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市場調査レポート
商品コード
1184260
高分子原薬CDMO(開発製造受託機関)の世界市場の規模、シェア、産業動向分析レポート:用途別、サービス別、エンドユーザー別、地域別展望と予測、2022年~2028年Global Large Molecule Drug Substance CDMO Market Size, Share & Industry Trends Analysis Report By Application, By Service, By End-user, By Regional Outlook and Forecast, 2022 - 2028 |
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高分子原薬CDMO(開発製造受託機関)の世界市場の規模、シェア、産業動向分析レポート:用途別、サービス別、エンドユーザー別、地域別展望と予測、2022年~2028年 |
出版日: 2022年12月30日
発行: KBV Research
ページ情報: 英文 278 Pages
納期: 即納可能
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世界の高分子原薬CDMO(開発製造受託機関)市場規模は、2028年までに192億米ドルに達し、予測期間中にCAGR8.7%の市場成長率で上昇すると予測されています。
そのため、医薬品開発を進める上で、CDMOの研究能力、知識、製造能力は非常に必要とされています。そのため、多くのCDMOは、バイオテクノロジー企業や製薬企業の資金や技術資産による支援を受けて、第三者との統合ベンチャーに取り組んでいます。また、多くの顧客は、CDMOが製造した後も、上市などのノウハウを提供することを期待しています。
これは、CDMOの顧客基盤が大手製薬会社だけでなく、中小のバイオテクノロジー企業にも広がっていることが主な理由です。また、多くの中小バイオテクノロジー企業は、製造の経験を持たずに、医薬品のパイプラインの進化に幅広く注力しています。したがって、開発および製造業務においてCDMOの助けを借りることで、中小バイオ企業の業務を早期に取り込むことも可能となります。
COVID-19影響度分析
一部の政府は、現地で生産された治療薬やワクチンの十分な量を調達するための規制を課しました。しかし、生産能力は、サプライチェーンとロックダウンの制約により、まだ最大値には達していません。さらに、ロックダウンの制約により、労働力の減少がもたらされました。これらの制約により、リードタイムは大幅に増加し、最大で4倍にもなっています。生産が遅れ、需要が増加したことは、CDMOの成長をさらに後押ししました。したがって、パンデミックは、高分子原薬CDMO(開発製造受託機関)市場にプラスの影響を与えました。
市場成長要因
生物製剤およびバイオシミラーの研究開発の増加
パンデミック以降、多くの企業が生物学的製剤やバイオシミラー化合物の創出に多大な投資を行っています。現在、ペプチド、タンパク質、モノクローナル抗体など、探索段階にある生物製剤が、治療薬として使用される予定の候補品のほぼ半分を占めています。また、バイオ医薬品企業が研究開発に力を入れるようになり、その結果、多くの新規バイオ医薬品が開発中またはパイプラインにあることが分かっています。したがって、これらの要因はすべて、高分子医薬品原薬CDMO市場の成長を後押ししています。
心血管疾患(CVD)およびCVDに起因する死亡の増加
Journal of the American College of Cardiologyに掲載された論文によると、心血管疾患(CVD)の総重量を調査した結果、(CVD)が原因で死亡する人の数は着実に増加しています。この数字は、2019年の世界全体の死因の3分の1も含んでいます。この統計は、修正可能な行動を通じて心臓病リスクを下げることに焦点を当てた、手頃な価格の公衆衛生イニシアチブを各国が設定することが急務であることを強調しています。
市場抑制要因
生物製剤の複雑な分析特性評価と厳格なパラメータおよび規制
高分子の特性解析は非常に困難です。生物製薬会社は、安定性、純度、機能など、さまざまな方法で特性評価を行う必要があります。高分子は、粒子の構造を効率的に検証するために、多くの低分解能と高分解能の技術を組み合わせることが日常的に要求されます。さらに、高分子では組換え合成法において多数の翻訳後修飾(PTM)が生成されます。したがって、研究開発および製品開発への投資の増加が、高分子医薬品原薬CDMO市場の成長と発展を後押ししています。
アプリケーション展望
高分子医薬品原薬CDMO市場は、用途別に哺乳類、微生物、その他に分類されます。微生物セグメントは、2021年の高分子原薬CDMO(開発製造受託機関)市場においてかなりの成長率を調達しました。微生物システムは、治療プロセスで使用される組換えタンパク質の生産に主に利用されます。市場で入手可能な医薬品のほとんどは組換え技術によって生産されているため、微生物システムの成長を促進しています。
サービス展望
高分子原薬CDMO(開発製造受託機関)市場は、サービス別に製造受託と開発受託に分けられます。受託製造部門は、2021年の高分子原薬CDMO(開発製造受託機関)市場で最大の収益シェアを獲得しました。受託製造は、ターゲットスクリーニングと同定、機能情報学とターゲットバリデーション、前臨床開発、候補の最適化とリードの同定などの様々な機能を実行します。
エンドユーザー別の展望
