India’s vaccine SUPREMACY
India has been able to mark its presence in both the human and livestock vaccine domain, thanks to rigorous research undertaken by government institutes and private vaccine manufacturers. Vaccines made by Indian companies have taken the country to newer heights and were lauded by the rest of the world as well, during the pandemic for India’s capacity to deliver vaccines to many nations in urgent need of jabs. We take a historical glance at India’s steady growth and prowess in the vaccine manufacture and research sphere since the 19th century, catering to inoculations for humans and livestock alike.

Indian Pharma Hits R&D Salvo
Pharma companies are constantly on the quest to discover the next big game-changer drug or therapeutic by leveraging the latest, cutting-edge innovation. While it is notable that biopharma companies eased up on their research and development (R&D) spending in FY 2022-23 after the world was hit by COVID-19-  induced economic slowdown, the budget for R&D has witnessed a steady increase. Departing a bit from their traditional drug portfolios, companies are increasingly focusing on R&D in next generation therapies to drive innovation, particularly in complex generics, biosimilars, cell and gene therapies and novel drug delivery systems.

BioPharma’s Transformative & Strategic  OUTLOOK 2025
The Indian biopharma industry witnessed notable transformative developments and
announcements, marked by innovation, regulatory advancements, and market expansion this year. From achieving global recognition in biosimilars to advancing biomanufacturing capabilities and precision therapeutics, the sector has solidified its role as a key player in the global pharmaceutical landscape. This progress underscores India’s strategic focus on leveraging its robust infrastructure, skilled talent pool, and government support to meet the evolving demands of the healthcare industry. Key developments in 2024 include an increase in
biosimilar approvals, enhanced collaborations for biologics and vaccines, and a focus on potential investments in cutting-edge technologies like Artificial Intelligence (AI), continuous manufacturing, and automation through biofoundries. Looking ahead, the industry is well-positioned to align with emerging trends that are shaping the global biopharma landscape for 2025 and beyond.These include the growing emphasis on precision medicine, a shift towards sustainablebiomanufacturing practices, and an increase in demand for advanced therapies such as cell
and gene therapies. With over $200 billion worth of biologic patents set to expire by 2030, Indiancompanies are poised to play a pivotal role in driving the next wave of innovation and accessibilityin biologics and biosimilars.

Will Boosting Biofoundries Transform India's Biomanufacturing Landscape?
Biofoundries hold the potential to emerge as the backbone of biomanufacturing 
and synthetic biology, offering integrated infrastructure to streamline the design, 
construction, and testing of genetically engineered organisms. Biofoundry is a place where biomanufacturing meets automation. The highly modular structure of a 
biofoundry helps accelerate the design-build-test-learn (DBTL) workflow to deliver 
products fast and in a streamlined fashion. Advanced platforms to enable rapid, 
high-throughput experimentation, and automating processes that were once labourintensive and time-consuming is a central theme. India has come up with multiple initiatives to support and set up biofoundries, including the BioE3 (Biotechnology for Economy, Environment and Employment) Policy, the Bio-RIDE scheme, and the Vigyan Dhara scheme. The BioE3 Policy lays out plans for accelerating the transition to biomanufacturing by promoting integrated use of Artificial Intelligence (AI), digitalisation with ‘omics’, and upstream biotechnology innovations through bio-AI hubs, biofoundries, and biomanufacturing hubs across the country. With the new BioE3 Policy in place, coming years will provide insight into how biofoundries will play a role in boosting innovation, scale-up and commercialisation of biobased products. In addition, with a Global Biofoundry Alliance now established to coordinate biofoundry activities and innovations worldwide, the question arises: how is India positioned in this rapidly evolving field, and what role do biofoundries play in India’s biomanufacturing initiatives? 

BHARAT EYES GLOBAL BIOMANUFACTURING DOMINANCE: Boosting Innovation, 
Collaboration & Entrepreneurship with BioE3 Policy Bharat has demonstrated a strong economic growth in the past decade and is poised to be amongst the global leaders in the next industrial revolution by leveraging emerging technologies 
and new innovative solutions. Bharat is competitively positioned to be amongst the global leaders in futuristic manufacturing that leverages living systems. Biomanufacturing can fundamentally transform the global economy from today’s consumptive manufacturing paradigm to the one based on regenerative principles. Biomanufacturing refers to the use of engineered microbial, plant, and animal (including human) cells with increasing precision and control to produce 
commercially important products on scale. These are versatile processes that have the potential to create bio-based products allowing efficient utilisation of resources, in a scalable and costeffective manner with reduced environmental impact. Keeping in view the national priority of steering Bharat on the path of accelerated ‘Green Growth’, an integrated BioE3 (Biotechnology for Economy, Environment and Employment) Policy for “Fostering High-Performance Biomanufacturing” with an aim to make a green, clean, prosperous, and self-reliant Bharat was released on September 12 at Global Bio-India (GBI) 2024. 

