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Global Cell and Gene Therapy Bioassay Services Market to 2030 – by Type of Therapy, Therapeutic Area, Scale of Operation and Geography – PR Newswire

DUBLIN, March 21, 2022 /PRNewswire/ -- The "Cell and Gene Therapy Bioassay Services Market by Type of Therapy, Therapeutic Area, Scale of Operation and Geography: Industry Trends and Global Forecasts, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current landscape and the likely future potential of cell and gene therapy bioassay service providers, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field.

Given the various advantages of cell and gene therapies and their ability to address the underlying causes of serious clinical conditions, the preference for such therapeutic modalities has increased over the years. As a result, several cell and gene therapies have been developed and approved for the treatment of a wide range of disease indications. In fact, at the time of this report's publication, more than 30 such therapies had been approved and over 1,200 therapeutic leads are under evaluation in different stages.

Owing to their rising popularity, these upcoming advanced therapeutic products are on the verge of becoming one of the highest valued therapeutic segments within the biopharmaceutical industry. Having said that, as is the case for all biological products, the development of cell and gene therapies is a complex, challenging and cost intensive process. Outsourcing is, therefore, a preferred operational model, with cell and gene therapy innovators relying heavily on specialty contract service providers to handle various aspects of their product development and manufacturing operations. In fact, over three quarters of the biopharmaceutical companies prefer to outsource their operations to the contract service providers and a large part of their expenditure goes to outsourcing services.

Amongst the various operations, the outsourcing of analytical testing services, including environment testing, bioanalytical testing, analytical testing, chemistry and stability testing, method development and validation, and product characterization, has witnessed significant rise in recent years.

The rising demand for outsourcing bioanalytical services has prompted the emergence of several contract research organizations that claim to offer bioassay services for cell and gene therapies. These companies usually have relatively more experience and are well equipped with the instruments and technological platforms to offer both pre-developed and customized bioassays.

In fact, these companies assist in bringing out the maximum efficiency of study design by offering several cost benefits and reducing the associated timelines. Given the benefits of outsourcing the bioassay services and the ongoing efforts of service providers to further improve / expand their respective offerings, we believe that the cell and gene therapy bioassay services market is likely to evolve at a steady pace, till 2030.

In addition to other elements, the study includes:

Key Questions Answered

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE

5. COMPANY COMPETITIVENESS ANALYSIS 5.1. Chapter Overview 5.2. Methodology 5.3. Key Parameters 5.4. Competitiveness Analysis: Companies Offering Cell and Gene Therapy Bioassay Services in North America 5.5. Competitiveness Analysis: Companies Offering Cell and Gene Therapy Bioassay Services in Europe and Asia-Pacific

6. CELL AND GENE THERAPY BIOASSAY SERVICE PROVIDERS IN NORTH AMERICA: COMPANY PROFILES 6.1. Chapter Overview 6.2. CCRM 6.2.1. Company Overview 6.2.2. Cell and Gene Therapy Bioassay Service Portfolio 6.2.3. Recent Developments and Future Outlook 6.3. Nexelis 6.3.1. Company Overview 6.3.2. Cell and Gene Therapy Bioassay Service Portfolio 6.3.3. Recent Developments and Future Outlook 6.4. Pacific BioLabs 6.4.1. Company Overview 6.4.2. Cell and Gene Therapy Bioassay Service Portfolio 6.4.3. Recent Developments and Future Outlook 6.5. PPD Laboratories 6.5.1. Company Overview 6.5.2. Cell and Gene Therapy Bioassay Service Portfolio 6.5.3. Recent Developments and Future Outlook 6.6. WuXi Advanced Therapies 6.6.1. Company Overview 6.6.2. Cell and Gene Therapy Bioassay Service Portfolio 6.6.3. Recent Developments and Future Outlook

7. CELL AND GENE THERAPY BIOASSAY SERVICE PROVIDERS IN EUROPE AND ASIA-PACIFIC: COMPANY PROFILES 7.1. Chapter Overview 7.2. AnaBioTec 7.2.1. Company Overview 7.2.2. Cell and Gene Therapy Bioassay Service Portfolio 7.2.3. Recent Developments and Future Outlook 7.3. Intertek Pharmaceutical Services 7.3.1. Company Overview 7.3.2. Cell and Gene Therapy Bioassay Service Portfolio 7.3.3. Recent Developments and Future Outlook 7.4. Lonza 7.4.1. Company Overview 7.4.2. Cell and Gene Therapy Bioassay Service Portfolio 7.4.3. Recent Developments and Future Outlook 7.5. Porton Bio 7.5.1. Company Overview 7.5.2. Cell and Gene Therapy Bioassay Service Portfolio 7.5.3. Recent Developments and Future Outlook

8. MARKET TREND ANALYSIS

9. GLOBAL EVENT AND STRATEGIC INITIATIVE ANALYSIS

10. CASE STUDY: MARKET LANDSCAPE OF CELL AND GENE THERAPIES 10.1. Chapter Overview 10.2. Cell Therapy Market 10.2.1. T-Cell Immunotherapies: Development Pipeline 10.2.1.1. Analysis by Type of Product 10.2.2. CAR-T Cell Therapies: Development Pipeline 10.2.2.1. Analysis by Phase of Development 10.2.2.2. Analysis by Therapeutic Area 10.2.2.3. Analysis by Type of Developer 10.2.2.4. Key Industry Players: Analysis by Number of CAR-T Cell Therapies in Development 10.2.3. TCR-based Therapies: Development Pipeline 10.2.3.1. Analysis by Phase of Development 10.2.3.2. Analysis by Therapeutic Area 10.2.3.3. Analysis by Type of Developer 10.2.3.4. Key Industry Players: Analysis by Number of TCR-based Therapies in Development 10.2.4. TIL-based Therapies: Development Pipeline 10.2.4.1. Analysis by Phase of Development 10.2.4.2. Analysis by Therapeutic Area 10.2.4.3. Analysis by Type of Developer 10.2.4.4. Key Industry Players: Analysis by Number of TIL-based Therapies in Development 10.3. Gene Therapy Market 10.3.1. Gene Therapy Market: Clinical and Commercial Pipeline 10.3.1.1. Analysis by Phase of Development 10.3.1.2. Analysis by Therapeutic Area 10.3.2. Gene Therapy Market: Development Pipeline 10.3.2.1. Analysis by Phase of Development 10.3.2.2. Analysis by Therapeutic Area

