High Energy Chemistry/Hazardous Chemistry-based API Manufacturing Services Market 2020-2030: Focus on High Temperature, Low Temperature/Cryogenic, High Pressure and Low Pressure Chemistries - ResearchAndMarkets.com

The "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" report has been added to ResearchAndMarkets.com's offering.

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.

One of the key objectives of this report was to estimate the existing market size and the future growth potential within the HEC/hazardous chemistry-based API manufacturing services market. Based on multiple parameters, such as the growth of the overall pharmaceutical drugs market, cost of goods sold, direct manufacturing costs and API manufacturing market, we have developed informed estimates on the financial evolution of the market, over the period 2020-2030.

The report also provides details on the likely distribution of the current and forecasted opportunity across:

• [A] reaction conditions (low temperature, high temperature, low pressure, high pressure)
• [B] company size (small, mid-sized, large/very large)
• [C] region (North America, Europe, and Asia Pacific) and [D] scale of operation (preclinical/clinical, commercial)

In pharmaceutical manufacturing, the use of certain hazardous chemical reactions has been shown to enable developers to optimize existing production processes, as well as improve yields. In other words, certain chemical reactions, which are generally regarded as harmful, offer a more direct route to the end product, requiring fewer raw materials and involving a limited number of side reactions. As a result, the number of process steps are essentially reduced, when compared to using conventional synthesis chemistries.

Prominent examples of hazardous chemical reactions include nitrations, oxidations, hydrogenations, alkylations, and reactions involving unstable or highly active compounds (such as azides, nitrate esters, peroxides, diazo compounds and highly potent substances). Generally, such reactions are carried out under specialized temperature and pressure conditions. However, they are usually not considered during the early drug development stages, owing to the associated risks.

From a large-scale manufacturing perspective, the use of such techniques has been proven to offer substantial time and cost-related benefits. In this context, it is also worth mentioning that using hazardous synthesis chemistries it is possible to design new chemical structures, which have interesting bio-active properties, and offer the means to improve overall product quality.

Given the inherent risks associated with hazardous chemistry-based manufacturing processes, innovator companies (especially in the fine chemicals and pharmaceutical industries) prefer to outsource such processes to contract service providers. Presently, there are a number of contract chemicals manufacturers that claim to have the necessary capabilities and infrastructure to support the synthesis of APIs under hazardous conditions.

It is worth highlighting that such reactions are best contained within continuous flow processes. However, owing to various reasons (such as reaction specific complexities, fluctuating volumes and certain application-specific requirements) the fine chemicals and pharmaceutical industries tend to rely on the traditional batch process. However, there is an evident shift in operating preferences to continuous systems, which is anticipated to bring about revolutionary changes in the long term.

Considering the growing global population and the rising demand for new and effective drugs, faster and more efficient pharmaceutical manufacturing processes have become a necessity. In fact, if a drug against COVID-19 is successfully developed, it is imperative to develop high-efficiency processes to ensure the production of sufficient volumes of the therapeutic to treat the global population.

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.

Amongst other elements, the report features:

• A detailed review of the overall landscape of companies offering contract and custom services for HEC/hazardous chemistry-based API manufacturing, along with information on type of manufacturer (contract and custom manufacturer), year of establishment, company size, location of headquarters, number and location of manufacturing facilities, general service portfolio (type of product (APIs, intermediates, and drug products), HPAPI manufacturing capability and availability of continuous flow technology), HEC specific service portfolio (type of conditions handled such as high temperature, low temperature, high pressure, low pressure for API manufacturing processes).
• A detailed list of over 125 manufacturing facilities equipped to handle API manufacturing processes/reactions under high temperature, low temperature, high pressure and low-pressure conditions. The chapter features geographical map representations highlighting the location of these manufacturing facilities, along with the logo landscape of manufacturers. The chapter also presents a detailed regional capability assessment framework which compares the capabilities of companies (based on manufacturing facilities) across different regions. It further include information on type of reaction conditions handled (high temperature, low temperature, high pressure, low pressure) and operating range.
• A competitiveness 3-D bubble analysis of HEC/hazardous chemistry-based contract and custom manufacturers, taking into consideration supplier strength (based year of establishment), service strength (general service portfolio (API, intermediate and FDF, availability of continuous flow technology), HEC/hazardous chemistry-based service portfolio (capability to handle API manufacturing processes under conditions, including high temperature, low temperature, high pressure, low pressure and other hazardous reaction capabilities), and a number of HEC-specific manufacturing facilities of companies.
• Elaborate profiles of the key players that offer a diverse range of capabilities for API manufacturing based on HEC/hazardous chemistry. Each profile includes a brief overview of the company, financial information (if available), details related to manufacturing facilities (pharmaceutical manufacturing facilities and HEC/hazardous chemistry specific facilities), information related to its HEC/hazardous chemistry-based API manufacturing service portfolio (high temperature and low-temperature reaction conditions handled, portfolio of hazardous reactions), recent developments and an informed future outlook.
• A case study providing insights on the general reaction portfolio related to small molecule synthesis processes. We have presented this information for HEC/hazardous chemistry-based companies, along with information on the availability of continuous flow technology and capabilities to handle varied reaction conditions, such as high temperature, low temperature, high pressure, and low-pressure controls.
• A detailed case study presenting a list of contract research organizations (CROs) and custom synthesis service providers which claim to have the required capabilities to provide a wide range of services, ranging from process development (including preliminary R&D), scale-up and small scale synthesis, for APIs based on HEC/hazardous chemistry.
• A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry's evolution, under an elaborate SWOT framework. It also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