Can India Reclaim API Throne from China?
Despite having the third-largest pharmaceutical industry by volume in the world and being the largest manufacturer of generic medicines globally, India is heavily dependent on China for imports of raw materials, Key Starting Materials (KSMs), and Active Pharmaceutical Ingredients (APIs). India is the source of around 60,000 generic brands across 60 therapeutic categories and manufactures more than 500 different APIs. However, India imports about 70 per cent of its APIs from China as it’s a cheaper option than manufacturing them domestically. There were 58 APIs in which India was heavily dependent on China. In the case of 45 APIs, India was dependent on China for 100 per cent of imports. Out of these 58 APIs, 29 APIs are manufactured through fermentation and 29 APIs are manufactured through chemical synthesis. The Department of Pharmaceuticals has drawn up a list of 56 APIs to prioritise them for the Make-in-India initiative. These include APIs or bulk drugs that go into the making of essential drugs, such as antibiotics, anti-HIV medicines, and the humble but indispensable paracetamol. The plan to make APIs in India has been in the works for some time but the Council of Scientific and Industrial Research (CSIR ) was engaged only recently. Let’s see how these steps taken by the government help to promote the production of KSMs and APIs in India in the coming years.

Why INDIA must turn BIOSIMILAR POWERHOUSE by 2030
Biosimilars could potentially enhance patient access to treatment of various malignant and nonmalignant conditions by reducing costs. Since the introduction of the first biosimilar in 2000 in India, a vaccine for hepatitis B, the development and utilisation of "biosimilars or similar biologics" have experienced significant growth. Each year, regulatory bodies are approving numerous similar biologics for the management of both cancerous and noncancerous illnesses. India has firmly positioned itself as a key player in the global production of similar biologics, benefiting from its large population. Despite the considerable potential and high expectations for India, there are substantial challenges that must be overcome to 
maintain this leadership position. To realise their full potential and sustain their global leadership, Indian biopharmaceutical companies must enhance their technological capabilities and enhance the skills of their workforce. This will require a supportive environment from both the government and regulatory agencies.

MediTech Stackathon 2024 to Drive Explosive Growth
India's medtech industry holds immense potential, with projections estimating a growth rate of 28 per cent annually, reaching a size of $50 billion by 2030. Currently, India is the fourth largest market for medical devices in Asia and among the top 20 globally. Net imports for 2022-23 stands at $4.101 billion with import coverage ratio of 0.45. The sector has witnessed a surge in imports, driven primarily by countries like the US, China, and Germany, however, India's robust policy ecosystem presents opportunities for exports and reducing import dependence through domestic manufacturing. Exports have overtaken imports in consumables and disposables during last year. The industry now needs to continue with the momentum in other pillars of the medtech sector. Against this backdrop of immense potential, the Department of Pharmaceuticals launched Meditech Stackathon 2024, which
seeks to harness the collective expertise of stakeholders to propel the industry towards unprecedented heights of innovation and self-reliance. With optimal support and participation from all stakeholders, initiatives like Meditech Stackathon will take the Indian medtech industry to the next levels to become self-reliant.

How Deep Tech is Powering India's Biopharma Future
Advancements in cutting-edge innovative  technologies and the increasing  availability of  data have enabled various domains of the biotech and pharma industries to leverage resourceful approaches in driving progress, maintaining 
competitive advantage and accomplishing the ultimate goal of improved patient outcomes. Deep tech ventures, also referred to as hard tech  as opposed to regular digital platforms, primarily focus on the fundamental core issues of a business. For India to become an ‘innovation hub’, with concerted transformative efforts of leaders 
and experts in life sciences, biotech, pharma, and healthcare, deep tech is pivotal. Experts opine that the next wave of startups from India, which is already gaining considerable traction, would be on  deep tech and IP-based devices. Let's take a closer  look at India’s deep tech startup landscape and the vision of a successful deep tech ecosystem.