11. LIKELY PARTNERS FOR CELL THERAPY BIOASSAY SERVICE PROVIDERS 11.1. Chapter Overview 11.2. Scope and Methodology 11.3. Potential Strategic Partners for Cell Therapy Bioassay Service Providers 11.3.1. Likely Partner Opportunities for Stem Cell Therapy Bioassay Service Providers 11.3.2. Likely Partner Opportunities for CAR-T Therapy Bioassay Service Providers 11.3.3. Likely Partner Opportunities for Dendritic Cell Therapy Bioassay Service Providers 11.3.4. Likely Partner Opportunities for Tumor Cell Therapy Bioassay Service Providers 11.3.5. Likely Partner Opportunities for NK Cell Therapy Bioassay Service Providers

12. LIKELY PARTNERS FOR GENE THERAPY BIOASSAY SERVICE PROVIDERS 12.1. Chapter Overview 12.2. Scope and Methodology 12.3. Potential Strategic Partners for Gene Therapy Bioassay Service Providers 12.3.1. Likely Partner Opportunities in North America 12.3.2. Likely Partner Opportunities in Europe 12.3.3. Likely Partner Opportunities in Asia-Pacific

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS

14. CONCLUSION

15. EXECUTIVE INSIGHTS

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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Global Cell and Gene Therapy Bioassay Services Market to 2030 - by Type of Therapy, Therapeutic Area, Scale of Operation and Geography - PR Newswire

Home | Eli and Edythe Broad Center of Regeneration …

In more than 140 labs across UCSF, scientists are carrying out studies in cell culture and animals with the goal of understanding and developing treatment strategies for such conditions as heart disease, diabetes, epilepsy, multiple sclerosis, Parkinsons disease, Lou Gehrigs disease, spinal cord injury and cancer.

The Broad Center is structured around eight research pipelines aimed at driving discoveries from the lab bench to the patient. Each pipeline focuses on a different organ system, including the blood, pancreas, liver, heart, reproductive organs, nervous system, musculoskeletal tissues, skin and eyes. Each of these pipelines is overseen by two leaders of international standing one representing the basic sciences and one representing clinical research. This approach has proven successful in the private sector for driving the development of new therapies.

Like all of UCSF, the Center fosters a highly collaborative culture, encouraging the cross-pollination of ideas between scientists of different disciplines and years of experience. Researchers studying pancreatic beta cells damaged in diabetes collaborate with those studying nervous system diseases, because at the heart of their research are stem cells that undergo similar molecular signaling on the way to becoming both cell types. The opportunity to work in this culture has drawn some of the countrys premier scientists to the center.

UCSF Mourns the Loss of EliBroad(1933-2021)

The UC San Francisco community is deeply saddened to learn of the passing of EliBroad, a renowned entrepreneur and philanthropist whose generosity supported scientific and medical research, the arts, and high-quality educational opportunities for students across the U.S.

The Eli and EdytheBroadCenter of Regeneration Medicine and Stem Cell Research at UCSF will be forever grateful to Mr.Broadfor his extraordinary vision and generosity. His investments in UCSFs stem cell endeavors have enabled our scientists to accelerate our research, by bringing some of the worlds leading stem cell scientists together under one roof and providing them with a setting that promotes collaboration and an exchange of ideas, both key to making clinical advances to improve human health. His legacy will live on through the breakthroughs and improvements in patient care made possible by his support of our work.

In fact, Mr.Broads impact on stem cell science at UCSF and beyond will be felt for generations to come. Along with his wife of over 60 years, Edye, Mr.Broadsupported stem cell research at a time when the country most needed national leadership in this area of scientific inquiry. Eager to leverage his philanthropic dollars for maximum impact, Mr.Broadsaw an opportunity to fund stem cell research when Californians passed a proposition funding $3 billion in bonds to support stem cell research and research facilities in 2004. Shortly after President George W. Bush vetoed a bill that would have supported federal funding of stem cell research, the couples philanthropic organization, The Eli and EdytheBroadFoundation, made an initial investment of $65 million to create three newBroadStem Cell Centers at UCSF, UCLA, and the University of Southern California. The Foundation has since made supplemental gifts bringing their total contribution to these centers to $113 million. The efforts have made California a leading center of stem cell research in the country.

To learn more about the remarkable life of EliBroad, please visitthis link.

In Memoriam: Katja Brueckner, PhD

In Memoriam: Zena Werb, MD, PhD

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MS in Stem Cell Biology and Regenerative Medicine

Discover the future of medicine

The Master of Science degree program invites you to chart the course for the medicine of the futureregenerative medicine. This is one of the first masters programs in stem cell biology and regenerative medicine in the United States.

Our one-year program offers courses in cutting-edge biomedical science, including developmental biology, human embryology, regenerative medicine, and the translational and therapeutic aspects of stem cell technology. The program also provides practical hands-on laboratory experience with the growth and differentiation of stem cells. Although not required, students are encouraged to engage in laboratory research during the year, with one of the 80+ lab groups that constitute USC Stem Cell. At the completion of the first year, students may informally continue to conduct research in their labs after receiving the MS diploma, or can petition to continue research with a guided and structured second research year culminating in a capstone thesis project.

After completing this program, you will be poised to apply to medical or PhD programs, enter the growing stem cell pharmaceutical domain, or engage in other academic, clinical or business efforts. You will possess a unique understanding of how the bodys own developmental and repair mechanisms can restore damaged cells, tissues and organsproviding new opportunities to treat conditions ranging from blindness to cancer, from organ failure to HIV/AIDS.

To apply, visit gradadm.usc.edu.

Please note that the application portal for Fall 2022 will open October 15th, 2021. The deadline to apply will be April 1st, 2022.

For questions, e-mail us at scrm@usc.edu or call (323) 865 1266.

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MS in Stem Cell Biology and Regenerative Medicine

Rising Focus on Exploring Potential of Stem Cells as Therapeutic Tools in Drug Targeting and Regenerative Medicine to Fuel Revenue Growth of Stem…

NEW YORK, Jan. 10, 2022 /PRNewswire/ --Reports and Data has published its latest report titled "Stem Cells Market By Product (Adult Stem Cells, Human Embryonic Stem Cells, IPS Cells, and Very Small Embryonic-Like Stem Cells), By Technology (Cell Acquisition, Cell Production, Cryopreservation, and Expansion & Sub-Culture), By Therapies (Allogeneic Stem Cell Therapy and Autologous Stem Cell Therapy), and By Application (Regenerative Medicine and Drug Discovery & Discovery), and By Region Forecast To 2028."

According to the latest report by Reports and Data, the global stem cells market size was USD 10.13 billion in 2020 and is expected to reach USD 19.31 Billion in 2028 and register a revenue CAGR of 8.4% during the forecast period, 2021-2028.

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Drivers, Restraints, & Opportunities

Stem cells are cells that have the potential to differentiate into different types of cells in the body. Stem cells have the ability of self-renewal and differential into specialized adult cell types. Stems cells are being explored for their potential in tissue regeneration and repair and in treatment of chronic diseases. Increasing number of clinical trials are underway to assess and establish safety and efficacy of stem cell therapy for various diseases and disorders. Rapid advancement in stem cell research, rising investment to accelerate stem cell therapy development, and increasing use of stem cells as therapeutic tools for treatment of neurological diseases and malignancies are some key factors expected to drive market revenue growth over the forecast period. in addition, growing incidence of type 1 diabetes, spinal cord injuries, Parkinson's diseases, and Alzheimer's disease, among others have further boosted adoption of stem cell therapies and is expected to fuel revenue growth of the market going ahead.

Stem cells are basic cells in the body from which cells with specialized functions are generated such as heart muscle cells, brain cells, bone cells, or blood cells. Maturation of stem cells into specialized cells have enabled researchers and doctors better understand the pathophysiology of diseases and conditions. Stem cells have great potential to be grown to become new tissues for transplant and in regenerative medicine. Stem cells that are programmed to differentiate into tissue-specific cells are widely being used to test new drugs that target specific diseases, such as nerve cells can be generated to test safety and efficacy of drugs that are being developed for nerve disorders and diseases. Stem cells are of two major types: pluripotent cells that can differentiate into any cells in the adult body and multipotent cells that are restricted to differentiate into limited population of cells. Increasing clinical research is being carried out to advance stem cell therapy to improve cardiac function and to treat muscular dystrophy and heart failure. Recent progress in preclinical and clinical research have expanded application scope of stem cell therapy into treating diseases for which currently available therapies have failed to be effective. This is expected to continue to drive revenue growth of the market going ahead.

However, immunity-related concerns associated with stem cell therapies, increasing incidence of abnormalities in adult stem cells, and rising number of ethical issues associated with stem cell research such as risk of harm during isolation of stem cells, therapeutic misconception, and concerns surrounding safety and efficacy of stem cell therapies are some key factors expected to restrain market growth to a certain extent over the forecast period.

To identify the key trends in the industry, research study at https://www.reportsanddata.com/report-detail/stem-cells-market

COVID-19 Impact Analysis

Rising use of Human Embryonic Stem Cells in Regenerative Medicine to Drive Market Growth:

Human embryonic stem cells (ESCs) segment is expected to register significant revenue growth over the forecast period attributable to increasing use of human embryonic stem cells in regenerative medicine and tissue repair, rising application in drug discovery, and growing importance of embryonic stem cells as in vitro models for drug testing.

Cryopreservation Segment to Account for Largest Revenue Share:

Cryopreservation segment is expected to dominate other technology segments in terms of revenue share over the forecast period. Cryopreservation techniques are widely used in stem cell preservation and transport owing to its ability to provide secure, stable, and extended cell storage for isolated cell preparations. Cryopreservation also provides various benefits to cell banks and have numerous advantages such as secure storage, flexibility and timely delivery, and low cost and low product wastage.

Regenerative Medicine Segment to Lead in Terms of Revenue Growth:

Regenerative medicine segment is expected to register robust revenue CAGR over the forecast period attributable to significant progress in regenerative medicine, increasing research and development activities to expand potential of stem cell therapy in treatment of wide range of diseases such as neurodegenerative diseases, diabetes, and cancers, among others, and rapid advancement in cell-based regenerative medicine.

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North America to Dominate Other Regions in Terms of Revenue Share:

North America is expected to dominate other regional markets in terms of revenue share over the forecast period attributable to increasing adoption of stem cell therapy to treat chronic diseases, rising investment to accelerate stem cell research, approval for clinical trials and research studies, growing R&D activities to develop advanced cell-based therapeutics, and presence of major biotechnology and pharmaceutical companies in the region.

Asia Pacific Market Revenue to Expand Significantly:

Asia Pacific is expected to register fastest revenue CAGR over the forecast period attributable to increasing R&D activities to advance stem cell-based therapies owing to rapidly rising prevalence of chronic diseases such as cancer and diabetes, rising investment to accelerate development of state-of-the-art healthcare and research facilities, establishment of a network of cell banks, increasing approval for regenerative medicine clinical trials, and rising awareness about the importance of stem cell therapies in the region.

Major Companies in the Market Include:

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Market Segmentation:

For the purpose of this report, Reports and Data has segmented the stem cells market based on product, technology, therapies, application, and region:

Product Outlook (Revenue, USD Billion; 2018-2028)

Technology Outlook (Revenue, USD Billion; 2018-2028)

Therapy Outlook (Revenue, USD Billion; 2018-2028)

Application Outlook (Revenue, USD Billion; 2018-2028)

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Regional Outlook (Revenue, USD Billion, 2018-2028)

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Genotyping assay marketsize was USD 17.7 Billion in 2020 and is expected to register a robust CAGR of 22.4% during the forecast period. Key factors driving market revenue growth are increasing prevalence of genetic disorders such as Turner syndrome, Alzheimer's, hemophilia, and Parkinson's, and rising demand for genotyping assays globally.

Nurse call system marketsize was USD 1.61 Billion in 2020 and is expected to register a revenue CAGR of 8.8% during the forecast period. Increasing need to improve communication among doctors and nurses, growing focus on reducing patient disturbances, and higher adoption of real-time location systems are key factors expected to drive market revenue growth over the forecast period. Moreover, increasing need to improve patient response time is another factor expected to drive market growth in the near future.

