#Antibody Drug Conjugates Contract Manufacturing Market Trends

[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.

[ashwetu]

Meticulous Research® Projects Global Pharmaceutical Contract Development & Manufacturing Market to Reach $261.57 Billion by 2031

Meticulous Research®, a leading global market intelligence and consulting firm, has released its latest report titled Pharmaceutical Contract Development & Manufacturing Market Size, Share, Forecast, & Trends Analysis by Service and End User – Global Forecast to 2031. According to the report, the pharmaceutical contract development and manufacturing market is poised to reach an impressive $261.57 billion by 2031, registering a compound annual growth rate (CAGR) of 7.4% from 2024 to 2031.

Download Complete Sample PDF Copy Here: https://www.meticulousresearch.com/download-sample-report/cp_id=5171

Key Market Drivers and Challenges

The expanding pharmaceutical contract development and manufacturing market is being driven by several critical factors. The increasing complexity of pharmaceutical manufacturing processes, coupled with manufacturers' adoption of advanced technologies, is fueling growth. In addition, growing investments in pharmaceutical research and development (R&D), the expiration of patents, and heightened demand for generic medicines and biologics are expected to further propel the market.

However, several challenges, including disruptions in the supply chain and stringent government regulations, are hindering growth. The market also faces ongoing issues related to intellectual property risks and a shortage of skilled professionals, posing significant challenges to sustained expansion.

Emerging Opportunities

Despite these hurdles, the pharmaceutical contract development and manufacturing market is expected to witness robust opportunities, particularly in the fields of cell and gene therapies, personalized medicine, and high-potency active pharmaceutical ingredients (HPAPI). The growing demand for antibody-drug conjugates (ADCs) is also projected to open new avenues for market participants.

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Competitive Landscape

Key players in the global pharmaceutical contract development and manufacturing market include industry giants such as Lonza Group Ltd. (Switzerland), Catalent Inc. (U.S.), Patheon (a subsidiary of Thermo Fisher Scientific Inc., U.S.), Recipharm AB (Sweden), and WuXi Biologics Inc. (China), among others. These companies continue to play a vital role in shaping the market through strategic collaborations, technological advancements, and capacity expansions.

Future Outlook by Service Type and End User

The market is segmented into key service categories, including pharmaceutical manufacturing (API and FDF), drug development, and biologics manufacturing. Of these, the biologics manufacturing services segment is projected to grow at the fastest rate, with an estimated CAGR of 11.1% during the forecast period. Within this segment, Finished Dosage Forms (FDF) manufacturing services, driven by the complexity of biologics manufacturing, are expected to witness particularly high demand.

Check complete table of contents with list of table and figures: https://www.meticulousresearch.com/product/pharmaceutical-contract-development-and-manufacturing-market-5171

On the basis of end users, large pharmaceutical companies are anticipated to dominate the market, accounting for 42.3% of the global share in 2024. The reliance of major pharmaceutical and biotech companies on external contract manufacturers, driven by increasing R&D complexity and the rising costs of maintaining in-house facilities, is a major factor contributing to this trend.

Geographic Insights

Regionally, North America is projected to capture the largest share of the market, accounting for 44.3% in 2024. The region's dominance is attributed to a combination of factors, including a diversified pharmaceutical pipeline, increased demand for biologics and generic drugs, and a robust base for clinical trials and API production. The presence of leading pharmaceutical companies and advanced manufacturing capabilities further bolster North America's market position.

Request  Sample PDF Copy Here: To gain deeper insights into the pharmaceutical contract development and manufacturing market, including growth opportunities, competitive analysis, and geographical trends, download the sample report here: https://www.meticulousresearch.com/request-sample-report/cp_id=5171

Key Questions Addressed in the Report:

What are the fastest-growing market segments by type, end user, and region?

What was the historical market size, and what are the forecasts through 2031?

What are the key market drivers, challenges, and emerging opportunities?

Who are the leading players, and what strategies are they employing?

Which regions are expected to witness the highest growth?

Contact Information:

Meticulous Research® Email: sales@meticulousresearch.com Sales Contact: +1-646-781-8004 Connect with us on LinkedIn

[colinwilson11]

The Global ADC Contract Manufacturing Market To Grow Significantly Due To Increasing Demand For Personalized Medicine

The Global ADC Contract Manufacturing market involves developing antibody drug conjugates (ADC) for pharmaceutical and biotechnology companies. ADCs are monoclonal antibodies that are attached to cytotoxic compounds or drugs to selectively target and kill cancer cells. The market is driven by the need for personalized medicine in the treatment of chronic diseases like cancer.

Global ADC Contract Manufacturing Market is estimated to be valued at US$ 1.79 Billion in 2024 and is expected to exhibit a CAGR of 13% over the forecast period 2024-2031.

Key players operating in the Global ADC Contract Manufacturing market include AbbVie Contract Manufacturing, Abzena, CARBOGEN AMCIS, Catalent Pharma Solutions, and Cerbios-Pharma. These players specialize in developing ADCs using various linker-drug combinations and conjugation technologies to maximize the potency and efficacy of the antibody drug conjugate. The Global ADC Contract Manufacturing Market is driven by the increasing demand for ADCs in cancer treatment due to their ability to target specific cancer antigens with high precision. Technological advancements in bioconjugation techniques have also improved the therapeutic index of ADCs.

Key Takeaways

Key players: Key players operating in the Global ADC Contract Manufacturing market are AbbVie Contract Manufacturing, Abzena, CARBOGEN AMCIS, Catalent Pharma Solutions, and Cerbios-Pharma.

