BCG結核ワクチンの世界市場規模：タイプ別、用途別、エンドユーザー別、地域範囲別、予測

BCG結核ワクチンの市場規模および予測

BCG結核（TB）ワクチンの市場規模は、2024年には5,349万米ドルとなり、2026～2032年にはCAGR 3.90%で成長し、2032年には7,264万米ドルに達すると予測されます。

• BCG（バチルス・カルメット・ゲリン）ワクチンは、主に結核の治療に使用されます。これは、結核を引き起こす結核菌に似た微生物であるマイコバクテリウム・ボビスの弱毒株です。
• このワクチンは、特に結核のリスクが高い乳児に、出産後すぐに接種されます。BCGワクチンは免疫学的反応を刺激し、致命的なタイプの結核から乳幼児を守る。また、膀胱がんの治療にも用いられます。

世界のBCG結核ワクチン市場力学

BCG結核ワクチン市場を形成している主な市場力学は以下の通りです。

主な市場促進要因

• 世界の結核罹患率の高さ：世界的に高い結核罹患率が続いていることは、BCGワクチン接種ビジネスの主要な促進要因です。世界保健機関（WHO）の「世界結核レポート2023」によると、2022年に結核に罹患した人は推定1,060万人で、うち130万人が小児です。この分析によると、結核は依然として世界最悪の感染症のひとつであり、2022年には130万人が死亡しています。この大きな疾病負担は、効果的な結核予防活動、特にBCGワクチン接種の継続的な必要性を浮き彫りにしています。
• 政府の取り組みと資金の増加：結核対策に対する政府の支援と資金調達の増加は、BCGワクチン市場を後押ししています。Stop TB Partnershipによると、2022年の世界の結核資金調達額は58億米ドルに達し、これまで報告された中で最高水準でした。しかし、これは「結核撲滅世界計画2018-2022」が示す2022年までに必要な年間支出130億米ドルには満たないです。結核撲滅に重点が置かれるようになったことで、予防接種の取り組みへの支出が強化されると予想されます。
• 新興諸国における意識の高まりと予防接種プログラムの拡大：特に結核罹患率の高い新興諸国における予防接種プログラムの拡大が、BCGワクチンの需要を押し上げています。ユニセフによると、世界のBCGワクチン接種率は2000年の85%から2019年には88%に増加しています。結核が流行している東南アジアでは、BCG接種率は2019年に95％に達しました。このような高負担地域におけるカバー率の拡大傾向は今後も続くと予測され、その結果、市場の成長が見込まれます。

主な課題

• BCGワクチン使用に伴う副作用：BCGワクチンには、リンパ節の腫れ、高熱、注射部位の皮膚感染などの副作用があります。まれではあるが、こうした副作用はワクチン接種の受け入れと市場成長の妨げとなっています。慎重なモニタリングと副作用のコントロールが不可欠です。
• BCGワクチンの有効性に関する懸念：BCGワクチンには、新たに出現した結核菌に対する予防効果に疑問があります。このような新型株に対してワクチン接種が無効であれば、需要が減少し、市場の成長が鈍化します。BCGワクチンの有効性を維持するためには、継続的な調査と改良が必要です。
• 供給不足：BCGワクチンの不足は市場拡大を制限します。サプライチェーンの問題、製造上の課題、または生産不足が供給不足を引き起こし、特に高負担国においてワクチンの入手が制限されます。世界の需要を満たし、結核を減らすには、十分かつ安定した供給が必要です。

主要動向：

• 高い結核罹患率による世界の需要の増加：結核の世界の蔓延は、特に低開発国において、依然として公衆衛生上の大きな懸念となっています。世界保健機関（WHO）は、毎年数百万人が新たに結核に感染すると予測しており、BCGワクチンの需要を煽っています。各国政府は結核対策の重要性を認識し、予防接種キャンペーンを開始し、ヘルスケア施設への投資を進めています。
• 小児予防接種プログラムへの注目：小児期の予防接種プログラムは、特に結核の有病率が高い地域ではますます重要になってきています。政府および保健機関は、結核性髄膜炎などの重篤な結核を予防するため、新生児へのワクチン接種を優先しています。この傾向は、結核予防の意識向上に焦点を当てた国際的なプログラムやキャンペーンによって強化され、BCGワクチンへの需要を高めています。
• 新規ワクチン候補の出現：組換えBCGワクチンやサブユニットワクチンなど、新しく改良された結核ワクチンが現在開発中です。これらの候補は、現行のBCGワクチンの限界を克服し、さまざまな結核株に対する有効性を向上させようとしています。これらの新規ワクチンの上市が見込まれることで、市場環境が破壊され、臨床試験や規制当局の承認が進むにつれて、将来の成長が促進されると予測されます。