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Wealth of Newer Treatment Options Span the Scope of Multiple Myeloma and Amyloidosis – OncLive

Tomer Mark, MD, discusses the emerging role of minimal residual disease as a surrogate end point in multiple myeloma, treatment selection for patients with newly diagnosed, early relapsed, and late relapsed disease, and the importance of daratumumab being introduced to the treatment paradigm of amyloidosis.

Treatment selection for patients with newly diagnosed, early relapsed, and late relapsed multiple myeloma requires consideration of patient-, disease-, and treatment-related factors, said Tomer Mark, MD, who added that the need for minimal residual disease (MRD) as a surrogate end point for survival is stronger now with optimal sequencing strategies remaining uncertain.

Multiple myeloma is moving very fast right now. There are a lot of new agentsthat are exciting, including oral options. There is an embarrassment of riches in terms of treatment for patients with multiple myeloma, so we have to sift through this treasure to find the best treatment for the right patient at the right time, said Mark in an interview with OncLive during an Institutional Perspectives in Cancer (IPC) webinar on multiple myeloma.

During the interview, Mark, an associate professor of medicine, clinical director of the Plasma Cell Disorders Program, and clinical director of the Autologous Stem Cell Transplant Program, in the Department of Medicine-Hematology, at the University of Colorado (UC) School of Medicine, of UCHealth, discussed the emerging role of MRD as a surrogate end point in multiple myeloma, treatment selection for patients with newly diagnosed, early relapsed, and late relapsed disease, and the importance of daratumumab (Darzalex) being introduced to the treatment paradigm of amyloidosis.

Mark: We are seeing the continued theme of MRD and how important it is as an end point. Although not quite universally accepted as a surrogate marker for survival, it certainly is much closer than what we had before with the IMWG [International Myeloma Working Group] criteria. It is good to see that more studies are using MRD as an end point. Also, its good that more patients are reaching that end point, even in the relapsed/refractory setting. We are seeing that in the CAR T-cell therapy studies with idecabtagene vicleucel [ide-cel; Abecma] and ciltacabtagene autoleucel [cilta-cel] that close to 50% of patients are reaching MRD negativity. Extended results with the use of monoclonal antibodies in the up-front setting, like the GRIFFIN study [NCT02874742], also show continued MRD negativity with continued treatment. Getting these very deep responses is the theme now, which is refreshing. Now our problem returns full circle to sequencing, which used to be a big issue a few years ago.

The message is that incorporation of a monoclonal antibody as part of induction therapy provides a great benefit that is durable to patients. Incorporating the monoclonal antibodies [into frontline treatment] is going to become the standard of care. The data we saw at [the 2021 ASH Annual Meeting and Exposition] simply reinforced those results.

The ICARIA-MM [NCT02990338] and IKEMA [NCT03275285] studies looking at isatuximab-irfc [Sarclisa] in combination with either carfilzomib [Kyprolis] or pomalidomide [Pomalyst] showed outstanding results in terms ofnearly a halving of the risk of progression at any point in time. The hazard ratio was between 0.5 and 0.6 in both studies.

Subgroup analyses were refreshing in that age and cytogenetics didnt seem to have much of an effect [on survival] or at least not as much of an effect as they used to with older agents. The theme continues of using monoclonal antibodies early on in therapy. One point to make about that is that sequential CD38-directed antibodies, no matter the order of daratumumab or isatuximab first followed by the other, does not seem to be an effective strategy. There needs to be a period between those sorts of therapies.

That is the major question [in this setting]. There are clinical trials looking at moving CAR T-cell therapy, as well as bispecific antibodies, closer to the frontline [setting]. We are still learning how to manage toxicities from these therapies, like cytokine release syndrome and immune effector cellassociated neurotoxicity syndrome. As we gather more data, these things are getting more predictable and we are managing them better; however, we are keeping patients in the hospital for 2 weeks to get their CAR T cells because we just dont know what will happen. With bispecific antibodies, we have step-up dosing because we just dont know what will happen. We need more experience with these agents.

That said, eventually, CAR T-cell therapy will become part of the standard of care at some point. Just like autologous stem cell transplant, [CAR T-cell therapy] requires some planning, so CAR T-cell therapy may be used in a more elective situation, not as a rescue therapy for patients. Perhaps, the decision will be made based on MRD status after induction. That has yet to be determined.

In emergent situations, we can use bispecific antibodies, which are the off-the-shelf T-cell harnessing therapies. There are practical reasons for using [bispecific antibodies] vs [CAR T-cell therapy].

One nice thing we saw is that we can give sequential antiBCMA-directed therapy, which is the opposite of what we know about [sequential] monoclonal antibodies. That means that we dont have to be as careful in terms of planning whether we are going to give belantamab mafodotin followed by antiBCMA-directed CAR T-cell therapy vs the other way around. Of course, there are some issues with belantamab mafodotin, such as corneal toxicities. The results of belantamab mafodotin in combination with dexamethasone were disappointing, although the later DREAMM trials [evaluating belantamab mafodotin] in combination with bortezomib [Velcade] showed much better results.

It seems that belantamab mafodotin is not destined to be a single-agent therapy and it will be used in combination. It is off-the-shelf, so that is a plus given that we need an ophthalmologic exam before each dose, which is a big minus. In an academic or large hospital where the ophthalmologist is down the hall, that isnt a problem, but in the community clinics where the ophthalmologist is across town, that isnt as practical. These things get baked into the equation.

When we look at comparisons over time, it seems that cilta-cel is a bit more effective than ide-cel. Id like to exercise caution [comparing] apples and oranges. The ide-cel population [comprised] sicker patients in general with higher-risk cytogenetics and higher-risk multiple myeloma. I imagine that if ide-cel were used in a very similar patient population to [the one in which] cilta-cel [was evaluated] this difference might not be so great. We are comparing 2 amazing therapies. For ide-cel, we have seen response rates around 80% with durations of response [DOR] lasting close to 1 year. With cilta-cel, we are looking at 90% to 100% response rates in some studies and a DOR not yet reached.

I get asked this question all the time: Which therapy should I give to give to my patients? The answer is whichever is available. There are manufacturing and supplier problems, as well as slot allocation problems for apheresis and lymphocyte collection. We are grabbing whatever opportunity we get.

It was amazing to perform such a large, randomized trial in AL amyloidosis. I am proud to have participated in this study. It has probably set the world record for the fastest accrual to an amyloidosis trial. That shows the faith that we have in daratumumab working.

