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市場調查報告書
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1818194

突破性療法市場報告：2031 年趨勢、預測與競爭分析

Breakthrough Therapy Drug Market Report: Trends, Forecast and Competitive Analysis to 2031
出版日期: | 出版商: Lucintel | 英文 150 Pages | 商品交期: 3個工作天內

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全球突破性療法市場前景光明，醫院、診所和門診服務市場都蘊藏著機會。預計2025年至2031年期間，全球突破性療法市場的複合年成長率將達到14.2%。該市場的主要驅動力是監管支持和快速核准，以及慢性病和罕見病患疾病率的上升。

  • Lucintel 預測，由於全球癌症、神經退化性疾病和感染疾病負擔的不斷增加，腫瘤學在預測期內仍將是最大的部門市場。
  • 從應用角度來看，由於危及生命的疾病和慢性疾病的發生率不斷上升，醫院預計將繼續成為最大的部門市場。
  • 依地區分類，預計北美在預測期內將經歷最高的成長。

突破性療法市場的新趨勢

全球突破性療法市場的新趨勢反映出，嚴重疾病的治療正轉向更個人化、標靶治療。這些趨勢正在顯著改變新治療方法的開發、核准和患者使用方式。技術創新、監管變化和不斷發展的市場動態正在推動這個快速成長的市場的發展方向。

  • 癌症治療日益受到關注：腫瘤學是突破性療法最熱門的領域之一。標靶治療藥物、免疫查核點抑制劑和個人化癌症治療的開發正在推動該領域顯著成長。基因組學、人工智慧和機器學習的進步正在改善藥物研發流程，從而能夠快速識別可行的候選治療方案。精準醫療的興起透過針對特定的基因突變來提高癌症治療的有效性。因此，預計腫瘤學將在未來幾年繼續主導突破性藥物市場。
  • 基因和細胞療法的創新：基因和細胞療法正成為治療遺傳性疾病、癌症和其他慢性疾病的強大工具。基因編輯、CRISPR技術和幹細胞研究的治療方法為治療先前無法治癒的疾病帶來了希望。這些治療方法正被包括美國食品藥物管理局（FDA）和歐洲藥品管理局（EMA）在內的全球監管機構快速核准。直接改變患者基因組成的能力帶來了變革性的潛力，使基因和細胞療法成為突破性療法市場中一個令人興奮的前沿領域。
  • 再生醫學的進展：再生醫學，包括幹細胞和組織工程，正成為突破性療法研發的重點。該領域在治療退化性疾病、損傷和器官衰竭方面擁有巨大潛力。再生療法旨在修復或取代受損組織，為傳統療法的不足之處提供潛在的治療方法。再生醫學的核准流程正在不斷演變，隨著科學的進步，再生醫學很可能成為創新藥物市場的重要領域。
  • 人工智慧 (AI) 和機器學習 (ML) 的作用日益增強：AI 和 ML 正在徹底改變藥物發現和開發流程。透過分析海量資料集，AI 可以預測藥物與人體的相互作用，從而加速突破性候選藥物的辨識。這些技術使研究人員能夠識別生物標記、最佳化臨床試驗並增強個人化醫療方法。隨著 AI 和 ML 的不斷發展，它們有望在突破性治療方法的開發中發揮越來越重要的作用，縮短救命療法的上市時間。
  • 臨床試驗全球化：隨著突破性療法需求的增加，臨床試驗的全球化趨勢日益凸顯。製藥公司正在包括新興市場在內的不同地區進行臨床試驗，以加速突破性治療方法的開發和核准。臨床試驗旨在確保更具代表性的患者群體，有助於提高這些藥物的國際適用性。這一趨勢也減少了將新治療方法推向市場的時間和成本，特別是對於在世界不同地區流行的疾病。

全球突破性療法市場正受到幾個新興趨勢的影響，包括對癌症治療的日益關注、基因和細胞療法的創新、再生醫學的進步、人工智慧和機器學習的作用以及臨床試驗的全球化。這些趨勢不僅加速了突破性新藥的開發，也使治療更加個人化，讓全球患者更容易取得。技術進步、監管支持和不斷變化的患者需求的融合，為突破性療法的發現、開發和交付方式的重大變革奠定了基礎。

突破性治療藥物市場的最新趨勢

突破性療法市場的最新趨勢反映了創新的快速發展和對新型療法日益成長的需求。製藥公司、政府和監管機構越來越注重營造有利於突破性治療方法開發的環境。這些發展凸顯了合作、監管支持和技術進步對於克服治療嚴重和危及生命的疾病的課題的重要性。

  • FDA突破性療法認定擴展：FDA的突破性療法認定 (BTD) 在加速新治療方法的開發和核准繼續發揮關鍵作用。 BTD計畫允許與FDA進行更頻繁的互動，加快臨床試驗，並允許優先審查藥物。隨著越來越多的療法獲得突破性認定，患者將能夠更快地獲得挽救生命的治療。這項進展在腫瘤學和罕見疾病領域尤其明顯，這些領域對新型療法的需求迫切。 BTD計畫正在全球擴展，影響著其他國家的醫藥品認證過程。
  • 免疫腫瘤學的進展：免疫腫瘤學繼續成為突破性治療方法研發的領先領域。免疫查核點抑制劑、CAR-T細胞療法和癌症疫苗的出現徹底改變了癌症治療方法。各大公司越來越重視刺激人體免疫系統對抗癌症的免疫療法。這些治療方法通常可快速核准，正在改變腫瘤學的治療模式，並將顯著提高各類癌症患者的存活率。
  • 基因編輯技術 (CRISPR)：CRISPR 等基因編輯技術為治療遺傳疾病和癌症提供了新的可能性。利用 CRISPR 技術，突破性的治療方法正在被開發出來，可以直接糾正致病基因突變。各大公司正在推進基於 CRISPR 的治療方法的臨床試驗，預計為此前無法治癒的疾病提供治療方法。監管機構越來越認知到基因編輯的潛力，並正在提供加速核准流程，為該技術的蓬勃發展創造良好的環境。
  • 開發罕見疾病治療方案：罕見疾病持續推動突破性療法市場的創新。許多公司專注於開發現有治療方案有限的罕見疾病療法。基因療法、生技藥品和酵素替代療法的進步為Duchenne氏肌肉失養症和脊髓性肌肉萎縮症等罕見遺傳疾病患者帶來了新的希望。隨著孤兒藥優惠待遇的增加以及監管機構加快監管力度，罕見疾病突破性治療方法市場預計將繼續快速擴張。
  • 生物製藥研發領域的夥伴關係與聯盟：製藥公司、研究機構和生技公司之間的夥伴關係與聯盟正在興起，旨在加速突破性治療方法的開發。透過整合藥物研發、臨床試驗和生產方面的專業知識，這些聯盟有助於加快創新治療方法的上市速度。策略夥伴關係關係也能使企業共用資源，降低開發突破性療法的風險，進而推動多個治療領域的進步，尤其是在腫瘤學、自體免疫疾病和罕見疾病領域。