Growing demand: The increasing demand for personalized medicine in cancer treatment is a major driver of the Global ADC Contract Manufacturing market. ADCs allow for targeted delivery of cytotoxic drugs to tumor cells while minimizing adverse effects on non-cancerous cells.

Technological advancement: Technological innovations in areas such as site-specific conjugation, optimal linker-payload combinations, and conjugation processes have improved the selectivity and efficacy of ADCs. These advancements are expected to increase the clinical potential of ADCs and fuel demand for contract manufacturing.

Market Trends

Consolidation of players: Large players are acquiring smaller players to expand their capabilities across various antibody engineering and ADC technologies. This allows for a one-stop-shop for end-to-end ADC development and manufacturing services.

Outsourcing of manufacturing: Pharma companies prefer outsourcing ADC manufacturing to contract manufacturers to avoid investments in facility setup and specialized expertise. This is a major trend driving the growth of contract manufacturing.

Market Opportunities

Development of solid tumor ADCs: Most approved ADCs target hematological cancers. Further development of ADCs for solid tumors like lung, breast and prostate cancer presents key opportunities.

Manufacturing of next-gen ADCs: Innovation in linker technologies, conjugation methods, and novel cytotoxic payloads can yield so-called "next-generation" ADCs with improved stability, tolerability and efficacy. This provides opportunities for contract manufacturers.

Impact Of COVID-19 On Global ADC Contract Manufacturing Market:

The COVID-19 pandemic had a significant impact on the global ADC contract manufacturing market. During the initial outbreak in early 2020, production and manufacturing facilities were shut down due to strict lockdown measures imposed globally. This led to major disruptions in supply chains and logistics networks. The demand for ADC therapeutics also declined initially due to the diversion of resources towards managing the crisis. However, as the pandemic intensified, emphasis on developing effective treatments grew substantially. This stimulated research activities into antibody-drug conjugates for COVID-19. Several pharma companies partnered with contract manufacturers to expedite their development.

As lockdowns eased from mid-2020, contract manufacturers steadily scaled up operations while implementing stringent safety protocols. The demand regained momentum as clinical trials entered late-stage testing. By late 2020, contract manufacturers worked round the clock to meet surge in demand. Their production capacities were under immense pressure to deliver on timely commitments. Ensuring workforce safety and minimizing disruptions remained key priorities. Looking ahead, partnerships are expected to increase further to enhance manufacturing throughput. Advanced manufacturing technologies will help optimize processes and flexibility. Efforts to diversify supplier networks can strengthen resilience against future public health emergencies.

Geographical Regions With Highest ADC Contract Manufacturing Value:

North America remains the dominant regional market for ADC contract manufacturing in terms of value. This is primarily due to strong presence of leading pharma companies and contract service providers in the US. Countries like the US have witnessed approvals and launch of several ADC drugs in cancer therapy in recent years. This has propelled demand for their large-scale production via reliable contract routes. Growing pipeline of ADC candidates entering clinical trials also offers lucrative opportunities. Meanwhile, Asia Pacific has emerged as the fastest growing regional market driven by expanding biotech industries in China, India, South Korea and others. Improving regulatory environment and lower production costs have encouraged companies to outsource to Asia Pacific contract manufacturers.

Fastest Growing Regional Market:

Asia Pacific is poised to be the fastest growing regional market for ADC contract manufacturing during the forecast period. This is attributed to increasing investments by international drug makers into the biologics manufacturing infrastructure of Asia Pacific nations. Countries like China and India offer skilled workforce, well-developed supply chains and strong government support for biopharma sector. Additionally, Asia Pacific contract manufacturers have enhanced their technological expertise to meet stringent quality standards. Their expanding service portfolios covering complex conjugation and analytical testing attract more collaborations. These factors are facilitating Asia Pacific's rise as a valuable outsourcing destination, thus driving the fastest growth of its regional ADC contract manufacturing market.

Get more insights on this topic:   https://www.pressreleasebulletin.com/global-adc-contract-manufacturing-market-is-estimated-to-witness-high-growth-owing-to-advancement-in-drug-development-technologies/

Author Bio:

Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163 )

What Are The Key Data Covered In This Global ADC Contract Manufacturing Market Report?

:- Market CAGR throughout the predicted period

:- Comprehensive information on the aspects that will drive the Global ADC Contract Manufacturing Market's growth between 2024 and 2031.

:- Accurate calculation of the size of the Global ADC Contract Manufacturing Market and its contribution to the market, with emphasis on the parent market

:- Realistic forecasts of future trends and changes in consumer behaviour

:- Global ADC Contract Manufacturing Market Industry Growth in North America, APAC, Europe, South America, the Middle East, and Africa

:- A complete examination of the market's competitive landscape, as well as extensive information on vendors

:- Detailed examination of the factors that will impede the expansion of Global ADC Contract Manufacturing Market vendors

FAQ’s

Q.1 What are the main factors influencing the Global ADC Contract Manufacturing Market?

Q.2 Which companies are the major sources in this industry?

Q.3 What are the market’s opportunities, risks, and general structure?

Q.4 Which of the top Global ADC Contract Manufacturing Market companies compare in terms of sales, revenue, and prices?

Q.5 Which businesses serve as the Global ADC Contract Manufacturing Market’s distributors, traders, and dealers?

Q.6 How are market types and applications and deals, revenue, and value explored?

