신규 분자 실체 의약품 시장 보고서 : 동향, 예측, 경쟁 분석(-2031년)
New Molecular Entity Drug Market Report: Trends, Forecast and Competitive Analysis to 2031
상품코드 : 1818412
리서치사 : Lucintel
발행일 : 2025년 09월
페이지 정보 : 영문 150 Pages
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한글목차

세계의 신규 분자 실체 의약품 시장의 미래는 병원 및 클리닉 시장에서의 기회로 유망시되고 있습니다. 세계의 신규 분자 실체 의약품 시장은 2025-2031년에 CAGR 5.1%로 성장할 것으로 예상됩니다. 이 시장의 주요 촉진요인은 전 세계에서 만성질환에 대한 부담이 증가하고 제약 연구에 대한 투자가 확대되고 있다는 점입니다.

신규 분자 실체 의약품 시장의 새로운 동향

신약 분자 실체 의약품 시장은 기술 발전, 규제 프레임워크의 진화, 개인 맞춤형 치료에 대한 관심 증가 등 몇 가지 새로운 동향에 의해 형성되고 있습니다. 이러한 추세는 신약의 개발, 승인, 환자 제공 방식에 영향을 미치고 있습니다.

이러한 추세는 혁신적인 치료법의 개발 및 승인을 가속화하고, 치료의 정확성을 향상시키며, 희귀질환에 대한 새로운 치료법에 대한 접근성을 확대함으로써 NME 의약품 시장에 변화를 가져오고 있습니다. 맞춤형 의료, 신속한 의약품 허가, AI의 활용은 의약품 개발 프로세스를 간소화하는 데 도움이 되고 있으며, 생물제제와 유전자 치료는 지금까지 치료할 수 없었던 질병에 대한 획기적인 솔루션을 제공합니다. 이러한 동향이 계속 발전함에 따라 의약품의 전망이 재구성되고, 환자 치료 결과가 개선되고, 시장 성장의 원동력이 될 것으로 보입니다.

신규 분자 실체 의약품 시장의 최근 동향

최근 몇 가지 주요 개발은 새로운 분자 화합물 시장을 형성하고, 기술 혁신을 촉진하고, 환자 치료를 개선하고 있습니다.

최근 신흥 시장에서의 최근 동향은 특히 암, 신경, 희귀질환 분야에서 기술 혁신을 가속화하고 있습니다. 획기적인 치료법의 승인, mRNA 기술의 발전, 생물제제의 등장으로 전 세계 환자들의 치료 옵션이 확대되고 있습니다. 또한 규제 변화로 인해 새로운 치료법이 시장에 출시되기까지의 과정이 빨라져 미충족 의료 수요에 대한 대응이 더욱 효율적으로 이루어지고 있습니다. 이러한 개발은 복잡한 질병에 대처하기 위한 새로운 치료법의 도입 속도와 정확성을 향상시키고, 신약 시장을 재편하고 있습니다.

목차

제1장 개요

제2장 시장 개요

제3장 시장 동향과 예측 분석

제4장 유형별 세계의 신규 분자 실체 의약품 시장

제5장 용도별 세계의 신규 분자 실체 의약품 시장

제6장 지역 분석

제7장 북미의 신규 분자 실체 의약품 시장

제8장 유럽의 신규 분자 실체 의약품 시장

제9장 아시아태평양의 신규 분자 실체 의약품 시장

제10장 기타 지역의 신규 분자 실체 의약품 시장

제11장 경쟁 분석

제12장 기회와 전략 분석

제13장 밸류체인 전체에 걸친 주요 기업의 기업 개요

제14장 부록

KSA
영문 목차

영문목차

The future of the global new molecular entity drug market looks promising with opportunities in the hospital and clinic markets. The global new molecular entity drug market is expected to grow with a CAGR of 5.1% from 2025 to 2031. The major drivers for this market are the increasing global burden of chronic conditions and the growing investments in pharmaceutical research.

Emerging Trends in the New Molecular Entity Drug Market

The new molecular entity drug market is being shaped by several emerging trends, including technological advancements, evolving regulatory frameworks, and increased focus on personalized treatments. These trends are impacting how new drugs are developed, approved, and delivered to patients.

These trends are revolutionizing the NME drug market by accelerating the development and approval of innovative therapies, improving the precision of treatments, and expanding access to novel treatments for rare diseases. Personalized medicine, accelerated regulatory approvals, and the use of AI are helping streamline the drug development process, while biologics and gene therapy are providing groundbreaking solutions for previously untreatable conditions. As these trends continue to evolve, they will reshape the pharmaceutical landscape, improving patient outcomes and driving market growth.

Recent Developments in the New Molecular Entity Drug Market

Several key developments have been shaping the new molecular entity drug market, driving innovation, and improving patient care in recent years.

Recent developments in the NME drug market have accelerated innovation, particularly in oncology, neurology, and rare diseases. The approval of breakthrough therapies, advances in mRNA technology, and the rise of biologics are expanding treatment options for patients worldwide. Regulatory changes have also sped up the process of getting new treatments to market, addressing unmet medical needs more efficiently. These developments are reshaping the NME drug market, improving the speed and precision with which new therapies are introduced to address complex diseases.

Strategic Growth Opportunities in the New Molecular Entity Drug Market

The new molecular entity drug market presents several strategic growth opportunities across various applications, with increasing demand for targeted and personalized therapies.

The strategic growth opportunities in the NME drug market are driven by the demand for innovative therapies in oncology, rare diseases, neurological disorders, and infectious diseases. Advances in personalized medicine and precision therapies are expanding treatment options and improving patient outcomes. These opportunities are reshaping the pharmaceutical industry, driving innovation and investment in the development of next-generation treatments that address complex and previously untreatable diseases.

New Molecular Entity Drug Market Driver and Challenges

The NME drug market is influenced by a variety of drivers and challenges, which include technological, economic, and regulatory factors.

The factors responsible for driving the new molecular entity drug market include:

1. Advancements in Biotechnology: Biotechnology innovations, particularly in gene editing and biologics, are driving the NME drug market forward. New technologies such as CRISPR and RNA-based therapies are enabling the development of novel treatments for complex diseases, paving the way for next-generation drugs. These advancements are helping pharmaceutical companies create more effective, targeted therapies that improve patient outcomes.

2. Increased Research and Development Investment: Significant investment in research and development (R&D) is fueling innovation in the NME drug market. Pharmaceutical companies, particularly biotech firms, are investing heavily in exploring new drug discovery approaches, clinical trials, and collaboration with research institutions. This increased investment is accelerating the development of novel treatments and expanding the drug pipeline.

3. Regulatory Support for Innovation: Regulatory agencies in key markets are supporting the development of innovative drugs through expedited approval pathways, such as the FDA's Breakthrough Therapy Designation and the EMA's PRIME program. These regulatory measures help reduce time-to-market for NME drugs, providing faster access to life-saving treatments for patients in need.

4. Growing Global Healthcare Demand: The increasing demand for healthcare services, driven by aging populations, chronic disease burdens, and emerging health threats like infectious diseases, is fueling the demand for new drugs. The global healthcare market is expanding, and NME drugs are at the forefront of meeting these needs, especially in underserved regions.

5. Collaborations and Partnerships: Collaborations between pharmaceutical companies, academic institutions, and healthcare providers are enabling faster drug discovery and development. By pooling resources and expertise, stakeholders can accelerate clinical trials, share research data, and bring new drugs to market more efficiently. These partnerships are essential for advancing the NME drug pipeline.

Challenges in the new molecular entity drug market are:

1. High Development Costs: The development of new molecular entities is expensive and time-consuming. Clinical trials, regulatory approvals, and the need for specialized expertise all contribute to the high costs associated with developing NMEs. This can limit the ability of smaller companies to compete and may delay the introduction of new treatments.

2. Market Access Barriers: Despite regulatory approvals, market access barriers, including pricing and reimbursement challenges, can hinder the availability of NME drugs. In many cases, the high cost of innovative therapies can limit their affordability and accessibility, particularly in low- and middle-income countries.

3. Complexity of Clinical Trials: The complexity of designing and conducting clinical trials, particularly for rare diseases and personalized medicine, presents a significant challenge in the NME drug market. Recruiting patients, managing diverse study populations, and ensuring rigorous trial methodologies require significant resources and time.

While drivers such as technological advancements, R&D investment, and regulatory support are fueling growth in the NME drug market, challenges like high costs, market access barriers, and clinical trial complexities remain key obstacles. Overcoming these challenges will be crucial to ensuring continued innovation and accessibility in the NME drug market.

List of New Molecular Entity 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 new molecular entity drug companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the new molecular entity drug companies profiled in this report include-

New Molecular Entity Drug Market by Segment

The study includes a forecast for the global new molecular entity drug market by type, application, and region.

New Molecular Entity Drug Market by Type [Value from 2019 to 2031]:

New Molecular Entity Drug Market by Application [Value from 2019 to 2031]:

New Molecular Entity Drug Market by Region [Value from 2019 to 2031]:

Country Wise Outlook for the New Molecular Entity Drug Market

The new molecular entity drug market has been undergoing significant growth due to advancements in biotechnology, precision medicine, and an increased understanding of disease mechanisms. These drugs are critical in treating conditions that have limited therapeutic options. With an emphasis on personalized treatment, the market in countries like the United States, China, Germany, India, and Japan is experiencing rapid innovation. Regulatory agencies, industry collaborations, and research institutions are playing pivotal roles in accelerating the discovery and approval of these groundbreaking treatments, impacting both healthcare systems and patient outcomes.

Features of the Global New Molecular Entity Drug Market

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

This report answers following 11 key questions:

Table of Contents

1. Executive Summary

2. Market Overview

3. Market Trends & Forecast Analysis

4. Global New Molecular Entity Drug Market by Type

5. Global New Molecular Entity Drug Market by Application

6. Regional Analysis

7. North American New Molecular Entity Drug Market

8. European New Molecular Entity Drug Market

9. APAC New Molecular Entity Drug Market

10. ROW New Molecular Entity Drug Market

11. Competitor Analysis

12. Opportunities & Strategic Analysis

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

14. Appendix

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