全球突破性療法市場的關鍵發展，包括FDA突破性療法認定的擴展、免疫腫瘤學、基因編輯技術、罕見疾病治療開發以及戰略合作夥伴關係，正在改變藥物開發的格局。這些發展正在加快核准，提供更具針對性的治療方案，並擴大患者獲得救命療法的管道。生物技術、基因組學和免疫療法領域的加速突破將在未來幾年進一步塑造市場格局，為全球患者帶來希望，並為醫藥創新樹立新的標準。

目錄

第1章摘要整理

第2章 市場概況

  • 背景和分類
  • 供應鏈

第3章：市場趨勢及預測分析

  • 宏觀經濟趨勢與預測
  • 產業驅動力與課題
  • PESTLE分析
  • 專利分析
  • 法規環境

第4章 全球突破性治療市場（依類型）

  • 概述
  • 依類型進行吸引力分析
  • 腫瘤學：趨勢與預測（2019-2031）
  • 抗病毒藥物：趨勢與預測（2019-2031）
  • 神經病學：趨勢與預測（2019-2031）
  • 其他：趨勢與預測（2019-2031）

第5章全球突破性治療市場（依應用）

  • 概述
  • 依用途進行吸引力分析
  • 醫院：趨勢與預測（2019-2031）
  • 診所：趨勢與預測（2019-2031）
  • 門診服務：趨勢與預測（2019-2031）

第6章 區域分析

  • 概述
  • 區域突破性療法市場

第7章：北美突破性療法市場

  • 概述
  • 美國突破性治療市場
  • 墨西哥的突破性療法市場
  • 加拿大的突破性療法市場

第 8 章：歐洲突破性療法市場

  • 概述
  • 德國突破性治療市場
  • 法國創新藥物市場
  • 西班牙創新藥物市場
  • 義大利的突破性治療市場
  • 英國突破性療法市場

9. 亞太地區突破性治療市場

  • 概述
  • 日本創新治療藥物市場
  • 印度突破性的治療市場
  • 中國創新藥物市場
  • 韓國突破性的治療市場
  • 印尼的突破性治療市場

第10章世界其他地區突破性療法市場

  • 概述
  • 中東突破性治療市場
  • 南美洲突破性療癒市場
  • 非洲突破性的治療市場

第11章 競爭分析

  • 產品系列分析
  • 營運整合
  • 波特五力分析
    • 競爭對手之間的競爭
    • 買方的議價能力
    • 供應商的議價能力
    • 替代品的威脅
    • 新進入者的威脅
  • 市佔率分析

第12章：機會與策略分析

  • 價值鏈分析
  • 成長機會分析
    • 依類型分類的成長機會
    • 依應用分類的成長機會
  • 全球突破性療法市場的新趨勢
  • 戰略分析
    • 新產品開發
    • 認證和許可
    • 合併、收購、協議、合作和合資企業

第13章 價值鏈主要企業的公司簡介

  • 競爭分析
  • Merck
  • Pfizer
  • AbbVie
  • Bristol-Myers Squibb Company
  • Genentech

第14章 附錄

  • 圖表目錄
  • 表格一覽
  • 調查方法
  • 免責聲明
  • 版權
  • 簡稱和技術單位
  • 關於我們
  • 聯絡處

The future of the global breakthrough therapy drug market looks promising with opportunities in the hospitals, clinics and ambulatory services markets. The global breakthrough therapy drug market is expected to grow with a CAGR of 14.2% from 2025 to 2031. The major drivers for this market are the regulatory support & fast-track approval and the rising prevalence of chronic & rare diseases.

  • Lucintel forecasts that, within the type category, oncology will remain the largest segment over the forecast period due to rising global burden of cancer, neurodegenerative, and infectious diseases.
  • Within the application category, hospitals will remain the largest segment due to increasing incidence of life-threatening & chronic diseases.
  • In terms of region, North America is expected to witness the highest growth over the forecast period.

Emerging Trends in the Breakthrough Therapy Drug Market

Emerging trends in the global breakthrough therapy drug market reflect the shift toward more personalized, targeted treatments for serious diseases. These trends are reshaping how new therapies are developed, approved, and delivered to patients. Technological innovations, regulatory changes, and evolving market dynamics are driving the direction of this fast-growing market.

