#HPAPI and Cytotoxic Drugs Manufacturing
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Cytotoxic Drugs Market | Industry Analysis | Market Size | 2035
The cytotoxic drugs and HPAPI manufacturing market is growing at a CAGR of approximately 12% in the coming years. The report features an extensive study of the current market landscape and the future potential of the HPAPI and cytotoxic drug manufacturing market over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Get a detailed insights report now!
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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
Pharmaceutical API Manufacturing Market
Highly Potent Active Pharmaceutical Ingredients are compounds with potent pharmacological effects even at low concentrations. These substances require specialized handling and manufacturing processes due to their toxicity and potency.
Several factors are driving the growth of the HPAPI manufacturing market:
Rising Incidence of Chronic Diseases
Advancements in Drug Development
Growing Focus on Personalized Medicine
Increased Outsourcing of API Manufacturing
Highly potent API pharmaceutical manufacturing market is poised for significant growth as pharmaceutical companies continue to prioritize the development of advanced therapies targeting complex diseases.
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.
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High Potency APIs (HPAPI) Market Trends, Demand & Value Analysis: 2028
High Potency APIs (HPAPI) Market by Type (Innovative API Market, Generic API Market), by Type of Synthesis (Synthetic API Market, Biotech API Market), by Manufactures, by Application, and by Region (North America, Europe, Asia-Pacific, Middle East and Africa and South America).
The global High Potency APIs (HPAPI) Market size is projected to reach a CAGR of 10.1% from 2023-2030.
High potency APIs, or HPAPIs, are pharmacologically active ingredients that are extremely effective even in very low doses. The high-potency APIs have a very specific action and can provide significant efficacy even at low daily therapeutic doses. They are utilized in the formulation of highly potent medications because of their capacity to target specific disease cells. Small molecules have been used in HPAPIs to provide new patient treatment for respiratory disorders, cancer, and hormonal imbalance. These drugs have minimal adverse effects and target specific locations, allowing the patient to recover faster with no lingering effects.
The major growth factors of the High Potency APIs (HPAPI) Market are, first up the increasing demand for oncological, haematological, and hormonal disorder medications, second, comes the rising emphasis of pharmaceutical companies on manufacturing of HPAPIs and more precision drugs as compared to other drugs in the market, third and lastly, the advancements in technologies and extensive R&D efforts to develop HPAPIs and other novel therapies.
The restraining factors of the market are the risks that are associated with HPAPI. Since HPAPIs exhibit high cytotoxicity and therefore there is further emphasis on the care taken to prevent cross-contamination (detrimental contamination with a different product) which becomes the major restraining factor. Another factor that affects the growth of the market is economics. Companies are under pressure to control costs and make these biopharmaceuticals available to general consumers.
The supply of API was severely affected due to the COVID-19 outbreak as the manufacturing hub of the HPAPI is in Southeast Asia namely China and India. The growth of the market slumped due to supply chain issues and manufacturing delays. Another blow was received by the sector in the form of the economic situation triggered by the pandemic in 2020. Players involved in manufacturing, however, are expected to benefit due to outsourcing to low-cost markets. The pressure from consumers to use active ingredient manufacturers makes the HPAPI market an attractive area for investment. Many firms in the HPAPI market had seen shrinking and lowering of profits during the pandemic which was followed by an explosive increase in the demand for the HPAPIs. This coupled with the opening of markets and easing of supply chains has led to a resurgence of the market as a whole and has led to many firms expanding at a rapid pace including those who were previously uninterested in the market or had little mainstream presence.
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Delvens Industry Expert's Standpoint
The rising demand for high-potency APIs is seen due to the growing demand for oncology drugs. The increasing incidence of cancer globally created a demand for highly specific and potential drugs and also an increasing prevalence of chronic and infectious diseases, which require the use of high-potency drugs for effective treatment. Further, there is a huge need for powerful API-formulated drugs for the aging population in case of older patients eventually drive the high-potency APIs. Advanced therapies are focused on providing personalized medicines for targeted diseases, and increasing the efficiency of manufacturing processes of these APIs led to grow the market of high potency APIs in the next coming years.
