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Visiongain has published a new report entitled Cell Therapy Technologies Market Report 2024-2034: Forecasts by Product (Sera, Media, Reagent, Cell Engineering Product, Cell Culture Vessels, Equipment, Systems and Software, Others), by Cell Type (T-Cells, Stem Cells, Other Cells), by Process (Cell Processing, Cell Preservation, Distribution, and Handling, Process Monitoring and Quality Control), by End-users (Biopharmaceutical & Biotechnology Companies, CROs, Research Institutes and Cell Banks) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.

The cell therapy technologies market is estimated at US$7,041.3 million in 2024 and is projected to grow at a CAGR of 10.7% during the forecast period 2024-2034.

The rise in chronic diseases like cancer, cardiovascular issues, and autoimmune disorders has created a pressing need for effective treatments. Supportive regulatory frameworks have encouraged the development & commercialization of cell therapies. Additionally, increased awareness and acceptance of these therapies among healthcare professionals and patients are driving demand further. Advancements in cell therapies offer lucrative opportunities for market players. Companies are focusing on enhancing the efficacy & safety of these therapies to provide better disease management outcomes for patients.

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How has COVID-19 had a Significant Impact on the Cell Therapy Technologies Market?

The COVID-19 pandemic has affected the market for cell therapy technologies market significantly. The pandemic initially caused significant disruptions to the manufacturing and supply chains of numerous industries, including the biotechnology sector. As a result, there were delays in cell therapy clinical trials, regulatory approvals, and commercialization initiatives. Furthermore, the shift in healthcare resources towards the management of the pandemic led to a reduction in funding and attention for medical research unrelated to COVID-19, such as the development of cell therapies.

However, the pandemic also made clear how crucial cutting-edge medical innovations like cell therapies are to solving the world's health crises. Consequently, there has been a surge in interest and funding for the study and advancement of cell therapy as a means of treating not only COVID-19 but also other chronic illnesses and infectious diseases. Additionally, the pandemic's adoption of telemedicine and remote monitoring has sped up the acceptance of decentralised clinical trials, which could advance cell therapy technologies by lowering trial costs and increasing patient access. The COVID-19 pandemic has, in the long run, created opportunities for innovation, collaboration, and growth, even though it initially presented challenges to the cell therapy technology market. The cell therapy sector is positioned to have a significant impact on how healthcare and illness management are provided in the future, even as the globe struggles to cope with the pandemic's aftermath.

How will this Report Benefit you?

Visiongains 305-page report provides 109 tables and 173 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the cell therapy technologies market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Cell Therapy Technologies. Get financial analysis of the overall market and different segments including product, cell type, process, end-users and capture higher market share. We believe that there are strong opportunities in this fast-growing cell therapy technologies market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Rise in Prevalence of Chronic & Degenerative Diseases

The healthcare sector faces numerous challenges from chronic illnesses like cancer, heart disease, neurological ailments, and autoimmune disorders. The management or cure of many disorders is frequently only partially successful with conventional therapeutic options.

With the ability to replace, regenerate, or repair damaged tissues or organs, cell therapy presents a viable substitute. Much emphasis has been paid to cell treatments' capacity to treat diseases at their root and encourage long-term healing.

Notable advancements in cell treatment technologies have been made over time to address degenerative and chronic illnesses. For example, developments in stem cell research have made it possible to identify and isolate several types of stem cells, each with a unique therapeutic potential. In order to create novel cell-based therapeutics, researchers are looking into the utilisation of hematopoietic stem cells, induced pluripotent stem cells, and mesenchymal stem cells.

Rigorous Efforts by Companies Towards Development of Proprietary & Supportive Technologies Anticipated to Boost Industry Growth

In regenerative medicine, cell therapy, which employs living cells to treat or cure diseases, has emerged as a promising area of study. Nevertheless, the efficacy of cell therapies is contingent upon the accessibility of cutting-edge technologies that facilitate the production, characterization, and transportation of cells.

Significant investments are being made by companies in the cell therapy industry in research and development of proprietary technologies that improve the safety, effectiveness, and scalability of cell therapies. The technologies in question comprise an extensive array of domains, such as tools for cell characterization, cell isolation and expansion techniques, and cryopreservation methods.

The advancement of cell culture systems is a primary area of emphasis. Organisations are currently engaged in the development and refinement of culture media, growth factors, and bioreactors that establish an optimal milieu for cellular proliferation while preserving the viability and functionality of the cells. The primary objectives of these proprietary culture systems are to increase cell yields, decrease production expenses, and facilitate the scalable production of cell therapies.

Considerable interest is being devoted to supportive technologies that affect cell isolation and purification. Innovative methods are being developed by businesses to isolate particular cell populations from complex mixtures, thereby ensuring the quality and purity of cells used in therapies. These technologies reduce the possibility of contamination or undesired cell populations while facilitating the efficient isolation of therapeutic cell types.

