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市場調查報告書
商品編碼
1851717

雙胍類藥物:市場佔有率分析、產業趨勢、統計、成長預測(2025-2030)

Biguanides - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2025 - 2030)

出版日期: | 出版商: Mordor Intelligence | 英文 132 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2025 年雙胍類藥物市場價值為 194.4 億美元,預計到 2030 年將達到 218.3 億美元,在此期間的複合年成長率為 2.34%。

甲胍市場-IMG1

二甲雙胍作為2型糖尿病第一線治療藥物的穩定需求仍然是主要的收入促進因素,而新製劑、女性健康適應症以及區域市場覆蓋範圍的擴大則推動了成長。亞太地區憑藉龐大的糖尿病患者群體和活躍的非專利競爭,推動了銷售量成長,而北美則透過高階固定劑量複方製劑保持了價值。涉及NDMA(亞硝基二甲胺)雜質的監管措施以及數位藥房的擴張,正在影響供應的韌性和分銷策略。因此,競爭的重點將放在生產品質、定價和製劑創新上,以捍衛市場佔有率並影響一線治療藥物的選擇,從而對抗GLP-1受體促效劑和SGLT-2抑制劑。

全球雙胍類藥物市場趨勢及洞察

全球第2型糖尿病(T2DM)盛行率不斷上升

預計到2045年,糖尿病患者人數將增加7.83億,二甲雙胍的處方量將持續成長,尤其是在亞太地區,該地區的糖尿病盛行率成長最為迅速。儘管隨著學名藥降低入門價格,新興市場的處方量大幅成長,但已開發市場更傾向於兼具血糖控制和心血管獲益的高階複方製劑。指引重申了二甲雙胍作為第一線治療藥物的地位,即使聯合治療發展迅速,其潛在需求依然保持穩定。因此,生產商採取雙管齊下的策略:一方面保護其銷量高的旗艦片劑,以滿足對成本敏感的醫療保健系統的需求;另一方面向富裕人群推廣高附加價值製劑。隨著糖尿病在全球範圍內的蔓延,在各國政府面臨醫療保健成本不斷上漲的情況下,雙胍類藥物市場不斷擴大,在預防和早期療育計畫中仍扮演著重要角色。

在大多數糖尿病指引中,該藥物被列為首選藥物。

2025 年糖尿病指南將二甲雙胍定位為一線藥物治療,確保了銷售量的持續穩定。該指南同時提倡儘早引入 SGLT-2 抑制劑等附加元件藥物,從而增加了二甲雙胍聯合用藥(包括雙聯和三聯療法)的機會。採取預防性策略的醫療系統正在將二甲雙胍的臨床效用擴大到糖尿病前期,從而增加了符合條件的患者數量。區域差異也逐漸顯現:歐洲強調成本效益,北美重視基於結果的證據,而新興市場則優先考慮價格可負擔性而非療效最佳化。整體而言,指引的統一性保障了二甲雙胍的需求,同時鼓勵生產者在製劑、給藥便利性以及核心糖尿病以外的患者群體等方面進行創新。

NDMA雜質召回事件損害了處方醫生的信任。

自2020年以來,多批二甲雙胍被發現含有超過監管限值的NDMA,迫使梯瓦製藥、Apotex等公司召回產品。最新研究表明,當片劑與亞硝酸鹽接觸時,NDMA會在體內生成,因此需要加強安全監測。生產商已採取措施,在顆粒中添加抗壞血酸等抗氧化劑,並實施嚴格的氣相檢測通訊協定,但臨床醫生仍保持警惕。美國和歐洲的監管機構現在要求在產品上市前進行批次特定的認證,這延長了前置作業時間。雖然供應保持穩定,但由於人們對二甲雙胍的認知不斷提高,加速了向其他藥物類別的轉變,並增加了合規成本,因此雙胍類藥物市場在短期內可能仍將保持低迷狀態。

