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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.

• Lucintel의 예측에 따르면 유형별로는 저분자 의약품이 예측 기간 중 가장 높은 성장세를 보일 것으로 예측됩니다.
• 용도별로는 병원이 가장 높은 성장이 예상됩니다.
• 지역별로는 아시아태평양이 예측 기간 중 가장 높은 성장을 보일 것으로 예측됩니다.

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.

• 맞춤형 의료: 맞춤형 의료는 NME 의약품 시장의 중요한 동향이며, 개인의 유전자 프로파일과 질병 특성에 따라 맞춤형 치료에 점점 더 초점을 맞추었습니다. 이 접근법은 특히 암 영역이나 희귀 유전성 질환에서 질병의 근본적인 원인을 타겟으로 하여 치료 효과를 높일 수 있습니다. 이에 따라 제약사들은 표적치료제 개발을 위해 정밀의료, 바이오마커 연구, 동반진단에 많은 투자를 하고 있습니다. 개인 맞춤형 치료는 부작용을 최소화하고 환자의 치료 결과와 만족도를 향상시키는데도 도움이 됩니다.
• 의약품 허가 신속화: 미충족 의료 수요에 대응하기 위해 미국, 중국, 일본을 포함한 많은 국가에서 미충족 수요 치료제에 대한 신속한 허가 취득을 시행하고 있습니다. FDA의 획기적 치료 지정(Breakthrough Therapy Designation)이나 EMA의 PRIME 프로그램과 같은 구상은 중증 질환 치료에 유망 의약품의 승인 절차를 가속화하기 위한 것입니다. 이러한 규제 개혁은 신약이 시장에 출시되는 시간을 단축하고, 혁신적인 치료법에 대한 접근성을 높이며, 세계 보건 문제에 보다 효율적으로 대응할 수 있도록 함으로써 환자와 제약사 모두에게 혜택을 주고 있습니다.
• 생물제제 및 유전자 치료: 생물제제 및 유전자 치료의 보급은 과거 치료 불가능하다고 여겨졌던 질병에 대한 새로운 치료 옵션을 제공함으로써 NME 의약품 시장에 변화를 가져오고 있습니다. 모노클로널 항체, 백신, 재조합 단백질을 포함한 생물제제는 암, 자가면역질환, 유전성 질환의 치료에 널리 보급되고 있습니다. 유전자 치료는 분자 수준에서 유전자 돌연변이를 교정할 수 있는 가능성을 제공하며, 이전에는 불치병이었던 질병에 대한 장기적인 해결책을 제시하고 있습니다. 이러한 변화는 NME 의약품 시장의 범위를 확장하고, 생물제제 및 유전자 치료 부문의 기업에게 새로운 기회를 가져다주고 있습니다.
• 인공지능(AI)과 머신러닝의 통합: AI와 머신러닝이 NME 신약개발 프로세스에 통합되고 있습니다. 이러한 기술은 연구자들이 대규모 데이터세트를 분석하고, 새로운 신약 타겟을 식별하고, 기존 방법보다 더 효율적으로 화합물의 효능을 예측하는 데 도움을 주고 있습니다. AI는 임상 검사 설계에도 활용되어 성공 가능성을 높이고 비용을 최소화하고 있습니다. AI 기술의 진화에 따라 신약개발에 적용함으로써 시장 출시까지의 시간이 단축되고, 다양한 질병에 대한 표적치료가 보다 성공적으로 이루어질 것으로 기대됩니다.
• 희귀질환에 대한 집중: 효과적인 치료법이 없는 희귀질환이나 희귀질환을 치료하기 위해 새로운 분자 실체를 개발하는 것이 중요해지고 있습니다. 이러한 추세는 희귀질환 치료제 지정과 같은 규제적 특혜와 이들 질환의 분자 기전에 대한 연구 증가에 의해 촉진되고 있습니다. 제약사들은 이러한 환자군의 미충족 수요를 충족시킴으로써 과학적으로나 상업적으로 성공할 수 있는 가능성을 인식하고 있습니다. 유전자치료, 생물제제, 맞춤의료의 발전으로 NME 의약품은 희귀질환의 치료 상황을 바꿀 수 있는 큰 잠재력을 가지고 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.