Key Findings
The type segment is further bifurcated into Innovative API Market and Generic API Market. The innovative segment will grow the largest share of the market. Some Factors contributing to the market growth can be increasing investments in R&D to drive the market growth of this segment.
The synthesis segment is further segmented into Synthetic API Market and Biotech API Market. The synthetic HPAPI segment is to command the largest share during the forecast period. An increasing number of new APIs, approvals, and ease of production are driving the growth of the synthetic segment.
The manufacturer’s segment is further fragmented into the Captive API Market ad Merchant API Market. The captive HPAPI manufacturers market accounts for the largest share of the market. Factors such as companies’ in-house manufacturing facilities for economic benefits drive the segment.
The therapeutic application segment is further segmented into Oncology, Hormonal Imbalance, Glaucoma, and Other therapeutic applications. The oncology segment to dominate the market during the forecast period. The growing prevalence of cancer and the launch of new target therapies are the key factors for the growth in the segment.
The market is also divided into North America, Europe, Asia-Pacific, South America, and Middle East and Africa. North America is expected to dominate the market during the forecast period. Factors such as the growing oncology sector, prevalence and incidence of chronic diseases, and lifestyle diseases drive the market segment in North America.
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Regional Analysis
North America to Dominate the Market
North America is expected to dominate the market during the forecast. Factors such as the growing oncology sector, prevalence and incidence of chronic diseases, and lifestyle diseases drive the market segment in North America.
Moreover, the increase in research and development activities and the presence of favorable healthcare infrastructure are fuelling the growth of the overall regional market.
Competitive Landscape
Pfizer Inc
F Hoffmann La Roche Ltd
Eli Lilly and Company
Bristol Myers Squibb Company
Novartis AG
Sanofi
Merck Sharp and Dohme Corp
Bayer AG
AbbVie
Teva Pharmaceutical Industries Ltd
Viatris Inc.
Recent Developments
In 2022, Pfizer acquired Arena Pharmaceuticals. The deal will benefit in bringing the pipeline of Arena Pharmaceuticals to the company’s Inflammation and Immunology Therapeutic Area, helping in the further developments to change the lives of those with immuno-inflammatory diseases.
In 2021, Sandoz, a Novartis division, successfully completed the acquisition of GSK’s Cephalosporin Antibiotics business. Through this transaction, Sandoz acquired the rights to three established brands (Zinnat, Zinacef, and Fortum) in more than 100 markets, further reinforcing its leading global position in antibiotics.
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Increase your understanding of the market for identifying the best and most suitable strategies and decisions on the basis of sales or revenue fluctuations in terms of volume and value, distribution chain analysis, market trends, and factors.
Gain authentic and granular data access for the High Potency APIs (HPAPI) Market so as to understand the trends and the factors involved in changing market situations.
Qualitative and quantitative data utilization to discover arrays of future growth from the market trends of leaders to market visionaries and then recognize the significant areas to compete in the future.
In-depth analysis of the changing trends of the market by visualizing the historic and forecast year growth patterns.
Report Scope
The high Potency APIs (HPAPI) Market is segmented into various segments such as type, synthesis, manufacturers, therapeutic application, and region:
On the basis of type
Innovative API Market
Generic API Market
On the basis of synthesis
Synthetic API Market
Biotech API Market
On the basis of manufacturers
Captive API Market
Merchant API Market
On the basis therapeutic application
Oncology
Hormonal Imbalance
Glaucoma
Other therapeutic applications
On the basis of region
Asia Pacific
North America
Europe
South America
Middle East & Africa
The prominent players in High Potency APIs (HPAPI) Market are
Pfizer Inc
F Hoffmann La Roche Ltd
Eli Lilly and Company
Bristol Myers Squibb Company
Novartis AG
Sanofi
Merck Sharp and Dohme Corp
Bayer AG
AbbVie
Teva Pharmaceutical Industries Ltd
Viatris Inc.
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Growing at an annualized rate of 12%, the HPAPI and cytotoxic drugs contract manufacturing market is projected to reach USD 25 billion by 2030
Manufacturing highly potent drug products is technically and financially demanding; as a result, drug manufacturers are becoming increasingly reliant on contract service providers
Roots Analysis is pleased to announce the publication of its recent study, titled, “HPAPI and Cytotoxic Drugs Manufacturing (3rd Edition) 2020-2030.”