India’s Life Science Instrumentation Industry: A Disruptor with Global Ambitions?
The Indian laboratory and analytical instrument industry is on the brink of a
transformative journey, propelled by rapid technological advancements and a growing emphasis on indigenous innovation. With the convergence of cutting-edge technologies such as Artificial Intelligence, Machine Learning, Big Data Analytics, Online and Atline testing, Cloud computing, and Process Analytical Technologies, the industry is poised for accelerated growth and expansion. Experts from different fields of the industry have highlighted the burgeoning opportunities for domestic players in the laboratory equipment and analytical instrument segment, exploring the evolving landscape, challenges, and strategies for fostering innovation and competitiveness.

Adopting ‘Green Approach’  in Drug Discovery
In the fast-changing global industrial arena, sustainability has become quite crucial. It is a critical issue across multiple  industries; the healthcare and clinical research sectors are no exception. Hospitals and clinical facilities produce tonnes of waste alongside carbon emissions. Medical research consumes non-renewable resources at a staggering rate, which can have a long-term impact on the environment. Sustainable drug discovery and development is positioned as a key initiative in the longdrawn fight against climate change and reducing the detrimental impact on the environment, linked with the health and clinical industry. Let’s explore how India can nail this ‘green target’.

What’s Shaking Up India’s Life Sciences Real Estate Sector?
India, in the last few decades, has witnessed the IT and manufacturing sectors invest heavily in real estate and infrastructure. However, in the post-pandemic era, we see life sciences companies require space to innovate, for R&D, and manufacture at scale. The demand for life sciences-related real estate has significantly increased. Both greenfield and brownfield projects have surged, as the pandemic fuelled the demand for locally manufactured pharma and medical products. This story attempts to encapsulate the changing facets of the life sciences real estate market in India, where the country is remarkably progressing in innovation and R&D, which in turn are fuelling the demand for specialised facilities, biotech/MedTech parks, research hubs with modern amenities and collaborative multidisciplinary ecosystems under one roof.

Can organoids usher in cheap & effective cancer therapeutics?
Dozens of science and technology development payloads returned to Earth from the International Space Station (ISS) as SpaceX’s 29th Commercial Resupply Services
(CRS) mission, contracted by NASA, successfully concluded on December 22, 2023. More than 30 payloads sponsored by the ISS National Laboratory returned on this mission, many of which were life science investigations aimed at benefiting
humanity by improving care for patients on Earth. One among the payloads was an investigation from the University of California, San Diego (UCSD), which studied microgravity’s effects on stem-cell derived brain organoids (lab grown replicas of human organs). While this might seem like science fiction, the story of organoids dates back to 1907. Fast forward to today, these tiny replicas of human organs are experiencing a dramatic surge in popularity, transforming the face of drug discovery research. Dubbed as powerful ‘human modelling systems’, organoids are paving the way for personalised medicines and shaking up the global drug development scene.
India, too, is joining the bandwagon. Let’s explore the world of organoids and how it is pushing the boundaries of personalised medicine research and precision oncology.

Can Biotech Industry Hit $150B by Leveraging Technology, Innovation & Startups?
The biotechnology industry is currently navigating a complex landscape. While revenues have normalised after the COVID’s surge, the looming patent cliff and increased regulatory pressures pose significant challenges. Despite these obstacles, the industry’s long-term potential remains strong, fuelled by a robust innovation pipeline and opportunities for operational efficiency. Biotech companies, according to a report by NoyMed CRO, can secure future growth and address market challenges by focusing on capital allocation, establishing beneficial partnerships, and leveraging technology. Though the path forward is complex, the future of the biotechnology industry remains bright in 2024 as India has set target of reaching $150 billion by 2025 due to its inherent strengths and dedication to innovation.

From Exponential Growth to PHARMA BOOM
The Indian pharmaceutical industry is experiencing a dynamic growth landscape, marked by strategic initiatives such as partnerships, investments, Memoranda of
Understanding (MoUs), and collaborations. Despite geopolitical uncertainties like
the Israel-Palestine and Russia-Ukraine conflicts lingering in 2023, the healthcare
and pharma sector in India continues to gain momentum through new investments
and collaborative efforts. Major global players are actively engaging in partnerships, MoUs, and collaborations to secure a substantial global market share.
In 2023 alone, more than 30 partnerships, MoUs and other collaborations have been
forged to boost India’s pharmaceutical growth trajectory. The Indian pharmaceutical products market is projected to hit $130 billion by the end of 2030.

