Global Advanced Therapy Medicinal Products Market to Grow Immensely at a CAGR of ~14% by 2032 | DelveInsight

The expansion of the advanced therapy medicinal products market is primarily fueled by the increasing incidence of chronic diseases. The rising prevalence of genetic disorders and cancer, along with growing R&D efforts and strategic collaborations among key industry players, are significant factors driving the market's positive growth from 2025 to 2032.

LAS VEGAS, Feb. 25, 2025 /PRNewswire/ -- DelveInsight's Advanced Therapy Medicinal Products Market Insights report provides the current and forecast market analysis, individual leading advanced therapy medicinal products companies' market shares, challenges, advanced therapy medicinal products market drivers, barriers, trends, and key market advanced therapy medicinal products companies in the market.

Key Takeaways from the Advanced Therapy Medicinal Products Market Report

• As per DelveInsight estimates, North America is anticipated to dominate the global advanced therapy medicinal products market during the forecast period. 
• In the type segment, the cell therapy medicines category is estimated to account for the largest market share in the advanced therapy medicinal products market due to the potential of cell therapies to transform disease treatment.
• Notable advanced therapy medicinal products companies such as Pfizer Inc., Novartis AG, Gilead Sciences, Inc., Kolon TissueGene, Inc., Bluebird Bio, Inc., F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb Company, Organogenesis Inc., BioNTech, Regeneron Pharmaceuticals Inc., ALLOGENE THERAPEUTICS, CRISPR Therapeutics, Autolus Therapeutics, Anixa Biosciences, Inc., Amgen Inc., Intellia Therapeutics, Inc., Adaptimmune, Voyager Therapeutics Inc., Sangamo Therapeutics, Inc., Biogen, and several others, are currently operating in the advanced therapy medicinal products market.
• In February 2025, Immix Biopharma, Inc. announced that the FDA has granted RMAT designation to its sterically-optimized CAR-T therapy, NXC-201, for the treatment of relapsed or refractory AL amyloidosis.
• In February 2025, BMS announced that BREYANZI achieved the primary endpoint in the MZL cohort of the Phase II TRANSCEND FL trial, showing a statistically significant and clinically meaningful overall response rate (ORR). This allows Bristol Myers Squibb to approach approval for a fifth indication for BREYANZI in the US.
• In February 2025, CARsgen Therapeutics Holdings Limited reported that the first patient treated with its allogeneic BCMA CAR-T therapy, developed using the THANK-u Plus platform, has achieved a stringent complete response (sCR) and tested negative for minimal residual disease (MRD) at the Day-28 evaluation.
• In December 2024, Bristol Myers Squibb and 2seventy bio, Inc. announced that the FDA approved ABECMA (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma. 
• In November 2024, Nanjing Leads Biolabs Co., Ltd. announced that LBL-034, a humanized bispecific T-cell engaging antibody targeting GPRC5D and CD3 for multiple myeloma, has received Orphan Drug Designation (ODD) from the U.S. FDA.
• In September 2024, Sanofi's SARCLISA (isatuximab) was approved by the FDA as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. 
• In April 2024, Pfizer Inc. announced that it received US FDA approval for BEQVEZ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B. BEQVEZ is an adeno-associated virus (AAV)-based one-time treatment gene therapy developed for patients suffering from hemophilia B.
• In February 2024, BioNTech and Autolus Therapeutics announced a strategic collaboration to develop CAR-T cell therapy aimed at advancing their pipeline and expanding late-stage programs. Through this partnership, both companies focused on accelerating pipeline programs to develop advanced therapies for multiple cancer indications.

To read more about the latest highlights related to the advanced therapy medicinal products market, get a snapshot of the key highlights entailed in the Global Advanced Therapy Medicinal Products Market Report

Advanced Therapy Medicinal Products Overview

Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge category of biopharmaceuticals that harness gene therapy, cell therapy, and tissue-engineered products to treat a range of complex and often life-threatening diseases. These therapies leverage innovative approaches, such as genetically modifying patient-derived or donor cells, using viral vectors for targeted gene delivery, and engineering tissues to regenerate damaged organs. ATMPs offer groundbreaking potential for conditions that have limited or no effective treatments, including rare genetic disorders, certain types of cancer, and degenerative diseases. Regulatory agencies like the EMA and the FDA have established specialized pathways to evaluate these therapies, ensuring their safety, efficacy, and long-term patient benefits.

Despite their promise, ATMPs face significant challenges in scalability, manufacturing, and cost-effectiveness. The complexity of developing and producing these therapies requires stringent quality control, advanced bioprocessing techniques, and robust supply chain logistics. Moreover, the high cost of ATMPs, driven by the need for personalized treatment and sophisticated infrastructure, poses reimbursement and accessibility challenges for healthcare systems worldwide. Ongoing advancements in automation, cryopreservation, and regulatory harmonization aim to address these hurdles, making ATMPs more widely available. As research progresses, the integration of artificial intelligence, synthetic biology, and next-generation gene-editing tools is expected to further refine these therapies, expanding their applications and improving patient outcomes.

Advanced Therapy Medicinal Products Market Insights

North America is projected to hold the largest share of the advanced therapy medicinal products market in the coming years. This dominance can be attributed to the increasing incidence of cancer and the growing R&D efforts by leading companies in the region, which are driving market expansion. 

The surge in R&D activities by key players to develop innovative advanced therapy medicinal products for chronic disease treatment is significantly contributing to market growth. For example, In December 2024, Bristol Myers Squibb and 2seventy bio, Inc. announced that the FDA approved ABECMA (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma. This approval follows the results from the KarMMa-3 trial and applies to patients who have undergone two or more prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. 

As a result, the rising cancer prevalence and increased research initiatives by major industry players are expected to further drive the growth of the advanced therapy medicinal products market in North America.

To know more about why North America is leading the market growth in the advanced therapy medicinal products market, get a snapshot of the Advanced Therapy Medicinal Products Market Outlook 

Advanced Therapy Medicinal Products Market Dynamics

The advanced therapy medicinal products market is experiencing significant growth driven by innovations in cell and gene therapy, as well as tissue-engineered products. ATMPs, which include chimeric antigen receptor T-cell (CAR-T) therapies, gene editing technologies, and regenerative medicine approaches, have emerged as revolutionary treatment options for various genetic, oncological, and rare diseases. The increasing number of regulatory approvals, such as those granted by the FDA and EMA, has boosted confidence in the sector, leading to heightened investment and commercialization efforts.

One of the key dynamics shaping the ATMP market is the rapid expansion of research and development (R&D) activities. Advances in CRISPR-based gene editing, exosome-based therapies, and complement inhibitors have fueled the pipeline of next-generation ATMPs. However, the high cost of R&D, coupled with stringent regulatory requirements, remains a challenge for smaller biotech firms looking to bring new therapies to market. Companies are increasingly forming strategic partnerships and collaborations to share expertise, accelerate development, and mitigate financial risks.

Market access and reimbursement remain critical hurdles for ATMP adoption. Given their high price tags, payers and healthcare systems are under pressure to develop innovative pricing and reimbursement models, such as value-based agreements and annuity-based payment structures. Governments and insurers are exploring outcome-based pricing, where payments are tied to patient response and long-term efficacy, to ensure broader patient access while managing costs.

Manufacturing and supply chain challenges also influence market growth. ATMPs often require complex, patient-specific production processes, such as autologous cell therapies, which pose logistical and scalability constraints. Innovations in allogeneic therapies and automation in cell processing are being explored to address these bottlenecks. Companies are investing in decentralized manufacturing models and advanced bioprocessing technologies to streamline production and ensure faster delivery of ATMPs to patients.

Looking ahead, the ATMP market is expected to continue its strong growth trajectory, driven by increasing regulatory support, technological advancements, and an expanding range of indications. The emergence of novel therapeutic modalities, such as mRNA-based approaches and hybrid cell-gene therapies, could further transform the landscape. As more ATMPs receive approval and enter mainstream healthcare systems, industry players will need to focus on optimizing cost structures, addressing reimbursement challenges, and scaling up manufacturing capabilities to unlock the full potential of these groundbreaking therapies.

Get a sneak peek at the advanced therapy medicinal products market dynamics @ Advanced Therapy Medicinal Products Market Dynamics Analysis

Advanced Therapy Medicinal Products Market Assessment

• Advanced Therapy Medicinal Products Market Segmentation
• Advanced Therapy Medicinal Products Market Segmentation By Type: Gene-Therapy Medicines, Cell Therapy Medicines, Tissue Engineered Products, Combined ATMPs
• Advanced Therapy Medicinal Products Market Segmentation By Indication: Oncology, Cardiology, Neurology, Genetic Disorders, Infectious Diseases, Metabolic Disease, and Others
• Advanced Therapy Medicinal Products Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
• Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View

Which MedTech key players in the advanced therapy medicinal products market are set to emerge as the trendsetter explore @ Advanced Therapy Medicinal Products Companies 

Table of Contents 

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