In order to account for future uncertainties and to add robustness to our forecast model, we have provided three scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Topics Covered

1. PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview

3.2. Overview of High Energy Chemistry (HEC)/Hazardous Chemistry for Small Molecule API Manufacturing

3.3. Low Temperature/Cryogenic Chemistry

3.3.1. Reaction Conditions

3.3.2. Advantages

3.3.3. Affiliated Production Processes

3.3.4. Other Specific Requirements/Equipment

3.4. High Temperature Chemistry

3.5. High Pressure Chemistry

3.6. Low Pressure Chemistry

3.7. Need for HEC/Hazardous Chemistry for Small Molecule Manufacturing

3.7.1. Development of New and Complex Molecular Structures

3.7.2. Low Cost Generic API Synthesis

3.7.3. Route Scouting for Novel, Complex Molecules

3.8. Shift Towards Continuous Flow Chemistry

4. CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES

4.1. Chapter Overview

4.2. Small Molecule and Large Molecule Drugs/Therapies

4.2.1. Comparison of Key Characteristics

4.2.2. Comparison of Manufacturing Processes

4.2.3. Comparison of Key Manufacturing-related Challenges

5. CURRENT MARKET LANDSCAPE

5.1. Chapter Overview

5.2. API Manufacturers with HEC Capability: Overall Market Landscape

5.2.1. Analysis by Type of Manufacturing Service

5.2.2. Analysis by Year of Establishment

5.2.3. Analysis by Company Size

5.2.4. Analysis by Geographical Location

5.2.5. Analysis by Location of Manufacturing Facilities

5.2.6. Analysis by General Pharmaceutical Manufacturing Portfolio

5.2.6.1. Analysis by Type of Product (API and FDF)

5.2.6.2. Analysis by HPAPI Manufacturing Capability

5.2.7. Analysis by Type of HEC Services Offered

5.2.7.1. Analysis by Temperature Conditions Handled

5.2.7.2. Analysis by Pressure Conditions Handled

5.2.8. Analysis by Availability of Continuous Flow Technology

6. REGIONAL CAPABILITY ASSESSMENT

6.1. Chapter Overview

6.2. List of Manufacturing Facilities having HEC Capabilities

6.2.1. Manufacturing Facilities in North America

6.2.1.1. Geographical Map Representation: Manufacturing Facilities with HEC Capabilities in North America

6.2.1.2. Analysis by Type of Reaction Conditions Handled

6.2.1.3. Analysis by Range of Reaction Conditions Handled

6.2.1.3.1. Analysis by Temperature Conditions Handled

6.2.1.3.2. Analysis by Pressure Conditions Handled

6.2.2. Manufacturing Facilities in Europe

6.2.3. Manufacturing Facilities in Asia-Pacific

6.3. Regional Capability Assessment Summary

7. COMPANY COMPETITIVENESS ANALYSIS

7.1. Chapter Overview

7.2. Key Parameters

7.3. Methodology

7.4. Competitiveness Analysis: Companies in North America

7.4.1. Companies in North America Offering HEC-based Contract Manufacturing

7.4.2. Companies in North America Offering HEC-based Custom Manufacturing

7.5. Competitiveness Analysis: Companies in Europe

7.6. Competitiveness Analysis: Companies in Asia-Pacific

7.7. Spider Web Analysis

8. COMPANY PROFILES

8.1. Chapter Overview

8.2. AGC Chemicals

8.2.1. Company Overview

8.2.2. Financial Information