  • Increased Focus on Oncology Treatments: Oncology remains one of the most prominent areas for breakthrough therapies. The development of targeted therapies, immune checkpoint inhibitors, and personalized cancer treatments is driving significant growth. Advances in genomics, AI, and machine learning are improving drug discovery processes, allowing for faster identification of viable treatment candidates. The push for precision medicine is enhancing the efficacy of cancer treatments by targeting specific genetic mutations. As a result, oncology will continue to dominate the breakthrough therapy drug market in the coming years.
  • Gene and Cell Therapy Innovations: Gene and cell therapies are emerging as powerful tools in the treatment of genetic disorders, cancer, and other chronic diseases. Breakthrough therapies in gene editing, CRISPR technology, and stem cell research are showing promise in treating previously untreatable conditions. These therapies are being fast-tracked for approval by regulatory bodies around the world, including the FDA and EMA. The ability to directly alter the genetic makeup of patients offers transformative potential, making gene and cell therapy an exciting frontier in the breakthrough therapy drug market.
  • Regenerative Medicine Advancements: Regenerative medicine, including the use of stem cells and tissue engineering, is becoming a key focus in the development of breakthrough therapies. This field holds great promise for treating conditions such as degenerative diseases, injuries, and organ failure. Regenerative therapies aim to repair or replace damaged tissues, offering potential cures where traditional treatments fall short. The regulatory approval process for regenerative medicines is evolving, and as the science progresses, regenerative medicine will increasingly become a significant segment of the breakthrough drug market.
  • Increased Role of Artificial Intelligence (AI) and Machine Learning (ML): AI and ML are revolutionizing drug discovery and development processes. By analyzing large datasets, AI can predict how a drug will interact with the human body, accelerating the identification of potential breakthrough drugs. These technologies enable researchers to identify biomarkers, optimize clinical trials, and enhance personalized medicine approaches. As AI and ML continue to advance, they are expected to play an increasingly crucial role in the development of breakthrough therapies, speeding up the time-to-market for life-saving treatments.
  • Globalization of Clinical Trials: As the demand for breakthrough therapies grows, there is a marked increase in the globalization of clinical trials. Pharmaceutical companies are conducting trials in diverse regions, including emerging markets, to accelerate the development and approval of breakthrough therapies. Clinical trials are being designed to ensure more representative patient populations, which helps to improve the global applicability of these drugs. This trend also reduces the time and costs associated with bringing new therapies to market, especially for diseases that are prevalent in different regions of the world.

The global breakthrough therapy drug market is being shaped by several key emerging trends, including a growing focus on oncology treatments, innovations in gene and cell therapies, advances in regenerative medicine, the role of AI and ML, and the globalization of clinical trials. These trends are not only accelerating the development of breakthrough drugs but are also making treatments more personalized and accessible to patients worldwide. The convergence of technological advancements, regulatory support, and evolving patient needs is setting the stage for significant transformation in the way breakthrough therapies are discovered, developed, and delivered.

Recent Developments in the Breakthrough Therapy Drug Market

Recent developments in the breakthrough therapy drug market reflect the rapid pace of innovation and the growing demand for novel treatments. Pharmaceutical companies, governments, and regulatory agencies are increasingly focused on fostering environments that accelerate the development of groundbreaking therapies. These developments highlight the importance of collaboration, regulatory support, and advancements in technology to overcome challenges in treating serious and life-threatening diseases.

  • FDA Breakthrough Therapy Designation Expansion: The FDA's Breakthrough Therapy Designation (BTD) continues to play a significant role in expediting the development and approval of new therapies. The BTD program allows for more frequent interactions with the FDA, accelerated clinical trials, and priority review of drugs. As more therapies receive breakthrough status, this has led to faster access for patients to life-saving treatments. This development is especially notable in oncology and rare diseases, where the need for novel therapies is urgent. The BTD program is expanding globally, influencing drug approval processes in other countries as well.
  • Advancements in Immuno-Oncology: Immuno-oncology continues to be a major area of development for breakthrough therapies. The advent of immune checkpoint inhibitors, CAR-T cell therapies, and cancer vaccines has revolutionized the way cancers are treated. Companies are increasingly focusing on immunotherapies that stimulate the body's immune system to fight cancer. These therapies, often fast-tracked for approval, are changing the treatment paradigm in oncology and are poised to make a significant impact on survival rates for patients with various types of cancer.
  • Gene Editing Technologies (CRISPR): Gene editing technologies, such as CRISPR, have opened up new possibilities for treating genetic disorders and cancers. Breakthrough therapies leveraging CRISPR technology are being developed to directly correct genetic mutations that cause disease. Companies are moving toward clinical trials for CRISPR-based treatments, which have the potential to provide cures for previously untreatable conditions. Regulatory agencies are increasingly recognizing the potential of gene editing, offering accelerated pathways for approval, and creating a robust environment for this technology to thrive.
  • Rare Disease Drug Development: Rare diseases continue to drive innovation in the breakthrough therapy market. Many companies are focusing on the development of treatments for orphan diseases that have few or no existing treatment options. Advances in gene therapies, biologics, and enzyme replacement therapies are providing new hope for patients with rare genetic disorders, such as Duchenne muscular dystrophy and spinal muscular atrophy. As orphan drug incentives increase and regulatory pathways are expedited, the market for breakthrough therapies in rare diseases is expected to continue to expand rapidly.
  • Partnerships and Collaborations in Biopharmaceutical R&D: There has been an increase in partnerships and collaborations between pharmaceutical companies, research institutions, and biotech firms to accelerate the development of breakthrough therapies. By combining expertise in drug discovery, clinical trials, and manufacturing, these collaborations are helping to bring innovative therapies to market more quickly. Strategic partnerships are also allowing companies to share resources and reduce the risks associated with developing breakthrough therapies, driving progress across multiple therapeutic areas, particularly oncology, autoimmune diseases, and rare conditions.

Key developments in the global breakthrough therapy drug market, including the expansion of FDA breakthrough designations, advancements in immuno-oncology, gene editing technologies, rare disease drug development, and strategic partnerships, are transforming the landscape of drug development. These developments are leading to faster approvals, more targeted therapies, and greater patient access to life-saving treatments. The continued acceleration of breakthroughs in biotechnology, genomics, and immunotherapies will further shape the market in the years to come, offering hope for patients worldwide and setting new standards for pharmaceutical innovation.