Q.7 What does a business area’s assessment of agreements, income, and value implicate?

*Note: 1. Source: Coherent Market Insights, Public sources, Desk research 2. We have leveraged AI tools to mine information and compile it

[123567-9qaaq9]

Pharmaceutical API Manufacturing Market Size, Volume, Demand, Outlook | BIS Research

The Pharmaceutical API Manufacturing Market is a crucial component of the pharmaceutical industry, responsible for the production of the active ingredients in medications. These APIs are the biologically active components of drugs that produce the desired therapeutic effects.

The global HPAPI 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.

Download the report and get a better understanding Click Here! 

Pharmaceutical API Manufacturing Overview 

APIs are the biologically active components within pharmaceutical formulations that elicit the desired therapeutic effects. 

API manufacturing encompasses diverse processes, including chemical synthesis, fermentation, biocatalysis, extraction from natural sources, and biotechnological methods such as recombinant DNA technology.

The Pharmaceutical API Manufacturing industry is a vital component of the pharmaceutical sector, playing a crucial role in ensuring the availability of safe, effective, and high-quality medications for global healthcare needs. 

Key Stages in Pharmaceutical API Manufacturing Market are as follows 

Raw material sourcing 

Chemical synthesis or Biotechnological processes 

Reaction and Purification 

Quality Control and Analysis 

Continuous Improvement and Optimization 

Download our sample page click here ! 

Market Segmentation 

Segmentation 1: based on Type

(i) by type of synthesis

(ii) by type of manufacturing 

Segmentation 2: based on Therapeutic Area

(i) Oncology 

(ii) Neurology 

(iii) Infectious Diseases 

(iv) Autoimmune Diseases 

(v) Cardiovascular Diseases 

Segmentation 3: based on Population Segmentation 

(i) Pediatric Population 

(ii)Geriatric Population 

(iii) Rare Diseases 

Segmentation 4: based on Geographic Segmentation

(i) Emerging Markets 

(ii) Developed Markets 

Segmentation 5: based on Technology 

(i) Biologicals 

(ii) Small Molecules 

Segmentation 6: by Regulatory Environmental Segmentation 

(i) FDA Approved Drugs 

(ii) EMA Approved Drugs 

.

Key Companies are as follows  

Almac Group

Asymchem Inc.

BASF Pharma Solutions

CARBOGEN AMCIS

CordenPharma International

Market Trends and Drivers 

Increasing demand for Oncology Treatments 

Shift towards personalized medicines 

Expansions of Biologics and Antibody Drug Conjugates 

Potent Biosimilars and Generics 

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.

Click here to have a look at Life Sciences & Biopharma page !

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 

Pharmaceutical API Manufacturing market  stands as a pivotal pillar within the pharmaceutical industry, serving as the cornerstone for the development and production of essential active ingredients that form the basis of numerous medications. 

The market's significance stems from its role in ensuring the availability of safe, effective, and high-quality pharmaceutical products that address diverse therapeutic needs.

[rohit0024]

Antibody Drug Conjugates Contract Manufacturing Market Worth $25.79 Billion By 2030

Antibody Drug Conjugates Contract Manufacturing Market Growth & Trends The global antibody drug conjugates contract manufacturing market size is expected to reach USD 25.79 billion by 2030, registering a CAGR of 12.9% over the forecast period, according to a new report by Grand View Research, Inc. The factors driving the industry growth include the complex nature of antibody drug conjugates…

[abbviecontractmfg]

Finding the Right Expertise in Potent Drug Contract Manufacturing

The highly-potent drug contract manufacturing industry continues to grow annually. The market for HPAPIs (highly potent active pharmaceutical ingredients), such as prostaglandins, anti-cancer drugs, opioids, and hormones, has a very high value.

Producing highly potent compounds involves extremely intricate, pricey facilities and processes. The compounds also come with high risks of contamination and toxicity. Because of these concerns, many pharmaceutical companies are partnering with contract manufacturing organizations. However, partnering with CMOs isn’t all it takes; finding the right expertise is the most important.

Handling Highly Potent Active Pharmaceutical Ingredients

Handling high potency active pharmaceutical ingredient formulations requires excellent and meticulous attention to detail, outstanding training, and a great understanding of the risks at every step of the manufacturing process.

This means that pharmaceutical manufacturing companies must take extreme care when choosing their contract manufacturing organization to partner with for HPAPI production. This is crucial to ensure that they are partnering with organizations that provide the best expertise.

There are many Positive Market Indicators in Potent Drug Contract Manufacturing

One of the top categories of high potency active pharmaceutical ingredients is oncology drugs. These drugs were already the most-valued therapeutic class of drugs in 2007. Here, $41.4 billion was accounted for, about 6.2 percent of the total global pharmaceutical market.

The sales of anti-cancer drugs such as cytotoxic active pharmaceutical ingredients have gone beyond double since then. About sixty percent of all the high-potency active pharmaceutical ingredients currently under development are focused on the cure of cancer.

However, cancer treatments are only a part of high-potency compound production. One of the most predominant trends in modern medicine is a slow but steady shift towards more potent, targeted treatments, which are biologically active in slight amounts. These treatments include lipids such as prostaglandins, therapeutic hormones, pain medicines such as opioids, and other highly potent active pharmaceutical ingredients for use in marketable compounds.

Pharmaceutical Companies are Investing in Potent Drug Contract Manufacturing

The increasing demand for these classes of drugs has raised 7 to 8-figure investments in high-potency active pharmaceutical ingredient contract manufacturing from leading pharmaceutical development firms worldwide.

