市场调查报告书
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mRNA 治疗合约开发和製造市场 - 2018-2028 年全球行业规模、份额、趋势、机会和预测,按应用、按适应症、按最终用户、按地区和竞争细分mRNA Therapeutics Contract Development & Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Application, By Indication, By End user, By Region and Competition |
2022 年,全球 mRNA 治疗合约开发和製造 (CDMO) 市场价值为 85.1 亿美元,预计在预测期内将出现令人印象深刻的增长,到 2028 年复合CAGR为7.11%。近年来,医学领域取得了重大进步,而最具革命性的突破之一是mRNA疗法的发展。这些尖端疗法利用了信使 RNA (mRNA) 的力量,有潜力解决从癌症到传染病等多种疾病。随着这一领域的不断发展,对专门从事 mRNA 疗法的合约开发和製造组织 (CDMO) 的需求也在不断增长。
信使 RNA (mRNA) 疗法代表了一种透过指示人类自身细胞产生治疗性蛋白质来治疗疾病的新方法。随着 Pfizer-BioNTech 和 Moderna 等公司开发并成功部署基于 mRNA 的疫苗,这项技术一直是对抗 COVID-19 大流行的最前线。除了疫苗之外,mRNA 疗法在治疗各种遗传性疾病、罕见疾病甚至某些癌症方面也具有巨大潜力。随着 mRNA 疗法的前景越来越明显,对专门 CDMO 的需求激增。 CDMO 在基于 mRNA 的药物的开发和製造中发挥关键作用,提供配方、生产、品质控制和监管合规方面的专业知识。这个细分市场正在迅速扩大,以满足製药和生物技术公司不断增长的需求,这些公司包括老牌企业和新创公司,它们正在大力投资基于 mRNA 的疗法。
主要市场驱动因素
市场概况 | |
---|---|
预测期 | 2024-2028 |
2022 年市场规模 | 85.1亿美元 |
2028 年市场规模 | 128.1亿美元 |
2023-2028 年CAGR | 7.11% |
成长最快的细分市场 | 生技与製药公司 |
最大的市场 | 北美洲 |
研究和开发投资不断增长正在推动全球 mRNA 治疗合约开发和製造 (CDMO) 市场
mRNA治疗市场的快速成长吸引了许多参与者,加剧了CDMO之间的竞争。规模较小的 CDMO 可能难以与拥有更多资源和专业知识的规模更大、更成熟的公司竞争。差异化服务以及建立品质和可靠性声誉对于在这个竞争激烈的行业中取得成功至关重要。
技术创新
mRNA 治疗领域不断发展,新发现和技术快速涌现。 CDMO 必须投资于研发,以维持创新的前沿。随时了解最新进展至关重要,因为过时的技术可能很快就会过时,从而影响 CDMO 的竞争力。
主要市场趋势
技术进步
医学和製药领域不断发展,近年来最令人兴奋的进步之一是 mRNA 疗法的发展。这些突破性的疗法在治疗从癌症到传染病等各种疾病方面显示出巨大的潜力。随着对 mRNA 疗法的需求不断增长,对专门从事该领域的合约开发和製造组织 (CDMO) 的需求也在不断增长。
mRNA 疗法技术进步的快速扩张一直是 CDMO 市场成长的驱动力。 mRNA 生产方法变得更有效率且可扩展。脂质奈米颗粒 (LNP) 和微流控技术的不断创新显着增强了 mRNA 分子的配方和封装,从而可以开发更稳定、更有效的疗法。定序和基因编辑技术的进步促进了个人化 mRNA 疗法的发展。 CDMO 现在更有能力为个别患者量身定制 mRNA 治疗,为精准医疗开闢了新的可能性。 CDMO 对其製造流程进行了微调,以提高产量并降低生产成本。这使得 mRNA 疗法在更广泛的医疗条件下更容易获得且经济可行。製药公司、研究机构和 CDMO 之间的合作加速了 mRNA 疗法的开发。这些合作伙伴关係汇集了 mRNA 技术、药物开发和製造的专业知识。
细分市场洞察
应用洞察
