Allergopharma GmbH & Co. KG

DUBLIN--( BUSINESS WIRE )--The "New Drug Approvals and Their Contract Manufacture - 2023 Edition" report has been added to ResearchAndMarkets.com's offering. In 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products comparative to other recent years. In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use. COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility. New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of long-running analysis of the CMO industry, using the FDA's NDA approvals as the primary indicator of performance. New Drug Approvals and their Contract Manufacture (formerly called 'CMO Scorecard') is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year's edition includes a discussion of Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers. Scope This report gives important, expert insight you won't find in any other source. 11 tables and 34 figures throughout the report illustrate major points and trends. This report is required reading for: CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management Private equity investors that need a deeper understanding of the market to identify and value potential investment targets Reasons to Buy Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments Detailed view of CDMO performance by number of drug and vaccine approvals An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing Key Topics Covered: Executive Summary Players Technology Briefing Innovative drug approvals Dose outsourcing of drug approvals Trends Industry Analysis Introduction FDA NDA approvals overview More biologic NME approvals than small molecule equivalents Cell and gene therapies First-in-class First-time approvals Rejected drugs Predicted approvals for 2023 Sponsor trends US vs. EU approval performance FDA EUAs in 2022 for COVID-19 FDA: outsourced dose manufacture Dosage form outsourcing Special product categories Accelerated approvals Orphan drug designation Fast track designation Breakthrough therapy designation Containment Solubility enhancement Outsourcing by company market cap CMO performance Dosage form Outsourced API approvals ANDA approvals What it means FDA approvals decline with a large decrease of NMEs approved COVID-19 vaccine demand waning but there are still lucrative contracts A few large CMOs gain majority of dose contracts High inflation and other business conditions Record high number of ATMP approvals in 2022 Value Chain Companies Appendix Methodology Bibliography Primary research - key opinion leaders Further reading About the Authors Contact the Publisher Companies Mentioned AbbVie Inc ACS Dobfar SpA Aenova Holding GmbH Afton Scientific Corp AGC Biologics Inc Ajinomoto Bio-Pharma Services Akorn Operating Company LLC Alcami Corp Alfasigma SpA Allergopharma GmbH & Co