細分市場分析

到2024年,二甲雙胍將佔據雙胍類藥物市場收入的95.51%,憑藉其無與倫比的臨床友善性和可負擔性,鞏固其在該領域的領先地位。苯乙雙胍7.65%的複合年成長率表明,在代謝腫瘤學領域未被滿足的需求以及特定地區核准的推動下,小分子藥物正在不斷擴大市場佔有率。儘管苯乙雙胍曾出現過安全性逆轉的案例,但其在抗癌項目中重新獲得了關注,這得益於其更深的粒線體滲透性,從而增強了腫瘤殺傷活性。領先的供應商正在透過繼續大規模生產二甲雙胍,同時減少對這些輔助雙胍類藥物的投資,來分散其投資組合的風險。雖然小眾藥物的定價彈性更大,但其適應症範圍有限,限制了其絕對收入潛力。儘管二甲雙胍的市場佔有率將逐漸下降,但隨著更廣泛的適應症維持處方量,預計其主導地位將在整個預測期內持續存在。僅二甲雙胍相關雙胍類藥物的市場規模就超過150億美元,凸顯了該分子的結構重要性。

第二代分子藥物正吸引大量研究經費,旨在最佳化生物有效性、標靶化組織特異性AMPK活化以及降低乳酸性酸中毒的風險。一個歐洲研究聯盟正在研究微劑量佈福明預防肝細胞癌的療效,而一個日本研究團隊正在測試苯乙雙胍與查核點抑制劑的聯合用藥。監管機構的批准將取決於其安全性,而早期結果表明,透過適當的劑量管理,該藥物具有可控的安全性。如果獲得腫瘤臨床試驗的核准,高定價策略或許能夠抵消患者數量的下降,從而為雙胍類藥物市場帶來新的、穩定的收入來源。

2024年,即時釋片將維持60.53%的市場佔有率,這主要得益於其成熟的處方習慣和最低的每毫克成本。同時,緩釋片預計將以6.85%的複合年成長率成長,這主要歸功於其每日一次的給藥方式,這種方式能夠提高患者的依從性並最大限度地減少胃腸道不適。緩釋片獨特的親水性基質和雷射穿孔滲透泵技術能夠有效控制藥物溶出,從而獲得更高的單價和更長的專利保護期。其1000毫克的高劑量配方能夠減輕患者的服藥負擔,並滿足超重患者的體重劑量指導原則。預計緩釋雙胍類藥物市場將從2025年的51億美元成長到2030年的71億美元。

口服製劑雖然市佔率較小,但卻能滿足無法吞嚥藥片的兒童和老年人的需求。新型掩遮罩輔料和小容量濃縮製劑旨在提高其接受度。專為資源匱乏環境設計的顆粒劑包裝可有效規避缺水問題,並簡化鄉村診所的給藥流程。多樣化的給藥方案有助於強化品牌形象,並使生產者能夠在日趨成熟的治療領域中,在價格之外實現差異化競爭。

區域分析

預計到2024年,亞太地區將佔全球總銷售額的35.62%,複合年成長率達8.35%。這主要得益於中國的集中採購,其在擴大銷售量的同時降低了價格;以及印度,該國擁有大量未接受治療的糖尿病患者。快速的都市化和生活方式的改變正在推動診斷率的提高,即使在價格管制下,處方量仍將持續成長。東南亞各國政府在其全民健保計畫中對二甲雙胍津貼,優先考慮的是價格的可負擔性而非昂貴的製劑。

北美市場以價值為導向,成熟的支付方傾向於使用活性心肌梗塞治療藥物,但成長較為溫和。儘管二甲雙胍類複方製劑仍重要,但GLP-1受體促效劑正日益成為處方優​​先選擇。 NDMA召回事件加速了醫院藥物管理計畫的實施,並提高了供應商的文件閾值。儘管銷售量保持平穩,但由於平均售價上漲,銷售額依然強勁。

歐洲正在努力平衡創新與預算監管。各國醫療體系透過協商基於用量的折扣,並在藥物經濟模型顯示緩釋片和複方製劑能夠降低併發症時,為其提供報銷。以患者為中心的治療方法,例如獲得歐洲藥品管理局(EMA)核准的每週一次胰島素,正在豐富治療手段,並鼓勵使用包含二甲雙胍的聯合治療。