エンドユーザーに基づき、高分子医薬品原薬CDMO市場は、バイオテクノロジー企業、CRO、その他に区分されます。CROセグメントは、2021年の高分子医薬品原薬CDMO市場で大幅に成長しました。臨床研究機関は、実験室、臨床、前臨床、および探索サービスに関するCDMOの支援を必要としています。また、さまざまな病気や障害の治療に対する需要の高まりも、実施すべき研究の量を増加させています。
地域別の展望
高分子医薬品原薬CDMO市場は、地域別に北米、欧州、アジア太平洋、LAMEAで分析されています。アジア太平洋地域は、2021年の高分子原薬CDMO(開発製造受託機関)市場において最大の収益シェアを獲得しました。熟練した労働力、準拠した規制、全体的なコストの低さが、この地域のCDMOへの高分子医薬品物質のアウトソーシングを推進する主な要因となっています。この地域には多くの消費者層が存在するため、より優れた医薬品や治療技術へのニーズが高まっています。
市場参入企業が採用している主な戦略は、パートナーシップです。Cardinalマトリックスで提示された分析によると、Boehringer Ingelheim International GmbHは、高分子原薬CDMO(開発製造受託機関)市場の先駆者です。FUJIFILM Diosynth Biotechnologies Texas LLC、WuXi Biologics(Cayman), Inc、Eurofins Scientific SEなどの企業は、Large Molecule Drug Substance CDMO Marketにおける主要な革新者の一人です。
List of Figures
The Global Large Molecule Drug Substance CDMO Market size is expected to reach $19.2 billion by 2028, rising at a market growth of 8.7% CAGR during the forecast period.
Contract development and manufacturing organization (CDMO) that provide services for processing large molecule or biologics drug substances are referred to as large molecule drug substance CDMO. These are companies that assist customers in drug discovery via manufacturing abilities by providing services and, thus, also help the pharmaceutical industry.
Large molecules are proteins that tend to have a therapeutic effect. These are highly complex, and most biologics are composed of approximately 1300 or more amino acids. These are prepared so that they resemble human proteins. The rise in molecule drug approvals, growing infectious disease prevalence, and increasing favorability for innovative therapeutics demand more CDMO setups for the rapid development and manufacturing of drugs.
Therefore, CDMOs' research, knowledge, and manufacturing abilities are highly necessary to proceed with drug development. As such, many CDMOs engage in integrating third-party ventures, which are also propelled by biotech and pharma companies' assistance through financial and technological assets. Most customers also expect CDMOs to offer their expertise even after manufacturing, like in commercial launches.
This is mainly because CDMO's customer base has expanded beyond the big pharmaceutical companies to smaller biotech firms. Additionally, many smaller biotech companies focus extensively on evolving their drug pipelines without any manufacturing experience. Therefore, taking help from CDMOs in development and manufacturing operations also enables the early incorporation of smaller biotech firms' operations.
