遺伝子治療のインド市場の評価：タイプ別、ベクター別、遺伝子デリバリー方法別、用途別、投与経路別、エンドユーザー別、地域別、機会、予測（2018年度～2032年度）

インドの遺伝子治療の市場規模は、2025年度の6,925万米ドルから2032年度に4億9,259万米ドルに達すると予測され、2025年度～2032年度の予測期間にCAGRで32.35％の成長が見込まれます。市場の成長を支えているのは、バイオテックスタートアップへの投資の増加、規制当局による承認や特許供与の増加、遺伝性疾患の脅威の増大、産学連携の増加などです。遺伝子治療の人気の高まりは、以前は不治の病とされていた幅広い疾患に対する治療の提供によるものと考えられます。

国内におけるさまざまな遺伝子治療の普及に向けた取り組みの活発化も、市場の拡大にプラスの影響を与えています。2024年2月、Christian Medical College（CMC）Velloreで、血友病Aに対する遺伝子治療の初のヒト臨床試験が実施されました。この臨床試験では、患者の造血幹細胞にFVIII導入遺伝子を発現させる新技術が展開されました。バイオテクノロジー庁は、このベクターがさらに臨床試験を進め、まもなくインドで製造されることを期待しています。

さらに、同国の研究活動により、さまざまな遺伝子治療の利用可能性が増大することも予測されています。2024年6月、Union Tribal Affairs Ministryの職員は、指定の部族の間で非常に流行している遺伝性血液疾患である鎌状赤血球症の効果的な遺伝子治療の開発に国が近づいていると発表しました。Lancetで公開された論文によると、インドではヘモグロビンS変異児の出生率が3番目に高いです。また、ヘモグロビンS対立遺伝子の頻度も世界でもっとも高いです。そのため、この病気を治療および管理する効果的な治療法へのニーズが高まっています。このような発展と政府の活動により、鎌状赤血球症の患者が効果的な治療法を受け、疾患に対抗することができるようになると予測されます。

当レポートでは、インドの遺伝子治療市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢などを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 インドの遺伝子治療市場の見通し（2018年度～2032年度）

• 市場規模の分析と予測
  • 金額
  • 数量
• 市場シェアの分析と予測
  • タイプ別
  • ベクター別
  • 遺伝子デリバリー方法別
  • 用途別
  • 投与経路別
  • エンドユーザー別
  • 地域別
  • 市場シェア分析：企業別（金額）（主要企業とその他 - 2024年度）
• 市場マップ分析（2024年度）
  • タイプ別
  • ベクター別
  • 遺伝子デリバリー方法別
  • 用途別
  • 投与経路別
  • エンドユーザー別
  • 地域別

第5章 需給分析

第6章 輸入と輸出の分析

第7章 バリューチェーン分析

第8章 ポーターのファイブフォース分析

第9章 PESTLE分析

第10章 価格分析

第11章 市場力学

• 市場促進要因
• 市場の課題

第12章 市場の動向と発展

第13章 規制枠組みとイノベーション

• 臨床試験
• 規制当局の承認

第14章 特許情勢

第15章 ケーススタディ

第16章 競合情勢

• 主要マーケットリーダーの競合マトリクス
• 主要企業のSWOT分析
• 市場の主要企業の情勢
  • ImmunoACT
  • APAC Biotech Pvt. Ltd.
  • Stempeutics Research Pvt Ltd.
  • SEWON E&C CO., LTD.

第17章 戦略的推奨

第18章 当社について、免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. India Gene Therapy Market, By Value, In USD Million, FY2018-FY2032F
• Figure 2. India Gene Therapy Market, By Volume, In Thousand Therapies, FY2018-FY2032F
• Figure 3. India Gene Therapy Market Share (%), By Type, FY2018-FY2032F
• Figure 4. India Gene Therapy Market Share (%), By Vector, FY2018-FY2032F
• Figure 5. India Gene Therapy Market Share (%), By Gene Delivery Method, FY2018-FY2032F
• Figure 6. India Gene Therapy Market Share (%), By Application, FY2018-FY2032F
• Figure 7. India Gene Therapy Market Share (%), By Route of Administration, FY2018-FY2032F
• Figure 8. India Gene Therapy Market Share (%), By End-user, FY2018-FY2032F
• Figure 9. India Gene Therapy Market Share (%), By Region, FY2018-FY2032F
• Figure 10. By Type Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 11. By Vector Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 12. By Gene Delivery Method Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 13. By Application Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 14. By Route of Administration Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 15. By End-user Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 16. By Region Map-Market Size (USD Million) & Growth Rate (%), FY2024

India gene therapy market is projected to witness a CAGR of 32.35% during the forecast period FY2025-FY2032, growing from USD 69.25 million in FY2025 to USD 492.59 million in FY2032. The growth of the market is supported by rising investments towards biotech startups, increasing approvals and provision of patents by regulatory bodies, growing threat of genetic diseases, and increasing industry-academia collaborations. The growing popularity of gene therapy can be attributed to the provision of treatment for a broad range of previously deemed incurable diseases.

