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表紙：ホモシスチン尿症の世界市場-2023年～2030年
市場調査レポート
商品コード
1352116

ホモシスチン尿症の世界市場-2023年～2030年

Global Homocystinuria Market - 2023-2030

出版日
ページ情報
英文 186 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.03円
ホモシスチン尿症の世界市場-2023年～2030年
出版日: 2023年09月27日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

概要

HCUは、ホモシステインの前駆体であるアミノ酸メチオニンの代謝不全により発症し、ホモシステインおよびその代謝産物が血液中および尿中に過剰に蓄積します。患者は、骨の異常、知的障害、致命的な血管閉塞を含む様々な症状を経験します。

代替療法はほとんどなく、多くの患者は厳しい制限食を守らなければなりません。ホモシスチン尿症に対する一般市民や専門家の意識の高まりは、市場を牽引する重要な要因の一つです。ホモシスチン尿症の症状に関する知識が深まり、診断検査が可能になったことで、早期かつ正確な診断が可能になっています。

数多くの国が、ホモシスチン尿症を含む多くの遺伝性疾患について乳児を検査する新生児スクリーニング・プログラムを実施しています。新生児スクリーニングによる早期発見により、疾病に迅速に介入・管理することができるため、治療成績が大幅に向上します。

ダイナミクス

研究活動の拡大

2023年5月、古典的ホモシスチン尿症（HCU）の治療薬として、全く新しい実験的酵素補充薬であるペグチバチナーゼが試験中であり、Travere Therapeutics, Inc.は、プラセボ対照第1/2相COMPOSE試験のコホート6から有望な結果を発表しました。このコホートでは、5人の患者のうち4人が治療群に割り付けられ、盲検下無作為化において、凍結乾燥ペグチバチナーゼ2.5mg/kgまたはプラセボを週2回（BIW）投与されました。

ベースラインからの総ホモシステイン（tHcy）の平均相対減少率は67.1％であり、6～12週にわたって平均tHcyが臨床的に有意な閾値である100M以下に維持されたことが、この最高用量コホートにおけるペグチバチナーゼ治療の効果でした。ペグチバチナーゼの忍容性は、これまでのところ一般的に良好です。

治療選択肢の増加

ピリドキシン応答性患者の治療には、医薬用量のピリドキシン、ビタミンD、葉酸とビタミンB12の追加補充が用いられます。100種類以上の酵素がビタミンB6（ピリドキシン）に依存しており、ビタミンB6はタンパク質や脂肪を含む多くの代謝経路にも関与しています。補酵素とは、重要な機能を担う体内酵素の「助っ人分子」の一種です。

このビタミンは、赤血球の色素であるヘモグロビン、免疫系、脳システムの発達に必要です。ピリドキシン塩酸塩またはピリドキサールリン酸塩（PLP）は、通常、栄養補助食品に含まれています。ピリドキシン（ビタミンB6）は通常、水に溶けやすい白色の結晶性化合物ピリドキシン塩酸塩（C8H12ClNO3）として医薬品に含まれています。プロドラッグのピリドキシンは、体内で活性型PLPに生体内変換されます。

古典的ホモシスチン尿症への注目の高まり

古典的ホモシスチン尿症（HCU）は、世界的に出生20万～33万5,000人に1人の割合で発症する重篤な希少遺伝病で、主にシスタチオニン合成酵素（CBS）遺伝子の変異によって発症します。メチオニン（Met）代謝の製品別であるホモシステイン（Hcy）は、CBSが機能していないとシスタチオニンに変換されません。

循環中の遊離Hcyと血清蛋白に結合したHcyの両方からなる総Hcy（tHcy）は、CBS欠損の存在下では高値であり、おそらく危険です。正常なtHcy値は15M以下ですが、未治療患者ではtHcy値が100Mを超えることが多いです。患者はまた、メチオニンのリサイクル経路がMetとHcyを相互変換する結果、Met値が高くなることがあります。HCU患者は、ヒトの正常血中濃度であるMet濃度が高い可能性がありますが、高メチオニン血症はMet濃度が1000M以下であれば良性であると考えられています。