中東和非洲的糖尿病盛行率正在上升,但基礎設施水準參差不齊。波灣合作理事會國家進口高品質的品牌藥,而撒哈拉以南非洲市場則依賴捐助者資助的學名藥。由於低溫運輸存在漏洞以及假冒仿冒品氾濫,藥品供應安全仍面臨挑戰。

在南美洲,以巴西為首的巴西,在巴西統一醫療系統(SUS)的監管下,二甲雙胍在妊娠糖尿病治療方案中的使用量不斷增加。價格管制限制了淨利率,但公共採購涵蓋人口眾多,確保了合規生產商的供貨量。整體而言,區域差異迫使企業調整包裝、價格分佈和分銷物流,從而在面臨區域性不利因素的情況下,維持了雙胍類藥物市場的整體擴張。

其他福利:

  • Excel格式的市場預測(ME)表
  • 3個月的分析師支持

目錄

第1章 引言

  • 研究假設和市場定義
  • 調查範圍

第2章調查方法

第3章執行摘要

第4章 市場情勢

  • 市場概覽
  • 市場促進因素
    • 全球第2型糖尿病(T2DM)盛行率不斷上升
    • 大多數糖尿病指引中的首選地位
    • 學名藥的快速普及推動了低收入和中等收入國家藥品價格的下降。
    • 二甲雙胍在女性健康(多囊性卵巢症候群、妊娠期糖尿病)的應用日益廣泛
    • 探索雙胍類藥物作為抗衰老和抗癌藥物
    • 人工智慧驅動的分子重定位加速了藥物組合的研發
  • 市場限制
    • NDMA雜質召回事件削弱了處方醫師的信心
    • GLP-1 Ras 和 SGLT-2 作為第一線治療藥物越來越受歡迎
    • 印度、中國和巴西的價格抑制政策正在擠壓利潤空間。
    • 電子商務通路中的劣質/仿冒品二甲雙胍
  • 波特五力模型
    • 供應商的議價能力
    • 買方的議價能力
    • 新進入者的威脅
    • 替代品的威脅
    • 競爭對手之間的競爭

第5章 市場規模與成長預測

  • 按分子
    • 二甲雙胍
    • 苯乙雙胍
    • 丁福明
  • 按劑型
    • 即時釋片
    • 緩釋片
    • 口服液
  • 指示
    • 2型糖尿病
    • 糖尿病前期
    • 卵巢症候群(PCOS)
    • 妊娠期糖尿病(GDM)
  • 依配方類型
    • 單藥治療
    • 固定組合藥物(FDC)
  • 透過分銷管道
    • 醫院藥房
    • 零售藥房
    • 網路藥房
  • 地區
    • 北美洲
      • 美國
      • 加拿大
      • 墨西哥
    • 歐洲
      • 德國
      • 英國
      • 法國
      • 義大利
      • 西班牙
      • 其他歐洲地區
    • 亞太地區
      • 中國
      • 日本
      • 印度
      • 韓國
      • 澳洲
      • 亞太其他地區
    • 中東和非洲
      • GCC
      • 南非
      • 其他中東和非洲地區
    • 南美洲
      • 巴西
      • 阿根廷
      • 其他南美洲

第6章 競爭情勢

  • 市場集中度
  • 市佔率分析
  • 公司簡介
    • Teva Pharmaceutical Industries
    • Merck & Co.
    • Takeda Pharmaceutical
    • GSK plc
    • Sanofi
    • Boehringer Ingelheim
    • Glenmark Pharma
    • Zydus Lifesciences
    • Bristol-Myers Squibb
    • Sun Pharma
    • Aurobindo Pharma
    • Lupin Ltd.
    • Ajanta Pharma
    • Granules India
    • Apotex
    • IOL Chemicals & Pharma
    • Sandoz AG
    • Dr. Reddy's Laboratories

第7章 市場機會與未來展望

簡介目錄
Product Code: 63836

The biguanides market size stood at USD 19.44 billion in 2025 and is forecast to reach USD 21.83 billion by 2030, advancing at a 2.34% CAGR over the period.