The majority of these contract manufacturing organizations produce not only the highly potent active pharmaceutical ingredients themselves but also the ADCs (Antibody Drug Conjugates) that bond with the small molecules, helping to circulate them throughout the body and send them into targeted cells.

The Best Expertise in Highly Potent Drug CMO

Over the past few years, CMOS and pharmaceutical companies have greatly increased their investments in highly potent active pharmaceutical ingredients. CDO like AbbVie have spent millions on facilities for themselves as well as their subsidiaries.

AbbVie is one of the few potent drug contract manufacturing organizations with highly potent facilities in both Europe and North America. Here, we apply outstanding compliance records and safety, and our intensive depth of scientific expertise to protect the compounds of our clients, from lab to patient. With topnotch facilities, proven processes, and experienced people, we follow EHS standards and the highest regulatory for handling potent drugs.

[rootsanalysis-blog]

The ADC contract manufacturing market is projected to grow at a CAGR of more than 13% till 2035

Owing to the fact that a number of ADC developers are outsourcing various aspects of their business processes, CMOs engaged in this domain have undertaken several expansion initiatives to become one-stop-shops to cater to the diverse needs of ADC developers.

 London

 Roots Analysis has announced the addition of “ADC Contract Manufacturing Market (5th Edition), 2022-2035” report to its list of offerings.

 In order to mitigate the challenges associated with Antibody Drug Conjugate manufacturing, around 70-80% of the therapeutics developers prefer to outsource their operations to contract manufacturing organizations (CMOs), which claim to have the required expertise and experience to leverage their capabilities and yield cost savings opportunities.

 To request a sample copy / brochure of this report, please visit  

https://www.rootsanalysis.com/reports/218/request-sample.html

 Key Market Insights

Presently, more than 30 players claim to offer ADC contract manufacturing services

This segment of the industry is dominated by the presence of large (more than 501 employees) and mid-sized (51-500 employees) players, which collectively represent more than 80% of the total contract manufacturers in this domain. In addition, around15% firms were established post 2010.

More than 84 expansions were reported in this industry, during 2012-2021

Of the total, 57% instances were focused on enhancing dedicated capabilities and capacities, followed by those carried out for the expansion / establishment of manufacturing facilities (42%).

 Partnership activity in this domain has increased at a CAGR of over 16%, during 2016- 2021

Manufacturing agreements emerged as the most popular type of partnership model adopted by industry stakeholders (18%), followed by product development agreements (16%) and research agreements (15%). Further, most of the deals were inked by players based in Europe (46%).

 Global, installed ADC contract manufacturing capacity is currently estimated to be close to 33 Kilograms

The maximum share of the current installed capacity is expected to be captured by large players. Moreover, close to 37% of the installed manufacturing capacity is available in the Asia-Pacific region.

 140,200+ patients have been enrolled in over 714 clinical trials, worldwide

Clinical research activity, in terms of number of trials registered, is reported to have increased at a CAGR of 21%, in the past three years. Of the total number of trials, close to 47% of the studies are recruiting patients, while 30% have been completed.

 Global demand for ADC contract manufacturing is anticipated to grow at a CAGR of 13%, during 2022-2035

The commercial demand for ADC therapeutics is projected to increase at a CAGR of 22%. Further, the clinical demand for ADC therapeutics in phase III trials is projected to increase at a CAGR of 10%.

 The market is anticipated to grow at a CAGR of nearly 13%, during the period 2022-2035

In terms of type of cancer, ADC therapeutics targeting solid tumors (48%) are anticipated to capture the highest share; this trend is unlikely to change in the foreseen future. Further, based on type of antibody isotype, majority of the revenue share (90%) of the overall market is likely to be driven by IgG1 antibodies. While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

 For additional details please visit https://www.rootsanalysis.com/reports/view_document/adc-contract-manufacturing-market/218.html or email sales@rootsanalysis.com

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

 Contact:

Ben Johnson

+1 (415) 800 3415

+44 (122) 391 1091

Ben.johnson@rootsanalysis.com

[rootsanalysis]

With over 280 therapies under evaluation, the stem cell therapy market is estimated to be worth USD 8.5 Billion by 2030

With multiple approved products, the field of stem cell therapies has gained substantial momentum over the last decade; several innovator companies are currently progressing their proprietary therapy candidates with cautious optimism. In fact, recent studies suggest that mesenchymal stem cells have the potential to end the Coronavirus (COVID-19) pandemic.

 Roots Analysis is pleased to announce the publication of its recent study, titled, “Global Stem Cells Market: Focus on Clinical Therapies, 2020–2030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent))”.

 The  report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes:

§  A detailed assessment of the current market landscape of companies engaged in the development of stem cell therapies for treatment of wide range of clinical conditions

§  Elaborate profiles of key industry players engaged in the development of stem cell therapies (shortlisted on the basis of the product portfolio).

§  An insightful competitiveness analysis featuring a four-dimensional bubble chart, highlighting the key players in this domain.

§  An assessment of over 20 commonly targeted therapeutic areas and details of stem cell-based therapies being developed to treat the same conditions.

§  A detailed proprietary 2×2 representation that was developed to assess the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.

§  An in-depth analysis of more than 1,500 grants that have been awarded to research institutes engaged in stem cell therapy-related projects, in the period between 2015 and 2019 (till November)

§  A detailed clinical trial analysis on more than 540 completed, ongoing and planned studies of various stem cell therapies, highlighting prevalent trends across various relevant parameters.