The report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of HPAPIs and cytotoxic drugs. The study also features a detailed analysis of the key drivers and trends related to this evolving domain. In addition to other elements, the study includes:
§ A detailed assessment of the current market landscape of companies offering contract services for manufacturing HPAPIs and cytotoxic drugs.
§ A competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers, featuring insightful representations.
§ Detailed profiles of leading contract manufacturers of HPAPI and cytotoxic drugs (shortlisted on the basis of proprietary criterion).
§ An analysis of the partnerships that have been established in this domain, in the recent past.
§ An analysis of the various expansion initiatives undertaken by the players in this domain.
§ An estimate of the overall, installed capacity for manufacturing HPAPIs and cytotoxic drugs based on data reported by industry stakeholders in the public domain.
§ A qualitative analysis to decide whether to manufacture the potent products in-house or engage the services of a CMO.
§ A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry’s evolution.
§ A case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers in this domain.
§ A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
§ Type of Product
§ HPAPIs
§ Highly Potent Finished Dosage Forms
§ Company Size
§ Small-sized
§ Mid-sized
§ Large / Very Large
§ Scale of Operation
§ Preclinical / Clinical
§ Commercial
§ Type of Pharmacological Molecule
§ Small Molecules
§ Biologics
§ Type of Highly Potent Finished Dosage Form
§ Injectables
§ Oral Solids
§ Creams
§ Others
§ Key geographical regions
§ North America
§ Europe
§ Asia Pacific
§ Rest of the World
The report includes detailed transcripts of discussions held with the following senior level representatives of stakeholder companies:
§ Antonella Mancuso (Vice President and Chief Operating Officer, BSP Pharmaceuticals) and Maria Elena Guadagno (Business Director, BSP Pharmaceuticals)
§ Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics)
§ Kevin Rosenthal (Business Head, Formulations and Finished Products, Alphora Research)
§ Jennifer L Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)
§ Roberto Margarita (Business Development Director, CordenPharma)
§ Allison Vavala (Senior Manager, Business Development, Helsinn)
§ Mark Wright (Site Head, Piramal Healthcare)
§ Javier E. Aznárez Araiz (Business Development Technician, Idifarma)
Key companies covered in the report
§ AbbVie Contract Manufacturing
§ CARBOGEN AMCIS
§ Catalent
§ Evonik
§ Formosa Laboratories
§ Intas
§ Lonza
§ MabPlex
§ Pfizer CentreOne
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1. Antibody Contract Manufacturing Market, 2020 – 2030
2. Cell Therapy Manufacturing Market (3rd Edition), 2019 – 2030
3. Biopharma Contract Manufacturing Market (3rd Edition), 2019 – 2030
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HPAPI and cytotoxic drugs contract manufacturing market is projected to reach USD 25 billion by 2030
HPAPI and cytotoxic drugs contract manufacturing market is projected to reach USD 25 billion by 2030
The “HPAPI and Cytotoxic Drugs Manufacturing Market 2021-2030” report features an extensive study of the current market landscape, offering an informed opinion on the manufacturing of HPAPIs and cytotoxic drugs over the next decade. Close to 120 companies across the globe claim to possess the required expertise and infrastructure to offer contract manufacturing services for HPAPIs and cytotoxic…
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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.
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HPAPIs and Cytotoxic Drugs Manufacturing Market (highly potent active pharmaceutical ingredients) are a rapidly growing segment of the global pharmaceutical industry.
Read more @ https://delightblogging.blogspot.com/2022/09/hpapis-and-cytotoxic-drugs.html
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The Report 'Hpapis And Cytotoxic Drugs Manufacturing Market, 2014-2024' Provides An In-Depth Examination Of The Rapidly Expanding Hpapis And Cytotoxic Drug Manufacturing Market
To achieve a therapeutic effect, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic dugs are used. In various scenarios, any active pharmaceutical ingredient (API) is considered potent. For example, when API produces biological activity at therapeutic doses of 1 milligramme per day or less, when API has high selectivity (Mechanism of action and binding site is specific) and the potential to cause cell toxicity, mutations, and cancer at low doses, and when API is a novel compound with unknown potency and toxicity. HPAPIs and cytotoxic drugs are becoming more popular as novel approaches to treating chronic diseases such as cancer, cardiovascular drugs, and diabetes.