Strategic Growth Opportunities in the Breakthrough Therapy Drug Market

The global Breakthrough Therapy Drug market represents a rapidly expanding and evolving sector in the pharmaceutical industry. Breakthrough therapy designation, granted by regulatory agencies like the U.S. FDA, is designed to expedite the development and review of drugs that show significant potential in treating serious or life-threatening conditions. This designation offers companies advantages such as faster regulatory approval, accelerated clinical trials, and market exclusivity, which can lead to lucrative opportunities.

  • Expanding Indications for Breakthrough Therapies: While the initial focus has been on oncology, several other therapeutic areas such as neurology, cardiology, rare diseases, and infectious diseases are gaining attention. The expansion of breakthrough therapy drugs beyond cancer treatments offers significant growth potential. For example, breakthroughs in Alzheimer's disease, Parkinson's disease, and genetic disorders are likely to attract increasing investments and regulatory support. Companies should explore unmet needs in these areas to capitalize on both high demand and potentially lucrative outcomes.
  • Personalized Medicine and Targeted Therapies: Advances in genomics, biomarkers, and cell and gene therapies are driving the development of more personalized and targeted drugs. Drugs tailored to specific genetic profiles have shown higher success rates in clinical trials and can be fast-tracked to market under breakthrough therapy designations. Companies that focus on precision medicine, especially in cancer and rare genetic disorders, stand to benefit from this growing trend. The ability to develop therapies targeting specific mutations or biomarkers can increase the chances of receiving breakthrough status, attracting investors and driving adoption in niche markets.
  • Artificial Intelligence (AI) and Machine Learning (ML) in Drug Development: AI and ML are revolutionizing drug discovery by identifying promising molecules and predicting outcomes much faster than traditional methods. By leveraging these technologies, companies can accelerate the drug development process and increase their chances of securing breakthrough therapy designation. Machine learning algorithms can also be used to identify patients who may benefit from a new therapy, helping to streamline clinical trials and reduce costs. This, in turn, creates significant opportunities for smaller biotech firms and startups to disrupt the market and gain early regulatory approval.
  • Strategic Partnerships and Collaborations: Collaborations between pharmaceutical companies, biotech firms, and academic institutions can provide access to cutting-edge research, expertise, and resources to develop breakthrough therapies. Strategic alliances with technology firms, particularly those focused on genomics, bioinformatics, and AI, are essential to staying competitive. Licensing agreements, co-development partnerships, and joint ventures can reduce risks associated with the high costs of R&D while allowing companies to share in the rewards of successfully bringing breakthrough therapies to market.
  • Regulatory Fast-Tracking and Global Expansion: The regulatory environment around breakthrough therapies continues to evolve globally, with agencies like the FDA, EMA, and other health authorities offering expedited processes for approval. Beyond the U.S., countries like China, Japan, and India are emerging as key markets for breakthrough drugs due to their increasing investment in healthcare infrastructure, growing populations with unmet medical needs, and regulatory reforms that allow faster market entry. Companies with a global strategy for breakthrough therapies can tap into these high-growth markets and maximize their reach and revenue potential.

The global breakthrough therapy drug market presents several strategic growth opportunities across key applications, including personalized treatments, immuno-oncology, gene therapies, and rare disease treatments. By capitalizing on advancements in AI, gene editing, and partnerships with research institutions, pharmaceutical companies can accelerate the development of innovative therapies. Emerging markets and collaborations also provide valuable opportunities for growth. As regulatory bodies continue to streamline approval processes, the market for breakthrough therapies is poised for significant expansion, with new and groundbreaking treatments making a real impact on patient outcomes worldwide.

Breakthrough Therapy Drug Market Driver and Challenges

The global breakthrough therapy drug market is influenced by several key drivers, including technological advancements, regulatory support, and a growing focus on precision medicine. However, challenges related to cost, regulatory complexity, and market access remain critical factors that could impact the pace of growth. Understanding these drivers and challenges is essential for navigating the dynamic landscape of breakthrough therapy drug development.

The factors responsible for driving the breakthrough therapy drug market include:

1. Regulatory Accelerations: Regulatory bodies worldwide are increasingly prioritizing breakthrough therapies, fast-tracking approval processes for drugs that show significant potential in treating serious conditions. This has led to quicker access to novel therapies for patients, especially in critical areas such as oncology and rare diseases.

2. Technological Advancements: Advancements in gene editing, immuno-oncology, and biotechnology are providing new ways to treat complex diseases. These innovations are creating exciting possibilities for breakthrough therapies, particularly in areas where traditional treatments have been ineffective.

3. Increased Funding for R&D: Government and private sector investments in pharmaceutical R&D are driving the development of breakthrough therapies. Increased funding allows for more extensive clinical trials, faster development timelines, and access to cutting-edge technologies, enabling quicker market entry for innovative drugs.

4. Growing Patient Demand: Patients and healthcare providers are increasingly demanding new treatments for serious and life-threatening diseases. The demand for breakthrough therapies is particularly high in oncology, rare diseases, and chronic conditions, driving pharmaceutical companies to prioritize the development of novel therapies.

5. Personalized Medicine: The growing shift toward personalized medicine, which tailors treatments to individual genetic profiles, is driving the market for breakthrough therapies. Advances in genomics and biomarkers are allowing for more precise and effective treatments, particularly in cancer and rare diseases.

Challenges in the breakthrough therapy drug market are:

1. High Development Costs: The costs of developing breakthrough therapies, particularly gene therapies and biologics, are often prohibitively high. These costs can limit access to these therapies for patients, particularly in emerging markets.

2. Regulatory Hurdles: Although regulatory bodies offer fast-tracking for breakthrough therapies, navigating complex approval processes remains a challenge. In some regions, regulatory frameworks are still evolving, making it difficult to gain approval for innovative therapies.

3. Market Access and Affordability: Even with regulatory approval, gaining market access and ensuring the affordability of breakthrough therapies remain significant challenges. High prices, limited insurance coverage, and lack of healthcare infrastructure in certain regions can hinder patient access to these life-changing treatments

The drivers of the global breakthrough therapy drug market include regulatory acceleration, technological advancements, increased funding for R&D, growing patient demand, and the shift toward personalized medicine. However, challenges such as high development costs, regulatory hurdles, and issues related to market access and affordability persist. By addressing these challenges while leveraging the market drivers, pharmaceutical companies can expand their presence in the growing breakthrough therapy drug market and improve patient outcomes.

