#cell therapy

[tha-wrecka-stow]

[jcmarchi]

Unlocking mRNA’s cancer-fighting potential

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Unlocking mRNA’s cancer-fighting potential

What if training your immune system to attack cancer cells was as easy as training it to fight Covid-19? Many people believe the technology behind some Covid-19 vaccines, messenger RNA, holds great promise for stimulating immune responses to cancer.

But using messenger RNA, or mRNA, to get the immune system to mount a prolonged and aggressive attack on cancer cells — while leaving healthy cells alone — has been a major challenge.

The MIT spinout Strand Therapeutics is attempting to solve that problem with an advanced class of mRNA molecules that are designed to sense what type of cells they encounter in the body and to express therapeutic proteins only once they have entered diseased cells.

“It’s about finding ways to deal with the signal-to-noise ratio, the signal being expression in the target tissue and the noise being expression in the nontarget tissue,” Strand CEO Jacob Becraft PhD ’19 explains. “Our technology amplifies the signal to express more proteins for longer while at the same time effectively eliminating the mRNA’s off-target expression.”

Strand is set to begin its first clinical trial in April, which is testing a proprietary, self-replicating mRNA molecule’s ability to express immune signals directly from a tumor, eliciting the immune system to attack and kill the tumor cells directly. It’s also being tested as a possible improvement for existing treatments to a number of solid tumors.

As they work to commercialize its early innovations, Strand’s team is continuing to add capabilities to what it calls its “programmable medicines,” improving mRNA molecules’ ability to sense their environment and generate potent, targeted responses where they’re needed most.

“Self-replicating mRNA was the first thing that we pioneered when we were at MIT and in the first couple years at Strand,” Becraft says. “Now we’ve also moved into approaches like circular mRNAs, which allow each molecule of mRNA to express more of a protein for longer, potentially for weeks at a time. And the bigger our cell-type specific datasets become, the better we are at differentiating cell types, which makes these molecules so targeted we can have a higher level of safety at higher doses and create stronger treatments.”

Making mRNA smarter

Becraft got his first taste of MIT as an undergraduate at the University of Illinois when he secured a summer internship in the lab of MIT Institute Professor Bob Langer.

“That’s where I learned how lab research could be translated into spinout companies,” Becraft recalls.

The experience left enough of an impression on Becraft that he returned to MIT the next fall to earn his PhD, where he worked in the Synthetic Biology Center under professor of bioengineering and electrical engineering and computer science Ron Weiss. During that time, he collaborated with postdoc Tasuku Kitada to create genetic “switches” that could control protein expression in cells.

Becraft and Kitada realized their research could be the foundation of a company around 2017 and started spending time in the Martin Trust Center for MIT Entrepreneurship. They also received support from MIT Sandbox and eventually worked with the Technology Licensing Office to establish Strand’s early intellectual property.

“We started by asking, where is the highest unmet need that also allows us to prove out the thesis of this technology? And where will this approach have therapeutic relevance that is a quantum leap forward from what anyone else is doing?” Becraft says. “The first place we looked was oncology.”

People have been working on cancer immunotherapy, which turns a patient’s immune system against cancer cells, for decades. Scientists in the field have developed drugs that produce some remarkable results in patients with aggressive, late-stage cancers. But most next-generation cancer immunotherapies are based on recombinant (lab-made) proteins that are difficult to deliver to specific targets in the body and don’t remain active for long enough to consistently create a durable response.

More recently, companies like Moderna, whose founders also include MIT alumni, have pioneered the use of mRNAs to create proteins in cells. But to date, those mRNA molecules have not been able to change behavior based on the type of cells they enter, and don’t last for very long in the body.

“If you’re trying to engage the immune system with a tumor cell, the mRNA needs to be expressing from the tumor cell itself, and it needs to be expressing over a long period of time,” Becraft says. “Those challenges are hard to overcome with the first generation of mRNA technologies.”

Strand has developed what it calls the world’s first mRNA programming language that allows the company to specify the tissues its mRNAs express proteins in.

“We built a database that says, ‘Here are all of the different cells that the mRNA could be delivered to, and here are all of their microRNA signatures,’ and then we use computational tools and machine learning to differentiate the cells,” Becraft explains. “For instance, I need to make sure that the messenger RNA turns off when it’s in the liver cell, and I need to make sure that it turns on when it’s in a tumor cell or a T-cell.”