The addition of daratumumab to [AL amyloidosis] treatment is probably as significant as the first use of proteasome inhibitors in amyloid treatment. It really is a sea change, and the difference in terms of progression-free survival and organ recovery is so profound that there is no question that daratumumab should be part of frontline care for AL amyloidosis. This is especially [true] for patients who are not transplant eligible.

In transplant-eligible patients, it is more of a question of whether we should transplant patients more up front and then [continue] later with antibody therapy. That is going to be a practical matter in terms of [evaluating] plasma-cell burden, how sick are they, and how many organs are affected. Overall, outcomes for [patients with] amyloidosis are much better now that we have this treatment.

We are working on developing an ex-vivo drug testing platform for patients with multiple myeloma. It is well known that myeloma is not one disease, it is many diseases, which accounts for the variety of outcomes we can see with therapy. This is an effort to tailor the therapy to that patients particular myeloma phenotype, meaning how it behaves in real life. This is opposed to risk-adapted therapy where we make guesses based on high-risk cytogenetics or mutations.

Of course, this only accounts for one aspect of a disease in which there are multiple mutations and clones going on at the same time. Our institution is focused on getting primary patient myeloma samples, real myeloma cells as opposed to cell lines, putting them in cultures with various drugs being tested, and making a prescription for the patient based on this. This is all experimental and more work needs to be done. We are just now doing our translational studies where we are testing this principle out in a clinical trial setting.

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Wealth of Newer Treatment Options Span the Scope of Multiple Myeloma and Amyloidosis - OncLive

Companies In The Regenerative Medicine For Cartilage Market Increase R&D On Gene Therapy Technique As Per – Benzinga

LONDON, Jan. 11, 2022 (GLOBE NEWSWIRE) -- According to The Business Research Company's research report on the regenerative medicine for cartilage market, gene therapies are most promising technique to effectively treat and regenerate the damaged cartilage in case of bone and joint injuries and severe bone deformities. Gene therapy is defined as the treatment and management of disease by the introduction of foreign genes or sequences of encoded proteins into different type of cells by using gene transfer technique. Many manufacturers constantly evaluate the feasibility and safety of this technique in clinical trials.

For instance, in 2017, Kolon TissueGene, Inc received marketing authorization for its gene therapy product Invossa (TissueGene-C) a cell mediated gene therapy that contains non-transduced human chondrocytes (hChonJ) and transduced (hChonJb#7) human allogeneic chondrocytes. The hChonJb#7 cells were transduced with TGF-1 gene by using retroviral vector and irradiated with gamma-ray, in South Korea, based on Phase 1 and Phase 2 clinical studies treating patients with moderate knee OA. In 2020, the US Food and Drug Administration (FDA) allowed the continuation of the Phase 3 clinical trial of Invossa, gene therapy for osteoarthritis, in the US.

The global regenerative medicine for cartilage market reached a value of nearly $4.83 billion in 2021 at a compound annual growth rate (CAGR) of 8.10%. Regenerative medicine for cartilage market growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact. The market is expected to reach $6.56 billion in 2025 at a CAGR of 7.94%.

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The global regenerative medicine for cartilage market is fragmented, with a few large players constituting significant market share. The top ten competitors in the market made up to 24.69% of the total market in 2020. The market consolidation can be attributed to the high barriers to entry in terms of high costs associated with the production of regenerative medicine for cartilage. Major players in the regenerative medicine for cartilage market are B. Braun Melsungen AG, Zimmer Biomet Holdings Inc., Vericel Corporation, Stryker Corporation, Smith & Nephew plc, Arthrex Inc., CONMED Corporation, Collagen Solutions PLC, BioTissue Technologies, CellGenix, Osiris Therapeutics Inc., and DePuy Synthes.

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TBRC's regenerative medicine for cartilage market analysis report segments the market by treatment modality into cell-based, and non-cell-based; by treatment type into palliative, intrinsic repair stimulus, and others; by site into knee cartilage repair, ribs, and others; by application into hyaline cartilage repair and regeneration, elastic cartilage repair and regeneration, and fibrous cartilage repair and regeneration; by end use into ambulatory surgical centers, hospitals & clinics, and others.

Pharmaceutical companies and federal governments are increasingly working together in partnerships and collaborations to provide funding and implement incentive programs for the research and development (R&D) of regenerative medicine for cartilage. These partnerships provide financial and technical assistance across different clinical development phases to pharmaceutical companies. As per the regenerative medicine for cartilage market trends, in 2021, Government of Canada along with various provincial government have announced multiple investment initiative to setup flexible biomanufacturing capacity and new biotech innovation hubs.

As per TBRC's regenerative medicine for cartilage market research, North America was the largest region in the regenerative medicine for cartilage market, accounting for 52.4% of the total in 2021. It was followed by the Western Europe, Asia Pacific and then the other regions. Going forward, the fastest-growing regions in the regenerative medicine for cartilage market will be Middle East and Africa where growth will be at CAGRs of 31.9% and 30.7% respectively during 2021-2026. These will be followed by Eastern Europe and Asia Pacific.

Regenerative Medicine For Cartilage Market Global Report 2022: Market Size, Trends, And Global Forecast 2022 - 2026 is one of a series of new reports from The Business Research Company that provide regenerative medicine for cartilage market overviews, regenerative medicine for cartilage market analyze and forecast market size and growth for the whole market, regenerative medicine for cartilage market segments and geographies, regenerative medicine for cartilage market trends, regenerative medicine for cartilage market drivers, regenerative medicine for cartilage market restraints, regenerative medicine for cartilage market leading competitors' revenues, profiles and market shares in over 1,000 industry reports, covering over 2,500 market segments and 60 geographies.

The report also gives in-depth analysis of the impact of COVID-19 on the market. The reports draw on 150,000 datasets, extensive secondary research, and exclusive insights from interviews with industry leaders. A highly experienced and expert team of analysts and modelers provides market analysis and forecasts. The reports identify top countries and segments for opportunities and strategies based on market trends and leading competitors' approaches.