• 획기적인 암 치료제 승인 최근 분자 화합물 시장에서 가장 중요한 동향 중 하나는 특히 면역종양학 분야에서 몇 가지 획기적인 암 치료제가 승인되었습니다는 점입니다. 면역관문억제제, CAR T 세포치료제 등의 치료는 다양한 암 치료에 혁명을 일으켰습니다. 이러한 치료법은 신체의 면역체계를 이용해 암과 싸우는 것으로, 진행성 및 난치성 암 환자들에게 희망을 주는 치료법입니다. 이러한 혁신적인 치료법의 승인은 임상시험에서 유망 결과를 보이고 임상 현장에서의 채택이 확대되고 있으며, 종양학의 새로운 시대를 예고하고 있습니다.
• mRNA 기반 백신의 발전: COVID-19 팬데믹은 백신뿐만 아니라 새로운 분자체의 개발에서도 mRNA 기술의 가능성을 부각시켰습니다. Moderna와 Pfizer와 같은 회사는 mRNA 백신 기술의 선구자이며, 이 접근법은 현재 암과 희귀 유전 질환을 포함한 다른 질병에 대해서도 검토되고 있습니다. mRNA 백신의 성공은 NME 의약품 개발의 새로운 길을 열었고, 분자 수준에서 특정 질병을 표적으로 하는 치료법을 신속하게 생산하고 맞춤화할 수 있게 했습니다.
• 알츠하이머병 치료에 집중: 신경퇴행성 질환 치료에 대한 수요가 증가함에 따라 알츠하이머병에 대한 NME 의약품 개발에 많은 투자와 연구가 이루어지고 있습니다. 최근 항아밀로이드 베타 요법 등 알츠하이머병의 진행을 늦추기 위한 새로운 분자체가 주목받고 있습니다. 이들 치료법 중 일부는 아직 초기 단계에 있지만, 이들 치료법이 승인되면 오랫동안 효과적인 치료법이 없었던 알츠하이머병 치료에 큰 진전이 있을 것으로 보입니다.
• 생물제제에 대한 투자 증가: NME를 개발하는 제약회사들에게 생물제제는 점점 더 중요한 초점이 되고 있습니다. 신약 승인에서 생물제제가 차지하는 비중이 높아지는 가운데, 각 제약사들은 모노클로널 항체, 유전자치료제, 유전자 재조합 단백질을 포함한 파이프라인을 확장하고 있습니다. 이러한 생물제제에 대한 관심은 특히 암, 자가면역질환, 희귀유전질환 분야에서 NME 의약품 시장을 발전시킬 것으로 기대됩니다. 생물제제 증가는 또한 제조 및 전달 방법의 발전에 박차를 가하여 이러한 고비용 치료에 대한 접근성을 향상시키고 있습니다.
• 의약품 승인 신속화를 위한 규제 개혁: FDA, EMA, NMPA 등 주요 시장 규제 당국은 신약 승인 속도를 높이기 위해 여러 가지 구상을 시행하고 있습니다. 패스트트랙 지정, 혁신치료제 지정, 우선심사 지정으로 유망 신약이 더 빨리 시장에 출시될 수 있게 되었습니다. 이러한 규제 변화로 인해 환자들은 혁신적인 치료법을 보다 빠르게 접할 수 있게 되었고, 중요한 치료법이 전 세계에서 출시되기까지 걸리는 시간이 단축되었으며, 제약사들 간의 차세대 신약 개발 경쟁이 더욱 치열해지고 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

• 배경과 분류
• 공급망

제3장 시장 동향과 예측 분석

• 거시경제 동향과 예측
• 산업 촉진요인과 과제
• PESTLE 분석
• 특허 분석
• 규제 환경

제4장 유형별 세계의 신규 분자 실체 의약품 시장

• 개요
• 유형별 매력 분석
• 항체 : 동향과 예측(2019-2031년)
• 폴리펩티드 : 동향과 예측(2019-2031년)
• 저분자 의약품 : 동향과 예측(2019-2031년)
• 기타 : 동향과 예측(2019-2031년)

