市場調查報告書
商品編碼
1406817
mRNA 治療合約開發和製造市場 - 2018-2028 年全球行業規模、佔有率、趨勢、機會和預測,按應用、按適應症、按最終用戶、按地區和競爭細分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 治療合約開發和製造 (CDMO) 市場價值為 85.1 億美元,預計在預測期內將出現令人印象深刻的成長,到 2028 年複合CAGR為7.11%。近年來,醫學領域取得了重大進步,而最具革命性的突破之一是mRNA療法的發展。這些尖端療法利用了信使 RNA (mRNA) 的力量,有潛力解決從癌症到傳染病等多種疾病。隨著這一領域的不斷發展,對專門從事 mRNA 療法的合約開發和製造組織 (CDMO) 的需求也在不斷成長。
信使 RNA (mRNA) 療法代表了一種透過指示人類自身細胞產生治療性蛋白質來治療疾病的新方法。隨著 Pfizer-BioNTech 和 Moderna 等公司開發並成功部署基於 mRNA 的疫苗,這項技術一直是對抗 COVID-19 大流行的最前線。除了疫苗之外,mRNA 療法在治療各種遺傳性疾病、罕見疾病甚至某些癌症方面也具有巨大潛力。隨著 mRNA 療法的前景越來越明顯,對專門 CDMO 的需求激增。 CDMO 在基於 mRNA 的藥物的開發和製造中發揮關鍵作用,提供配方、生產、品質控制和監管合規方面的專業知識。這個細分市場正在迅速擴大,以滿足製藥和生物技術公司不斷成長的需求,這些公司包括老牌企業和新創公司,它們正在大力投資基於 mRNA 的療法。
主要市場促進因素
市場概況 | |
---|---|
預測期 | 2024-2028 |
2022 年市場規模 | 85.1億美元 |
2028 年市場規模 | 128.1億美元 |
2023-2028 年CAGR | 7.11% |
成長最快的細分市場 | 生技與製藥公司 |
最大的市場 | 北美洲 |
研究和開發投資不斷成長正在推動全球 mRNA 治療合約開發和製造 (CDMO) 市場
mRNA治療市場的快速成長吸引了許多參與者,加劇了CDMO之間的競爭。規模較小的 CDMO 可能難以與擁有更多資源和專業知識的規模更大、更成熟的公司競爭。差異化服務以及建立品質和可靠性聲譽對於在這個競爭激烈的行業中取得成功至關重要。
技術創新
mRNA 治療領域不斷發展,新發現和技術快速湧現。 CDMO 必須投資於研發,以維持創新的前沿。隨時了解最新進展至關重要,因為過時的技術可能很快就會過時,從而影響 CDMO 的競爭力。
主要市場趨勢
技術進步
醫學和製藥領域不斷發展,近年來最令人興奮的進步之一是 mRNA 療法的發展。這些突破性的療法在治療從癌症到傳染病等各種疾病方面顯示出巨大的潛力。隨著對 mRNA 療法的需求不斷成長,對專門從事該領域的合約開發和製造組織 (CDMO) 的需求也在不斷成長。
mRNA 療法技術進步的快速擴張一直是 CDMO 市場成長的驅動力。 mRNA 生產方法變得更有效率且可擴展。脂質奈米顆粒 (LNP) 和微流控技術的不斷創新顯著增強了 mRNA 分子的配方和封裝,從而可以開發更穩定、更有效的療法。定序和基因編輯技術的進步促進了個人化 mRNA 療法的發展。 CDMO 現在更有能力為個別患者量身定做 mRNA 治療,為精準醫療開闢了新的可能性。 CDMO 對其製造流程進行了微調,以提高產量並降低生產成本。這使得 mRNA 療法在更廣泛的醫療條件下更容易獲得且經濟可行。製藥公司、研究機構和 CDMO 之間的合作加速了 mRNA 療法的開發。這些合作夥伴關係匯集了 mRNA 技術、藥物開發和製造的專業知識。
