첨단 치료제(ATMP) 시장 보고서 : 동향, 예측, 경쟁 분석(-2030년)

Advanced Therapy Medicinal Products Trends and Forecast

The future of the global advanced therapy medicinal products market looks promising with opportunities in the cell therapy, CAR-T therapy, gene therapy, and tissue engineered product markets. The global advanced therapy medicinal products market is expected to reach an estimated $19.9 billion by 2030 with a CAGR of 13.5% from 2024 to 2030. The major drivers for this market are rising healthcare spending, increasing prevalence of chronic diseases, and favorable regulatory environment and growing government support.

Within this market, tissue engineered product will remain the largest segment due to its increasing adoption in wound healing and regenerative medicine applications.

North America will remain the largest segment due to high prevalence of chronic diseases, such as cancer, cardiovascular diseases, and neurodegenerative diseases.

Emerging Trends in the Advanced Therapy Medicinal Products Market

There are several key trends that are reshaping the landscape of advanced medical treatments, leading to an evolution of the advanced therapy medicinal products (ATMPs) market. These include changes in technology, regulations and research priorities, which shape the development and adoption of ATMPs.

• Integration of AI and Machine Learning: It is a growing trend to use artificial intelligence (AI) and machine learning for developing and optimizing ATMPs. This is where AI is used to analyze complex biological data, identify potential targets for therapy, streamline development processes among others. The integration ensures accuracy in treatment while speeding up time-to-market for new drugs.
• Personalised Medicine Expansion: Personalised medicine is dominating the ATMP market. Genomics and biotechnology are becoming more advanced making it possible to create therapies for people with different genes. The entire plan is focused on ensuring that treatment is improved with minimal side effects in order to develop effective therapeutic agents.
• Innovations Driving Regenerative Medicine: Tissue engineering, stem cell therapy and other facets of regenerative medicine are rapidly advancing today. From degenerative diseases to traumatic injuries, these advancements offer new approaches for dealing with medical conditions. The area of regenerative medicine has created opportunities, which have in turn increased the scope of ATMPs.
• Rise in Regulatory Backing: There is now greater support for developing and approving ATMPs by regulatory bodies around the world. Easy approval methods and updated guidelines assist in speeding up the introduction of new therapies into the market. This signifies a worldwide interest in encouraging inventions as well as improving patient access to superior treatments.

The field of advanced therapies is being reshaped by emerging trends in the ATMP market such as AI integration; regenerative medicine innovations; personalized medicine and regulatory support among others. Ultimately these trends are improving development, effectiveness of ATMPs that leads to better patient outcomes thus driving growth in this sector.

Recent Developments in the Advanced Therapy Medicinal Products Market

Recently, there have been significant developments that are influencing the evolution of the advanced therapy medicinal products (ATMPs) market. This transformation is driven by innovations in gene and cell therapies as well as technological breakthroughs and regulatory advancements. Thus, these strides not only increase therapeutic options but also improve their affordability and efficiency, thus shaping the global markets trends.

• Approval of Novel Gene Therapies: Recent approvals of novel gene therapies have had a marked effect on the ATMP market. These treatments offer new possibilities for treating genetic conditions once deemed incurable. For instance, where gene therapy has been approved for Zolgensma for spinal muscular atrophy, this suggests that gene therapy can target rare or complex disorders and other similar groundbreaking initiatives will follow suit.
• Advances in CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy has experienced notable advances with newer therapies being introduced and existing ones expanded indications. For example, Kymriah and Yescarta are some of such treatments which have shown great efficacy against certain forms of cancer thus improving treatment options hence growth in the oncology segment of ATMP market.
• Expansion of Regulatory Frameworks: A development and refinement of regulatory frameworks has allowed the progress and approval of ATMPs. Regulatory agencies are creating fast-track approval procedures and providing clearer instructions, thus simplifying the path from research to market. These developments are necessary for supporting innovation and commercialization of advanced therapies.
• Integration of Personalized Medicine: The integration of personalized medicine approaches in ATMPs is on a fast track. Technology such as next-generation sequencing is now enabling tailored therapies that are based on one's own genetic profile. This customization improves treatment efficacy, reflecting the increasing trend towards personalized healthcare.