제5장 용도별 세계의 신규 분자 실체 의약품 시장

• 개요
• 용도별 매력 분석
• 병원 : 동향과 예측(2019-2031년)
• 클리닉 : 동향과 예측(2019-2031년)

제6장 지역 분석

• 개요
• 지역의 신규 분자 실체 의약품 시장

제7장 북미의 신규 분자 실체 의약품 시장

• 개요
• 북미의 신규 분자 실체 의약품 시장(유형별)
• 북미의 신규 분자 실체 의약품 시장(용도별)
• 미국의 신규 분자 실체 의약품 시장
• 멕시코의 신규 분자 실체 의약품 시장
• 캐나다의 신규 분자 실체 의약품 시장

제8장 유럽의 신규 분자 실체 의약품 시장

• 개요
• 유럽의 신규 분자 실체 의약품 시장(유형별)
• 유럽의 신규 분자 실체 의약품 시장(용도별)
• 독일의 신규 분자 실체 의약품 시장
• 프랑스의 신규 분자 실체 의약품 시장
• 스페인의 신규 분자 실체 의약품 시장
• 이탈리아의 신규 분자 실체 의약품 시장
• 영국의 신규 분자 실체 의약품 시장

제9장 아시아태평양의 신규 분자 실체 의약품 시장

• 개요
• 아시아태평양의 신규 분자 실체 의약품 시장(유형별)
• 아시아태평양의 신규 분자 실체 의약품 시장(용도별)
• 일본의 신규 분자 화합물 의약품 시장
• 인도의 신규 분자 실체 의약품 시장
• 중국의 신규 분자 실체 의약품 시장
• 한국의 신규 분자 실체 의약품 시장
• 인도네시아의 신규 분자 실체 의약품 시장

제10장 기타 지역의 신규 분자 실체 의약품 시장

• 개요
• 기타 지역의 신규 분자 실체 의약품 시장(유형별)
• 기타 지역의 신규 분자 실체 의약품 시장(용도별)
• 중동의 신규 분자 실체 의약품 시장
• 남미의 신규 분자 실체 의약품 시장
• 아프리카의 신규 분자 실체 의약품 시장

제11장 경쟁 분석

• 제품 포트폴리오 분석
• 운영 통합
• Porter's Five Forces 분석
  • 경쟁 기업 간 경쟁 관계
  • 바이어의 교섭력
  • 공급 기업의 교섭력
  • 대체품의 위협
  • 신규 진출업체의 위협
• 시장 점유율 분석

제12장 기회와 전략 분석

• 밸류체인 분석
• 성장 기회 분석
  • 유형별 성장 기회
  • 용도별 성장 기회
• 세계의 신규 분자 실체 의약품 시장에서의 새로운 동향
• 전략 분석
  • 신제품 개발
  • 인증과 라이선싱
  • 합병, 인수, 계약, 제휴, 합병사업

제13장 밸류체인 전체에 걸친 주요 기업의 기업 개요

• 경쟁 분석
• UCB
• Otsuka Pharmaceutical
• Eli Lilly
• Genentech
• Eisai
• Biogen
• Menarini Group
• GSK
• Chest
• Travere

제14장 부록

• 도표
• 표 리스트
• 조사 방법
• 면책사항
• 저작권
• 약어와 기술 단위
• Lucintel 소개
• 문의처

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.

• Lucintel forecasts that, within the type category, small molecule drugs are expected to witness the highest growth over the forecast period.
• Within the application category, hospitals are expected to witness the highest growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

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.