目次

第1章 BCG結核（TB）ワクチンの世界市場導入

• 市場の導入
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 BCG結核ワクチンの世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 BCG結核ワクチンの世界市場：タイプ別

• 概要
• 免疫BCG
• 治療BCG

第6章 BCG結核ワクチンの世界市場：用途別

• 概要
• 小児
• 成人

第7章 BCG結核ワクチンの世界市場：エンドユーザー別

• 概要
• 病院
• 診療所

第8章 BCG結核ワクチンの世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東

第9章 世界の結核ワクチン市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第10章 企業プロファイル

• Merck
• Sanofi Pasteur
• Japan BCG Lab
• China National Biotec
• Serum Institute of India
• Intervax
• GSBPL

第11章 付録

• 関連調査

BCG Tuberculosis (TB) Vaccine Market Size and Forecast

BCG Tuberculosis (TB) Vaccine Market size was valued at USD 53.49 Million in 2024 and is projected to reach USD 72.64 Million by 2032, growing at a CAGR of 3.90% from 2026-2032.

• The BCG (Bacillus Calmette-Guerin) vaccine is primarily used to treat tuberculosis. It is a weakened strain of Mycobacterium bovis, a microbe similar to M. tuberculosis that causes tuberculosis.
• The vaccine is provided shortly after delivery, particularly to infants at high risk of tuberculosis. The BCG vaccine stimulates an immunological response, protecting babies and young children from deadly types of tuberculosis. It is also used to treat bladder cancer.

Global BCG Tuberculosis (TB) Vaccine Market Dynamics

The key market dynamics that are shaping the BCG Tuberculosis (TB) vaccine market include:

Key Market Drivers

• High Global Tuberculosis Burden: The persistently high worldwide tuberculosis load is a major driver of the BCG vaccination business. According to the World Health Organization's Global Tuberculosis Report 2023, an estimated 10.6 million individuals became ill with tuberculosis in 2022, including 1.3 million children. According to the analysis, tuberculosis remains one of the world's worst infectious diseases, accounting for 1.3 million fatalities in 2022. This significant disease burden highlights the ongoing need for effective tuberculosis prevention efforts, particularly BCG vaccination.
• Increasing Government Initiatives and Funding: Growing government support and financing for tuberculosis control initiatives is propelling the BCG vaccine market. According to the Stop TB Partnership, global TB financing reached $5.8 billion in 2022, the highest level reported to date. However, this falls short of the $13 billion yearly expenditure required by 2022, as indicated by the Global Plan to End Tuberculosis 2018-2022. The increased emphasis on tuberculosis elimination is anticipated to enhance expenditure on vaccination efforts.
• Rising Awareness and Expanding Immunization Programs in Developing Countries: Expanding immunization programs, particularly in developing countries with high tuberculosis burdens, are driving up demand for BCG vaccines. According to UNICEF, global BCG vaccine coverage has increased from 85% in 2000 to 88% in 2019. In South-East Asia, where tuberculosis is endemic, BCG coverage reached 95% in 2019. This trend of expanding coverage in high-burden areas is projected to continue, resulting in market growth.

Key Challenges:

• Side Effects Associated with the Use of BCG Vaccine: The BCG vaccine has side effects such as swollen lymph nodes, high fever, and skin infections at the injection site. Despite their rarity, these side effects hinder vaccination acceptance and market growth. Careful monitoring and control of any adverse effects is essential.
• Concerns Regarding the Efficacy of BCG Vaccines: There are questions regarding the BCG vaccine's effectiveness to protect against new tuberculosis strains that have appeared. If the vaccination is ineffective against these new strains, it diminishes demand and slows market growth. Ongoing research and improvement are required to ensure that the BCG vaccine stays effective.
• Shortage of Supply: A lack of BCG vaccines limits market expansion. Supply chain problems, manufacturing challenges, or underproduction cause shortages and restrict the availability of the vaccine, particularly in high-burden nations. Meeting global demand and reducing tuberculosis require an adequate and stable supply.

Key Trends:

• Increasing Global Demand Due to High TB Prevalence: The global prevalence of tuberculosis remains a major public health concern, particularly in underdeveloped nations. The World Health Organization (WHO) predicts millions of new tuberculosis infections each year, fueling demand for the BCG vaccine. As governments acknowledge the importance of combating tuberculosis, they are launching vaccination campaigns and investing in healthcare facilities, which are projected to considerably enhance market growth in the future years.
• Focus on Childhood Immunization Programs: Childhood immunization programs are becoming increasingly important, particularly in areas with high tuberculosis prevalence. Governments and health organizations are prioritizing neonatal vaccination to prevent serious types of tuberculosis, such as TB meningitis. This focus is reinforced by international programs and campaigns focused on raising awareness about tuberculosis prevention, which drives higher demand for the BCG vaccine.
• Emergence of Novel Vaccine Candidates: New and improved tuberculosis vaccines, such as recombinant BCG vaccines and subunit vaccinations, are now under development. These candidates seek to overcome the limitations of the current BCG vaccine and improve its efficacy against various tuberculosis strains. The prospective launch of these novel vaccines is projected to disrupt the market environment and drive future growth as they go through clinical trials and regulatory approval.

Global BCG Tuberculosis (TB) Vaccine Market Regional Analysis

Here is a more detailed regional analysis of the BCG Tuberculosis (TB) vaccine market:

Asia Pacific:

• According to Verified Market Research, the Asia Pacific region is estimated to dominate over the forecast period. The Asia Pacific area has a disproportionately high tuberculosis load, fueling up demand for BCG vaccines. According to the World Health Organization's Global Tuberculosis Report 2023, six of the eight countries responsible for two-thirds of global tuberculosis cases in 2022 were in Asia Pacific: India (27%), Indonesia (9.2%), China (7.4%), the Philippines (7%), Pakistan (5.7%), and Bangladesh (3.6%). This high disease load demands ongoing and extended immunization efforts in the region.
• BCG immunization is primarily targeted at the Asia Pacific region's huge and rising pediatric population. According to the United Nations Population Division, Asia is home to about half of the world's children, with a projected 1.2 billion under the age of 18 in 2020. According to UNICEF, India, which has the region's highest pediatric population, there were roughly 27 million births in 2022. The region's BCG vaccine demand is driven by its large and expanding pediatric population.
• Furthermore, many Asia Pacific countries are currently working to improve their healthcare infrastructure and increase immunization coverage. For example, according to WHO and UNICEF estimates of national vaccination coverage, BCG vaccine coverage in Southeast Asia increased from 87% in 2000 to 95% by 2022. Since 2000, BCG coverage in the Western Pacific region, which includes China and other East Asian countries, has generally been higher than 95%. This trend of upgrading healthcare systems and extending vaccination programs is a major driver of the BCG vaccine market in the region.

North America:

• North America is estimated to exhibit significant growth during the forecast period. North America, particularly the United States, sees a lot of immigration from countries with high tuberculosis rates, which drives up the demand for BCG immunization. According to the Centers for Disease Control and Prevention (CDC), 8,300 tuberculosis (TB) infections were reported in the United States in 2022. The CDC also states that foreign-born individuals account for the bulk of tuberculosis cases in the United States, with an incidence rate 14 times higher than that of U.S.-born people in 2022. This demographic pattern highlights the importance of BCG immunization in the region.
• Furthermore, the BCG vaccine is being utilized as an immunotherapy for bladder cancer, which is generating demand in North America. According to the American Cancer Society, approximately 82,290 new cases of bladder cancer (62,460 in men and 19,830 in women) are expected to be detected in the United States by 2023. The association also believes that bladder cancer is the fourth most frequent malignancy in men. The increasing prevalence of bladder cancer in North America has increased the need for the BCG vaccine as a therapy option.

Europe:

• Europe region is estimated to exhibit substantial growth during the forecast period. Europe has seen a considerable influx of immigrants from countries with high tuberculosis prevalence, pushing up demand for BCG vaccine. According to the European Centre for Disease Prevention and Control (ECDC), foreign-born people accounted for 29.4% of TB infections in the EU/EEA in 2019. Foreign-born cases ranged from 0% to 95.7% in reporting nations. This demographic transition has led to a greater emphasis on tuberculosis prevention techniques, such as BCG vaccination for high-risk groups.
• Furthermore, TB vaccine research and development in Europe is on the rise, with enhanced BCG formulations among the highlights. Between 2003 and 2020, the European & Developing Countries Clinical Trials Partnership (EDCTP) contributed more than €157 million in 52 grants for clinical research on tuberculosis vaccines. This investment comprises around 15% of EDCTP's total portfolio. The increased R&D focus is likely to stimulate innovation in the BCG vaccine industry and potentially broaden its applications.

BCG Tuberculosis (TB) Vaccine Market: Segmentation Analysis

The BCG Tuberculosis (TB) Vaccine Market is segmented based on Type, Application, End-User, and Geography.

BCG Tuberculosis (TB) Vaccine Market, By Type

• Immune BCG
• Therapy BCG

Based on Type, the market is segmented into Immune BCG and Therapy BCG. The immune BCG segment is estimated to dominate the BCG Tuberculosis (TB) vaccine market due to immune BCG's success in preventing tuberculosis, which has led to widespread acceptance and incorporation into national immunization programs around the world. The lack of alternative vaccinations for immune BCG has further strengthened its standing, as healthcare providers continue to rely on it for tuberculosis prevention.

BCG Tuberculosis (TB) Vaccine Market, By Application

• Pediatrics
• Adults

Based on Application, the market is segmented into Pediatrics and Adults. The pediatrics segment is estimated to dominate the BCG Tuberculosis (TB) vaccine market. BCG vaccination is primarily administered to infants and young children because it gives up to 80% protection against severe types of pediatric tuberculosis, such as TB meningitis. Children have a higher risk of contracting tuberculosis than adults. Continuous government measures for tuberculosis immunization in children are helping to drive the segment's growth.

BCG Tuberculosis (TB) Vaccine Market, By End-User

• Hospitals
• Clinics

Based on End-User, the BCG Tuberculosis (TB) vaccine market is divided into Hospitals and Clinics. According to VMR analyst, the hospital segment is estimated to dominate the market over the forecast period due to hospitals' extensive healthcare services, which include immunization programs for babies and at-risk groups. Hospitals are frequently equipped with the required infrastructure and skilled personnel to properly deliver the BCG vaccine, making them an ideal location for TB preventive initiatives. Furthermore, hospitals play an important role in handling tuberculosis patients, which helps to secure their market position.

BCG Tuberculosis (TB) Vaccine Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the BCG Tuberculosis (TB) vaccine market is classified into North America, Europe, Asia Pacific, and the Rest of the World. The Asia Pacific region is expected to dominate the market during the forecasted period. This domination is mostly due to the high incidence of tuberculosis in countries such as India and China, which account for a sizable proportion of worldwide TB cases. Government attempts to increase vaccine coverage, as well as raising knowledge about tuberculosis prevention, contribute to the region's strong market position. As a result, Asia Pacific is projected to continue to drive the BCG vaccination market.

Key Players

• The "BCG Tuberculosis (TB) Vaccine Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Merck, Sanofi Pasteur, Japan BCG Lab, China National Biotec, Serum Institute of India, Intervax, and GSBPL.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• BCG Tuberculosis (TB) Vaccine Market Recent Developments
• In July 2021, The New Jersey-based Hackensack Meridian Center for Discovery and Innovation (CDI) announced that it had received USD 6.4 million in funding from the National Institutes of Health to investigate a novel idea for a tuberculosis vaccine. The CDI team has suggested that BCG would be enhanced by designing it to promote B-cell proliferation and survival.
• In March 2022, The Serum Institute of India Pvt. Ltd. requested the Drugs Controller General of India, seeking the emergency usage of authorization for its recombinant BCG vaccination to combat tuberculosis. Throughout the projected period, the BCG vaccine market will benefit from the approval of this vaccine.
• In January 2023, The WHO intended to establish a new "TB Vaccine Accelerator Council". The committee will speed up the formation of a high-level coalition comprising international organizations, donors, end users, and governments to identify and address obstacles to the development of tuberculosis vaccines like BCG. It will also help authorize and implement innovative TB vaccines

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET

• 1.1 Introduction of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET, BY TYPE

• 5.1 Overview
• 5.2 Immune BCG
• 5.3 Therapy BCG

6 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Pediatrics
• 6.3 Adults

7 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET, BY END-USER

• 7.1 Overview
• 7.2 Hospitals
• 7.3 Clinics

8 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East

9 GLOBAL BCG TUBERCULOSIS (TB) VACCINE MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Merck
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Sanofi Pasteur
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Japan BCG Lab
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 China National Biotec
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Serum Institute of India
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Intervax
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 GSBPL
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments

11 Appendix

• 11.1 Related Research