Advanced Therapies in Biopharmaceutical Medicine Market Growth Accelerates with AI, Oncology Demand and RMAT Approvals in 2025

The global advanced therapies in biopharmaceutical medicine market is poised for substantial growth between 2025 and 2034, driven by rapid technological advancements, increasing demand for personalized treatments, and evolving healthcare priorities. These factors are reshaping the future of medicine and unlocking significant revenue potential across the sector.

The global advanced therapies in biopharmaceutical medicine market is driven by the accelerating prevalence of rare and life-threatening diseases, including genetic disorders and cancers, increasing R&D investments, and technological advancements. Major breakthroughs in gene editing technologies like CRISPR, along with advancements in cell and tissue engineering, are fueling the development of novel therapies, such as cell and gene therapies, and tissue-engineered products.

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Advanced Therapies in Biopharmaceutical Medicine Market Highlights:

•  North America led the market in 2024.

•  Asia-Pacific is expected to grow at the fastest CAGR during 2025-2034.

•  By therapy type, the gene therapy segment held a major revenue share of the market in 2024.

•  By therapy type, the CAR-T segment is expected to grow at the fastest CAGR during the forecast period.

•  By application type, the oncology segment was dominant in the advanced therapies in biopharmaceutical medicine market in 2024.

•  By application type, the cardiovascular diseases segment is expected to register a rapid expansion in the upcoming years.

•  By product type, the tissue-engineered products segment led the market in 2024.

•  By product type, the combined ATMPs segment is expected to grow rapidly in the projected period.

•  By distribution channel type, the hospital pharmacies segment registered dominance in the market in 2024.

•  By distribution channel type, the online pharmacies segment is expected to grow at the fastest CAGR during 2025-2034.

•  By end user, the hospital segment led the global advanced therapies in biopharmaceutical medicine market in 2024.

•  By end user, the clinics segment is expected to show the fastest growth during the forecast period.

Market Overview

The advanced therapies in biopharmaceutical medicine market, primarily including gene, cell, and tissue-based therapies, represent a paradigm shift in treating issues by directly altering or substituting damaged genes, harnessing living cells, or regenerating damaged tissues. Nowadays, ongoing developments are raising clinical trial activity, advancements in manufacturing and regulatory frameworks, and widespread applications beyond rare diseases. These advances are focused on the regeneration or repair of damaged tissues and organs using cells, biomaterials, and bioactive molecules. Inclusion of regenerating cartilage and bone, especially in joint injury applications. 

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Broder Adoption in the Development of Various Therapies: Major Potential

Numerous applications are growing in the advanced therapies in biopharmaceutical medicine market, including the development of different therapies such as gene therapy, cell therapy, and tissue engineering. Gene therapies are widely adopted in growing inherited disorders, some cancers, and rare genetic conditions, such as cystic fibrosis. Besides this, cell therapies are employed in Parkinson's disease and a few kinds of cancers. On the other hand, a robust application of tissue engineering is used in burn victims and developing artificial cartilage for joint problems.

Emerging Production Constraints and High Expense: Major Challenges

Mainly, patient-specific production approaches are time-consuming and resource-intensive, and need strong and measurable supply chains are restrict the growth of the advanced therapies in the biopharmaceutical medicine market. As well as the emergence of high spending in the development of advanced therapies is challenging the market expansion.

The Advanced Therapies in Biopharmaceutical Medicine Market: Regional Analysis

North America held a major revenue share of the market in 2024. Mainly, this region’s market is fueled by the accelerating demand for tailored medicine by applying individual patient data, along with advancements in technologies, such as gene editing technologies, including CRISPR, and the progression of cell and gene therapies. However, this region is heavily involved in strategic partnerships with many companies to expand expertise, accelerate development, and mitigate financial risks.

Whereas, the US is greatly facing major expansion due to the rising outsourcing trend of manufacturing advanced therapy medicinal products (ATMPs) to Contract Development and Manufacturing Organizations (CDMOs), and an increase in clinical trials for advanced therapies with a novel and robust pipeline of treatments.