AI-Driven Therapeutics for DIABETES
Diabetes mellitus, a chronic metabolic non-communicable disease (NCD), has attained epidemic proportions worldwide. Several studies conducted over the last two decades have revealed a huge burden of diabetes in India, which translates to a large population of individuals at risk of not only cardiovascular disease but also chronic complications of diabetes such as kidney, foot, and eye disease. The cost of 
treating them is crippling not just individuals, but also the society and the country as a whole. For instance, diabetic foot ulcers and infections are responsible for more than 30 per cent of hospitalisations related to diabetes mellitus. On the other hand, there is a higher prevalence of diabetic retinopathy among the urban population than in the rural population. India must step up state-specific policies and technological interventions on a war footing to arrest the rapidly rising epidemic of diabetes.

Transforming Healthcare With Generative AI
Generative AI is making a significant impact in the fields of life sciences and healthcare, transforming the way research, diagnosis, and treatments  are  conducted. By leveraging the power of Generative models, researchers are now exploring ways to generate synthetic data, simulate biological processes, optimize treatment strategies, and facilitate the development of novel therapeutics. This technology is the latest trend that has got global and India’s C-Suite health science professionals explore its implications to develop indigenous solutions. This story, therefore, explores how Generative AI is selling itself to emerge as the new frontier 
in the horizon for the booming healthcare industry. Highlighting some of the significant developments in this technology space, this article also has a few Indian leaders voicing their opinions on exploring Generative AI to progress their businesses and services.

Will 3D Bioprinting Turn Disruptor in Healthcare? 
3D bioprinting has come to the limelight recently and a lot of research activities have been undertaken for the same. Creating organ models that can be used for preclinical testing of drugs and other interventional molecules and creating organ scaffolds for clinical transplantation can become a breakthrough in the healthcare domain. Though the technology is yet to be accepted fully among India’s medical sector, current efforts by academics and research labs will ensure that 3D bioprinting provides personalised solutions for individual patients.

Rise of HEALTHCARE WEARABLES
Wearable technology is becoming increasingly popular in the healthcare industry.
These devices can track a variety of health metrics, including heart rate, blood pressure and sleep patterns. They can also be used to provide remote patient monitoring and early warning systems. The wearable healthcare market in India is rapidly growing due to the increasing awareness of health and fitness among the Indian population, the prevalence of chronic diseases and the government’s support for the adoption of wearables. Of course, there are a few challenges that need to be addressed, such as the lack of regulatory guidelines for wearables, the high cost of some devices and the lack of awareness about the benefits of wearables among the general public. Despite these challenges, the wearable healthcare market in India is expected to continue to grow in the coming years. This growth will be driven by the increasing demand for wearables from consumers and healthcare providers. Let’s explore further.

The verdict is out. And the result has drawn applause – for the industry captains who are winners of the Indian Bio & Health Sciences Industry awards and also for the Jury members who managed this tough task in a two-hour-long deliberation. Since its institution in 2003, the BioSpectrum Excellence Awards honour the achievements of the Indian Bio & Health Sciences Industry leaders. The Annual Gala Awards Nite on June 30, 2023, where these were given away, has been the most eagerly awaited event in the industry.

Can India Create 50K BIOTECH STARTUPS?
2021 was a landmark year for the startup ecosystem when for the first time biotech industry in India recorded over 1000 new startup registrations in a single year, as per the Bioeconomy Report 2022. Dr Jitendra Singh, Union Minister of Science & Technology, Government of India, has revealed that the number of Biotech startups in the country has increased from 50 to over 5,000 in the last 8 years, because of the support and enabling environment provided by Prime Minister Narendra Modi since
2014. It is expected to cross the figure of 10,000 by 2025, he said.

Could 7.5% R&D Spends Make India PHARMA INNOVATION HUB?
Areport by India Brand Equity Foundation (IBEF) stated that India’s domestic pharmaceutical market was estimated at $42 billion in 2021, which is likely to reach $ 65 billion by 2024 and may further expand to reach nearly $120-130 billion by 2030. The country’s vast pool of scientific talent, strong system of higher education, low operating costs, conducive regulatory environment and supportive government
policies have made it an attractive destination for drug development, clinical trials, and commercial manufacturing. A growing population, significant R&D investments, a modernised manufacturing base and the prevalence of chronic diseases have fuelled the growth of the pharma sector. And the backbone of the success can be largely attributed to robust R&D measures in recent years. Post COVID-19, pharma players have increased their R&D investment.

BIOTECH INDUSTRY LEADERS 2021-22
Serum Institute of India continues to lead the Indian Biopharmaceutical Industry Survey 2022 . BioSpectrum India brings to you the survey results of the Biotechnology Industry, across verticals such as biopharma, bioservices, industrial enzymes, medical devices and diagnostic sectors, for FY 21-22. Read more to find out the winners of our biotech industry survey 2022.

