#Healthcare CDMO

[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

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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.

[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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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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Job opportunity for Formulation R&D at Aizant Drug Research Solutions

Aizant® offers comprehensive drug development solutions as an integrated provider. Founded by seasoned pharmaceutical experts with international experience, we have evolved into a dynamic formulation CDMO and CRO. Our wide-ranging capabilities cater to healthcare firms focused on new molecular entities (NME’s), generics (ANDA’s), and over the counter (OTC’s) products worldwide. We enhance the R&D…

[lanettcdmo]

The Strategic Alliance: How Small Pharmaceutical Companies Benefit from Partnering with CDMOs

Introduction

Small pharmaceutical companies are playing an increasingly significant role in the healthcare landscape, driving innovation through specialized products and niche therapies. However, limited resources can present challenges in scaling production, meeting regulatory requirements, or navigating complex supply chains. This is where Contract Development and Manufacturing Organizations (CDMOs) come into play.

1. The Rise of Small Pharma

Small pharmaceutical companies are flourishing because of:

Specialization: Focusing on niche areas (rare diseases, generic therapies, or targeted therapies).

Innovation: Lean teams foster quicker decision-making and adaptability.

Acquisitions: Larger firms often acquire small pharma to gain access to new technologies and molecules.

However, these smaller companies often lack the infrastructure to handle manufacturing, regulatory compliance, or clinical trial supply chain management.

2. How CDMOs Bridge the Gap

CDMOs are integral to small pharma’s success, offering tailored solutions across the product lifecycle. Key services include:

Development Services: Formulation development, analytical testing, and clinical trial material supply.

Manufacturing: Access to state-of-the-art facilities for small- or large-scale production.

Regulatory Expertise: Guidance on compliance with FDA and global regulatory bodies.

Speed to Market: Faster product launches through efficient processes and expertise.

3. Key Advantages of Partnering with a CDMO

Cost Efficiency: No need for massive infrastructure investment.

Access to Expertise: CDMOs specialize in handling the latest technologies and regulatory complexities.

Focus on Core Strengths: Small pharma companies can dedicate their energy to R&D and innovation.

Scalability: CDMOs provide flexibility as production demands fluctuate.

4. Challenges to Consider

Finding the Right Fit: Not all CDMOs specialize in every therapeutic area.

Intellectual Property Concerns: Trust and legal agreements are crucial for safeguarding sensitive information.

Communication & Collaboration: Strong partnerships rely on transparent, consistent communication.

5. CDMOs and the Future of Small Pharma

The increasing demand for personalized and precision medicines creates an ideal environment for small pharma to thrive, with CDMOs acting as essential partners. Trends such as advanced biologics, cell and gene therapies, and specialized generics require expertise that CDMOs are positioned to provide.

Additionally, supply chain resilience—especially after disruptions like the COVID-19 pandemic—has become a critical focus, further highlighting the importance of CDMOs in providing diversified production capabilities.

Conclusion

The partnership between small pharmaceutical companies and CDMOs is a powerful combination. CDMOs allow small pharma to scale their innovations efficiently and compliantly, unlocking growth without compromising focus on what they do best—developing novel therapies.

By leveraging the right CDMO partnerships, small pharmaceutical companies can accelerate time to market, streamline operations, and remain competitive in a rapidly evolving industry.

[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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[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.

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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

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Small Molecule Innovator CDMO Market Size, Analysis and Forecast 2031

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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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Aizant Drugs walk-in interview for B.Sc., M.Sc., B Pharm, M Pharm Freshers and Experienced on 5th July 2024

Aizant® offers comprehensive drug development solutions as an integrated provider. Founded by seasoned pharmaceutical experts with international experience, we have evolved into a dynamic formulation CDMO and CRO. Our wide-ranging capabilities cater to healthcare firms focused on new molecular entities (NME’s), generics (ANDA’s), and over the counter (OTC’s) products worldwide. We enhance the R&D…

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Highly Potent Active Pharmaceutical Ingredients Market Report | BIS Research 

Highly Potent Active Pharmaceutical Ingredients are pharmacologically active compounds that exhibit significant potency, typically requiring small doses to achieve therapeutic effects. They possess high selectivity for specific molecular targets, enabling precise modulation of biological pathways associated with disease progression.Due to their potency, HPAPIs may pose safety challenges during manufacturing, handling, and administration, necessitating specialized facilities and stringent safety protocols.