• Personalized Medicine: Personalized medicine is a key trend in the NME drug market, with an increasing focus on tailoring treatments based on individual genetic profiles and disease characteristics. This approach improves the efficacy of treatments by targeting the underlying causes of diseases, especially in oncology and rare genetic disorders. As a result, pharmaceutical companies are investing heavily in precision medicine, biomarker research, and companion diagnostics to develop targeted therapies. Personalized treatments also helps to minimize side effects and improve patient outcomes and satisfaction.
• Accelerated Regulatory Approvals: To address unmet medical needs, many countries, including the U.S., China, and Japan, are implementing faster regulatory pathways for NME drugs. Initiatives like the FDA's Breakthrough Therapy Designation and the EMA's PRIME program are designed to expedite the approval process for drugs that show significant promise in treating serious conditions. These regulatory changes are reducing the time it takes for new drugs to reach the market, benefiting both patients and pharmaceutical companies by speeding up access to innovative therapies and addressing global health challenges more efficiently.
• Biologics and Gene Therapy: The increasing use of biologics and gene therapies is transforming the NME drug market, as these therapies offer new treatment options for diseases that were once considered untreatable. Biologics, which include monoclonal antibodies, vaccines, and recombinant proteins, are becoming more prevalent in treating cancer, autoimmune diseases, and genetic disorders. Gene therapies are offering the potential to correct genetic mutations at the molecular level, providing long-term solutions for previously incurable conditions. This shift is expanding the scope of the NME drug market, creating new opportunities for companies in the biologics and gene therapy space.
• Integration of Artificial Intelligence (AI) and Machine Learning: AI and machine learning are increasingly being integrated into the NME drug discovery process. These technologies are helping researchers analyze large datasets, identify new drug targets, and predict the effectiveness of compounds more efficiently than traditional methods. AI is also being used to design clinical trials, improving the likelihood of success and minimizing costs. As AI technology evolves, its application in drug discovery and development is expected to reduce time-to-market and lead to more successful, targeted therapies for a range of diseases.
• Focus on Rare Diseases: There is a growing emphasis on developing new molecular entities to treat rare and orphan diseases, which often lack effective treatments. This trend is being driven by regulatory incentives, such as orphan drug designations, and increased research into the molecular mechanisms of these diseases. Pharmaceutical companies are recognizing the potential for both scientific and commercial success in addressing unmet needs in this underserved patient population. With advancements in gene therapies, biologics, and personalized medicine, there is significant potential for NME drugs to transform the treatment landscape for rare diseases.

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.

• Approval of Breakthrough Cancer Therapies: One of the most significant recent developments in the NME drug market is the approval of several breakthrough cancer therapies, particularly in immuno-oncology. Drugs like immune checkpoint inhibitors and CAR T-cell therapies have revolutionized the treatment of various cancers. These therapies harness the body's immune system to fight cancer, offering hope for patients with advanced or refractory cancers. The approval of these innovative treatments has marked a new era in oncology, with promising results in clinical trials and growing adoption in clinical settings.
• Advances in mRNA-Based Vaccines: The COVID-19 pandemic highlighted the potential of mRNA technology, not only for vaccines but also for developing new molecular entities. Companies like Moderna and Pfizer have been pioneers in mRNA vaccine technology, and this approach is now being explored for other diseases, including cancer and rare genetic disorders. The success of mRNA vaccines has opened new avenues for NME drug development, allowing for rapid production and customization of therapies to target specific diseases at the molecular level.
• Focus on Alzheimer's Disease Treatments: There has been significant investment and research into developing NME drugs for Alzheimer's disease, driven by the growing need for treatments for neurodegenerative disorders. In recent years, several new molecular entities aimed at slowing the progression of Alzheimer's have received attention, including anti-amyloid beta therapies. While some of these therapies are still in the early stages, their approval would represent a major step forward in treating Alzheimer's, which has long lacked effective therapeutic options.
• Increased Investment in Biologics: Biologics are increasingly becoming a key focus of pharmaceutical companies developing NMEs. With biologics accounting for a growing share of new drug approvals, companies are expanding their pipelines to include monoclonal antibodies, gene therapies, and recombinant proteins. This focus on biologics is expected to drive the NME drug market forward, particularly in the areas of oncology, autoimmune diseases, and rare genetic disorders. The rise in biologics has also spurred advances in manufacturing and delivery methods, improving the accessibility of these high-cost treatments.
• Regulatory Changes to Speed Drug Approvals: Regulatory agencies in key markets, such as the FDA, EMA, and NMPA, have implemented several initiatives to expedite the approval of NMEs. Fast Track Designations, Breakthrough Therapy Designations, and Priority Review designations have allowed promising new drugs to reach the market more quickly. These regulatory changes are enabling patients to access innovative therapies sooner, reducing the time it takes for critical treatments to be available globally, and driving competition among pharmaceutical companies to develop the next generation of NME drugs.