根据应用类别,病毒疫苗将在 2022 年成为全球 mRNA 治疗合约开发和製造 (CDMO) 市场的主导者。病毒疫苗在 mRNA 治疗 CDMO 市场中的主导地位对公共健康来说是个好兆头,因为它有望快速开发新兴传染病的疫苗,并有望在癌症免疫治疗方面取得突破。它还强调了 CDMO 在将 mRNA 技术转化为有形治疗方法、最终造福全世界患者方面发挥的关键作用。美国 FDA 等监管机构已经认识到 mRNA 技术的潜力,并正在简化基于 mRNA 的疫苗和治疗药物的审批流程。这种支持鼓励了该领域的进一步开发和製造。製药巨头和生技新创公司都在基于 mRNA 的疗法上投入大量投资。针对各种疾病和病症开发 mRNA 疫苗的竞赛为专门从事病毒疫苗生产的 CDMO 创造了一个蓬勃发展的市场。基于 mRNA 的癌症疫苗和免疫疗法在生物製药行业中势头强劲。这些疗法利用人体的免疫系统专门针对癌细胞。随着该领域研究的进展,CDMO 越来越多地参与针对个别患者量身定制的个人化癌症疫苗的生产。除了 COVID-19 之外,mRNA 疫苗在解决其他传染病方面也显示出前景。 CDMO 在开发流感、寨卡病毒和其他病原体的 mRNA 疫苗方面发挥着至关重要的作用。 mRNA 技术的多功能性使其能够快速适应新的病毒株,使其成为疫苗开发的一个有吸引力的选择。
最终使用者见解
生物技术和製药公司部门预计在预测期内将经历快速成长。生物技术和製药公司处于 mRNA 治疗研究和开发的前沿。他们投入大量资金来确定新的治疗标靶、设计 mRNA 序列并进行临床前研究以评估这些疗法的安全性和有效性。这些公司拥有启动和管理大规模临床试验的资源和基础设施,这对于获得监管部门的批准至关重要。 mRNA 疗法在治疗各种疾病方面显示出巨大的前景,製药巨头热衷于利用这一潜力。生物技术和製药公司已经与医疗保健提供者建立了分销网络和关係,这使得他们在获得监管部门批准后更容易将 mRNA 疗法推向市场。这种管道对于确保这些创新疗法惠及有需要的患者至关重要。虽然 CDMO 专注于製造,但生物技术和製药公司通常拥有自己的製造设施或与 CDMO 建立策略合作伙伴关係。当有前景的 mRNA 疗法透过临床试验取得进展时,这使他们能够快速扩大生产规模。
区域洞察
到2022年,北美将成为全球mRNA治疗合约开发和製造(CDMO)市场的主导者,以价值计算,占据最大的市场份额。北美在 mRNA 治疗 CDMO 市场占据主导地位的主要原因之一是其蓬勃发展的生物技术生态系统。该地区拥有丰富的生物技术公司、学术机构、研究中心和新创公司网络。这些实体合作推进 mRNA 技术、开发创新疗法并提供全面的 CDMO 服务。波士顿、旧金山和圣地牙哥等主要城市已成为全球生物技术创新中心,拥有许多处于 mRNA 研究和开发前沿的公司。世界一流的人才、研究基础设施和资本投资的存在使北美能够突破 mRNA 疗法的界限。北美领先地位的另一个关键因素是强而有力的政府支持和监管框架。美国食品药物管理局 (FDA) 等政府机构透过简化监管流程、加快审批速度以及提供研发资金,为 mRNA 疗法铺平了道路。为了因应COVID-19大流行,美国的Operation Warp Speed加速了mRNA疫苗的研发与製造。这项倡议展示了 mRNA 技术的敏捷性和潜力,并进一步巩固了北美作为该领域领导者的地位。
Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market has valued at USD 8.51 Billion in 2022 and is anticipated to project impressive growth in the forecast period with a CAGR of 7.11% through 2028. The realm of medicine has witnessed significant advancements in recent years, and one of the most revolutionary breakthroughs is the development of mRNA therapeutics. These cutting-edge treatments, which leverage the power of messenger RNA (mRNA), have the potential to tackle a wide range of diseases, from cancer to infectious diseases. As this field continues to grow, so does the demand for contract development and manufacturing organizations (CDMOs) specializing in mRNA therapeutics.
