Overview


According to FutureWise analysis the market for advanced therapy medicinal products is expected to register a CAGR of 13.40% from 2023-2031.

Advanced therapy medicinal products (ATMPs) are human therapies based on genes, tissues, or cells. Advanced therapy medicinal products represent a new class of biological medicines. The European regulation has categorized ATMPs into three types: gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered medicinal products. These therapies are expected to benefit health and substantially impact the pharmaceutical budget. Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. If one of these types incorporates a medical device, the therapy is defined as a combined advanced therapy medicinal product. The specificity and intricacy of these innovative drugs required a total reorganization of hospital and pharmaceutical processes, from patient eligibility to drug administration. Indeed, increased interaction and collaboration between healthcare professionals are essential to guarantee these innovative medicines' quality and safety.

The first advanced therapy medicinal product (ATMP) was approved in the European Union in 2009 by the authorization of ChondroCelect, a tissue-engineered product designed for the treatment of cartilage defects. In the United States, the first approved ATMP came out one year later with PROVENGE, a somatic cell therapy for the treatment of prostate cancer. The first authorized gene therapy was launched in 2012 when Glybera achieved marketing authorization in the E.U. (European Medicines Agency, 2012).

FutureWise Market Research has published a report that provides an insightful analysis advanced therapy medicinal products market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. According to the analysis conducted by FutureWise research analysts, advanced therapy medicinal products market is estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organisation to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base.

  • Uniqure
  • Pfizer
  • Bluebird Bio Inc.
  • BioMarin Pharmaceutical
  • Novartis AG
  • GE Healthcare
  • Shire Biotechnology
  • Kite Pharma
  • Spark Therapeutics, Inc.
  • Celgene Corporation
  • Gilead Lifesciences, Inc.
  • Kolon TissueGene, Inc.
  • JCR Pharmaceuticals Co., Ltd.
  • MEDIPOST
  • Vericel Corporation
  • PHARMICELL Co., Ltd
  • Organogenesis Inc.

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent Developments in Advanced Therapy Medicinal Products Market:

  • In April 2022- The FDA broadened its recommendations for advanced biological products and offered further information to developers and manufacturers, with draught guidance for the development, manufacture, and control of chimeric antigen receptor (CAR) T cell products.

  • In March 2022- Rentschler Biopharma and Vetter Unveil Xpert Alliance. This strategic collaboration delivers practical solutions to address clients' changing and developing needs in the area of complex biopharmaceuticals.

The rising incidences of chronic and genetic diseases continue to grow globally, and the focus on finding innovative and effective treatments has increased, propelling the advanced therapy medicinal products growth market. With conventional therapies often providing inadequate outcomes or limited disease management, there is a crucial need for advanced treatments. ATMPs, including gene therapies, cell-based therapies, and tissue engineering, have the potential to revolutionize healthcare by addressing the underlying causes of these conditions. Moreover, collaborations and partnerships in advanced therapy medicinal products (ATMPs) provide a unique opportunity to leverage diverse expertise, resources, and capabilities. By bringing together the collective knowledge and experience of research institutions, biotechnology companies, and pharmaceutical industries, these collaborations may foster cooperation that facilitates the growth and commercialization of advanced therapy medicinal products market. Furthermore, the high development costs associated with ATMPs significantly restrain the adoption and accessibility of these advanced therapy medicinal products market. The complexity of research and development in this field involves extensive preclinical and clinical trials, stringent regulatory compliance, and specialized manufacturing processes personalized to individual patients. Smaller biotechnology companies and startups find it difficult to invest in advanced therapy medicinal product development due to the high costs involved, which could be burdensome.

By Products

  • Somatic Cell Therapy Medicinal Products
  • Tissue Engineered Medicinal Products
  • Gene Therapy Medicinal Products

By Disease

  • Alzheimer’s
  • Cystic Fibrosis
  • Muscular Dystrophies
  • Hemophilia

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered highest share in the market in 2022. Owing to the favorable regulatory environment, increased product launches, and growing investments in research and development are the major factors contributing to the region's dominance in the advanced therapy medicinal products market. Also, the rapidly increasing clinical trials in this new treatment modality in the U.S. supplement regional growth further driving the market growth. For instance, in July 2021, Kriya Therapeutics announced an investment of USD 100 million in a Series B funding round. The funding aims to advance its platform for designing and developing next-generation gene therapies. Therefore, the factors mentioned above are expected to boost market growth during the projection period in the region.

  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Advanced Therapy Medicinal Products Market By Products, By Disease and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders

  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study

  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Advanced Therapy Medicinal Products Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Advanced Therapy Medicinal Products Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Advanced Therapy Medicinal Products Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Advanced Therapy Medicinal Products Market, By Products Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Somatic Cell Therapy Medicinal Products
        2. Tissue Engineered Medicinal Products
        3. Gene Therapy Medicinal Products

  • 8.   Advanced Therapy Medicinal Products Market, By Disease Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Alzheimer’s
        2. Cystic Fibrosis
        3. Muscular Dystrophies
        4. Hemophilia

  • 9.   North America Advanced Therapy Medicinal Products Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 10.   Latin America Advanced Therapy Medicinal Products Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 11.   Europe Advanced Therapy Medicinal Products Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 12.   Asia Pacific Advanced Therapy Medicinal Products Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 13.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 14.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 15.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. Uniqure
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Pfizer
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Bluebird Bio Inc.
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. BioMarin Pharmaceutical
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Novartis AG
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. GE Healthcare
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Shire Biotechnology
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Kite Pharma
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Spark Therapeutics, Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Celgene Corporation
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11. Gilead Lifesciences, Inc.
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12. Kolon TissueGene, Inc.
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13. JCR Pharmaceuticals Co., Ltd.
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview
        14. MEDIPOST
         14.1. Company Overview
         14.2. Product Portfolio
         14.3. SWOT Analysis
         14.4. Financial Overview
         14.5. Strategic Overview
        15. Vericel Corporation
         15.1. Company Overview
         15.2. Product Portfolio
         15.3. SWOT Analysis
         15.4. Financial Overview
         15.5. Strategic Overview
        16. PHARMICELL Co., Ltd
         16.1. Company Overview
         16.2. Product Portfolio
         16.3. SWOT Analysis
         16.4. Financial Overview
         16.5. Strategic Overview
        17. Organogenesis Inc.
         17.1. Company Overview
         17.2. Product Portfolio
         17.3. SWOT Analysis
         17.4. Financial Overview
         17.5. Strategic Overview

  • 16.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 17.   FutureWise SME Key Takeaway Points for Client

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