The increasing efforts to propel the availability of different gene therapies in the country also positively influence the market's expansion. In February 2024, the first human clinical trials for gene therapy for hemophilia A were conducted at Christian Medical College (CMC) Vellore. The trials included deploying a new technology for expressing FVIII transgene in the patient's hematopoietic stem cell. The Department of Biotechnology hopes the vector will proceed with further clinical trials and soon be manufactured in India.

Additionally, the country's research efforts are also expected to augment the availability of different gene therapies. In June 2024, officials of the Union Tribal Affairs Ministry announced that the country is getting closer to developing an effective gene therapy for sickle cell disease, a highly prevalent genetic blood disorder among the scheduled tribes. According to an article published in the Lancet, India has the third-highest birth rate for babies with hemoglobin S mutation. It is among the highest hemoglobin S allele frequencies across the globe. Thus, the country's need for effective therapies to treat and manage the condition is increasing. Such developments and government efforts are expected to allow the patient population living with sickle cell disease to receive effective therapeutic solutions and combat the disease.

Rising Number of Approvals Boost the Market

The rise in approvals for gene therapies from different regulatory bodies and the provision of patents are propelling the Indian gene therapy market size. In January 2024, Kolon Life Science, Inc. announced that their patent KLS-3021, recombinant vaccinia virus for anti-cancer gene therapy, and KLS-2031, treating and alleviating pain for neuropathic pain gene therapy, won registration in India. Such approvals can be attributed to the successful outcomes of different gene therapies in clinical trials and their promise of delivering more effective and targeted treatments, especially for patients with chronic and rare diseases for which effective treatment options remain unavailable. The innovative approach aids in treating various diseases by delivering functional genes in cells to replace defective or missing genes.

Additionally, due to the vast potential of gene therapy to provide a cure for a wide range of diseases and disorders, research activities to assess their functioning and evaluate their safety and efficacy are increasing, ensuring the availability of new therapies and supporting the India gene therapy market growth.

Increasing Collaborations Support Market Expansion

The increasing collaborations between leading biotech companies and research institutions in the country are expected to bolster the India gene therapy market. In July 2024, Miltenyi Biotec B.V. & Co. KG and Translational Health Science and Technology Institute (THSTI) announced a partnership for exploring gene and cell therapies for cancer treatment. Through collaboration, both organizations aim to address the increasing requirements for innovative cancer therapies and sickle cell disease. Such partnerships are expected to bolster the development and availability of novel therapeutic solutions to meet the unmet demands of patients in arenas where conventional treatment solutions have fallen short.

Due to the broader economic and societal impact of different chronic diseases that are devoid of affordable and effective treatment solutions, research activities towards gene therapies are increasing to address the underlying cause of chronic disease and halt its progression.

Increasing Investments Bolster Market Growth

The rising investments in the development and availability of gene therapies in India are expected to provide lucrative growth opportunities to the market. These therapies can potentially treat inherited disorders and often require a course for a short period or a single dose administration and address the cause of the disease, often providing a cure. Thus, various biotech startups are increasingly focusing on developing gene therapies, including CAR-T, and are receiving more investments from major healthcare and pharmaceutical companies, augmenting the growth of the India gene therapy market. The enhanced funding opportunities and strategic partnerships allow biotech startups to focus on strengthening their in-house research and development capabilities for potential gene therapies. The potential gene therapies and their affordability for patients in India are expected to significantly impact the treatment of previously incurable diseases, including lymphoma and blood cancer, among others.

Oncological Diseases Account for Major Market Share

The growing threat of cancer in the country is propelling the India gene therapy market demand. According to estimates from the National Centre for Disease Informatics and Research (NCDIR), the estimated number of new cancer cases in the country in 2022 was 1,461,427. About one in nine individuals in the country are expected to receive a diagnosis of cancer during their lifetime. This increase is augmenting the requirement for effective treatment alternatives for cancer and bolstering investments toward developing gene therapies that aid in combating oncological diseases. Gene therapy prevents cancer growth by controlling genetic mutations or altered genes. This approach is known as somatic gene therapy and uses the cells and genes of the patients. It does not impact the germ-line cells in the reproductive system, ensuring that no genetic alterations are passed on to the next generation.

Future Market Scenario (FY2025-FY2032F)

As per the India gene therapy market analysis, the market is expected to witness significant growth in the coming years due to the increasing investments in the development of gene therapies and increasing industry-academia collaborations.

The escalating cases of chronic diseases are driving the need for effective therapeutic solutions in India, creating a pressing demand for gene therapy. The estimates and projections from the National Cancer Registry Program further underline this urgency, with the incidence of cancer cases expected to surge by 12.8% in 2025 compared to 2020.

Streamlining of regulatory processes is expected to encourage industry and investigators to initiate more clinical trials for gene therapies in the country without sacrificing rigor. Additionally, the increasing awareness about the current developments in gene therapies is expected to bridge the information gap between government-sponsored organizations, patients, scientists, and clinicians and ensure the availability of effective treatments for patients with genetic disorders.

Key Players Landscape and Outlook

The increasing efforts of the market players to launch affordable and accessible gene therapies in the country in collaboration with leading research and educational institutions are bolstering the growth of the Indian gene therapy market. In April 2024, the first home-grown gene therapy was launched in India, and it is a major breakthrough in aiding the country in battling cancer. The country's first CAR-T cell therapy was developed with a collaboration between ImmunoACT, the Indian Institute of Technology, Bombay, and Tata Memorial Hospital and is expected to inspire similar industry-academia partnerships. Such collaborations are also expected to boost the availability and accessibility of different gene therapies in India and allow the country to battle prevalent diseases that lack effective treatment solutions.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. India Gene Therapy Market Outlook, FY2018-FY2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Type
    • 4.2.1.1. Gene Augmentation
    • 4.2.1.2. Gene Silencing
    • 4.2.1.3. Others
  • 4.2.2. By Vector
    • 4.2.2.1. Viral Vectors
    • 4.2.2.2. Non-Viral Vectors
  • 4.2.3. By Gene Delivery Method
    • 4.2.3.1. In vivo
    • 4.2.3.2. Ex vivo
  • 4.2.4. By Application
    • 4.2.4.1. Oncological Diseases
    • 4.2.4.2. Genetic Diseases
    • 4.2.4.3. Cardiovascular Diseases
    • 4.2.4.4. Neuromuscular Diseases
    • 4.2.4.5. Hematological Diseases
    • 4.2.4.6. Infectious Diseases
    • 4.2.4.7. Others
  • 4.2.5. By Route of Administration
    • 4.2.5.1. Intravenous
    • 4.2.5.2. Others
  • 4.2.6. By End-user
    • 4.2.6.1. Hospitals
    • 4.2.6.2. Cancer and Research Institutes
    • 4.2.6.3. Clinics
    • 4.2.6.4. Others
  • 4.2.7. By Region
    • 4.2.7.1. North
    • 4.2.7.2. East
    • 4.2.7.3. West and Central
    • 4.2.7.4. South
  • 4.2.8. By Company Market Share Analysis (Top Companies and Others - By Value, FY2024)
• 4.3. Market Map Analysis, FY2024
  • 4.3.1. By Type
  • 4.3.2. By Vector
  • 4.3.3. By Gene Delivery Method
  • 4.3.4. By Application
  • 4.3.5. By Route of Administration
  • 4.3.6. By End-user
  • 4.3.7. By Region

5. Demand Supply Analysis

6. Import and Export Analysis

7. Value Chain Analysis

8. Porter's Five Forces Analysis

9. PESTLE Analysis

10. Pricing Analysis

11. Market Dynamics

• 11.1. Market Drivers
• 11.2. Market Challenges

12. Market Trends and Developments

13. Regulatory Framework and Innovation

• 13.1. Clinical Trials
• 13.2. Regulatory Approvals

14. Patent Landscape

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top Market Leaders
• 16.2. SWOT Analysis for Top Players
• 16.3. Key Players Landscape for Top Market Players
  • 16.3.1. ImmunoACT
    • 16.3.1.1. Company Details
    • 16.3.1.2. Key Management Personnel
    • 16.3.1.3. Products and Services
    • 16.3.1.4. Financials (As Reported)
    • 16.3.1.5. Key Market Focus and Geographical Presence
    • 16.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 16.3.2. APAC Biotech Pvt. Ltd.
  • 16.3.3. Stempeutics Research Pvt Ltd.
  • 16.3.4. SEWON E&C CO., LTD.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

17. Strategic Recommendations

18. About Us and Disclaimer