List of Breakthrough Therapy Drug 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 breakthrough therapy drug companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the breakthrough therapy drug companies profiled in this report include-

  • Merck
  • Pfizer
  • AbbVie
  • Bristol-Myers Squibb Company
  • Genentech

Breakthrough Therapy Drug Market by Segment

The study includes a forecast for the global breakthrough therapy drug market by type, application, and region.

Breakthrough Therapy Drug Market by Type [Value from 2019 to 2031]:

  • Oncology
  • Anti-Viral
  • Neurology
  • Others

Breakthrough Therapy Drug Market by Application [Value from 2019 to 2031]:

  • Hospitals
  • Clinics
  • Ambulatory Services

Breakthrough Therapy Drug Market by Region [Value from 2019 to 2031]:

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

Country Wise Outlook for the Breakthrough Therapy Drug Market

The global breakthrough therapy drug market has experienced significant developments in recent years, spurred by advancements in biotechnology, a growing focus on precision medicine, and increasing regulatory support. Breakthrough therapy designation (BTD) by regulatory bodies like the FDA accelerates the development and review of drugs that show substantial improvement over existing therapies for serious or life-threatening conditions. The US, China, Germany, India, and Japan have become key players in this market, with major pharmaceutical companies driving research and development (R&D) to create life-changing treatments. These countries are embracing innovative approaches to accelerate drug approval and bring new therapies to market faster.

  • United States: The US has seen remarkable progress in the breakthrough therapy drug market, thanks to the FDA's Breakthrough Therapy Designation, which expedites the approval process for drugs with the potential to significantly improve treatment options for serious diseases. The rapid growth in the oncology, rare disease, and immunotherapy sectors is driving drug development. Additionally, the US government has increased funding for biopharmaceutical research, encouraging innovation. Notable therapies in oncology, gene therapy, and rare disease treatments have been fast-tracked for approval, helping to shape the global landscape of breakthrough drugs.
  • China: In China, the breakthrough therapy drug market has been rapidly growing, with the Chinese FDA (CFDA) implementing a similar fast-track approval process to the US. China has made significant strides in biotechnology, with increasing investment in pharmaceutical research and development, especially in oncology and immunotherapies. Chinese pharmaceutical companies are also focusing on the development of biosimilars and next-generation biologics. Additionally, the Chinese government has pushed for reforms in regulatory pathways, streamlining the approval process for innovative drugs. With a growing healthcare infrastructure and increasing demand for advanced therapies, China is quickly emerging as a key player in the global market.
  • Germany: Germany has a well-established pharmaceutical market, and recent developments have centered around personalized medicine and breakthrough therapies for oncology and autoimmune diseases. The country benefits from strong regulatory support and a robust healthcare system. German pharmaceutical companies, often in collaboration with research institutions, are leading the development of biologics and gene therapies. Furthermore, Germany is a prominent hub for clinical trials in Europe, which aids in the faster approval of breakthrough drugs. The focus on innovative therapies is transforming the healthcare landscape, positioning Germany as a leader in the European breakthrough drug market.
  • India: India is emerging as a significant player in the global breakthrough therapy drug market, with a focus on affordable and innovative treatments for chronic diseases, including cancer, diabetes, and cardiovascular diseases. The Indian pharmaceutical industry, known for its generic drug manufacturing capabilities, is increasingly investing in biopharmaceutical research and development. The government's focus on improving regulatory pathways and providing incentives for research has spurred innovation in breakthrough therapies. India is also becoming a key location for clinical trials, offering cost-effective solutions for global pharmaceutical companies looking to develop new therapies quickly.
  • Japan: Japan's pharmaceutical market has been at the forefront of breakthrough therapy drug development, particularly in the fields of oncology, rare diseases, and regenerative medicine. The Japanese government has implemented policies to accelerate the approval of innovative drugs, including fast-track pathways for breakthrough therapies. Japanese companies are investing heavily in advanced biotechnologies, including gene editing, stem cell research, and immunotherapy. Additionally, Japan's aging population is driving demand for novel treatments, making the country a significant market for breakthrough therapies. Japanese regulatory agencies have also streamlined approval processes to expedite access to critical therapies.

Features of the Global Breakthrough Therapy Drug Market

  • Market Size Estimates: Breakthrough therapy drug market size estimation in terms of value ($B).
  • Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
  • Segmentation Analysis: Breakthrough therapy drug market size by type, application, and region in terms of value ($B).
  • Regional Analysis: Breakthrough therapy drug market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
  • Growth Opportunities: Analysis of growth opportunities in different type, application, and regions for the breakthrough therapy drug market.
  • Strategic Analysis: This includes M&A, new product development, and competitive landscape of the breakthrough therapy drug market.

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

This report answers following 11 key questions:

  • Q.1. What are some of the most promising, high-growth opportunities for the breakthrough therapy drug market by type (oncology, anti-viral, neurology, and others), application (hospitals, clinics, and ambulatory services), 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?