Messenger RNA (mRNA) therapeutics represent a novel approach to treating diseases by instructing the body's own cells to produce therapeutic proteins. This technology has been at the forefront of the fight against the COVID-19 pandemic, with the development and successful deployment of mRNA-based vaccines by companies like Pfizer-BioNTech and Moderna. Beyond vaccines, mRNA therapeutics hold immense potential in the treatment of various genetic disorders, rare diseases, and even certain cancers. As the promise of mRNA therapeutics becomes increasingly evident, the demand for specialized CDMOs has surged. CDMOs play a pivotal role in the development and manufacturing of mRNA-based drugs, offering expertise in formulation, production, quality control, and regulatory compliance. This market segment is expanding rapidly to meet the growing needs of pharmaceutical and biotechnology companies, both established players and startups, who are investing heavily in mRNA-based therapies.
Key Market Drivers
Market Overview | |
---|---|
Forecast Period | 2024-2028 |
Market Size 2022 | USD 8.51 Billion |
Market Size 2028 | USD 12.81 Billion |
CAGR 2023-2028 | 7.11% |
Fastest Growing Segment | Biotechnology & Pharmaceutical Companies |
Largest Market | North America |
Growing Investment in Research and Development is Driving the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market
The surge in investment in R&D within the mRNA therapeutics sector has been a driving force behind the growth of the mRNA CDMO market. Several factors contribute to this increased investment. The remarkable success of mRNA-based COVID-19 vaccines has bolstered investor confidence in the technology. This has led to substantial funding for companies engaged in mRNA research and development. The mRNA therapeutics pipeline has expanded rapidly, with candidates in various stages of development for a wide range of diseases. Investors see the potential for mRNA to transform the treatment landscape across multiple therapeutic areas, spurring greater investment. Biopharmaceutical companies are forming partnerships and collaborations with CDMOs to accelerate the development and manufacturing of mRNA therapies. These partnerships often come with substantial financial commitments. Governments worldwide recognize the importance of mRNA therapeutics in addressing public health challenges. As a result, they are allocating significant funding to support research and development efforts in this field.
Expanding Therapeutic Applications is Driving the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market
One of the primary factors propelling the mRNA therapeutics CDMO market's growth is the increasing number of therapeutic applications. Initially, mRNA technology gained prominence for its potential in developing vaccines, as seen in the rapid development of COVID-19 vaccines by Pfizer-BioNTech and Moderna. However, its utility extends far beyond vaccines.
mRNA therapeutics are being explored for cancer treatment, with the ability to trigger an immune response against cancer cells or directly target them with specific therapies. mRNA can be used to correct genetic mutations responsible for rare diseases, offering hope to patients who previously had limited treatment options. mRNA technology can be adapted to create vaccines and treatments for various infectious diseases, from influenza to HIV. mRNA can be harnessed to modulate the immune system's response and treat autoimmune conditions like multiple sclerosis and rheumatoid arthritis. Researchers are investigating mRNA therapies to combat heart diseases by targeting specific genes associated with these conditions. mRNA therapeutics hold promise in treating neurological disorders, including Alzheimer's and Parkinson's disease.
As research continues to uncover new therapeutic opportunities, the demand for mRNA therapeutics CDMOs is expected to surge, as these organizations play a pivotal role in translating research into market-ready therapies. Contract development and manufacturing organizations specializing in mRNA therapeutics are crucial to the industry's success. These CDMOs provide essential services to biopharmaceutical companies, startups, and research institutions, allowing them to leverage mRNA technology without building their own production capabilities from scratch.
