The formulation development outsourcing (FDO) market is also going through big changes. These changes can be seen in the science and drug industries. This business, which is very important to the growth of drugs, is shaped by a few big market trends:
As drug firms work on more complicated treatment areas and new ways to give drugs, they need people who are experts in making new products more than ever. More and more companies are exporting to companies that have a history of success in specific areas like biologics and controlled-release formulas.
Today, the FDO market is growing all over the world. This is because companies in the science and medicine fields want to find cheaper ways to do things and use the knowledge of outsourcing partners in other countries. Emerging economies, especially those in Asia, are becoming more important in outsourcing formulation development because they can help the economy and have a lot of skilled workers.
It's now more important than ever for drug makers and FDO service providers to plan their work together. There is a movement toward this because research and development done in-house don't always work well with each other. Strategic relationships make it easier for people to share information, which speeds up the process. They also make processes better and cut down on the time it takes to make new drugs.
Changes in the technology used to move drugs have an effect on the FDO market. More and more people are seeing specialized and precision care, which makes them more interested in new ways to give drugs. It is becoming more normal to work with contract partners who know how to give drugs in new ways, such as with nanoparticles or focused delivery.
Because of how strict the rules are, everyone in the pharmaceutical business has to follow them to the letter. To meet the needs of drug companies and regulatory bodies, companies that outsource product development are putting more effort into maintaining high quality standards and following rules set by regulatory bodies.
The number of processes that are handled for formulation development in this field has grown at the same rate that the production of biopharmaceuticals and biologics has grown. Because of the growing need for experts in protein formulas, cell treatments, and monoclonal antibodies, the biotech industry is making more and more outsourcing deals.
Drug businesses want to be able to grow and change, so they are becoming more interested in outsourcing services. They can grow their businesses as needed, change with the needs of projects, and offer a wide range of services, from early-stage research to mass production. This helps them stay ahead of the competition in formulation development outsourcing.
It is still very important for the FDO business to save money. Medicine companies want to find ways to cut costs as much as possible without slowing down the development of new products. A plus is being able to find hiring partners who can offer solutions that are both cheap and up to high standards for research and development.
In the FDO business, green and eco-friendly methods are growing in importance, and sustainability is beginning to get more attention. Pharmaceutical companies are becoming more concerned with being good business citizens. This is in line with outsourcing partners who focus on making medicines in eco-friendly ways. These ways include "green chemistry" and "sustainable procurement of raw materials."
The stem cell therapy market size was valued at USD 0.11 billion in 2023 and is projected to grow from USD 0.13 Billion in 2024 to USD 0.36 billion by 2032, exhibitinga compound annual growth rate (CAGR) of 13.16% during the forecast period (2024 - 2032). The market's growth is primarily attributed to the increasing prevalence of chronic disorders across the globe. Furthermore, the growing spending on medical research and expanding pharmaceutical industry are the key market drivers for the growth of the stem cell therapy market.
Source Secondary Research, Primary Research, MRFR Database, and Analyst Review
The rising global incidence of chronic diseases is the primary factor driving market expansion. Market expansion for stem cell treatment is also being fueled by rising government funding for medical research and a flourishing pharmaceutical sector.
An expanding cell therapy production infrastructure and an increasing number of clinical studies are seen as key growth drivers for the market. Tissue engineering and stem cell therapies, both relatively new fields, have shown promise as possible treatments for a variety of illnesses.
In addition, the rise in research activities associated with stem cells generation, storage, and characterisation, as well as the rising need for stem cell banking, are anticipated to drive revenue growth in the market. The anticipated rise in demand for stem cells over the projection period is supported by a number of reasons, including technological advancements in the parent and auxiliary market for stem cell utilization.
August 2023, the FDA approved ANPD001, an investigational stem cell treatment developed by Aspen Neuroscience to restore damaged nerve cells in Parkinson's disease patients. The purpose of the open-label Phase 1/2a trial is to evaluate the early effectiveness, safety, and dose-ranging tolerability of ANPD001 in patients with moderate to severe Parkinson's disease. The ultimate goal of ANPD001 is to restore dopaminergic neuron function in people with Parkinson's disease. The manufacturing process for stem cell treatment consists of three stages.
Because of the rising cancer incidence worldwide, cancer treatments must be adjusted by local and international priorities. According to estimates from the International Agency for Research on Cancer 2020, 1 in 5 people will develop cancer at some point in their lives, and 1 in 8 men and 1 in 11 women will pass away. Women are more likely than males to develop lung and prostate cancer, accounting for almost one-third of all male cancers. Women are more likely to develop breast, colorectal, lung, cervical, and thyroid cancer.
Certain cancers, including leukemia, multiple myeloma, neuroblastoma, and some lymphomas, can be treated by a bone marrow or stem cell transplant. Both allogeneic and autologous stem cells have been used in cancer therapy.