COVID-19 Impact Analysis
Some governments imposed regulations that resulted in the procurement of sufficient volumes of therapeutics and vaccines that were produced locally. However, production capacities were still not at their maximum because of supply chain and lockdown constraints. Disrupted supply chains interfered with the procurement of goods needed in the production processes, like the single-use plastic bags, which CDMOs use in the reactors. In addition, the lockdown constraints introduced a reduction in the workforce. These constraints resulted in a significant increase in the lead times, which increased up to four times. The delayed production and increased demand further helped in the growth of the CDMOs. Therefore, the pandemic positively impacted the large molecule drug substance CDMO market.
Market Growth Factors
Increasing Research And Development Of Biologics And Biosimilar
Since the pandemic, numerous businesses have been making significant investments in the creation of biologics and biosimilar compounds. Presently, biologics such as peptides, proteins, and monoclonal antibodies in the discovery stage are making up almost half of the candidates intended to be used as therapeutics. Biopharmaceutical businesses are increasingly putting their resources into research and development, and as a result, many novel biologics are either being developed or are in the pipeline. Hence, all of these factors aid in the growth of the large molecule drug substance CDMO market.
Growing Cardiovascular Diseases (CVD) And CVD-Induced Deaths
According to a paper published in the Journal of the American College of Cardiology that examined the total severity of cardiovascular disease (CVD) burden, the amount of people who die from (CVD) is steadily increasing. This number also includes one-third of all deaths globally in 2019. The statistics highlight the urgent need for nations to set up affordable public health initiatives that are affordable and focused on lowering heart disease risk through modifiable behaviors.
Market Restraining Factors
Complex Analytical Characterization Of Biologics And Strict Parameters And Regulations
The characterization of large molecules is extremely challenging. Biopharmaceutical companies are needed to characterize in numerous ways, including stability, purity, and function. Large molecules routinely demand a combination of many low and high-resolution techniques to validate the particle's structure efficiently. Additionally, numerous post-translational modifications (PTMs) are produced by large molecules during the recombinant synthesis method. Hence, the rise in R&D and investments in product development are boosting the growth and advancement of the large molecule drug substance CDMO market.
Application Outlook
Based on application, the large molecule drug substance CDMO market is categorized into mammalian, microbial, and others. The microbial segment procured a considerable growth rate in the large molecule drug substance CDMO market in 2021. Microbial systems are mostly utilized in the production of recombinant proteins to be used in therapeutic processes. As most of the drugs available in the market are produced through recombinant technologies, they propel the growth of microbial systems.
Service Outlook
On the basis of service, the large molecule drug substance CDMO market is divided into contract manufacturing and contract development. The contract manufacturing segment acquired the largest revenue share in the large molecule drug substance CDMO market in 2021. Contract manufacturing performs various functions like target screening and identification, functional informatics and target validation, preclinical development, and candidate optimization and lead identification.
End-User Outlook
Based on end-user, the large molecule drug substance CDMO market is segmented into biotech companies, CRO, and others. The CRO segment witnessed a considerable growth rate in the large molecule drug substance CDMO market in 2021. The clinical research organization needs the CDMOs assistance with the laboratory, clinical, preclinical, and discovery services. In addition, the rising demand for treatments of various diseases and disorders has also increased the volume of research to be conducted.
Regional Outlook
On the basis of region, the large molecule drug substance CDMO market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The Asia Pacific segment garnered the maximum revenue share in the large molecule drug substance CDMO market in 2021. A skilled workforce, compliable regulations, and lower overall costs are the main factors that propel the outsourcing of large molecule drug substances to the CDMOs of this region. The presence of a considerable consumer base present in this region has increased the need for improved medicines and treatment techniques.