The report ' HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014-2024' provides an in-depth examination of the rapidly expanding HPAPIs and cytotoxic drug manufacturing market. HPAPIs and cytotoxics have emerged as one of the key focus areas of researchers worldwide due to their numerous advantages and increased applications in the treatment of cancer and other disorders. These compounds have several advantages over traditional therapeutic products. The primary goal of this report is to comprehend the likely future evolution of contract manufacturing of HPAPIs and cytotoxics over the next decade.
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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.
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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
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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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How will this Market Intelligence Report Benefit You?
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.
The 2021 Annual Global High Potency Active Pharmaceutical Ingredients Market offers:
100+ charts exploring and analysing the Global High Potency Active Pharmaceutical Ingredients Market from critical angles including retail forecasts, consumer demand, production and more
15+ profiles of top producing states, with highlights of market conditions and retail trends
Regulatory outlook, best practices, and future considerations for manufacturers and industry players seeking to meet consumer demand
Benchmark wholesale prices, market position, plus prices for raw materials involved in Global High Potency Active Pharmaceutical Ingredients Market type
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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.
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High Potency Active Pharmaceutical Ingredients Market Changing Dynamics Of Competition With Forecast To 2026
High potency active pharmaceutical ingredients (HPAPIs) are small-molecule, biologic, or hybrids of antibody–drug conjugates, which link a cytotoxic small-molecule to a monoclonal antibody. Demand for high potency active pharmaceutical ingredients (HPAPIs) is rapidly increasing due to its ability to target diseased cells more precisely and selectively than other APIs and is regarded as a relatively more efficient treatment for cancer and chronic diseases such as diabetes and heart diseases, worldwide. According to estimates from the International Agency for Research on Cancer (IARC), in 2012, 14.1 million new cancer cases and 8.2 million cancer deaths were recorded worldwide. This global burden of cancer is expected to account for 21.7 million new cancer cases and cause 13 million deaths by 2030.
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Growing demand for Antibody Drug Conjugates (ADC) is expected to augment market growth:
High potency active pharmaceutical ingredients is considered as a growing area for pharmaceutical manufacturers and contract manufacturing organizations (CMOs) with much R&D focusing on more specialized medicines especially in the field of oncology. According to IMS institute of healthcare informatics, 2016, 586 drugs are under development for oncology treatment, with over 70 new cancer treatments (for over 20 tumor types), entering the market over the past five years (2010-2015). HPAPIs are also increasingly being used in the form of Antibody Drug Conjugates (ADCs), which is an important and effective breakthrough in cancer treatment. However, high capital costs associated with the specialized containment technology required to protect both employees and the environment, as well as lack of harmonization in GMP regulations preventing cross contamination in some countries may hamper growth of the high potency active pharmaceutical ingredients market.
Increasing investment in research and development by manufacturers is expected to propel high potency active pharmaceutical ingredients market growth:
Increasing number of major pharmaceutical companies are continuously focusing on expansion of their product line in HPAPIs or considering investing in new HPAPIs production facilities, further outsourcing the manufacturing of HPAPIs to contract manufacturers. This in turn will increase the benefits from the latter’s competency and expertise, as captive manufacturing of HPAPIs is expensive and requires stringent safety and handling specifications. This is thus expected to boost growth of the high potency active pharmaceutical ingredients market. The outsourcing of HPAPIs manufacturing is increasing in India, China, and Eastern European countries due to the low cost of manufacturing as compared to North America and Western Europe regions. For instance, in Oct 2017, Piramal Pharma Solutions (PPS), a contract development and manufacturing organization invested US$ 55 million across its sites in Asia, to expand its API manufacturing capabilities and capacities. Furthermore, companies such as Evonik and Lonza are actively involved in providing contract manufacturing services to other companies.