Strand also uses techniques like mRNA self-replication to create more durable protein expression and immune responses.

“The first versions of mRNA therapeutics, like the Covid-19 vaccines, just recapitulate how our body’s natural mRNAs work,” Becraft explains. “Natural mRNAs last for a few days, maybe less, and they express a single protein. They have no context-dependent actions. That means wherever the mRNA is delivered, it’s only going to express a molecule for a short period of time. That’s perfect for a vaccine, but it’s much more limiting when you want to create a protein that’s actually engaging in a biological process, like activating an immune response against a tumor that could take many days or weeks.”

Technology with broad potential

Strand’s first clinical trial is targeting solid tumors like melanoma and triple-negative breast cancer. The company is also actively developing mRNA therapies that could be used to treat blood cancers.

“We’ll be expanding into new areas as we continue to de-risk the translation of the science and create new technologies,” Becraft says.

Strand plans to partner with large pharmaceutical companies as well as investors to continue developing drugs. Further down the line, the founders believe future versions of its mRNA therapies could be used to treat a broad range of diseases.

“Our thesis is: amplified expression in specific, programmed target cells for long periods of time,” Becraft says. “That approach can be utilized for [immunotherapies like] CAR T-cell therapy, both in oncology and autoimmune conditions. There are also many diseases that require cell-type specific delivery and expression of proteins in treatment, everything from kidney disease to types of liver disease. We can envision our technology being used for all of that.”

[rodspurethoughts]

FDA Approves Omisirge, a Cell Therapy for Blood Cancer Patients Undergoing Stem Cell Transplantation

The FDA has recently approved a cell therapy called Omisirge (omidubicel-onlv) for patients with blood cancers who are undergoing stem cell transplantation. This allogeneic cord blood-based cell therapy can help speed up the recovery of neutrophils in the body, a type of white blood cell, and reduce the risk of infection. Omisirge is intended for use in adults and pediatric patients 12 years and…

[healthcare-skyquest]

Cell Therapy Market: Driving Breakthroughs in Regenerative Medicine

The Cell Therapy market is gaining momentum as a cutting-edge approach in regenerative medicine, offering promising solutions for treating various diseases. With advancements in stem cell research and growing demand for innovative treatments, the cell therapy market is poised for remarkable growth. This article delves into the latest trends, market segmentation, key growth drivers, and top players in the cell therapy industry.

Market Overview

SkyQuest’s Cell Therapy Market report estimates the market value at USD 6.7 Billion in 2023, with a projected CAGR of 52%. The market is expanding due to increasing investments in stem cell research, rising prevalence of chronic diseases, and a shift towards personalized medicine.

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Market Segmentation

By Therapy Type:

Autologous Therapy: Uses the patient's own cells for treatment, minimizing the risk of rejection.

Allogeneic Therapy: Involves using donor cells, which are more accessible but may require immune suppression.

By Application:

Cancer: Cell therapies, such as CAR-T cell therapy, are revolutionizing cancer treatment by targeting and destroying cancer cells.

Autoimmune Disorders: Cell therapies are being used to modulate the immune system in conditions like multiple sclerosis and lupus.

Cardiovascular Diseases: Emerging therapies aimed at regenerating damaged heart tissues after heart attacks.

Neurological Disorders: The development of cell-based treatments for diseases like Parkinson's and spinal cord injuries.

By End-User:

Hospitals and Clinics: Primary centers for the administration of cell therapies.

Academic and Research Institutes: Pioneers in the development of new cell therapy solutions.

Biotechnology and Pharmaceutical Companies: Leading the commercialization of cell therapy products.

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Key Growth Drivers

Advancements in Stem Cell Research: Breakthroughs in stem cell technologies are enabling the development of more effective therapies.

Growing Prevalence of Chronic Diseases: The increasing burden of diseases like cancer, autoimmune disorders, and cardiovascular diseases drives the demand for cell therapies.

Increasing R&D Investment: Significant investments in cell therapy research and clinical trials are accelerating the discovery of new treatments.

Shift Towards Personalized Medicine: Personalized cell therapies are tailored to individual patients, offering more effective and targeted treatments.

Leading Companies in the Market

SkyQuest’s Cell Therapy Market report highlights the following major players:

Novartis AG

Gilead Sciences

Bristol-Myers Squibb

Celgene Corporation

JCR Pharmaceuticals Co., Ltd.