Table of Contents

1. Executive Summary

2. Market Overview

  • 2.1 Background and Classifications
  • 2.2 Supply Chain

3. Market Trends & Forecast Analysis

  • 3.1 Macroeconomic Trends and Forecasts
  • 3.2 Industry Drivers and Challenges
  • 3.3 PESTLE Analysis
  • 3.4 Patent Analysis
  • 3.5 Regulatory Environment

4. Global Breakthrough Therapy Drug Market by Type

  • 4.1 Overview
  • 4.2 Attractiveness Analysis by Type
  • 4.3 Oncology: Trends and Forecast (2019-2031)
  • 4.4 Anti-Viral: Trends and Forecast (2019-2031)
  • 4.5 Neurology: Trends and Forecast (2019-2031)
  • 4.6 Others: Trends and Forecast (2019-2031)

5. Global Breakthrough Therapy Drug Market by Application

  • 5.1 Overview
  • 5.2 Attractiveness Analysis by Application
  • 5.3 Hospitals: Trends and Forecast (2019-2031)
  • 5.4 Clinics: Trends and Forecast (2019-2031)
  • 5.5 Ambulatory Services: Trends and Forecast (2019-2031)

6. Regional Analysis

  • 6.1 Overview
  • 6.2 Global Breakthrough Therapy Drug Market by Region

7. North American Breakthrough Therapy Drug Market

  • 7.1 Overview
  • 7.4 United States Breakthrough Therapy Drug Market
  • 7.5 Mexican Breakthrough Therapy Drug Market
  • 7.6 Canadian Breakthrough Therapy Drug Market

8. European Breakthrough Therapy Drug Market

  • 8.1 Overview
  • 8.4 German Breakthrough Therapy Drug Market
  • 8.5 French Breakthrough Therapy Drug Market
  • 8.6 Spanish Breakthrough Therapy Drug Market
  • 8.7 Italian Breakthrough Therapy Drug Market
  • 8.8 United Kingdom Breakthrough Therapy Drug Market

9. APAC Breakthrough Therapy Drug Market

  • 9.1 Overview
  • 9.4 Japanese Breakthrough Therapy Drug Market
  • 9.5 Indian Breakthrough Therapy Drug Market
  • 9.6 Chinese Breakthrough Therapy Drug Market
  • 9.7 South Korean Breakthrough Therapy Drug Market
  • 9.8 Indonesian Breakthrough Therapy Drug Market

10. ROW Breakthrough Therapy Drug Market

  • 10.1 Overview
  • 10.4 Middle Eastern Breakthrough Therapy Drug Market
  • 10.5 South American Breakthrough Therapy Drug Market
  • 10.6 African Breakthrough Therapy Drug Market

11. Competitor Analysis

  • 11.1 Product Portfolio Analysis
  • 11.2 Operational Integration
  • 11.3 Porter's Five Forces Analysis
    • Competitive Rivalry
    • Bargaining Power of Buyers
    • Bargaining Power of Suppliers
    • Threat of Substitutes
    • Threat of New Entrants
  • 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

  • 12.1 Value Chain Analysis
  • 12.2 Growth Opportunity Analysis
    • 12.2.1 Growth Opportunities by Type
    • 12.2.2 Growth Opportunities by Application
  • 12.3 Emerging Trends in the Global Breakthrough Therapy Drug Market
  • 12.4 Strategic Analysis
    • 12.4.1 New Product Development
    • 12.4.2 Certification and Licensing
    • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

  • 13.1 Competitive Analysis
  • 13.2 Merck
    • Company Overview
    • Breakthrough Therapy Drug Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.3 Pfizer
    • Company Overview
    • Breakthrough Therapy Drug Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.4 AbbVie
    • Company Overview
    • Breakthrough Therapy Drug Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.5 Bristol-Myers Squibb Company
    • Company Overview
    • Breakthrough Therapy Drug Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.6 Genentech
    • Company Overview
    • Breakthrough Therapy Drug Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing

14. Appendix

  • 14.1 List of Figures
  • 14.2 List of Tables
  • 14.3 Research Methodology
  • 14.4 Disclaimer
  • 14.5 Copyright
  • 14.6 Abbreviations and Technical Units
  • 14.7 About Us
  • 14.8 Contact Us