The strategic initiatives taken by the market players are also propelling the growth of the segment growth. For instance, in February 2020, the Institute of Stem Cell Therapy and Research (GIOSTAR) inaugurated a new stem cell and cancer research and therapy center in Chandigarh, India. This facility represents the latest milestone in expansion efforts spearheaded by GIOSTAR in India, Mexico, the United States, and numerous other countries.
Therefore, a medical condition related to leukemia, multiple myeloma, neuroblastoma, and some lymphomashas recently enhanced the Stem Cell Therapy market CAGR across the globe.
However, there have been significant advances in treatment innovations to cater to the demand. For instance, several introductionsof Stem Cell Therapyimplants are another factor driving the growth of the Stem Cell Therapy market revenue.
The Stem Cell Therapy market segmentation is divided into Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood-Derived, IPSCs, PPSCs based on cell sources. Due to the growing use of these cells in treating inflammatory diseases, injuries, and traumas, the Adipose Tissue sector is anticipated to rule the market during the expected time frame. The segment will be further driven by the numerous benefits of using stem cells derived from adipose tissue, including the ease of harvesting stem cells using minimally invasive techniques, the simplicity of the isolation approach, and the higher quality and proliferation capacity of the stem cells.
February 2022- Cynata Therapeutics, a cell therapeutics biotech, to get a patent covering its proprietary Cymerusmesenchymal stem cell, or "MSC" technology, from China's patent office. The company anticipates receiving the patent by the end of May 2022, valid until March 2037.
January 2022- Gamida Cell, a prominent biotech company, announced it would start a rolling FDA submission for the blood cancer treatment omidubicel. Still, it seeks a little help from slashing staff and a strategic partner to get it across the finish line.
The Stem Cell Therapy market segmentation, based on type, the market is divided into Allogeneic Stem Cell Therapy and Autologous Stem Cell Therapy. The Allogeneic Stem Cell Therapy segment is subcategorized into Musculoskeletal Disorders, Wounds and Injuries, Surgeries, Acute Graft-Versus-Host Disease (AGVHD), and Other Disorders. Autologous Stem Cell Therapy is divided into Cardiovascular Diseases, Wounds and Injuries, Gastrointestinal Diseases, and Other Applications. The Allogenic stem cell therapy segment dominates the market because of its contiguous use in cancer treatment because of its graft vs-cancer impact.
This response allows the donor stem cells to employ their immune system cells to attack cancer cells. The donor's immune system reaction is far more significant than the recipient's. So, it is used to treat disorders such as lymphomas, leukemias, and myelomas. Additionally, the autologous therapy segment is witnessing tremendous growth during the forecast period due to its benefits, like less complexity owing to the low risk of graft rejection. Also, factors like high patient survival rate, low cost, no need for HLA typing for matching donors, minimal risk, and the possibility to use these cells without going through clinical trials or meeting strict manufacturing requirements will further propel the market growth.
Figure 1 Stem Cell Therapy Market, by Type, 2022& 2030(USD Billion)
Source Secondary Research, Primary Research, MRFR Database, and Analyst Review
July 2023: Abeona Therapeutics, a biopharmaceutical company in the early stages of the clinical development of its lead product, EB-101, has secured $25 million in funding from a small group of existing investors as of July 2023. The money will be used by the firm to be ready for the launch of EB-101 and the submission of the biologics license application (BLA). Recessive dystrophic epidermolysis bullosa is being treated with an autologous, engineered cell treatment called EB-101. After the BLA is approved, the business can apply for a priority review voucher (PRV) from the FDA because of the drug's rare paediatric illness classification.
October 2022: The objective of Global Stem Cells Group is to develop its therapies and technologies to fulfill market need in populous parts of the world. Meso Numismatics, Inc., a technology business specialized in Biotech and Numismatics, has announced a new relationship that will facilitate this goal. One of the most prominent cosmetic clinics in Mexico City, Dr. Vanessa Rodriguez Pares, has partnered with the brand-new STEM LIFE clinic in the hopes of raising the bar for regenerative medicine services across the country.
The Stem Cell Therapy market data has been Based on Therapeutic Applications; the market is bifurcated into Cancer, Diabetes, Musculoskeletal Disorders, Cardiovascular, Gastrointestinal Diseases, Others. The musculoskeletal disorders segment is expected to dominate the market during the forecasted period due to the rising incidence of musculoskeletal disorders such as osteoarthritis, bone repair, and regeneration.
February 2022- Likarda, LLC, a cell therapy company developing innovative delivery systems, has announced an agreement with eQcell. The deal includes exercise options for a worldwide license of the customized hydrogel encapsulation product for their equine multipotent stromal cells.This approval has further broadened the growth opportunity for the Stem Cell therapy industry.