Biguanides - Market - IMG1

Steady demand for metformin as first-line therapy in type-2 diabetes anchors revenue, while incremental growth arises from newer dosage forms, women's health indications, and wider regional access. Asia-Pacific drives volume through large diabetic populations and vigorous generic competition, whereas North America sustains value through premium fixed-dose combinations. Regulatory actions that contain N-nitrosodimethylamine (NDMA) impurities, alongside digital pharmacy expansion, shape both supply resilience and distribution strategy. Competitive focus therefore rests on manufacturing quality, pricing agility, and formulation innovation to protect share against GLP-1 receptor agonists and SGLT-2 inhibitors that now influence first-line choices.

Global Biguanides Market Trends and Insights

Rising Global Prevalence of Type-2 Diabetes (T2DM)

The projected rise to 783 million diabetes cases by 2045 sustains prescription volumes for metformin, particularly in Asia-Pacific where incidence is climbing fastest. Emerging markets deliver high unit growth because competitive generics reduce entry price; developed markets prefer premium fixed-dose combinations that couple glycemic control with cardiovascular benefit. Guideline reaffirmation of metformin as first-line therapy sustains baseline demand even while combination therapy gains momentum. Manufacturers therefore pursue dual strategy: defend high-volume core tablets for cost-sensitive health systems and promote value-added formats in wealthier segments. The global footprint of diabetes ensures that biguanides market expansion remains linked to prevention and early intervention programs as governments confront mounting healthcare costs.

Favourable First-Line Therapy Status in Most Diabetes Guidelines

Diabetes guidelines for 2025 kept metformin at the center of initial pharmacologic treatment, a position that guarantees continued volume stability. The same updates advocate earlier introduction of add-on agents such as SGLT-2 inhibitors, increasing opportunities for dual and triple combinations that embed metformin. Health systems adopting preventive approaches extend metformin's clinical utility to prediabetes, enlarging its candidate pool. Regional nuances appear: Europe stresses cost-effectiveness, North America rewards outcome-based evidence, and emerging markets weigh affordability over optimization. Overall, guideline alignment secures metformin demand while encouraging manufacturers to innovate around combination ratios, dosing convenience, and patient groups beyond core diabetes.

NDMA Impurity Recalls Denting Prescriber Confidence

Successive recalls since 2020 exposed NDMA levels above regulatory limits in several metformin batches, forcing stock withdrawals from Teva, Apotex, and others. New research shows NDMA can form in-vivo when tablets encounter nitrites, intensifying safety scrutiny. Manufacturers responded by adopting antioxidants such as ascorbic acid in granulation and installing tighter gas-phase testing protocols, but clinician wariness lingers. U.S. and European regulators now require lot-specific certificates before market release, lengthening lead times. While supply has stabilized, heightened awareness accelerates switching to alternative drug classes and raises compliance costs, moderating the biguanides market trajectory in the near term.

Other drivers and restraints analyzed in the detailed report include:

  1. Rapid Genericisation Driving Affordability in LMICs
  2. Increasing Use of Metformin in Women's Health (PCOS, GDM)
  3. Rising Popularity of GLP-1 RAs & SGLT-2s as First-Line Options

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Metformin generated 95.51% of biguanides market revenue in 2024, underpinning class leadership through unmatched clinical familiarity and affordability. Buformin's 7.65% CAGR highlights how unmet needs in metabolic oncology and specific regional approvals allow smaller molecules to carve shares. Phenformin finds renewed interest in anticancer programs despite historic safety withdrawals, leveraging deeper mitochondrial penetration for enhanced tumoricidal effect. Major suppliers hedge portfolios by investing modest sums into these secondary biguanides while continuing high-volume metformin manufacture. Pricing flexibility is greater in niche molecules, but limited indication scope constrains absolute revenue potential. Observers expect metformin's share to taper gradually yet remain dominant throughout the forecast window as broader labels sustain prescriptions. The biguanides market size attached to metformin alone still exceeds USD 15 billion, underscoring the molecule's structural importance.

Second-generation molecules attract research funding aimed at optimizing bioavailability, targeting tissue-specific AMPK activation, and reducing lactic acidosis risk. European consortia explore buformin micro-dosing for hepatocellular carcinoma prevention, while Japanese groups test phenformin in combination with checkpoint inhibitors. Regulatory acceptance rests on demonstrable safety margins, and early results suggest manageable profiles with proper dosing controls. If oncology trials yield approval, premium pricing could offset smaller patient pools, contributing fresh but measured top-line additions to the biguanides market.

Immediate-release tablets retained a 60.53% share in 2024 owing to entrenched prescribing habits and the lowest cost per milligram. Extended-release tablets, though, are advancing at 6.85% CAGR as once-daily regimens boost adherence and minimize gastrointestinal discomfort. Proprietary hydrophilic matrices and laser-drilled osmotic pumps sustain controlled dissolution, commanding higher unit prices and lengthier patent life. High-strength 1,000 mg formats reduce pill burden and align with weight-based dosing guidelines in overweight populations. The biguanides market size tied to extended-release lines is projected to rise from USD 5.1 billion in 2025 to USD 7.1 billion by 2030.

Oral solutions, though minor, serve pediatric and geriatric segments unable to swallow tablets. Novel taste-masking excipients and small-volume concentrates aim to widen acceptance. Sachet granules tailored for low-resource settings bypass water scarcity issues and simplify dosing in rural clinics. Collectively, dosage-form diversification strengthens brand identity, allowing manufacturers to differentiate beyond price in a maturing therapeutic category.

The Biguanide Market Report is Segmented by Molecule (Metformin, Phenformin, and Buformin), Dosage Form (Immediate-Release Tablets, and More), Indication (Type-2 Diabetes Mellitus, Prediabetes, and More), Formulation Type (Monotherapy and Fixed-Dose Combinations), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

Asia-Pacific generated 35.62% of 2024 revenue and is on track to deliver an 8.35% CAGR, driven by China's centralized procurement that cut prices yet expanded volume and India's vast untreated diabetic base. Rapid urbanization coupled with lifestyle shifts boosts diagnosis rates, ensuring prescription growth even under price caps. Southeast Asian governments subsidize metformin within universal coverage schemes, emphasizing affordability over premium formulations.

North America embodies a value-focused yet slower-growing arena where sophisticated payers favor agents offering cardiorenal benefit. Fixed-dose combinations that integrate metformin maintain relevance, but GLP-1 receptor agonists increasingly command formulary preference. NDMA recall fallout accelerated hospital stewardship programs, raising documentation thresholds for suppliers. Despite flat volumes, revenue holds steady owing to higher average selling prices.

Europe balances innovation adoption with budget oversight. National health systems negotiate volume-based discounts yet reimburse extended-release and combination tablets when pharmacoeconomic models demonstrate reduced complications. EMA approvals of patient-centric modalities such as weekly insulin augment the therapeutic toolbox and encourage combination regimens featuring metformin.

Middle East & Africa experience rising diabetes prevalence but variable infrastructure. Gulf Cooperation Council states import high-quality brands, while sub-Saharan markets rely on donor-financed generics. Supply security challenges persist due to cold-chain gaps and counterfeit penetration.

South America, led by Brazil, witnesses rising metformin uptake in gestational diabetes protocols under the SUS system. Price controls limit margins, but public procurement covers vast populations, offering volume certainty for compliant manufacturers. Collectively, regional heterogeneity obliges companies to tailor packaging, price tiers, and distribution logistics, sustaining overall biguanides market expansion despite localized headwinds.

  1. Teva Pharmaceutical Industries
  2. Merck
  3. Takeda Pharmaceuticals
  4. GlaxoSmithKline
  5. Sanofi
  6. Boehringer Ingelheim
  7. Glenmark Pharma
  8. Zydus Lifesciences
  9. Bristol-Myers Squibb
  10. Sun Pharmaceuticals Industries
  11. Aurobindo Pharma
  12. Lupin
  13. Ajanta Pharma
  14. Granules India
  15. Apotex
  16. IOL Chemicals & Pharma
  17. Sandoz Group
  18. Dr. Reddy's Laboratories

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Global Prevalence Of Type-2 Diabetes (T2DM)
    • 4.2.2 Favourable First-Line Therapy Status In Most Diabetes Guidelines
    • 4.2.3 Rapid Genericisation Driving Affordability In LMICs
    • 4.2.4 Increasing Use of Metformin In Women's Health (PCOS, GDM)
    • 4.2.5 Exploration of Biguanides As Geroprotective & Anti-Cancer Agents
    • 4.2.6 AI-Enabled Molecule Repurposing Accelerating Fixed-Dose Combos
  • 4.3 Market Restraints
    • 4.3.1 NDMA Impurity Recalls Denting Prescriber Confidence
    • 4.3.2 Rising Popularity Of GLP-1 Ras & SGLT-2s As First-Line Options
    • 4.3.3 Price-Control Policies In India, China And Brazil Compressing Margins
    • 4.3.4 Sub-Standard / Counterfeit Metformin In E-Commerce Channels
  • 4.4 Porter's Five Forces
    • 4.4.1 Bargaining Power of Suppliers
    • 4.4.2 Bargaining Power of Buyers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitutes
    • 4.4.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Molecule
    • 5.1.1 Metformin
    • 5.1.2 Phenformin
    • 5.1.3 Buformin
  • 5.2 By Dosage Form
    • 5.2.1 Immediate-Release Tablets
    • 5.2.2 Extended-Release Tablets
    • 5.2.3 Oral Solution
  • 5.3 By Indication
    • 5.3.1 Type-2 Diabetes Mellitus
    • 5.3.2 Prediabetes
    • 5.3.3 Polycystic Ovary Syndrome (PCOS)
    • 5.3.4 Gestational Diabetes Mellitus (GDM)
  • 5.4 By Formulation Type
    • 5.4.1 Monotherapy
    • 5.4.2 Fixed-Dose Combinations (FDCs)
  • 5.5 By Distribution Channel
    • 5.5.1 Hospital Pharmacies
    • 5.5.2 Retail Pharmacies
    • 5.5.3 Online Pharmacies
  • 5.6 Geography
    • 5.6.1 North America
      • 5.6.1.1 United States
      • 5.6.1.2 Canada
      • 5.6.1.3 Mexico
    • 5.6.2 Europe
      • 5.6.2.1 Germany
      • 5.6.2.2 United Kingdom
      • 5.6.2.3 France
      • 5.6.2.4 Italy
      • 5.6.2.5 Spain
      • 5.6.2.6 Rest of Europe
    • 5.6.3 Asia-Pacific
      • 5.6.3.1 China
      • 5.6.3.2 Japan
      • 5.6.3.3 India
      • 5.6.3.4 South Korea
      • 5.6.3.5 Australia
      • 5.6.3.6 Rest of Asia-Pacific
    • 5.6.4 Middle East and Africa
      • 5.6.4.1 GCC
      • 5.6.4.2 South Africa
      • 5.6.4.3 Rest of Middle East and Africa
    • 5.6.5 South America
      • 5.6.5.1 Brazil
      • 5.6.5.2 Argentina
      • 5.6.5.3 Rest of South America

6 Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Teva Pharmaceutical Industries
    • 6.3.2 Merck & Co.
    • 6.3.3 Takeda Pharmaceutical
    • 6.3.4 GSK plc
    • 6.3.5 Sanofi
    • 6.3.6 Boehringer Ingelheim
    • 6.3.7 Glenmark Pharma
    • 6.3.8 Zydus Lifesciences
    • 6.3.9 Bristol-Myers Squibb
    • 6.3.10 Sun Pharma
    • 6.3.11 Aurobindo Pharma
    • 6.3.12 Lupin Ltd.
    • 6.3.13 Ajanta Pharma
    • 6.3.14 Granules India
    • 6.3.15 Apotex
    • 6.3.16 IOL Chemicals & Pharma
    • 6.3.17 Sandoz AG
    • 6.3.18 Dr. Reddy's Laboratories

7 Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-Need Assessment