The goal of the interdisciplinary discipline of regenerative medicine is to create novel treatments to restore, replace, or regenerate diseased or damaged human body tissues and organs. It blends ideas from biology, engineering, genetics, and other fields of science to solve the shortcomings of current medical practices and provide fresh approaches to a range of medical issues. Regenerative medicine has promise in the treatment of a variety of illnesses, such as diabetes, musculoskeletal injuries, cardiovascular diseases, and neurodegenerative disorders.
Market Size Growth Rate:
According to the DataM market research report, the global regenerative medicine market size is valued at USD 12.1 billion in 2022, it is expected to reach USD 62.5 billion by 2030, with growth at a CAGR of 23.7% over the forecast period 2023-2030. North America is estimated to contribute 40.6% to the growth of the global market over the forecast period.
The global regenerative medicine market is driven by factors such as increasing prevalence of chronic diseases, advancements in stem cell research, and growing investment in research and development. On the other hand, regulatory challenges, ethical and social considerations, long development timelines, costs and reimbursement, and technical challenges restrain market growth.
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Active major players are driving the market growth. For instance, in June 2023, Wacker Biotech, a contract development and manufacturing organization (CDMO), and Caeregen Therapeutics, a producer of regenerative medicine therapeutics, will work together to create CTR-107 (Noregen), a novel regenerative therapeutic for the treatment of retinal-related vision loss. Wacker Biotech will develop drug substances at its facility in Halle, Germany, as Caeregen’s CDMO partner for CTR-107, and finish clinical trial drug product production at its facility in Amsterdam, the Netherlands, to support the start of Phase I/II clinical study in 2024.
The first program to treat Familial Exudative Vitreoretinopathy (FEVR) with U.S. FDA Rare Pediatric Disease Designation is CTR-107. Norrin, a naturally occurring human protein that encourages the development of healthy, structured blood vessels and neurons in the human eye, ear, and central nervous system, is mimicked by CTR-107, a synthetic targeted growth factor.
Regenerative medicine encompasses complex biological procedures including gene editing, tissue engineering, and stem cell differentiation. It takes time to fully comprehend these mechanisms and to optimize them for therapeutic uses. Because regenerative therapies are so novel, regulatory agencies frequently want voluminous proof of their effectiveness and safety. Regenerative medicine clinical trials must adhere to precise standards, which can dramatically lengthen trial times.
These phases include safety assessment, dose optimization, and long-term follow-up. Regenerative medicine products must undergo extensive research in animal models to determine their safety and efficacy before going on to human trials. Understanding potential adverse effects, dosage, and treatment regimens depends on these investigations.
The new product launches by key players are opening up new opportunities for the market. For instance, in September 2022, the first “made in India” over-the-counter cell therapy treatment, called “StemOne,” has been introduced by Alkem Laboratories and Stempeutics to treat knee osteoarthritis (OA). The business declared that the product now has regulatory approval from the Drugs Controller General of India (DCGI). The businesses stated in a joint statement that it is the first allogeneic cell therapy product to be approved for commercial use in India for Knee OA.
Over a twelve-year span, the product was created. A cost-effective production procedure is made possible by the company’s patented technological platform, making the medicine available to patients at an affordable price.
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COVID-19 Impact Analysis:
Regenerative medicine studies have slowed down or been redirected as a result of numerous researchers and laboratories shifting their attention and resources to COVID-19 research. Research labs were compelled to close or operate with restrictions due to lockdowns and social isolation tactics, which halted current trials and slowed development. clinical studies were significantly impacted for regenerative medicine treatments. Travel limitations, overburdened healthcare systems, and safety concerns caused delays in participant enrollment, monitoring, and data collecting.
Russia-Ukraine War Impact Analysis:
Due to strained diplomatic ties and restricted researcher travel between nations, international scientific partnerships may be hampered. Researchers from Russia, Ukraine, and other countries may encounter delays or interruptions in their collaborative endeavors. Economic instability brought on by the conflict may affect the funding of regenerative medicine research initiatives and start-up businesses. Reduced financing could impede innovation and slow down advancement.
Recent Developments in the Industry:
In November 2023, AstraZeneca disclosed its acquisition agreement with Neogene Therapeutics Inc. to expand its range of cell treatments for solid cancers. This tactical move supports both businesses’ goals of creating TCR-Ts (T cell receptor T cell therapies) that can identify intracellular targets and cancer-specific mutations, thereby increasing their footprint in the rapidly evolving field of regenerative medicine.