Cryopreservation technologies are indispensable for the transportation and long-term storage of cells. Organisations are presently preoccupied with the advancement of cryopreservation techniques that preserve the genetic stability, viability, and functionality of cells throughout the freezing and thawing processes.

These developments guarantee the presence of viable cells during therapy administration, notwithstanding the logistical obstacles that may arise from cell storage and transportation.

The development of proprietary and supportive technologies will therefore likely contribute to the expansion of the global market for cell therapy technologies.

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Where are the Market Opportunities?

Emerging nations present a substantial potential for the progression and integration of cell therapy technologies. These countries are currently experiencing notable advancements in their healthcare systems, as significant financial resources are being allocated to accommodate the growth of their populations. Concurrent with this growth, developing nations are confronted with an increasing prevalence of chronic and non-communicable ailments as a result of urbanisation, alterations in lifestyles, and the ageing of their populations. Cell therapy technologies are of particular relevance in these regions due to the innovative solutions they offer to address these urgent medical needs.

Moreover, in comparison to developed countries, the execution of clinical trials in emerging economies frequently demonstrates greater cost-effectiveness, predominantly attributable to reduced labour and operational expenditures. The financial benefits associated with this incentive motivate pharmaceutical companies and research institutions to investigate and advance cell therapies in these areas. Furthermore, numerous developing nations provide favourable regulatory structures and incentives in order to promote the progress and acceptance of cutting-edge medical technologies, such as cell therapies. The convergence of these elements renders developing nations an optimal setting for the proliferation and integration of cell therapy technologies, holding the potential to yield substantial advantages for healthcare providers and patients.

Competitive Landscape

The major players operating in the cell therapy technologies market are Thermo Fisher Scientific Inc., Novartis AG, Gilead Sciences, Inc., Merck KGaA, Danaher Corporation, Bristol-Myers Squibb Company, Sartorius AG, FUJIFILM Diosynth Biotechnologies, Lonza, GE Healthcare, Terumo BCT, Avantor, Inc., Bio-Techne Corporation, and Corning Incorporated among others. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Recent Developments

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Cell Therapy Technologies market is projected to grow at a CAGR of 10.7% by 2034: Visiongain - GlobeNewswire

The global gene therapy market size was valued at USD 8.75 billion in 2023 and is poised to grow from USD 10.47 billion in 2024 to USD 52.40 billion by 2033, growing at a CAGR of 19.6% in the forecast period (2024-2033).

Gene therapy is a technique that uses a gene to treat, prevent or cure a disease or medical disorder. Often, gene therapy works by adding new copies of a gene that is broken, or by replacing a defective or missing gene in a patients cells with a healthy version of that gene. Both inherited genetic diseases (e.g., hemophilia and sickle cell disease) and acquired disorders (e.g., leukemia) have been treated with gene therapy.

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The development of the market is owing to an increase in the number of gene therapy-based discoveries, increasing investment in this sector, and rising approval of gene therapy products. According to the WHO, 10 to 20 new cell and gene therapies are expected to be approved each year by 2025.

Continuous developments in recombinant DNA technology are anticipated to enhance the efficiency of gene therapy in the coming years. Hence, ongoing progresses in recombinant DNA technology are anticipated to expand the number of ongoing clinical trials for gene therapy. Primarily, these advancements are taking place in the context of various gene-editing tools and expression systems to augment the R&D for products. The advent of CRISPR/Cas9 nuclease, ZFN, and TALEN allows easy & precise genome editing. As a result, in recent times, the gene-editing space has witnessed a substantial number of research activities, which, in turn, is expected to influence the growth of the gene therapy market.

The growth of the gene therapy market is expected to be majorly benefitted from the increasing prevalence of cancer. The ongoing increase in cancer patients and related death per year emphasizes the essential for the development of robust treatment solutions. In 2020, there were around 18.1 million new cases of cancer worldwide. 9.3 million of these cases involved men, while 8.8 million involved women. Continuing developments in tumor genetic studies have delivered substantial information about cancer-related molecular signatures, which in turn, is expected to support ongoing clinical trials for cancer therapeutics.

With rising demand for robust disease treatment therapies, companies have focused their efforts to accelerate R&D for effective genetic therapies that target the cause of disease at a genomic level. . Furthermore, the U.S. FDA provides constant support for innovations in this sector via a number of policies with regard to product manufacturing. In January 2020, the agency released six final guidelines on the manufacturing and clinical development of safe and efficient products.

Furthermore, facility expansion for cell and gene therapies is one of the major factors driving the gene therapy market growth. Several in-house facilities and CDMOs for gene therapy manufacturing have begun investing to enhance their production capacity, which, in turn, is anticipated to create lucrative opportunities for market players. For instance, in April 2022, the FDA approved commercial licensure approval to Novartis for its Durham, N.C. site. This approval permits the 170,000 square-foot facility to make, test, and issue commercial Zolgensma, as well as manufacture therapy products for current & upcoming clinical trials.