Osiris Therapeutics, Inc.

Vericel Corporation

Fate Therapeutics

Bluebird Bio

Kolon TissueGene

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Challenges and Opportunities

The cell therapy market faces challenges such as high costs, stringent regulatory requirements, and manufacturing complexities. However, these obstacles also present opportunities for companies to develop cost-effective solutions and scalable production methods.

Future Outlook

The future of the cell therapy market looks promising, with increasing clinical trials, expanding treatment applications, and growing partnerships between academic institutions and pharmaceutical companies. As the industry evolves, companies that focus on innovation and overcoming regulatory challenges will thrive.

Conclusion

The cell therapy market is at the forefront of medical innovation, offering transformative treatments for chronic and life-threatening diseases. Decision-makers in the healthcare sector should stay informed about emerging trends and developments in this rapidly growing field. For in-depth insights and strategic recommendations, consult SkyQuest’s Cell Therapy Market report.

[omshinde5145]

Primary Cells Market Trends, Review, and Forecast 2024–2030

The Primary Cells Market was valued at USD 1.6 billion in 2023 and will surpass USD 3.1 billion by 2030; growing at a CAGR of 10.0% during 2024 - 2030. Primary cells, derived directly from living tissues, maintain the physiological relevance of human biology, making them invaluable in scientific research. Unlike immortalized cell lines, primary cells retain their unique characteristics, providing more accurate models for in vitro studies. This blog explores the key trends, growth drivers, opportunities, and challenges within the primary cells market.

Key Market Trends Driving Growth

Increasing Adoption in Drug Discovery and Development Pharmaceutical companies and research institutions are leveraging primary cells for drug screening and toxicity testing. These cells offer a more accurate prediction of drug responses compared to traditional cell lines. As personalized medicine gains momentum, primary cells enable more individualized and predictive models, allowing researchers to identify specific responses to therapeutic agents.

Advancements in 3D Cell Culture and Organoid Models One of the major trends in the primary cells market is the increasing use of 3D cell culture and organoid models. These advanced culture systems more closely mimic the structure and function of human tissues, offering an enhanced platform for studying disease progression, drug efficacy, and patient-specific therapies. The integration of primary cells into these models is expected to further accelerate research in fields such as oncology, neurology, and regenerative medicine.

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Growing Demand in Cancer Research Primary cells, especially cancer-associated cells such as tumor cells or cancer-associated fibroblasts, are crucial in cancer research. With the rising incidence of cancer, there is a pressing need for more accurate in vitro models that replicate the complex tumor microenvironment. Primary cancer cells, derived directly from patient tissues, are providing researchers with the tools to develop more effective therapies and understand tumor behavior better.

Expansion of Biobanking and Cryopreservation The expansion of biobanks and cryopreservation services is another major factor contributing to the market’s growth. Primary cell biobanks offer vast repositories of cells from diverse human populations, allowing researchers to study genetic variations and disease-specific models. With the increasing emphasis on precision medicine, the demand for high-quality, well-characterized primary cells has surged, enhancing the role of biobanks in supplying these valuable resources.

Opportunities in the Primary Cells Market

Rising Interest in Regenerative Medicine Regenerative medicine is poised to transform the treatment of various degenerative diseases, and primary cells play a key role in this revolution. Stem cells, a type of primary cell, have shown tremendous potential in regenerative therapies for conditions such as heart disease, neurological disorders, and diabetes. The growing pipeline of regenerative therapies represents a lucrative opportunity for companies specializing in primary cell production and related services.

Emerging Markets and Technological Innovations Emerging markets, particularly in Asia-Pacific and Latin America, are becoming attractive for key players in the primary cells market. The increasing healthcare investments, supportive government policies, and growing focus on biotechnology research in these regions are expected to fuel demand for primary cells. Additionally, technological innovations in cell isolation, culture, and cryopreservation techniques are likely to open new avenues for growth in the market.

Partnerships and Collaborations As the complexity of cellular research increases, partnerships between academic institutions, biotech companies, and pharmaceutical firms are becoming more common. Collaborations in areas such as cell sourcing, assay development, and therapeutic applications are enhancing the capabilities of market players. These partnerships are expected to drive innovation and accelerate the adoption of primary cell-based models in various industries.

