Israel: A Modern Beacon for Clinical Trials Innovation
Israel’s dynamic blend of cutting-edge medical innovation, world-class research institutions, and a supportive regulatory environment makes it an increasingly attractive destination for conducting clinical trials that hold the promise of breakthrough discoveries in healthcare.
In this Insight we look at the clinical trials landscape within the country and why it is a compelling destination for clinical research.
Clinical Trials Environment
According to, ClinicalTrials.gov there have been more than 1,766 clinical trials in Israel since 2020. The country has attracted pharmaceutical companies from around the globe wishing to carry out clinical trials. Up until 2022, clinical trials averaged 300 studies per year. This figure temporarily reduced in 2021 due to Covid19 restrictions. However, since the start of 2022, a further 278 trials have been registered and it is anticipated that by 2023, clinical trial numbers will have returned to previous levels.
According to Global Data, Israel’s healthcare market analysis showed that the Israel pharmaceutical industry was valued at $2.4 bn in 2018. This is expected to increase further by 2027. Key drivers of this market are a strong network of academic and research institutions R&D facilities and developed medical facilities.
There are currently 1,800 operational life sciences companies in Israel. These are divided into four main sectors: Telemedicine, Medical Devices, Biotechnology and Pharmaceutical therapies. In Q2 2022, a study by Longevity Israel showed that oncology was responsible for the majority of clinical trials within the country at that time (650+). This was followed by cardiology (132+), gastroenterology (130+) and kidney treatments (110). Over 100 clinical trials are researching infectious disease, with almost 30% of these devoted to Covid19. Another area of important research was women’s health and there were approximately 90 studies looking at infertility, labour, and pre-eclampsia.
A study by Longevity Israel, shows that Tel Aviv has the largest number of research and development hubs, BioTech companies and clinics and hospitals running clinical trials.
In 2021, the Medical Device sector accounted for approximately 36% of R&D companies whilst Telemedicine was the second largest sub-sector, experiencing a 3% increase in representation in life science companies in 2020. This makes it the fastest growing sub sector. BioTech and Pharmaceutical businesses remained consistent in 2020. Looking ahead to 2022, the distribution of sub-sectors remains unchanged from 2021 during the first 9 months of the year.
Government Incentives and Favourable Regulatory Support
In a bid to encourage sponsors to conduct their clinical trials in the country, the Government offers grants, funding and tax incentives to new business investors in addition to providing a favourable regulatory environment for the running of trials. For example, all IMPs require licences but most of the exported drugs do not require an export licence. The Government’s favourable incentives have resulted in cost advantages compared to Europe, US and some Asian countries. Advanced Tech Industries Group advises that approximately 66% of the total life science companies are less than a decade old attracted by Government incentives. The Government has designated national priority areas and development zones in peripheral areas to help stimulate economic growth, incentivising entrepreneurs to establish businesses within these regions. The MoH has also gone as far as to set-up a dedicated, centralised database of clinical studies conducted within the country, making readily available the latest information on clinical research activities.
Population
With a population of over 9.5 million people, Israel benefits from a diverse patient pool. The population is insured through national health insurance and the medical history of individuals is easily tracked over time. This means that the Israeli healthcare system offers significant advantages in the long-term monitoring of participants.
Geography
Situated in the Middle East on the Mediterranean Sea, Israel has excellent airport connections. Combined with a small geographical footprint and extensive road networks, transportation within the country is smooth enabling quick access to clinical trial sites.
Opportunities
Artificial Intelligence (AI)
The rapid evolution of AI has brought about significant transformations across multiple industries, not least of which is the healthcare industry which has seen significant advancements with the promise of even more remarkable progress in the years to come. These upcoming innovations hold the potential to significantly improve healthcare for billions of people worldwide. Machine learning is opening up new possibilities for discoveries across a variety of areas including early disease detection via imaging and diagnostics in breast cancer and diabetic retinopathy screening. There are also opportunities, with the benefits of genomics, for personalised healthcare.
Researchers, technology giants and traditional pharmaceutical establishments, are all investing in the potential solutions of cutting-edge AI with a view to providing improved patient access and care to patients.
According to Tracxn (1), as of April 2023, there are 211 AI healthcare startups in Israel. Of, these 106 are based in Tel Aviv. Some of the most diverse research includes: home based urine analysis using smartphone; AI-based eyewear attachment with features to improve text reading, face recognition, colour identification and more and an AI-based social robot that acts as a companion for the elderly.
Medical Cannabis
Israel is considered a global leader in the field of medical cannabis research and innovation. Backed by a pro-active Government, it has attracted research organisations from across the world, keen to take advantage of the Ministry of Health’s sponsorship of cannabis research, and regulatory acquiescence.
Oximio, Israel
Launched in 2011, Oximio, Israel, has established a reputation as a reliable provider of high-quality, global, end-to-end supply chain solutions for clinical trials. With a flexible approach and excellent, long-standing relationship with the Ministry of Health, it is recognised for its agile approach to providing customer solutions. Situated in Caesarea, it benefits from excellent transport links and its own fleet of vehicles enabling quick access to hospitals. Its comprehensive services provide a start to finish solution for clinical trials logistics.
Local Depot
Certification
- GMP License
- GDP License
- MIA License
- ISO9001:2015 Certification
Product Types
- Controlled Drug (CD)
- Dangerous Goods (DG)
- Biological Goods
- Blood Product or Derivative
- Genetically Modified Organism (GMO)
- Antibiotic
- Cytotoxic
Storage conditions
- Overall storage capacity 1312 m2
- Uncontrolled ambient
- Controlled ambient: +15°C to +25°C
- Refrigerated: +2°C to +8°C
- Frozen: -25°C to -15°C
- Ultra-low: -80°C to -60°C
- Liquid nitrogen (LN2) on request
QP Documents for IMPs:
- Invoice
- Shipping documents: Packing list, AWB
- Temperature (if applicable – humidity) monitoring results during shipment
- Label proofs: primary and secondary
- Form 7
- CoA from manufacturing site
- Authorized person statement of release
- GMP compliance certificates of all manufacturing chain facilities, inc. product manufacturing, testing, labelling and packaging
- Pedigree documentation – all involved in the manufacturing chain: manufacturing, testing, packaging and labelling, storage must be included
- Declaration stating if a product contains/ does not contain ingredients originated from human blood or plasms
- Lot linking documents in case of kit, linking the kit lot number and the lot number of product/s inside
- Confirmation on the product cytotoxicity
- Label proofs for all IMPs
- Clinical Trial Instruction (CTI)
- Site list
- Logistics documents: Temperature monitor instruction sheet, Request for order to site, Request for collection of return forms site to depot, Request for destruction
- Codes for IRT system (if applicable)
List of documents required for project start-up
- MSA between parties
- Quality Agreement (Applicable when import of medicinal products is included in the scope of services)
- Copy of Study approval issued by the Ministry of Health (MoH) Form 7 (site specific form): one form 7 is required for IL application. A site-specific form 7 is required before dispatch to sites.
Contact Us
If you need support with logistics for clinical trials in Israel, please contact us. We’d be delighted to explain or end-to-end logistics services.
Further reading:
Whitepaper: The Emergence of Israel & Türkiye as Popular Destinations for Clinical Trials
Insights: The Evolving Landscape of Medical Cannabis
References:
(1) https://tracxn.com/explore/AI-in-Healthcare-Startups-in-Israel