疼痛分为急性疼痛和慢性疼痛，急性疼痛主要涉及创伤和术后疼痛，慢性疼痛则涉及多种疾病，包括感受伤害性疼痛（如骨质疏松症和类风湿性关节炎）、神经病性疼痛（中枢性，如中风后疼痛、脊髓损伤、偏头痛、艾滋相关神经疼痛等；外周性，如疱疹后神经痛、糖尿病性神经痛）、脏器相关疼痛（如内脏相关疼痛、胰腺炎、炎症性肠综合征等）、混合性疼痛（如腰痛、癌痛、纤维肌痛等）等等。
根据全球领先的制药与医疗保健顾问公司Decision Resources日前发布的一份新报告，在2013年，美国、日本、欧洲5国（法国、德国、意大利、西班牙、英国）全球7大主要医药市场，疼痛治疗市场市值365亿美元，未来15年（2013-2028），疼痛治疗市场预计将保持平稳，2028年市值维持在380亿美元。在2013-2028预测期，前半期数个重磅疼痛药物专利到期导致的销售锐减，将由当前药物类别以及新型药物类别中出现的新产品的快速市场接纳所抵消。
——单抗类新型镇痛药商业化最成功：目前，阿片类止痛药和非甾体抗炎药（NSAIDs）主宰疼痛治疗市场。然而，这些药物普遍存在安全性和耐受性问题，也并非对所有患者足够有效，这就为相对当前治疗方案具有临床显著改善的新药，尤其是具有独特作用机制的新药，提供了显著的商业机会。根据报告，在未来，抗神经生长因子（anti-NGF）单克隆抗体类药物，将成为商业化最为成功的新型镇痛药物类别，预计到2028年，该类药物的销售额将达到77亿美元。
——疼痛早期管线仍然非常活跃：在研发对临床疼痛管理实践方面具有显著改善的化学药、生物制剂、基因疗法方面仍存在着重大挑战。目前为止，尚未取得概念验证的数以百计的开发项目中，只有少数新药靶标引起了行业关键意见领袖（KOLs）的兴趣。
——电压门控离子通道是关键治疗靶标：接受采访的思想领袖仍然认为，选择性靶向疼痛通路中的电压门控离子通道亚型——尤其是Nav1.7，将成为一种行之有效的方法，将提供显著的商业潜力。2种亚型-选择性离子通道调节剂，梯瓦（Teva）/Xenon的TV-45070（原XEN-402）和Convergence制药公司的CNV-1014802，这2种药物已在II期临床试验中实现神经性疼痛治疗的概念验证，并已进入III期临床开发。
——神经性疼痛市场存重磅商业机会：接受采访的疼痛专家重申，在疼痛治疗领域，对持续有效且能够提供长期缓解疼痛的药物，仍存在着巨大的医疗需求。专家特别指出，从有效治疗药物方面考虑，神经性疼痛综合征患者群体是治疗最欠缺的群体，该细分市场为创新疗法提供了相当大的市场机会。
——2种单抗药将实现重磅销售：当前，疼痛市场已由多个成熟、廉价的仿制药统治，未来上市的所有新型止痛药物，必须在疗效、安全性和/或耐受性方面提供具有临床意义的改善，才能够赢得医生的纳税人的接纳，才能够在市场中立足。在预测期内，2种单抗药物有望实现重磅销售：辉瑞和礼来的tanezumab以及强生和武田的fulranumab，这2种新药有望提供显著改善的疗效。此外，在难以治疗的神经性疼痛病症方面，靶向疼痛通路的亚型-选择性离子通道调节剂前景看好。
英文原文：By 2028, One-Quarter of Total Pain Sales Will be Attributable to Novel Drug Classes
BURLINGTON, Mass., Oct. 9, 2014 /PRNewswire/ -- Decision Resources Group finds that the overall pain market will maintain $38 billion in sales in 2028 across the major pharmaceutical markets (United States, France, Germany, Italy, Spain, the United Kingdom, and Japan); the loss of sales due to the generic entry of several blockbuster pain therapies in the first half of the 2013-2028 forecast period will be offset by the uptake of emerging agents in current drug classes as well as products representing novel drug classes. Decision Resources Group expects anti-nerve growth factor (anti-NGF) monoclonal antibodies to be the most commercially successful novel analgesic drug class, garnering $7.7 billion in sales by the end of 2028.
Other key findings from the Pharmacor report entitled Novel Approaches to Pain Therapy include:
——The pipeline for early-stage pain therapies remains highly active: There are substantial challenges associated with discovering molecules, biologics, and gene therapies that possess suitable clinical profiles for practical pain management. Of the hundreds of development programs that have yet to reach proof-of-concept, only a small number of novel drug targets have piqued the interest of key opinion leaders interviewed by Decision Resources Group.
——Voltage-gated ion channels within pain pathways are a key therapeutic target: Thought leaders interviewed still consider the selecive targeting of subtypes of voltage-gated ion channels within pain pathways—particularly Nav1.7— to be an approach that offers significant commercial potential. Two subtype-selective ion channel modulators, Teva/Xenon's TV-45070 (formerly XEN-402) and Convergence Pharmaceuticals' CNV-1014802, have now demonstrated proof-of-concept for the treatment of neuropathic pain in Phase II clinical trials and are entering later-stage development.
Comments from Decision Resources Group Principal Business Insights Analyst Natalie Taylor, Ph.D.:
——"Pain specialists interviewed by Decision Resources Group reiterate that there is still a great need for pain medications that are consistently effective and that can provide pain relief over the long term. Experts also state that patients with neuropathic pain syndromes are the most inadequately served in terms of effective treatments, and therefore this segment of the pain market offers considerable market opportunity for novel therapies."
——"All novel emerging pain agents will be competing in a market occupied by multiple well-established, inexpensive generic agents. Novel analgesics must offer improvements in efficacy, safety, and/or tolerability that are clinically meaningful over generic competitors to gain acceptance from both prescribers and payers. The novel drugs expected to achieve blockbuster status during the forecast period—tanezumab (Pfizer/Eli Lilly) and fulranumab (Johnson & Johnson/Takeda)—are expected to offer clear improvements in efficacy, albeit balanced against safety risks. Furthermore, subtype-selective ion channel modulators hold the potential to specifically target pain pathways and relieve pain in difficult-to-treat neuropathic pain conditions."
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