Among regions, North America holds the largest market share, followed by Europe in the global high potency active pharmaceutical ingredients market. The dominance of this region is due to high prevalence rate of cancer in the region, which in turn is increasing the potential of oncology drugs. For instance, according to an American Cancer Society estimations, 2017, 1,688,780 people are estimated to be diagnosed with cancer and 600,920 cancer deaths are estimated to occur in the US. Furthermore, increasing incidence of age related diseases associated with changing lifestyle and eating habits is also expected to boost growth of the high potency active pharmaceutical ingredients market. As the nature and extents of HPAPIs is different for the ageing population than that for a younger population thus, HPAPIs have become a mitigating factor in reducing the disease burden especially in geriatric population. According to the U.S. census bureau, 2014, 46.2 million people aged 65 years and above, accounted for 14.5% of the total population, which is projected to be 98.2 million by 2060. Moreover, market in Asia Pacific is also gaining significant traction, owing to growing API manufacturing sectors in countries such as China and India, due to expansion of low cost manufacturing facilities by manufacturers/CMOs to produce generic HPAPIs.
Key players in the high potency active pharmaceutical ingredients market include Lonza, Novartis International AG, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, Sigma-Aldrich Corporation, and Sanofi Aventis.
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#High Potency Active Pharmaceutical Ingredients Market#High Potency Active Pharmaceutical Ingredients Market 2028#high potency active pharmaceutical ingredients
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The Future of ADC Cytotoxic Payloads / Warheads Market Forecast, 2021-2035
A number of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) offering HPAPI and cytotoxic drug related services have been established to meet the growing demand for cytotoxic payloads in ADCs and other similar therapeutic interventions.
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The multi-step process for manufacturing cytotoxic payloads used in ADCs requires contained environments, dedicated manufacturing facilities, specialized analytical and purification techniques, and storage facilities. However, many ADC developers lack the in-house capacity to produce cytotoxic payloads at a commercial scale and rely on contract manufacturers. According to estimates, 70-80% of ADC manufacturing operations are outsourced.
In addition, several ADC developers have entered into strategic partnerships with payload providers to develop pipeline ADC candidates. Given the growing clinical pipeline of ADCs, coupled with various technological advancements, the market for ADC payloads and warheads is expected to grow significantly in the coming years.
Top Key Players:
AbbVie
Abzena
ACES Pharma
Celltrion
Cerbios
General Catalyst
Glycotope
Recipharm
Regeneron
Novartis
Novasep
Novo Holdings
Permira
Pfizer
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The High Energy / Hazardous Chemistry-based API manufacturing services market is estimated to be worth USD 29 billion in 2030
Although hazardous reaction chemistries are not used during early drug development stages owing to the associated risks, they offer a wide range of benefits over traditional approaches, especially from the perspective of large-scale manufacturing
Roots Analysis is pleased to announce the publication of its recent study, titled, “High Energy Chemistry / Hazardous Chemistry-based API Manufacturing Services Market: Focus on High Temperature, Low Temperature / Cryogenic, High Pressure and Low Pressure Chemistries, 2020-2030.”
High energy chemistry market : We are led to believe that the use of high energy chemistry and hazardous chemistries have much to offer in the aforementioned context. As a consequence, the contract services market catering to this segment of the pharmaceutical industry is anticipated to witness substantial growth in the coming years.
The report features an extensive study on the current landscape and the likely future potential of the companies offering services for API manufacturing based on high energy chemistry (HEC) / hazardous chemistry. The study features an in-depth analysis, highlighting the capabilities of a diverse set of industry stakeholders. In addition to other elements, the study includes:
§ A detailed assessment of the current market landscape of service providers offering contract and custom services for HEC / hazardous chemistry-based API manufacturing.
§ A detailed list of around 150 manufacturing facilities equipped to handle API manufacturing under high temperature, low temperature, high pressure and low pressure conditions.
§ A competitiveness 3-D bubble analysis of HEC / hazardous chemistry-based contract and custom manufacturers
§ Elaborate profiles of the key players that offer a diverse range of capabilities for API manufacturing based on HEC / hazardous chemistry.
§ A qualitative case study providing insights on the general reaction portfolio related to small molecule synthesis processes.
§ A detailed case study presenting a list of contract research organizations (CROs) and custom synthesis service providers engaged in this domain.
§ A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry’s evolution.