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Companies In The Regenerative Medicine For Cartilage Market Increase R&D On Gene Therapy Technique As Per - Benzinga

Regenerative Medicine: The Promise Of Undoing The Ravages Of Time – Hackaday

In many ways, the human body is like any other machine in that it requires constant refueling and maintenance to keep functioning. Much of this happens without our intervention beyond us selecting what to eat that day. There are however times when due to an accident, physical illness or aging the automatic repair mechanisms of our body become overwhelmed, fail to do their task correctly, or outright fall short in repairing damage.

Most of us know that lizards can regrow tails, some starfish regenerate into as many new starfish as the pieces which they were chopped into, and axolotl can regenerate limbs and even parts of their brain. Yet humans too have an amazing regenerating ability, although for us it is mostly contained within the liver, which can regenerate even when three-quarters are removed.

In the field of regenerative medicine, the goal is to either induce regeneration in damaged tissues, or to replace damaged organs and tissues with externally grown ones, using the patients own genetic material. This could offer us a future in which replacement organs are always available at demand, and many types of injuries are no longer permanent, including paralysis.

Our level of understanding of human physiology and that of animals in general has massively expanded since the beginning of the 20th century when technology allowed us to examine the microscopic world in more detail than ever before. Although empirical medical science saw its beginnings as early as the Sumerian civilization of the 3rd millennium BCE, our generalized understanding of the processes and components that underlie the bodys functioning are significantly more recent.

DNA was first isolated in 1869 by Friedrich Miescher, but its structure was not described until 1953. This discovery laid the foundations for the field of molecular biology, which seeks to understand the molecular basis for biological activity. In a sense this moment can be seen as transformative as for example the transition from classical mechanics to quantum mechanics, in that it changed the focus from macroscopic observations to a more fundamental understanding of these observations.

This allowed us to massively increase our understanding of how exactly the body responds to damage, and the molecular basis for regenerative processes, as well as why humans are normally not able to regrow damaged limbs. Eventually in 1999 the term regenerative medicine was coined by William A. Haseltine, who wrote an article in 2001 on what he envisions the term to include. This would be the addressing of not only injuries and trauma from accidents and disease, but also aging-related conditions, which would address the looming demographic crisis as the average age of the worlds populations keeps increasing.

The state of the art in regenerative medicine back in 2015 was covered by Angelo S. Mao et al. (2015). This covers regenerative methods involving either externally grown tissues and organs, or the stimulating of innate regenerative capabilities. Their paper includes the biomedical discipline of tissue engineering due to the broad overlap with the field of regenerative medicine. Despite the very significant time and monetary requirement to bring a regenerative medicine product to market, Mao et al. list the FDA-approved products at that time:

While these were not miracle products by any stretch of the imagination, they do prove the effectiveness of these approaches, displaying similar or better effectiveness as existing products. While getting cells to the affected area where they can induce repair is part of the strategy, another essential part involves the extracellular matrix (ECM). These are essential structures of many tissues and organs in the body which provide not only support, but also play a role in growth and regeneration.

ECM is however non-cellular, and as such is seen as a medical device. They play a role in e.g. the healing of skin to prevent scar tissue formation, but also in the scaffolding of that other tantalizing aspect of regenerative medicine: growing entire replacement organs and body parts in- or outside of the patients body using their own cells. As an example, Mase Jr, et al. (2010) report on a 19-year old US Marine who had part of his right thigh muscle destroyed by an explosion. Four months after an ECM extracted from porcine (pig) intestinal submucossa was implanted in the area, gradual regrowth of muscle tissue was detected.

An important research area here is the development of synthetic ECM-like scaffolding, as this would make the process faster, easier and more versatile. Synthetic scaffolding makes the process of growing larger structures in vitro significantly easier as well, which is what is required to enable growing organs such as kidneys, hearts and so on. These organs would then ideally be grown from induced pluropotent stem cells (iPS), which are a patients own cells that are reverted back to an earlier state of specialization.

It should come as little surprise that as a field which brings together virtually every field that touches upon (human) biology in some fashion, regenerative medicine is not an easy one. While its one thing to study a working system, its a whole different level to get one to grow from scratch. This is why as great as it would be to have an essentially infinite supply of replacement organs by simply growing new ones from iPS cells, the complexity of a functional organ makes this currently beyond our reach.

Essentially the rule is that the less complicated the organ or tissue is, the easier it is to grow it in vitro. Ideally it would just consist out of a single type of cell, and happy develop in some growth medium without the need for an ECM. Attractive targets here are for example the cornea, where the number of people on a waiting list for a corneal transplant outnumber donor corneas significantly.

In a review by Mobaraki et al. (2019), the numerous currently approved corneal replacements as well as new methods being studied are considered. Even though artificial corneas have been in use for years, they suffer from a variety of issues, including biocompatibility issues and others that prevent long-term function. Use of donor corneas comes with shortages as the primary concern. Current regenerative research focuses on the stem cells found in the limbus zone (limbal stem cells, LSC). These seem promising for repairing ocular surface defects, which has been studied since 1977.

LSCs play a role in the regular regenerative abilities of the cornea, and provide a starting point for either growing a replacement cornea, or to repair a damaged cornea, along with the addition of an ECM as necessary. This can be done in combination with the inhibiting of the local immune response, which promotes natural wound healing. Even so, there is still a lot more research that needs to be performed before viable treatments for either repairing the cornea in situ, or growing a replacement in vitro can be approved the FDA or national equivalent.

A similar scenario can be seen with the development of artificial skin, where fortunately due to the large availability of skin on a patients body grafts (autografts) are usually possible. Even so, the application of engineered skin substitutes (ESS) would seem to be superior. This approach does not require the removal of skin (epidermis) elsewhere, and limits the amount of scar formation. It involves placing a collagen-based ECM on the wound, which is optionally seeded with keritanocytes (skin precursor cells), which accelerates wound closure.

Here the scaffolding proved to be essential in the regeneration of the skin, as reported by Tzeranis et al. (2015). This supports the evidence from other studies that show the cell adhesion to the ECM to be essential in cell regulation and development. With recent changes, it would seem that both the formation of hair follicles and nerve innervation may be solved problems.

It will likely still be a long time before we can have something like a replacement heart grown from a patients own iPS cells. Recent research has focused mostly on decellularization (leaving only the ECM) of an existing heart, and repopulating it with native cells (e.g. Glvez-Montn et al., 2012). By for example creating a synthetic scaffold and populating it with cells derived from a patients iPS cells, a viable treatment could be devised.