Based on End Users, the Stem Cell therapy industry has been a segmented into Hospitals & Clinics, Ambulatory Surgical Centers (ASCs), Academic and Research Centers, Others. The increasing frequency of chronic diseases, the rise in clinical trials, the expansion of strategic initiatives, and advances in healthcare services are some of the causes that can be credited to the Hospitals & Clinics increased segment share. For instance, StemCyte, Inc. received FDA permission in August 2022 for their Phase II clinical trial using umbilical cord blood stem cells for Post-COVID Syndrome. Also, the US FDA approved BioCardia's Application for an Investigational New Drug (IND) in April 2022, allowing BioCardia to begin a Phase I/II clinical trial with BCDA-04 in adults recovering from acute respiratory distress syndrome associated with COVID-19.
By region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North American stem Cell Therapy market accounted for USD 0.1billion in 2022 and is expected to exhibit a significant CAGR growth during the study period. The North American Region is expected to dominate the market during the forecasted period due to key players engaged in developing stem cell therapies, advanced healthcare infrastructure, extensive Research & Development, supportive reforms from the healthcare sector, and strong reimbursement policies.
Further, the significant countries studied in the market report are The U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 2 STEM CELL THERAPY MARKET SHARE BY REGION 2022 (%)
Source Secondary Research, Primary Research, MRFR Database, and Analyst Review
Europe's Stem Cell Therapymarket accounts for the second-largest market share Due to an increase in the willingness of patients to undergo stem cell treatment and a growing number of chronic and neurological disorders cases.Further, the Germany Stem Cell Therapymarketheld the largest market share, and the UK Stem Cell Therapymarket was the fastest-growing market in the European Region.
The Asia-Pacific Stem Cell TherapyMarket is the fastest-growingCAGR from 2022 to 2030. This is due toAdvanced healthcare infrastructure, extensive Research & Development, supportive reforms from the healthcare sector, and strong reimbursement policies. Moreover, India's Stem Cell Therapymarket was the fastest-growing market in the Asia-Pacific region.
For instance, the IndiaStem Cell Therapymarket is the favored destination for medical travelers due to the availability of surgeons, cutting-edge technology, & cost-effective treatments. On the other hand, The Indian government has established modern stem cell research facilities in 40 top medical research and educational institutions. In the past three years, the government has invested USD 80 million in specialized research programs through the Indian Council of Medical Research (ICMR).
Stem Cell Therapy Key Market Players & Competitive Insights
Major market players are spending a lot of money on R&D to increase their product lines, which will help the Stem Cell Therapymarket grow even more. Market participants are also taking various strategic initiatives to expand their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the Stem Cell therapy industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.
One of the primary business strategies manufacturers adopt in the Stem Cell therapy industry to benefit clients and expand the market sector is manufacturing locally to reduce operating costs. The Stem Cell Therapy industry has provided medicine with some of the most significant benefits in recent years. The Stem Cell Therapy market major player such as Seraxis, Inc. (Germany), ViaCyte, Inc. (US), Betalin Therapeutics Ltd (Israel), NextCellPharma AB (US), Kadimastem (Israel), Vertex Pharmaceuticals (US), Fresenius Medical Care AG & Co. KGaA (Germany), Sernava Corp (Canada), Novo Nordisk A/S (Denmark), Generex Biotechnology (Canada).
American CryoStem and BioTherapeutic Laboratories Corp began working together in February 2021 to conduct stem cell research and development. The primary goal of this collaboration was to create and enhance protocols using the human umbilical cord-based product lines from BTL and CRYO's ATCell.
Aspen is developing induced-pluripotent stem cells (iPSCs) to address diseases with high unmet medical need, beginning with autologous neuron replacement for both sporadic and genetic forms of Parkinson’s disease (PD) and extending across the brain and affected organs. Aspen Neuroscience, Inc., in collaboration with several clinical screening locations in the United States, started the first patient screening trial of its sort in April 2022. To submit an Investigational New Drug (IND) Application to the US Food & Drug Administration for ANPD001 and the study of iPSC-derived cell replacement therapy for Parkinson's disease, the business undertook a Trial-Ready Cohort Study.
Key Companies in the Stem Cell Therapy market include
Stem Cell Therapy Industry Developments
November 2023 - Gamida Cell announces the launch of its new stem cell therapy, GC007, for the treatment of patients with advanced acute myeloid leukemia (AML). GC007 is a first-in-class CD34+ CD71+ AML therapy that has been shown to be effective in clinical trials.Autolus Therapeutics announces that its new stem cell therapy, CART-19, has been approved by the FDA for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). CART-19 is a second-generation CAR-T cell therapy that has been shown to be highly effective in clinical trials.Fate Therapeutics announces that its new stem cell therapy, FT500, has shown promising results in a clinical trial for the treatment of patients with Duchenne muscular dystrophy (DMD). FT500 is an induced pluripotent stem cell (iPSC)-derived therapy that has the potential to restore muscle function in DMD patients.
February 2022- Cynata Therapeutics, a cell therapeutics biotech, to get a patent covering its proprietary Cymerusmesenchymal stem cell, or "MSC" technology, from China's patent office. The company anticipates receiving the patent by the end of May 2022, valid until March 2037.
Stem Cell TherapyRegional Outlook
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