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市场扩容+政策加持 巴基斯坦生物药与仿制药赛道释放巨大对华投资机遇

市场扩容+政策加持 巴基斯坦生物药与仿制药赛道释放巨大对华投资机遇 茂本供应链
2026-07-21
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7月17—19日,2026中巴医药保健B2B投资大会在巴基斯坦伊斯兰堡举办,巴基斯坦药品监管局(DRAP)现场发布产业白皮书,全面披露本国生物治疗药物、通用注射剂仿制药市场现状、监管体系与重点投资赛道,面向中国药企释放多重合作红利,吸引超450家中巴医药企业现场对接洽谈。

From July 17 to 19, the 2026 China-Pakistan Pharmaceutical and Healthcare B2B Investment Conference was held in Islamabad, Pakistan. The Pakistan Drug Regulatory Authority (DRAP) released an industry white paper on-site, fully disclosing the current status of the country's biotherapeutic drugs, generic injectable market, regulatory system, and key investment areas, offering multiple cooperation benefits to Chinese pharmaceutical companies, and attracting more than 450 Chinese and Pakistani pharmaceutical companies for on-site matchmaking and negotiations.

巴基斯坦总人口达2.55亿,庞大刚需持续拉动医药产业增长。数据显示,2024年巴医药市场规模已达44亿美元,本土持证制药厂商超700家,包含十余家跨国药企;行业预测2030年市场规模将攀升至66亿美元,年均保持稳定增长。当前产业短板突出对外依存度:生物治疗药物年进口额19亿美元,通用注射剂年进口约3000万支,原料药(API)本土产能仅覆盖国内10%-15%需求,高度依赖海外采购,进口替代空间广阔。

Pakistan's total population has reached 255 million, and the enormous rigid demand continues to drive the growth of the pharmaceutical industry. Data shows that in 2024, the size of Pakistan's pharmaceutical market has reached $4.4 billion, with over 700 certified domestic pharmaceutical manufacturers, including more than a dozen multinational pharmaceutical companies; the industry predicts that by 2030 the market size will climb to $6.6 billion, maintaining a stable annual growth rate. Currently, the industry's weaknesses lead to high external dependence: the annual import value of biopharmaceuticals is $1.9 billion, about 30 million units of generic injections are imported annually, and domestic production capacity of active pharmaceutical ingredients (APIs) only covers 10%-15% of domestic demand, making it highly dependent on overseas procurement, with broad potential for import substitution.

作为全国唯一药品监管机构,DRAP依据2012年《药品监管局法案》搭建标准化监管体系,全面对标ICH、PIC/S、WHO国际生物制品规范,企业统一采用 CTD 通用技术文件线上申报,提供全流程电子化审批通道。产品注册分两条路径:经WHO预认证、参考监管机构(RRA)获批的药品可走快速通道,大幅压缩审核周期;未获国际权威认证的创新生物药、疫苗需完整科学评审,审批周期180至300个工作日。针对创新生物药、公共卫生刚需药品、新建生产厂区,DRAP开通优先审批通道,营业执照、新药注册审批时限压缩至三个月,大幅降低外资落地时间成本。

As the country's only drug regulatory authority, DRAP has established a standardized regulatory system based on the 2012 'Drug Regulatory Authority Act,' fully aligning with ICH, PIC/S, and WHO international biologics standards. Companies uniformly use the CTD common technical document for online submissions, providing a fully electronic approval channel. Product registration follows two pathways: drugs that are WHO pre-qualified or approved by reference regulatory authorities (RRA) can take a fast-track route, significantly shortening the review period; innovative biologics and vaccines not certified by international authorities require a full scientific review, with an approval period of 180 to 300 working days. For innovative biologics, essential public health drugs, and new manufacturing facilities, DRAP has opened a priority approval channel, reducing the timeframe for business licenses and new drug registration approval to three months, significantly lowering the time cost for foreign investment establishment.

本次大会明确两大核心投资赛道。其一为生物治疗领域,非专利胰岛素是核心机会,产业链覆盖配方研发、无菌灌装、成品包装全环节;巴基斯坦糖尿病患者基数庞大,胰岛素市场缺口显著,本土产能不足,外资建厂具备稳定市场兜底。其二为通用注射剂仿制药,重点布局注射级 API 原料,终端成品覆盖肿瘤、激素、镇痛、抗炎四大临床品类,完整无菌生产链路包含原料储存、无菌过滤、灌装封口、灭菌稳定、成品包装五大标准化工序,产业落地路径清晰。

This conference clearly identifies two core investment tracks. The first is the field of biotherapy, with non-patented insulin being the core opportunity. The industry chain covers the entire process, including formulation development, sterile filling, and finished product packaging. Pakistan has a large diabetic population, a significant insulin market gap, insufficient local production capacity, and foreign investment in factories can ensure a stable market. The second is generic injectable drugs, focusing on the layout of injectable-grade API materials. The end products cover four major clinical categories: oncology, hormones, pain relief, and anti-inflammatory. The complete sterile production chain includes five standardized processes: raw material storage, sterile filtration, filling and sealing, sterilization and stabilization, and finished product packaging, with a clear path for industrial implementation.

为吸引海外资本,巴基斯坦搭建多层级投资服务体系:DRAP负责监管政策与技术指导;总理直管特别投资促进委员会(SIFC)提供一站式投资代办、跨部门协调服务;巴基斯坦制药制造商协会(PPMA)联动行业资源,推动本土药企合资合作;全国特殊经济区配套税收、贸易优惠与稳定电力基础设施,全方位降低建厂运营成本。针对中国投资者,DRAP专门设立专属服务窗口,提供技术转让、企业对接、MOU签约全链条配套服务,鼓励中巴企业签署双边合作备忘录,落地合资生产项目。

To attract overseas capital, Pakistan has set up a multi-level investment service system: DRAP is responsible for regulatory policies and technical guidance; the Prime Minister-led Special Investment Facilitation Committee (SIFC) provides one-stop investment facilitation and cross-department coordination services; the Pakistan Pharmaceutical Manufacturers Association (PPMA) leverages industry resources to promote joint ventures and cooperation among local pharmaceutical companies; nationwide special economic zones offer tax, trade incentives, and stable power infrastructure, comprehensively reducing the costs of establishing and operating factories. For Chinese investors, DRAP has established a dedicated service window that provides full-chain support services including technology transfer, enterprise matchmaking, and MOU signing, encouraging Chinese and Pakistani companies to sign bilateral cooperation memoranda and implement joint production projects.

大会官方表示,巴基斯坦医药产业正加速推进原料药本土化生物药自主化,依托庞大内需与简化监管政策,生物治疗、注射剂仿制药、API生产将成为未来数年最具成长性赛道。中巴医药产业优势互补,中国成熟制药技术、完整供应链与巴基斯坦本地市场、区位优势深度结合,有望打造南亚区域医药制造枢纽,实现互利共赢。

The conference officials stated that Pakistan's pharmaceutical industry is accelerating the localization of active pharmaceutical ingredients and the independence of biopharmaceuticals. Relying on massive domestic demand and simplified regulatory policies, biologic therapies, injectable generics, and API production will become the most growth-oriented sectors in the coming years. With complementary advantages in the China-Pakistan pharmaceutical industry, the integration of China's mature pharmaceutical technology and complete supply chain with Pakistan's local market and geographical advantages is expected to create a pharmaceutical manufacturing hub in South Asia, achieving mutual benefit and win-win outcomes.

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