 Key companies covered in the report

§  Anterogen

§  Athersys

§  CHABiotech

§  Cytopeutics

§  Hope Biosciences

§  Japan Regenerative Medicine

§  Lineage Cell Therapeutics

§  Orchard Therapeutics

§  Osiris Therapeutics

§  Pluristem Therapeutics

§  Promithera Biosciences

§  Regenexx

§  Stempeutics Research

§  SCM Life Sciences

§  TICEBA

 For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/global-stem-cell-therapy-market-focus-on-cardiovascular-and-metabolic-disorders-2019-2030/246.html

 Other Recent Offerings

1.      Stem Cell Therapy Contract Manufacturing Market, 2019-2030

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3.      Cell and Advanced Therapies Supply Chain Management Market, 2019-2030: Focus on Technological Solutions

4.      Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030

 About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

 Contact:

Ben Johnson

+1 (415) 800 3415

ben.johnson@rootsanalysis.com

[neha24blog]

Antibody Drug Conjugates Contract Manufacturing Market Expanding At A CAGR 12.3% For The Forecast Period From 2021 To 2028: Grand View Research Inc.

Antibody Drug Conjugates Contract Manufacturing Market Expanding At A CAGR 12.3% For The Forecast Period From 2021 To 2028: Grand View Research Inc.

San Francisco, 10 Nov 2021: The Report Antibody Drug Conjugates Contract Manufacturing Market Size, Share & Trends Analysis Report By Condition (Myeloma, Lymphoma, Breast Cancer), By Linker (Cleavable Linker, Non-cleavable Linker), By Region, And Segment Forecasts, 2021 – 2028 The global antibody drug conjugates contract manufacturing market size is anticipated to reach USD 18.4 billion by 2028,…

[decisionforsight]

Global High Potency Active Pharmaceutical Ingredients Market

Global High Potency Active Pharmaceutical Ingredients Market Size, Share, Growth, Industry Trends and Forecast 2020-2030

The global high potency active pharmaceutical ingredients (APIs) market was valued at USD 16.4 billion in 2020 and is expected to reach 43.8 billion by 2030 with a CAGR of 10.3% over the forecast period.API (Active Pharmaceutical Ingredient) is the active compound that is present in the medicine. Highly potent APIs are capable of targeting diseased cells selectively and more precisely than any other compounds. An increase in cancer-related cases is expected to drive the HPAPI market over the forecast period. Since chemotherapy has some disadvantages also, which results in affecting the non-cancerous cells during the medical treatment process and this is the reason why the targeted therapy approach is gaining popularity, in this process of therapy non-cancerous cells are not harmed by the medicines. This is why HPAPI came into existence and they are used as antibody-drug conjugates (ADCs) too. ADCs are the most important & effective treatment in combination with monoclonal antibodies & biologically active drugs for cancer. HPAPI are therefore used in hormonal drugs that are used for treating breast cancer. One of the important use of HPAPI is in treating Glaucoma disease. Further HPAPIs have application use in cardiovascular drugs, central nervous system drugs, and musculoskeletal drugs. The drug’s being used for cancer treatment is cytotoxic in nature and is harmful to non-cancerous cells which results in extensive damage to patient’s health. To overcome such issue the pharmaceutical industry is looking forward to preparing biologic drug which will not harm the non- cancerous cell during the treatment procedure. One of the major challenges with the use of less effective drugs is its ineffectiveness during the cancer treatment and hence the need for a targeted therapy approach came into existence. 

Download Sample Copy of the Report to understand the structure of the complete report (Including Full TOC, Table & Figures) @ https://www.decisionforesight.com/request-sample/DFS020192

Market Dynamics and Factors:

Due to the rise in the frequency of chronic diseases such as cancer and more demand for generic drugs like HPAPIs is attracting the growth of these drugs in the market. However, the contract manufacturers need to invest heavily in infrastructure and specifically designed machines will raise the cost, which is considered as major restraint. Also, the rising demand for biologic and synthesis drugs with innovative therapeutics will boost the high potency active pharmaceutical ingredients market. Moreover, due to the continuous evolution of industry standards, technology and regulations will be a major challenge.

Market Segmentation:

Global High Potency Active Pharmaceutical Ingredients Market – By Product

Synthetic

Biotech

Global High Potency Active Pharmaceutical Ingredients Market – By Manufacturer

In-house

Outsourced

Global High Potency Active Pharmaceutical Ingredients Market – By Application

Oncology

Hormonal

Glaucoma

Others

Global High Potency Active Pharmaceutical Ingredients Market – By Geography

North America

U.S.

Canada

Mexico

Europe

U.K.

France

Germany

Italy

Rest of Europe

Asia-Pacific

Japan

China

India

Australia

Rest of Asia Pacific

ROW

Latin America

Middle East

Africa

New Business Strategies, Challenges & Policies are mentioned in Table of Content, Request TOC at @ https://www.decisionforesight.com/toc-request/DFS020192

Geographic Analysis:

Developing nations such as India and China present high growth opportunities for players in the High Potency Active Pharmaceutical Ingredients market. In most of these geographies, the market is expected to show a high growth rate in the coming years due to their huge population and improving living standards. Diseases like glaucoma, musculoskeletal diseases, and precisely cancer have a significant impact on the health status of people worldwide. According to the WHO, in 2014, nearly 66% of all cancer-related deaths occurred in developing countries. Additionally, according to GLOBOCAN 2012, a total of 6.8 million new cancer cases were reported in 2012 in Asia; which is expected to reach 8.4 million cases by 2020, by 24%. Furthermore, developing regions have mild and adaptable regulations, which make these markets highly lucrative for providers who are unable to meet the stringent standards set by the federal government in the US. Moreover, developing countries like China and India offer enormously low manufacturing and labor costs and highly skilled labor; this inspires players in developed regions to invest in this market.