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Challenges Facing the Primary Cells Market

Limited Availability and High Costs One of the primary challenges in the market is the limited availability of certain types of primary cells, particularly those from rare or difficult-to-access tissues. The cost of isolating, culturing, and maintaining these cells can be prohibitively high, which can restrict their widespread adoption, especially in resource-constrained settings. Additionally, ethical concerns surrounding the sourcing of human tissues remain a challenge that needs to be carefully managed.

Variability and Short Lifespan Unlike immortalized cell lines, primary cells have a finite lifespan, and their characteristics can vary between donors. This variability can introduce challenges in reproducibility and consistency of experimental results, making it difficult to standardize protocols across different labs. While efforts to improve cell culture techniques and reduce variability are ongoing, this remains a significant obstacle for researchers.

Regulatory Hurdles As primary cells are increasingly used in drug development and regenerative therapies, navigating the complex regulatory landscape is becoming a key challenge. Regulatory bodies such as the FDA and EMA require stringent validation of cell-based models, which can delay the approval and commercialization of new therapies. Ensuring compliance with ethical standards for human tissue sourcing and use further complicates the regulatory process.

Conclusion

The primary cells market is poised for robust growth in the coming years, driven by advancements in personalized medicine, drug discovery, and regenerative therapies. The increasing adoption of 3D cell culture systems, expansion of biobanking, and the growing focus on cancer research are key trends shaping the market's future. However, challenges such as high costs, cell variability, and regulatory complexities must be addressed to unlock the full potential of primary cells. As technological innovations continue to emerge and collaborations expand, the primary cells market is set to play a pivotal role in the future of biomedical research and therapeutic development.

[airises]

What are induced pluripotent stem cells, and how are they different from embryonic stem cells?

What are induced pluripotent stem cells (iPSCs)? Reprogrammed adult cells: iPSCs are created in the lab by taking adult cells (often skin or blood cells) and genetically reprogramming them back to an immature, embryo-like state. Pluripotency: Like embryonic stem cells, iPSCs are pluripotent. This means they have the exceptional potential to develop into almost any type of cell in the body. Key…

[regenhealthsolutions]

A micro-fragmented collagen gel as a stem cell-assembling platform for critical limb ischemia repair

Critical limb ischemia is a condition in which the main blood vessels supplying blood to the legs are blocked, causing blood flow to gradually decrease as atherosclerosis progresses in the peripheral arteries. It is a severe form of peripheral artery disease that causes progressive closure of arteries in the lower extremity, leading to the necrosis of the leg tissue and eventual…

[mindfulcells]

Mira's Lymphoma Warrior Journey: Hope and CAR-T Therapy

Estimated reading time: 7 minutes The bold headlines proclaimed the promise of CAR T therapy and its efficacy in combating lymphoma’s relentless grip. Mira – a woman who had weathered the storm of cancer diagnosis, treatment, and remission. She paused to reflect on hope with her life-changing lymphoma warrior journey. As the city’s symphony of car horns echoed outside her window, she stepped…

[dontsweatthefresh]

Danny Brown - Jenn's Terrific Vacation (Official Video)

Goodie Mob - Cell Therapy (Official HD Video)

Kassa Overall: Tiny Desk Concert

[jcmarchi]

Navigating the Digital Revolution in Healthcare: A Strategic Guide for Healthcare Leaders

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Navigating the Digital Revolution in Healthcare: A Strategic Guide for Healthcare Leaders

Healthcare is witnessing an unprecedented pace of change. There are several forces at play, creating a shift in how we approach health and wellness.

First, is demographics. There is a growing gap between lifespan and healthspan. People aren’t just getting older—they’re facing different types of health challenges too. Chronic diseases and morbidities are showing up earlier in life and there is a growing focus on wellness. To cater to this changing demographics, healthcare needs to be more personalized and proactive, moving beyond just reacting to illness.

On the bright side, we’re getting better at understanding the human body and finding new ways to treat it. Healthcare technologies are evolving rapidly and care delivery is becoming more connected and collaborative thanks to digital transformation efforts and technologies like Generative AI. Game-changing innovations like CAR-T cell therapy, radioligand treatments, and advanced diagnostics (e.g., 11.7 Tesla MRI machines) are transforming how we treat and manage diseases. At the same time, device miniaturization and advancements in healthcare informatics are enabling self-management of conditions, creating new possibilities for remote patient care and monitoring.

