#Healthcare CDMO Share

[industryforecastnews]

Healthcare Contract Development And Manufacturing Organization Market To Reach USD 471.0 Billion By 2030

Healthcare Contract Development and Manufacturing Organization Market Growth & Trends

The global healthcare contract development and manufacturing organization market size is expected to reach USD 471.0 billion by 2030, growing at a CAGR of 9.68% from 2024 to 2030, according to a new report by Grand View Research, Inc. The market is expected to show lucrative growth due to rising outsourcing trends and increasing R&D expenditure.

Healthcare contract development and manufacturing organization (CDMO) provide outsourcing services to various pharmaceutical industries on a contract basis. An increase in outsourcing by pharmaceutical companies, expansions in the pharmaceutical industry, and the support of CDMOs in reducing operational and capital expenses are some of the major factors anticipated to propel the market growth in the forecast period.

In addition, growing requirement among pharmaceutical and medical device companies to follow stringent timelines has increased the demand for outsourcing development and manufacturing activities to CDMOs. Further, due to the increasing demand for medical devices in emerging countries, various companies are shifting their focus on research and development activities for medical device contract development and manufacturing. Over the past 10 years, several pharmaceutical companies have turned to CMOs, CROs, and CDMOs to assist in pre-formulation and development & manufacturing of their novel innovations. Outsourcing is a high growth market, and most spending is focused on early development.

Around 75% of new drug pipelines come from small- and midsized biopharmaceutical companies. These companies have high profit margins, which make them easy targets for healthcare providers who are trying to reduce costs. Thus, instead of investing in establishing their own infrastructure, it is profitable for these companies to outsource services to third-party organizations that have expertise and the required equipment. Several pharmaceutical companies are seeking outsourced services for optimizing the development of their molecules. Furthermore, a large number of CDMO collaborations, expansions, mergers & acquisitions, and other strategic initiatives undertaken by market players operating in the country are anticipated to boost the market. For instance, In March 2023, Remedium Bio, a U.S.-based biotechnology company, entered into a collaboration agreement with Exothera, a Belgium-based CDMO, to scale up the production of Remedium’s lead gene therapy drug candidate, AAV2-FGF18 in the treatment of osteoarthritis. Similarly, in January 2024, Enzene Biosciences, a subsidiary of Alkem Labs announced the manufacturing site in the U.S. Such innovations are anticipated to drive the market.

However, increasing logistic costs, serialization issues faced by healthcare organizations, and the threat of infringement of Intellectual Property (IP) rights are anticipated to restrain the market growth for healthcare contract development & manufacturing organization over the forecast period.

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Healthcare Contract Development and Manufacturing Organization Market Report Highlights

Based on services, the contract manufacturing segment dominated the market with a revenue share of 73.50% in 2023 due to increase in the outsourcing of manufacturing services by pharmaceutical and medical device companies.In addition, cost-effectiveness, and the increasing number of CMOs are some of the key factors that are positively affecting the market growth

By small molecule contract development sub-segment, the preclinical/segment is expected to register the highest CAGR of 9.53% in the forecast period due to the rising pipeline of novel therapeutics

North America dominated the healthcare contract development and manufacturing organization industry with the largest revenue share of 40.91%in 2023. High shares of the region are majorly due to the presence of a large number of actively functioning CROs and CMOs in the region, especially across the U.S.

Healthcare Contract Development and Manufacturing Organization Market Segmentation

For this study, Grand View Research has segmented the healthcare contract development and manufacturing organization market based on services and region:

Healthcare CDMO Services Outlook (Revenue, USD Billion, 2018 - 2030)

Contract Development

Small Molecule

Preclinical

Bioanalysis and DMPK Studies

Toxicology Testing

Other Preclinical Services

Clinical

Phase I

Phase II

Phase III

Phase IV

Laboratory Services

Bioanalytical Services

Analytical Services

Large Molecule

Cell Line development

Process Development

Upstream

Microbial

Mammalian

Others

Downstream

MABs

Recombinant Proteins

Others

Others

Contract Manufacturing

Small Molecule

Large Molecule

MABs

Recombinant Proteins

Others

High Potency API

Finished Dose Formulations

Solid Dose Formulation

Liquid Dose Formulation

Injectable Dose Formulation

Medical Devices

Class I

Class II

Class III

Healthcare CDMO Regional Outlook (Revenue, USD Billion, 2018 - 2030)

North America

U.S.                

Canada

Europe

Germany

UK

France

Italy

Spain

Netherlands

Belgium

Denmark

Norway

Sweden

Asia Pacific

China

India

Japan

Australia

South Korea

Malaysia

New Zealand

Singapore

Philippines

Thailand

Latin America

Brazil

Mexico

Argentina

Colombia

Chile

Middle East & Africa

South Africa

Saudi Arabia

UAE

Israel

Kuwait

List of Key Players in the Healthcare CDMO Market

Catalent Inc.

Lonza

Recipharm AB

Siegfried Holding AG

Thermo Fisher Scientific, Inc.

Labcorp Drug Development

Jabil Inc

Syngene International Limited

IQVIA Inc.

Almac Group

Ajinomoto Bio-Pharma

Adare Pharma Solutions

Alcami Corporation

Vetter Pharma International

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/healthcare-contract-development-manufacturing-organization-market

[healthcaremarketanalysis]

Lipid Nanoparticles Market to Reach USD 350.5M by 2029

The Global Lipid Nanoparticles Market is expected to grow from USD 271.8 million in 2024 to USD 350.5 million by 2029, with a CAGR of 5.2%, while the LNP services market is projected to rise from USD 135.5 million in 2024 to USD 238.1 million by 2029 at a CAGR of 11.9%. Growth is driven by advancements in LNP-based pharmaceuticals, particularly in anti-cancer and mRNA therapies, though regulatory challenges and formulation issues pose potential constraints. Key opportunities include the demand for advanced drug delivery systems and scalable mRNA vaccines. The market's key players include Avanti Polar Lipids, Merck KGaA, and FUJIFILM Pharmaceuticals, with North America being the leading regional market. The sector is influenced by diverse product segments such as ionizable and PEGylated lipids, with applications spanning COVID-19 and cancer treatments.

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Browse in-depth TOC on "Lipid Nanoparticles Market"

398 - Tables

53 - Figures

316 - Pages

Factors Influencing Market Trends

The expansion of the lipid nanoparticles market is driven by increasing research and development efforts to create lipid nanoparticle-based drugs. However, stringent regulatory requirements may impede growth.

Product Segment Insights

The market is segmented by product into ionizable lipids, PEGylated lipids, neutral lipids, phospholipids, kits & reagents, and other formulation materials, with ionizable lipids leading due to their crucial role in mRNA vaccines like Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273.

LNP Type Breakdown

Segmented into solid lipid nanoparticles, nanostructured lipid carriers, and other types, the solid lipid nanoparticles segment holds the largest share, favored for vaccine production and as an alternative drug delivery carrier.

Molecule Type Distribution

The market is divided by molecule type into siRNA, mRNA, and other molecules. The mRNA segment dominates due to its effectiveness in vaccine production and the enhanced delivery capabilities of lipid nanoparticles.

Application Areas

Segmented into commercial and clinical applications, the commercial segment currently holds the largest market share due to its extensive use in vaccine production. The clinical applications segment, however, is expected to grow the fastest, driven by advancements in targeted drug delivery and personalized medicine.

End-User Analysis for Raw Materials

For raw materials, the market is divided into pharmaceutical & biotechnology companies, academic & research institutes, and CDMOs, with pharmaceutical & biotechnology companies holding the largest share due to their high use of lipid nanoparticles in drug development.

Service Type Analysis

The lipid nanoparticles services market, categorized into formulation development services, manufacturing services, and other services, sees the largest share in manufacturing services. This is driven by the high demand for raw materials and ongoing requirements from pharmaceutical and biotechnology companies.

End-User Analysis for Services

The services market is segmented by end users into pharmaceutical & biotechnology companies and academic & research institutes, with pharmaceutical & biotechnology companies leading due to their need for specialized manufacturing services and expertise.

