Advanced Therapy Medicinal Products (ATMP) Market Size, Share & Trends Analysis Report By Therapy Type (Cell Therapy, Gene Therapy, CAR-T Therapy, Tissue Engineered Products), By Manufacturer (Biopharmaceutical Companies, Contract Development and Manufacturing Organizations (CDMOs), Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Advanced Therapy Medicinal Products (ATMP) Market Size

The global advanced therapy medicinal products (ATMP) market size was valued at USD 11.99 billion in 2023 and is projected to grow from USD 14.61 billion in 2024 to USD 35.59 billion by 2032, exhibiting a CAGR of 6.73% during the forecast period (2024-2032). The projected growth in the market is driven by increasing investments in gene and cell therapies, advancements in regenerative medicine, and expanding regulatory approvals, which are accelerating the development and commercialization of novel therapies.

Advanced Therapy Medicinal Products (ATMP) Market Trends

Increased Focus on Gene Editing Technologies

The advanced therapy medicinal products (ATMP) market is witnessing a significant trend toward the integration of gene editing technologies, such as CRISPR-Cas9, to develop innovative therapies for genetic disorders. These technologies are enhancing the precision and efficiency of gene therapies, allowing for targeted treatment approaches that were previously unattainable. The growing body of research and successful clinical trials involving gene editing is driving market adoption.

• For instance, in December 2023, CRISPR Therapeutics' and Vertex received FDA approval on CRISPR, the gene-editing technology in treating sickle cell disease and beta-thalassemia highlight the potential of these technologies to transform therapeutic landscapes.

As these technologies improve, they are expected to contribute substantially to the growth of the advanced therapy medicinal products (ATMP) market by enabling the development of more effective and personalized treatments.

Expansion of Regenerative Medicine Applications

Regenerative medicine, a critical component of the advanced therapy medicinal product (ATMP) market, is expanding beyond traditional applications such as wound healing and tissue regeneration. Emerging areas like organ transplantation and central nervous system repair are gaining traction, with new therapies being developed to address unmet medical needs. The increasing prevalence of chronic diseases and the growing aging population are driving the demand for regenerative therapies.

• For Instances: In May 2022, Athersys announces that its partner, HEALIOS K.K., reported topline data from the treasure multistem ischemic stroke study. The company is leading the way with their multiStem cell therapy, which is being explored for treating stroke, respiratory conditions, and other critical illnesses.

This market trend is expected to boost market growth by broadening the scope and application of regenerative medicines.

Advanced Therapy Medicinal Products Market Growth Factors

Advancements in Biotechnological Research

Ongoing advancements in biotechnological research are propelling the advanced therapy medicinal product (ATMP) market growth. Breakthroughs in areas such as gene editing, stem cell research, and tissue engineering are enabling the development of innovative therapies with the potential to transform patient care.

• For instance, in September 2021, as per the article of NCBI, advancements in induced pluripotent stem cell (iPSC) technology are facilitating the creation of patient-specific cell therapies for regenerative medicine applications.

These technological advancements are expanding the therapeutic possibilities of advanced therapy medicinal products (ATMPs) and attracting significant investment from both public and private sectors. As biotechnological research continues to evolve, it will drive the development and adoption of advanced therapies.

Growing Investment in Advanced Therapy Medicinal Products (ATMP) Development

The advanced therapy medicinal products (ATMP) market is experiencing a surge in investment from both pharmaceutical companies and venture capital firms. This surge of investment is crucial for funding the research, development, and commercialization of advanced therapies. Companies are increasingly recognizing the potential of ATMPs to address unmet medical needs and are committing substantial resources to develop these therapies.

• For instance, in April 2018, Novartis' significant investment in gene therapy programs, including the acquisition of AveXis for $8.7 billion, underscores the growing confidence in the ATMP market.

Such investment is expected to accelerate the development of new therapies and expand the market's reach.

Market Restraints

High Cost of Treatment

The high cost associated with ATMPs is a significant restraint for the market. Advanced therapies like gene and cell therapies often involve complex manufacturing processes, rigorous quality control, and extensive clinical trials, all of which contribute to their high cost.

• For instance, in January 2023 as per the report of The New York Times, Zolgensma, a gene therapy for spinal muscular atrophy, cost more than USD 2 million per treatment, making it one of the most expensive drugs in the world.

These high costs can limit patient access, especially in regions with limited healthcare funding or where insurance coverage is inadequate. As a result, the widespread adoption of ATMPs may be hindered, particularly in developing countries where affordability is a major concern.

Manufacturing and Scalability Challenges

Manufacturing ATMPs is highly complex and presents significant scalability challenges. The production of these therapies often requires specialized facilities, stringent quality control measures, and highly skilled personnel, making it difficult to scale up production to meet growing demand.

• For instance, the production of CAR-T therapies involves the extraction and modification of a patient’s own cells, a process that is both time-consuming and labor-intensive.

These challenges can lead to supply shortages and delays in bringing therapies to market. Additionally, the high cost of establishing and maintaining manufacturing facilities can be a barrier for smaller companies, limiting the market’s growth potential.

Advanced Therapy Medicinal Products Market Regional Insights

North America: Dominant region with 41.75% market share

North America maintains its position as the leading market for advanced therapy medicinal products (ATMP), due to its robust healthcare infrastructure, significant investment in research and development, and a supportive regulatory environment. The region hosts numerous biopharmaceutical companies, top-tier research institutions, and advanced manufacturing facilities, which drive innovation in the ATMP sector. 

Key trends shaping the North American Advanced Therapy Medicinal Products (ATMP) Market include:

• Rapid advancements in gene and cell therapies are driving innovation and expanding treatment options.
• Growing investment from both pharmaceutical companies and venture capital firms is fueling development and commercialization efforts.
• Strategic collaborations between biopharmaceutical companies and research institutions are enhancing the development of novel therapies.
• Increased regulatory support and accelerated approval procedures are expanding market entry for new therapies.

Asia-Pacific: Rapid growth in China, India, and Southeast Asia

The Asia-Pacific region is experiencing rapid growth in the Advanced Therapy Medicinal Products (ATMP) Market, driven by increasing healthcare investments, expanding clinical trials, and rising demand for innovative treatments. The region's growing patient population and prevalence of chronic and genetic diseases further stimulate market expansion. Key opportunities in this market include:

• Expansion of clinical trials and research collaborations offers new avenues for therapy development.
• Growing investment in healthcare infrastructure enhances the production and distribution capabilities of ATMPs.
• Advancements in biotechnology and manufacturing technologies enable more efficient and scalable production of ATMPs.

The region has become a hub for clinical trials, with countries like China and India rapidly expanding their research programs. This activity is driven by a large and diverse patient population, offering ample opportunities for testing new therapies.

Advanced Therapy Medicinal Products Market Segmentation Analysis

By Therapy Type

CAR-T Therapy Segment Dominate the Market with the Highest Market Revenue

By therapy type, the market is bifurcated into cell therapy, gene therapy, CAR-T therapy and tissue-engineered products.

In 2023, the CAR-T therapy segment dominated the advanced therapy medicinal products (ATMP) market due to its efficacy in treating various complex and rare conditions, such as certain cancers and genetic disorders. The ability of cell-based gene therapies to offer personalized treatment options tailored to individual patients' needs has further fuelled their adoption. Additionally, advancements in cell engineering and manufacturing processes have improved the scalability and accessibility of these therapies, contributing to their market dominance.

• For instance, in December 2020, Arcellx, a clinical-stage biopharmaceutical company, has released initial clinical data from the first six patients in its ongoing Phase 1 trial of CART-ddBCMA for treating relapsed and refractory multiple myeloma. CART-ddBCMA is a genetically engineered cell therapy that features a novel, computationally designed synthetic binding domain, known for its high stability and reduced immunogenicity.

By Manufacturer

Biopharmaceutical Companies Segment Dominate the Market with the Highest Market Revenue

By manufacturer, the market is divided into biopharmaceutical companies, contract development and manufacturing organizations (CDMOs) and others.

In 2023, the biopharmaceutical companies segment dominated the market with the largest market share due to their significant investments in research and development of advanced therapies, including gene and cell therapies. These companies possess the resources, expertise, and infrastructure needed to drive innovation in the ATMP sector, leading to the creation of cutting-edge treatments for complex diseases. The strong pipeline of biopharmaceutical firms, combined with their ability to navigate regulatory pathways and bring new therapies to market, has positioned them at the forefront of the industry. Additionally, the increasing number of collaborations and partnerships between biopharmaceutical companies and academic institutions or smaller biotech firms has further accelerated the development of novel therapies.

• For instance, In July 2023, the collaboration between Bristol Myers Squibb (BMS) and bluebird bio. This partnership has focused on developing and commercializing novel cell therapies, particularly in the treatment of multiple myeloma. Through their collaboration, BMS and bluebird bio co-developed Abecma (idecabtagene vicleucel), the first CAR-T cell therapy for multiple myeloma.

Company Market Share

Key Players are Developing Advanced Therapies to Cure Chronic and Rare Diseases.

Key market players in the market are strategically investing in improving their advanced therapies infrastructure to meet the increasing demand. These players also focus on key business strategies, such as strategic collaborations, relevant acquisitions, and innovative partnerships, among others.

Orchard Therapeutics: An Emerging Player in the Advanced Therapy Medicinal Products (ATMP) Market

Orchard Therapeutics focuses on developing innovative gene therapies to address rare and genetic diseases. Orchard Therapeutics is notable for its advanced programs, including OTL-200 for metachromatic leukodystrophy (MLD) and OTL-103 for severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). The company is leveraging cutting-edge gene editing and cell therapy technologies to create potentially curative treatments, positioning itself as a key player in the evolving ATMP landscape.

Recent developments at Orchard Therapeutics include:

• In August 2023, Orchard Therapeutics presented positive results for long-term results from an updated integrated analysis of 39 patients with metachromatic leukodystrophy (MLD) treated with investigational OTL-200, a gene therapy in the clinical development program. This will enhance confidence in gene therapies and drive further investment and innovation in the sector.

Recent Developments

• In September 2022, Myrtelle Inc., a clinical-stage gene therapy company focused on neurodegenerative diseases, announced that the European Medicines Agency (EMA) had categorized the company's lead gene therapy product candidate, for treating Canavan disease, as an Advanced Therapy Medicinal Product (ATMP) and specifically as a Gene Therapy Medicinal Product (GTMP).
• In February 2021, the U.S. FDA approved Bristol Myers Squibb's CAR-T therapy, Breyanzi, for the treatment of adults with relapsed or refractory large B-cell lymphoma.

Analyst Opinion

The Advanced Therapy Medicinal Products (ATMP) market is poised for substantial growth, driven by ongoing advancements in gene, cell, and tissue therapies that offer transformative treatment options for various rare conditions. The market benefits from increasing investment in research and development, coupled with supportive regulatory frameworks that facilitate faster approvals. As technology advances and manufacturing processes become more streamlined, we can expect broader adoption and reduced costs, making these therapies more accessible. Moreover, the market's expansion is supported by the promising clinical outcomes and innovative approaches emerging from leading biopharmaceutical companies and research institutions.