Global Advanced Therapy Medicinal Products CDMO Market Report: By Product (Gene Therapy, Cell Therapy, Tissue Engineered, and Others) By Phase (Phase I, Phase II, Phase III, and Phase IV), and Region (North America, Europe, Asia-Pacific, Latin America, Middle-East and Africa) Global Industry Analysis, Size, Share, Growth, Trends, Regional Analysis, Competitor Analysis and Forecast 2023-2031.
Global Advanced Therapy Medicinal Products CDMO market is predicted to reach approximately USD 17.65 billion by 2031, at a CAGR of 15.96% from 2022 to 2031.
The Global Advanced Therapy Medicinal Products (ATMP) Contract Development and Manufacturing Organization (CDMO) market has witnessed significant growth in recent years, reflecting the expanding landscape of advanced therapies in the pharmaceutical and biotechnology sectors. Advanced Therapy Medicinal Products encompass cell and gene therapies, offering innovative solutions for previously incurable diseases. These therapies involve the manipulation of living cells or genetic material to treat or prevent diseases at the genetic level, showcasing a paradigm shift in healthcare. The ATMP CDMO market plays a pivotal role in supporting the development and manufacturing of these ground-breaking therapies by providing specialized services such as process development, manufacturing, and analytical testing.
The market for ATMP CDMOs is expanding as a result of pharmaceutical companies outsourcing their manufacturing processes to specialised CDMOs in response to the growing demand for advanced therapies. These companies provide the infrastructure, know-how, and regulatory compliance required for the intricate and strictly regulated manufacturing of cutting-edge treatments. A wide variety of CDMOs serving various stages of the ATMP development lifecycle, from early-stage process development to large-scale commercial manufacturing, define the market.
Global Advanced Therapy Medicinal Products CDMO report scope and segmentation.
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Report Attribute |
Details |
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Estimated Market Value (2022) |
USD 4.65 billion |
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Projected Market Value (2031) |
USD 17.65 billion |
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Base Year |
2022 |
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Forecast Years |
2023 – 2031 |
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Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment- Based on By Product, by Phase, by Indication & Region. |
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Segments Covered |
By Product, by Phase, by Indication & By Region. |
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Forecast Units |
Value (USD Billion or Million), and Volume (Units) |
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Quantitative Units |
Revenue in USD million/billion and CAGR from 2023 to 2031. |
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Regions Covered |
North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. |
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Countries Covered |
U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Argentina, GCC Countries, and South Africa, among others. |
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Report Coverage |
Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, market attractiveness analysis by segments and region, company market share analysis. |
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Delivery Format |
Delivered as an attached PDF and Excel through email, according to the purchase option. |
Global Advanced Therapy Medicinal Products CDMO dynamics
The need for novel therapeutic strategies has increased due to the rising incidence of complicated and previously incurable diseases, especially those involving cell and gene therapies. Due to the increased demand, biotechnology and pharmaceutical companies are collaborating with specialised ATMP CDMOs to take advantage of their experience navigating the complex manufacturing processes involved in producing these cutting-edge therapies.
The industry dynamics are further influenced by the expanding landscape of clinical trials for ATMPs, as regulatory agencies continue to provide frameworks for the development and commercialization of these ground-breaking treatments. The need for scalable and cost-effective manufacturing solutions has led to a rise in strategic collaborations and partnerships between pharmaceutical companies and CDMOs, fostering a dynamic and collaborative ecosystem. These partnerships aim to optimize the efficiency of ATMP development by leveraging the complementary strengths of each party involved.
Global Advanced Therapy Medicinal Products CDMO drivers
The global ATMP CDMO market is significantly driven by the rising incidence of complex diseases, such as cancers and different genetic disorders, as well as an increase in the number of unmet medical needs. Novel treatment modalities, such as cell and gene therapies, are available for conditions for which there are few or no effective therapeutic options. Pharmaceutical companies are enlisting ATMP CDMOs to leverage their specialised manufacturing capabilities in response to the growing demand for innovative therapies that address unmet needs, which is driving market growth.
Continuous advancements in technology and manufacturing processes within the ATMP space contribute as a driving force for the CDMO market. Technological innovations enhance the efficiency, scalability, and cost-effectiveness of manufacturing advanced therapies. This includes improvements in vector design, gene editing technologies, and process automation, enabling CDMOs to meet the increasing demand for large-scale production. The integration of cutting-edge technologies attracts pharmaceutical companies seeking state-of-the-art facilities and expertise for the development and production of advanced therapies, positioning the ATMP CDMO market at the forefront of innovation.