Regional Market Overview

The lipid nanoparticles market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. North America held the largest share in 2023, benefiting from advanced healthcare infrastructure and significant R&D investments. However, the Asia Pacific region is anticipated to be the fastest-growing market during the forecast period, driven by increased healthcare expenditure, government initiatives, and favorable regulatory conditions.

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Growth Drivers and Challenges

The growth of the lipid nanoparticles market is driven by their increasing use in anti-cancer and RNA-based therapies. However, stringent regulatory requirements related to lipid nanoparticles may pose challenges to market expansion.

Market Consolidation

The lipid nanoparticles market is largely consolidated, with major players such as Avanti Polar Lipids (Croda International plc), Merck KGaA, NOF CORPORATION, and Nippon Fine Chemical holding 70-75% of the global market share.

Company Profiles

Avanti Polar Lipids (US): Established in 1967, Avanti specializes in high-purity lipids for biochemical and pharmaceutical research. The company offers a broad portfolio of lipid nanoparticles and custom synthesis services, heavily investing in R&D and collaborating with academic institutions to advance lipid formulations.

Merck KGaA (Germany): This healthcare and life sciences company provides a range of lipid nanoparticles products for research and clinical applications. Merck KGaA has strengthened its RNA production capabilities and recently acquired Exelead for approximately USD 780 million to enhance its CDMO services.

NOF CORPORATION (Japan): NOF CORPORATION is a prominent chemical manufacturer known for its lipid nanoparticle formulations. In April 2024, NOF collaborated with Phosphorex to provide lipid nanoparticles using their COATSOME® SA Series, which offers efficient nucleic acid delivery with minimal toxicity. NOF continues to innovate with high-purity lipid derivatives and liposome formulations for various drug applications.

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Global Peptide And Oligonucleotide CDMO Market Analysis 2024: Size Forecast and Growth Prospects

The peptide and oligonucleotide cdmo global market report 2024from The Business Research Company provides comprehensive market statistics, including global market size, regional shares, competitor market share, detailed segments, trends, and opportunities. This report offers an in-depth analysis of current and future industry scenarios, delivering a complete perspective for thriving in the industrial automation software market.

Peptide And Oligonucleotide CDMO Market, 2024report by The Business Research Company offers comprehensive insights into the current state of the market and highlights future growth opportunities.

Market Size - The peptide and oligonucleotide CDMO market size has grown rapidly in recent years. It will grow from $1.93 billion in 2023 to $2.16 billion in 2024 at a compound annual growth rate (CAGR) of 11.8%. The growth in the historic period can be attributed to a rise in demand for therapeutic agents, advancements in synthesis and manufacturing, personalized medicine trends, regulatory guidelines, and increased focus on antiviral peptides and mRNA vaccines highlighting the potential of oligonucleotides in vaccine development.

The peptide and oligonucleotide CDMO market size is expected to see rapid growth in the next few years. It will grow to $3.39 billion in 2028 at a compound annual growth rate (CAGR) of 12.0%. The growth in the forecast period can be attributed to the growing demand for personalized medicine, advancements in biotechnology, expanding applications, increasing outsourcing, and the growing burden of chronic diseases. Major trends in the forecast period include personalized therapies, technological advancements, quality control challenges, global expansion, and increased collaboration among biopharmaceutical companies.

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Scope Of Peptide And Oligonucleotide CDMO MarketThe Business Research Company's reports encompass a wide range of information, including:

1. Market Size (Historic and Forecast): Analysis of the market's historical performance and projections for future growth.

2. Drivers: Examination of the key factors propelling market growth.

3. Trends: Identification of emerging trends and patterns shaping the market landscape.

4. Key Segments: Breakdown of the market into its primary segments and their respective performance.

5. Focus Regions and Geographies: Insight into the most critical regions and geographical areas influencing the market.

6. Macro Economic Factors: Assessment of broader economic elements impacting the market.

Peptide And Oligonucleotide CDMO Market Overview

Market Drivers -The growing adoption of personalized medicine is expected to propel the growth of the peptide and oligonucleotide CDMO markets going forward. Personalized medicine is an approach to healthcare that tailors medical decisions and treatments to individual characteristics, such as genetics, environment, and lifestyle. The growing adoption of personalized medicine is due to several factors such as advancements in genomic technologies, increased understanding of disease mechanisms at the molecular level, and the demand for more effective and targeted treatment options tailored to individual patients' genetic profiles and medical histories. Peptide and oligonucleotide contract development and manufacturing organizations (CDMOs) play a crucial role in personalized medicine by producing customized therapeutic peptides and oligonucleotides tailored to individual patient needs. For instance, in February 2024, according to the Personalized Medicine Coalition, a UK-based organization promoting the adoption of personalized medicine, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 16 new personalized treatments for rare disease patients, up from 6 in 2022. Therefore, the growing adoption of personalized medicine is driving the growth of the peptide and oligonucleotide CDMO market.

Market Trends - Major companies operating in the peptide and oligonucleotide CDMO market are focusing on developing strategic partnerships to enhance their service offerings, expand their technological capabilities, and increase their market reach. Peptide development and production partnerships refer to collaborative agreements between two organizations focused on developing and manufacturing peptide-based therapeutics. For instance, in May 2023, PolyPeptide Group AG, a US-based contract development and manufacturing organization (CDMO), partnered with Numaferm GmbH, a Germany-based biotechnology company, for peptide development and production. This partnership aims to utilize PolyPeptide's cGMP manufacturing capacities and market access, along with Numaferm's expertise in sustainable peptide manufacturing and biochemical production platforms. The partnership is focused on jointly exploring the development of suitable peptide candidates with the goal of more sustainable production of peptide-based APIs.

The peptide and oligonucleotide cdmo market covered in this report is segmented –

1) By Product: Peptides, Oligonucleotides 2) By Service Type: Contract Development, Contract Manufacturing, 3) By Application: Therapeutics, Research Applications, Diagnostics, Other Applications 4) By End User: Biopharmaceutical Companies, Pharmaceutical Companies, Research Institutes, Academic and Government Organizations, Others End Users

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Regional Insights - North America was the largest region in the peptide and oligonucleotide CDMO market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the peptide and oligonucleotide cdmo market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

Key Companies - Major companies operating in the peptide and oligonucleotide cdmo market are Thermo Fisher Scientific Inc., Merck KGaA, Ajinomoto Co. Inc., Lonza Group Ag, Wuxi Apptec Co. Ltd., Catalent Inc., Piramal Pharma Ltd, Curia Global Inc., Almac Group, Euroapi SA., CordenPharma International, Bachem Holding AG, Genscript Biotech Corporation, PolyPeptide Group, Rentschler Biopharma SE, Ambiopharm Inc, ScinoPharm, Senn Chemicals AG, Aurigene Pharmaceutical Services, Creative Peptides, Sylentis S.A.

Table of Contents 1. Executive Summary 2. Peptide And Oligonucleotide CDMO Market Report Structure 3. Peptide And Oligonucleotide CDMO Market Trends And Strategies 4. Peptide And Oligonucleotide CDMO Market – Macro Economic Scenario 5. Peptide And Oligonucleotide CDMO Market Size And Growth ….. 27. Peptide And Oligonucleotide CDMO Market Competitor Landscape And Company Profiles 28. Key Mergers And Acquisitions 29. Future Outlook and Potential Analysis 30. Appendix

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[globalindustrytrends]

Mammalian Cell Culture Dominates Biologics CDMO Industry

The global biologics contract development and manufacturing organization market achieved revenue of USD 17.1 billion in 2024 and is expected to grow at a rate of 11.0% between 2024 and 2030, reaching USD 31.8 billion by the end of the forecast period. This expansion is largely driven by the increasing prevalence of chronic diseases, the growing trend of outsourcing R&D activities, collaborations between biologics CDMOs and businesses for new product launches, and the rising aging population.

In 2023, the drug substance segment led the market, generating USD 8,525.4 million. Factors such as the rise in biologics approvals, particularly from the FDA, robust clinical pipelines, and lower failure rates of biologic drugs are boosting the demand for drug substances. Additionally, the biologics industry’s growth is propelling the demand for processes, often outsourced to CDMOs by small and mid-sized pharmaceutical firms. Outsourced biologics development activities include assay development, toxicology studies, and the establishment of master cell banks.