高い開発コスト

新規薬剤を開発する場合、病気の原因や将来の標的を理解するために多大な研究が必要です。治療戦略を確認するためには、実験室や動物での前臨床試験が必要です。新しい治療法の有効性と安全性をヒトで評価するには、臨床試験が重要です。臨床試験にはいくつかの段階があり、それぞれに多額の費用がかかります。希少疾患は患者数が少ないため、募集期間を長くする必要があります。

FDAやEMAのような保健当局が課す規制基準を満たすためには、膨大な文書化、試験、コンプライアンス作業が必要であり、これらすべてが費用を増大させます。医薬品を高い品質レベルで、一貫して、法律に従って製造するためには、複雑な製造手順と品質管理技術が必要となります。

患者数の少なさ

ホモシスチン尿症は珍しい疾患であり、患者数が少ないことが多いです。罹患者数が少ないことは困難なことが、同時に製薬企業や医療提供者にとっても特別な問題を提起しています。この病気は希少であるため、臨床試験に十分な数の患者を登録することが困難です。

そのため、試験スケジュールの延長や開発プロセスの遅延を引き起こす可能性があります。限られた患者集団から統計的に意味のあるデータを得ることは困難であり、臨床試験の結果の信頼性や結果を一般化する能力に影響を与えます。ホモシスチン尿症は稀な疾患であるため、医療従事者はホモシスチン尿症の認識や治療に関する経験や知識が不足している可能性があります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 治療選択肢の増加
      • 治療の選択肢の増加
      • 古典的ホモシスチン尿症への注目の高まり
      • 認識と教育
    • 抑制要因
      • 高い開発コスト
      • 患者数の少なさ
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析
  • ロシア・ウクライナ戦争の影響分析
  • DMIの見解

第6章 COVID-19分析

第7章 治療薬別

  • ピリドキシン
  • ベタイン
  • 葉酸
  • コバラミン

第8章 形状別

  • 錠剤
  • 懸濁液
  • 錠剤
  • カプセル

第9章 投与経路別

  • 経口
  • 非経口

第10章 流通チャネル別

  • 病院薬局
  • 小売薬局
  • オンライン薬局

第11章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋
  • 中東・アフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • Travere Therapeutics
    • 企業概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な動向
  • Aeglea BioTherapeutics
  • Ginkgo Bioworks
  • Cosette Pharmaceuticals, Inc.
  • Eton Pharmaceuticals, Inc.
  • Others

第14章 付録

目次
Product Code: PH6874

Overview

Homocysteine and its metabolites accumulate excessively in a person's blood and urine as a result of HCU, which is caused by an inability to metabolize the amino acid methionine, a precursor to homocysteine. Patients experience a variety of symptoms, including bone abnormalities, intellectual impairments, and potentially fatal blood vessel obstructions.

Few therapeutic alternatives are available, and many patients must adhere to rigorous, restrictive diets. Increased public and professional awareness of homocystinuria is one of the key factors driving the market. Early and accurate diagnosis have been made possible by better knowledge of the symptoms of the condition and the availability of diagnostic testing.

Numerous nations have put in place newborn screening programs that examine infants for a number of hereditary diseases, including homocystinuria. The ability to quickly intervene and control the disease due to early discovery through neonatal screening can considerably enhance results.

Dynamics

Increasing Research Activities

In May 2023, Pegtibatinase, a brand-new experimental enzyme replacement medication, is being tested for the treatment of classical homocystinuria (HCU), and Travere Therapeutics, Inc. has published encouraging results from cohort 6 in the placebo-controlled Phase 1/2 COMPOSE Study. Four of the five patients in this cohort were assigned to the treatment group, which received 2.5 mg/kg of lyophilized pegtibatinase or a placebo twice weekly (BIW) in a blinded randomization.

A 67.1% mean relative decrease in total homocysteine (tHcy) from baseline and the maintenance of mean tHcy below the clinically significant threshold of 100 M over weeks 6 to 12 were the effects of pegtibatinase treatment in this highest dose cohort to date. Pegtibatinase has so far been generally well tolerated in the trial.

The Increasing Treatment Options

Pharmaceutical doses of pyridoxine, vitamin D, and extra folic acid and vitamin B12 supplementation are used to treat pyridoxine-responsive patients. More than 100 enzymes rely on vitamin B6 (pyridoxine), which is also involved in numerous metabolic pathways involving protein and fat. A cofactor is a type of "helper molecule" for our body's enzymes, which are in charge of critical functions.

The vitamin is necessary for the development of hemoglobin, the pigment of red blood cells, the immune system, and the brain system. The so-called pyridoxine hydrochloride or the pyridoxal phosphate (PLP) in its already-active state is typically present in dietary supplements. Pyridoxine, or vitamin B6, is typically found in medications as the white, crystalline compound pyridoxine hydrochloride (C8H12ClNO3), which is easily soluble in water. The prodrug pyridoxine is biotransformed in the body into the active PLP.

Increasing Focus Towards Classical Homocystinuria

Classical homocystinuria (HCU), a severe rare genetic condition that affects 1 in 200,000 to 335,00 births globally, is primarily brought on by mutations in the cystathionine-synthetase (CBS) gene. Homocysteine (Hcy), a byproduct of methionine (Met) metabolism, cannot be transformed into cystathionine in the absence of a functional CBS.

Total Hcy (tHcy), which comprises both circulating free Hcy and Hcy bound to serum proteins, is high and possibly hazardous in the presence of CBS deficiency; normal tHcy levels are below 15 M, whereas untreated patients frequently have tHcy values above 100 M. Patients may also have higher Met levels as a result of the methionine recycling pathway's interconversion of Met and Hcy. Although HCU patients may have elevated levels of Met, which is the normal human blood concentration, hypermethioninemia is thought to be benign at Met levels under 1000 M.

High Development Cost

Understanding the illness causes and prospective targets requires substantial research when developing a novel medication. To confirm the treatment strategy, preclinical testing in labs and on animals is required. To evaluate a new treatment's efficacy and safety in humans, clinical trials are crucial. There are several stages to these trials, and each one costs a lot of money. Due of the small patient populations, rare diseases may necessitate longer recruitment periods.

It takes significant documentation, testing, and compliance work to meet the regulatory criteria imposed by health authorities like the FDA or EMA, all of which add to expenses. Complex manufacturing procedures and quality control techniques are needed to produce medications at a high quality level, consistently, and in accordance with laws.

Small Patient Population

Homocystinuria is an uncommon disease that frequently has a tiny patient population. The small number of affected people provides difficulties, but it also raises special issues for pharmaceutical firms and healthcare providers. The rarity of the illness makes it challenging to enroll a sufficient number of individuals in clinical studies.

This may cause trial schedule extensions and development process delays. It can be difficult to get statistically meaningful data from a limited patient population, which has an impact on the reliability of clinical trial outcomes and the capacity to generalize results. Healthcare practitioners could lack experience and knowledge in recognizing and treating homocystinuria due to the disease's rarity.

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Segment Analysis

The global homocystinuria market is segmented based on drug treatment, form, route of administration, distribution channel and region.

Betaine accounts for largest market share during the forecast period

Oral betaine (N, N, N-trimethylglycine) is administered as a methyl donor to provide an additional channel for the remethylation of Hcy to methionine catalyzed by betaine-homocysteine methyl transferase if the tHCy target cannot be achieved with pyridoxine alone.

Due to this, the amount utilized (which in adults may be higher than the UK-licensed dose of 3 g twice daily) is the highest that allows for the maintenance of methionine at less than 1000 mol/L. A combination of pyridoxine and betaine alone can frequently provide appropriate and secure treatment for patients who are only partially responsive to pyridoxine.

Geographical Penetration

Infrastructure Development, Urbanization and Construction Projects

North America has been a dominant force in the global homocystinuria market. In order to cure homocystinuria, blood homocysteine levels must be kept under control. Taking a vitamin B6 supplement is typically part of the treatment. If one has classical homocystinuria that responds to vitamin B6, vitamin B6 administration can be sufficient to lower and regulate homocysteine levels.

In addition, in March 2023, in a contract with ANI Pharmaceuticals, Inc., Cosette Pharmaceuticals, Inc. acquired the US marketing rights to Betaine Anhydrous for Oral Solution 180gm ("Betaine") and started distributing to clients in March month.

Patients with homocystinuria, a rare genetic disorder in which the body accumulates too much homocysteine, utilize betaine. With this launch, a safe, effective, and easily accessible treatment alternative will be made available to patients with homocystinuria and the healthcare professionals who are providing care to those patients.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global Homocystinuria market. Due to lockdowns, the worry of virus transmission, and the diversion of resources, access to healthcare facilities was restricted during the pandemic. This might have delayed the diagnosis and start of treatment for those with homocystinuria. As the number of in-person visits decreased, telemedicine and virtual consultations became more popular.

Despite the fact that telemedicine made it easier to maintain continuity of care, it might not entirely replace the requirement for thorough in-person examinations, particularly for rare disorders. Due to difficulties in patient recruitment, site closures, and the redirection of resources into COVID-19 research, several clinical studies were postponed, stopped, or delayed. Data collection and trial progress were hindered by travel restrictions, limited access to healthcare institutions, and patient safety concerns.

Russia-Ukraine War Impact Analysis

The ability to provide medical care, diagnoses, and treatments including those for rare disorders like homocystinuria may be harmed or destroyed as a result of the conflict. The availability of specialized treatments for uncommon diseases may be impacted if healthcare resources are diverted to urgent care and emergency situations.

Homocystinuria sufferers may have trouble accessing healthcare because to their dislocation, a lack of resources, and interruptions in their continuity of care. Conflict-related disruptions may have an impact on efforts to discover novel therapies for rare diseases like homocystinuria.

By Drug Treatment

  • Pyridoxine
  • Betaine
  • Folate
  • Cobalamin

By Form

  • Tablets
  • Suspension
  • Pills
  • Capsules

By Route of Administration

  • Oral
  • Parenteral

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Key Developments

  • In May 2023, Eton Pharmaceuticals, Inc, a pharmaceutical company engaged in developing and commercializing treatments for rare diseases, reported the commercial availability of Betaine Anhydrous for Oral Solution 180 grams for the treatment of homocystinuria.

Competitive Landscape

The major global players in the market include Travere Therapeutics, Aeglea BioTherapeutics, Ginkgo Bioworks, Cosette Pharmaceuticals, Inc., Eton Pharmaceuticals, Inc., and Others.

Why Purchase the Report?

  • To visualize the global homocystinuria market segmentation based on drug treatment, form, route of administration, distribution channel and region as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of homocystinuria market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.

The global homocystinuria market report would provide approximately 64 tables, 57 figures and 186 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Drug Treatment
  • 3.2. Snippet by Form
  • 3.3. Snippet by Route of Administration
  • 3.4. Snippet by Distribution Channel
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. The Increasing Treatment Options
      • 4.1.1.2. The Increasing Treatment Options
      • 4.1.1.3. Increasing Focus Towards Classical Homocystinuria
      • 4.1.1.4. Awareness and Education
    • 4.1.2. Restraints
      • 4.1.2.1. High Development Cost
      • 4.1.2.2. Small Patient Population
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Russia-Ukraine War Impact Analysis
  • 5.6. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Drug Treatment

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 7.1.2. Market Attractiveness Index, By Drug Treatment
  • 7.2. Pyridoxine*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Betaine
  • 7.4. Folate
  • 7.5. Cobalamin

8. By Form

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 8.1.2. Market Attractiveness Index, By Form
  • 8.2. Tablets*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Suspension
  • 8.4. Pills
  • 8.5. Capsules

9. By Route of Administration

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.1.2. Market Attractiveness Index, By Route of Administration
  • 9.2. Oral*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Parenteral

10. By Distribution Channel

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.1.2. Market Attractiveness Index, By Distribution Channel
  • 10.2. Hospital Pharmacies*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Retail Pharmacies
  • 10.4. Online Pharmacies

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.7.1. U.S.
      • 11.2.7.2. Canada
      • 11.2.7.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.7.1. Germany
      • 11.3.7.2. UK
      • 11.3.7.3. France
      • 11.3.7.4. Italy
      • 11.3.7.5. Spain
      • 11.3.7.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan
      • 11.5.7.4. Australia
      • 11.5.7.5. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Treatment
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Form
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Travere Therapeutics*
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Aeglea BioTherapeutics
  • 13.3. Ginkgo Bioworks
  • 13.4. Cosette Pharmaceuticals, Inc.
  • 13.5. Eton Pharmaceuticals, Inc.
  • 13.6. Others

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us