As per the research analysis, the global regenerative medicine market is segmented by product (primary cell-based therapeutics, stem cell & progenitor cell-based therapeutics, cell-based immunotherapies, and gene therapies), by material (synthetic material, biologically derived material, genetically engineered material, pharmaceutical), by application (dermatology, musculoskeletal, immunology & inflammation, oncology, cardiovascular, ophthalmology, and others), and by end-user (hospitals & clinics, commercial industries, and government & academic research institutes).
- Based on the product, the stem cell & progenitor cell-based therapeutics segment is estimated to contribute 38.6% to the growth of the global market over the forecast period (2023-2030). The extracellular matrix (ECM) and fibroblast buildup in pulmonary fibrosis (PF), a chronic interstitial lung disease, cause the breakdown of healthy alveolar structures, which ultimately results in respiratory failure. Advanced PF patients are unable to work physically, and their cough and dyspnea frequently coexist, which significantly lowers their quality of life.
- As per the article published in Stem Cell Research and Therapy in 2022, stem cells are attractive therapeutic agents for the treatment of interstitial lung illness due to their capacity for pluripotency and paracrine activities, and a substantial body of evidence supports the therapeutic efficacy of stem cells in lung fibrosis. Although pulmonary fibrosis treatment with stem cell transplantation may be very effective.
The global Regenerative Medicine market is segmented into major countries, including North America, Europe, South America, Asia Pacific, and Middle East & Africa.
North America Regenerative Medicine Market:
The prevalence of chronic diseases like cardiovascular disease, diabetes, neurological diseases, and orthopedic issues is rising over most of the world, including North America. Potential treatments and better management options for various illnesses are provided by regenerative medicine. The potential for regenerative therapies has been increased due to ongoing developments in stem cell research, such as the creation of induced pluripotent stem cells (iPSCs) and a better knowledge of their potential therapeutic uses.
Asia-Pacific Regenerative Medicine Market:
The Asia-Pacific area has a sizable and diversified population, which contributes to a higher prevalence of age-related health problems, degenerative diseases, and chronic illnesses that could be treated with regenerative medicine treatments. The aging of the population in many Asia-Pacific countries has increased the demand for creative approaches to age-related diseases and ailments.
Europe Regenerative Medicine Market:
With numerous prominent academic and research institutions advancing regenerative medicine technology and treatments, Europe has a strong research and innovation environment. Through financing initiatives, grants, and partnerships between academic institutions and business partners, many European nations have contributed to the research and development of regenerative medicine. Regenerative medicine therapies, which may provide remedies for difficult medical ailments, are in demand as European patients look for cutting-edge and new therapeutic choices.
There are numerous international, regional, and local suppliers in the global regenerative medicine industry. The competition in the local market is fierce. The vendors compete based on price, product quality, and dependability. As a result, to prosper and survive in a competitive market, suppliers must provide cost-efficient and effective products.
Major companies working towards the market’s growth include AstraZeneca plc, F. Hoffmann-La Roche Ltd., Integra Lifesciences Corp., Astellas Pharma, Inc., Cook Biotech, Inc., Bayer AG, Pfizer, Inc., Merck KGaA, Abbott, and Novartis AG, and others.
Additional Benefits Post Purchase:
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The Full Report has the below insights:
- The report offers a comprehensive evaluation of the market in terms of market value (US) and Y-o-Y Growth Rates (%). It does so via in-depth qualitative insights, historical data (2021-2022), and verifiable projections about market size during the forecast period (2023-2030).
- Visualize the composition of the global regenerative medicine market segmentation by mode, product, services, and region, highlighting the key commercial assets and players.
- By Product: primary cell-based therapeutics, stem cell & progenitor cell-based therapeutics, cell-based immunotherapies, and gene therapies.
- By Material: synthetic material, biologically derived material, genetically engineered material, pharmaceutical
- By Application: dermatology, musculoskeletal, immunology & inflammation, oncology, cardiovascular, ophthalmology, and others.
- By End-user: hospitals & clinics, commercial industries, and government & academic research institutes.
- By Region: North America, South America, Europe, Asia Pacific, Middle East & Africa.
- Identify commercial opportunities in the global regenerative medicine market by analyzing trends and co-development deals.
- The report also covers data insights on various industry forces such as Porter’s five forces analysis, supply chain analysis, pricing analysis, and regulatory analysis.
- Excel data sheet with thousands of data points of global Regenerative Medicine market-level 4/5 segmentation.
- PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
- Product mapping in Excel for the key product of all major market players
- The report will provide access to approximately 61 market data tables, 64 figures, and close to 180 pages.
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