The ATMP market is being shaped significantly by recent developments that include advancements in gene and cell therapies, improvements in regulations governing the sector, and increased investment. These occurrences are expanding the treatment options available to patients, improving patient outcomes and fueling market growth thereby setting a platform for more innovation and advancement of ATMPs.

Strategic Growth Opportunities for Advanced Therapy Medicinal Products Market

There are several strategic growth opportunities across different applications within advanced therapy medicinal products (ATMPs) market. Technological advancements, increasing patient needs and supporting regulatory environments provide these opportunities. Market expansion can be driven through exploring these areas that can lead to future ground breaking treatments.

• Expansion of Oncology Treatments: The oncology segment of the ATMP market offers significant growth prospects. CAR-T innovations and other cell-based therapies have presented new treatment alternatives for non-responsive cancer ailments. Expanding these therapies among wide range of patients as well as diverse cancers represents one large opportunity for growth.
• Rare Disease Therapies Development: Developing therapies for rare and orphan diseases is a major area of growth. Gene therapies for specific genetic conditions are becoming popular and other advanced treatments. Apart from addressing medical needs that have not been met, this approach also attracts huge investments as well as regulatory support.
• Advances in Regenerative Medicine: The field of regenerative medicine is rapidly evolving through stem cell treatments and tissue engineering. A lot of room for growth exists in repairing or replacing damaged tissues or organs. Inventions can however deliver new remedies to heart ailments-spine injuries-neurodegenerative states.
• Merging Digital Health Technologies: The use of ATMPs together with digital health technologies could be an opportunity for growth. By employing these digital tools in the monitoring patients, collecting data and optimizing treatment methods, it is possible to enhance the effectiveness of these therapeutic options. This will add enhanced solutions like personalized treatments methods along with improved patient management into this combination.

Strategic growth opportunities in the ATMP market include advancements in oncology treatments, rare disease therapies, regenerative medicine, digital health integration and expansion into emerging markets. These can propel the market to significant growth. Through these opportunities, development of innovative therapies and improving patient care globally is possible.

Advanced Therapy Medicinal Products Market Driver and Challenges

The development and growth of the advanced therapy medicinal products (ATMPs) market are influenced by several drivers and challenges. These include technological advances, regulatory support as well as increased patients' demand respectively. On one hand; increased costs high regulations and complex manufacturing processes remain top challenges regarding this area. To successfully navigate the market therefore, it is critical to understand these issues.

The factors responsible for driving the advanced therapy medicinal products market include:

1. Technological Advancements: Gene editing, cell therapy and regenerative medicine have acted as a major driver for ATMP market. In terms of treatment of incurable diseases novel technologies including CRISPR gene editing tool or CAR-T cells usage represent new achievements in medical sciences. Consequently, their reach has been broadened enhancing their efficiency for advanced therapies themselves.

2. Regulatory Support: The growth and approval of ATMPs are being facilitated by supportive regulatory environments. Accelerated approval processes are being implemented by regulatory agencies as well as clearer guidelines that provide a clear path from research to commercialization. It is important to note that the innovation and market expansion depend on this regulation support.

3. Increasing Patient Demand: Market expansion is driven by increasing awareness and demand for advanced therapies. Treatment options need to be personalized, effective and tailored mainly for patients with complex rare diseases who seek healthcare services. This demand continues to push the ATMP sector towards further research & development.

Challenges in the advanced therapy medicinal products market are:

1. High Costs: One of the challenges in the development and production of ATMPs is their high cost. These therapies are intricate and costly to research and produce, thus limiting access to them and impeding market growth. For broader adoption as well as sustainability it is important to address cost concerns.

2. Regulatory Hurdles: Navigating through ATMP regulatory frameworks can be complex as well as time-consuming. This has been despite establishment of supportive legal frameworks; however, stringent requirements have made it hard for these companies in obtaining approvals. Successful entry into the market necessitates a close management of all regulatory processes by these firms.