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.

• Oncology Treatments: The oncology segment remains one of the most significant growth opportunities in the NME drug market. New molecular entities are revolutionizing cancer treatment, particularly through immunotherapy, targeted therapies, and personalized medicine. As cancer continues to be a leading cause of death worldwide, the demand for effective and innovative cancer treatments is high. Pharmaceutical companies are investing heavily in developing NMEs to address unmet needs in oncology, especially for rare and difficult-to-treat cancers.
• Rare and Orphan Diseases: There is a growing focus on developing NMEs for rare and orphan diseases, which often have limited treatment options. Regulatory incentives such as orphan drug designations are encouraging pharmaceutical companies to develop therapies for these underserved patient populations. Advances in gene therapies, biologics, and precision medicine are creating new opportunities to address complex diseases, offering hope for patients with previously untreatable conditions.
• Neurological Disorders: The neurological disorder segment is another key area of growth for the NME drug market. Diseases such as Alzheimer's, Parkinson's, and multiple sclerosis are gaining increased attention from researchers and drug developers. The aging global population and the lack of effective treatments for many neurological conditions create a substantial market opportunity. Innovations in gene therapy, biologics, and targeted small molecules are driving growth in this sector.
• Infectious Diseases: The rise in antimicrobial resistance and the growing demand for new treatments for infectious diseases create significant opportunities in the NME drug market. With the COVID-19 pandemic underscoring the importance of rapid drug development and global collaboration, the focus on developing NMEs for infectious diseases has intensified. Companies are exploring new mechanisms of action, such as antiviral and antibacterial-resistant drugs, to address emerging global health threats.
• Personalized Medicine and Precision Therapies: The increasing shift toward personalized medicine presents a significant growth opportunity for the NME drug market. With the help of biomarkers, genetic testing, and AI-driven tools, pharmaceutical companies can develop tailored therapies that address individual patient profiles. This approach is particularly promising in oncology, rare diseases, and autoimmune conditions. Personalized medicine allows for more effective treatments with fewer side effects, providing long-term value for both patients and healthcare systems.

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-

• UCB
• Otsuka Pharmaceutical
• Eli Lilly
• Genentech
• Eisai
• Biogen
• Menarini Group
• GSK
• Chest
• Travere

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]:

• Antibody
• Polypeptide
• Small Molecule Drug
• Other

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

• Hospitals
• Clinics

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

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

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.