KG Almac Group Ltd Alpex Pharma SA Altasciences Co Inc Alvogen Inc AOP Health ARx LLC ASM Aerosol-Service AG AstraZeneca Plc Astrea SA AtomVie Global Radiopharma Inc Aurobindo Pharma Ltd AustarPharma LLC Avara Pharmaceutical Services Inc Baccinex SA Basic Pharma Bausch & Lomb Pharmaceuticals Inc Baxter Biopharma Solutions Bayer AG Berkshire Sterile Manufacturing LLC BioRamo LLC BioReliance Corp Boehringer Ingelheim Biopharmaceuticals GmbH Boehringer Ingelheim RCV GmbH & Co KG Bora Pharmaceuticals Co Ltd Bristol Myers Squibb Co BSP Pharmaceuticals SpA Bushu Pharmaceuticals Ltd Cambrex Corp Catalent Inc Cenexi SAS Cerovene Inc Chia Tai Tianqing Pharmaceutical Group Co Ltd Contract Pharmaceuticals Ltd Corden Pharma International GmbH CoreRx Inc Corium Inc Curia Global Inc Delpharm SAS Dexcel PT Israel Ltd DPT Laboratories Ltd Eisai Co Ltd EMD Serono Inc Emergent BioSolutions Inc EuroAPI SAS Eurofins Scientific SE And Many More Companies! For more information about this report visit https://www.researchandmarkets.com/r/a0j1ls Source: GlobalData About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

对于过敏，大众绝不陌生。据世界变态反应组织报告，全世界有30%~40%的人深受过敏疾病困扰，过敏性疾病已成为世界第六大慢性疾病。世界卫生组织早已把过敏性疾病列为21世纪重点研究和防治的疾病之一。回望国内，受环境、生活习惯等影响，中国过敏性疾病患病人数逐年增多。据中华医学会变态反应学分会的调研估算，我国仅成人过敏性鼻炎患者数量就已高达1.5亿人。与基数庞大的患病人群形成鲜明对比的是紧缺的医疗资源。根据中华医学会变态反应学分会数据，全国变态（过敏）反应专科医生不到350人，能够进行变态反应诊疗的医生不超过3000人，全国拥有过敏反应专科的医疗机构占比小于1%。过敏专科作为一门新兴学科，并非医院的标配科室，供需失衡导致诊疗不仅匮乏且存在诸多不规范的乱象。阿罗格（Allergopharma，以下称作：阿罗格制药）是一家超过50年历史的德国公司，在全球过敏性疾病诊断和脱敏治疗领域具领导地位。自1999年进入中国市场以来，作为国内唯一的“双螨脱敏制剂”制药企业，阿罗格制药一直致力于加快引入和研发更多的过敏原诊断产品和特异性免疫治疗的产品，也积极推动国内的医生培训和行业交流，助力中国过敏性疾病研究和治疗水平不断提高。风雨五十载，始终秉持“研发就是公司的DNA”“在半个世纪的流转中，阿罗格制药始终坚守着为过敏性疾病患者带来福音的初心，以彻底治愈过敏性疾病为宗旨，致力于找到更好、最好的过敏性疾病治疗方法。”阿罗格制药中国总裁邱宁说。阿罗格制药是1969年由两位科学家创立的私营公司。公司自成立之初就致力于过敏性疾病的诊断和治疗，成立仅3年便研发出第一款产品，并立即将这款天然过敏原制剂的治疗产品投入临床使用，造福深受过敏困扰的广大患者。上世纪八十年代，阿罗格制药开始急速扩张业务，同时也多元化研发系列诊疗产品。在过敏原诊断方面从最早的皮肤点刺产品延伸到体外诊断产品；在脱敏治疗方面，囊括皮下制剂和舌下滴剂，甚至覆盖过敏原防护、急救产品、防螨床单洗涤用品等产品 …… 其终极目标就是要找到最为有效的过敏性疾病综合治疗办法。“对过敏性疾病的诊断和治疗探索可以是一个方向，但清洁产品不应该成为一家药厂应该专注的事情。”邱宁说。因此，进入九十年代，阿罗格制药进行了业务调整和研发优化，将核心业务之外的产品砍掉，聚焦所有精力投入到核心产品的研发当中。据了解，脱敏治疗一般分两个阶段：初始治疗阶段和维持治疗阶段。初始治疗阶段，在患者能够耐受的前提下，从最低浓度的最小剂量爬坡到最高浓度，即达到最大耐受剂量。进入维持阶段后，注射间隔时间延长至1个月至1个半月，整个治疗疗程不低于3年。在业务扩张期，阿罗格制药完成了对第一代产品的升级。第二代产品通过对天然过敏原进行化学修饰，达到降低致敏原性，保留免疫原性，可以明显减少患者在剂量爬坡阶段的打针次数，将初始治疗阶段的注射疗程从平均4-5个月缩短到1.5个月，在确保免疫治疗疗效的同时大大提高了患者的耐受性和依从性，从而优化免疫治疗全程。据邱宁介绍，无论是一代还是二代产品，其产品的制作都受制于天然原料，因此，阿罗格制药在全球率先开始探索皮下的人工基因重组脱敏制剂。虽然重组制剂临床II期研究获得了成功，但未能达到III期临床终点，其近二十年的研发经验为基因重组产品在全球的研发做出了突出的贡献。期间证实，既往公认的主要过敏原组分即为引发过敏性疾病的主要原因，但事实上仅仅关注主要致敏原组分远远不够，这一点在近期的临床试验中也得到了证明。阿罗格制药一直在疾病机理上和产品制剂上不断探索求新，在探索过程中不断地揭开过敏性疾病的奥秘。2020年2月，默克集团将阿罗格制药的股权转让给德国德拜集团（Dermapharm Holding），阿罗格制药仍独立运营，继续专注于过敏领域的产品研发。回望过去，50余年风风雨雨，阿罗格制药始终致力于为过敏疾病患者提供最佳的解决方案，集中世界顶尖科学家的专业智慧共同探索过敏性疾病的诊断和治疗，希望研发出最为有效的脱敏产品。