List of Figures

  • Figure 1.1: Trends and Forecast for the Global Breakthrough Therapy Drug Market
  • Figure 2.1: Usage of Breakthrough Therapy Drug Market
  • Figure 2.2: Classification of the Global Breakthrough Therapy Drug Market
  • Figure 2.3: Supply Chain of the Global Breakthrough Therapy Drug Market
  • Figure 3.1: Trends of the Global GDP Growth Rate
  • Figure 3.2: Trends of the Global Population Growth Rate
  • Figure 3.3: Trends of the Global Inflation Rate
  • Figure 3.4: Trends of the Global Unemployment Rate
  • Figure 3.5: Trends of the Regional GDP Growth Rate
  • Figure 3.6: Trends of the Regional Population Growth Rate
  • Figure 3.7: Trends of the Regional Inflation Rate
  • Figure 3.8: Trends of the Regional Unemployment Rate
  • Figure 3.9: Trends of Regional Per Capita Income
  • Figure 3.10: Forecast for the Global GDP Growth Rate
  • Figure 3.11: Forecast for the Global Population Growth Rate
  • Figure 3.12: Forecast for the Global Inflation Rate
  • Figure 3.13: Forecast for the Global Unemployment Rate
  • Figure 3.14: Forecast for the Regional GDP Growth Rate
  • Figure 3.15: Forecast for the Regional Population Growth Rate
  • Figure 3.16: Forecast for the Regional Inflation Rate
  • Figure 3.17: Forecast for the Regional Unemployment Rate
  • Figure 3.18: Forecast for Regional Per Capita Income
  • Figure 3.19: Driver and Challenges of the Breakthrough Therapy Drug Market
  • Figure 4.1: Global Breakthrough Therapy Drug Market by Type in 2019, 2024, and 2031
  • Figure 4.2: Trends of the Global Breakthrough Therapy Drug Market ($B) by Type
  • Figure 4.3: Forecast for the Global Breakthrough Therapy Drug Market ($B) by Type
  • Figure 4.4: Trends and Forecast for Oncology in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 4.5: Trends and Forecast for Anti-Viral in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 4.6: Trends and Forecast for Neurology in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 4.7: Trends and Forecast for Others in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 5.1: Global Breakthrough Therapy Drug Market by Application in 2019, 2024, and 2031
  • Figure 5.2: Trends of the Global Breakthrough Therapy Drug Market ($B) by Application
  • Figure 5.3: Forecast for the Global Breakthrough Therapy Drug Market ($B) by Application
  • Figure 5.4: Trends and Forecast for Hospitals in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 5.5: Trends and Forecast for Clinics in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 5.6: Trends and Forecast for Ambulatory Services in the Global Breakthrough Therapy Drug Market (2019-2031)
  • Figure 6.1: Trends of the Global Breakthrough Therapy Drug Market ($B) by Region (2019-2024)
  • Figure 6.2: Forecast for the Global Breakthrough Therapy Drug Market ($B) by Region (2025-2031)
  • Figure 7.1: Trends and Forecast for the North American Breakthrough Therapy Drug Market (2019-2031)
  • Figure 7.2: North American Breakthrough Therapy Drug Market by Type in 2019, 2024, and 2031
  • Figure 7.3: Trends of the North American Breakthrough Therapy Drug Market ($B) by Type (2019-2024)
  • Figure 7.4: Forecast for the North American Breakthrough Therapy Drug Market ($B) by Type (2025-2031)
  • Figure 7.5: North American Breakthrough Therapy Drug Market by Application in 2019, 2024, and 2031
  • Figure 7.6: Trends of the North American Breakthrough Therapy Drug Market ($B) by Application (2019-2024)
  • Figure 7.7: Forecast for the North American Breakthrough Therapy Drug Market ($B) by Application (2025-2031)
  • Figure 7.8: Trends and Forecast for the United States Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 7.9: Trends and Forecast for the Mexican Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 7.10: Trends and Forecast for the Canadian Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 8.1: Trends and Forecast for the European Breakthrough Therapy Drug Market (2019-2031)
  • Figure 8.2: European Breakthrough Therapy Drug Market by Type in 2019, 2024, and 2031
  • Figure 8.3: Trends of the European Breakthrough Therapy Drug Market ($B) by Type (2019-2024)
  • Figure 8.4: Forecast for the European Breakthrough Therapy Drug Market ($B) by Type (2025-2031)
  • Figure 8.5: European Breakthrough Therapy Drug Market by Application in 2019, 2024, and 2031
  • Figure 8.6: Trends of the European Breakthrough Therapy Drug Market ($B) by Application (2019-2024)
  • Figure 8.7: Forecast for the European Breakthrough Therapy Drug Market ($B) by Application (2025-2031)
  • Figure 8.8: Trends and Forecast for the German Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 8.9: Trends and Forecast for the French Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 8.10: Trends and Forecast for the Spanish Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 8.11: Trends and Forecast for the Italian Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 8.12: Trends and Forecast for the United Kingdom Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 9.1: Trends and Forecast for the APAC Breakthrough Therapy Drug Market (2019-2031)
  • Figure 9.2: APAC Breakthrough Therapy Drug Market by Type in 2019, 2024, and 2031
  • Figure 9.3: Trends of the APAC Breakthrough Therapy Drug Market ($B) by Type (2019-2024)
  • Figure 9.4: Forecast for the APAC Breakthrough Therapy Drug Market ($B) by Type (2025-2031)
  • Figure 9.5: APAC Breakthrough Therapy Drug Market by Application in 2019, 2024, and 2031
  • Figure 9.6: Trends of the APAC Breakthrough Therapy Drug Market ($B) by Application (2019-2024)
  • Figure 9.7: Forecast for the APAC Breakthrough Therapy Drug Market ($B) by Application (2025-2031)
  • Figure 9.8: Trends and Forecast for the Japanese Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 9.9: Trends and Forecast for the Indian Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 9.10: Trends and Forecast for the Chinese Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 9.11: Trends and Forecast for the South Korean Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 9.12: Trends and Forecast for the Indonesian Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 10.1: Trends and Forecast for the ROW Breakthrough Therapy Drug Market (2019-2031)
  • Figure 10.2: ROW Breakthrough Therapy Drug Market by Type in 2019, 2024, and 2031
  • Figure 10.3: Trends of the ROW Breakthrough Therapy Drug Market ($B) by Type (2019-2024)
  • Figure 10.4: Forecast for the ROW Breakthrough Therapy Drug Market ($B) by Type (2025-2031)
  • Figure 10.5: ROW Breakthrough Therapy Drug Market by Application in 2019, 2024, and 2031
  • Figure 10.6: Trends of the ROW Breakthrough Therapy Drug Market ($B) by Application (2019-2024)
  • Figure 10.7: Forecast for the ROW Breakthrough Therapy Drug Market ($B) by Application (2025-2031)
  • Figure 10.8: Trends and Forecast for the Middle Eastern Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 10.9: Trends and Forecast for the South American Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 10.10: Trends and Forecast for the African Breakthrough Therapy Drug Market ($B) (2019-2031)
  • Figure 11.1: Porter's Five Forces Analysis of the Global Breakthrough Therapy Drug Market
  • Figure 11.2: Market Share (%) of Top Players in the Global Breakthrough Therapy Drug Market (2024)
  • Figure 12.1: Growth Opportunities for the Global Breakthrough Therapy Drug Market by Type
  • Figure 12.2: Growth Opportunities for the Global Breakthrough Therapy Drug Market by Application
  • Figure 12.3: Growth Opportunities for the Global Breakthrough Therapy Drug Market by Region
  • Figure 12.4: Emerging Trends in the Global Breakthrough Therapy Drug Market