Competitive Scenario:

The major players high potency active pharmaceutical ingredients market are Pfizer (US), Novartis International AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (US), Teva (Israel), Eli Lilly and Company (US), Merck (US), AbbVie (US), Mylan (US), and F. Hoffmann-La Roche (Switzerland).

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The report offers statistical data in terms of value (US$) as well as Volume (units) till 2030.

Exclusive insight into the key trends affecting the Global High Potency Active Pharmaceutical Ingredients industry, although key threats, opportunities and disruptive technologies that could shape the Global High Potency Active Pharmaceutical Ingredients Market supply and demand.

The report tracks the leading market players that will shape and impact the Global High Potency Active Pharmaceutical Ingredients Market most.

The data analysis present in the Global High Potency Active Pharmaceutical Ingredients Market report is based on the combination of both primary and secondary resources.

The report helps you to understand the real effects of key market drivers or retainers on Global High Potency Active Pharmaceutical Ingredients Market business.

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Regulatory outlook, best practices, and future considerations for manufacturers and industry players seeking to meet consumer demand

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The Importance of CMO & CDMO in the Pharmaceutical World

Pharmaceutical companies today are under immense pressure to develop a robust vaccine for Covid-19. Cost containment continues to be another concern amidst the danger of any previously unimagined business interferences. Today, the race to outsource the manufacturing and development of life-saving drugs to reliable service providers is gaining speed.

The battle for end-to-end outsourcing with Contract Development and Manufacturing Organizations (CDMO) and Contract Manufacturing Organizations (CMO) takes on completely new meanings for smaller manufacturers in comparison to large pharmaceutical firms. With limited resources, smaller firms must rely on their outsourcing allies for additional services that several large firms retain. Although smaller firms have equal dependence as large drug companies on their CMO/CDMO partners, they are focused more on a unique set of service offerings.

Evolution in the CMO Market

The CMO market witnessed an evolution in the past couple of decades with a rise in service offerings to develop industrial processes, production cell lines, and analytical methods. By extending “one-stop” manufacturing and development services, CMOs can get customers early in their product-development timelines and retain them throughout the clinical development process and onto the commercial market once they are successful.

Outsourcing Drivers

The existing push from pharmaceutical companies for outsourcing actions along a broader stretch of the supply chain is because of various factors. 

Complex manufacturing processes and equipment are needed for expanding sophistication of Active Pharmaceutical Ingredients and innovative molecular structures.

The development and production of medications require capital. With shrinking margins for generic drugs, firms are lowering the investment scale in this category.

Growing demand for generic biologics and medicines. The Food and Drug Administration (FDA) approved 1,171 generic medicines in 2019, a larger quantity in comparison to all preceding years. In the same time, the FDA cleared 48 new biologics and drugs. 

Growth of the CMO/CDMO Market

To keep pace with the contemporary biopharmaceutical industry trends and dynamic biotech industry paradigms, CMOs are moving away from the model of only “renting” production capacity to one that offers distinguished and widespread development and production support. CDMOs and CMOs today offer several value-added and dedicated services for customers with early-stage development needs. As the market for gene and cell therapies and Antibody Drug Conjugates (ADC) has expanded, CDMO and CMO markets have countered by providing dedicated services. Service providers today are offering vertically integrated suites of services since this strategic shift, such as:

Focused production processes and capabilities for ADCs with powerful tumor chemotherapy agents.

CMO technology and dedicated capacity to manufacture ADCs 

Comparability studies that entail the use of advanced instrumentation and orthogonal analytical methods to fully characterize complex molecules.

Enhanced execution and analytical development that include combining product characterization     technology to help early and late-stage development.

CDMO distribution of a master cell bank after obtaining customer protein     sequence for a product, thereby accelerating time to clinic and lowering     development time.

Patented cell line development technologies like patented transfection vectors combined with strong parental cell lines of established pedigree that are augmented to develop in suspension and in media without animal-derived-elements.

Virtually Outsourced Model

Unlike traditional outsourcing, small-market customers make use of the virtually outsourced solution with their CMO/CDMO allies to obtain API and other components. Virtual producers and smaller firms with reduced human and financial resources collaborate with these firms. 

Several virtual outsourcing companies are large entities so proceeds alone are not the distinguishing quality of businesses that seek the virtual outsourced model. However, many businesses practising this method are smaller with inadequate resources. Irrespective of their bottom line, such clients often rely on their outsourcing affiliate for project management tasks that are internal functions within most bigger firms.

The objective of pioneering CMO/CDMO allies to provide ‘end-to-end’ solutions changes depending on the preferred client base. Larger-scale CMO/CDMO firms start their end-to-end services with production and development of Active Pharmaceutical Ingredients and make headway through each service with the help of routine oversight by the customer. This outsourced model centers on large firms with presence across the world. These firms have internal departments with a particular understanding of quality assurance, regulatory compliance, sales and marketing, and pharmaceutical development that operate alongside their CMO/CDMO affiliates.