CDMOs can synthesize mRNA molecules tailored to specific therapeutic targets, ensuring precise and effective treatments. They optimize mRNA production processes, improving efficiency, scalability, and cost-effectiveness. CDMOs have the infrastructure and expertise to manufacture mRNA therapeutics at scale, meeting the growing demand. Ensuring that mRNA therapies meet rigorous quality and regulatory standards is vital, and CDMOs excel in this area. CDMOs expedite the development and production of mRNA therapeutics, allowing treatments to reach patients faster.
Key Market Challenges
Regulatory Hurdles
One of the most significant challenges in the mRNA therapeutics CDMO market is navigating complex regulatory landscapes. mRNA-based therapies represent a new frontier in medicine, and regulatory agencies worldwide are continually updating and adapting their guidelines. Manufacturers must ensure that their production processes and facilities meet stringent regulatory standards, which can vary from one region to another. Achieving regulatory compliance is a resource-intensive and time-consuming task that can delay product development and market entry.
Scalability Issues
Scalability is another major challenge faced by CDMOs in the mRNA therapeutics market. The production of mRNA vaccines and therapies requires state-of-the-art manufacturing facilities and equipment. Scaling up production capacity quickly to meet high demand, as seen during the COVID-19 pandemic, can be a logistical nightmare. Furthermore, mRNA therapies often involve complex and delicate processes that must be carefully controlled to maintain product quality and efficacy during scale-up.
Supply Chain Vulnerabilities
The global supply chain is vulnerable to various disruptions, including geopolitical tensions, natural disasters, and unexpected events like the COVID-19 pandemic. These disruptions can lead to shortages of critical raw materials, equipment, and skilled personnel needed for mRNA production. CDMOs must develop resilient supply chains, diversify sourcing options, and establish contingency plans to mitigate these risks.
Intellectual Property and Licensing
The mRNA therapeutics market is characterized by a complex web of intellectual property rights and licensing agreements. Many key technologies and patents are held by different companies and institutions, making it challenging for CDMOs to navigate the landscape. Negotiating licensing agreements, royalty payments, and compliance with various patents can add significant complexity and costs to mRNA therapy development.
Cost and Pricing Pressures
Developing and manufacturing mRNA therapies can be costly, especially in the early stages when technologies are still being optimized. Pricing pressures, both from healthcare systems and patient advocacy groups, can limit the profitability of mRNA CDMOs. Balancing the need for affordable treatments with the costs of research, development, and manufacturing poses a constant challenge.
The rapid growth of the mRNA therapeutics market has attracted numerous players, increasing competition among CDMOs. Smaller CDMOs may struggle to compete with larger, more established firms that have greater resources and expertise. Differentiating services and establishing a reputation for quality and reliability are vital for success in this highly competitive industry.
Technological Innovation
The mRNA therapeutics field is continuously evolving, with new discoveries and technologies emerging at a rapid pace. CDMOs must invest in research and development to stay at the forefront of innovation. Staying updated with the latest advancements is crucial, as outdated technologies can quickly become obsolete, impacting the competitiveness of a CDMO.
Key Market Trends
Technological Advancements
The field of medicine and pharmaceuticals is constantly evolving, and one of the most exciting advancements in recent years has been the development of mRNA therapeutics. These groundbreaking therapies have shown immense potential in treating various diseases, from cancer to infectious diseases. As the demand for mRNA therapeutics continues to grow, so does the need for contract development and manufacturing organizations (CDMOs) specialized in this field.
The rapid expansion of technological advancements in mRNA therapeutics has been a driving force behind the growth of the CDMO market. mRNA production methods have become more efficient and scalable. Continuous innovations in lipid nanoparticles (LNPs) and microfluidic technologies have significantly enhanced the formulation and encapsulation of mRNA molecules, allowing for the development of more stable and effective therapies. Advancements in sequencing and gene editing technologies have enabled the development of personalized mRNA therapies. CDMOs are now better equipped to tailor mRNA treatments to individual patients, opening up new possibilities in precision medicine. CDMOs have fine-tuned their manufacturing processes to increase yields and reduce production costs. This has made mRNA therapies more accessible and economically viable for a broader range of medical conditions. Collaboration between pharmaceutical companies, research institutions, and CDMOs has accelerated the development of mRNA therapies. These partnerships bring together expertise in mRNA technology, drug development, and manufacturing.