• United States: The United States remains at the forefront of NME drug development, with a significant number of new molecular entities being approved by the U.S. Food and Drug Administration (FDA). Key therapeutic areas such as oncology, immunology, and neurology are seeing rapid advancements in NME treatments. The FDA's expedited approval pathways, such as Breakthrough Therapy and Accelerated Approval, have been instrumental in bringing innovative treatments to market faster. Additionally, the growing emphasis on personalized medicine and biologics is driving innovation in the U.S. NME drug market, with many biotech firms focusing on targeted therapies for rare diseases and cancer.
• China: China's pharmaceutical industry has seen substantial growth in recent years, with a strong focus on developing and commercializing new molecular entities. The country has made significant strides in regulatory reform, with the China National Medical Products Administration (NMPA) accelerating drug approval processes, leading to an increase in NME drug launches. Areas like oncology, diabetes, and cardiovascular diseases are seeing increasing numbers of new drugs entering the market. China is also becoming a hub for clinical trials, with multinational pharmaceutical companies leveraging the country's vast population to test new drugs, facilitating faster approval and commercialization.
• Germany: Germany, as a leader in Europe, has been making notable progress in the NME drug market, particularly in oncology, immunology, and rare diseases. The country's robust healthcare infrastructure, strong regulatory environment, and innovative biotech companies have contributed to the rapid development of new drugs. The European Medicines Agency (EMA) has played a vital role in expediting approvals within the EU, with Germany benefiting from these initiatives. Moreover, Germany's emphasis on precision medicine and its investment in research collaborations with academic institutions and global pharmaceutical companies is helping shape the future of NME drug development in the region.
• India: The Indian NME drug market is seeing rapid growth due to an increasing focus on research and development (R&D) and the country's growing biotech ecosystem. Indian pharmaceutical companies are increasingly involved in the development of new molecular entities, particularly for treating infectious diseases, cancer, and diabetes. The Indian government's initiatives, such as the "Pharma Vision 2020," aim to boost the country's pharmaceutical R&D capabilities. Additionally, India is playing a crucial role in the global supply chain, with a growing number of clinical trials being conducted in the country, contributing to NME drug discovery and development.
• Japan: Japan is a key player in the NME drug market, with strong government support for pharmaceutical innovation. The Japanese Ministry of Health, Labour, and Welfare (MHLW) has created a favorable environment for drug approval with initiatives such as the Sakigake Designation System, which accelerates the development of innovative drugs. Japan's aging population is a key driver for the demand for NME drugs, especially in the fields of oncology, neurodegenerative diseases, and cardiovascular disorders. Additionally, Japan is home to several global pharmaceutical companies that are investing in cutting-edge research and clinical trials to develop new drugs that address unmet medical needs.

Features of the Global New Molecular Entity Drug Market

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

• Q.1. What are some of the most promising, high-growth opportunities for the new molecular entity drug market by type (antibody, polypeptide, small molecule drug, and other), application (hospitals and clinics), 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 New Molecular Entity Drug Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Antibody: Trends and Forecast (2019-2031)
• 4.4 Polypeptide: Trends and Forecast (2019-2031)
• 4.5 Small Molecule Drug: Trends and Forecast (2019-2031)
• 4.6 Other: Trends and Forecast (2019-2031)

5. Global New Molecular Entity 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)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global New Molecular Entity Drug Market by Region

7. North American New Molecular Entity Drug Market

• 7.1 Overview
• 7.2 North American New Molecular Entity Drug Market by Type
• 7.3 North American New Molecular Entity Drug Market by Application
• 7.4 United States New Molecular Entity Drug Market
• 7.5 Mexican New Molecular Entity Drug Market
• 7.6 Canadian New Molecular Entity Drug Market

8. European New Molecular Entity Drug Market

• 8.1 Overview
• 8.2 European New Molecular Entity Drug Market by Type
• 8.3 European New Molecular Entity Drug Market by Application
• 8.4 German New Molecular Entity Drug Market
• 8.5 French New Molecular Entity Drug Market
• 8.6 Spanish New Molecular Entity Drug Market
• 8.7 Italian New Molecular Entity Drug Market
• 8.8 United Kingdom New Molecular Entity Drug Market

9. APAC New Molecular Entity Drug Market

• 9.1 Overview
• 9.2 APAC New Molecular Entity Drug Market by Type
• 9.3 APAC New Molecular Entity Drug Market by Application
• 9.4 Japanese New Molecular Entity Drug Market
• 9.5 Indian New Molecular Entity Drug Market
• 9.6 Chinese New Molecular Entity Drug Market
• 9.7 South Korean New Molecular Entity Drug Market
• 9.8 Indonesian New Molecular Entity Drug Market

10. ROW New Molecular Entity Drug Market

• 10.1 Overview
• 10.2 ROW New Molecular Entity Drug Market by Type
• 10.3 ROW New Molecular Entity Drug Market by Application
• 10.4 Middle Eastern New Molecular Entity Drug Market
• 10.5 South American New Molecular Entity Drug Market
• 10.6 African New Molecular Entity 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 New Molecular Entity 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 UCB
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Otsuka Pharmaceutical
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Eli Lilly
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Genentech
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Eisai
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Biogen
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Menarini Group
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 GSK
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Chest
  • Company Overview
  • New Molecular Entity Drug Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Travere
  • Company Overview
  • New Molecular Entity 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