Cell and Gene Therapy Market :https://www.biospace.com/article/releases/u-s-cell-and-gene-therapy-clinical-trial-services-industry-is-rising-rapidly/

Gene Therapy Market Report Highlights

U.S. Gene Therapy Market Size in U.S. 2024 to 2033

The U.S. gene therapy market size was estimated at USD 3.19 billion in 2023 and is projected to surpass around USD 18.50 billion by 2033 at a CAGR of 19.22 % from 2024 to 2033.

North America dominated the market in 2023 with the largest revenue share of 65.12% in 2023. This region is expected to become the largest routine manufacturer of gene therapy in terms of the number of approvals and revenue generated during the forecast period. Increasing investments in R&D from large and small companies in the development of ideal therapy drugs are anticipated to further boost the market.

Furthermore, the increasing number of investments by the governments and the growing prevalence of targeted diseases are the factors fueling the market. According to the Spinal Muscular Atrophy Foundation, in 2020, around 10,000 to 25,000 children and adults in the U.S. were affected by spinal muscular atrophy, making it a fairly common disease among rare diseases.

Europe is estimated to be the fastest-growing regional segment from 2024 to 2030. This is attributed to its large population with unmet medical needs and increasing demand for novel technologies in the treatment of rare but increasingly prevalent diseases. Asia Pacific market for commercial application of genetic therapies is anticipated to witness significant growth in the forecast period, which can be attributed to the easy availability of resources, local presence of major companies, and increased investment, by the governments.

UK Gene Therapy Market

The UK gene therapy market is anticipated to witness accelerated growth over the forecast period, due to increased investments by various big companies and governments, including the NHS & research laboratories. For instance, in March 2022, the UK government invested USD 326.45 million to accelerate healthcare research and manufacturing. Under this investment, additional $80 million of the fund will help companies at the forefront of invention with their commercial-scale manufacturing investments in areas like gene and cell therapies, as well as improved diagnostic technologies, among others. Various mergers & partnerships between manufacturers, universities, and other government bodies are expected to boost the market over the forecast period.

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What is gene therapy used for?

Most gene therapies are still in the clinical trial phase. Clinical trials play an important role in finding treatments that are safe and effective. Clinical trials are investigating gene therapy for the treatment ofcancer,macular degenerationand other eye diseases, certaingenetic conditionsandHIV/AIDS.

The U.S. Food and Drug Administration (FDA) has approved two gene therapies for use in the U.S.:

Is gene therapy safe?

The first gene therapy trial was run more than thirty years ago. The earliest studies showed that gene therapy could have very serious health risks, such as toxicity, inflammation, and cancer. Since then, researchers have studied the mechanisms and developed improved techniques that are less likely to cause dangerous immune reactions or cancer. Because gene therapy techniques are relatively new, some risks may be unpredictable; however, medical researchers, institutions, and regulatory agencies are working to ensure that gene therapy research, clinical trials, and approved treatments are as safe as possible.

Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). The U.S. Food and Drug Administration (FDA) regulates all gene therapy products in the United States and oversees research in this area. Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants.

The National Institutes of Health (NIH) also plays an important role in ensuring the safety of gene therapy research. NIH provides guidelines for investigators and institutions (such as universities and hospitals) to follow when conducting clinical trials with gene therapy. These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities. The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at a RAC public meeting.

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution's potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research.

The clinical trial process occurs in three phases. Phase I studies determine if a treatment is safe for people and identify its side effects. Phase II studies determine if the treatment is effective, meaning whether it works. Phase III studies compare the new treatment to the current treatments available. Doctors want to know whether the new treatment works better or has fewer side effects than the standard treatment. The FDA reviews the results of the clinical trial. If it determines that the benefits of the new treatment outweigh the side effects, it approves the therapy, and doctors can use it to treat a disorder.

What are CAR T cell therapy, RNA therapy, and other genetic therapies?

Several treatments have been developed that involve genetic material but are typically not considered gene therapy. Some of these methods alter DNA for a slightly different use than gene therapy. Others do not alter genes themselves, but they change whether or how a genes instructions are carried out to make proteins.

Cell-based gene therapy

CAR T cell therapy (or chimeric antigen receptor T cell therapy) is an example of cell-based gene therapy. This type of treatment combines the technologies of gene therapy and cell therapy. Cell therapy introduces cells to the body that have a particular function to help treat a disease. In cell-based gene therapy, the cells have been genetically altered to give them the special function. CAR T cell therapy introduces a gene to a persons T cells, which are a type of immune cell. This gene provides instructions for making a protein, called the chimeric antigen receptor (CAR), that attaches to cancer cells. The modified immune cells can specifically attack cancer cells.