And most importantly, given the rising cost of care, healthcare payments are now tied to value-based, outcome-oriented care rather than transactions. Payers are also stepping in to play a bigger role in managing care. This is pushing organizations to find new ways to cut costs while improving care delivery and create new outcome-based payment models.

Together, these forces are reshaping healthcare in extraordinary ways. So, in the light of these changes, what does the future look like?

The future of healthcare delivery: self-managed, connected, and boundaryless

In the light of the changes in disease mix, focus on wellness rather than treatment, and tech advancements, healthcare delivery is set to evolve in a few key ways:

Digital tiers of care: The traditional model of primary, secondary, and tertiary care is expanding to include a new “digital” tier. Digital interventions will drive connectivity, enabling remote consultations, virtual care, and better patient monitoring—making healthcare more flexible and boundaryless.

Patient-centric models: Patients, especially those with chronic conditions, will play a more active role in managing their health. This shift towards patient empowerment will reduce the reliance on hospital settings and promote continuous, proactive care.

Evolving payment models: We’ll see the right payment models emerging that emphasize value over episodic transactions and reward preventive care. These future payment frameworks will holistically focus on wellness, behavioral health, and care management rather than just individual treatments.

Coordinated patient journeys: Joining the dots in fragmented patient journeys, future care models will focus on coordination across providers, payers, and care settings. With better data sharing, patients will experience smoother, more efficient care, leading to better outcomes.

Immediate priorities for healthcare organizations

While these evolving futuristic models have a lot of potential, but to get there, healthcare organizations need to navigate some existing on ground realities—starting with finding the money for transformation, innovating at “digital native” speeds, and finding new, sustainable business models.

1. Driving down healthcare costs

We all know that healthcare costs across the system – be it care, research, or administration – are extremely high. For example, 1/7th of the total healthcare spending in the US is on administrative tasks! Every healthcare leader is asking, “How can we become a more cost-effective and efficient organization?”

The answer lies leveraging AI to reimage, optimize, and automate existing processes and operations. For example, one of the ways an AI driven predictive analytics solution can save costs is by identifying high-risk patients, suggesting and implementing targeted interventions, and reducing hospital readmissions.

 2. Embracing agility with digital transformation

To provide the best possible care and patient experience, the healthcare ecosystem needs to adopt digital technologies at scale and become more agile and collaborative. However, just implementing the latest tech is not enough. Take AI for example. We’ve seen that despite POC successes, putting AI into production at scale, ensuring it is ethically sound, accurate, and essentially flawless continues to be a challenge.

The goal for digital transformation should be to achieve true agility—not just in software development, but in how the entire organization operates. This means looking at how doctors, clinicians, payers, and patients interact, improving the speed of care delivery, and ensuring everyone is working together more effectively.

That is only possible when organizations think carefully about their strategy, prioritize use cases that can improve operations and care delivery, and seamlessly weave technology into everyday workflows.

3. Exploring new, sustainable business models

One of the biggest opportunities in digital healthcare is taking the “tribal knowledge” — the valuable insights that come from years of experience — and turning it into AI models that can be monetized. Instead of that knowledge staying locked in the minds of a few experts, it becomes something repeatable and scalable, leading to more personalized and effective care for patients.

Keeping pace with industry shifts: Strategies for healthcare leaders

If we think of an organization like a person, it has a head and a heart—intelligence and feelings. To move the needle on transformation, healthcare leaders need to balance strategy, tactics, and empathy. Successful leaders will:

Look at transformation from a dual lens: Make current operations more efficient while also creating space for new ways of working. Challenge the status quo and prepare for the transition to newer models.

Think big, start small, scale wisely: Large-scale transformations can be overwhelming. It’s important to have a big-picture vision, but the key is to start small. Experiment, test things out, and then gradually expand on what works. By proving the value of digital solutions early, you can reduce risks and build confidence as you move forward.

Embrace multimodal transformation and commit to change: Transformation isn’t just about processes—it’s about people, customers, and change orchestration. Successful change requires buy-in at all levels, from top leadership to employees on the ground. Ensure that employees can adapt to new processes and technologies as they evolve.