§ A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Reaction Conditions
§ High Temperature
§ Low Temperature
§ High Pressure
§ Low Pressure
Key Geographical Region
§ North America
§ Europe
§ Asia-Pacific and the Rest of the World
The report features inputs from the following eminent industry stakeholders, according to whom, as more companies become aware of the benefits of exploiting novel synthetic routes, via hazardous reaction chemistries, for drug development, the demand for HEC-based manufacturing services may be anticipated to increase in the coming years.
§ Eric Fang, Chief Scientific Officer, Snapdragon Chemistry
§ Anonymous, Novasep
§ Edward Price, President / Chief Executive Director, PCI Synthesis
Key companies covered in the report
§ AGC Chemicals
§ Beijing Mediking Biopharm
§ Cambrex
§ CordenPharma
§ Evonik Industries
§ Hovione
§ Patheon
§ PCI Synthesis
§ Siegfried
For more information please click on the following link:
https://www.rootsanalysis.com/reports/high-energy-chemistry.html
Other Recent Offerings
1. China Pharmaceutical Contract Manufacturing Services Market, 2020-2030
2. Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030
3. HPAPI and Cytotoxic Drugs Manufacturing Market (3rd Edition), 2020-2030
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 [email protected]
Contact:
Ben Johnson
+1 (415) 800 3415
+44 (122) 391 1091
#high energy chemistry market#hazardous chemistry#cryogenic#high energy chemistry#market insights#market research#RootsAnalysis
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Highly Potent Active Pharmaceutical Ingredients (HPAPI) 2018
SMi is delighted to announce its 2nd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 21st – 22nd May 2018. http://www.highlypotentapi.com/phev
Conference Overview
The global market for Highly Potent Active Pharmaceutical Ingredients is currently largely driven by its major use in oncology for cancer treatment and more often in the form of ADCs. Over a quarter of drugs worldwide now contain HPAPIs, as they have proven to be more effective than other APIs. However, working with APIs high in potency and cytotoxicity comes with many regulations and requirements, and presents pharmaceutical companies with challenges such as handling, containment, cost and security questions.
This conference will cover many important and in-demand aspects of the HPAPI industry, creating a networking platform for industry professionals and key players to share their knowledge and find innovative new solutions.
This Year’s Speakers Include:
Chair for 2018:
Justin Mason-Home, Director, HPAPI Project Services Limited
Key Speakers:
– Pascal Drago, Principal Technical Manager, Roche – Jeff Parry, Senior Scientist Manufacturability, AstraZeneca – Ulrich Ruemenapp, Head of Launch Preparation and Coordination, Bayer – Greg Sowell, Principal Scientific Manager, Genentech – Ildikó Zeigler, Validation Expert, Gedeon Richter – Vincenzo De Sio, HPAPI Specialist, Cristália – Henri Motte, Head of Pilot Plant, UCB Pharma
Featured Highlights this May:
– Discover practical approaches to HPAPI manufacturing in a controlled and efficient manner – Explore different containment methods and learn about which strategy best suits your needs – Evaluate the use of containment risk mitigation tools in early phase development – Learn how to manage and effectively and safely dispose of HPAPI, post-production waste – Discuss the most important regulations surrounding potent ingredients
PLUS…Two Interactive Half-Day Post-Conference Workshops:
Workshop A: Practical Steps for Delivering HPAPI Projects Workshop Leader: Justin Mason-Home, Director, HPAPI Project Services Limited
Brief Overview: Learn key HPAPI project elements, what factors are important and how to build information designed to underpin HPAPI project investments.
Workshop B: Preventing Cross Contamination & Employee Exposures in the context of HPAPIs – What you may not know Workshop Leader: Dean Calhoun, President/ CEO, Affygility Solutions LLC
Brief Overview: This workshop will provide an overview of the regulatory basis for ADEs and PDEs, will discuss how they are determined and present the basics of preventing cross-contamination.
Download the complete brochure for all sessions and full speaker line-up: http://www.highlypotentapi.com/phev
Register online with special early-bird rates available!
The post Highly Potent Active Pharmaceutical Ingredients (HPAPI) 2018 appeared first on Pharmaphorum.
from Pharmaphorum https://pharmaphorum.com/events/highly-potent-active-pharmaceutical-ingredients-hpapi-2018/
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