[ratiram]

According to study, “Global PEGylated Proteins Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2024” the key companies operating in the global market areENZON Pharmaceuticals, Roche, Merck Sharp & Dohme, Crealta (Savient), Pfizer, UCB, Amgen, Thermo Fisher Scientific Inc., Jenkem Technology, Celares GmbH, NOF American Corp., Creative PEGworks, Quanta Biodesign Ltd., Laysan Bio Inc., IRIS BioTech GmbH, Biomatrik Inc.

PEGylation is a process of covalent & non-covalent attachment of polyethylene (PE) glycol polymer chains to molecules, such as a therapeutic protein, drug, or vesicle. It improves stability & solubility of drug and decreases immunogenicity through changing the electrostatic binding, hydrophobicity and confirmation of the molecule. It decreases the dose frequency by reducing renal excretion & proteolysis, and rises tension time of conjugates in blood & stability of drug. PEGylation proteins enhanced the management of numerous chronic diseases, including leukemia, cancer, hepatitis C, severe combined immunodeficiency disease, rheumatoid arthritis, and Crohn’s disease. Pegaspargase, pegaptanib, pegfilgrastim, certolizumabpegol, pegademase bovine,pegvisomant, and interferons are the most important PEGylated drugs.

Based on product type,PEGylated proteins market is segmented into services and consumable. Services are further sub-segmented into development of analytical methods, development of PEGylatedbiosimilars, pilot production of peg drug conjugate,process development of peg-drug conjugate manufacturing and Pegylationfeasibility studies services. Consumable products are further sub-segmented into PEGlyation reagents and PEGylation kits. Pegylation reagents include branched PEGs, Mono-functional linear PEGs, multi-arm PEGS, bi-functional PEGS and other PEGylation reagents. Based on protein type, market is segmented into colongy stimulating factors, recombinant factor viii, interferons, monoclonal antibodies, Erythropoietin (EPO) and other protein type.Based on process type, market is segmented into enzymatic PEGylation, chemical PEGylation, and genetic PEGylation. Based on sales channel, market is segmented into online providers, hospital pharmacy, retail pharmacy and others. Based on application, market is segmented into chronic kidney disease, cancer treatment,HEPAtitis, gastrointestinal disorder, hemophilia, multiple sclerosis and other applications. In addition, based on end-user, market is segmented into contract research organization, pharmaceutical & biotechnology companies, academic research institutes and others. The pharmaceutical & biotechnology segment is expected to witness high growth during the forecast period due to rise in research & development (R&D) spending in pharmaceutical & biotechnology sectors globally.

The PEGylated proteins market is driven by increase in adoption of protein-based drugs over non-protein-based drugs, followed by rise in R&D spending, high prevalence rate of lifestyle diseases, growth in biologics sector and surge in protein’s stability & circulating half-life. However failure of drug development & recall of products and high costs associated with drug development may impact the market. Moreover, growth in adoption of PEGylated protein therapeutics and untapped emerging economies are key opportunities for market.

Based on geography, the North-American and European regions hold major share in PEGylated proteins market owing to rise in awareness about the disease among patients and increase in available therapies in the regions. The Asian-Pacific region is projected to witness fastest growth rate due to growth in prevalence of lifestyle diseases, rise in medical tourism and increase in health care spending over the forecast period. It is predicted that future of the market will be bright caused by rise in mortality rates associated with chronic ailments and growth in incidence of cancer during the forecast period. The worldwide market is estimated to grow at a CAGR of approximately 3.9% over the next five years, will reach US $3910 million in 2024, from US $3230 million in 2019.

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Global PEGylated Proteins Market

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PEGylated Proteins Market Research: Global Status & Forecast by Geography, Type & Application (2015-2025)

Global PEGylated Proteins Market Analysis 2013-2018 and Forecast 2019-2024

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Meticulous Research® Projects Global Pharmaceutical Contract Development & Manufacturing Market to Reach $261.57 Billion by 2031

Meticulous Research®, a leading global market intelligence and consulting firm, has released its latest report titled Pharmaceutical Contract Development & Manufacturing Market Size, Share, Forecast, & Trends Analysis by Service and End User – Global Forecast to 2031. According to the report, the pharmaceutical contract development and manufacturing market is poised to reach an impressive $261.57 billion by 2031, registering a compound annual growth rate (CAGR) of 7.4% from 2024 to 2031.

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Key Market Drivers and Challenges

The expanding pharmaceutical contract development and manufacturing market is being driven by several critical factors. The increasing complexity of pharmaceutical manufacturing processes, coupled with manufacturers' adoption of advanced technologies, is fueling growth. In addition, growing investments in pharmaceutical research and development (R&D), the expiration of patents, and heightened demand for generic medicines and biologics are expected to further propel the market.

However, several challenges, including disruptions in the supply chain and stringent government regulations, are hindering growth. The market also faces ongoing issues related to intellectual property risks and a shortage of skilled professionals, posing significant challenges to sustained expansion.

Emerging Opportunities

Despite these hurdles, the pharmaceutical contract development and manufacturing market is expected to witness robust opportunities, particularly in the fields of cell and gene therapies, personalized medicine, and high-potency active pharmaceutical ingredients (HPAPI). The growing demand for antibody-drug conjugates (ADCs) is also projected to open new avenues for market participants.

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Competitive Landscape

Key players in the global pharmaceutical contract development and manufacturing market include industry giants such as Lonza Group Ltd. (Switzerland), Catalent Inc. (U.S.), Patheon (a subsidiary of Thermo Fisher Scientific Inc., U.S.), Recipharm AB (Sweden), and WuXi Biologics Inc. (China), among others. These companies continue to play a vital role in shaping the market through strategic collaborations, technological advancements, and capacity expansions.