Find the right partner: To navigate these shifts, it’s important to find a partner who truly understands the healthcare industry and values continuous learning and innovation. For example, at CitiusTech, we work across the entire healthcare ecosystem—payers, providers, life sciences, and medtech. This gives us a unique perspective, helping our clients connect the dots and turn their big ideas into reality.

Ultimately, success in the new paradigm of healthcare will be about rethinking how healthcare services are delivered, whether through new business models or innovative  tech that can bring real benefits to patients and providers alike.

[root-analysis]

TIL Cell Therapy Market CAGR | Analysis Size & Forecast (2035) 

The TIL therapy market, a part of the broader cell therapy market, is experiencing significant growth and is projected to grow at a compounded annual growth rate (CAGR) of 40% during the forecast period. The report also provides sales forecasts for TIL therapies market CAGR that are currently in the mid-to-late stages of development. Get a detailed insights report now!

[healthcaretechnologynews]

Cell & Gene Therapy Clinical Trials Market by Phase (Phase I, Phase II), Indication (Oncology, Cardiology) – Global Outlook & Forecast 2023-2031

According to the deep-dive market assessment study by Growth Plus Reports, the global cell & gene therapy clinical trials market was valued at US$ 9.59 billion in 2022 and is expected to register a revenue CAGR of 13.5% to reach US$ 29.69 billion by 2031. 

Cell & Gene Therapy Clinical Market Fundamentals

Cell and gene therapy clinical trials refer to research studies conducted to evaluate the safety, efficacy, and potential applications of cell and gene therapies in human patients. These trials aim to assess the therapeutic benefits and risks associated with these innovative treatment approaches. Clinical trials for cell and gene therapies are typically conducted in multiple phases. In early-phase trials (Phase I and Phase II), the primary focus is on evaluating the safety and tolerability of the therapy, determining the optimal dosage and administration route, and gathering preliminary efficacy data. These trials often involve a small number of participants and closely monitor their responses.

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Cell & Gene Therapy Clinical Market Dynamics

The rising incidence of genetic disorders, chronic diseases such as cancer and cardiovascular diseases, and other conditions with limited treatment options have created a strong demand for innovative therapies like cell & gene therapy. Clinical trials in this field aim to develop effective treatments for these diseases, driving cell & gene therapy clinical trialsmarket growth. According to the WHO, cardiovascular diseases are the main cause of mortality worldwide, accounting for an estimated 17.9 million lives per year, or 32% of all fatalities worldwide. More than 75% of deaths occur in low and middle-income nations. Rapid advancements in biotechnology, gene editing technologies (such as CRISPR-Cas9), and our understanding of genetics have significantly contributed to developing cell and gene therapies. These advancements have enabled scientists to identify target genes and develop precise therapies, leading to increased clinical trials. Several landmark clinical trials have demonstrated the safety and efficacy of cell and gene therapies in treating various diseases. Positive outcomes in trials for diseases like leukemia, lymphoma, and inherited retinal disorders have generated enthusiasm among researchers, clinicians, and patients, leading to increased participation in clinical trials and further driving the cell & gene therapy clinical trialsmarket demand. The field of cell & gene therapy has attracted significant investments and funding from both public and private sources. Pharmaceutical companies, venture capitalists, and government organizations recognize the potential of these therapies and are investing in research and development, infrastructure, and clinical trials, which are also expected to boost the growth of the cell & gene therapy clinical trialsmarket.

However, developing and conducting cell & gene therapy clinical trials can be extremely expensive due to the complexity of these therapies. Costs are associated with research and development, manufacturing, regulatory compliance, and clinical trial operations. These high costs pose a challenge for small biotech companies and academic institutions with limited resources, restricting the growth of gene therapy clinical trials. While regulatory agencies have made efforts to facilitate the development and approval of cell and gene therapies, navigating the regulatory landscape can still be challenging. Meeting regulatory requirements for safety, efficacy, and quality is essential but can involve complex processes and lengthy approval timelines, which is also hindering the growth of the gene therapy clinical trialsmarket. 

Cell & Gene Therapy Clinical Market Ecosystem

The global cell & gene therapy clinical trialsmarket is analyzed from three perspectives: phase, indication, and region. 

Cell & Gene Therapy Clinical Market by Phase

Based on the phases, the global cell & gene therapy clinical trialsmarket is segmented into phase I, phase II, phase III, and phase IV.