Possibly easier to translate into a standard treatment is the regrowth of nerves in the spinal cord after trauma, with a recent article by lvarez et al, (2021) (press release) covering recent advances in the use of artificial scaffolds that promotes nerve regeneration, reduces scarring and promotes blood vessel formation. This offers hope that one day spinal cord injures may be fully repairable.

If we were to return to the body as a machine comparison, then the human body is less of a car or piece of heavy machinery, and more of a glued-together gadget with complex circuitry and components inside. With this jump in complexity comes the need for a deeper level of understanding, and increasingly more advanced tools so that repairs can be made efficiently and with good outcomes.

Even so, regenerative medicine is already saving the lives of for example burn victims today, and improving the lives of countless others. As further advances in research continue to translate into treatments, we should see a gradual change from youll have to learn to live with that, to a more optimistic give it some time to grow back, as in the case of an injured veteran, or the victim of an accident.

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Regenerative Medicine: The Promise Of Undoing The Ravages Of Time - Hackaday

Fertilis medical advance uses automation to support cells – Healthcare Global – Healthcare News, Magazine and Website

An Australian medtech startup, Fertilis, has announced Horizons Ventures as its lead investor, following an AUS$2.75mn seed round.

Founded in 2019, Fertilis is headquartered in Adelaide, Australia and develops medical technology which transforms the IVF process by increasing IVF success rates. The company hopes that this technology will make the discovery of new treatments easier for a range of other chronic conditions, including cancer, diabetes and Cystic Fibrosis.

Infertility impacts one in seven couples in the USA and IVF has a success rate of 11% - 30%.

Despite being carried out by trained professionals, IVF is a complicated process, subject to external variables. Even human errors can have consequences for anxious patients, who must bear the financial and emotional toll.

With Fertilis automation technology, some of these variables are removed, which can improve pregnancy rates.

The Fertilis technology includes a new class of 3D printed micro-medical device (0.01 to 1.0 mm across, the width of a human hair) which can hold a single cell through to a small group of cells. This allows for the culturing of cells - such as an embryo - in micro environments, that resemble the conditions in the human body. Via monitoring and automation, the cells environment can be altered in a controlled manner, by removing the need for specialists to move the cells several times throughout the process.

Fertilis' technology reduces the number of cycles required to get pregnant, by 30-40%. Women usually need three cycles of IVF in order to become pregnant, but Fertilis' technology can reduce this to two.

The funding will permit the Fertilis team to expand its scientific development and in 2022, it will enter global IVF clinical trials, to market the application of cell culture automation.

Fertilis hopes to enter the IVF market in 2023 and then enter other parts of the healthcare sector, including gene therapy.

Due to its ability to significantly increase the accuracy and productivity of cell culture laboratory processes, we believe Fertilis' technology will have a transformative impact on a wide range of healthcare applications that ranges from diagnostics and treatment to the creation of specific cell culture products, said Chris Liu, Horizons Ventures. We look forward to working closely with Fertilis as the company begins clinical trials next year and scales internationally thereafter.

IVF can be an incredibly difficult and stressful experience, fraught with anxiety and uncertainty, said Professor Jeremy Thompson, Founder, CSO and Lead Researcher. Every failed attempt is devastating for aspiring parents and its heartbreaking for them to know that an IVF cycle is still more likely to fail than succeed. IVF is a fragile and complicated process with many variables; things like handling and transferring embryos from dish to dish, even the air quality in a lab can affect the result. Our technology allows for much greater precision and consistency, meaning we can offer women and couples with fertility issues a better chance of getting pregnant and having a healthy baby.

We believe our technology represents the most significant development in cell culture precision and consistency in over 30 years, said Marty Gauvin, Co-Founder and CEO. Starting with IVF, we will work with clinics and labs to build solutions that occupy the same space as their incubators do today. We are partnering with IVF facilities around the world to conduct full scale clinical trials; a crucial step in making this medical breakthrough available to couples and individuals dealing with infertility. For the clinics themselves we believe our offering is compelling; our technology is easy to adopt, its more reliable and transparent, giving lab technicians better control. This unique enabling technology is the future of IVF treatment and cell culture."

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Fertilis medical advance uses automation to support cells - Healthcare Global - Healthcare News, Magazine and Website

Biological Safety Testing Market to Witness Growth Acceleration | Sigma-Aldrich Corporation (US), Avance Biosciences, Inc. (US) Industrial IT -…

A2Z Market Research released the comprehensive research on Biological Safety Testing Market. The market is predictable to grow at a significant pace in the coming years. Biological Safety Testing Market 2021 research report presents analysis of market size, share, growth, trends, investments, cost structure, statistical and comprehensive data of the global market.

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Top Key Vendors of this Market are:

Sigma-Aldrich Corporation (U.S.), Avance Biosciences, Inc. (U.S.), Charles River Laboratories International, Inc. (U.S.), Merck & Co., Inc. (U.S.), Toxikon Corporation (U.S.), Lonza Group (Switzerland), SGS SA (Switzerland), WuXi PharmaTech (Cayman), Cytovance Biologics, Inc. (U.S.), BSL Bioservice (Germany).

As analytics have become an inherent part of every business activity and role, form a central role in the decision-making process of companies these days is mentioned in this report. In the next few years, the demand for the market is expected to substantially rise globally, enabling healthy growth of the Biological Safety Testing Market is also detailed in the report. This report highlights the manufacturing cost structure includes the cost of the materials, labor cost, depreciation cost, and the cost of manufacturing procedures. Price analysis and analysis of equipment suppliers are also done by the analysts in the report.

Depending on the important parameters this report elucidates a detailed outline of Biological Safety Testing market. For better understanding end users, products, regions and many other segments are studied and explained by the analyst. An impacting such as the driving forces which help make the market progressing are discussed in order to help the client understand the future market position.

Also, regional data of the key geographic segments with respect to Biological Safety Testing market is explained in detail for the readers. This gives an idea about which region is leading in this particular market helping make a better future investment plan. Further, the upcoming challenges, ongoing trends, strengths, and weaknesses are meticulously researched and discussed.