The expanding biopharma sector is driving strong demand for biologics outsourcing services. Small and mid-sized biotech companies are increasingly relying on outsourcing due to limited capacities and R&D capabilities.

Meanwhile, large pharmaceutical companies are also outsourcing R&D activities to biologics CDMOs, which offer comprehensive solutions aimed at reducing R&D costs, mitigating risks, and allowing companies to focus on core competencies for greater efficiency. This trend suggests that the biologics outsourcing market will experience significant growth in the coming years.

In 2023, mammalian cell culture was the leading segment, accounting for around 56% of the market share. This dominance is attributed to the growing development of more complex biologics, such as antibody-drug conjugates and multi-specific antibodies.

Moreover, the increasing demand for biologics CDMOs from pharmaceutical companies is boosting growth in this segment. Major players like Samsung Biologics, Lonza, and WuXi Biologics are expected to expand their mammalian cell culture capacities by 30–40% over the next decade.

By 2030, the biologics CDMO market in North America is projected to reach USD 7,802.9 million in revenue. This growth is driven by factors such as the increasing aging population, the rising incidence of chronic and serious diseases, and growing R&D investments by pharmaceutical and biotech companies. For instance, the U.S. elderly population, aged 65 and above, increased from 50 million in 2018 to 55 million in 2021.

According to the CDC, chronic illnesses such as diabetes, cancer, and heart disease were the leading causes of death in the U.S., costing healthcare systems over USD 4 trillion in 2021. Furthermore, data from the Partnership to Fight Chronic Disease (PFCD) suggests that approximately 45% of the U.S. population has at least one chronic disease, with 165 million Americans expected to have multiple chronic conditions by 2025.

[health-views-updates]

Global CMO/CDMO Market Share: A Competitive Landscape Analysis

The global CMO/CDMO market revenue is experiencing significant growth, with the market size valued at USD 20.9 billion in 2023. Projections indicate the market will reach USD 51 billion by 2032, growing at a compound annual growth rate (CAGR) of 10.4% over the forecast period from 2024 to 2032.

The CMO/CDMO market plays a critical role in the pharmaceutical and biotechnology industries by offering outsourced services for the development and manufacturing of drugs, biologics, and other healthcare products. With increasing demand for pharmaceutical production efficiency and cost reduction, companies are increasingly turning to CMOs and CDMOs to support their drug development pipelines and manufacturing processes.

Key Market Drivers

Growing Biopharmaceutical and Pharmaceutical Demand: The rise of biopharmaceuticals, biologics, and personalized medicine has significantly increased the need for outsourced services in drug development and manufacturing. CMOs and CDMOs are essential in enabling biopharma companies to accelerate the commercialization of new drugs and biologics while reducing operational costs. The complexity of biologics, cell therapies, and gene therapies has further driven demand for CDMO expertise in these specialized areas.

Cost Efficiency and Focus on Core Competencies: The outsourcing of manufacturing and development services to CMOs and CDMOs allows pharmaceutical companies to focus on their core competencies, such as research and innovation. CMOs/CDMOs offer economies of scale, regulatory expertise, and advanced manufacturing facilities, helping companies reduce costs and time-to-market for new therapies. This trend is especially prevalent among small- and mid-sized biopharma companies that lack in-house capabilities for large-scale production.

Increasing Investment in Research and Development: Investment in research and development (R&D) is at an all-time high, particularly in the fields of oncology, immunology, and rare diseases. The surge in clinical trials and new drug approvals is driving demand for specialized CMO/CDMO services, from clinical-stage development to full-scale manufacturing. As pharmaceutical companies seek to streamline R&D processes, outsourcing to CDMOs has become an attractive solution to navigate complex production processes and regulatory requirements.

Rising Demand for Biologics and Biosimilars: The growing market for biologics and biosimilars is a key driver for CDMO services. The complexity and high manufacturing costs associated with biologics necessitate advanced production technologies, which CDMOs are equipped to provide. The growing acceptance and adoption of biosimilars, driven by cost savings and increasing healthcare needs, are further fueling the demand for contract manufacturing services.

Increasing Focus on Cell and Gene Therapy: The advancement of cell and gene therapies, including CAR-T therapies and gene editing technologies, is expanding the scope of CMO/CDMO services. These therapies require specialized production facilities and regulatory expertise, which CMOs and CDMOs are increasingly investing in to support the growing market for these innovative treatments.

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Challenges and Opportunities

While the market presents substantial growth opportunities, challenges such as regulatory complexities, high manufacturing costs, and the need for skilled labor can present obstacles. Additionally, capacity constraints and lead times for large-scale biologics manufacturing may pose hurdles for CMOs and CDMOs in meeting the rising demand.

However, these challenges also present opportunities for investment in cutting-edge manufacturing technologies such as single-use bioreactors, continuous manufacturing, and automation. CMOs and CDMOs that invest in advanced capabilities will be well-positioned to capture market share, particularly in high-growth areas like biologics, cell therapies, and gene therapies.

Regional Insights

North America currently dominates the CMO/CDMO market, with significant investments in pharmaceutical research, strong healthcare infrastructure, and the presence of leading biopharmaceutical companies. Europe also holds a substantial market share, driven by its robust regulatory environment and focus on innovation in the life sciences sector.

The Asia-Pacific region is expected to experience the highest growth during the forecast period, bolstered by increasing pharmaceutical and biotech R&D activities, cost-effective manufacturing, and growing demand for innovative therapies in countries like China, India, and Japan. The region's favorable government policies and expanding healthcare infrastructure further support this growth.

Future Outlook

The global CMO/CDMO market is positioned for dynamic growth, driven by increasing demand for outsourced pharmaceutical services, the rise of biologics and biosimilars, and the rapid development of cell and gene therapies. As companies seek greater efficiency and specialization, outsourcing to CMOs and CDMOs will continue to be a strategic imperative in the pharmaceutical and biotech industries.

With a projected CAGR of 10.4% from 2024 to 2032, the CMO/CDMO market is set to expand significantly, from USD 20.9 billion in 2023 to an estimated USD 51 billion by 2032. The evolving landscape of drug development and manufacturing will further cement CMOs and CDMOs as key enablers of innovation and growth in the healthcare industry.

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[lanettcdmo]

Transforming the Trial: How Digital Innovation is Reshaping Clinical Research

Clinical trials are the backbone of medical progress, but they've traditionally been slow, expensive, and geographically limited. Thankfully, the winds of change are blowing through the industry, driven by a powerful force: digital transformation.

The Rise of the Digital Patient

Today's patients are tech-savvy and expect convenience. Digital platforms are making clinical trials more accessible than ever before. Imagine enrolling in a study from the comfort of your couch, using a mobile app to report symptoms, or wearing a wearable device that transmits health data remotely. This is the reality of decentralized trials, and it's attracting a wider pool of participants, leading to more diverse and generalizable results.

Data Sharing on Steroids

Clinical trials generate a mountain of data. But siloed systems and paper-based processes often hinder its efficient collection and analysis. Secure digital platforms are changing this game. By facilitating seamless data sharing between researchers, sponsors, and CDMOs, these platforms accelerate trial progress and provide real-time insights.

The CDMO Advantage in a Digital Age

Contract Development and Manufacturing Organizations (CDMOs) are at a crossroads. Those that embrace digital transformation will be the frontrunners in this evolving landscape. By integrating cutting-edge technologies like remote monitoring, data analytics, and telehealth into their services, CDMOs can offer pharma companies a significant edge:

Faster Trial Completion: Streamlined data collection and analysis shave valuable time off trial timelines.

Reduced Costs: Decentralized trials and remote monitoring minimize travel expenses for patients and sites.

Enhanced Patient Engagement: Digital tools empower patients to be active participants in their own healthcare journey.

Improved Data Quality: Real-time data capture and standardized platforms minimize errors and ensure data integrity.

The Future is Now

The digital transformation of clinical trials is not a futuristic vision; it's happening now. CDMOs that invest in these technologies are positioning themselves as invaluable partners in the race to bring life-saving treatments to patients faster and more efficiently. This digital revolution promises a brighter future for medical research, one that benefits patients, researchers, and the healthcare industry as a whole.

[123567-9qaaq9]

Digital Biomanufacturing Market , Market Size, Market Share, Key Players | BIS Research 

The global digital manufacturing market report highlights that the market was valued at $15,768.9 million in 2021 and is expected to reach $55,564.9 million by the end of 2031. The market is expected to grow at a CAGR of 13.12% during the forecast period from 2022 to 2031.

 In the ever-evolving landscape of biomanufacturing, the integration of digital technologies has emerged as a game-changer, revolutionizing the industry's efficiency, flexibility, and sustainability. This Digital Biomanufacturing Market Report delves into the key trends, opportunities, challenges, and growth prospects that define this transformative sector.

Overview of Digital Biomanufacturing:

Digital biomanufacturing refers to the incorporation of digital technologies such as automation, artificial intelligence (AI), machine learning (ML), and data analytics into the production processes of biopharmaceuticals and other biological products. This approach aims to enhance productivity, reduce costs, and streamline operations in the highly complex and regulated biomanufacturing industry.

Market Dynamics:

Market Drivers:

Increased Efficiency: Automation and digitalization reduce manual errors, enhance precision, and significantly accelerate production timelines.

Cost Reduction: Digital technologies optimize resource utilization, minimize waste, and ultimately contribute to cost savings.

Regulatory Compliance: Integration of digital tools aids in ensuring compliance with stringent regulatory requirements, improving the overall quality control process.

Market Challenges:

Implementation Costs: Initial investments in digital infrastructure can be substantial, posing a challenge for some manufacturers.

Skill Gap: The need for a skilled workforce proficient in both biomanufacturing and digital technologies is a hurdle for widespread adoption.

Data Security Concerns: With the increasing reliance on digital platforms, ensuring the security of sensitive data becomes paramount.

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Key Technological Trends:

Automation and Robotics:

Robotic systems play a crucial role in automating repetitive tasks, minimizing errors, and increasing overall production efficiency.

Artificial Intelligence (AI) and Machine Learning (ML):

AI and ML algorithms optimize bioprocess parameters, predictive maintenance, and quality control, leading to improved yields and reduced downtime.

Data Analytics:

Advanced analytics tools provide insights into manufacturing processes, enabling real-time decision-making, and facilitating continuous improvement.

Digital Twins:

Creating digital replicas of biomanufacturing processes allows for virtual testing and optimization, leading to enhanced process understanding and control.

Market Segmentation:

By Product Type:

Single-Use Systems

Control Systems

Software Solutions

By End-User:

Biopharmaceutical Companies

Contract Development and Manufacturing Organizations (CDMOs)

By Region:

North America

Europe

Asia-Pacific

Latin America

Middle East & Africa

Leading Players in the Digital Biomanufacturing Market:

Prominent companies driving innovation in this space include:

Thermo Fisher Scientific

Siemens AG

Emerson Electric Co.

Merck KGaA

GE Healthcare

Future Outlook and Opportunities:

Personalized Medicine and Therapies:

Digital biomanufacturing facilitates the production of personalized medicines tailored to individual patient needs.

Biologicals and Biosimilars:

The growing demand for biological drugs and biosimilars presents opportunities for digital biomanufacturing to enhance production efficiency.

Global Collaborations:

Collaborations between technology providers, biomanufacturers, and regulatory bodies are crucial for developing industry standards and ensuring a smooth transition towards digitalization.

Conclusion:

The Digital Biomanufacturing Market is poised for remarkable growth, driven by technological advancements, increasing demand for biopharmaceuticals, and a growing focus on sustainability. As the industry continues to evolve, embracing digital technologies will be essential for manufacturers to stay competitive, meet regulatory requirements, and contribute to the advancement of healthcare through innovative and efficient biomanufacturing processes.

[sanpdr1994]

Automated Cell Biology Systems Market 2022 Analysis, Research, Review, Applications and Forecast to 2032

According to Future Market Insights’ most recent industry report, the global Automated Cell Biology Systems Market stands at US$ 14.1 Bn in 2022 and is expected to rise at a CAGR close to 9.0% over the forecast period, with an anticipated worth of around US$ 33.5 Bn in 2032.

The development of powerful new technologies and applications is made possible by laboratory automation, a major force in the biotechnology sector. Automation in research and production, specifically in the area of personalized therapies, is a requirement for achieving cost effectiveness and widespread accessibility of customized treatments.

Over the last two decades, the biotechnology sector has paid increasingly more attention to laboratory automation. With the development of digitalization and Industry 4.0, biotech automation has spread from its initial focus on analytical laboratories to now being used widely throughout the industry.

In fact, it is widely acknowledged that many aspects of future medicine would only be possible with the help of automation. These include automated complicated data processing for precision medicine, healthcare robotics for surgery and care, automated production, and sophisticated supply chains for innovative therapeutics.

This is especially true for cell-based personalized medicines, which depend on automation to lower costs and increase accessibility. Whether for personalized drug research or autologous cell treatments, patient-derived cell multiplication is labor-intensive and characterized by substantial batch-to-batch variability.

Additionally, because individual batch sizes are small, personalized medicine requires a high overall throughput in order to be economically viable. These factors pose a demand for automated cell biology systems, thus propelling the overall market value over the forecast period.

Key Takeaways from Market Study

Automated cell counters (single function) are the leading segment as product, and hold approximately 6% market share in 2021, as they provide accurate cell counts.

Drug development applications hold a market share of around 4% in 2021, owed to robust growth of biopharmaceutical industry.

Infinite cell line cultures account for around 2% in 2021, as they are easy to culture than primary cell cultures.

Biopharmaceutical companies as prime end users hold a share of around 4% in 2021, owed to growing CMO/CDMO activities for drug manufacturing.

North America holds a dominant share of 4% in 2021, owed to a high economic output in the region.

“Rising Demand for Personalized Medicine, and Growth in Total Lab Automation Techniques will Propel Overall Market Growth,” says an analyst of Future Market Insights.

Market Competition

Automated cell biology system manufacturers have been substantially investing in research to offer long-term solutions for both the biopharmaceutical and packaging industries. Players in the automated cell biology systems market are also focusing on innovations and alliances to strengthen their market position.

Key Market Segments Covered in Automated Cell Biology Systems Industry Research

By Product:

Cell Culture Process Automatization Instrument or Robot (Multiple Function)

Automated Bioreactor (Single or Multiple Function)

Automated Cell Culture Media Exchange System (Single Function)

Automated Culture Media Analyzer (Single Function)

Automated Cell Wash-and-Concentrate System (Single Function)

Automated Cell Counter (Single Function)

Automated Fill And Finish System (Single Function)

Automated Cell Storage Equipment (Single Function)

Management Software

By Cell Culture:

Finite Cell Line Cultures

Infinite Cell Line Cultures

By Application:

Cell Therapy

Drug Development

Stem Cell Research

Regenerative Medicine

By End User:

Mega Pharmaceutical companies

Biopharmaceutical companies

CDMOs/CMOs

Research organizations

Academic institutes

[mysticalcrowntyphoon]

The Quality of API will Directly Affect Your Finished Drug Product.

Table of Content

·Active Pharmaceuticals Ingredients

 Increasing API Manufacturing

 Benefits of APIs

 Akums Drugs and Pharmaceuticals Ltd. 

Active Pharmaceuticals Ingredients

With so many health hazards prevailing nowadays, living a stress and ailment-free life seem difficult. Maintaining good health has become a goal for everyone. Having a disease or any ailment would nearly end in moving from pillar to post in search of good healthcare services whereas sometimes it ends only on Over counter medications. The same is even offered to young kids of the family firmly believing in the quality and name of the company. We intake the medicine without giving a second thought to API or its composition. Have you ever thought that if the quality of Active Pharmaceutical Ingredients is hampered then the quality of finished drugs will get affected? Thanks to API contract manufacturing whose accountability and integrity have helped mankind to get the best out of its facilities.

Any drug or medicine is made up of two important constituents. One is mentioned as the organically vigorous element of a drug product, and the principal ingredient is recognized as API. Additional components in drug products are known as excipients. The constituencies which make up an elastic share of the medication are required to be safe. Active Pharmaceutical Ingredients are used for a pharmacologic act in the finding, treatment, reasoning, handling, or prevention of illness or to affect the structure or function of the body.

 Increasing API Manufacturing

The international Active Pharmaceutical Ingredient souk extent is intensifying every day and is probable to increase more than this proportion in the approaching years. Progression in API manufacturing and significant progress in the biopharmaceutical sector has directed the development of the API market. A foremost portion of aging people is also accountable for the enlargement of API Manufacturing. The growing rate of recurrence of communicable sicknesses plays a dynamic role too.

Benefits of APIs

API CDMO manufacturing assists by providing the following benefits of API:

•    Reduced risk of drug contact

•    Enlarged understanding of the medication and its action

•    Augmented obedience from the patient

•    Better reception of the drug’s side effects and signs

Though API manufacturing is a hard and multi-faced procedure that needs to experience many unconventional exams and procedures to get support and to meet strict worth standards. Amplified regulations in engineering and severe compliance have made Contract API Manufacturing show a chief role in providing the same for medicinal companies. They do their work with extreme authority and skill.

Bargaining the API worth can hinder the entire preparation which may put somebody in danger. Even well-being threats can be too hazardous that the life of an individual may be put up at risk. If API's quality gets negotiated then, the status of the pharmaceutical or manufacturing companies can also be screwed. The belief and the certainty of the patrons get crushed and the creation if launched in the market will not be accepted by the customers. The business leaders will be bothered, and the company will not be able to continue further. Even contaminated or polluted API will not get consent on the firm standards and regulations destined for their manufacturing. Deprived of the required consideration, it cannot be launched in the market too.

Akums Drugs and Pharmaceuticals Ltd.

Akums Drugs and Pharmaceuticals Ltd. is a top API CDMO in India that has never negotiated on the feature they are recognized for the finest quality with unparalleled excellence and transparency. Their strict value up keeping and obedience to all the regulations has helped them to get so many authorizations which make them the best API CDMO manufacturers.

Key Takeaways

·Bargaining the API worth can hinder the entire preparation which may put somebody in danger.

 Akums Drugs and Pharmaceuticals Ltd. is a top API CDMO in India that has never negotiated on the feature, they are recognized for the finest quality with unparalleled excellence and transparency.

[researchvishal]

Bioprocess Technology Market Revenue, Worth, Size, Segment by Type, Application, Key Companies | FMI

According to a recent study by Future Market Insights (FMI), the global Bioprocess Technology Market was valued at US$ 17.3 Bn in 2020 and is expected to register a CAGR of 15.2% during the forecast period (2021-2031). It is projected to generate a revenue of US$ 81.2 Bn by the end of 2031.

Technology has always been at the heart ofbiotech. The emergence of advanced computing technology such as machine learning and artificial intelligence has enabled companies to expand the scale of their research and improve efficiency in the manufacturing process—both of which reduce the time it takes for biotech firms to bring new products to market.

Increasing research and development spending on pharmaceutical products has improved the well-being of patients to a significant level. Today vaccines have proven to be one of the most effective ways to prevent children from infectious diseases. This is highly possible due to increased government spending on research & development in the life science stream.

For instance, in May 2020, AbSci Inc. closed USD 15.4 Mn in series D funding to accelerate the growth and scale of disruptive protein printing technology, by announcing an exclusive co-marketing partnership with KBI Biopharma.

There are currently more than 1,500 biomolecules undergoing clinical trials, which target more than 100 hundred types of diseases and success rate for biologics has so far been over twice that of small-molecule products.

Key Takeaways from Bioprocess Technology Market Study

In 2021, the BIOTECH/BIOPHARMACEUTICAL COMPANIES segment is expected to dominate the global bioprocess technology market with a 44.0% market share, whereas, CDMO/contract research organization segment is expected to occupy over 40% of the market share.

By product, the upstream segment dominated the global Bioprocess Technology Market with a 64.8% market share.

Europe and East Asia dominated the global Bioprocess Technology Market occupying over 24.3% and 14.7% market share, respectively.\

Who is winning?

Some of the leading companies of Bioprocess Technology Market are focusing on their extensive portfolio of single-use cell culture bioreactors, containers, strong distribution channels, and strategic selling to the leading biopharmaceutical manufacturing entities.

Thermo Fisher Scientific Inc. is a multinational biotech company that develops, manufactures, and distributes products in the areas of healthcare & diagnostics, life sciences, pharmaceuticals, and others. In Sep 2020, Thermo Fisher Scientific Inc. announced the opening of its new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri.

Sartorius AG is a leading provider of contract testing services to the global biotechnology and biopharmaceutical industries. In July 2020, Sartorius Stedim Biotech acquired a majority stake in CellGenix to strengthen its product portfolio for cell and gene therapies.

Danaher Corporation designs manufacture and markets professional, medical, industrial, and commercial products and services. In March 2020 Danaher Corporation acquired the Biopharma business from General Electric’s Life Sciences division.

The key market players covered by FMI include Thermo Fisher Scientific Inc, Sartorius, Merck KGa, Danaher Corporation, Applikon Biotechnology B.V., Lonza AG, Bio-Rad Laboratories, Agilent technologies, Solida Biotech GmBH, and Waters Corporation.

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Key Segments:

Product:

Upstream Equipment

Cell culture development products

Cell line development products

Cell Lines

Media, Sera and other additives

Cell line development kits

Lab-scale Bioreactors

Continuous Stirred Tank Bioreactors

Bubble Column Bioreactors

Airlift Bioreactors

Fluidized Bed Bioreactors

Packed Bed Bioreactors

Photo-Bioreactors

Scale-up and production products

Cell culture media and feeds

BioProcess Containers & Fluid Transfer Solutions

Single-use

Reusable

BioReactors

Single-Use Bioprocess Equipment

Continuous Bioprocess Equipment

Real-Time Bioprocess Equipment

Harvest and collection

Harvest and separation products

Centrifuges for bioprocessing

Storage & Transport Products v. Production Tanks and Drums v. Outer Support Containers

Testing Products

Cell Counters & Viability Analysis Systems

Contamination & impurity testing products

Probes and Accessories

Downstream Equipment

Downstream purification

Chromatography Instruments

Chromatography Columns

Others (Resins and accessories)

Buffer preparation and supply

Reagents

mixing systems

Process analytical testing

Host cell residual DNA quantitation

Protein quantitation

Microbial identification

Others

Probes and Accessories

End-User:

Biotech / Biopharmaceutical Companies

CDMO / Contract Research Organization

Research / Academic Institutes

Region:

North America

Latin America

Europe

East Asia

South Asia

Oceania

The Middle East and Africa (MEA)

[industryforecastnews]

North America Biotechnology And Pharmaceutical Services Outsourcing Market To Reach USD 16.81Bn By 2030

North America Biotechnology and Pharmaceutical Services Outsourcing Market Growth & Trends

The North America biotechnology and pharmaceutical services outsourcing market size is expected to reach USD 16.81 billion by 2030, according to a new report by Grand View Research, Inc., growing at a CAGR of 5.13% from 2024 to 2030. Increasing competition to launch novel molecules with better RoI is expected to heighten the demand for CRO service providers across the globe. Pharmaceutical companies face complexity in regulations along with increased research costs, creating a need for expertise in numerous portfolios and driving the need for outsourcing in the market. With increasing clinical trial privatization, there has been an increase in outsourcing functions to CROs and CDMOs to focus on core capabilities. Pharmaceutical and biotechnology companies have started outsourcing R&D activities, which are complex and need a strict timeline to follow up. A CRO’s function is to bring new products to the market as per the timeline given by the client. CROs have the required infrastructure and skilled expertise, which provides several advantages associated with cost, time, and efficiency. The cost saved helps in offering the best savings for sponsors and patients.

Drug discovery and development is an integral strategy adopted by pharmaceutical and biotechnology companies. An increase in the prevalence of chronic and long-term diseases led to a rise in the demand for extensive R&D investments in the drug development process. Growing clinical trial failure rates coupled with increasing drug development costs lead to huge losses in revenue for manufacturers. Setbacks faced in clinical studies have led smaller pharmaceutical companies to go bankrupt. Many private investors have been observed to withdraw venture capital support from startup drug companies, considering their investments would suffer if there were a disruption in the drug development process. To circumvent these situations and gain a substantial return on investment, pharmaceutical companies are now adopting computational biology-based predictive models over traditional methods of clinical trials, which are expected to drive market growth during the forecast period. Insights gained from subject-matter experts, R&D executives, and clinical professionals help a company save a large amount, which can be spent on R&D, thereby boosting demand for consulting services.

The healthcare outsourcing industry has recently witnessed a surge in mergers and acquisitions. The sector's rapid growth and promising potential have attracted significant investment from pharmaceutical companies, biotech firms, & venture capitalists. As a result, companies seek to expand their portfolios and capabilities through strategic acquisitions to capitalize on emerging opportunities and strengthen their competitive position in the market. For instance, in May 2024, Sartorius AG announced a collaboration with NVIDIA to help the development of new therapies, leveraging NVIDIA’s AI-powered computing software and platform. Moreover, the complexity and high costs associated with developing therapeutics are leading to increased collaboration & consolidation within the industry. Mergers & acquisitions offer companies complementary technologies, expertise, and resources, enabling them to overcome development challenges, accelerate product development timelines, and enhance manufacturing capabilities.

Request a free sample copy or view report summary: https://www.grandviewresearch.com/industry-analysis/north-america-biotechnology-pharmaceutical-services-outsourcing-market-report

North America Biotechnology And Pharmaceutical Services Outsourcing Market Report highlights

Based on service, the consulting segment held the largest revenue share in 2023. The large segment growth is owing to the growing adoption of consulting services to meet regulatory compliance, quality assurance, remediation challenges, and strategic consulting requirements by sponsors. Furthermore, regulatory consulting services are widely used owing to increasing fraud cases, discrepancies in Intellectual Property Rights (IPR), and rising technological innovation, which are some of the major challenges faced by pharmaceutical and biotechnology companies. Another factor driving the demand for consulting services is the consolidated nature of the market, which leads to an increase in the number of joint ventures, takeovers, acquisitions, and mergers. Such factors are anticipated to drive the market growth.

Based on end use, the pharmaceutical companies segment held the largest revenue share of over 57.79% in 2023. The segment growth is owing to an increasing preference for outsourcing non-core activities such as clinical trials, data management, regulatory compliance, and manufacturing to CROs and CMOs among pharmaceutical companies is anticipated to boost segment revenue growth. Outsourcing to CROs and CMOs provides pharmaceutical companies with cost-effective solutions compared to maintaining extensive in-house capabilities.

The U.S. dominated the biotechnology and pharmaceutical services outsourcing market with a share of 87.37% in 2023. The country’s revenue growth is owing to high R&D spending on clinical trials, which is another major factor expected to fuel market growth. For instance, in October 2021, the U.S. FDA approved 11 new clinical trial research, resulting in over USD 25 million in funding over the next four years. These grants aim to support the development of new medical products specifically for treating rare diseases. The growing presence of these companies expanding their manufacturing capabilities to cater to the rising demand for pharmaceuticals is anticipated to propel market growth.

North America Biotechnology And Pharmaceutical Services Outsourcing Market Segmentation

Grand View Research has segmented the North America biotechnology and pharmaceutical services outsourcing market based on service, end use, and region: 

North America Biotechnology And Pharmaceutical Service Outlook (Revenue, USD Million, 2018 - 2030)

Consulting

Regulatory Consulting

Clinical Development Consulting

Strategic Planning & Business Development Consulting

Quality Management Systems consulting

Others

Regulatory Affairs

Legal Representation

Regulatory Writing & Publishing

Product Registration & Clinical Trial Applications

Regulatory Submissions

Regulatory Operations

Others

Product Design & Development

Research, Strategy, & Concept Generation

Concept & Requirements Development

Detailed Design & Process Development

Design Verification & Validation

Process Validation & Manufacturing Transfer

Production & Commercial Support

Auditing and Assessment

General Auditing

Gap Assessments

Due Diligence Assessments

Mock Audits/Inspections

Inspection/Audit Management and Support

Others

Product Maintenance

Training & Education

Others

North America Biotechnology And Pharmaceutical End Use Outlook (Revenue, USD Million, 2018 - 2030)

Pharmaceutical Companies

Biotech Companies

North America Biotechnology And Pharmaceutical Country Outlook (Revenue, USD Million, 2018 - 2030)

U.S.

Canada

Mexico

Puerto Rico

List of Key Players in the North America Biotechnology And Pharmaceutical Services Outsourcing Market

Parexel International Corporation

The Quantic Group

IQVIA

Lachman Consultant Services, Inc.

GMP Pharmaceuticals Pty Ltd.

LabCorp

Charles River Laboratories

ICON plc.

Syneos Health

Lonza

Catalent Inc.

Samsung Biologics

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/north-america-biotechnology-pharmaceutical-services-outsourcing-market-report

[healthcaremarketanalysis]

Lipid Nanoparticles Market to Reach USD 350.5M by 2029

The Global Lipid Nanoparticles Market is expected to grow from USD 271.8 million in 2024 to USD 350.5 million by 2029, with a CAGR of 5.2%, while the LNP services market is projected to rise from USD 135.5 million in 2024 to USD 238.1 million by 2029 at a CAGR of 11.9%. Growth is driven by advancements in LNP-based pharmaceuticals, particularly in anti-cancer and mRNA therapies, though regulatory challenges and formulation issues pose potential constraints. Key opportunities include the demand for advanced drug delivery systems and scalable mRNA vaccines. The market's key players include Avanti Polar Lipids, Merck KGaA, and FUJIFILM Pharmaceuticals, with North America being the leading regional market. The sector is influenced by diverse product segments such as ionizable and PEGylated lipids, with applications spanning COVID-19 and cancer treatments.

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Browse in-depth TOC on "Lipid Nanoparticles Market"

398 - Tables

53 - Figures

316 - Pages

Factors Influencing Market Trends

The expansion of the lipid nanoparticles market is driven by increasing research and development efforts to create lipid nanoparticle-based drugs. However, stringent regulatory requirements may impede growth.

Product Segment Insights

The market is segmented by product into ionizable lipids, PEGylated lipids, neutral lipids, phospholipids, kits & reagents, and other formulation materials, with ionizable lipids leading due to their crucial role in mRNA vaccines like Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273.

LNP Type Breakdown

Segmented into solid lipid nanoparticles, nanostructured lipid carriers, and other types, the solid lipid nanoparticles segment holds the largest share, favored for vaccine production and as an alternative drug delivery carrier.

Molecule Type Distribution

The market is divided by molecule type into siRNA, mRNA, and other molecules. The mRNA segment dominates due to its effectiveness in vaccine production and the enhanced delivery capabilities of lipid nanoparticles.

Application Areas

Segmented into commercial and clinical applications, the commercial segment currently holds the largest market share due to its extensive use in vaccine production. The clinical applications segment, however, is expected to grow the fastest, driven by advancements in targeted drug delivery and personalized medicine.

End-User Analysis for Raw Materials

For raw materials, the market is divided into pharmaceutical & biotechnology companies, academic & research institutes, and CDMOs, with pharmaceutical & biotechnology companies holding the largest share due to their high use of lipid nanoparticles in drug development.

Service Type Analysis

The lipid nanoparticles services market, categorized into formulation development services, manufacturing services, and other services, sees the largest share in manufacturing services. This is driven by the high demand for raw materials and ongoing requirements from pharmaceutical and biotechnology companies.

End-User Analysis for Services

The services market is segmented by end users into pharmaceutical & biotechnology companies and academic & research institutes, with pharmaceutical & biotechnology companies leading due to their need for specialized manufacturing services and expertise.

Regional Market Overview

The lipid nanoparticles market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. North America held the largest share in 2023, benefiting from advanced healthcare infrastructure and significant R&D investments. However, the Asia Pacific region is anticipated to be the fastest-growing market during the forecast period, driven by increased healthcare expenditure, government initiatives, and favorable regulatory conditions.

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Growth Drivers and Challenges

The growth of the lipid nanoparticles market is driven by their increasing use in anti-cancer and RNA-based therapies. However, stringent regulatory requirements related to lipid nanoparticles may pose challenges to market expansion.

Market Consolidation

The lipid nanoparticles market is largely consolidated, with major players such as Avanti Polar Lipids (Croda International plc), Merck KGaA, NOF CORPORATION, and Nippon Fine Chemical holding 70-75% of the global market share.

Company Profiles

Avanti Polar Lipids (US): Established in 1967, Avanti specializes in high-purity lipids for biochemical and pharmaceutical research. The company offers a broad portfolio of lipid nanoparticles and custom synthesis services, heavily investing in R&D and collaborating with academic institutions to advance lipid formulations.

Merck KGaA (Germany): This healthcare and life sciences company provides a range of lipid nanoparticles products for research and clinical applications. Merck KGaA has strengthened its RNA production capabilities and recently acquired Exelead for approximately USD 780 million to enhance its CDMO services.

NOF CORPORATION (Japan): NOF CORPORATION is a prominent chemical manufacturer known for its lipid nanoparticle formulations. In April 2024, NOF collaborated with Phosphorex to provide lipid nanoparticles using their COATSOME® SA Series, which offers efficient nucleic acid delivery with minimal toxicity. NOF continues to innovate with high-purity lipid derivatives and liposome formulations for various drug applications.

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MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.

Earlier this year, we made a formal transformation into one of America's best management consulting firms as per a survey conducted by Forbes.

The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.

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[meditech-insights]

Cell & Gene Therapy (CGT) CDMO Market is likely to grow at a CAGR of ~25% to reach ~$5 billion by 2025

Robust CGT pipeline with rising number of product approvals, strong support from large pharma and biotech, and consistent investor enthusiasm (~$20 bn raised in 2020) is set to increase the demand for CGT services. An increasing pipeline of therapies are nearing regulatory decisions. Out of 1,220 ongoing clinical trials in 2020, 152 were in Phase 3 — FDA and EMA expect approval of 10-20 cell and gene therapies each year by 2025.

The global cell & gene therapy (CGT) CDMO market is anticipated to witness a CAGR of ~25% to reach ~$5 billion by 2025. This growth will be fueled by the rising incidence of cancer and other targeted diseases, rapidly expanding research on CGTs, substantial funding by VCs and technological innovations.

Growing Demand for Full-service/One-stop-shop CDMOs

Full-service CDMOs that can support with both development and manufacturing are in utmost demand. Recently, smaller biotech companies or research universities that rely on CDMOs for everything preclinical development to packaging have accounted for a large share of CGT development.

“There is increasing demand for Cell and Gene Therapy CTDMOs who can offer integrated development, manufacturing, and testing services. For CGT companies, outsourcing manufacturing and testing operations to a capable CTDMO can reduce development timelines, provide supplementary capacity, and ultimately control costs.” - Senior Director, Tier 1 CGT CDMO, US

Explore Premium Report on Cell & Gene Therapy (CGT) CDMO Market @ https://meditechinsights.com/cell-and-gene-therapy-cdmo-market/

Significant Outsourcing in CGT Industry due to Lack of Internal Capabilities

The level of outsourcing in CGT now approaches 60%, which is far higher than the level observed in the entire pharma/biologics industry. A high level of expertise is necessary in the complex field of cell & gene therapy. Also, it has costly production and different manufacturing process/infrastructure requirements as compared to traditional small molecules.

Big pharma currently lacks production-ready infrastructure and are increasingly looking for CGT CDMOs to enter/expand their presence in fast-growing CGT market. Additionally, the increasing number of small biotech’s entering the market with limited manufacturing capabilities and/or lack of expertise presents CGT CDMOs with additional growth opportunities.

North America is the Largest and Fastest Growing Region for Cell & Gene Therapy (CGT) CDMO Market

North America is projected to witness fastest growth and continue its dominance in the coming 5 years owing to growing manufacturing capacity for CGTs, favorable regulatory approval process, growing CGT approvals per year, and strong product pipeline of CGTs in the U.S.

Competitive Landscape Analysis of Cell & Gene Therapy (CGT) CDMO Market

The cell & gene therapy (CGT) CDMO market is marked by presence of both established players and several small and mid-sized players. Some of the leading players include Lonza, Catalent, Patheon, Wuxi Advanced Therapies and Charles River Laboratories. Other promising players include Vive Biotech, SK Bioscience, Fujifilm, Vibalogics, Exothera, Takara, Oxford Biomedica, Viralgen and AGC Biologics, among several others.

For More Detailed Insights, Contact Us @ https://meditechinsights.com/contact-us/

About Medi-Tech Insights

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services.

Contact:

Ruta Halde

Associate, Medi-Tech Insights

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[sanjay-chem]

Bioresorbable Polymers Market Set to Witness an Uptick Size USD 5 Billion to 2032

The global Bioresorbable Polymers market is anticipated to garner US$ 5 Billion while expanding at a CAGR of 13% during the forecast period. The market is estimated at US$ 1.3 Billion in 2021 and US$ 1.47 Billion in 2022. Technological advancements, innovations in plastics, and evolved decontamination devices are boosting the product demand, thereby augmenting the industry’s growth.

Bioresorbable polymers can biodegrade inside the human body, which permits physicians to eradicate the necessity for the following surgery to eliminate temporary implants. It also minimizes the post-surgery risk to the patient without causing a threat to the patient’s body. Owing to these factors, the product is finding wide application in the healthcare industry for the manufacturing of stents and other implants.

In recent years, the demand for bioresorbable polymers has burgeoned at a significant rate, backed by the growing health concerns among consumers. Consumers do not want to take unnecessary medications and therapies which may cause adverse effects on the human body after surgery. In terms of product type, the demand for polylactic acid is rising at an impressive rate owing to the growing adoption by manufacturers as a raw material for the development of implants.

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Key Takeaways:

By     Product type, the polylactic acid segment of the Bioresorbable Polymers     segment expanded at a ~12% CAGR

Based     on Application, the orthopedic segment of Bioresorbable Polymers is     estimated to record an ~13% CAGR

North     America region is likely to account for the majority share of nearly 32%     during the forecast period

Europe     region is estimated to gain significant traction in the market for     Bioresorbable Polymers, Germany is likely to hold the majority share.

“With the growing adoption of the minimally invasive surgery, the prominent manufacturers are compelled to develop the biodegradable implants which in turn is likely to boost the demand for the bioresorbable polymers over the coming years”.

Competitive Landscape

Key players in the global Bioresorbable Polymers market include Corbion NV, Evonik Industries AG, Poly-Med Inc., Foster Corp., Abbott, KLS Martin Group, 3D Biotek LLC., Sunstar Suisse S.A., DSM, Futerro, among others.

Recent key developments among players are:

In     June 2021, NatureWorks LLC invested USD 600 million for a PLA facility in     Thailand. The company is focusing on increasing its annual PLA production     capacity to 75,000 tons for Ingeo PLA grade.

In     Jan 2021, Evonik closed its previously announced acquisition of the     LACTEL® Absorbable Polymers product line from DURECT Corporation. The     acquisition of the LACTEL® business strengthened the company’s innovation     growth field in Healthcare Solutions and Evonik’s position as a globally     leading integrated CDMO for drug delivery solutions.

In     Feb 2022, 3D Biotek Introduced a new 3D InsertTMPCL scaffolds     for large-scale 3D cell expansion. As Compared with traditional 2D     culture, 3D InsertTM PCL technology more closely resembles     an in vivo In September 2020, DSM announced a partnership with PBC Biomed,     an Ireland-based medical device design and development company. This     partnership will focus initially on the development of regenerative bone     adhesives for safe and cost-effective surgical procedures.

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Key Segments Covered in the Bioresorbable Polymers Industry Analysis

Bioresorbable Polymers Market by Product:

Polysaccharides     Bioresorbable Polymers

Proteins     Bioresorbable Polymers

Polylactic     Acid Bioresorbable Polymers

Polyglycolic     Acid Bioresorbable Polymers

Polycaprolactone     Bioresorbable Polymers

Others

Bioresorbable Polymers Market by Application:

Bioresorbable     Polymers in Drug Delivery

Bioresorbable     Polymers in Orthopedics

Others

Bioresorbable Polymers Market by Region:

North     America Bioresorbable Polymers Market

Latin     America Bioresorbable Polymers Market

Europe     Bioresorbable Polymers Market

East     Asia Bioresorbable Polymers Market

South     Asia Bioresorbable Polymers Market

Oceania     Bioresorbable Polymers Market

Middle     East & Africa Bioresorbable Polymers Market

More Valuable Insights

Future Market Insights, in its new offering, presents an unbiased analysis of the bioresorbable polymers market presenting a historical analysis from 2017 to 2021 and forecast statistics for the period of 2022-2032.