The major strategies followed by the market participants are Partnerships. Based on the Analysis presented in the Cardinal matrix; Boehringer Ingelheim International GmbH is the forerunner in the Large Molecule Drug Substance CDMO Market. Companies such as FUJIFILM Diosynth Biotechnologies Texas LLC, WuXi Biologics (Cayman), Inc., Eurofins Scientific SE are some of the key innovators in Large Molecule Drug Substance CDMO Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Eurofins Scientific SE, WuXi Biologics (Cayman), Inc, Catalent, Inc., Boehringer Ingelheim International GmbH, FUJIFILM Diosynth Biotechnologies Texas LLC (Fujifilm Corporation), Samsung Biologics Co., Ltd. (Samsung Group), Rentschler Biopharma SE, AGC Biologics, Inc. (AGC, Inc.), Recipharm AB (EQT AB), and Siegfried Holding AG.
Recent Strategies Deployed in Large Molecule Drug Substance CDMO Market
Partnerships, Collaborations and Agreements:
Oct-2022: WuXi partnered with Toregem BioPharma, a Japan-based biotechnology company, primarily into providing therapeutic agents meant for designing dental regenerative medicines. The partnership involves developing TRG035, an antibody meant for the treatment of congenital adentia. The partnership aligns with WuXi's aim to help global partners innovate new biologics solutions for patients worldwide.
Oct-2022: FUJIFILM Diosynth Biotechnologies collaborated with RoosterBio, a US-based biotechnology company, primarily into providing stem cell products. The collaboration involves GMP manufacturing of exosome and cell therapies. The collaboration allows FUJIFILM to offer comprehensive cell therapy CDMO services to its customers.
Dec-2021: WuXi partnered with ImmuneOncia, a South-Korea based Biotechnology Company, primarily into providing immunotherapies intended for the treatment of different types of cancer. The partnership involves leveraging WuXi's cell line development, bioassay development, cell culture development, and biologics manufacturing to develop bio specific antibodies. The antibody targets Programmed death-ligand 1 (PD-L1), and Cluster of Differentiation 47 (CD47).
Sep-2021: Boehringer teamed up with Twist Bioscience, a US-based synthetic biology company. The collaboration involves combining Twist's skill in generating potent, diverse therapeutic antibodies and Boehringer's expertise in drug discovery and development, which would enhance Boehringer's ability to better serve its clients and patients.
Apr-2021: Samsung Biologics teams up with TG Therapeutics, a US-based biotechnology company. The collaboration involves expansion of contract manufacturing for TG Therapeutics' ublituximab, an antigen meant for use in lymphoma, leukemia, and multiple sclerosis. This collaboration aligns with Samsung Biologics' vision to better serve humanity by bringing required treatments to the patients.
Jan-2021: Boehringer partnered with Google, a US-based global technology company. The partnership involves integrating Boehringer's competence in computer-based drug design and silico modeling with Google's expertise in algorithms and quantum computers to work on R & D. The partnership aims to advance R & D processes, thereby introducing more medical developments.
Oct-2020: WuXi collaborated with AB2 Bio, a Switzerland-based drug development and discovery company. The collaboration involves advancing Commercial-Scale Manufacturing of Tadekinig alfa, an IL-18 binding protein meant for monogenic Hemophagocytic Lymphohistiocytosis (HLH). Based on the agreement, AB2 Bio would transfer commercial manufacturing of Tadekinig alfa to WuXi.
Sep-2020: Samsung Biologics signed an agreement with AstraZeneca, a UK-based public company, primarily into marketing drugs for several diseases including, gastrointestinal, respiratory, cancer, etc. The agreement involves Samsung Biologics providing large-scale manufacturing of drug substances and drug products supporting AstraZeneca's biologics therapeutics. The agreement aligns with Samsung Biologics' purpose to support clients bring out innovative solutions.