3. Manufacturing Complexities: The manufacturing process for ATMPs involves intricate procedures and quality control steps. Maintaining consistent product quality and scalability can prove challenging leading to inefficiency in production and high costs. Overcoming these challenges is important if we want to meet the demands of the market while ensuring that our products remain reliable.

Technological advancements, increasing patient demand, regulatory support among others are some of the drivers influencing advanced therapy medicinal products (ATMPS) market while other challenges include high costs, regulatory hurdles, manufacturing complexities among others. Drivers like this require being tackled alongside such obstacles so that more innovation can take place within this field thereby expanding its market growth rate whereas making sure patents receive better actuation towards advanced medical care facilities.

List of Advanced Therapy Medicinal Products Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies advanced therapy medicinal products companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the advanced therapy medicinal products companies profiled in this report include-

• Spark Therapeutics
• Bluebird Bio
• Novartis
• Uniqure
• Celgene Corporation
• Gilead Lifesciences
• Kolon Tissue gene
• JCR Pharmaceuticals
• Medipost
• Vericel Corporation

Advanced Therapy Medicinal Products by Segment

The study includes a forecast for the global advanced therapy medicinal products by product and region.

Advanced Therapy Medicinal Products Market by Product [Analysis by Value from 2018 to 2030]:

• Cell Therapy
• CAR-T Therapy
• Gene Therapy
• Tissue Engineered Product

Advanced Therapy Medicinal Products Market by Region [Analysis by Value from 2018 to 2030]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Advanced Therapy Medicinal Products Market

Advanced therapy medicinal products market is changing significantly across the globe as a result of developments in gene and cell therapies, as well as regenerative medicine. These transformations are determining the shape of medical treatments that concentrate on individualized treatments, better performance, and wider reachability. United States, China, Germany, India and Japan are the leading countries in this regard who have contributed differently to grow and change the advanced therapy medicinal products market.

• United States: In America, there have been significant advancements in ATMPs with emphasis on acceptance and commercialization of genes as well as cell therapies. FDA has recently certified a number of high-profile genetic disorder and cancer treatments resulting to more inventions and growth in the sector. New guidelines setting up and funding initiatives are facilitating researches in this area too.
• China: With considerable investments made towards CRISPR gene editing technology development alongside progressing clinical trials for cellular based therapies, China is quickly making headways into ATMPs. Thus advanced therapies have been developed more quickly both through policy changes by Chinese government as well as funding from it thereby transforming it into one of key players within global market.
• Germany: Germany has strengthened its position in the market for Advanced Therapy Medicinal Products (ATMPs) by developing regenerative medicine and stem cell research. For example, the establishment of specialized centers for cell and gene therapy research is promoting creativity and collaboration among the scientists. Moreover, Germany's regulatory infrastructure is changing to allow safe integration of ATMPs into clinical practice.
• India: In India, the ATMP market is expanding with increasing focus on developing affordable and accessible gene and cell therapies. In addition, emerging biotechnological advancements as well as supportive government policies are pushing for expansion. Furthermore, Indian companies collaborate internationally so as to advance research and bring new therapies to market thereby contributing to global ATMP developments.
• Japan: Japan is leading in regenerative medicine with notable progress in stem cell therapies and gene editing. The Japanese government has made it easy to approve ATMPs thus encouraging innovation through investment communities. Besides that Japan is now focusing on bringing advanced therapies directly into mainstream healthcare services hence improving choices for patients.

Features of the Global Advanced Therapy Medicinal Products Market

Market Size Estimates: Advanced therapy medicinal products market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.

Segmentation Analysis: Advanced therapy medicinal products size by product and region in terms of value ($B).

Regional Analysis: Advanced therapy medicinal products market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different products and regions for the mucopolysaccharidosis treatment market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the advanced therapy medicinal products market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

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FAQ

Q.1 What is the advanced therapy medicinal products market size?

Answer: The global advanced therapy medicinal products market is expected to reach an estimated $19.9 billion by 2030.

Q.2 What is the growth forecast for advanced therapy medicinal products market?

Answer: The global advanced therapy medicinal products market is expected to grow with a CAGR of 13.5% from 2024 to 2030.

Q.3 What are the major drivers influencing the growth of the advanced therapy medicinal products market?

Answer: The major drivers for this market are rising healthcare spending, increasing prevalence of chronic diseases and favorable regulatory environment and growing government support.

Q4. What are the major segments for advanced therapy medicinal products market?

Answer: The future of the advanced therapy medicinal products market looks promising with opportunities in the cell therapy, CAR-T therapy, gene therapy, and tissue engineered product markets.

Q5. Who are the key advanced therapy medicinal products market companies?

Answer: Some of the key advanced therapy medicinal products companies are as follows:

• Spark Therapeutics
• Bluebird Bio
• Novartis
• Uniqure
• Celgene Corporation
• Gilead Lifesciences
• Kolon Tissue gene
• JCR Pharmaceuticals
• Medipost
• Vericel Corporation

Q6. In advanced therapy medicinal products market, which region is expected to be the largest in next 5 years?

Answer: North America will remain the largest segment due to high prevalence of chronic diseases, such as cancer, cardiovascular diseases, and neurodegenerative diseases.

Q.7 Do we receive customization in this report?

Answer: Yes, Lucintel provides 10% customization without any additional cost.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the advanced therapy medicinal products market by product (cell therapy, CAR-T therapy, gene therapy, and tissue engineered product), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?
• Market Report

Table of Contents

1. Executive Summary

2. Global Advanced Therapy Medicinal Products Market : Market Dynamics

• 2.1: Introduction, Background, and Classifications
• 2.2: Supply Chain
• 2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2018 to 2030

• 3.1. Macroeconomic Trends (2018-2023) and Forecast (2024-2030)
• 3.2. Global Advanced Therapy Medicinal Products Market Trends (2018-2023) and Forecast (2024-2030)
• 3.3: Global Advanced Therapy Medicinal Products Market by Product
  • 3.3.1: Cell Therapy
  • 3.3.2: CAR-T Therapy
  • 3.3.3: Gene Therapy
  • 3.3.4: Tissue Engineered Product

4. Market Trends and Forecast Analysis by Region from 2018 to 2030

• 4.1: Global Advanced Therapy Medicinal Products Market by Region
• 4.2: North American Advanced Therapy Medicinal Products Market
  • 4.2.1: North American Advanced Therapy Medicinal Products Market by Product: Cell Therapy, CAR-T Therapy, Gene Therapy, and Tissue Engineered Product
• 4.3: European Advanced Therapy Medicinal Products Market
  • 4.3.1: European Advanced Therapy Medicinal Products Market by Product: Cell Therapy, CAR-T Therapy, Gene Therapy, and Tissue Engineered Product
• 4.4: APAC Advanced Therapy Medicinal Products Market
  • 4.4.1: APAC Advanced Therapy Medicinal Products Market by Product: Cell Therapy, CAR-T Therapy, Gene Therapy, and Tissue Engineered Product
• 4.5: ROW Advanced Therapy Medicinal Products Market
  • 4.5.1: ROW Advanced Therapy Medicinal Products Market by Product: Cell Therapy, CAR-T Therapy, Gene Therapy, and Tissue Engineered Product

5. Competitor Analysis

• 5.1: Product Portfolio Analysis
• 5.2: Operational Integration
• 5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

• 6.1: Growth Opportunity Analysis
  • 6.1.1: Growth Opportunities for the Global Advanced Therapy Medicinal Products Market by Product
  • 6.1.2: Growth Opportunities for the Global Advanced Therapy Medicinal Products Market by Region
• 6.2: Emerging Trends in the Global Advanced Therapy Medicinal Products Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Advanced Therapy Medicinal Products Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Advanced Therapy Medicinal Products Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: Spark Therapeutics
• 7.2: Bluebird Bio
• 7.3: Novartis
• 7.4: UniQure
• 7.5: Celgene Corporation
• 7.6: Gilead Lifesciences
• 7.7: Kolon TissueGene
• 7.8: JCR Pharmaceuticals
• 7.9: MEDIPOST
• 7.10: Vericel Corporation