Global Biological Safety Testing Market Segmentation:

Market Segmentation: By Type

Adventitious Agents Detection Test, Bioburden Testing, Cell Line Authentication And Characterization Tests, Endotoxin Tests, Residual Host Contaminant Detection Tests, Sterility Testing, Other Tests

Market Segmentation: By Application

Blood & Blood Products, Cellular & Gene Therapy Products, Stem Cell Products, Tissues & Tissue Products, Vaccines and Therapeutics

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Biological Safety Testing systems help in maintaining updated information of patients, cut down healthcare costs, and enhance efficiency and accuracy. Owing to these benefits, they are being increasingly acknowledged by many physicians around the globe. Moreover, favorable initiatives introduced by several governments worldwide are promoting the adoption of Biological Safety Testing systems for healthcare facilities. The emergence of digital and connected healthcare technologies is also providing a significant push to the market.

The key regional markets methodically examined in the research report are North America, Europe, Japan, China, India, and Southeast Asia. North America is expected to represent a substantial share in the market during the forecast period. The growth of the region is primarily driven by the healthcare IT market in the U.S., which is one of the most prominent and mature markets worldwide. The stringent regulatory norms and Biological Safety Testing incentivizing policies in the region are prompting hospitals and clinics in the region to implement Biological Safety Testing solutions.

The global Biological Safety Testing Market Report covers:

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Precautions After PRP Injections: What to Do and What to Avoid

PRP injections are being used for a growing number of orthopedic injuries and conditions. What is PRP? What are the different types of PRP? Are there precautions after PRP injections that should be followed? Lets dig in.

PRP stands for platelet-rich plasma. This is a concentration of the patients own blood platelets in their serum. Blood is drawn from a peripheral site such as the arm or hand and then spun down in a centrifuge concentrating the platelets. Platelets contain growth factors and chemical mediators which can reduce inflammation, pain, improve blood flow and turbocharge the natural healing process. Current indications for PRP include patellar, hamstring and Achilles tendon injuries, golfers elbow, and mild knee osteoarthritis (1).

Did you know that there are three different types of PRP? Yes, and which one is used is critical to your clinical improvement.

The PRP is actually red in color as it contains both red and white blood cells. This was the first type of PRP available and is produced by older, less advanced centrifuges. A centrifuge is a small tabletop machine that spins the blood which allows for separation and concentration of the blood. Red PRP is typically concentrated to lower levels.

This PRP is actually amber in color and contains few white and red blood cells. It is typically concentrated to lower levels and causes less tissue reaction and swelling.

This PRP is also amber in color and contains few white and red blood cells. It is concentrated to a higher level which is not possible at most clinics as they use bedside centrifuges. At Centeno-Schultz Clinic we understand the importance of having different PRP concentrations to treat different conditions. We have a state of the art laboratory with stem cell scientists that can super concentrate PRP to ensure for your best clinical outcome. Our current publication demonstrates that higher concentrations of PRP are useful for tendon injuries (2).

To better understand PRP and how it functions please click on the video below.

Despite what many websites and clinics recommend, ice should not be used after PRP injections. Inflammation is an important part of the healing process. Ice reduces inflammation and swelling and therefore may compromise the healing process (3). Ice also prompts the blood vessels to get smaller thereby restricting blood flow. Blood flow is critical to healing. One of the precautions after PRP injections is to avoid ice. To learn more about the ligament healing after PRP or stem cell injections please click on the video below.

Rest and healing are important after PRP injections. It is important that the injected PRP be given the opportunity to heal the affected area. In order of this to happen the PRP must be given the opportunity to set in place. Platelets release important growth factors and proteins that promote tissue regeneration and healing. It takes up to seven days for the growth factors to be released from the platelets (4) Exercise may displace and move the PRP from injected site thereby compromising healing and outcome. For example, if your kneecap tendon was injected, running or heavy weightlifting immediately after the injection may result in the PRP being pushed out of the tendon. Rest for the first two weeks followed by the gradual return to normal exercise is ideal closely monitoring pain and swelling. One of the precautions after PRP Injection is to avoid vigorous exercise and weightlifting and rest which will allow the PRP work and promote healing.

Alcohol can negatively affect platelet function. Specifically, it can decrease its platelet activation and aggregation (5) and response to other proteins and enzymes. (6). Alcohol can also affect stem cell numbers and function which may compromise healing. The effectiveness of PRP is based on your own bodys ability to heal. Commit yourself to healthy foods, good sleep and no alcohol for maximal healing.One of the precautions after PRP injections is to avoid alcohol.

PRP is a concentration of the patients own blood platelets in their serum. Platelets contain growth factors and mediators that reduce inflammation, improve blood flow and turbocharge the natural healing process. There are different types of PRP which are available in different concentrations. Precautions after PRP injections include avoiding the use of ice, limiting exercise and alcohol. For the best clinical outcome use heat, rest and adopt a healthy lifestyle.

1. Hussain N, Johal H, Bhandari M. An evidence-based evaluation on the use of platelet rich plasma in orthopedics a review of the literature. SICOT J. 2017;3:57. doi:10.1051/sicotj/2017036

2.Berger DR, Centeno CJ, Steinmetz NJ. Platelet lysates from aged donors promote human tenocyte proliferation and migration in a concentration-dependent manner.Bone Joint Res. 2019;8(1):3240. Published 2019 Feb 2. doi:10.1302/2046-3758.81.BJR-2018-0164.R1

3.Hsu SL, Liang R, Woo SL. Functional tissue engineering of ligament healing.Sports Med Arthrosc Rehabil Ther Technol. 2010;2:12. Published 2010 May 21. doi:10.1186/1758-2555-2-12

4.Golebiewska EM, Poole AW. Platelet secretion: From haemostasis to wound healing and beyond.Blood Rev. 2015;29(3):153162. doi:10.1016/j.blre.2014.10.003

5. Mukamal KJ, Massaro JM, Ault KA, et al. Alcohol consumption and platelet activation and aggregation among women and men: the Framingham Offspring Study. Alcohol Clin Exp Res.2005;29(10):19061912.DOI:10.1097/01.alc.0000183011.86768.61.

6. Olas B, Wachowicz B, Saluk-Juszczak J, Zieliski T. Effect of resveratrol, a natural polyphenolic compound, on platelet activation induced by endotoxin or thrombin. Thromb Res.2002;107(34):141145.DOI:10.1016/s0049-3848(02)00273-6.

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Precautions After PRP Injections: What to Do and What to Avoid