时至今日，阿罗格制药已经在全球过敏性疾病诊断和脱敏治疗领域稳居优势地位，公司的过敏原诊断以及皮下脱敏产品（一代天然变应原和二代化学修饰变应原）涵盖一百多种过敏原，补充和丰富了德拜公司的过敏领域产品线，并为其拓展国际市场带来了更多的机遇。 国内唯一批准的双螨制剂，更符合中国过敏性疾病特点中国市场是阿罗格制药的重要增长引擎，也是德拜集团全球范围内最具重要战略意义的市场之一。早在1999年，阿罗格制药的产品阿罗格（粉尘螨+屋尘螨）就在中国获批上市。默克集团旗下的过敏事业部自2000年起，在中国已开展业务二十余年，为过敏性疾病的专业人士和患者提供了针对病因的特异性免疫治疗药物（脱敏治疗），并帮助大中型医院建立了近四百个“脱敏治疗中心”，累计治疗近 10 万个过敏性患者。在从默克集团分剥出来后，2020年5月，阿罗格（北京）医药科技有限公司（简称：阿罗格中国）作为德国阿罗格制药的中国全资子公司在北京成立，致力于为中国过敏性疾病的医护人员和患者提供最好的服务和最好的产品，让更多患者能够受益于阿罗格制药的脱敏产品，摆脱过敏性疾病的困扰。相关数据统计，我国在过去的二十年中，过敏性疾病（过敏性鼻炎、过敏性哮喘、特异性皮炎）的患病率呈井喷式增长，仅成人敏性鼻炎的患病率由2005年的11.1%上升到2011年的17.6%。儿童过敏性哮喘的患病率从1990年的1.09%上升到2010年的3.02%。其中主要致病的过敏原是尘螨，远高于花粉等其它过敏原。在2008年到2018年的十年期间，尘螨的两个亚种：粉尘螨的致敏率由45.4%上升至52.1%，屋尘螨的致敏率由44.5%上升到51.7%。此外，近八成的尘螨过敏患者对尘螨的两个亚种粉尘螨、屋尘螨同时过敏。阿罗格（粉尘螨+屋尘螨）是德国阿罗格制药于1972年开发的第一代产品。截至2020年，全球已有超过56万患者接受了阿罗格治疗，临床有效性和安全性得到了充分的验证。阿罗格（粉尘螨+屋尘螨）在中国获批的适应症为由吸入性变应原诱发、IgE介导的变态反应性疾病：如过敏性鼻炎、过敏性结膜炎、支气管哮喘等。该产品是在中国唯一获批的同时含有粉尘螨和屋尘螨的标准化皮下脱敏制剂。继1999年注册临床之后，又分别于2012年（成人+儿童）、2016年（儿童）在国内做了两个大规模上市后四期临床，实验结果充分验证了阿罗格在中国过敏性鼻炎或/和过敏性哮喘的成人和儿童患者中均具有良好的疗效和安全性。鉴于中国过敏性疾病流行病学特点——绝大多数患者是由粉尘螨或屋尘螨所致，且大多数患者对两种尘螨同时过敏，阿罗格（粉尘螨+屋尘螨）更加满足中国过敏性疾病患者的治疗需求，能够为中国过敏性患者提供更加确切的疗效保障。来自2021年一项国外研究（Augustin S，2021）使用国际公认的脱敏诊疗产品成分检测方法即质谱分析法，检测多个欧洲临床上常使用的皮下脱敏治疗制剂（包括国内临床上正在使用的），以明确是否含有已知的尘螨体内36种过敏原组分。结果显示，阿罗格（粉尘螨+屋尘螨）覆盖了94.4%的尘螨过敏原组分（34/36，覆盖全部主要和中间过敏原组分），而其他产品只覆盖了部分中间过敏原组分和少量次要过敏原组分。此结果进一步夯实了阿罗格（粉尘螨+屋尘螨）独一无二的产品优势，是目前中国市场上获批的产品中最能满足中国过敏性疾病治疗需求的标准化脱敏制剂。根据脱敏治疗的各国际专业学会的指导原则，阿罗格（粉尘螨+屋尘螨）的疗程分为初始阶段（剂量爬坡）和维持阶段，整个疗程至少为期3年。与国内其他脱敏产品相比，阿罗格不仅是双螨制剂且几乎覆盖所有的尘螨过敏原组分，更符合中国过敏性疾病的特点和中国尘螨致敏患者的治疗需求。   环境与过敏医学专委会成立，助推行业交流和医生培训在过去十年中，我国过敏领域已成为最热门的治疗领域之一。在国际上高影响因子的学术期刊中，不断有来自中国的研究发表，标志着作为跨多个学科的过敏领域越来越受到临床医生们的关注，也成为易出高质量基础或临床研究的热点领域。如开头所述，在我国专科医生培训系统中，过敏领域尚未成为医院“专科”，过敏性疾病的诊治基本上分散在耳鼻喉科、呼吸科（成人或儿童）、皮肤科，而且通常不能直接做过敏原检测。为了改善过敏性疾病临床操作不规范，没有实现标准化的难题，阿罗格中国自2016年开始开展医护人员培训，一方面是与中华医学会变态反应分会合作，开展“示范门诊”项目，旨在邀请具有经验丰富的脱敏治疗领域专家，在全国各地为医生和护士做培训，讲解具体的操作，包括过敏原的诊断如何判别、脱敏治疗如何操作、过敏症患者如何全程综合管理等。“这是一个有理论、有操作、有旁观的学习过程，历时两天到两天半。从2016年到2019年年底，我们一共开展了10期完整的培训。”邱宁介绍到。另一项工作是举办“欧洲大师班”培训，与德国领先的变态反应科合作，每年资助10-12位30-40岁的年轻医生，进行为期一周的讲课和实地观摩，包括过敏性疾病的诊断治疗基础知识、疾病在不同器官的表现、真实病例教学等。在疫情期间，阿罗格中国还开办国内“精英班”，以国内经验丰富的过敏研究中心为培训基地，邀请资深专家为年轻医生讲解过敏性疾病的诊断治疗。此外，在规范医生的脱敏治疗流程方面，阿罗格中国与卡柠科技合作研发了一套脱敏治疗智能引导系统——敏识医云，为医护人员提供标准引导服务，包括患者评估、患者评分、检查项目、注射后观察、注意事项等。目前全国有八十多个中心在使用这套系统。“敏识医路”则是面向所有脱敏治疗相关的医护人员的平台，为专科医生提供知识更新和交流服务。启动会现场，阿罗格制药中国总裁邱宁发言2022年12月17日，中国绿发会环境与过敏医学专业委员会正式启动。阿罗格中国作为此次专委会的赞助商以及战略合作伙伴，将推进环境与过敏领域的学术交流和合作，助力中国过敏性疾病研究和治疗水平的提高。启动仪式现场为专委会成员授牌邱宁表示，环境与过敏性疾病密切相关，治理好室内外环境对过敏性疾病的预防尤为重要。成立环境与过敏医学专业委员会，旨在交流过敏医学领域的学术经验、先进技术，提高过敏医学的医疗和学术水平，为临床过敏诊治医生提供一个相互交流与学习的平台，为探索过敏的预防与诊治提供一个规范发展的平台。未来，阿罗格中国公司将持续“过敏性疾病的诊治”业务，并针对中国常见过敏原，尝试各种创新方式，加快在中国引入和研发更多的过敏原诊断产品和特异性免疫治疗产品，帮助医疗专业人士和医疗系统，更好的应对过敏性疾病患病率不断上升所带来的社会负担。同时，公司希望在疫情政策全面放开后将重启“欧洲大师班”，开展更多的线下培训，可以让更多国内的年轻医生看到全球最高的过敏治疗标准、最先进的治疗理念，提高国内过敏性疾病诊疗水平。此外，借助“跨境电商”等创新商业模式，将德拜公司在欧洲细分市场排名第一的维生素、微量元素、激素产品、皮肤科产品、妇女健康等高品质产品引入中国，更好地服务于中国的医疗健康领域和广大患者，为中国人民的健康生活做出贡献。*封面图片来源：123rf如果您想对接动脉网所报道的企业，请扫描小程序码进入VB100人脉圈查看。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