May-2020: Rentschler Biopharma collaborated with Genmab, a Denmark-based biotechnology company. The collaboration involves a business model that aligns with the expansion strategy of Rentschler Biopharma's U.S. site in Milford, MA, and aims to manufacture and process the development of bispecific antibodies built on Genmab's DuoBody® technology platform.
Feb-2020: Catalent signed a contract with Zumutor Biologics, a US-based biotechnology company, primarily into providing NK cell therapeutics. The agreement involves manufacturing Zumutor's ZM008 meant for solid tumor treatment.
Acquisitions and Mergers:
Aug-2022: Catalent acquired Metrics Contract Services (Metrics), a US-based organization, primarily into providing contract development and manufacturing services for the medical sector. The acquisition advances Catalent's ability to better serve its clients, particularly those clients with R & D pipelines having rare, orphan, diseases for oncology and other therapeutic areas.
Apr-2022: Catalent took over a manufacturing facility in Oxfordshire from Vaccine Manufacturing and Innovation Centre UK Limited (VMIC Ltd.). The new facility enables Catalent to join forces with the biomedical science community, thereby furnishing opportunities to reshape innovation, and ideas into treatment for patients.
Feb-2022: Recipharm took over GenIbet, a Portuguese company, primarily into providing CDMO services. The acquisition strengthens Recipharm's plan to expand in the Biologics market, particularly in drug substance manufacturing of novel ATMPs.
Feb-2022: Recipharm took over Arranta Bio, a US-based company, primarily into supporting the development of health therapies. This acquisition forms a keystone in Recipharm's plan to furnish drug developers with CDM services. Moreover, the acquisition expands Recipharm's presence in the US.
Jan-2022: Samsung Biologics acquired the remaining share of Biogen in Samsung Bioepis, a Joint Venture between Biogen and Samsung Biologics. The acquisition would advance development in therapeutics R&D and biosimilars.
Dec-2021: Eurofins acquired Genetic Lab, a Japanese company, primarily into pathological diagnostics services. This acquisition complements Eurofins' global network of clinical diagnostic laboratories and further boosts Eurofins' Asia expansion.
Sep-2021: Boehringer took over Abexxa Biologics, a US-based biotechnology company. The acquisition strengthens Boehringer's devotion towards the discovery of tumor-antigen, and Abexxa's expertise in antigen discovery and antibody generation complements Boehringer's current approach to enable immune-targeting of cancer cells.
Aug-2021: AGC Biologics acquired a commercial facility in Longmont, Colorado, USA from Novartis Gene Therapies. The acquisition expands AGC's manufacturing capacity supporting its global end-to-end Cell and Gene Therapy (C>) offerings and further expanding cell and gene therapy presence in the US.
Feb-2020: Siegfried took over two manufacturing sites in Spain from Novartis. This acquisition expands Siegfried's global manufacturing network and aligns with its corporate strategy EVOLVE. The two new manufacturing facilities complement Siegfried's current operations in drug products.
Geographical Expansions:
Nov-2022: WuXi opened a new manufacturing facility in Fengxian, Shanghai. The facility is a Contract Research, Development, and Manufacturing (CRDMO) center, which would provide end-to-end services including process development, drug product development, analytical development, clinical drug substance, etc. The CRDMO center would enhance manufacturing and development capacity and would support the development of new biologics programs.
Oct-2022: WuXi expanded its manufacturing facilities network, by opening a new facility in Shijiazhuang, Hebei Province, China. The new facility is a Contract Research, Development and Manufacturing Organization (CRDMO) center, named MFG8. MFG8 aligns with the company's foundation for commencing any project within 4 weeks and allows WuXi to better serve evolving needs for drug substance services.
Oct-2022: Catalent expanded its geographical footprint by setting up a new facility in Kansas City, Missouri. The expansion includes setting up two new analytical development laboratories to fulfill evolving demands of assay development.
Market Segments covered in the Report:
By Application
By Service
By End-user
By Geography
Companies Profiled
Unique Offerings from KBV Research