For instance,

•  In May 2025, Azenta Life Sciences and Form Bio made a strategic partnership to advance AAV gene therapy development.

Canada is heavily involved in major investments in research and development (R&D) of advanced therapies, especially in cell and gene therapy, along with adaptable regulatory frameworks and rules from agencies that simplify the approval process, supporting innovation and commercialization.

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The Asia Pacific is expected to Grow Rapidly During the Forecast Period

Asia Pacific is anticipated to register rapid expansion in the upcoming years. By the contribution of several factors, like rising cases of chronic diseases such as cancer and heart conditions, are acting as major drivers for the advanced therapies in the biopharmaceutical medicine market growth. ASAP is also accelerating a surge of biologics and biosimilars development is driving the biopharmaceutical companies. Governments of ASAP countries and private leaders are broadly investing in R&D of advanced therapies is also boosting the market growth.

Although the advanced therapies in biopharmaceutical medicine market in China have a huge pool of pharmaceutical and biotechnology companies, which are increasingly involved in the development of numerous biologics, vaccines, biosimilars, and other important therapies, besides this, China’s government is widely encouraging research and development activities in the advancement of novel drug molecules used in many serious health conditions.

Wide range progression in clinical trials, development of different therapies in India, is propelling the advanced therapies in the biopharmaceutical medicine market. As well as increasing awareness about chronic disease with the adoption of advanced remedies in India, along with boosting collaborations with global companies by India is accelerating the overall market growth.

The Advanced Therapies in Biopharmaceutical Medicine Market: Segmentation Analysis

By therapy type analysis

The gene therapy segment dominated the market in 2024. The segment is driven by major investments from venture capital, pharmaceutical companies, and government bodies are impelling R&D, clinical trials, and the commercialization of gene therapies. Also, the breakthroughs in gene delivery technologies, such as viral and non-viral vectors, and genome editing technologies like CRISPR, are boosting the overall segment growth.

The CAR-T segment is estimated to grow at the fastest CAGR during 2025-2034. Around the globe, the escalating burden of cancer, especially hematological malignancies, with the rising number of approved CAR-T products and their evolving applications in diverse cancer types, like diffuse large B-cell lymphoma and multiple myeloma, is fueling the adoption of CAR-T and its expansion.

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Latest Developments in the CAR-T Segment

Company

Recent Drifts

PromiCell (March 2025)

Launched an accredited investor-only campaign to advance next-gen CAR T & TCR T cancer treatments

CARsgen Therapeutics (February 2025)

Introduced Zhuhai SB Xinchuang to escalate allogeneic CAR-T Cell products development in Mainland China

Leveragen (January 2025)

Partnered with Moonlight Bio to advance T cell therapies using proprietary fully human single-domain antibody technology

Vyriad, Inc. (November 2024)

Collaborated with Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies.

By application type analysis

The oncology segment dominated the advanced therapies in biopharmaceutical medicine market in 2024. Consistent growth in cancer cases, with significant investment in research and development of novel oncology drugs by numerous biopharmaceutical industries, including targeted therapies and immunotherapies to boost the immune system against cancer.

Whereas, the cardiovascular diseases segment will expand rapidly, due to the greater global burden of cardiovascular disease (CVD), like heart failure, heart attack, the restriction of traditional therapies, and the potential of advanced therapies like gene therapy and biologics to highlight unmet needs. Along with biologics, such as monoclonal antibodies and recombinant proteins, can be created to alter specific biological pathways involved in CVD. 

By product type analysis

The tissue-engineered products segment was dominant in the advanced therapies in biopharmaceutical medicine market in 2024. The segment is influenced by the growing demand for regenerative medicines, along with the increasing incidence of chronic and degenerative disorders. Also, the breakthroughs in tissue engineering technologies, like biomaterials, stem cell sourcing, tissue construct vascularization, and 3D bioprinting, are impelling the segment growth.