List of Tables

  • Table 1.1: Growth Rate (%, 2023-2024) and CAGR (%, 2025-2031) of the Breakthrough Therapy Drug Market by Type and Application
  • Table 1.2: Attractiveness Analysis for the Breakthrough Therapy Drug Market by Region
  • Table 1.3: Global Breakthrough Therapy Drug Market Parameters and Attributes
  • Table 3.1: Trends of the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 3.2: Forecast for the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 4.1: Attractiveness Analysis for the Global Breakthrough Therapy Drug Market by Type
  • Table 4.2: Market Size and CAGR of Various Type in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 4.3: Market Size and CAGR of Various Type in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 4.4: Trends of Oncology in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 4.5: Forecast for Oncology in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 4.6: Trends of Anti-Viral in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 4.7: Forecast for Anti-Viral in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 4.8: Trends of Neurology in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 4.9: Forecast for Neurology in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 4.10: Trends of Others in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 4.11: Forecast for Others in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 5.1: Attractiveness Analysis for the Global Breakthrough Therapy Drug Market by Application
  • Table 5.2: Market Size and CAGR of Various Application in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 5.3: Market Size and CAGR of Various Application in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 5.4: Trends of Hospitals in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 5.5: Forecast for Hospitals in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 5.6: Trends of Clinics in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 5.7: Forecast for Clinics in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 5.8: Trends of Ambulatory Services in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 5.9: Forecast for Ambulatory Services in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 6.1: Market Size and CAGR of Various Regions in the Global Breakthrough Therapy Drug Market (2019-2024)
  • Table 6.2: Market Size and CAGR of Various Regions in the Global Breakthrough Therapy Drug Market (2025-2031)
  • Table 7.1: Trends of the North American Breakthrough Therapy Drug Market (2019-2024)
  • Table 7.2: Forecast for the North American Breakthrough Therapy Drug Market (2025-2031)
  • Table 7.3: Market Size and CAGR of Various Type in the North American Breakthrough Therapy Drug Market (2019-2024)
  • Table 7.4: Market Size and CAGR of Various Type in the North American Breakthrough Therapy Drug Market (2025-2031)
  • Table 7.5: Market Size and CAGR of Various Application in the North American Breakthrough Therapy Drug Market (2019-2024)
  • Table 7.6: Market Size and CAGR of Various Application in the North American Breakthrough Therapy Drug Market (2025-2031)
  • Table 7.7: Trends and Forecast for the United States Breakthrough Therapy Drug Market (2019-2031)
  • Table 7.8: Trends and Forecast for the Mexican Breakthrough Therapy Drug Market (2019-2031)
  • Table 7.9: Trends and Forecast for the Canadian Breakthrough Therapy Drug Market (2019-2031)
  • Table 8.1: Trends of the European Breakthrough Therapy Drug Market (2019-2024)
  • Table 8.2: Forecast for the European Breakthrough Therapy Drug Market (2025-2031)
  • Table 8.3: Market Size and CAGR of Various Type in the European Breakthrough Therapy Drug Market (2019-2024)
  • Table 8.4: Market Size and CAGR of Various Type in the European Breakthrough Therapy Drug Market (2025-2031)
  • Table 8.5: Market Size and CAGR of Various Application in the European Breakthrough Therapy Drug Market (2019-2024)
  • Table 8.6: Market Size and CAGR of Various Application in the European Breakthrough Therapy Drug Market (2025-2031)
  • Table 8.7: Trends and Forecast for the German Breakthrough Therapy Drug Market (2019-2031)
  • Table 8.8: Trends and Forecast for the French Breakthrough Therapy Drug Market (2019-2031)
  • Table 8.9: Trends and Forecast for the Spanish Breakthrough Therapy Drug Market (2019-2031)
  • Table 8.10: Trends and Forecast for the Italian Breakthrough Therapy Drug Market (2019-2031)
  • Table 8.11: Trends and Forecast for the United Kingdom Breakthrough Therapy Drug Market (2019-2031)
  • Table 9.1: Trends of the APAC Breakthrough Therapy Drug Market (2019-2024)
  • Table 9.2: Forecast for the APAC Breakthrough Therapy Drug Market (2025-2031)
  • Table 9.3: Market Size and CAGR of Various Type in the APAC Breakthrough Therapy Drug Market (2019-2024)
  • Table 9.4: Market Size and CAGR of Various Type in the APAC Breakthrough Therapy Drug Market (2025-2031)
  • Table 9.5: Market Size and CAGR of Various Application in the APAC Breakthrough Therapy Drug Market (2019-2024)
  • Table 9.6: Market Size and CAGR of Various Application in the APAC Breakthrough Therapy Drug Market (2025-2031)
  • Table 9.7: Trends and Forecast for the Japanese Breakthrough Therapy Drug Market (2019-2031)
  • Table 9.8: Trends and Forecast for the Indian Breakthrough Therapy Drug Market (2019-2031)
  • Table 9.9: Trends and Forecast for the Chinese Breakthrough Therapy Drug Market (2019-2031)
  • Table 9.10: Trends and Forecast for the South Korean Breakthrough Therapy Drug Market (2019-2031)
  • Table 9.11: Trends and Forecast for the Indonesian Breakthrough Therapy Drug Market (2019-2031)
  • Table 10.1: Trends of the ROW Breakthrough Therapy Drug Market (2019-2024)
  • Table 10.2: Forecast for the ROW Breakthrough Therapy Drug Market (2025-2031)
  • Table 10.3: Market Size and CAGR of Various Type in the ROW Breakthrough Therapy Drug Market (2019-2024)
  • Table 10.4: Market Size and CAGR of Various Type in the ROW Breakthrough Therapy Drug Market (2025-2031)
  • Table 10.5: Market Size and CAGR of Various Application in the ROW Breakthrough Therapy Drug Market (2019-2024)
  • Table 10.6: Market Size and CAGR of Various Application in the ROW Breakthrough Therapy Drug Market (2025-2031)
  • Table 10.7: Trends and Forecast for the Middle Eastern Breakthrough Therapy Drug Market (2019-2031)
  • Table 10.8: Trends and Forecast for the South American Breakthrough Therapy Drug Market (2019-2031)
  • Table 10.9: Trends and Forecast for the African Breakthrough Therapy Drug Market (2019-2031)
  • Table 11.1: Product Mapping of Breakthrough Therapy Drug Suppliers Based on Segments
  • Table 11.2: Operational Integration of Breakthrough Therapy Drug Manufacturers
  • Table 11.3: Rankings of Suppliers Based on Breakthrough Therapy Drug Revenue
  • Table 12.1: New Product Launches by Major Breakthrough Therapy Drug Producers (2019-2024)
  • Table 12.2: Certification Acquired by Major Competitor in the Global Breakthrough Therapy Drug Market