The global highly potent API market is projected to reach $84.20 billion by 2033 from $27.44 billion in 2023, growing at a CAGR of 11.86% during the forecast period 2023-2033.

Highly Potent API Overview 

Highly Potent API. These substances are pharmacologically active compounds that exhibit significant therapeutic effects even at low doses. Their potency allows for the creation of medicines that are more effective, targeted, and often associated with fewer side effects. 

This characteristic makes HPAPIs indispensable in the treatment of various diseases, including cancer, autoimmune disorders, and chronic conditions.

Applications of HPAPIs

Oncology : Potent anticancer drugs, such as cytotoxic agents and targeted therapies, leverage the high potency of HPAPIs to induce apoptosis or inhibit tumor growth with minimal impact on healthy tissues.

Biologics and Immunotherapy: agents target specific antigens or cellular pathways involved in immune regulation, making them effective in treating autoimmune disorders, inflammatory conditions, and certain cancers.

Central Nervous System Disorders:development of drugs for neurological and psychiatric disorders, including antidepressants, antipsychotics, and analgesics. Their high potency enables precise modulation of neurotransmitter activity or receptor function, leading to therapeutic effects in conditions such as depression, schizophrenia, and chronic pain.

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Highly Potent API Market Segmentation 

Segmentation 1: by Type

Segmentation 2: by Therapeutic Area

Segmentation 3: by Type of Manufacturing

Segmentation 4: by Type of Synthesis

Segmentation 5: by End User

Segmentation 6: by Region

China dominated the Asia-Pacific highly potent API market in 2022. The country has a growing population with cancer, and hormonal disorder. Highly potent API offers effective and accessible results for these conditions.

Key Companies in Highly Potent API Market 

Almac Group

Asymchem Inc.

BASF Pharma Solutions

CARBOGEN AMCIS

CordenPharma International

Highly Potent Compound Development Market 

The highly potent compound development market presents lucrative opportunities for pharmaceutical companies, CDMOs, and technology providers. By investing in safety measures, technological innovations, and regulatory compliance, stakeholders can capitalize on the growing demand for highly potent compounds and drive innovation in healthcare and other industries.

Recent Developments in the Highly potent API Market

In December 2022, Almac concluded the initial phase of its good manufacturing practice (GMP) active pharmaceutical ingredient (API) facility expansion as part of a multi-million-pound investment program.

In October 2022, Asymchem Inc., a prominent global provider of contract development and manufacturing services, and AUM Biosciences (AUM), a global biotech company in the clinical stage, with a focus on the discovery, acquisition, and development of next-generation targeted oncology therapeutics, jointly declared the successful conclusion of their inaugural GMP production campaign for AUM601.

In April 2022, Asymchem Inc. announced the construction of a new facility at its Dunhua production site in China. This facility is dedicated to the extensive implementation of continuous flow technology in manufacturing processes.

In October 2023, Axplora's subsidiary Farmabios secured cGMP approval from AIFA for expanded HPAPI and steroid production capacity.

In January 2022, Helsinn and Immedica established an exclusive partnership for the commercialization of cancer supportive care products in key European markets.

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Key Question Answers 

Q  What is the estimated global market size for the highly potent API market?

Q  What are the different types of highly potent API market available in the market?

Q  How has the COVID-19 outbreak affected the future trajectory of the highly potent API market?

Q What are the key trends influencing the global highly potent API market, and what is their potential for impacting the market?

Q What does the patent landscape of the global highly potent API market look like? Which year and country witnessed the maximum patent filing between January 2020 and December 2023?

Conclusion 

Highly Potent Active Pharmaceutical Ingredients (HPAPIs) represent a pivotal component of modern drug development, enabling the creation of targeted therapies with enhanced efficacy and safety profiles.However, the utilization of HPAPIs also necessitates diligent adherence to safety protocols, regulatory standards, and ethical considerations to ensure the responsible use and maximal benefit of these potent compounds in improving global healthcare.