DUBLIN--( BUSINESS WIRE )--The "Allergy Treatment: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for Allergy Treatment estimated at US$18.9 Billion in the year 2020, is projected to reach a revised size of US$27.2 Billion by 2027, growing at a CAGR of 5.3% over the analysis period 2020-2027. Asthma, one of the segments analyzed in the report, is projected to record a 5.9% CAGR and reach US$6.6 Billion by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Rhinitis segment is readjusted to a revised 6.2% CAGR for the next 7-year period. The U.S. Market is Estimated at $5.2 Billion, While China is Forecast to Grow at 8.6% CAGR The Allergy Treatment market in the U.S. is estimated at US$5.2 Billion in the year 2020. China, the world's second largest economy, is forecast to reach a projected market size of US$5.7 Billion by the year 2027 trailing a CAGR of 8.6% over the analysis period 2020 to 2027. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 2.5% and 4.7% respectively over the 2020-2027 period. Within Europe, Germany is forecast to grow at approximately 3.1% CAGR. Skin Allergy Segment to Record 3.4% CAGR In the global Skin Allergy segment, USA, Canada, Japan, China and Europe will drive the 3% CAGR estimated for this segment. These regional markets accounting for a combined market size of US$1.4 Billion in the year 2020 will reach a projected size of US$1.8 Billion by the close of the analysis period. China will remain among the fastest growing in this cluster of regional markets. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$3.6 Billion by the year 2027, while Latin America will expand at a 4.4% CAGR through the analysis period. Select Competitors (Total 12 Featured) - ALK-Abello A/S Allergan PLC ALLERGOPHARMA GmbH & Co. KG Allergy Therapeutics plc Genentech, Inc. GlaxoSmithKline Plc Johnson & Johnson Merck & Co., Inc. Sanofi SA Stallergenes Greer What`s New for 2022? Global competitiveness and key competitor percentage market shares Market presence across multiple geographies - Strong/Active/Niche/Trivial Online interactive peer-to-peer collaborative bespoke updates Access to digital archives and Research Platform Complimentary updates for one year Key Topics Covered: I. METHODOLOGY II. EXECUTIVE SUMMARY 1. MARKET OVERVIEW Influencer Market Insights World Market Trajectories Allergy Treatment - Global Key Competitors Percentage Market Share in 2022 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) Impact of Covid-19 and a Looming Global Recession 2. FOCUS ON SELECT PLAYERS 3. MARKET TRENDS & DRIVERS 4. GLOBAL MARKET PERSPECTIVE III. MARKET ANALYSIS IV. COMPETITION For more information about this report visit https://www.researchandmarkets.com/r/wlgu6t