Leveraging  Early Cancer Detection Tech
Cancer is fast turning into an ‘epidemic’ and is the second leading cause of death 
globally. As per the Globocan Report of 2020, the annual global burden of cancer 
in 2020 in the country had hit the 1.93 crore mark with an annual death of 1 crore. 
The projected annual new cases globally will be 2.84 crore in 2040. According to 
the same report, the number of new cancer cases in India will be a whopping 17 
lakh annually by 2035. In light of such alarming numbers, early detection still holds 
the key to cancer prevention. Though several technologies have been launched that 
can provide solace to the medical fraternity and patients alike in early detection, 
awareness on the disease and pre-testing remains a challenge in India. There are 
a few ‘Breakthrough Tech’ that hold a lot of promise. For instance, the Imperial 
College London has recently developed a surgical knife capable of identifying 
tumours that can detect endometrial cancer within seconds. The surgical knife 
could aid the treatment strategies for cancer by enhancing the diagnosis time and 
giving the go-ahead for treatment. Let’s explore some notable new technologies 
and also try to uncover the challenges in the fight against cancer.

How genomics Can REVOLUTIONISE HEALTHCARE
A genomic revolution is taking place in India, where the value of genomic tests is being recognised in the prevention and diagnosis of diabetes, cardiovascular, cancer, carrier status, among others. Having the power to identify accurate preventive solutions to chart out treatment options for patients, predictive genomic testing is seen as the next major weapon in the arsenal of cutting-edge healthcare tech that can improve patient outcomes without relying on a curative approach. Let’s learn more from industry leaders and experts in the field of leveraging genomics.

Can INDIA Dethrone CHINA In API PRODUCTION?
The past decade has witnessed a steady growth and commitment of the Indian government in addressing issues like ‘self-reliance and self-sufficiency’ in all aspects of governance and decisions. While sops and subsidies were, indeed, crucial to many concerns of industries and stakeholders, key decisions and schemes were lacking, until numerous ‘Aatmanirbhar Projects’ were kicked off by the Centre. One such crucial initiative addresses the need for Bulk Drugs Parks in India, making the country less dependent on Chinese Active Pharmaceutical Ingredients (APIs), providing more employment and generating more revenue that will add to the country’s GDP. A laudable step has been taken with the launching of three Bulk Drugs projects across three states in the country, with an estimated time of completion set at 5 years. We shall take a closer look at what the project entails and seek expert views from a few industry stalwarts.

Is AMR Modern-day FRANKENSTEIN’S MONSTER?
Antimicrobial Resistance (AMR) continues to pose a significant public health problem in terms of mortality and economic loss. The rising AMR is a matter of huge concern that needs to be tactfully handled and health authorities of several countries, including India, have formulated action plans for its containment. Significant efforts by the government, an active involvement of startups and diagnostic players is a good start. The question remains, whether this will be enough.

Welcome Spike In mRNA TECH?
At least three decades in the making, mRNA vaccine technology has come a long way indeed. While many researchers and scientists worked on mRNA technology, tirelessly burning the midnight oil, a few names do come to the forefront. Dr Robert Malone, developmental biologists Paul Krieg and Douglas Melton, and molecular
biologists Tom Maniatis and Michael Green have been the notable researchers who paved the way for this technology. At the same time, there are doubts raised about the safety and efficacy of mRNA vaccines. Moreover, challenges associated with the manufacture and the logistic needs of the mRNA vaccines are also some of the areas that need more focus and innovation. Let’s dig deeper into the world of mRNA tech.

DRIVING UP DRUG DISCOVERY
 As India takes baby steps in the field of drug discovery, it becomes crucial that the government steps up and provides requisite support to usher in a conducive environment for pharma companies to excel. Concrete measures are warranted to boost and promote drug discoveries by Indian players to add another dimension to the larger Aatmanirbhar Bharat mission.

IMPROVING AIR QUALITY QUOTIENT WITH TECH
Air quality affects all living organisms in diverse ways. Airborne pathogenic microbes are associated with many infectious diseases such as tuberculosis, severe acute respiratory syndrome (SARS), avian flu, anthrax, and SARS-CoV-2. In particular, the COVID-19 pandemic has demonstrated the real need for mechanisms to control the spread of airborne respiratory pathogens. Thus, preventing the spread of disease from pathogens has come to the forefront of the public consciousness. And this has brought an increasing demand for novel technologies to prioritise clean air by both big and small players. Startups are flaring up with innovations and technology that have the potential to change the situation, providing methods to combat air pollution and related infections sustainably, intelligently and in an affordable manner.

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