The study reveals essential insights based on Product (Polysaccharides, Proteins, Polylactic Acid, Polyglycolic Acid, Polycaprolactone, Others) by Application (Drug Delivery, Orthopedics, Other) & Region (North America, Europe, East Asia, South Asia, Oceania, Middle East & Africa, and Latin America).

Table of Content

1. Executive Summary

1.1. Global Market Outlook

1.2. Demand Side Trends

1.3. Supply Side Trends

1.4. Analysis and Recommendations

2. Market Overview

2.1. Market Coverage / Taxonomy

2.2. Market Definition / Scope / Limitations

2.3. Inclusions/Exclusions

3. Key Market Trends

to be continued…!

About FMI

Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

Contact:

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[health-views-updates]

Cell & Gene Therapy Manufacturing Services Market | Size, Share, Analysis, Overview, Segments, Key Players, Industry Research Trends & Forecast Report 2024-2032

The global cell & gene therapy manufacturing services market revenue is set for extraordinary growth, with the market size valued at USD 11.4 billion in 2023 and projected to reach USD 70.7 billion by 2032. This represents a compound annual growth rate (CAGR) of 22.4% during the forecast period from 2024 to 2032. The demand for advanced therapies and innovative manufacturing solutions is driving the significant expansion of this market, which is expected to play a critical role in the future of healthcare.

Cell and gene therapies offer transformative potential to treat and cure a range of chronic and rare diseases, including genetic disorders, cancer, and autoimmune diseases. These therapies involve altering genetic material within a patient’s cells to treat or prevent diseases, presenting a cutting-edge approach to modern medicine.

Key Market Drivers

Rising Demand for Cell & Gene Therapies: The increasing prevalence of genetic disorders and chronic diseases is driving the demand for innovative cell and gene therapies. Treatments like CAR-T cell therapy, gene editing, and stem cell transplants are gaining traction due to their ability to offer long-lasting or curative solutions for previously untreatable conditions. As these therapies continue to evolve, the need for specialized manufacturing services is also growing rapidly.

Growing Investment in Biopharmaceutical R&D: Pharmaceutical companies and biotechnology firms are significantly increasing their investments in the development of cell and gene therapies. This has led to a surge in clinical trials, with a growing number of cell and gene therapies moving through the development pipeline. The need for efficient and scalable manufacturing services is becoming paramount as these therapies progress from clinical stages to commercialization.

Advancements in Manufacturing Technologies: The development of advanced manufacturing technologies, such as automation, 3D bioprinting, and artificial intelligence (AI), is revolutionizing the cell and gene therapy manufacturing process. These technologies are helping to streamline production, reduce costs, and ensure product consistency and quality. Moreover, innovations in bioprocessing and single-use technologies are enhancing scalability, enabling manufacturers to meet the growing demand for these therapies.

Regulatory Support and Approvals: The global regulatory landscape is evolving to accommodate the rapid growth of cell and gene therapies. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have implemented expedited approval pathways for advanced therapies, encouraging the development and commercialization of these innovative treatments. The increasing number of approved therapies is contributing to the rising demand for manufacturing services.

Outsourcing of Manufacturing Services: The complexity and high cost of manufacturing cell and gene therapies have led many biopharmaceutical companies to outsource their production needs to contract development and manufacturing organizations (CDMOs). CDMOs provide specialized expertise, state-of-the-art facilities, and scalable production capabilities, allowing companies to focus on research and development while ensuring the efficient and compliant production of therapies.

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Challenges and Opportunities

Despite the impressive growth potential, the cell and gene therapy manufacturing services market faces several challenges. These include the high cost of production, difficulties in scaling up manufacturing processes, and the need for stringent quality control. Additionally, the industry requires highly specialized talent and infrastructure to manage the complexities of these therapies.

However, these challenges also present opportunities for innovation. The development of more efficient, cost-effective manufacturing processes, along with advancements in automation and AI-driven technologies, is expected to address many of these barriers. The growing demand for specialized manufacturing services also opens the door for CDMOs and other service providers to expand their capabilities and capacity.

Regional Insights

North America holds the largest share of the cell and gene therapy manufacturing services market, driven by significant investments in biopharmaceutical R&D, a strong presence of leading biotech companies, and supportive regulatory frameworks. Europe is another major market, with growing research activities and government initiatives aimed at fostering the development of advanced therapies.

The Asia-Pacific region is expected to experience the highest growth rate over the forecast period, fueled by the expansion of healthcare infrastructure, rising investments in biotechnology, and increasing demand for innovative therapies in countries such as China, Japan, and India.

Future Outlook

As the field of cell and gene therapy continues to evolve, the demand for high-quality, scalable manufacturing services is expected to grow exponentially. The projected CAGR of 22.4% from 2024 to 2032 highlights the vast potential of the market, with innovations in manufacturing technologies and regulatory support paving the way for further advancements.

In conclusion, the cell and gene therapy manufacturing services market is entering a phase of rapid expansion, with a projected growth from USD 11.4 billion in 2023 to USD 70.7 billion by 2032. As the demand for these life-changing therapies rises, the market will play a critical role in shaping the future of healthcare, offering new hope for patients with previously untreatable conditions.

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5 Reasons to Conduct Early Clinical Development in Canada

Is your organization starting clinical research and looking for a way to conduct it in a safe, timely, and cost-effective manner? Is the program designed to meet regulatory requirements for the multiple jurisdictions where you plan to request market authorization? Consider conducting your early clinical development in Canada. Many biotechnology and pharmaceutical companies have moved their initial clinical research to Canada to get earlier access to first-in-human data, high-quality clinical research, and reliable study participants. Plus, it can help keep costs down. Here are some of the advantages your organization can expect when moving your early phase clinical research to Canada.

Start First-In-Human Trials Earlier Access to FIH trials in Canada is slightly different than in America. You can start FIH clinical trials before obtaining Investigational New Drug approval. That means your contract research organization can conduct study participant recruitment and screening at the same time as the Clinical Trial Application. This follows Institutional Review Board Approval. With a 21-day timeline, the CTA process itself is also streamlined. Overlapping activities and shorter timelines present an opportunity for significantly earlier access to FIH trial data. You can then use that data to strategically enhance your IND submission in the U.S. Tax Credits and Favorable Exchange Rates Another major benefit of conducting early clinical development in Canada is cost savings. If your company already has a presence in Canada, attractive tax credits can contribute to your development program’s cost-effectiveness. A lower currency value, thanks to favorable exchange rates, is another cost-saving factor. Canadian research operates at the same level as the United States’ technology, and the country has comparable scientific advancement. As a result, your organization gets to benefit from these similarities. Quality of Clinical Research Canada complies with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and many reputable clinical research teams call Canada home. These teams are experienced in managing complex studies that span international borders. Plus, they have health research networks and strong information-management systems to support their efforts. High-Quality Potential Participants Your clinical trials will have high-quality potential participants, thanks to publicly funded free universal healthcare. The Government of Canada supports the Medicare initiative, which is universally administered while each province is individually managed. There is a “continuum of care” across the country, helping manage patient health and making recruiting for clinical trials more efficient. Pharmaceutical and biotechnology companies can leverage the high quality of potential trial participants during pivotal early phase clinical trials. Easier Access to Clinical Teams Canadian contract research organizations offer U.S.-based clients relative proximity, meaning live interactions with staff and program monitoring are possible. Same-day travel to Phase 1 clinical trial units is also possible, and in many cases, travel documents or visas are not required. This can facilitate smooth program deployment and interactions between your organization and the CRO. About Altasciences As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff. Partner with Altasciences for early clinical development in the US and Canada at https://www.altasciences.com/ Original Source: https://bit.ly/3SNa7an