Restraints:
The ATMP CDMO market faces challenges associated with the complex regulatory landscape governing the development and manufacturing of advanced therapies. Stringent quality standards and regulatory requirements pose significant barriers, requiring substantial investments in compliance and validation processes. This complexity can result in extended timelines and increased costs, impacting the overall efficiency of ATMP development and hindering market growth.
The market participants are limited by the significant initial capital needs for the establishment and upkeep of cutting-edge manufacturing facilities for ATMPs. Significant upfront costs are associated with the specialised infrastructure and equipment required for the production of gene and cell therapies. Furthermore, there are difficulties that could restrict the scalability of operations and impede market expansion due to the intrinsic complexity of the manufacturing processes for these therapies, such as maintaining cell viability during production and guaranteeing consistent product quality.
Opportunities:
The increasing number of clinical trials for cell and gene therapies presents a substantial opportunity for the ATMP CDMO market. As more therapies progress through the development pipeline, CDMOs stand to benefit from the expanding demand for manufacturing services. Moreover, the exploration of new therapeutic applications beyond oncology, such as in rare diseases and autoimmune disorders, opens avenues for CDMOs to diversify their service offerings and capture emerging market opportunities.
Segment Overview
The ATMP market encompasses several product types, including gene therapy, cell therapy, tissue-engineered products, and other emerging modalities. Gene therapy involves the introduction, deletion, or replacement of genetic material to treat or prevent diseases at the genetic level. Cell therapy focuses on using living cells, often modified or engineered, for therapeutic purposes. Tissue-engineered products involve the creation of biological substitutes to repair or replace damaged tissues.
The developmental phases of advanced therapies are categorized into Phase I, Phase II, Phase III, and Phase IV. Phase I involves initial human testing to assess safety and dosage, Phase II explores efficacy in a larger sample, Phase III evaluates safety and efficacy in a broader patient population, and Phase IV involves post-marketing surveillance. Understanding the developmental phase of each therapy is crucial for assessing its progression toward commercialization and widespread clinical use.
The therapeutic indications for advanced therapies span a wide range of medical fields. These include oncology, addressing various forms of cancer; cardiology, focusing on heart-related conditions; central nervous system applications for neurological disorders; musculoskeletal treatments for bone and muscle-related issues; infectious disease interventions; dermatology for skin-related conditions; endocrine, metabolic, and genetic therapies; immunology & inflammation targeting immune-related disorders; ophthalmology for eye-related conditions, and other indications that may emerge as the field evolves. Each indication reflects the diverse applications of advanced therapies in addressing a spectrum of diseases and medical challenges.
Global Advanced Therapy Medicinal Products CDMO Overview by Region
North America stands as a major hub for ATMP development and manufacturing, driven by a robust biotechnology sector, significant research and development activities, and supportive regulatory frameworks. The region's leadership is underscored by a high concentration of pharmaceutical companies and Contract Development and Manufacturing Organizations (CDMOs) specializing in advanced therapies, particularly in the United States.
Europe is not far behind, with the EU creating an environment that is conducive to ATMP innovation through joint research projects and regulatory actions. An important regulatory pathway for ATMP approvals is provided by the European Medicines Agency (EMA). As major players in the ATMP market, nations like the UK, Germany, and Switzerland are home to several manufacturing facilities and clinical trials.
Due to its rapidly developing healthcare infrastructure, expanding patient base, and rising investments in life sciences, Asia-Pacific offers significant growth potential. Research and development on ATMPs has advanced significantly in nations like China, Japan, and South Korea. Additionally, favourable regulatory reforms in Japan have facilitated expedited approval processes for regenerative medicine products, further propelling the market.
Global Advanced Therapy Medicinal Products CDMO market competitive landscape
Key industry players are strategically positioning themselves to capitalize on the burgeoning demand for advanced therapies, such as gene and cell therapies, that are revolutionizing the treatment landscape.
Prominent pharmaceutical companies, including Novartis, Gilead Sciences, and Spark Therapeutics, have established themselves as frontrunners in the ATMP market, leveraging their expertise in research, development, and commercialization. These companies often engage in strategic collaborations and partnerships with CDMOs to enhance their manufacturing capabilities and expand their portfolios.