However, the combined ATMPs segment will grow rapidly, due to the boost in clinical pipelines and regulatory approvals, technological advancements in areas like gene editing and cell engineering, as well as cell-based therapies embedded in scaffolds, which are transforming through clinical trials, driving the segment growth.

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By distribution channel type analysis

The hospital pharmacies segment held the biggest share of the advanced therapies in biopharmaceutical medicine market in 2024. Due to rising demand for advanced therapies like biologics, immunotherapies, and targeted oncology drugs, which require specialized handling and administration in hospital pharmacies, this enhances patient care. Hospitals possess robust and advanced hospital pharmacies, with a major distribution of compounded drugs is assisting the segment expansion.

The online pharmacies segment is predicted to expand at a rapid CAGR because of escalating consumer preference for online purchases, advancements in technology, and the growth of personalized medicine. This segment is characterized by the convenience, availability, and affordable coupled with purchasing medications online. 

By end-user analysis

The hospital segment dominated the global advanced therapies in biopharmaceutical medicine market in 2024. Segment is propelled by the accelerating prevalence of chronic diseases, technological advancements in cell and gene therapies, and supportive government initiatives enhancing biomanufacturing and healthcare access. 

The clinics segment is anticipated to grow fastest during the forecast period. Widely impacting factors on the segment’s expansion are increasing demand for cell and gene therapies, coupled with advancements in related technologies. This expansion is further impelled by the growing number of clinical trials and regulatory approvals, especially for treatments targeting oncology, rare genetic disorders, and other complex diseases. 

Top Companies and Their Contributions to the Advanced Therapies in Biopharmaceutical Medicine Market

Company

Contributions & Offerings in Advanced Therapies

Pfizer Inc.

Partnered with BioNTech on mRNA technology for vaccines; advancing gene therapies for rare diseases like hemophilia and DMD.

Johnson & Johnson

Through Janssen, developing cell and gene therapies in oncology and rare diseases; invested in CAR-T and RNA technologies.

AbbVie Inc.

Focuses on gene therapy for neurological and retinal disorders; acquired Allergan to expand biopharma capabilities.

F. Hoffmann-La Roche

Active in cell therapy through subsidiary Genentech; advancing personalized medicine in oncology and ophthalmology.

Merck & Co. Inc.

Invests in viral vector technologies and immune cell engineering; collaborates on gene editing and regenerative therapies.

Eli Lilly and Co.

Expanding into gene therapy for diabetes and neurodegenerative diseases, acquired Prevail Therapeutics.

AstraZeneca Plc

Leveraging mRNA and gene editing for rare diseases and cancer; strong pipeline in cell-based immunotherapies.

Novartis AG

A pioneer in CAR-T (Kymriah), advancing gene therapies for spinal muscular atrophy (Zolgensma) and eye diseases.

Amgen Inc.

Focuses on genetic medicines and oncology-based biotherapeutics; uses viral vectors and RNA tech platforms.

Novo Nordisk AS

Investing in gene therapies for metabolic disorders; acquired Dicerna to expand RNAi capabilities for rare and chronic diseases.

Advanced Therapies in Biopharmaceutical Medicine Market Companies

•  Pfizer Inc.

•  Johnson & Johnson

•  AbbVie Inc.

•  F. Hoffmann-La Roche Ltd.

•  Merck & Co. Inc.

•  Eli Lilly and Co.

•  AstraZeneca Plc

•  Novartis AG

•  Amgen Inc

•  Novo Nordisk AS

•  Sanofi

•  Bristol-Myers Squibb Co

•  Regeneron Pharmaceuticals Inc.

•  GlaxoSmithKline Plc

•  Gilead Sciences Inc.

•  CSL Ltd.

•  Takeda Pharmaceutical Co. Ltd.

•  Moderna Inc.

•  Vertex Pharmaceuticals Inc.

•  Bayer AG

Browse More Insights of Towards Healthcare:

The global biopharmaceuticals Contract Research Organization (CRO) market is on a strong upward trajectory and is expected to generate substantial revenue growth, potentially reaching hundreds of millions over the forecast period from 2025 to 2034.