Segmental Insights
Application Insights
Based on the category of Application, Viral Vaccines emerged as the dominant player in the global market for mRNA Therapeutics Contract Development & Manufacturing (CDMO) in 2022. The dominance of viral vaccines in the mRNA Therapeutics CDMO market bodes well for public health, as it promises the rapid development of vaccines for emerging infectious diseases and the potential for breakthroughs in cancer immunotherapy. It also highlights the critical role CDMOs play in translating mRNA technology into tangible treatments, ultimately benefiting patients worldwide. Regulatory agencies such as the U.S. FDA have recognized the potential of mRNA technology and are streamlining the approval process for mRNA-based vaccines and therapeutics. This support encourages further development and manufacturing in this space. Pharmaceutical giants and biotech startups alike are pouring substantial investments into mRNA-based therapies. The race to develop mRNA vaccines for various diseases and conditions has created a booming market for CDMOs specializing in viral vaccine production. mRNA-based cancer vaccines and immunotherapies are gaining momentum in the biopharmaceutical industry. These therapies leverage the body's immune system to target cancer cells specifically. As research in this field advances, CDMOs are increasingly involved in the manufacturing of personalized cancer vaccines tailored to individual patients. Beyond COVID-19, mRNA vaccines have demonstrated promise in addressing other infectious diseases. CDMOs are playing a vital role in developing mRNA vaccines for influenza, Zika virus, and other pathogens. The versatility of mRNA technology allows for rapid adaptation to new viral strains, making it an attractive option for vaccine development.
End User Insights
The Biotechnology & Pharmaceutical Companies segment is projected to experience rapid growth during the forecast period. Biotechnology and pharmaceutical companies are at the forefront of mRNA therapeutic research and development. They invest heavily in identifying new therapeutic targets, designing mRNA sequences, and conducting pre-clinical studies to evaluate the safety and efficacy of these therapies. These companies have the resources and infrastructure to initiate and manage large-scale clinical trials, which are crucial for gaining regulatory approvals. mRNA therapies have shown immense promise in treating various diseases, and pharmaceutical giants are keen to capitalize on this potential. Biotechnology and pharmaceutical companies have established distribution networks and relationships with healthcare providers, making it easier for them to bring mRNA therapies to market once they receive regulatory approval. This access is crucial for ensuring that these innovative treatments reach patients in need. While CDMOs specialize in manufacturing, biotechnology and pharmaceutical companies often have their own manufacturing facilities or strategic partnerships with CDMOs. This enables them to scale up production quickly when a promising mRNA therapy advances through clinical trials.
Regional Insights
North America emerged as the dominant player in the global mRNA Therapeutics Contract Development & Manufacturing (CDMO) market in 2022, holding the largest market share in terms of value. One of the primary reasons for North America's dominance in the mRNA therapeutics CDMO market is its thriving biotechnology ecosystem. The region boasts a rich network of biotech companies, academic institutions, research centers, and startups. These entities collaborate to advance mRNA technology, develop innovative therapies, and provide comprehensive CDMO services. Key cities like Boston, San Francisco, and San Diego have become global hubs for biotech innovation, housing numerous companies at the forefront of mRNA research and development. The presence of world-class talent, research infrastructure, and capital investment has allowed North America to push the boundaries of mRNA therapeutics. Another pivotal factor in North America's leadership is the strong government support and regulatory framework in place. Government agencies such as the Food and Drug Administration (FDA) in the United States have paved the way for mRNA therapies by streamlining regulatory processes, expediting approvals, and providing funding for research and development. In response to the COVID-19 pandemic, Operation Warp Speed in the United States accelerated the development and manufacturing of mRNA vaccines. This initiative showcased the agility and potential of mRNA technology and further solidified North America's position as a leader in the field.
Danaher corporation (Aldevron)
Recipharm AB
Biomay AG
Samsung Biologics
Lonza Group AG
Catalent , Inc
Bio-Indication Inc
Kaneka Eurogentec S.A
TriLink BioTechnologies
BioNTech SE
In this report, the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below: