in July 2019, SEKISUI XenoTech announced collaboration with the Drug Development Solutions Center to offer a full suite of ADME testing services. In May 2020, SEKISUI XenoTech received a US patent for an in vitro method to evaluate xenobiotics as immune-modulators of drug transport and metabolism For More Insights check out the report here

In Vitro ADME Testing Services Market, 2019-2030

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Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

The targeted protein degradation approach is believed to possess the potential to unlock the undruggable proteome, which was traditionally considered to be inaccessible. Compared to conventional inhibition strategies, degradation offers several benefits, which include the opportunity to completely remove aberrant proteins and associated systemic malfunctions. As a result, targeted protein degradation-based therapeutics have generated enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine.

Consistent research efforts in this domain can be validated from the fact that over 200 articles were published in the past three years

Given the extensive R&D activity in this domain, the targeted protein degradation-based therapeutics pipeline is growing at a substantial pace. As a result, there has been a significant increase in the number of scientific articles published related to therapeutics and technologies based on the aforementioned mechanism. Stakeholders in this industry are actively publishing their findings related to innovative targeted protein degradation approaches in peer-reviewed scientific journals.

Targeted protein degradation-based therapy development efforts have also garnered the attention of various private and public investors, resulting in significant capital investments in the past decade

The efforts of players engaged in the development of targeted protein degradation-based therapeutics and technology platforms have gained significant interest of various venture capital investors. In fact, since 2014, over USD 3.5 billion (across ~100 funding instances) has been invested by both private and public investors in companies involved in developing such therapies.

Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

Further, around USD 1.4 billion was raised through secondary offerings, representing 41% of the total capital raised by industry players in the last several years. In addition, around 21% of the investment was raised through other equity investments; these include instances of private placements of share and exercised warrants.

Moreover, more than 120 investors have supported the programs undertaken by small / mid-sized companies in this domain; European Regional Development Fund, RA Capital Management, Atlas Venture, Cardinal Partners, Cormorant Asset Management, Hatteras Venture Partners, Innovate UK, Novartis Bioventures, and  Lilly Asia Ventures emerged as some of the prominent investors in this field.

The increasing interest in this field is also reflected in recent partnership activity

Several partnerships have been forged between companies involved in this domain and other industry players / research institutes during the period, 2014–Q3 2019. It is worth highlighting that over 45 collaborations were established after 2017, indicating that the activity in this domain is increasing at a significant pace. Over 50% of the partnerships were research agreements and R&D agreements, indicating the sustained focus on the discovery and development efforts in this upcoming field of therapeutics.

Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

Current and future market potential of targeted protein degradation market

The commercial success of targeted protein degradation therapeutics is still dependent on ongoing clinical studies, as none of such protein degraders have been approved so far. However, given the increasing number of licensing deals and the growing preclinical / clinical pipeline, we expect the market to grow at a significant pace in the foreseen future.

Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

To know more about the evolving targeted protein degradation market, check out the report here.

Targeted Protein Degradation is Anticipated to Become a Major Therapeutic Modality in the Coming Decade

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In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

Over time, the complexities associated with drug discovery have increased, especially in case of large molecule drugs, which are inherently more complex than conventional small molecules. As a result, an increase in the overall research and development (R&D) expenditure in the pharmaceutical / biotechnology sector has been witnessed. In addition to the complexities involved, the drug discovery process is extremely demanding, both in terms of capital expenses and time. 

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

What is the current market landscape of in silico service providers?

Around 40% of the companies claim to specialize in antibodies, proteins and peptides across different steps of drug discovery. Within the antibodies segment, nearly 60% of in silico service offerings are focused on the discovery of monoclonal antibodies. This is followed by companies providing services for antibody fragments (43%), bispecific antibodies (34%) and polyclonal antibodies (26%).

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

What are the novel computational techniques for the overall drug discovery process?

The integration of novel computational techniques, such as artificial intelligence and cloud-based platforms, with in silico approaches is likely to revolutionize the overall drug discovery process.

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

What is the likely cost saving opportunity associated with the use of in silico tools?

In silico drug discovery approaches have been estimated to save nearly 35% of the total cost involved in developing a new drug, resulting in growing demand for more efficient drug discovery services for large molecules. By 2030, we anticipate net, annual cost savings of over USD 23 billion to be brought about by the adoption of in silico tools in large molecule drug discovery processes. The computation approach also enables researchers to expedite the overall process, thereby, saving a significant amount of time, as well.

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

What are the popular business strategies being used by in silico drug discovery service providers?

Computational technologies have evolved significantly in the past few years. However, one of the key challenges faced by in silico drug discovery service providers is the lack of clarity on which business model should be adopted in order to maintain an edge in this highly competitive industry. In order to achieve success, it is highly important for service providers to choose a model / strategy (based on their current capabilities) that is not only beneficial for their business, but also provides various advantages to their partners (pharmaceutical companies / academic players). For instance, our proprietary analysis indicated that most of the players engaged in the in silico drug discovery services market are challenger firms. We believe that these players should continue to offer customized services to the clients and expand their services offerings for novel biologic classes. 

Likely Growth of the In Silico Drug Discovery Services Market

North America and Europe are anticipated to capture over 75% of the market share by 2030. Within North America, US is anticipated to hold the 90% of the market share. It is worth mentioning that the market in Asia-Pacific region is anticipated to grow at a relatively faster rate (16.1%).

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

To get detailed insights about this market, check out the report here

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

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