The global biopharmaceutical third-party logistics market is valued at USD 143.44 billion in 2024, expected to grow to USD 152.93 billion in 2025, and is projected to reach approximately USD 276.24 billion by 2034.

The U.S. biopharmaceutical third-party logistics market is valued at USD 56.77 billion in 2024, growing to USD 61.08 billion in 2025, and is anticipated to reach around USD 118.12 billion by 2034, expanding at a CAGR of 7.6% between 2025 and 2034.

The global antibody therapy market is estimated at USD 278.25 billion in 2024, projected to increase to USD 314.64 billion in 2025, and expected to reach approximately USD 951.24 billion by 2034, growing at a CAGR of 13.08% from 2025 to 2034.

The global next-generation therapies market is experiencing rapid expansion and is poised for substantial revenue growth, with projections indicating significant value generation in the hundreds of millions during the 2025 to 2034 forecast period.

The global AAV (Adeno-Associated Virus) gene therapy market is undergoing significant growth, with projections suggesting revenue will reach several hundred million dollars by the end of the forecast period from 2025 to 2034.

The global mechanobiology-centered therapy market is emerging as a promising field and is expected to witness substantial revenue growth throughout the forecast period from 2024 to 2034.

The global viral vector gene therapy market is gaining strong momentum, with expectations of significant revenue expansion from 2025 through 2034.

The global CAR-T cell therapy isolator market is on a robust growth path, anticipated to achieve substantial revenue gains, potentially reaching hundreds of millions between 2025 and 2034.

The exosome cell and gene therapy market is emerging as a high-potential segment due to its growing application in the treatment of chronic conditions, with oncology being one of its major therapeutic areas.

How is the Advanced Therapies in Biopharmaceutical Medicine Market Progressing?

•  In July 2025, Vie Ventures, a new life sciences venture capital firm, launched advanced next-generation therapies for autoimmune diseases.

•  In May 2025, Stylus Medicine, a biotech startup, was introduced with $85m to advance in vivo gene editing therapies.

•  In May 2025, BIH partnered with BioLabs to launch a Clinical Incubator for Biomedical Translation of Advanced Therapy Medicinal Products (ATMPs).

•  In April 2025, Thermo Fisher Scientific inaugurated its Advanced Therapies Collaboration Center (ATxCC) in San Diego to support the expansion of cell therapy development.

•  In January 2025, Lutris Pharma, a clinical-stage biopharmaceutical company, secured a $30 million financing to advance the development of LUT014, an innovative topically applied gel aimed at eliminating EGFRi-induced rashes.

Advanced Therapies in Biopharmaceutical Medicine Market Segmentation

By Therapy Type

•  Gene Therapy

•  Cell Therapy

•  Stem Cell Therapy

•  Non-Stem Cell Therapy

•  CAR-T Therapy

•  Tissue-Engineered Products

•  Others (e.g., combined ATMPs, biodegradable scaffolds)

By Application

•  Oncology

•  Cardiovascular Diseases

•  Musculoskeletal Disorders

•  Dermatology

•  Others (e.g., ophthalmology, neurology, immunology)

By Product Type

•  Tissue-Engineered Products

•  Somatic Cell Therapy Products

•  Combined ATMPs

•  Others 

By Distribution Channel

•  Hospital Pharmacies

•  Retail Pharmacies

•  Online Pharmacies

•  Others

By End-User

•  Hospitals

•  Clinics

•  Others (e.g., research institutions, home care)

By Region

•  North America

•  U.S.

•  Canada

•  Asia Pacific

•  China

•  Japan

•  India

•  South Korea

•  Thailand

•  Europe

•  Germany

•  UK

•  France

•  Italy

•  Spain

•  Sweden

•  Denmark

•  Norway

•  Latin America

•  Brazil

•  Mexico

•  Argentina

•  Middle East and Africa (MEA)

•  South Africa

•  UAE

•  Saudi Arabia

•  Kuwait

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