CDMOs play a crucial role in the competitive landscape, offering specialized services in process development, manufacturing, and analytical testing for advanced therapies. Leaders in this space, such as Lonza Group, Catalent, and Thermo Fisher Scientific, provide end-to-end solutions to pharmaceutical companies, addressing the complex manufacturing requirements of ATMPs. The competitive dynamics involve CDMOs continuously investing in infrastructure, technological capabilities, and regulatory compliance to meet the evolving needs of the industry.
Global Advanced Therapy Medicinal Products CDMO Recent Developments
Scope of global Advanced Therapy Medicinal Products CDMO report
Global Advanced Therapy Medicinal Products CDMO report segmentation
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ATTRIBUTE |
DETAILS |
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By Product |
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By Phase |
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By Indication |
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By Geography |
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Customization Scope |
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Pricing |
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Objectives of the Study
The objectives of the study are summarized in 5 stages. They are as mentioned below:
Research Methodology
Our research methodology has always been the key differentiating reason which sets us apart in comparison from the competing organizations in the industry. Our organization believes in consistency along with quality and establishing a new level with every new report we generate; our methods are acclaimed and the data/information inside the report is coveted. Our research methodology involves a combination of primary and secondary research methods. Data procurement is one of the most extensive stages in our research process. Our organization helps in assisting the clients to find the opportunities by examining the market across the globe coupled with providing economic statistics for each and every region. The reports generated and published are based on primary & secondary research. In secondary research, we gather data for global Market through white papers, case studies, blogs, reference customers, news, articles, press releases, white papers, and research studies. We also have our paid data applications which includes hoovers, Bloomberg business week, Avention, and others.
Data Collection
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Primary Research
After the secondary research process, we initiate the primary research phase in which we interact with companies operating within the market space. We interact with related industries to understand the factors that can drive or hamper a market. Exhaustive primary interviews are conducted. Various sources from both the supply and demand sides are interviewed to obtain qualitative and quantitative information for a report which includes suppliers, product providers, domain experts, CEOs, vice presidents, marketing & sales directors, Type & innovation directors, and related key executives from various key companies to ensure a holistic and unbiased picture of the market.
Secondary Research
A secondary research process is conducted to identify and collect information useful for the extensive, technical, market-oriented, and comprehensive study of the market. Secondary sources include published market studies, competitive information, white papers, analyst reports, government agencies, industry and trade associations, media sources, chambers of commerce, newsletters, trade publications, magazines, Bloomberg BusinessWeek, Factiva, D&B, annual reports, company house documents, investor presentations, articles, journals, blogs, and SEC filings of companies, newspapers, and so on. We have assigned weights to these parameters and quantified their market impacts using the weighted average analysis to derive the expected market growth rate.
Top-Down Approach & Bottom-Up Approach
In the top – down approach, the Global Batteries for Solar Energy Storage Market was further divided into various segments on the basis of the percentage share of each segment. This approach helped in arriving at the market size of each segment globally. The segments market size was further broken down in the regional market size of each segment and sub-segments. The sub-segments were further broken down to country level market. The market size arrived using this approach was then crosschecked with the market size arrived by using bottom-up approach.
In the bottom-up approach, we arrived at the country market size by identifying the revenues and market shares of the key market players. The country market sizes then were added up to arrive at regional market size of the decorated apparel, which eventually added up to arrive at global market size.
This is one of the most reliable methods as the information is directly obtained from the key players in the market and is based on the primary interviews from the key opinion leaders associated with the firms considered in the research. Furthermore, the data obtained from the company sources and the primary respondents was validated through secondary sources including government publications and Bloomberg.
Market Analysis & size Estimation
Post the data mining stage, we gather our findings and analyze them, filtering out relevant insights. These are evaluated across research teams and industry experts. All this data is collected and evaluated by our analysts. The key players in the industry or markets are identified through extensive primary and secondary research. All percentage share splits, and breakdowns have been determined using secondary sources and verified through primary sources. The market size, in terms of value and volume, is determined through primary and secondary research processes, and forecasting models including the time series model, econometric model, judgmental forecasting model, the Delphi method, among Flywheel Energy Storage. Gathered information for market analysis, competitive landscape, growth trends, product development, and pricing trends is fed into the model and analyzed simultaneously.
Quality Checking & Final Review
The analysis done by the research team is further reviewed to check for the accuracy of the data provided to ensure the clients’ requirements. This approach provides essential checks and balances which facilitate the production of quality data. This Type of revision was done in two phases for the authenticity of the data and negligible errors in the report. After quality checking, the report is reviewed to look after the presentation, Type and to recheck if all the requirements of the clients were addressed.