The phase II segment accounted for the largest revenue share, with a 51% cell & gene therapy clinical trials market share. Phase II trials aim to assess the efficacy of the therapy in a larger patient population. They provide more extensive data on the therapeutic benefits and effectiveness of the treatment. This phase often involves comparing the therapy to existing standard treatments or placebos, allowing for a more comprehensive evaluation of its efficacy. Phase II trials help refine the dosage and administration protocols of the therapy. The initial Phase I trials provide some insight into dosage levels, but Phase II allows for a more systematic exploration of different doses and administration schedules to identify the optimal therapeutic regimen. Phase II trials often involve a larger number of patients, allowing for better selection and inclusion of a diverse patient population. This enables researchers to assess the therapy's efficacy in different subgroups and evaluate its potential benefits across a broader range of patients. Regulatory agencies typically require data from well-designed Phase II trials to support the advancement of therapies to Phase III and subsequent stages. The data collected from Phase II trials are crucial for demonstrating the therapy's efficacy and safety profile, supporting regulatory submissions, and obtaining further approvals for larger-scale trials. Positive results from Phase II trials often generate significant interest from investors, as they indicate the therapy's potential for success. Promising efficacy and safety data from Phase II trials can attract funding and partnerships for further development and commercialization of the therapy, driving market dominance in this phase.

Cell & Gene Therapy Clinical Market by Indication 

Based on the indications, the global cell & gene therapy clinical trialsmarket is segmented into oncology, cardiology, CNS, musculoskeletal, infectious diseases, immunology & inflammation, ophthalmology, dermatology, endocrine, metabolic, genetic, hematology, gastroenterology, and others.

The oncology segment accounted for the prominent cell & gene therapy clinical trials market share in 2022, with a 45% market share. Oncology represents a significant unmet medical need, with a wide range of cancers having limited treatment options.  According to GLOBOCAN 2020 report, approximately 10 million deaths were cases by cancer in 2020.  Cell and gene therapies offer potential breakthroughs in cancer treatment by targeting specific genetic alterations or enhancing the immune system's ability to recognize and eliminate cancer cells. The urgent need for effective cancer treatments drives the focus on oncology in clinical trials. Oncology has been a well-established area of research and development for many years. This has led to a deeper understanding of cancer biology, genetic alterations, and immune responses in the context of cancer. The infrastructure and expertise required for conducting clinical trials in oncology are well-established. Oncology research centers, academic institutions, and specialized hospitals often have the necessary infrastructure, multidisciplinary teams, and patient populations available to conduct cell & gene therapy clinical trials. The market potential for oncology treatments is significant, given the high prevalence of cancer and the increasing demand for more effective therapies. Successful cell and gene therapies in oncology have the potential for commercial success, attracting investments from both pharmaceutical companies and venture capitalists. This market potential further drives the growth of the oncology segment in the cell & gene therapy clinical trials market.

Cell & Gene Therapy Clinical Market by Region

Geographically, the global cell & gene therapy clinical trials market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. 

The North America region has the largest cell & gene therapy clinical trials market size in terms of revenue generation accounting for around 46.2% share of the market. North America boasts a strong biotechnology and pharmaceutical industry, with numerous research institutions, academic centers, and biotech companies at the forefront of cell & gene therapy development. These entities contribute to the discovery, development, and commercialization of innovative therapies, driving the growth of clinical trials in the region. North America has a well-established, advanced healthcare infrastructure, including specialized treatment centers, research institutions, and clinical trial networks. This infrastructure supports the conduct of clinical trials by providing access to patient populations, expert clinicians, and specialized facilities required to deliver cell and gene therapies. North America is a hub for biotech and venture capital investments, attracting significant funding for cell & gene therapy research and development. Academic institutions, government agencies, and private investors provide financial support to advance clinical trials in the region. North America fosters a collaborative environment, with academic institutions, biotech companies, and research organizations working together on cell & gene therapy projects. Collaborations between academia and industry and partnerships between different stakeholders facilitate knowledge sharing, access to resources, and the progression of clinical trials.

Cell & Gene Therapy Clinical Market Competitive Landscape

The prominent players operating in the global cell & gene therapy clinical trials market are:

ICON Plc

IQVIA

Charles River Laboratories International, Inc.

Laboratory Corporation of America Holdings

Syneos Health

PAREXEL International Corp.

Medpace Holdings, Inc.

PPD Inc.