8.2.3. Manufacturing Facility Details

8.2.4. HEC Specific Service Offerings

8.2.5. Recent Developments and Future Outlook

8.3. Beijing Mediking Biopharm

8.4. Cambrex

8.5. Corden Pharma

8.6. Evonik

8.7. Hovione

8.8. Patheon

8.9. PCI Synthesis

8.10. Siegfried

9. CASE STUDY I: SYNTHESIS REACTION PORTFOLIO OF COMPANIES

9.1. Context and Background

9.2. Reaction Portfolios of API Manufacturers with HEC Capabilities

9.2.1. Analysis by Most Popular Reactions

9.2.1.1. Most Popular Reactions: Portfolio of Large Players

9.2.1.2. Most Popular Reactions: Portfolio of Mid-sized Players

9.2.1.3. Most Popular Reactions: Portfolio of Small Players

9.2.1.4. Most Popular Reactions: Portfolio of Other Players

9.2.2. Analysis by Moderately Popular Reactions

9.2.3. Analysis by Less Popular Reactions

9.2.4 Analysis by Least Popular Reactions

10. CASE STUDY II: INNOVATION MAPPING IN HEC MARKET

10.1. Context and Background

10.2. HEC-based Contract Research and Custom Synthesis Service Providers: Overall Market Landscape

10.2.1. Analysis by Year of Establishment

10.2.2. Analysis by Company Size

10.2.3. Analysis by Geographical Location

10.2.4. Analysis by HEC Conditions Handled

10.2.5. Analysis by Availability of Continuous Flow Technology

10.2.6. Company Competitiveness Analysis

11. MARKET FORECAST

11.1. Chapter Overview

11.2. Forecast Methodology and Key Assumptions

11.3. Global HEC-based API Manufacturing Services Market, 2020-2030

11.4. HEC-based API Manufacturing Services Market: Distribution by Region, 2020-2030

11.4.1. HEC-based API Manufacturing Services Market in North America

11.4.2. HEC-based API Manufacturing Services Market in Europe

11.4.3. HEC-based API Manufacturing Services Market in Asia Pacific

11.5. HEC-based API Manufacturing Services Market: Distribution by Reaction Conditions, 2020-2030

11.6. HEC-Based API Manufacturing Services Market: Distribution by Scale of Operation, 2020-2030

11.7. Global HEC-Based API Manufacturing Services Market: Distribution by Company Size, 2020-2030

12. SWOT ANALYSIS

12.1 Chapter Overview

12.2. SWOT Analysis

12.3. Strengths

12.4. Weaknesses

12.5. Opportunities

12.6. Threats

12.7. Concluding Remarks

13. EXECUTIVE INSIGHTS

14. COVID-19 IMPACT

14.1. Chapter Overview

14.2. Evaluation of Impact of COVID-19 Outbreak

14.2. Evaluation of Impact of COVID-19 Outbreak

14.2.1. Current Initiatives and Recuperative Initiatives of Key Players

14.2.2. Impact on the future opportunity for HEC/Hazardous Chemistry-based API Manufacturing Services Market

14.3. Recuperative Strategies: Author's Perspective

14.3.1. Propositions for Immediate Implementation

14.3.2. Short/Long Term Steps

15. CONCLUSION

Companies Mentioned

• 3A Chemie
• Aarti Drugs
• ABA Chemicals
• Acharya Group
• Aether
• AGC Chemicals
• Ajinomoto Bio-Pharma
• Albemarle
• Alcami
• Almac
• Alven Laboratories
• Amar Chemistry
• AMPAC Fine Chemicals
• AMRI
• AnaCipher
• Analytica Chemie
• Angelini Pharma
• Anthem Biosciences
• Anuh Pharma
• Anvi Pharmaceuticals
• Apeloa Pharmaceutical
• Apex Molecular
• APIchem
• APICMO