細分市場洞察
應用洞察
根據應用類別,病毒疫苗將在 2022 年成為全球 mRNA 治療合約開發和製造 (CDMO) 市場的主導者。病毒疫苗在 mRNA 治療 CDMO 市場中的主導地位對公共健康來說是個好兆頭,因為它有望快速開發新興傳染病的疫苗,並有望在癌症免疫治療方面取得突破。它還強調了 CDMO 在將 mRNA 技術轉化為有形治療方法、最終造福全世界患者方面發揮的關鍵作用。美國 FDA 等監管機構已經認知到 mRNA 技術的潛力,並正在簡化基於 mRNA 的疫苗和治療藥物的核准流程。這種支持鼓勵了該領域的進一步開發和製造。製藥巨頭和生技新創公司都在基於 mRNA 的療法上投入大量投資。針對各種疾病和病症開發 mRNA 疫苗的競賽為專門從事病毒疫苗生產的 CDMO 創造了一個蓬勃發展的市場。基於 mRNA 的癌症疫苗和免疫療法在生物製藥行業中勢頭強勁。這些療法利用人體的免疫系統專門針對癌細胞。隨著該領域研究的進展,CDMO 擴大參與針對個別患者量身定做的個人化癌症疫苗的生產。除了 COVID-19 之外,mRNA 疫苗在解決其他傳染病方面也顯示出前景。 CDMO 在開發流感、寨卡病毒和其他病原體的 mRNA 疫苗方面發揮著至關重要的作用。 mRNA 技術的多功能性使其能夠快速適應新的病毒株,使其成為疫苗開發的一個有吸引力的選擇。
最終使用者見解
生物技術和製藥公司部門預計在預測期內將經歷快速成長。生物技術和製藥公司處於 mRNA 治療研究和開發的前沿。他們投入大量資金來確定新的治療標靶、設計 mRNA 序列並進行臨床前研究以評估這些療法的安全性和有效性。這些公司擁有啟動和管理大規模臨床試驗的資源和基礎設施,這對於獲得監管部門的批准至關重要。 mRNA 療法在治療各種疾病方面顯示出巨大的前景,製藥巨頭熱衷於利用這一潛力。生物技術和製藥公司已經與醫療保健提供者建立了分銷網路和關係,這使得他們在獲得監管部門批准後更容易將 mRNA 療法推向市場。這種管道對於確保這些創新療法惠及有需要的患者至關重要。雖然 CDMO 專注於製造,但生物技術和製藥公司通常擁有自己的製造設施或與 CDMO 建立策略合作夥伴關係。當有前景的 mRNA 療法透過臨床試驗取得進展時,這使他們能夠快速擴大生產規模。
區域洞察
到2022年,北美將成為全球mRNA治療合約開發和製造(CDMO)市場的主導者,以價值計算,佔據最大的市場佔有率。北美在 mRNA 治療 CDMO 市場佔據主導地位的主要原因之一是其蓬勃發展的生物技術生態系統。該地區擁有豐富的生物技術公司、學術機構、研究中心和新創公司網路。這些實體合作推進 mRNA 技術、開發創新療法並提供全面的 CDMO 服務。波士頓、舊金山和聖地牙哥等主要城市已成為全球生物技術創新中心,擁有許多處於 mRNA 研究和開發前沿的公司。世界一流的人才、研究基礎設施和資本投資的存在使北美能夠突破 mRNA 療法的界限。北美領先地位的另一個關鍵因素是強而有力的政府支持和監管框架。美國食品藥物管理局 (FDA) 等政府機構透過簡化監管流程、加快核准速度以及提供研發資金,為 mRNA 療法鋪平了道路。為了因應COVID-19大流行,美國的Operation Warp Speed加速了mRNA疫苗的研發與製造。這項舉措展示了 mRNA 技術的敏捷性和潛力,並進一步鞏固了北美作為該領域領導者的地位。
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: