バイオ医薬品産業の現状（2024年版）

COVID-19との闘いは遠い過去のことではありませんが、マクロ経済的および地政学的な要因によってすでに影が薄くなっています。同時に、進行中の薬価と償還の制約、規制当局からの圧力、バイオテクノロジー企業の資金調達の不安定性などが、今後数年間も製薬産業に試練を与える見込みです。

• COVID-19後の回復には、マクロ経済的および地政学的にさまざまな課題があります。
• ゲノミクス、IO医薬品開発、個別化/精密医療、CGTは、2024年にバイオ医薬品産業でもっともの影響力のある動向として優位に立ちます。
• もっとも影響のある動向の中では、細胞・遺伝子治療が2024年における重要な焦点となります。
• 地政学的紛争、インフレ、薬価の圧力が製薬部門の成長を抑制する最大の要因となります。
• 垂直統合、生物製剤の特許切れ、ESG要因が製薬産業に最大の好影響を与えると予測されます。
• ビッグデータとAIは、2024年も引き続き医療部門の変革力として優位に立ちます。
• 製薬バリューチェーンの構成要素全体では、医薬品開発とエンドユーザーエクスペリエンスがイノベーション採用で遅れをとっています。
• バイオ医薬品産業は、2023年と比べて今後1年間の産業の成長について楽観的ですが、楽観性のレベルはまだ2022年のレベルを下回っています。
• 調査回答者の44%は、2024年のバイオテクノロジーの資金調達の回復について楽観的または非常に楽観的な見方を示しました。
• 2023年に臨床試験が開始される分野は、がん、中枢神経系、感染症が中心です。
• 2024年に向け、依然としてがんが最大の治療領域となっていますが、代謝性疾患がもっとも高い伸びを示します。
• IRAは、すべての医薬品で政府の価格交渉への扉を開くと考えられています。

主なハイライト

• 2024年に安定性を増す見込みですが、道のりはまだ険しいです。
• CGTは2024年も引き続き、医薬品産業にもっとも大きな影響を与える動向です。
• インフレ、地政学的紛争、薬価および償還関連の懸念が産業成長の抑制要因となります。
• 垂直統合、生物製剤の特許切れ、ESG要因が産業にもっとも有利な影響を与えます。
• AIが製薬産業に破壊的変化をもたらす見込みです。
• 製薬部門の成長見通しに対する楽観性は、2023年の最低水準から回復しました。

目次

第1章 エグゼクティブサマリー

第2章 研究デザイン

第3章 新たな産業動向

第4章 新たな規制とマクロ経済動向

第5章 新技術

第6章 産業の成長見通し

第7章 注意

第8章 主な調査結果のサマリー

第9章 付録

第10章 著者、寄稿者

第11章 Thematic Researchの調査手法

第12章 連絡先

List of Tables

List of Tables

• Table 1: First-in-class personalized medicine drugs launching in 2024 for oncology indications
• Table 2a: Use of digital/connected devices among patients
• Table 2b: Agreement level with digital/connected devices ability to improve health management
• Table 3: Percentage of patients who agreed or strongly agreed with different statements
• Table 4: AI can be used across the entire pharma value chain
• Table 5: Inflation Reduction Act
• Table 6: Products selected for Medicare price negotiation
• Table 7: Drug Launches - 2024
• Table 8: Abbreviations
• Table 9: Abbreviations
• Table 10: Related reports

List of Figures

List of Figures

• Figure 1: Respondent Mix - Geography
• Figure 2a: Respondent Mix - Seniority Level
• Figure 2b: Respondent Mix - Company size
• Figure 3: Respondent Mix - Headquarter locations
• Figure 4: Top emerging pharmaceutical industry trend for 2024
• Figure 5: The importance of industry trends: 2023 versus 2024
• Figure 6: The most impactful industry trends by region
• Figure 7: The most impactful industry trends by region
• Figure 8: Trend having the greatest impact on the pharmaceutical industry in 2024
• Figure 9: CGT Market Value by Indication 2022-2029
• Figure 10: Number of RWE Trials by Sponsor Type and Year
• Figure 11a: mRNA Vaccines in Oncology by Trial Phases
• Figure 11b: mRNA Vaccines in Oncology - Company vs Instituion
• Figure 12a: mRNA Vaccines for Infectious Diseases by Trial Phases
• Figure 12b: mRNA Vaccines for Infectious Diseases - Company vs Instituion
• Figure 13a: Development of ICIs
• Figure 13b: Development of CART-T Therapies
• Figure 14: International Reference Pricing Policy Changes Influenced by Drug Shortages
• Figure 15: DTx in Europe - Number of Products Reimbursed per Market
• Figure 16a: Microbiome Agents in Development in Different Therapy Areas
• Figure 16b: Percentage of Microbiome Agents in Development for Different Indications in Infectious Diseases
• Figure 16c: Percentage of Microbiome Agents in Development for Different Gastrointestinal Indications
• Figure 16d: Number of Clinical Trials Initiated per Year with Microbiome-Targeting Therapeutics
• Figure 17: Most Commonly Used Component in DCTs
• Figure 18: Percentage of Clinical Trials Using Decentralized/Virtual Clinical Trial Components
• Figure 19: Emerging Regulatory and Macroeconomic Trends Expected to Have Positive and Negative Impact on Pharmaceutical Industry in 2024
• Figure 20: Emerging Regulatory and Macroeconomic Trends - High Positive Score vs Low Negative Score
• Figure 21: Pharmaceutical Price Trends, 2018-2022
• Figure 22: Number of 2023 Risk Events with a Positive or Negative Impact on Market Access
• Figure 23a: Annual Company Reports with Inflation Mentions
• Figure 23b: Annual Company Reports with Recession Mentions
• Figure 24: Geopolitical Conflicts Expected to bring Negative Impact on Pharmaceutical Industry in 2024
• Figure 25a: Crohn's Disease: Biosimilar Sales Forcast, 8MM, 2022-2032
• Figure 25b: Crohn's Disease: Average Biosimilar Prescription, 8MM, 2022-2032
• Figure 26: Number of New COVID-19 Clinical Trials by Year
• Figure 27: Emerging Regulatory and Macroeconomic Trends - Greatest Positive Score vs Greatest Negative Score
• Figure 28: Top Positive Emerging Regulatory and Macroeconomic trends by Geography
• Figure 29: Emerging Regulatory and Macroeconomic Trends - High Positive Scores vs Low Negative Scores, 2022 vs 2023
• Figure 30: Anticipated Impact of Emerging Technologies on the Pharmaceutical Industry in 2024
• Figure 31: Top 5 Most Impactful Emerging Technologies 2020-2024
• Figure 32: Value Chain Components Lagging Behind the Most with the Adoption of Innovations
• Figure 33: Increase in Investment in Emerging Technologies Due to Inflation
• Figure 34: Decrease in Investment in Emerging Technologies Due to Inflation
• Figure 35: Emerging Technologies Expected to Have the Greatest Impact on the Pharmaceutical Industry in 2024
• Figure 36: Top 6 Emerging Technologies Expected to Have the Greatest Impact on the Pharmaceutical Industry 2020-2024
• Figure 37a: Optimism on Industry's Growth during the Next 12 Months
• Figure 37b: Optimism on Industry's Growth during the Next 12 Months, by Geography
• Figure 38: Optimism on Industry's Growth during the Next 12 Months, 2020-2024
• Figure 39a: Most Disruptive Technologies in the Next Two Years
• Figure 39b: Most Disruptive Technologies in the Next Two Years, 2019-2022
• Figure 40a-h: Top Technologies Best Positioned to Improve Processes within Pharmaceutical Value Chain
• Figure 41a: GlobalData's US Market Outlook in Obesity: GLP-1 RA Class, 2021
• Figure 41b: GlobalData's US Market Outlook in Obesity: GLP-1 RA Class, 2031
• Figure 42: IRA's Impact on the Biopharmaceutical Industry
• Figure 43a: Optimism regarding the biotech funding recovery in the next 12 months
• Figure 43b: Optimism regarding the biotech funding recovery in the next 12 months, by geography
• Figure 44a: Support measures to tackle the downturn in biotech funding
• Figure 44b: Support measures to tackle the downturn in biotech funding, by geography
• Figure 45: Private Biotech Venture Financing, 2013-2023
• Figure 46a: Small business innovation grant funding
• Figure 46b: NIH grant funding to academia
• Figure 47a: Planned clinical trials in 2023 by phase
• Figure 47b: Top industry sponsors for planned clinical trials in 2024
• Figure 48a: Top countries for planned clinical trials in 2024 by number and phase
• Figure 48b: Drug types for planned clinical trials in 2024 by phase
• Figure 49a: Top therapy areas for planned clinical trials to be initiated in 2024
• Figure 49b: Top indications for planned clinical trials to be initiated in 2024
• Figure 50a: Projected trial completion in 2023 by phase
• Figure 50b: Top industry sponsors for trials projected to be completed in 2024
• Figure 51: Top 10 prescription drugs, 2023 vs 2024
• Figure 52: Top 10 therapy areas, 2023 vs 2024

Abstract

While the fight against COVID-19 is not in the distant past, it has been already overshadowed by a range of macroeconomic and geopolitical factors. At the same time, ongoing drug pricing and reimbursement constraints, regulatory pressures, and biotech funding instability will continue to test pharmaceutical industry in the coming years. In this "Thematic Intelligence: The State of the Biopharmaceutical Industry 2024 Edition" report, GlobalData examines the business environment and trends that are going to shape the biopharmaceutical industry in 2024. The report highlights the most impactful emerging technologies, industry trends, regulatory trends, and microeconomic factors that are going to impact and dominate the industry throughout 2024.

• Post-COVID-19 recovery is met by a range of macroeconomic and geopolitical challenges.
• Genomics, IO drug development, personalized/precision medicine and CGTs will dominate as the most impactful trends in the biopharmaceutical industry in 2024.
• Among the most impactful trends, cell and gene therapies will be the key focus in 2024.
• Geopolitical conflicts, inflation, and drug pricing pressures will be the top hindrances for pharmaceutical sector growth.
• Vertical integration, patent expiry of biologics, and ESG factors are anticipated to have the greatest positive impact on the pharmaceutical industry.
• Big data and AI will continue to dominate as transformational forces in the healthcare sector in 2024.
• Across pharma value chain components, drug development and end users experience are lagging behind with innovation adoption.
• The biopharmaceutical industry is more optimistic about industry growth in the next 12 months as compared to 2023, but level of optimism is still below 2022 levels.
• A total of 44% of survey respondents expressed an optimistic or very optimistic sentiment on the biotech funding recovery in 2024.
• Oncology, CNS, and infectious diseases will be the dominant areas for clinical trials initiated in 2023.
• Oncology remains the single largest therapy area going into 2024, but metabolic disorders display the highest growth.
• The IRA is believed to open the door to government price negotiation across all pharmaceuticals.

Key Highlights

• There is hope for more stability in 2024, but the road is still rocky.
• CGT is the trend that will continue to have the greatest impact on the pharmaceutical industry in 2024.
• Inflation, geopolitical conflicts, and drug pricing and reimbursement-related concerns will be the leading impediment to industry growth.
• Vertical integration, patent expiry of biologics, and ESG factors will have the most positive impacts on industry.
• AI is set to bring disruptive change in pharmaceutical industry
• Optimism about the pharmaceutical sector's growth prospects recovered from the lows seen in 2023.

Scope

• Benchmark the impact of major themes on the biopharmaceutical industry in 2024, including: emerging technologies, regulatory trends, macroeconomic trends, industry trends.
• Identify themes that will have the greatest positive or negative impact in 2024.
• Capture opinions on these themes from industry respondents.
• Predict the industry's growth prospects in 2024.

Reasons to Buy

• Stay up to date with the major emerging technologies, regulatory, macroeconomic, and industry trends that will impact the pharmaceutical industry in 2024.
• Explore how the biopharmaceutical landscape has changed.
• Identify the most impactful anticipated regulatory approvals and drug launches in the industry in 2024.
• Gain insight into the regulatory and microeconomics trends that will have positive and negative effects on the biopharmaceutical industry.
• Identify emerging industry trends and innovations to gain a competitive advantage.

Table of Contents

Table of Contents

1. Executive Summary

2. Study Design

3. Emerging Industry Trends

4. Emerging Regulatory and Macroeconomic Trends

5. Emerging Technologies

6. Industry's Growth Prospects

7. Watch Outs

8. Summary of Key Findings

9. Appendix

10. Authors and Contributors

11. Our Thematic Research Methodology

12. Contact Us