Future Outlook by Service Type and End User

The market is segmented into key service categories, including pharmaceutical manufacturing (API and FDF), drug development, and biologics manufacturing. Of these, the biologics manufacturing services segment is projected to grow at the fastest rate, with an estimated CAGR of 11.1% during the forecast period. Within this segment, Finished Dosage Forms (FDF) manufacturing services, driven by the complexity of biologics manufacturing, are expected to witness particularly high demand.

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On the basis of end users, large pharmaceutical companies are anticipated to dominate the market, accounting for 42.3% of the global share in 2024. The reliance of major pharmaceutical and biotech companies on external contract manufacturers, driven by increasing R&D complexity and the rising costs of maintaining in-house facilities, is a major factor contributing to this trend.

Geographic Insights

Regionally, North America is projected to capture the largest share of the market, accounting for 44.3% in 2024. The region's dominance is attributed to a combination of factors, including a diversified pharmaceutical pipeline, increased demand for biologics and generic drugs, and a robust base for clinical trials and API production. The presence of leading pharmaceutical companies and advanced manufacturing capabilities further bolster North America's market position.

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Key Questions Addressed in the Report:

What are the fastest-growing market segments by type, end user, and region?

What was the historical market size, and what are the forecasts through 2031?

What are the key market drivers, challenges, and emerging opportunities?

Who are the leading players, and what strategies are they employing?

Which regions are expected to witness the highest growth?

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Antibody Drug Conjugates Market: Shows Increasing Demand To Be Observed In The Coming Decade

Antibody drug conjugate is a significant class of highly potent bio drugs envisioned as a broad therapy for treatment of cancer. Unlike chemotherapy, antibody drug conjugate are proposed to mark and kill only cancer cells. Antibody drug conjugates are compound molecules that comprise antibodies linked to a biologically active cytotoxic drug.  

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By uniting the exclusive targeting capacities of mAB with anti-cancer drugs, ADCs allow for subtle judgment between healthy and diseased tissue. This entails that the antibody drug conjugates kill only cancer cells and ensure that other dynamic cells are less severely affected. This exceptional phenomenon of killing only cancer cells increase the importance of use of ADCs, which would indirectly boost growth of the global antibody drug conjugates market.

Commercialization of 7-10 ADCs in the following decade, would lead to revenue to surge to over US$ 10 billion over the forecast period of market

In terms of marketing, three antibody drug conjugates have received regulatory approval.  The U.S. FDA approved one of the ADC in 2001 manufactured and developed by Pfizer/Wyeth, to treat acute myelogenous leukemia. The drug was subsequently withdrawn in June 2010, leaving only two antibody drug conjugates in the market. The two drugs marketed for ADCs are Brentuximab vedotin and Trastuzumab emtansine, developed and manufactured by Seattle Genetics and Millennium/Takeda and Genentech and Roche, respectively. Around 45 antibody drug conjugates molecules are under clinical trials, with the preclinical pipeline expanding at a high rate. Of all the 45 molecules, around 25% are under Phase II or Phase III of development. Frequently used cytotoxins for antibody drug conjugates under trials include auristatin, calicheamicin, maytansine and duocarmycin. Auristatin is the dominant compound accounting for over 50% of antibody drug conjugates in clinical development. Roche has 10 compounds under clinical trials, and this is the most developed pipeline of antibody drug conjugates. Globally, 70%-80% of antibody drug conjugates manufacturing is currently outsourced. There are limited number of contract manufacturers that have high-end manufacturing equipment for development of cytotoxins.

Antibody drug conjugates market is still in its infancy, with two approved ADCs to propel the market to two digit billion dollar mark by 2020

The global antibody drug conjugates market is segmented on the basis of drug and geography. On the basis of drug, the market is divided into Adcetris and Kadcyla.

Major pharmaceutical company opt for contract manufacturer for development and manufacture of antibody drug conjugates

Regional segmentation of the antibody drug conjugates market by Coherent Market Insights comprises North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. Europe accounts for the largest share in the global market mainly due to presence of many contract manufacturing companies with advanced manufacturing equipment. Lonza is one of the top contract manufacturing companies in Europe, which has operations across France and Germany, with its headquarters in Switzerland.  One of the facilities operated by the company is a deck to chemical manufacturing capabilities and develop peptides, small molecule active pharmaceutical ingredients, highly potent active pharmaceutical ingredients, cytotoxics agents, antibody drug conjugates, and microbial products. The company also offer proficiency in chemical, pharmaceutical, agrochemical and food industries by providing clients with yields such as high-class active substances, organic chemicals and intermediates.

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Large number of clinical trial molecules in pipeline to boost growth of antibody drug conjugates market

Key players operating the antibody drug conjugates market include Hoffmann-La Roche Ltd, Seattle Genetics, Takeda, ImmunoGen Inc, Pfizer Inc., Sanofi, AbbVie Inc, Cellldex Therapeutics, Synthon, and Progenics Pharmaceuticals. Major companies in the antibody drug conjugates industry are constantly working on research and development, as the market is largely untapped and offer highly lucrative growth opportunities. For instance, there are only two antibody drug conjugates available worldwide that are used to treat cancer, and there are over 40 molecules under clinical trials. Considering the alarmingly high incidence rate of cancer across the globe, the antibody conjugates market is expected to ride on a wave of positive growth in the foreseeable future.

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