Novotech

Veristat, LLC

Cell & Gene Therapy Clinical Market Strategic Developments

In June 2023, Arrowhead Pharmaceuticals submitted an application seeking approval to initiate a Phase I clinical trial of ARO-SOD1 to treat amyotrophic lateral sclerosis (ALS) harbouring superoxide dismutase 1 (SOD1) mutations. In compliance with the Australian Department of Health and Ageing's Therapeutic Goods Administration's clinical trial notification process, the company filed the application to an ethics committee. The RNAi-based experimental drug ARO-SOD1 is being tested in adults with ALS with SOD1 mutations in a dose-escalation, placebo-controlled, randomized research.

In June 2023, Beacon Therapeutics entered into the gene therapy field with a $120m Series A financing. The new ocular gene therapy firm was founded by integrating Applied Genetic Technologies Corporation's (AGTC) late-stage X-linked retinitis pigmentosa (XLRP) program with two unique preclinical studies. The finance includes AGTC's acquisition and funds to help speed Beacon Therapeutics' candidate development, with participation from Oxford Science Enterprises (OSE). The total amount of funding was £96 million ($120 million).

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[jupiterlaser]

Thing People Get Wrong About Benefits of Stem Cell Therapy

You may find yourself in an emotionally charged situation if you engage yourself in a discussion related to stem cell. While the controversy about stem cell therapy will cross the religious and political beliefs, it is controversial topic of discussion for everybody.

Due to personal biasness, much of the contention is the result of misleading and incorrect information. While the clinical research that was necessary to advance this field of medicine, personal biasness has slowed it down.

When researchers discovered that cells were building blocks of life, cell research started in the mid — 1880s. Doctors had performed 200 allogeneic stem cell transplants in human by 1950s and 60s without any success.

While treating immune deficiency through bone marrow transplant, stems cells in the late 1960s were also used for treatment of leukemia and aplastic anemia.

It is seen that there are some myths and facts related to stem cell, which are discussed in this article. Let us dig it in.

Stem Cells Are Taken from Embryos

True/False

It is said that practices, and clinics do use embryonic stem cells for their procedures. When it comes to medical injection therapy, it is not the case. It is seen that you can classify stem cell into two categorise viz: embryonic and adult cell.

It is seen that doctors can easily replicate the stem cells into other types of cells, which they use through the adult mesenchymal cells. These cells are very undifferentiated with the normal adult cells.

Before injecting to the affected site, these adults stem cells are taken from the patient’s stem cell or adipose tissue. Doctors can use platelet rich plasma injections for curing the condition.

Stem Cell Is Unsafe

False

If you go to an unreliable, and unauthorized clinic, you will know that doctors are providing unsafe stem cell therapy. It is seen that doctors will not provide such improper practices, as you do not have worry about it.

It is the trained team of doctors, who will perform such therapies. These doctors will take an autologous approach so that you do not get a transmitted infectious disease. While doctors try to make it risk free, you will know that the therapy is minimally invasive.

After analyzing the medical history of patients, doctors will go ahead with the injection therapy. Before administering the injection therapy, they will brief you about the process.

Therapy is Prone to Body Rejection

False

There is no chance of body rejecting the injected cells, as stem cells is autologous. While there are chances of elimination of chances of rejection which is a cause of concern in donor transplant, your immune system would not treat them as a foreign invasion.

While assisting the degenerative alignments, and condition, the stem cells will stimulate the body’s natural healing response. It will provide a long — lasting and quick solution.

Therapy Will Cure Several Aliments

True

Doctors can treat several illnesses, and medical conditions, as it has become possible with stem cell. While used for the healing sports related injuries like bruised tendons, torn ligaments and muscle pain, the therapy is very useful for the musculoskeletal injuries.

The therapy is also very effective for the osteoarthritis. It is seen stem cell therapy will promote cartilage regeneration.

Re Adult Stem Cells as Good — Or Better — Than Embryonic Stem Cells?

While helping for future therapies, adult stem cells have great potential and are extremely valuable. While adult stem cells can only follow certain paths, embryonic cells can grow virtually into any cell type in the body.

While the embryonic stem cells are not so flexible in treating all types of diseases, adult stem cells do not grow indefinitely in the labs.

Final Thoughts

There are lots of benefits for stem cell. You should not remain in notion that stem cell is a dangerous therapy for your disease.