• Arch Pharmalabs
• Arevipharma
• ASolution Pharmaceuticals
• Asymchem
• Austin Chemical
• Avara Pharmaceutical
• Avigna Pharma
• Avista Pharma Solutions
• Avra Laboratories
• Bachem
• BASF
• Beijing Mediking Biopharm
• Biddle Sawyer
• Bioindustria L.I.M
• Cambrex
• Chandra Life Sciences
• Changzhou Carbochem
• ChemCon
• ChemFuture PharmaTech
• Chemigran
• Chemsigma International
• Chemwill Asia
• ChengDu TongChuangYuan Pharmaceutical
• Chiral Biosciences
• Chromo Laboratories
• CiVentiChem
• Corden Pharma
• CsFlowChem
• Dalton Pharma Services
• Delmar
• Dipharma
• Dishman
• DIVERCHIM
• Divi's Laboratories
• DOTTIKON ES
• Dr. Reddy's Laboratories
• DSL Chemicals
• Enaltec
• Enbridge PharmTech
• Esteve Qumica
• Eurofins Alphora
• Evonik
• Evotec
• F.I.S. - Fabbrica Italiana Sintetici
• Fareva
• Farmak
• Farmhispania
• FDC
• Flamma
• Fuji Chemical Industries
• Fujimoto Chemicals
• Grace
• GVK Biosciences
• Hangzhou Chemipanda Bio-Tech
• Hangzhou Panyu Chemical
• Helsinn Healthcare
• Hikal
• Hisun Pharmaceuticals USA
• Holochem
• Hovione
• Hubei Biocause Pharmaceutical
• ICROM
• Ind-Swift Laboratories
• Inventys
• IPOCHEM
• Iwaki Seiyaku
• Jiangsu Allyrise Pharmaceutical
• Jiangsu Quality Horizons Pharmtech
• Jiangxi Long Life Bio-pharmaceutical
• Johnson Matthey
• K.A.Malle Pharmaceuticals
• Keryx Biopharmaceuticals
• Key Organics
• Kingchem Life Science
• Kongo Chemical
• Kopran
• KriSan Biotech
• Lebsa
• LOBA Feinchemie
• Lonza
• M2i Life Sciences
• Maithili Life Sciences
• Malladi
• Mankind Pharma
• Medichem
• Medkem
• MENADIONA
• MercachemSyncom
• Metrochem API
• MINAKEM
• Modepro India
• Morepen
• MSN Laboratories
• Nanjing Finetech Chemical
• Nanjing Pharmatechs
• NCK
• NerPharMa
• Neuland Laboratories
• Norchim
• Novasep
• Olon
• Oman Chemicals & Pharmaceuticals
• Onyx Scientific
• Orchid Chemicals & Pharamaceuticals
• Patheon
• PCI Synthesis
• Pfanstiehl
• Pfizer
• Pfizer CentreOne
• PharmaCore
• Pharmaron
• PharmaZell
• Pi-Process Intensification
• Piramal Pharma Solutions
• PMC Isochem
• Porton Pharma Solutions
• Procos
• Quality Horizons
• RA Chem Pharma
• Rakshit Drugs
• Raybow Pharma
• Recipharm
• Recordati
• Regis Technologies
• Richman Chemical
• Robinson Brothers
• Sai Life Sciences
• Sambi Pharma
• Saniver
• Saurav Chemicals
• SCI Pharmtech
• ScinoPharm Taiwan
• Seqens
• SeQuent
• Servier
• Shanghai Hobor Chemical
• Shanghai Ruiyi Medical Tech
• Sharon Bio-Medicine
• Siegfried
• Sinolite
• SK biotek
• Snapdragon Chemistry
• Solara Active Pharma Sciences
• Solvias
• SONEAS
• Spectrum Chemical Manufacturing
• SRC Laboratories
• Sterling Pharma Solutions
• Sumitomo Chemical
• Synthelia
• THINQ Pharma
• Tianjin Pharmacn Medical Technology
• UBE Industries
• Valsynthese
• Vamsi Labs
• Vinkem
• WeylChem InnoTec
• Wisdom Pharmaceutical
• WuXi STA
• XINXIANG BEST PHARMACEUTICAL
• Zambon
• ZCL Chemicals
• Zhejiang Changming Pharmaceutical
• ZHIWE ChemTech

For more information about this report visit https://www.researchandmarkets.com/r/2v0r9o

View source version on businesswire.com: https://www.businesswire.com/news/home/20200818005449/en/