RNA therapy

Several techniques, called RNA therapies, use pieces of RNA, which is a type of genetic material similar to DNA, to help treat a disorder. In many of these techniques, the pieces of RNA interact with a molecule calledmessenger RNA(or mRNA for short). In cells, mRNA uses the information in genes to create a blueprint for making proteins. By interacting with mRNA, these therapies influence how much protein is produced from a gene, which can compensate for the effects of a genetic alteration. Examples of these RNA therapies include antisense oligonucleotide (ASO), small interfering RNA (siRNA), and microRNA (miRNA) therapies. An RNA therapy called RNA aptamer therapy introduces small pieces of RNA that attach directly to proteins to alter their function.

Epigenetic therapy

Another gene-related therapy, called epigenetic therapy, affectsepigenetic changesin cells. Epigenetic changes are specific modifications (often called tags) attached to DNA that control whether genes are turned on or off. Abnormal patterns of epigenetic modifications alter gene activity and, subsequently, protein production. Epigenetic therapies are used to correct epigenetic errors that underlie genetic disorders.

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Vector Insights

The AAV segment shows a significant revenue contribution of 22.9% in 2023. Several biopharma companies are offering their viral vector platform for the development of AAV-based gene therapy product. For instance, in September 2016, Lonza signed an exclusive agreement with Massachusetts Eye and Ear to support its novel Anc-AAV gene therapy platform for development and commercialization of next-generation gene therapies based on their AAV platform. Similarly, RegenxBio had made an agreement with companies AveXis & Biogen in March 2014 and May 2016, respectively, which would allow both companies to use RegenxBios AAV vector platform for development of gene therapy molecules. Furthermore, in May 2021, Biogen Inc. and Capsigen Inc. entered into a strategic research partnership to engineer novel AAV capsids that have the possibility to deliver transformative gene therapies, which can address the fundamental genetic causes of numerous neuromuscular and CNS disorders. In July 2021, the U.S. Department of Commerces National Institute of Standards and Technology (NIST), National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and United States Pharmacopeia (USP) announced a collaboration to evaluate analytical methods and develop standards for AAV. As part of this partnership, NIST and USP will be conducting an interlaboratory study in which several laboratories will measure these serious quality attributes, and their results will be linked and examined. This collaboration will support the development of new promising gene therapies that will significantly advance peoples lives.

Indication Insights

The spinal muscular atrophy (SMA) segment dominated the market in 2023. Although SMA is a rare disorder, it is one of the most common fatal inherited diseases of infancy. The development of Zolgensma (AVXS-101), has proven its effectiveness in treating SMA and altering the phenotype of the illness. The FDA approved Novartis' Zolgensma approval in May 2019, which is aimed at treating the underlying cause of SMA. As of now, Zolgensma is the only gene treatment in this field to have been approved. The approval of this gene therapy is evidence of the growing use of therapies to treat serious hereditary illnesses like SMA.

The Beta-Thalassemia Major/SCD segment is anticipated to register the fastest CAGR over the forecast period. Gene therapy for SCD and -thalassemia is based on transplantation of gene-modified hematopoietic stem cells. Clinical and preclinical studies have shown the efficacy and safety of this therapeutic modality. However, several other factors, such as suboptimal gene expression levels & gene transfer efficiency, limited stem-cell dose and quality, and toxicity of myeloablative regimens are still hampering its efficacy. Despite these challenges, in June 2019, bluebird Bios Zynteglo (formerly LentiGlobin) received conditional approval in Europe for the treatment of -thalassemia and is expected to receive U.S. FDA approval in August 2022. Moreover, the product has already received Orphan Drug status by the U.S. FDA for treatment of patients with sickle cell disease (SCD). Furthermore, in April 2021, Vertex Pharmaceuticals and CRISPR Therapeutics amended partnership for the development, production, and commercialization of CTX001 in sickle beta thalassemia and cell disease. These achievements in this segment are anticipated to significantly boost the adoption of the product in this segment.

Route of Administration Insights

The intravenous segment dominated the global gene therapy market in 2023. Large number of approved products along with strong pipeline for IV candidates is the major reason for the segment dominance. The segment is also expected to emerge as the most lucrative over the forecast period.

Recent Developments

Some of the prominent players in the Gene therapy market include:

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global gene therapy market.

Indication

Vector Type

Route of Administration

By Region

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Read the original here:
Gene Therapy Market Size Poised to Surge USD 52.40 Billion by 2033 - BioSpace

Gene Therapy Approvals Expected to Ramp Up in 2024 Amid Manufacturing, Cost Challenges  BioSpace

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Gene Therapy Approvals Expected to Ramp Up in 2024 Amid Manufacturing, Cost Challenges - BioSpace